Supreme Court of The United States
Case BriefsForeign Courts

Supreme Court of The United States: The Full Bench of the SCOTUS on 13th January, 2022 gave its decision on the Vaccine Mandates issued for large employers and healthcare workers. While the Court with a ratio of 6:3, put a stay on the Biden Administration’s vaccine-or-test rule for large private employers; however, at the same time the Bench with a ratio of 5:4, upheld a regulation issued by the Secretary of Health and Human Services that mandated vaccines for employees at hospitals, nursing homes and other healthcare providers.

National Federation of Independent Businesses v. Dept. of Labor, Occupational Safety and Health Administration  

Background: In the backdrop of unprecedented challenges posed by Covid19 pandemic and in view of the rising cases, on September 9, 2021, President Biden announced a new plan to require more Americans to be vaccinated. The Secretary of Labor, acting through the Occupational Safety and Health Administration (hereinafter OSHA), thus enacted a vaccine mandate for USA’s work force. The mandate was applicable to roughly 84 million workers, covering approximately all employers with at least 100 employees. It required that covered workers receive a COVID–19 vaccine, and it pre-empts contrary state laws. The only exception is for workers who obtain a medical test each week at their own expense and on their own time, and also wear a mask each workday.

The Congress enacted the Occupational Safety and Health Act in 1970 in order to – ensure occupational safety—“safe and healthful working conditions.” by enforcing occupational safety and health stand­ards promulgated by the Secretary. Such stand­ards must be “reasonably necessary or appropriate to pro­vide safe or healthful employment.” They must also be developed using a rigorous pro­cess that includes notice, comment, and an opportunity for a public hearing.

The Challenge: OSHA’s ‘never done before’ Vaccine Mandate was challenged by many States, businesses, and nonprofit organizations in Courts of Appeals across USA. The Fifth Circuit initially entered a stay, but when the cases were consolidated before the Sixth Circuit, that court lifted the stay and allowed OSHA’s rule to take effect. The challengers contended that OSHA’s mandate exceeds its statutory authority and is therefore unlawful.

Key Observations by the Majority: The Majority comprising of John Roberts, CJ., Samuel Alito, Clarence Thomas, Brett Kavanaugh, Neil Gorsuch (concurring) and Amy Coney Barret, JJ., focused upon the core issue of institutional competence- whether the 1970 Act plainly authorizes the OSHA’s mandate. It was observed that, “Administrative agencies are creatures of statute. They accordingly possess only the authority that Congress has provided”. Mandating roughly 82 million Americans “to either obtain a COVID–19 vaccine or undergo weekly medical testing at their own expense” is a major encroachment in the life and health of a vast number of employees.

The majority observed that the Act empowers the Secretary to set workplace safety standards, not broad public health measures; furthermore no provision of the Act addresses public health more generally, which falls outside of OSHA’s sphere of expertise. “Although COVID–19 is a risk that occurs in many workplaces, it is not an oc­cupational hazard in most. COVID–19 can and does spread at home, schools, sporting events, and gatherings. That kind of universal risk is no different from the day-to-day dangers that all face from crime, air pollution, or any number of communicable dis­eases”; therefore permitting OSHA to regulate the hazards of daily life, would significantly ex­pand OSHA’s regulatory authority without clear congres­sional authorization.

The majority further noted that OSHA indeed has the authority to regulate occu­pation-specific risks related to COVID–19, however, their indiscrimi­nate approach fails to take account of a crucial distinction between occupational risk and risk more generally and ac­cordingly the vaccine mandate takes on the character of a general public health measure, rather than an occupational safety or health standard.

Lastly, the majority noted that in its half century of existence, OSHA has never adopted a broad public health regulation of this kind—addressing a threat that is untethered, in any causal sense, from the workplace. “This lack of historical precedent, coupled with the breadth of authority that the Secretary now claims, is a “telling indication” that the man­date extends beyond the agency’s legitimate reach”.

With the aforementioned observations, the Court put a stay on OSHA’s Covid–19 Vaccination and Testing; Emergency Temporary Standard, 86 Fed. Reg. 61402.

The Dissent:  Stephen Breyer, Sonia Sotomayor and Elena Kagan, JJ., dissented with the decision to stay the vaccine mandate for the work force. Expressing their disappointment with the reasoning applied by the majority, the Judges observed that OSHA – an agency charged by Congress with safeguarding employees from workplace dangers has decided that action is needed by thoroughly evaluating the risks that the disease poses to workers across all sectors of the economy. It has considered the extent to which various pol­icies will mitigate those risks and the costs those policies will entail. After detailed considerations it landed on an approach that encourages vaccination, but allows employers to use masking and test­ing instead. In doing all this, it has acted within the four corners of its statutory authorization. OSHA, has responded in the way necessary to alleviate the dan­ger” that workplace exposure to the “new hazard” the COVID–19 poses to employees across the USA,for OSHA is responsible to the President, and the President is responsible to—and can be held to account by—the American public”.

The dissenting Judges also stated that as disease and death are raging due to the pandemic, this Court’s decision to tell off the concerned agency that it cannot respond in the most effective way possible, undercuts the capacity of the responsible federal officials, acting well within the scope of their au­thority, to protect American workers from grave danger. Who decides how much protection, and of what kind, American workers need from COVID–19? An agency with expertise in workplace health and safety, act­ing as Congress and the President authorized? Or a court, lacking any knowledge of how to safeguard workplaces, and insulated from responsibility for any damage it causes?

Joseph R. Biden Jr. v. Missouri

Background: The instant matter dealt with the same issue, but this time the concerned sector was healthcare.  In November 2021, the Secretary of Health and Human Services announced that, in order to receive Medicare and Medicaid funding, participating facilities must ensure that their staff (unless exempt for medical or religious reasons) are vaccinated against Covid–19. A facility’s failure to comply would lead to monetary penalties, denial of payment for new admis­sions, and ultimately termination of participation in the programs.

Submissions: The Secretary submitted before the Court that the interim rule was issued after finding that vaccina­tion of healthcare workers against COVID–19 was neces­sary for the health and safety of individuals to whom care and services are furnished. That deter­mination was based on data showing that COVID–19 can spread rapidly among healthcare workers and from them to patients, and that such spread is more likely when healthcare workers are unvaccinated and any further delay would endanger patient health and safety, given the spread of the Delta variant and the upcoming winter season.

The States of Louisiana and Missouri challenged the mandate terming it as arbitrary and impulsive and that the Secretary examine the relevant data before imposing the vac­cine mandate instead of a testing mandate. They also contended that in issuing the mandate, the Secretary departed from the agency’s prior approach of merely encouraging vaccination.

Key Observations: For this matter, Chief Justice John Roberts and Justice Brett Kavanaugh along with Stephen Breyer, Sonia Sotomayor and Elena Kagan, JJ., noted the overwhelming support that the vaccine mandate got from the healthcare workers and public health officials.

Deliberating upon the question that whether the Secretary had exceeded his statutory authority in issuing the vaccine mandate in order ensure eligibility for Medicare and Medicaid dollars, the majority stated that Congress has authorized the Secretary to impose conditions on the receipt of Medicaid and Medicare funds that “the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services”. Given the highly dangerous and contagious nature of Covid19, especially for the patients, the Secretary determined that a COVID–19 vaccine man­date will substantially reduce the likelihood that healthcare workers will contract the virus and transmit it to their patients and concluded that a vaccine mandate was “necessary to pro­mote and protect patient health and safety” in the face of the ongoing pandemic.  Ensuring that providers take steps to avoid transmitting a dangerous virus to their patients is con­sistent with the fundamental principle of the medical pro­fession.

The Majority concluded their observations by holding that the Secretary of Health and Human Services did nothing out of his statutory purview in issuing the vaccine mandate fir the healthcare workers. “The challenges posed by a global pandemic do not allow a federal agency to exercise power that Congress has not con­ferred upon it. At the same time, such unprecedented cir­cumstances provide no grounds for limiting the exercise of authorities the agency has long been recognized to have”.

The Dissent: Meanwhile Amy Coney Barret, Samuel Alito, Clarence Thomas and Neil Gorsuch, JJ., dissented on the matter. Commenting upon how the Executive ‘already touches nearly every aspect of Americans’ lives’, the Judges noted that Majority’s decision will “ripple through administrative agen­cies’ future decision making” because if Congress had wanted to grant the concerned authority to impose a nationwide vaccine mandate, and consequently alter the state-federal balance, it would have said so clearly.

In conclud­ing that the Secretary had good cause to avoid notice-and-comment rulemaking while issuing the vaccine mandate, “the Court shifts the presumption against com­pliance with procedural strictures from the unelected agency to the people they regulate. Neither CMS nor the Court articulates a limiting principle for why, after an un­explained and unjustified delay, an agency can regulate first and listen later, and then put more than 10 million healthcare workers to the choice of their jobs or an irre­versible medical treatment”.

[NFIB v. OSHA, Nos. 21A244 and 21A247 and Biden v. Missouri, Nos. 21A240 and 21A241, decided on 13.1.2022]


Sucheta Sarkar, Editorial Assistant has reported this brief.

Foreign LegislationLegislation Updates

The Ohio Department of Health has released guidelines for administering booster shots of the Pfizer COVID-19 vaccine across the state. Key points of the guidelines are:

  • Pfizer booster shots are now available for people who have gone six months past completing their second dose of the vaccine.
  • According to the guidance, the criteria for people eligible to get booster shots are:
    1. Ages 65 years and older or residents in long-term care settings should receive a booster shot.
    2. Ages 50 to 64 with certain underlying medical conditions should receive a booster shot.
    3. Ages 18 to 49 with certain underlying medical conditions may receive a booster shot based on their individual benefits and risks.
    4. Age 18 and older who are at increased risk for COVID-19 exposure and transmission because of their job or living in an institutional setting may receive a booster shot based on their individual benefits and risks.

 


*Tanvi Singh, Editorial Assistant has reported this brief.

COVID 19

The UK government has released a new guidance for international travel on September 21, 2021. The key points of the guidance are:

 

  • UK government has listed the various countries to be eligible to enter UK under an approved vaccination programme in the UK, Europe, USA or UK vaccine programme overseas with a full course of the Oxford/AstraZeneca, Pfizer BioNTech, Moderna or Janssen vaccines from a relevant public health body in Australia, Antigua and Barbuda, Barbados, Bahrain, Brunei, Canada, Dominica, Israel, Japan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Korea, Taiwan or the United Arab Emirates (UAE).
  • They have Formulated a list of following vaccines as approved vaccines:
    1. AstraZeneca Covishield,
    2. AstraZeneca Vaxzevria
    3. Moderna Takeda.
  • From October 4, the rules for international travel will change from the red, amber, green classification of countries to a single red list of countries. For travel from countries not on the red list, the rules will depend only the traveller’s vaccination status.
  • One must have had a complete course of an approved vaccine at least 14 days before you arrive in UK.
  • The fully vaccinated passengers could replace day 2 PCR tests with cheaper lateral flow tests – from the end of October – and no longer need to take pre-departure tests (PDTs).
  • Until 4 October, mixed vaccines are only permitted if you are vaccinated under the UK, Europe, USA or UK overseas vaccination programme. The rules for fully vaccinated people will also apply if you are either:
    1. Less than 18 years and resident in the UK or one of the listed countries or territories with approved vaccination programmes
    2. taking part in an approved COVID-19 vaccine trial in the UK, Australia, Canada or the USA

 

If you qualify as fully vaccinated, you will have to:

  1. book and pay for a day 2 COVID-19 test – to be taken after arrival in England
  2. complete your passenger locator form – any time in the 48 hours before you arrive in England
  3. take a COVID-19 test on or before day 2, after you arrive in England
  • Under the new rules, the pre-departure test and 8th day COVID-19 test will not be required.

