Case BriefsCOVID 19High Courts

In times of crisis, we need to bind, not bicker.

-Gujarat High Court

COVID 19 crisis is a humanitarian crisis, not a political crisis.

Gujarat High Court: A Division Bench of Vikram Nath, CJ and J.B. Pardiwala, J. while addressing certain issues with regard to COVID-19 , stated that,

Healthcare access is the ability to obtain healthcare services such as prevention, diagnosis, treatment and management of diseases, illness, disorders, and other health ­impacting conditions. For healthcare to be accessible it must be affordable and convenient.

Cognizance of report filed by State Government

Issue of Migrant Workers

Supreme Court has already taken care of the issue of migrant workers and thus no new directions needs to be issued by this Court.

Court though observes that,

if there are any other migrant workers in the State of Gujarat, who are desirous to go back their native States, then they may come forward so that necessary arrangements can be made for their departure. The State Government shall ensure that necessary arrangements are made for such migrants inclusive of providing food, water and other basic amenities.

Private/Corporate Hospitals designated by the State Government

Court took notice of the fact that the private / corporate hospitals agreed to reduce their rates by 30% and now they further agree to reduce by 10% for the private beds (B category) for Ward and HDU and 5% for : (1) isolation + ICU and (2) ventilation + isolation + ICU.

President of the Association namely Dr Gadhavi assured the Court that they would not raise any objection with regard to the further reduction of 10% and 5% respectively.

In the wake of the fact that the Association has readily accepted to reduce the rates by further 10% and 5% respectively, the State Government now need not renegotiate further in this regard.

Bench also added in the regard of exorbitant fees as mentioned in its last Order, that, right to health is a fundamental right and it is for the State to ensure that such right of its citizen is not infringed in any manner. It is, in such circumstances, we had to observe that the private / corporate hospitals cannot charge exorbitant fees from a helpless individual who has no means to get himself treated in a private / corporate hospitals.

Senior Counsel, Soparkar, submitted while assuring the Court that he will definitely speak and impress upon his client to ensure that all the designated hospitals strictly adhere to the terms and conditions of the Memorandum of Understanding and would not create any trouble or hardship in future for any patient who is in need of treatment.

State Government os directed to keep a close watch on all the designated private / corporate hospitals who have been directed to reserve 50% beds so that a common man may not have to suffer.

Court also clarified that, if any patient is referred by the Civil Hospital or the S.V.P. Hospital to any private / corporate hospital, then there shall be no pre­ deposit, but, if any patient directly comes to the private / corporate hospital for being treated for COVID­19, then in such circumstances, it shall be open for the hospital concerned to demand for a reasonable pre­ deposit and thereafter, raise the demand in phases as and when need arises.

Medicine is a humanitarian profession.

All the hospitals whether private or public are considered moral agent and hence have a moral responsibility. The responsibility to act in certain ways falls upon those who may make up these hospitals.

Testing Policy

Once the doctor prescribes the COVID-­19 test for the purpose of taking due care before the surgery is performed or before any particular treatment commences, then why permission is to be obtained from the DHO / CDHO?

In the above view, Court called upon the Advocate General to explain the rationale behind the said policy, as the bench found the most disturbing feature of the policy that the DHO or CDHO hardly find time to grant necessary permission.

Advocate General submitted that the report of the three experts makes it abundantly clear as regards what should be the testing policy. According to the Advocate General, the State Government is bound to comply with the guidelines issued by the ICMR.

In view of the above, Court stated that it is conscious of the facts that High Court in exercise of its jurisdiction, should not enter into the domain of policy matters. However, while dealing with a very delicate issue and that too at a point of time when situation is very critical.

In the present circumstances, Court stated that it would like to go further into this issue with the assistance of ICMR, State Government and applicants who raised the particular concern.

Thus, Court called upon the ICMR to answer the following questions:

[1] What is the rational behind its testing policy?

[2] In what manner the ICMR wants the private hospitals / laboratories to get accredited? We would like to understand from the ICMR as regards the procedure which the private hospitals / laboratories need to undertake for the purpose of conducting the COVID­19 test.

[3] What are the guidelines of the ICMR with regard to the testing through the private laboratories?

[4] Whether the guidelines issued by the ICMR are statutory in nature?

[5] Whether such ICMR guidelines are binding upon the State Government or they are only recommendatory in nature?

[6] Whether without any prescription from any Physician, an individual can go to designated private hospital / laboratory for the purpose of testing?

Court asked State Government to furnish the following information:

[1] How many private laboratories are there in the State of Gujarat recognised by the ICMR / or COVID­19 testing?

[2] In what manner a private hospital / laboratory can apply with the ICMR if it intends to carry out the COVID­19 test?