Travel from INDIA:

The Government of United Kingdom has included AstraZeneca Covishield in its list of accepted vaccines against Covid-19. Regardless of the vaccination status, travellers from India have to take a pre-departure test, and Covid-19 test on or before Day 2nd on or after Day 8, and self-isolate for 10 days.

For details, click HERE and HERE.

 


*Tanvi Singh, Editorial Assistant has reported this brief.

Case BriefsCOVID 19High Courts

Meghalaya High Court: The Division Bench of Biswanath Somadder, CJ. and H.S. Thangkhiew, J., had asked the Department of Health and Family Welfare, Government of Meghalaya to file a status report.

Upon perusing the report the Court found that it didn’t reveal any step taken by Meghalaya Police in order to specifically identify and book those persons who are responsible for spreading false rumours using various social media platforms with regard to the efficacy of the vaccines, in order to create an element of fear psychosis in the society, which is one of the primary reasons for vaccine hesitancy in the State of Meghalaya.

The Court appreciated the steps taken by the Department of Health and Family Welfare of the Government of Meghalaya, but opined that they cannot allow the rumour-mongers to go scot-free. The Court sarcastically commented that these defaulters could be easily apprehended by the Meghalaya Police (provided it has the will to do so), since all of them are invariably using various social media platforms, thereby leaving an electronic trail.

The Court asked the Advocate General to take serious note of this matter and apprise the Court specifically on the next date the steps taken by the Meghalaya Police in this regard.[Registrar General v.  State of Meghalaya, PIL No.6 of 2021, order dated 09-08-2021]


Suchita Shukla, Editorial Assistant has reported this brief.

Uttarakhand High Court
Case BriefsHigh Courts

Uttaranchal High Court: The Division Bench of Raghvendra Singh Chauhan, CJ. and Alok Kumar Verma, J., dealt with the petition which came up in pursuance to order dated 07-07-2021. All the affidavits submitted were taken on record.

It was informed to the Court that there were 8,590 Isolation Centres which have been established and that State Government had directed the district administration to analyze the influx of tourists during the weekends at the tourist spots in their respective districts, and to cap the number of persons permitted to visit such tourist destinations keeping in mind its capacity and its geographical conditions after the Court had directed in the previous order dated 12-07-2021. However the affidavit was silent with regard to the steps which were required to be taken by the police against the erring tourists.

Next affidavit dealt with the operationalisation of COVID Care Services for Children and Adolescents. According to the data, at the peak, there were about 10,000 cases which were reported in Uttarakhand. The total number of beds required for children at the peak of the surge would be 600; the total number of ward beds required for children would be 360; and the total number of High Dependency Unit (HDU)/Intensive Care Unit (ICU) beds required for children would be 240. It was informed to the Court that State was well-equipped to tackle any challenge that may come in its way in the wake of the third wave of COVID-19 pandemic. It was further informed that, presently, the number of COVID-19 cases in the State was on the decline.

In case of availability of Ambulances it was informed that there were 272 ambulances in the Dial-108 Emergency Service and out of those, 54 ambulances were Advanced Life Support (ALS) Ambulances, and the remaining 218 were the Basic Life Support (BLS) Ambulances in the State. State Government has already sent requisition and a proposal to the Central Government for buying 41 more ALS ambulances.

It was submitted that there were large number of vacancies in the cadre of Medical Officers and the selection process has already commenced; 451 Medical Officers have been selected, out of which 250 Medical Officers have already joined their duties.

In relation to availability of vaccines it was submitted that State has received three lakhs vaccines from the Central Government and State was well equipped to vaccinate its people.

The affidavit was silent about the any information relating to emergence of Delta variant in the State. It was brought to the notice of the Court that although the State Government had made a public announcement that it is increasing the stipend being paid to the intern Doctors, the matter relating to the amount to be paid to the intern Doctors was “still under consideration of the Government”.

It was further pointed out that despite the existence of the Uttarakhand Anti-Littering and Anti-Spitting Act, 2016, the said Act was not being implemented by the Nagar Palikas, the Municipal Corporations and the Municipalities for ensuring hygienic conditions of the towns and villages. It was further added that there is no incentive scheme launched by the State Government, which will applaud those entities, which continue to abide by the SOPs. Since, there is no encouragement or appreciation by the State Government of those entities, which do abide by the SOPs, such followers of SOPs are disheartened when they see others, who are going scot-free while they violate the SOPs.

The Court issued certain directions keeping in mind the above submissions:

(i) Mr. Amit Negi, the learned Secretary, Medical Health and Family Welfare, is directed to inform this Court with regard to :

 (a) the availability of paediatric ventilators and paediatric wards available in the Government Hospitals;

(b) with regard to the steps taken, if any, for filling up the vacancies of Staff Nurses, Lab Technicians, Female Health Workers (ANMs), and the present status of the selection process, if already initiated;

(c) with regard to either the presence, or the discovery of the Delta Plus variant in the State; and

(d) with regard to the 300 samples, which were sent to the NCDC lab at Noida, and whether any case of Delta Plus variant has been discovered in those 300 samples, or not? (ii) The State is directed to take a decision with regard to the increase in the stipend of the intern Doctors as expeditiously as possible, and preferably before the next date of this case. Moreover, the State is directed to ensure that the stipend is paid to the intern Doctors on time, rather than with delay.

(iii) The State is further directed to enforce the Uttarakhand Anti-Littering and AntiSpitting Act, 2016, and to issue the necessary directions for the implementation of the same for the benefit of the competent authorities under the Act.

(iv)The State is directed to initiate a campaign for removing any superstition, suspicion, or misinformation that people may have with regard to vaccination for COVID19. Simultaneously, the State is directed to increase the number of vaccinations being carried out throughout the State.

(v) The State is directed to instruct all the District Magistrates to discover the number of physically challenged persons within their jurisdiction, who may be unable to come to the “Near to Home Vaccination Centres”. As and when such persons are discovered by the District Magistrates, it shall be the duty of the concerned District Magistrate to ensure that those physically challenged persons, who cannot possibly leave their homes, are inoculated by the medical staff at their homes. The steps so taken by the District Magistrates shall be informed to this Court by the next date. Moreover, the District Magistrates are directed to ensure that in case any camps were to be held for the benefit of the physically challenged persons, the date, the time, and the place is informed well in advance to the community at large by the use of print and electronic media. The necessary arrangements at the camps should be made to ensure that comfortable accommodation is provided to the physically challenged persons, and their other needs such as food, water and availability of toilets are met by the Civil Administration, or by the Medical Health Department.

(vi) The State is also directed to reconsider its decision of withdrawing the 25% reservation of beds in the private Hospitals for the weaker sections of the society. Therefore, the State should reconsider whether it should withdraw the order dated 25.07.2021, or not?

(vii) Mr. Amit Negi, the learned Secretary, Medical Health and Family Welfare, and the State are directed to consider the Audit Report vis-à-vis the condition, the capacity, and the lack of infrastructure of the Ambulances, which are attached with the District Hospitals. Mr. Amit Negi should also inform this Court with regard to the steps taken for filling up the lacunae pointed out in the Audit Report by the next date.

The Counsel for the petitioner had filed an application wherein he had sought the continuation of the Stay Order dated 28-06-2021 passed by this Court, whereby this Court had stayed the opening of the Char Dham Yatra submitting that the stay was granted by this Court only for a period of four weeks, and since the said period of four weeks was over, the SLP filed by the State Government, against the said order, before the Hon’ble Supreme Court has become infructuous. He prayed that since the conditions continue to be as hazardous as ever, and considering the fact that even the Central Government and the ICMR are constantly speaking about ensuring that people do not congregate in large numbers for religious purposes the stay order must continue.

The Court directed that the ban on Char Dham Yatra would continue till the Supreme Court pronounces its judgment in the said SLP.

Matter to be taken up next on 18-08-2021.[Sachdanand Darbal v. Union of India, Writ Petition (PIL) No. 58 of 2020, decided on 28-07-2021]


Suchita Shukla, Editorial Assistant has reported this brief.

Case BriefsCOVID 19High Courts

Meghalaya High Court: The Division Bench of Biswanath Somadder, CJ. and H.S. Thangkhiew, J., decided on the question as to whether vaccination can at all be made mandatory and whether such mandatory action can adversely affect the right of a citizen to earn his/her livelihood.

The Court at first deemed fit to discuss the fundamental rights in question at length and drew an analogy that right to health care, which includes vaccination, is a fundamental right. The Court however believed that vaccination by force or being made mandatory by adopting coercive methods, vitiates the very fundamental purpose of the welfare attached to it.

Any action of the State which is in absolute derogation of this basic principle is squarely affected by Article 19(1)(g). Although, Article 19(6) prescribes “reasonable restrictions” in the “interest of general public”, the present instance is exemplary and clearly distinguishable. It affects an individual‟s right, choice and liberty significantly more than affecting the general public as such or for that matter, the latter‟s interests being at stake because of the autonomous decision of an individual human being of choosing not to be vaccinated.

The Court found that in this case there is a clear lack of legitimacy in prohibiting freedom of carrying on any occupation, trade or business amongst a certain category or class of citizens who are otherwise entitled to do so, making the notification/order illconceived, arbitrary and/or a colourable exercise of power. The Court further opined that the burden lies on the State to disseminate and sensitize the citizens of the entire exercise of vaccination with its pros and cons and facilitate informed decision making particularly in a situation where the beneficiaries are skeptical, susceptible and belonging to vulnerable/marginalised section of the society, some of whom are also gullible members of the indigenous communities who are constantly being fed with deliberate misinformation regarding the efficacy of vaccination by some persons/organisations with oblique motives. The welfare nature of the State isn‟t for coercive negative reinforcement by seizing their right to livelihood, proscribing them to earn from their occupation and/or profession without any justification in the garb of public interest, but lies in walking together with concerted efforts attempting to effectuate a social order as mandated under Article 38 by approaching the people directly by engaging them in one-to-one dialogues and dwelling on the efficiency and the positive aspects of administering of the vaccine without compromising its duty under Article 47 nor abrogating its duty to secure adequate means of livelihood under Article 39(a).