[3] How many pathological laboratories are there in the State of Gujarat, who may not be designated for the purpose of the COVID – 19 test, but, still well­ equipped to perform such test?

[4] Whether any pathological test / diagnosis is a fundamental right of the citizens of this country? To put it in other words, whether pathological testing / diagnosis is one of the facets of the right to health as embodied in Article 21 of the Constitution of India?

[5] Whether the State Government can evolve a policy of its own based on the guidance issued by the ICMR contrary to the fundamental right of its citizens with regard to the pathological test / diagnosis?

Bench felt appropriate to deal with a very urgent issue:

Whether or not to wait for the approval of the Superintendent of the GMERS, Ahmedabad and the District Health Officers in other districts before testing for COVID­19?

Disease is a natural catastrophe that fells its victims unpredictably.

On examining the guidelines of ICMR regarding testing and the three member committee report of the State Government, certain categories of patients are enumerated in the report where testing should be done.

In Court’s opinion, categories of patients, as referred above, would not be insisted for an approval from Superintendent of GMERS, Ahmedabad or the DHO for other districts, but the COVID­-19 testing should be done forthwith without any delay and only intimation of such patients may be forwarded to the  authorities concerned by the treating consultants.

Thought Court also gave clarification with regard to persons who would be categorised in the above category that the COVID-19 testing by treating Physician or Surgeon would require approval to be obtained but the same should be granted within 24 hours.

No one should be condemned to a life below the basic level of dignified human existence.

Civil Hospital

Court called upon the Advocate General to give a fair idea with regard to the condition prevailing as on date in the Civil Hospital.

Court directed the State Government to concentrate on the following issues to maintain the level of administration and functioning of Civil Hospital in the interest of patients and specialists, doctors, paramedical and all others serving at the Civil Hospital:

[1] There should be no shortage of manpower in all categories: specialists, doctors, nurses, servants, technicians, physiotherapists etc;

[2] The patients admitted in the COVID Hospitals are demanding attention and care in terms of the medical care protocols required for proper treatment. There are different medical protocols for different categories of patients. There could be severely symptomatic patients, there could be moderately symptomatic patients and there could be mild symptomatic patients and for each of the categories of such patients, the protocols to be followed are different. It is alleged that the medical protocols required for different categories of patients are not being strictly followed.

[3] There is another circumstance which relates to the COVID patients. No Attendants are allowed to assist and take care of the patients. Normally admitted non­COVID patients are allowed one attendant who takes care of their hygiene, their food, their daily necessities. However, for COVID patients, such care is to be taken by the Nurses, attendants and other staff of the hospitals.

[4] Although not confirmed, but, there are reports both in the print and digital medias that the COVID patients have lost their lives on account of proper care and attention not being provided to them. It has also come to our knowledge on account of dehydration and other negligence, COVID patients have lost their lives.

[5] There are also reports that necessary precaution are not being taken for the attending doctors and staff in terms of providing essential protective gadgets, consumables, PPE kits, etc. They cannot be put to risk under any circumstances.

All necessary medical protocols, as are laid down, for different categories of patients, should strictly be adhered to so that no life is lost because of any kind of negligence or non­ attendant.

Further, the Court stated that, Health Minister of the State; the Chief Secretary, Health Department and all other authorities to keep a very close watch on the administration and functioning of the Civil Hospital. There should not be any laxity in this regard.

A very disturbing thing was brought to the notice of the Court by Counsel Brijesh Trivedi, that, Health department is unable to withstand the pressure and in such circumstances, they may start restricting the admission of the COVID-19 patients in Civil Hospital.

Thus, the Court wants that the Civil Hospital should function at its full strength. Not a single bed should be kept vacant. If the Health Department is not able to withstand the pressure, then it should immediately make necessary arrangements to increase the strength of the doctors, nursing staff, etc.

In its parting statements, Court held that,

Ordinarily, the High Court would not interfere with the functioning of the State Government.

The Court steps in by mandamus when the State fails to perform its duty. The true test of an efficient Government can be determined from its performance in times like the present one.

All that we are doing is to remind the State Government of its constitutional obligations and the directive policies of the State.

If Court finds any remiss, negligence or carelessness, we shall come down heavily.

Bench also expressed it’s anguish over the unnecessary debates and comments that are going on as on date on the social media and other platforms.

PILs are not meant to advance the political gain and also to seek any political mileage. The Public Interest Litigation should never be made a political battle.

Court with regard to politicising the issues, stated that,

Merely criticising the government in power is not going to magically cure people of COVID 19, nor is it going to to make the dead come back to life.

Simply highlighting the flaws and gaps in the State’s handling of the situation only creates fear in the minds of people. People are least concerned about political ideologies and rivalries when their lives are at stake.