Advocate General submitted that it has been advised by the Principal Secretary to the Government of Meghalaya, Health and Family Welfare Department, that the orders in the districts have to be seen as a “persuasive advisory” and not as coercion with regards to the issue of vaccination. The Principal Secretary to the Government of Meghalaya, Health and Family Welfare Department, while issuing the guidelines on 22-06-2021 has also laid down 7 points that are required to be considered for effecting change in the COVID vaccine compliance in the respective districts of Meghalaya. The Principal Secretary has clearly stated that the existing orders on vaccine compliance may be modified in the light of the new policy directions as spelt out in the guidelines and the requirement of vaccination should be directory and not mandatory. The Court agreed that it was the right step in this direction.

The Court further issued certain directions in the interest of general public:

  • All shops/establishments/local taxis/auto-rickshaws/maxi cabs and buses should display prominently at a conspicuous place, a sign, “VACCINATED”, in the event all employees and staff of the concerned shop/establishment are vaccinated. Similarly, in the case of local taxis/auto-rickshaws/maxi cabs and buses where the concerned driver or conductor or helper(s) are vaccinated.
  • All shops/establishments/local taxis/auto-rickshaws/maxi cabs and buses should display prominently at a conspicuous place, a sign, “NOT VACCINATED”, in the event all the employees and staff of the concerned shop/establishment are not vaccinated. Similarly, in the case of local taxis/auto-rickshaws/maxi cabs and buses where the concerned driver or conductor or helper(s) are not vaccinated.

[Registrar General, v. State of Meghalaya, 2021 SCC OnLine Megh 130, decided on 23-06-2021]


Suchita Shukla, Editorial Assistant has reported this brief.

COVID 19Op EdsOP. ED.

The beginning of the year 2021 lured in a long-coveted optimism with decline in reported cases of Covid-19 accompanied with the Government of India’s announcement of roll out of the vaccination drive powered by locally manufactured vaccines, to vaccinate around 300 million priority groups[1] against the coronavirus. However, the lull was only the calm before the storm that was the devastating second wave of the pandemic which grappled the entire country towards the end of March, overshooting capacities of the healthcare system everywhere. As the first phase of vaccination catered only to frontline workers, the rapid surge in infection rate necessitated for amplifying the sphere of inoculation to citizens above the age of 45 years.

As the relentless efforts towards containing the tidal resurge continue being made at all levels, the Central Government has announced a goal to inoculate 300 million people by August 2021. Thus, in a bid to beat back infection rates, as of May 1, anyone over 18 years of age has been made eligible for vaccinations across India.

However, taking into account the persisting circumstances where country’s inoculation programme is racing much faster than production, the main question that arises is how can India ramp up its Covid-19 vaccine production in order to supply vaccines to another 600 million people when acute shortage is already apparent in the previous programme of inoculating aforementioned priority groups? This article will attempt to answer this question by highlighting the options available with the Central Government in terms of provisions contained in the Patents Act, 1970[2] and arrangements in place in other developing and developed nations across the globe.

Covid-19 immunisation structure

At present, the Central Drugs Standard Control Organisation (CDSCO) which is India’s drug regulator has approved two vaccines for emergency use— Covishield and Covaxin.

The former i.e. Covishield, which has been developed by the British-Swedish drug maker AstraZeneca in connection with Oxford University, is being produced locally by the Serum Institute of India (“SII” for brevity), the world’s largest vaccine manufacturer, for the supply of the vaccine to the Indian Government and also to a large number of countries around the world. The University of Oxford holds the patent for the vaccine technology, which is used in Covishield, and AstraZeneca has in turn entered into a licence agreement with SII to share the said technology. Although, the production capacity of SII is promising, it will have a tough time meeting both its national and international obligations.

The other is Covaxin, which is being indigenously developed by the Indian pharmaceutical company based in Hyderabad viz. Bharat Biotech in close collaboration with the Indian Council of Medical Research (ICMR), New Delhi and National Institute of Virology, Pune. Apparently, there seems to be no information in the public domain on who owns the intellectual property rights for Covaxin and the funding agreement between Bharat Biotech and ICMR is also not available online, which makes it unclear as to whether the Government retains the IP rights to Covaxin. However, since Covaxin has been co-developed as part of a public-private partnership between the ICMR – National Institute of Virology (NIV) and Bharat Biotech, the Central Government should have the control over the IP behind Covaxin.

Recently, Dr Reddy’s Laboratories, a Hyderabad based pharmaceutical company has also announced the commercial launch of first 250 million imported doses of Russia’s Covid-19 vaccine candidate viz. Sputnik V which has been developed by Moscow’s Gamaleya Institute[3]. However, supply of Sputnik V vaccine is only expected to scale-up when Indian firms shall begin local production of Sputnik V vaccine under the supervision of Dr Reddy’s Laboratories and till then, India will remain dependant mostly on two previously approved Covaxin and Covishield.

Expansion of vaccine production: A solution

 Presently, immunisation offers to be the surest and most promising exit out of Covid-19; however, in order to achieve the target of immunisation of an entire country of 1.39 billion people which is to be administered in two doses, it is imperative to gear up vaccine production and keep a check on the supply crunch. Thus, need of the hour is to ramp up production of both Covaxin and Covishield.

Expansion of vaccine production is major challenge which is being faced in the country right now as the two vaccines i.e. the Covaxin and Covishield which are being administered in the country are currently being produced by Bharat Biotech at its Hyderabad facility and by SII at Pune respectively. Now in order to ramp-up the production the main legal impediment is patent on these two vaccines which gives only the patent holder, the monopoly to manufacture the vaccines or to licence them to other players and because of this monopoly the vaccine is not being produced in enough quantities to meet the demand owing the limited manufacturing capacity of Bharat Biotech and SII at present. Thus, there arises a need to grant licences to other pharma companies who are willing and have the desired capability to manufacture these vaccines.

As far as the case of Covishield is concerned, as already mentioned in the preceding paragraphs, Covishield has been jointly developed by AstraZeneca and University of Oxford and SII manufactures Covishield in India on a licence with AstraZeneca. However, as far as Covaxin is concerned, it is an indigenously developed vaccine, however, there is no clarity as to who owns the IP rights for Covaxin. As per some news articles, the IP rights for Covaxin are jointly owned by ICMR and Bharat Biotech as the memorandum of understanding entered into between ICMR and Bharat Biotech provides for a royalty sharing clause between the two entities.[4] Thus, in a way the Government of India is the owner of IP Rights of the “Bharat ka vaccine” i.e. Covaxin.

Therefore, it is imperative to discuss the various provisions under the Patents Act, 1970, which the Government of India can invoke in order to ramp-up production of Covaxin so as to make it available to the masses. However, before one delves into such provisions of the Patents Act, 1970, it is necessary to briefly discuss the developments on the diplomatic front which India is trying to achieve through the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council at the World Trade Organisation (WTO).

India along with South Africa in the month of October 2020 had moved a resolution (Resolution No. IP/C/W/669)[5] in the WTO’s TRIPS Council for a temporary waiver of intellectual property on Covid-19 vaccine and other pandemic related products, so that the production can be ramped up and all the nations can benefit from technology transfer and more producers can enter the market which would result in expediting the fight against Covid-19. However, though the said proposal can be passed only on the basis of consensus of member nations, it was opposed by many developed nations on the ground that IP over the vaccines and drug is least of a barrier when it comes to accessibility and they argue that accessibility can be achieved through voluntary licensing, technology transfer agreements and donor-funded Covax advance market commitment for vaccines.[6] One can get an idea about why was there a need for India and South Africa to move a resolution to the WTO for waiver of IP Rights, from India’s statement at the WTO on 20-11-2020, which is reproduced hereunder for reference of readers:

“On one hand, these countries are buying up as much of the limited supply as they can, leaving no vaccines in the pie for developing and least developed countries. On the other hand, and very strangely, these are the same countries who are arguing against the need for the waiver that can help increase the global manufacturing and supply to achieve not just equitable, but also timely and affordable access to such vaccines for all countries.”

 As far as the status of the waiver requested by India and South Africa is concerned, no consensus has yet been formed amongst the member countries and therefore, it would be important to watch the developments that would take place in the subsequent meetings of the TRIPS Council where this waiver would be on agenda.

In addition, to the said effort on part of the Indian Government on an International level to request for waiver of IP rights on Covid-19 vaccine and other related products and technology so as to make it accessible to all, there are provisions available within the Patent Act, 1970 itself that the Indian Government is within its authority to invoke so as to enable other players to manufacture the patented product resulting in more production so as to meet the demand. Some of such provisions of the Patent Act, 1970 are being briefly discussed hereunder:

Voluntary licensing

 India is globally known for its generic drug manufacturing market on which many nations rely for their supply of cheap and affordable drugs. Not only is India known for drug manufacturing but is also one of the largest vaccine producers in the world. However, despite this the country is facing shortage of Covid-19 vaccine and therefore it is the need of the hour to resort to provisions like voluntary licensing.

Voluntary licensing is an arrangement wherein a patent holder voluntarily grants licence to another party to manufacture and enjoy the patented product upon payment of licence fee and royalty to the patent holder. This licence can be for a specific period and can be exclusive or non-exclusive with respect to the other party. A voluntary licence is like any other licence wherein the patent holder i.e. the licensor agrees to part with his exclusive privilege upon payment of some consideration in form of licence fee.

Voluntary licence is much talked about these days and is seen as potential way to ramp-up production of Covid-19 vaccine. It is indeed a viable option available with the Central Government with respect to Covaxin of which the Indian Government ought to have the IP Rights. It can be used in way that the Indian Government can grant voluntary licences to other pharmaceutical companies who are willing and have the capacity and capability to manufacture Covaxin. This in a way will not only bring down the production cost but at the same time would assist in ramping upon the vaccine production at a much faster pace. Now the question arises if this option is available why it is not been resorted to. The answer to this is the lack of adequate infrastructure required for vaccine production. Vaccines like Covaxin and Covishield require a biosafety level 3 facility for manufacturing and therefore even if voluntary licences are granted the licensee will have to upgrade the manufacturing facility. Moreover, the task does not get over upon voluntary licence being granted, technology transfer is the next important step which the patent holder has to ensure. Therefore, in addition to expediting the process of grant of voluntary licences, it has to be ensured that there is simultaneous transfer of technology and know-how in order for the voluntary licence to be effective and result in ramping up production.

Compulsory licence

Another available alternative way to ramp-up production of vaccines in addition to the above referred arrangement of voluntary licensing, is by resorting to what is known as “compulsory licensing” of the Covid-19 vaccine, which would enable the Central Government to override a patent and grant licence to a local manufacturer to produce a global vaccine for “domestic use” without the authorisation of the patent holder. Many nations including Israel, Canada, Germany and Chile have enacted laws or employed resolutions for the purpose of compulsory licensing of Covid-related medicines.