Thus, Court requested with regard to be being very careful before commenting or entering into any debate with regard to Court Orders.

If the State Government would not have been doing anything, as alleged, then probably, by now, we all would have been dead.

Matter is to be posted on 19th June, 2020. [Suo Motu v. State of Gujarat, 2020 SCC OnLine Guj 836, decided on 29-05-2020]

Op EdsOP. ED.

Introduction

On the whole technology has been a powerful force in the development of civilisation, all the more so as its link with science is forged. In today’s world, technology is a complex social enterprise that includes research, design and crafts but also manufacturing. Technology extends our abilities to change the world. We use technology that tries to change the world to suit us better. But the result of changing the world is often complicated and unpredictable. They can include unexpected benefits, costs, and unexpected risks.

The commercialisation of pharmaceuticals has led the corporation to seek patent protection for their pharmaceuticals inventions. Pharmaceuticals help mankind in manifold respects. In the areas of health sector due to inventions made by the pharmaceutical industries, the human life and standard of living has improved alarmingly. However, in the modern intellectual property era, where it gives exclusive right to inventor to exploit his invented technology, it is becoming a cost affair concept and it is not in the hands of a common middle class man.

Intellectual property law regulates the creation, use and exploitation of mental as well as the creative labour.[1] Patent is one of the prominent among all the intellectual property rights. In the modern scientific era, patent is proved to be most used or abused intellectual property. It is expected that grant of patent will reward to original creativity and would thereby foster advanced research and development leading to further inventions and progress.  However, more often the patent rights may be subject to abuse by the patent owner.[2]

Drug patenting is the grant of negative right to the holder which excludes others from right of manufacturing of that drug. Monopoly rights granted by IPRs were regarded as crucial to prevent the developing countries from further undergoing the “catching-up” process towards industrialisation based on imitating and copying technologies, as the developed countries themselves had done. In other words, IPR protection was a tool to guarantee the comparative advantage that had so far ensured the developed countries technological supremacy.[3]

Affluent societies are spending vast sums of money understandably on the search for new products and processes to alleviate suffering and to prolong life. In the process, drug manufactures have become a powerful industry. The situation was furthermore complicated after the TRIPS agreement which grants patent to both the product as well as the process as contrast to earlier process protection. The product patent will grant absolute protection of the product while process patent will provide protection to the technology and method of manufacture. Prior to the implementation of the TRIPS agreement various developing countries did not grant patent protection to pharmaceuticals as it was incumbent for the promotion of access to drugs at competitive price. Assenting to TRIPS provisions by recognising and strengthening protection of IPRs on pharmaceutical products and processes will lead to many hardships for developing countries. Implementation of the TRIPS agreement will consequently lead to high drug prices, low access and a weakening of national pharmaceutical industries. The current legal scenario is evidently helping the pharmaceutical industry to flourish in India.

The author opts for the study of Indian patent law as how it is in conflict as well as in sync with the international agreement of TRIPS, that is, the Agreement on Trade-Related Aspects of Intellectual Property Rights, signed by the members of World Trade Organisation. Keeping in view the international obligations, the researcher will address two major issues, what are the repercussions of complying TRIPS on pharmaceutical patenting and the repercussions of TRIPS on public access to health.

Public Health VIS-à-VIS Pharmaceuticals Patent

(i) Right to Health as Fundamental Rights

It is also pertinent to note that Article 21 of our Constitution guarantees right of life, which further includes right to good health. The courts through judicial pronouncements concluded that right to life includes right to health and “access to medical treatment” as well.[4] The Government must make every effort to provide access to the life saving drugs to its citizens.[5] The State is under constitutional obligation to see that there is no violation of fundamental right of any person.[6] The Preamble and the Directive Principles of State Policy (DPSP) of our Constitution need policies in order to balance social and economic rights. So, while formulating patent legislations the balance must be made between public health and the economic interests of pharmaceutical industries.

According to the Ayyangar Committee Report[7], India being a developing nation, grant of patent confers monopolistic rights which will deny major population of our nation from access to medicines. So policies which grant monopolistic rights violate the Preamble and also the fundamental rights guaranteed under Article 21 of our Constitution. Meeting the needs of its population came before meeting the needs of foreign innovators. As quoted by the former Prime Minister of India, Indira Gandhi in the World Health Assembly in 1982, The idea of a better ordered world is one in which medical discoveries will be free of patents and there will be no profiteering of life and death.

Affluent societies are spending vast sums of money understandably on the search for new products and processes to alleviate suffering and to prolong life. In the process, drug manufactures have become a powerful industry. My idea of a better ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death.

(ii) Patent and  Right to Health

Health is a basic human right and access to medicine is a basic tool to ensure health. However, the right as well as the means to secure the same are facing a major issue in the current regime. Pharmaceutical patent play a major role in access to medicine in order to guarantee health.