The TRIPS Agreement to which India too is a signatory clearly lays down the provision for compulsory licensing which can be invoked by a signatory country in case of a national emergency. Article 31 of the TRIPS Agreement makes an explicit provision for compulsory licensing wherein the member nation can allow the use of the subject-matter of patent without the authorisation of the patent holder. Article 31(b) of the TRIPS Agreement, provides that in normal circumstances any third party may approach the patent holder and would make efforts to obtain the authorisation from the patent holder to use the patented subject matter on reasonable commercial terms and it is only when such efforts are not successful within a reasonable period of time that the member nation upon application of the interested third party would permit the use of the patented subject-matter by the third party.

However, there is an exception to the aforementioned normal procedure for grant of compulsory licence wherein, the process is cut short, and the member nation can directly grant licences to third parties for use of the patented subject-matter without requiring the third party to approach the patent holder and to have waited for a reasonable time for the negotiations to not come through. Such a process can be resorted to by a member nation in case of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.

The provisions with regard to compulsory licensing have been enumerated under Chapter XVI (Sections 84-92) of the Patents Act, 1970[7].  Section 84[8] of the Patents Act, 1970 spells out that “any person interested” after expiration of three years from the date of the grant of a patent may make an application for grant of a compulsory licence to the controller of patents on any of the following grounds:

(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied; or

(b) that the patented invention is not available to the public at a reasonably affordable price; or

(c) that the patented invention is not worked in the territory of India.

Besides the aforesaid, Section 92[9] of the Patents Act, 1970 is a special provision which enables the Central Government to issue compulsory licence suo moto to local pharma manufacturers to produce generic versions of patented drugs in case of national public health emergency. In times as these, the Central Government can invoke the provisions of aforesaid Section 92 to declare a national emergency due to Covid-19 pandemic and notify the patents in questions after which any person interested in manufacturing the said patented commodity can make an application to the controller of patents who can then issue a compulsory licence without following the regular procedure which is time-consuming. Once a declaration of national emergency is made, and the relevant patents notified, any person interested in manufacturing the drug can make an application to the Controller General of Patents who can then issue a compulsory licence. The Section 92 of the Patents Act, 1970 approach is sustainable, in the sense that licences could be given in times of necessity with the same being withdrawn as soon as the pandemic is over and it may not alienate big pharmaceutical companies.

Section 92 of the Patents Act, 1970 similar to the TRIPS provision under Article 31, provides for a provision for granting compulsory licences, wherein, a declaration is made by the Central Government vide a notification published in the Official Gazette whereupon, the controller grants the applicant a compulsory licence upon certain terms and conditions keeping into consideration the rights of the patent holder.

Section 92 of the Patents Act, 1970 similar to Article 31 of the TRIPS Agreement can be invoked in cases of national emergency or in circumstances of extreme urgency or in case of public non-commercial use. Now the question arises whether a pandemic like Covid-19 would qualify the conditions for invocation of the provisions for grant of compulsory licences? The answer to this lies in Doha Declaration on the TRIPS Agreement and Public Health issued in November 2001 which clarifies a key flexibility afforded to countries under Article 31 of the TRIPS Agreement — the right to grant compulsory licences. Clause 5(c) provides that: “public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics” can constitute “a national emergency or other circumstances of extreme urgency”. Thus, there remains no doubt that the Central Government is well within its power to issue a declaration for grant of compulsory licence for Covid-19 vaccine to other pharmaceutical companies who are willing and have the technological capability to manufacture the Covid-19 vaccine so as to ramp-up the production.

However, one must remember that mere grant of compulsory licence is not going to solve the problem of production. Grant of compulsory licence can only be a first step in the direction to ramp-up the production and it has to be necessarily supplemented with active partnership, training of human resources, sourcing of raw material, etc. with the patent holder as the patent holder has done all the research and development (R&D) which has now resulted in the production of a Covid-19 vaccine and a third party to whom a compulsory licence is granted would not be in a position to immediately start production unless there is an active partnership between the patent holder and the licensee and it is here that the Government authorities would have to play a major role as the patent holder would not be readily inclined to part with its R&D and make it available to the generic company in whose favour the Government has granted compulsory licence.

Other provisions under Patents Act, 1970

Although Section 156[10] of the Patents Act, 1970 clearly lays down that a patent shall have the same effect against the Government as it has against any other person, yet there are various other provisions contained in the Patents Act, 1970 which vest the Government with ample powers to break the monopoly of a foreign patentee as also the affordability and access barriers in times of necessity.

Another enabling provision under the Patents Act, 1970 is the one contained in Section 100[11] which reserves the power to the Central Government to authorise specific companies to use any patents or patent applications for the “purpose of Government”. Once the Central Government gives an authorisation under Section 100 of the Patents Act, 1970 to a local company then such a company can begin with the manufacturing while negotiations regarding royalties to the patentee concerned can continue simultaneously. However, if it so happens that the Central Government or company authorised under aforesaid Section 100 fails to reach an agreement with the patentee, it is up to the High Court to fix the reasonable royalty that is payable to the patentee.

Apart from the aforesaid, reference may also be drawn towards Section 102[12] of the Patents Act, 1970 which provides for “acquisition of inventions and patents by the Central Government” and enables the Government to simply acquire the patent in question and allow the generic companies to manufacture the patented commodity.

In a scenario, where local pharma companies are not well-equipped to step in and apply for compulsory licences and help in scaling up production, Section 47[13] of the Patents Act, 1970 may be invoked by the Central Government. The Section 47 of the Patents Act, 1970 provides that the grant of patents is subject to certain conditions and, inter alia, stipulates that the Government may import any patented commodity or make or have made on its behalf any such patented commodity “for the purpose merely of its own use”. By exercising its powers under aforesaid Section 47, the Central Government can, without any preconditions or procedural requirements import any patented vaccine, medicine or drug for the purpose of distribution through its own hospitals/dispensaries or any hospital/dispensary notified to do so on its behalf. Thus, in situations, where there is a dire need of wide spread medicines or drugs, this is an available option with the Central Government under its own law which can be put to use so as to bridge the gap between the required doses of Covid-19 vaccines and the current rate of supply of such vaccines.

Conclusion 

There can be no doubt about the fact that the ongoing Covid-19 pandemic qualifies as a national public health emergency and owing to present unprecedented demand for vaccines, the production processes have been uncommonly strained. One of the many strategies that serve the need of the hour is to invoke the provisions as discussed above contained in the Patents Act, 1970 in order to accelerate vaccine production and maximise the output responsibilities of locally manufactured overseas vaccines and indigenously developed candidates. Ultimately, it lies in the wisdom of the Government to avail the provisions contained in the Patents Act, 1970 to break the patent impasse in order to proliferate avenues of Covid-19 vaccine production on a large scale.


Author is a practising advocate before the Lucknow Bench of the Hon’ble Allahabad High Court and is a graduate of the University of Cambridge, United Kingdom with specialisation in International Commercial Laws.

†† Co-author is a practising advocate before the Lucknow Bench of the Hon’ble Allahabad High Court and is a gold medalist in law from Unity Post Graduate and Law College, Lucknow (affiliated to Lucknow University, Lucknow).

The authors deeply acknowledge the guidance of Mr Gaurav Mehrotra, Advocate Hon’ble High Court of Judicature at Allahabad, Lucknow Bench, Lucknow.

[1] The vaccination drive announced by the Government of India on 16-1-2021 was to cover 300 million priority groups who are at higher risk of getting infected which figure was estimated to include 10 million health workers, 20 million frontline workers and around 270 million persons above age 50 years and/or with comorbidities.

[2] <http://www.scconline.com/DocumentLink/r4qFF5wg>.

[3] Joint statement issued by Russian Direct Investment Fund (RDIF), which is marketing the Sputnik V vaccine and Dr Reddy’s Laboratories on 28-5-2021.

[4] <https://scroll.in/latest/994052/covaxins-intellectual-property-rights-shared-between-icmr-and-bharat-biotech-says-balram-bhargava>.

[5] <https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True>.

[6] <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32581-2/fulltext>.

[7] <http://www.scconline.com/DocumentLink/r4qFF5wg>.

[8] <http://www.scconline.com/DocumentLink/QG2bzuTV>.

[9] <http://www.scconline.com/DocumentLink/3Aqr67YD>.

[10] <http://www.scconline.com/DocumentLink/HfRCqFa0>.

[11] <http://www.scconline.com/DocumentLink/KbXnuDb6>.

[12] <http://www.scconline.com/DocumentLink/0R92159A>.

[13] <http://www.scconline.com/DocumentLink/7abvLPRZ>.

Tripura High Court
Case BriefsHigh Courts

Tripura High Court: The Division Bench of Akil Kureshi, CJ. and S. Talapatra, J., pursuant to their order on 31-05-2021 perused the affidavit submitted by the State administration and framed certain issues after hearing the counsel for the parties.

  • The Court noticed that the Government had accepted their suggestion of publishing vaccination bulletin on daily basis. These details which would now be in public domain and easily accessible to the members of the public would certainly give idea of the precise position of the vaccination progress to the members of the public;

From the date of the bulletin, counsel for the petitioner and amicus curiae Mr Somik Deb pointed out that there was a severe shortage of vaccines for the persons in the age group of 18 to 44 years and very few people in this age group have been vaccinated. The Court held that the disproportionate distribution of vaccines in the age group where there is a severe shortage needs to be addressed by the State administration. Prima facie, such disparity could be on account of severe shortage of doses as compared to the persons eligible to receive and are willing to receive the vaccine and the requirement of online registration. We request the State administration to address this issue and to ensure that the vaccine doses whenever available for such age group are not monopolized by any region or class of citizens and that there is a more equitable distribution of such vaccines.

  • In the second issue the Court dealt with the policy of the Government of allowing one relative per patient in Covid wards who can become potential carrier of the virus. The Court expected that the administration would take all necessary precautions while allowing any relative of the patient to enter the Covid ward.[Court on its own motion v. State, 2021 SCC OnLine Tri 303, decided on 04-06-2021]

Suchita Shukla, Editorial Assistant has reported this brief.

Case BriefsHigh Courts

Karnataka High Court: A Division Bench of Abhay Shreeniwas Oka, CJ and Aravind Kumar J. gave a slew of directions regarding vaccine allocation.

The following recommendations have been accepted by the Government of India

(a) The second dose of COVISHIELD can be administered after an interval of 12 to 16 weeks from the date of the first dose instead of the interval of 6 to 8 weeks; and

(b) The interval between the two doses of COVAXIN of 4 to 6 weeks remains unchanged.

The Court thus directed “it is imperative for all concerned to ensure that the recommendations of the body of experts which are accepted by the Government of India are followed in its true letter and spirit.”

Submissions made by State and Central Government

  • The Mission Director, National Health Mission has addressed letters to the Deputy Commissioners of all Districts and Special Commissioner of the Bruhat Bengaluru Mahanagara Palike (BBMP) to utilise 100% of the allocated vaccines for the second dose.
  • All Health Care Workers and Frontline Workers in the age group of 18 to 44 years can also avail the second dose of vaccine.
  • 70% of the allocated doses of COVISHIELD and 100% of the allocated doses of COVAXIN have been ordered to be kept reserved for the second dose
  • The administration of the first dose of COVAXIN has been stopped and first dose of COVISHIELD is being administered only to the Health Care Workers and the Frontline Workers
  • 9,17,310 free doses will be supplied by the Central Government to Karnataka and 7,04,050 doses can be directly procured by the State

COVISHIELD

The Court observed that “as far as COVISHIELD is concerned, looking at the larger picture, by taking the aforesaid figures as correct, there is going to be a huge shortage. The State Government will place on record what efforts it has made to procure 7, 04,050 doses.”

COVAXIN

The Court after taking stock of the situation observed “one-third of the beneficiaries who have completed six weeks will get the second dose and the remaining two-third will not get it. This is a very sorry state of affairs.”

The Court directed the State Government to place on record what steps it has taken to procure 2,44,170 doses of COVAXIN.

The Court further observed that “Both the Governments are under an obligation to see that everyone who has taken the first dose must get the second dose within the time interval fixed by the experts.”

Administration of the second dose

It was observed that the State Government cannot create a situation in which those who are above 60 years do not get the second dose, but those who are in the age group of 44 to 60 years get the second dose. The second aspect is about the administration of the first and second dose of vaccines by the private agencies.

The Court observed, “the Central Government will have to take a stand on this issue whether in the context of the situation prevailing in the State of Karnataka; the private agencies can be permitted to administer the first dose of vaccine.”

[Mohammed Arif Jameel v. Union of India,  2021 SCC OnLine Kar 12466, decided on 20-05-2021]


Arunima Bose, Editorial Assistant has reported this brief.

Gauhati High Court
Case BriefsHigh Courts

Gauhati High Court: The Division Bench of Songkhupchung Serto and S. Hukato Swu, JJ., directed the State government to verify whether the family has sufficient rooms and other facilities in the house where the infected person can be isolated before directing a person to stay under home isolation. The Bench stated,

“Taking into account the economic status of the people by and large it may be that only few privilege people who belong to higher economic strata may have the facilities for such isolation in their own homes.”

Issues before the Bench

On 05-05-2021, the instant PIL was taken up on Suo Moto and the Bench had directed the State to file an affidavit on the following 6 issues;

  1. A district wise list of number of infected persons as per category such as critical, serious, mild etc.
  2. Number of hospital beds category wise i.e. ventilator facilities with oxygen facilities etc. made available across the State/district
  3. Number of manpower made available district wise specially for treatment of Covid persons
  4. Contingency plans
  5. Availability of oxygen, medicine district wise
  6. How many persons have been given vaccine and what is the plan to reach everyone in the State.

Home Isolation

Noticing the disturbing trend on the ever-increasing number of Covid-19 infected persons especially, in the rural areas, the Bench stated that during the first wave of pandemic the State Government had set up quarantine centers for isolation of Covid positive populace; even the villagers had set up such centers on their own, but no such facilities were made available in the second wave. Instead, home isolation for Covid positive persons had been put to practice by and large. However, said the Bench, taking into account the economic status of the people it may be that only few privilege people who belong to higher economic strata may have the facilities for such isolation in their own homes. Therefore, the Bench directed the government that before directing a person to stay under home isolation, the Surveillance teams constituted by the Government should first see/verify whether the family has sufficient rooms and other facilities in the house where the infected person can be isolated. The surveillance team was directed to stick a notice on the gate of the house stating that the inmate(s) of the house are under isolation to avoid visiting of people. The Surveillance team was also directed to ensure that none of the inmates of such house venture out till directed time and their medical and other needs should be met by the Government.

The Bench directed the State to designate places for isolation for those families who have no facilities for home isolation. It was further directed that the State shall maintain proper sanitization and high standard of hygiene at such centers and all medical needs of the patients should be met.

Covid Testing

Regarding Covid testing, the Bench stated that testing is very important in our fight with the pandemic. Unless people are tested, there is no way one can know whether they had been infected with the virus or not. Opining that the earlier the infected persons are identified further spread of the virus by such persons can be prevented, the Bench stated,

Since we are in the midst of the virus spreading far and wide even in the rural areas, we are of the view that fees should not be charged even from persons who come on their own for testing.

Observing the number of testing on daily basis in the state and noticing that RT-PCR testing facilities were available only at 3 places i.e. at Dimapur, Kohima and Tuensang, the Bench directed the State to ramp-up testing and explore feasibility of establishing testing facilities even at other strategic places.

Vaccination

On the issue of vaccination, the Bench observed that as per the affidavit so far 1,81,443 persons (45+ years of age inclusive of frontline and health workers) had been vaccinated as on 11-05-2021, and out of that 51,650 had been given 2nd dose. The Bench stated,

“In a State where the population is 22.8 lakhs the vaccination done so far is precious too little and it is still too far from the target. Therefore, while not belittling the efforts made by the State Government and all those who are working day and night, we are constraint to urge that the vaccine be made available at the earliest and vaccination drive also be done on war footing so that people of the State can be vaccinated at the earliest.”

Hence, the Bench directed the State to increase fixed days for vaccination in a week for the age group of 18 to 44 years to make the vaccine available to those who come forward at the earliest. Further, noticing the reluctance of people to take vaccine, the Bench directed the State to take appropriate steps in coordination with Doordarshan, All India Radio and other print and digital media to spread awareness so that any fear or reservation that is in the mind of the people would be removed and the vaccination drive would go on smoothly and the same is completed at the earliest.

Other Directions

Additionally, the Bench issued the following directions:

  1. State should make special arrangements to reach out to the aged and physically challenged persons with the vaccine.
  2. Noticing the CHC had no doctors inspite of demand of the people, the Bench directed State to do everything at their command and post east some Doctors at the CHC concerned and post the required number of Doctors and other man powers within a period of 5 days.
  3. The required equipments, medicines and other requirements should be made available in all the Government hospitals/PHCs/CHCs in the districts.
  4. On the issue of crematoriums charging exorbitantly high for burials for Covid affected bodies, the Bend directed the government to take the burden at least for those who cannot afford. The government was also directed to take appropriate action to keep a check on burial charges.

[Kohima v. State of Nagaland, In re.,  2021 SCC OnLine Gau 1170, order dated 24-05-2021]


Kamini Sharma, Editorial Assistant has reported this brief. 

Case BriefsForeign Courts

Federal Court of Canada: The Bench of Gagné, Associate CJ., upheld the validity of one pneumococcal vaccine patents pertaining to Prevnar 13 owned by Pfizer’s Wyeth LLC while held the other two patents invalid.

Finally, if the Court were to side with Wyeth on the construction of Claim 1, the Court would have to choose a cap on the number of serotypes covered by the invention or…the ambit of Wyeth’s monopoly could grow over the life of the 363 Patent as new serotypes – or their structure – are discovered.

Background

The Merck Canada Inc. and Merck Sharp & Dohme Corp. (together Merck) had sought to  impeach three Canadian patents, one composition patent and two formulation patents, property of Wyeth LLC, pertaining to a 13-valent pneumococcal polysaccharide protein conjugate vaccine commercialized under the name Prevnar® 13. Evidently, Merck had filed a New Drug Submission to sell a 15-valent pneumococcal polysaccharide protein conjugate vaccine [V114] in Canada, apprehending that Wyeth may try to use its patents to block V114 from entering the Canadian market, Merck persuaded to challenge its validity.

Analysis by the Court

Merck argued that each of claims 1 to 6, 13, 14, 17 to 19, 22 to 30 and 36 to 38 of the 363 Patent [the Impugned Claims] were invalid. The 363 Patent was issued on June 16, 2015 which included three groups of claims: (i) Composition Claims; (ii) Use Claims; and (iii) Method/Process Claims. Claim 1 described a multivalent immunogenic composition comprising 13 distinct conjugates prepared from 13 serotypes each individually conjugated to CRM197. The Bench opined that the PSA (Person of Skill in the Art) would have understood that the 363 Patent describe the “next generation” of Wyeth’s conjugate development program and that Wyeth had managed to exceed the known limits of serotype coverage with its PCV-13 and that the 363 Patent describe a “platform” technology disclosing the details of Wyeth’s conjugation technology that were needed in order to replicate its success. The PSA would have used the platform to add other serotypes in a future vaccine, just as Merck did with its V114.

The Bench opined that both Claim 1 and the 363 Patent in its entirety indicated that Claim 1 was limited to 13 serotypes as there were sufficient bases for adding adjuvants, buffers and other excipients. However, there is no basis to go beyond 13 serotypes. Moreover, the Summary of the Invention described the invention as providing a 13-valent pneumococcal conjugate composition comprising the seven serotypes contained in Prevnar 7 (4, 6B, 9V, 14, 18C, 19F and 23F), plus six additional serotypes (1, 3, 5, 6A, 7F and 19A), which was specific and limited. There was no mention in the 363 Patent of a need, a desire, or a basis for adding any other serotype. Again, all of the 16 examples provided in the 363 Patent, which contain instructions needed by the PSA, refer only to the specific 13 serotypes recited in the claims, no others.

Hence, the Bench held that Claim 1 of the 363 Patent was limited to 13 serotypes and did not disclose any “platform” for making a vaccine with greater coverage.

Validity of 368 Patents

 Obviousness

Analyzing the two sets of claims challenged by Merck: i) the Composition Claims; and ii) the Method/Process Claims, the Bench said that Merck had failed to meet the burden to prove that the difference between the inventive concept of the Composition Claims and the state of the art was obvious to the PSA and that the PSA would have expected that if you made the 13-valent PCV conjugated with CRM197, it would be immunogenic. Opining that conjugating is a complex endeavor and that the increasing reports on immune interference could have deterred the skilled person to pursue a 13-valent PCV all conjugated with CRM197, the Bench agreed with Wyeth that the composition of independent Claims 1 and 17 were not found in the prior art. The state of the art did not include an immunogenic composition comprising 13 individual pneumococcal conjugates (including 6A and 19A) using CRM197 as a single carrier protein. Accordingly, the composition Claims 2-5, 18 and 19, which depend directly or indirectly on Claims 1 and/or 17, by adding an adjuvant (or specific adjuvant(s)), were also not obvious at the priority date. Similarly, refuting the obviousness of the process claim, the Bench said that since the Claims 1 and 17 were neither “obvious” nor “obvious to try”, the invention disclosed in the Method/Process Claims would not have been achieved by the PSA without prolonged and arduous experimentation. Therefore, it was not “obvious to try” either.

Validity of the Formulation Patents

The 056 Patent and 111 Patent together were referred to as the Formulation Patents which were assailed by Merck for anticipation, obviousness and double patenting. Regarding the question of obviousness, the Court held that the invention as claimed would have been obvious to the PSA and the Formulation Patents were invalid for obviousness, with the exception of the serotype selection claims that were invalid for double patenting. As 7-valent claims (Claims 19 of the 056 Patent and Claim 20 of the 111 Patent) were obvious as of April 2006. Prevnar 7 had been on the market for years and was well known. Agreeing with  Merck, the Bench held that the formulations disclosed in the Formulation Patents (except for the serotype selection claims) would have been obvious to the PSA in light of the common general knowledge and the state of the art. Similarly, it would have been obvious to try to obtain stability by adding a surfactant. Therefore, there was nothing inventive about trying a surfactant to see if it would work in a polysaccharide-protein conjugate formulation and the same was an obvious solution to a well-known problem.

Double Patenting

The doctrine of double-patenting prevents a patentee from “evergreening” or from extending the monopoly given by a first patent by filing a new patent that did not disclose a new invention to the public. Noticing that the 111 Patent claimed a formulation comprising the same ingredients, the Bench said that as in 2005-2006, the use of a siliconized container means would have been obvious. Also, the 056 Patent broadly claimed a formulation containing one or more polysaccharide protein conjugates, a pH buffered saline solution with a pKa of about 3.5 to 7.5, and a surfactant. Opining that adding a surfactant to a polysaccharide protein conjugate vaccine was routine, common, and would have been obvious, the Bench held that  the claims of the Formulation Patents were all obvious variants of the invention claimed in the 363 Patent that claims a composition of 13 specific pneumococcal polysaccharides conjugated to the carrier protein CRM197 in a buffer with aluminum phosphate. The 13-valent claims (Claims 18 and 20 of the 056 Patent and Claims 19 and 21 of the 111 Patent) of the Formulation Patents were therefore held invalid for obviousness-type double patenting.

Verdict

In the backdrop of above, the Bench opined that Merck had partly succeeded in meeting its burden and in establishing that Claim 1 of the 363 Patent was limited to 13 serotypes and that no particular level of immunogenicity should be read into Claim 1 of the 363 Patent. However, the Bench reached to the conclusion that Claims 1-6, 13-14, 17-19, 22-30, and 36-38 of the 363 Patent were valid, though limited to 13 serotypes. The Formulation Patents were invalid for obviousness, with the exception of the serotype selection claims that were held invalid for double patenting. As a result, Claims 1-3, 6-15, 17-24, and 29-38 of the 056 Patent as well as Claims 1-12, 17-28 of the 111 Patent were held to be invalid, void, unenforceable and of no effect.

[Merck Sharp & Dohme Corp. v. Wyeth LLC, 2021 FC 317, Decided on 30-04-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Case BriefsCOVID 19High Courts

9-key points from the observations by Delhi High Court decision on essential drugs, dearth of oxygen and vaccine:

  • Centre to review the allocation of oxygen on a dynamic basis.
  • Hospital that are running out of their supplies of oxygen, Centre to make the availability.
  • Notice of contempt to M/s INOX for non-compliance with this Court’s Order.
  • Medical Machines/Equipment’s, medicines, etc. that are imported should be handled and cleared at top priority.
  • Centre and the ICMR, to review the form in which the information is required to be uploaded by the testing agencies, to reduce their burden and wastage of time, as this appears to be acting as a bottleneck in the matter of preparation of reports.
  • Central Government & its agencies to issue necessary directions to all the licensee and Government should undertake to check on a regular basis to unearth all such cases of hoarding which are leading to scarcity of drugs for needy patients | Strict Penal Action.
  • Centre to review the distribution of Remedesivir Drug daily.
  • Manufacturers to be encouraged so as to ramp up their production on a war footing of all essential medications for COVID treatment.
  • Criminal Waste: If even a single dose of vaccine is wasted, it would amount to criminal waste. | Government to devise ways for registering volunteers below the age of 45 and above the age of 18 to take residual doses of vaccine.

[Rakesh Malhotra v. GNCTD, 2021 SCC OnLine Del 1811, decided on 20-04-2021]


Delhi HC on status of availability of COVID Beds, supply of ventilators, need of medical oxygen and essential medications || “Wastage of a single dose of vaccine is a criminal waste”

Case BriefsCOVID 19High Courts

Bombay High Court: The Division Bench of Nitin Jamdar and C.V Bhadang, JJ., upheld the order of the District Court refusing to pass injunction against the use of the name “Covishield” by Serum Institute of India for its COVID-19 vaccine.

What is the subject matter of the instant appeal?

Instant appeal is with regard to the trademark ‘Covishield’.

Factual Matrix

Appellant and Respondent applied for registering the above-stated trademark and their application have been pending.

In the present suit, Cutis Biotech sought an interim injunction to restrain Serum Institute from using the trademark ‘Covishield’ and maintain the accounts regarding the sale.

The above stated interim application was rejected by the District Judge/Commercial Court, therefore, Cutis Biotech filed an appeal before this Court under Section 13 of the Commercial Court Act, 2015.

On 29th April, 2020 Cutis Biotech had filed an application for the registration of trademark ‘COVISHIELD’ under Class-5 and the same is pending and in June, 2020 the Serum Institute applied for the registration of trademark ‘Covishield’.

While rejecting the interim application, District Court held that:

The District Court considered the law on the subject and the tests required for grant of injunction in case of passing off. The District Court held that Cutis Biotech had earned no goodwill in a short time. There was no dishonest deception by Serum Institute for passing off or to divert the business of Cutis Biotech.

Analysis, Law and Decision

Bench noted that neither Cutis Biotech nor Serum Institute have a registration for the trademark ‘Covishield’, but as per Section 27(1) of the Trade Marks Act, 1999 it is mandated that no person shall be entitled to institute any proceeding to prevent or recover damages for the infringement of an unregistered trademark. Though sub-section 2 of the above provision, reserves the right to take action against any person for passing off his goods or services as the goods and services of the applicant and preserves the remedies to prevent passing off actions.

Hence in the instant case, Cutis Biotech has based its case on the action of passing off.

Ingredients to grant an injunction 

While granting an injunction in the case of passing off, both ingredients of injunction i.e. prima facie case and balance of convenience should exist in favour of the applicant.

Court must be satisfied that there are serious questions to be tried at the suit, irreparable damage will be caused to the applicant and hardship would be more to the applicant, and therefore an interim injunction is necessary.

Bench remarked that,

“foundation of passing off action is the existence of goodwill. Further as to who conceived and adopted the mark earlier is also relevant.”

 High Court found no prima facie case to be established by Cutis Biotech with respect to the prior user.

On evaluating the evidence on record, Court found that Serum Institute had coined the word ‘Covishield’ and took substantial steps towards its development and manufacture. Thus, the evidence demonstrates the prior adoption of the mark by Serum Institute. Hence, no perversity was found with the finding that Cutis Biotech cannot claim to be a prior user of ‘Covishield’.

Likelihood of deception and Whether the products of Cutis Biotech and Serum Institute are in the common field

To establish the above-stated point, actual confusion is not required to be established and a likelihood of confusion is enough to establish the ingredients of passing off.

In the present matter, a common-sense approach will have to be adopted to find out whether Serum Institute’s conduct was calculated to pass off its goods as that of the Cutis Biotech’s or at least create confusion in the mind of the customers leading to the Serum Institute benefiting at the expense of the Cutis Biotech.

Bench expressed that the vaccine ‘Covishield’ produced by Serum Institute is not available across the counter and is being administered through Government agencies. The buyer of the product ‘Covishield’ of Serum Institute is the Government of India. The administration of the vaccine is through an injection. The sale of disinfectant or hand sanitiser, though it may relate to the same field, that, health care products, cannot be said to cause confusion in the mind of average consumers.

Court remarked that, it would be too farfetched to hold that there will be confusion in the average consumers’ minds between the use of a trademark in a Government administered vaccine at designated places and over the counter sanitizer products.

Adding to the decision, Bench held that Cutis’s contention that people may buy its products of thinking they are protected against coronavirus because of the use of mark ‘Covishield’ is self-destructive and against the concept of passing off.

Cutis Biotech through its submissions could not establish a case of passing off action, whereas the High Court observed that Serum Institute claimed the ingredients of passing off action, yet it had not moved any cause for restraining Cutis Biotech for passing off action.

Regarding maintaining accounts, a direction to maintain accounts is not a routine order and cannot be issued when there is no prima facie case made out by Cutis Biotech.

Balance of Convenience

Vaccine ‘Covishield’ of Serum Institute had started being administrated from 16 January 2021. The Government of India rolled out an extensive vaccine administration programme and identified almost 300 million people for the vaccine in the first round, and the first order for 11 million doses for the ‘Covishield’ vaccine was placed. The second dose would be administered after the stipulated weeks. On 1 March 2021, a vaccination drive for those above the age of sixty and the age of forty-five years with comorbidities was launched. ‘Covishield’ vaccine of Serum Institute was supplied through the States and Union Territories.

Serum Institute has also placed on record that it has spent Rs 28 crore on the development, research and is expected to spend a further Rs 20 crore. With these facts, the balance of convenience is not in favour of Cutis Biotech.

A temporary injunction directing Serum Institute to discontinue the use of mark ‘Covishield’ for its vaccine will cause confusion and disruption in the Vaccine administration programme of the State.

 Hence, grant of an injunction would have large scale ramification traversing beyond the parties to the suit.

Scope of an Appeal

High Court observed that appellate court doesn’t generally interfere if the conclusion arrived at by the trial court is reasonably possible.

A total deference to the discretion by the trial court is not expected from the appellate court if the order is arbitrary or perverse.

 Bench held that, in the present case, discretion used by District Judge in refusing to grant an injunction was not arbitrary or perverse.[Cutis Biotech v. Serum Institute of India (P) Ltd., 2021 SCC OnLine Bom 616, decided on 20-04-2021]


Advocates before the Court:

Mr Abhinav Chandrachud and Mr Aditya Soni with Chetan Alai, Shriniwas Bade and Mr Swaraj Jadhav i/b. White & Brief Advocates & Solicitors for the Appellant.

Dr Birendra Saraf, Senior Advocate with Mr Rohan Savant, Mr Hitesh Jain, Ms Pooja Tidke, Ms Monisha Mane Bhangale and Ms Warisha Parkar i/b. Parinam Law Associates for the Respondent.

Experts CornerShantanu Mukherjee

Introduction

The bargain implicit in a patent – the Faustian pact, as Bently and Sherman put it – is classic: a limited monopoly granted by the State in exchange for public disclosure of an invention. Over the years, perhaps nowhere has this pact fuelled as much academic and policy debate as in the pharmaceutical industry. The basis for the debate is understandable: medicines can save lives, and therefore monopolies that potentially restrict access to medicines are a matter of public concern, but on the other hand, for the private sector, drug development and manufacture is a business, and an expensive business at that.

 

When the Covid-19 pandemic first hit, it was clear that global commitment to research collaborations and technology licensing would be crucial to scale up research, development, manufacturing and supply of vaccines and therapies. Even after a vaccine or vaccines had been developed, no pharmaceutical company would in itself have the manufacturing capacity to meet global demand for vaccines. One would need to manufacture around 5 billion doses to vaccinate the world, for a single-dose vaccine, and 10 billion for a two-dose vaccine.[1] To contextualise the sheer enormity of this challenge, consider that all the vaccine companies in the world together produce less than 6 billion doses a year (including flu shots, routine childhood immunisations, etc.). This means that in order to meet global demand for Covid-19 vaccines without cutting back on any others, global vaccine manufacturing capacity would need to double at the very least, and more likely almost triple.[2] This would require cross-border licensing, technology transfer and contract manufacturing deals to be struck by vaccine developers at a scale and pace hitherto unheard of.

 

Furthermore, hundreds of patents associated with the treatment of viral infections such as Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), influenza and Ebola had the potential to be repurposed for treating Covid (as remdesivir, favipiravir and lopinavir, among others, eventually were)[3]. Could this be achieved if patent-holders clung to monopoly-based rent-seeking ideologies? Could innovators be trusted to grant licences fairly, quickly and on reasonable terms? Would vaccine nationalism and corporate self-interest impede the global effort to combat Covid, and limit access to vaccines and therapies? These were the questions being asked by concerned citizens and organisations early in 2020[4], much as they had in the context of other public health crises[5].

 

Now, less than a year later, several vaccines have been approved for public use, supply deals worth billions of dollars have been struck and governments around the world have begun massive vaccination drives for their citizens. Were the naysayers wrong? Has the world managed to rise above petty national and corporate interests and come together, as the Beatles had hoped?

 

As is often the case when ideals collide with realpolitik, the situation is rather more intricate than that.

Through these series of articles, we aim to explore the legal and commercial issues at the heart of the biggest global vaccination effort the world has ever seen.

Part 1: Ideals v. Deals

 

  1. “You Got The Cash, We Got The Doll”

In early 2020, as Covid-19 raged across the world and companies raced to develop therapies and vaccines, supported by billions of dollars in government aid, concerns grew regarding access.

 

In March 2020, it was reported that the Trump administration was trying to secure a vaccine being developed by CureVac, a privately held German biotechnology group, exclusively for the United States (US), by persuading the group to move its development efforts to the US, in exchange for a large financial donation.[6] CureVac’s investors denied the story and German officials conveyed their disapproval of any such exclusive access deal in no uncertain terms. A few months later, the German government bought a 23% stake in CureVac, effectively ensuring it can keep an eye on – and likely a veto over – similar overtures.[7]

 

On 13 May 2020, Sanofi’s CEO, Paul Hudson, said in an interview that the US would likely get Sanofi’s Covid-19 vaccine (if approved) before the rest of the world, because the US was first to fund Sanofi’s vaccine research and expected that “if we’ve helped you manufacture the doses at risk, we get the doses first”.[8]

 

This, understandably, did not go down well in Europe. The French Prime Minister delicately reminded Sanofi that it was a “deeply French company” and emphasised that “equal access to a vaccine for all is non-negotiable”.[9]

 

Hours after Hudson’s interview appeared, Sanofi clarified that while vaccines from US production sites would be mainly reserved for Americans, production capacity elsewhere would supply Europe and the rest of the globe.[10]

 

This echoes a more recent controversy, arising out of an interview given by AstraZeneca’s CEO[11], in which, while seeking to explain the company’s recent inability to meet its vaccine supply commitments (which he characterised as being on a “best efforts” basis), he gave the impression that vaccine production from AstraZeneca’s British plants were being reserved for the United Kingdom (UK), while the European Union (EU) was being supplied by a plant in Belgium (which was facing production issues, hence the supply disruption). We will examine the EU/AstraZeneca Advance Purchase Agreement (recently released in redacted form), and other commercial deals that define the current vaccine access landscape, in greater detail in future instalments of this series (including “Part 2: Follow the Money”).

 

The CureVac and Sanofi incidents underscored a larger trend. As the US, UK and other wealthy nations rushed to enter into Advance Purchase Agreements with vaccine manufacturers such as Moderna, Pfizer and AstraZeneca for the purchase of under-development vaccines, an overwhelming majority of the world’s (already limited) vaccine manufacturing capacity was being blocked for them, effectively denying access to poorer countries that could not afford to enter into these at-risk vaccine pre-purchase deals.

 

The effort to develop and distribute a vaccine was beginning to look less like a collaborative global endeavour and more like an undignified Black Friday stampede, or a brawl for the last action figure in a store the night before Christmas.

2. “Cohagen, Give These People Air!”

Pressure mounted from the open access lobby for a more equitable approach. On 14th May 2020, 140 political leaders and economists released a letter[12], drafted by United Nations Programme on HIV/AIDS (UNAIDS)  and Oxfam, calling for a World Health Organisation (WHO) administered global agreement that (i) ensured mandatory global sharing of all Covid-19 related knowledge with a pool of licences freely available to all countries; (ii) established a global manufacturing and distribution plan “fully funded by rich nations”; and (iii) guaranteed that Covid-19 vaccines, diagnostics, tests and treatments were provided “free of charge to everyone, everywhere”. On the same day, members of European Parliament expressed support for compulsory licensing as a means of ensuring Europeans access to approved Covid-19 vaccines.[13]

 

Meanwhile several health advocacy groups, including Doctors Without Borders, Third World Network and India’s Cancer Patients Aid Association, asked the Indian government to invalidate three Gilead patents protecting Remdesivir (at that time, the only drug approved in the US for emergency treatment of Covid-19).[14] This was despite the fact that Gilead had issued voluntary licences to manufacturers in India and Pakistan allowing them to make and sell Remdesivir in 127 countries.[15]

 

At the same time, other global initiatives such as the Medicines Patent Pool (MPP)[16], the World Health Organisation (WHO) Covid-19 Technology Access Pool (C-TAP)[17] and the Open Covid Pledge[18] were trying to put in place voluntary pooling mechanisms to share the intellectual property (IP) and technology necessary to fight Covid, but these failed to gather critical mass and take off. Industry leaders appeared generally dismissive[19] of these initiatives, and they failed to attract any pledges or licences from drug companies developing Covid therapies or vaccines. Although 18 generic drug manufacturers did offer their capacity to develop and supply Covid-19 treatments to those in need via the MPP, no patent licences for such treatments have been placed in the MPP pool to date.

 

It was reported[20] that apart from lacking industry support, these initiatives had been edged out by the WHO’s more popular program, the Access to Covid-19 Tools (ACT) Accelerator.[21] The ACT Accelerator was preferred, the article theorised, because it respected and preserved the intellectual property status quo, while the C-TAP sought to challenge it.[22]

 

However, with even the European Commission now admitting the unanticipated challenges in scaling up production of vaccines and mulling voluntary licensing mechanisms[23], the dynamics of the conversation around voluntary sharing approaches may shift.

 

3. “I’ll Live To See You Eat That Contract”

On 2 October 2020, India and South Africa tabled a joint proposal before the World Trade Organisation (WTO) requesting that a temporary waiver be granted to WTO members permitting them to choose not to implement, apply or enforce certain obligations related to Covid-19 products and technologies under Sections 1 (copyrights and related rights), 4 (industrial design), 5 (patents) and 7 (protection of undisclosed information) of Part II of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, for the duration of the Covid crisis.[24] The proposal argues that it offers a way to ramp up global production of vaccines and calls on members to ensure that IP rights do not impede timely access to affordable vaccines and medicines.[25]

 

The proposal was opposed by several other countries on the basis of the argument that existing TRIPS allowances for compulsory licensing and parallel importing were sufficient to address the relevant concerns.

 

Proponents of the waiver proposal countered that such TRIPS allowances are illusory, as compulsory licences, when granted in the past by countries such as India, Malaysia and Colombia, have faced backlash from other member States and pharmaceutical companies, including threats of trade sanctions.[26] Interestingly, the draft of the waiver proposal requires that WTO members do not challenge any measures taken in conformity with the waiver, including through the WTO’s Dispute Settlement Mechanism.

 

Recent news reports indicate that more than 400 US civil society groups and lawmakers are calling on the US President to support the TRIPS waiver.[27] On 3 February 2021, 14 members of the European Parliament, in a letter to the EU leadership, asked the EU to support the waiver and issue compulsory licences to facilitate the scaling up of Covid-19 vaccine production.[28] The WTO General Council (GC) will receive an update from the TRIPS Council on this matter during the GC meeting on 1-2 March 2021.

 

Increasing inability by vaccine manufacturers to meet their supply commitments, resulting contractual and diplomatic tensions and allegations of vaccine nationalism will likely cause the conversation to return to the TRIPS waiver proposal periodically, although the proposal itself is unlikely to pass (ultimately). Some believe that the political push for a TRIPS waiver may well lead voluntary pooling initiatives such as C-TAP to finally take off, in that, faced with the prospect of a TRIPS waiver or compulsory licensing, the industry may move to adopt voluntary approaches. Further, while the TRIPS waiver proposal can, in theory, expedite response to the pandemic by suspending intellectual property protection to trade secrets, it may not eventually be able to actually force technology transfer[29]. If potential vaccine manufacturers cannot get access to the complex technological know-how necessary to manufacture the vaccines or therapies (where such know-how has not been disclosed in the patent filings and is protected as confidential knowhow or trade secrets), the TRIPS waiver would do little good[30]. Under those circumstances, a voluntary mechanism for facilitating technology transfer such as the C-TAP could come into its own.

 

Conclusion to Part 1

The biopharma industry’s lukewarm response to sweeping initiatives like the Open Covid Pledge, the WHO/MPP patent pools and the TRIPS waiver proposal, when contrasted with the range of voluntary measures (such as voluntary licensing and IP waivers) taken by the industry over the past year suggest that patent-holders would much rather adopt a case-by-case approach to waiving or licensing their IP than sign up to a blanket, global commitment in respect of such IP. While drug companies can probably live without making large profits[31] from the ongoing vaccine development frenzy (given the substantial government funding they’ve received towards development and commercialisation), they can’t simply give away the IP they develop without retaining any say in the manner of its exploitation, either. From the perspective of a pharma CEO who is, ultimately, a salaried professional answerable to shareholders that demand a return on their investment, this would likely amount to throwing the baby out with the bathwater.

 

The second part of this series (“Part 2: Follow the money”) will examine how compulsory licensing failed to move beyond the statute books other than in Israel but did, arguably, trigger a few voluntary IP non-enforcement pledges by vaccine manufacturers, and how access to vaccines today is a function not of the sweeping global “open access” schemes argued for by so many, but on a patchwork of bilateral advance purchase agreements between governments and vaccine developers, and public-private initiatives such as COVAX[32].

 

† Shantanu is the founder of Ronin Legal, a legal boutique with a focus on pharma, biologics and healthcare. He can be reached at shantanu@roninlegal.in and on Twitter [@LegalRonin]. 

[1]<https://www.gatesnotes.com/About-Bill-Gates/Year-in-Review-2020?WT.mc_id=20201222100000_YIR2020_BG-TW_&WT.tsrc=BGTW>.

[2]Ibid.

[3]<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7474498/>.

[4]<https://www.iam-media.com/coronavirus/the-danger-coronavirus-presents-biopharma-patent-owners>. See also <https://www.iam-media.com/coronavirus/global-calls-compulsory-covid-19-patent-licensing-build>. See also the Médecins Sans Frontières Technical Briefing Document “Voluntary Licenses and Access to Medicines” available HERE

[5]See, among others, Hoen, Ellen, Private Patents and Public Health, Changing Intellectual Property Rules for Access to Medicines, available HERE

[6]<https://www.nytimes.com/2020/03/15/world/europe/cornonavirus-vaccine-us-germany.html>.

[7]<https://www.fiercebiotech.com/biotech/after-a-turbulent-few-months-germany-takes-a-stake-covid-vaccine-drugmaker-curevac>.

[8]<https://www.bloomberg.com/news/articles/2020-05-13/u-s-to-get-sanofi-covid-vaccine-first-if-it-succeeds-ceo-says>.

[9]<https://sciencebusiness.net/covid-19/news/transatlantic-tensions-over-access-covid-19-vaccines-mount-after-sanofi-ceo-says-us?_sm_au_=iVVTQQcQ7tvsNHsQvMFckK0232C0F

[10]<https://endpts.com/sanofi-walks-back-paul-hudsons-promise-of-early-vaccine-access-for-the-us-sort-of/>.

[11]In an exclusive interview to an Italian newspaper, available Here.

[12] Full text available HERE.

[13] Global Calls for Compulsory Covid-19 Patent Licensing Build, available HERE .

[14]See HERE. See also HERE.

[15] <https://generics.pharmaintelligence.informa.com/GB149889/Gilead-Licenses-Remdesivir-To-Five-Firms>. Generic versions of Remdesivir are now available in India. See  HERE.

[16]On 31-3-2020, the Medicines Patent Pool (MPP) – which has hitherto focused on increasing access to HIV, tuberculosis and hepatitis C drugs in developing nations through patent pooling arrangements – decided to temporarily expand its mandate to include any Covid-related health technology where licensing could improve access.

[17] C-TAP was launched in May 2020, to act as a platform to voluntarily share Covid-related knowledge, intellectual property and data and accelerate the scale up of manufacturing. See  HERE.

[18] The Open Covid Pledge (OCP) website <https://opencovidpledge.org/> lists patent-holders who are making their intellectual property available free of charge for use in alleviating the Covid-19 pandemic. The OCP attracted significant participation from technology giants (its founding partners included Facebook, Amazon and Microsoft) but none from companies developing Covid vaccines or therapies.

[19]Pharma Leaders Shoot down WHO Voluntary Pool for Patent Rights on Covid-19 Products, available HERE .

[20]Constraints Facing the Covid-19 Technology Access Pool (C-TAP) available HERE.

[21] The Accelerator is a global collaboration to accelerate the development, production, and equitable access to Covid-19 tests, treatments, and vaccines. It was set up by the WHO, European Commission, France and the Bill & Melinda Gates Foundation in April 2020.

[22]<https://genevahealthfiles.substack.com/p/constraints-facing-the-covid-19-technology>.

[23]“The Commission will foster the creation, if need be, of a voluntary dedicated licensing mechanism, which would allow technology owners to retain a continued control over their rights whilst guaranteeing that technology, knowhow and data are effectively shared with a wider group of manufacturers.” Communication from the Commission to the European Parliament, the European Council and the Council dated 17-2-2021, available HERE .

[24] Text of proposal available HERE

[25]See generally, Médecins Sans Frontières Briefing Document dated 8-10-2020 available HERE.

[26]<https://www.openaccessgovernment.org/trips-covid-19-waiver/103738/>.

[27]<https://timesofindia.indiatimes.com/world/us/us-civil-society-groups-lawmakers-press-biden-to-support-indias-trips-waiver-proposal-on-covid-19-vaccines/articleshow/81244149.cms>.

[28]<https://www.aninews.in/news/world/europe/eu-parliamentarians-strongly-back-india-south-africa-proposal-for-covid-vaccine-patent-waiver20210205044636/>.

[29]<https://genevahealthfiles.substack.com/p/constraints-facing-the-covid-19-technology>.

[30]<https://medicineslawandpolicy.org/2020/12/what-is-the-know-how-gap-problem-and-how-might-it-impact-scaling-up-production-of-covid-19-related-diagnostics-therapies-and-vaccines/>.

[31] Where do Covid-19 Vaccine Players Stand on Pricing? So Far, It’s No Profit, Slight Profit or Undecided available HERE.

[32] COVAX, the vaccines pillar of the Access to Covid-19 Tools (ACT) Accelerator, is co-led by Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, The Vaccine Alliance and WHO. It is a global initiative that works with Governments, vaccine manufacturers, UNICEF, the World Bank, and others to ensure rapid and equitable access to Covid-19 vaccines for all countries.

COVID 19Legislation UpdatesNotifications

Central Government directs that the National Institute of Biologicals, Noida shall along with existing functions perform the function of Central Drugs Laboratory as an additional facility in respect of COVID-19 vaccine and the functions of the Director in respect of COVID-19 vaccine shall be exercised by the Director of the said Institute.

What does the Notification states?

S.O. 4206(E)— Whereas, there has been an outbreak of COVID-19 pandemic in India and worldwide;

Whereas, the Central Government is satisfied that making available suitable COVID-19 vaccines is essential to meet the requirements of emergency arising due to the pandemic COVID-19 and, therefore, in public interest, it is necessary and expedient to regulate the testing of COVID-19 vaccine for prevention and management of COVID-19 infection;

Whereas, the Central Government, in consultation with the Drugs Controller (India), is of the considered view that the supply of COVID-19 vaccine must not get affected and the vaccine must remain available to the public;

Now, therefore, in the exercise of the powers conferred by sections 6 and 26B read with section 33P of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rule 3 of the Drugs and Cosmetics Rules, 1945, the Central Government, hereby directs that the National Institute of Biologicals, Noida, in addition to its existing functions shall perform the function of Central Drugs Laboratory as an additional facility in respect of COVID-19 vaccine and the functions of the Director in respect of COVID-19 vaccine shall be exercised by the Director of the said Institute.

2. In case of any inconsistency between this notification and any rule made under the said Act, the provisions of this notification shall prevail over such rule in public interest so as to meet the requirements of emergency which have arisen due to COVID-19 pandemic.

3. This order shall come into force on the date of its publication in the Official Gazette.

4. The notification shall remain into force for a period upto 30th November, 2021.

NOTIFICATION


Ministry of Health and Family Welfare

[Notification dt. 24-11-2019]

National Consumer Disputes Redressal Commission
Case BriefsTribunals/Commissions/Regulatory Bodies

National Consumer Disputes Redressal Commission (NCDRC): The Coram of Dr S.M. Kantikar (Presiding Member) and Dinesh Singh (Member), while deciding the present matter stated that,

“The provisions of the Consumer Protection Act are in addition to and not in derogation of other laws in force.”

In the present case, Complainant 1, an IPS officer filed a complaint against the opposite party – Bharat Biotech International Limited, a pharmaceutical company.

19-06-2001: For Hepatitis–B prophylaxis; Complainant 1 took the first dose of Hepatitis- vaccine ‘Energix-B’ manufactured by Smith Kline Beecham and on taking the same he did not experience any adverse reaction.

Complainant took the second dose of the vaccine with the trade name ‘Revac-B’ vaccine manufactured by Bharat Biotech Ltd. The vaccine was administered at the complainant’s residence and in a matter of 5 minutes of administering the same, the complainant started getting pain on the right deltoid region which went on increasing and inflammation started in that area. He also started feeling breathless with severe intolerable pain and thereafter he was rushed to a nearby hospital.

Complainant then approached Nizam Institute of Medical Sciences (NIMS), wherein the doctor gave him life-saving drugs and steroids. Thus the Complainant 1 had to battle for his life during his stay in NIMS from 19-06-2001 to 27-06-2001.

Complainant 1’s investigation about the vaccine

Complainant 1 enquired about the details of the company and came to know that drug control had issued a notice to the OP and it accused of not having printed the proper generic name of the said product in accordance with the prescribed manner. It was alleged that, the vaccine was released before the approval of the Central Research Institute, Kasauli.

Further, the allegation added to the list of allegations was that the drug department had received complaints that some people who used the vaccine ‘Revac-B’ of the same batch number as complainants developed pain at the place of injection. Complainant 1 was shocked and surprised on knowing that even after the drug department had issued directives, OP was doing unethical sales in the market.

OP manufactured the said dangerous vaccine in violation of license from drug controller with utter disregard to the value and importance of human life. Complainant further submitted that due to the said episode, his entire family suffered mentally as well as financially.

Thus in view of the above, Complainant 1 requested investigation and withholding of license to manufacture their vaccine using “Pischia Pastoris” pending the Drug Controller General’s investigation.

19-07-2001: OP was served legal notice due to the supply of sub-standard vaccines which did not meet the standard of purification. Aggrieved by the entirety, the complainant filed a complaint about the recovery of damages due to negligence of OP-Company.

OP’s Defence

Denying the entire set of allegations by Complainant 1 stated that, the complaint was based on the wrong premise. OP stated that it had obeyed the direction/ communication issued by Drugs Controller of Andhra Pradesh calling upon the OP to withdraw batch no. 009 from the market.  However, it was an administrative direction and not a conclusion about the quality of the vaccine because of the said batch no. 009 was already certified by the Central Drugs Laboratory, Kasauli, as being fit for human administration.

According to the OP, Complainant 1 did not belong to the high-risk category of immunization of ‘Hepatitis-B’. OP further submitted that there was no prescription with the Complainant 1 for ‘Hepatitis-B’ vaccination. The Complainant 1 neither produced bill showing his name and details of the purchase of Engerix-B (1 st dose) and the Revac-B (2 nd dose). The vaccine was administered by Dr Indeevar Reddy, the doctor of the police department which might have administered with lack of due care and caution.

Conclusion

On perusal of the affidavits of evidence and the medical record of NIMS, following were the observations:

  • Complainant 1 suffered severe pain after injections of ‘Revac B’, there are several reasons which could be due to faulty administration or storage/ refrigeration at the pharmacy. Therefore, how OP – Company made liable.
  • It is surprising that, how Dr Indeveer Reddy suggests the Complainant 1 to take ‘Revac B’ when already 1st dose of Energix-B was given.
  • NCDRC being impressed by the contention raised by Complainant 1 with respect to the use of vector ‘Pischia Pastoris’ for the manufacture of the vaccine. Drug authorities certified the product fit for human use and in the instant case, Central Drugs Laboratory certified the vaccine as being fit for human use and for release in the market.
  • When the vaccine caused the alleged problem, the complainant should have preserved the product literature and the vial of the vaccine as evidence before this commission.

Thus in view of the above-stated observations, a vaccine manufactured by OP was not hazardous. OP complied with WHO standards and manufacturing norms under Drugs and Cosmetic Act, 1940. In the present case, drug authorities have certified the product fit for human use and it was fit for release in the market.

According to the Commission, there is nothing on record to prove that the vaccine was either defective or of sub-standard quality. Complainant’s own statement about his life-threatening condition is totally false and the complainant’s motive in the present case was only to harass the OP in one way or the other. [M.L. Kumawat  v. Bharat Bio-Tech International Ltd., 2019 SCC OnLine NCDRC 325 , decided on 09-10-2019]