It has been argued that a fully functional patent system would result in an inverse relationship between the cost of such products and affordability of access. This has led some to suggest that the global intellectual property system may be facing a crisis of public legitimacy as patents may be blocking the access of ordinary people to medicines and their “right to health”.

Impact of TRIPS on Pharmaceutical Patents

One of the significant and fundamental changes in the global trade policy is set out by the Uruguay Round of trade negotiations, with the commitment by the World Trade Organisations member to comply with the requirements of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which lays down minimum standard of protection for intellectual property rights and their enforcement, which are mandatory for WTO member countries for implementation. The TRIPS agreement is the most comprehensive multilateral agreement on intellectual property which in its clear terms specifies the idea of patentable subject-matter along with substantive and procedural aspects of patentability.[8]

(iii) Objectives of TRIPS

The prime objective of TRIPS is the protection and enforcement of intellectual property rights which will contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) attempts to strike a balance between the long-term social objective of providing incentives for future inventions and creation, and the short-term objective of allowing people to use existing inventions and creations.

The introduction of patent to pharmaceutical industries has provided incentive to the private sector in the area where they are granted.  In the pharmaceutical sector, the private health sector finds them indispensable.[9] One of the advantages for grant of patent to pharmaceutical industries is that it motivates the private players to indulge themselves more in research and development for finding cures for the disease prevalent in developing countries.[10] Invention and creativity in themselves should provide social and technological benefits. Intellectual property protection encourages inventors and creators because they can expect to earn some future benefits from their creativity. This encourages new inventions, such as new drugs, whose development costs can sometimes be extremely high, so private rights also bring social benefits.[11] With such broad objective in consideration, the pharmaceutical patents was made compulsory under TRIPS agreement in member countries of WTO.

(iv) TRIPS not a Beneficial Bargain

However, contrary results have been manifested. Instead of welcoming TRIPS regulation, developing countries have objected the implementation of the same. The developing and the least developed countries did not consider TRIPS to be a favourable negotiation as regime will consequently hike the prices of drugs which will ultimately make the drugs inaccessible to their citizens. Although TRIPS agreement may also lead to increased research on diseases common in developing countries, these benefits can be obtained in alternative ways, without high costs. Thus, TRIPS agreement is not in the national interest, hence it is not a beneficial bargain.[12]

The legislature enacted Patents Act, 1970 which significantly favoured the Indian player as well the poor sections of the society, as the Indian legislation only recognised process patent and not the product patent. This also resulted in the decline of share of multinational firm as the pharmaceutical companies based on developing countries were expecting an increase in sales and profits by the grant of worldwide patent. Pursuant to this, the patent applications filed by foreign entities decreased from 4248 in 1968 to 1010 in 1979.[13] It also resulted in the rise of generic drug manufacturing industry and a reduction in drug prices in India.[14] The domestic players were granted a rapid boost to reproduce and market the newly invented drugs in the Indian market by merely changing the process of production. With such prevailing circumstances, Indian pharmaceutical managed to produce drugs at lower price, thus making the drugs available for the poor sections of society.

However, this smooth functioning of system was interfered with TRIPS agreement. All the countries who are the members of WTO were compelled to implement TRIPS as a result of the dispute settlement body of WTO. India was initially reluctant but India was forced to implement the same, when US complained against India that it was not implementing the TRIPS properly by not providing an appropriate procedure for the filing of patent application and secondly, by not providing the exclusive marketing rights. Consequently, India changed the patent law in 2005. This instance manifests that complying with TRIPS is not a choice rather it is a matter of compulsion.

During the pre-TRIPS regime the patent protection granted was relatively less stringent which was far better as the accessibility and availability of medicine was not a problem but the post-TRIPS scenario, the medicines being priced beyond the reach of the poor, working as detrimental to their interest and causing a serious loss as now they cannot obtain new medicines that they could have in the pre-TRIPS era.

Ensuring Right To Health under Current Patents Regime 

Although, TRIPS is not seen as a beneficial bargain, it cannot be criticised thoroughly also. Various clauses of the agreement (Articles 7, 8, 27, 30 and 31) reflects liberal treatment towards the developing nations and seeks to achieve a balance between rights and obligations thereby driving a way towards public policy goals including access to essential drugs.

(i) Article 7 of TRIPS tries to maintain the balance between innovation and social and economic welfare. Intellectual property rights should be regulated in such a way that it should contribute to the promotion of technological innovation, and similarly, it should be transferred in a manner conducive to the social and economic welfare.

(ii) Article 8 provides autonomy to the States that they can adopt measures necessary to protect public health and to promote the public importance in sectors of vital importance to their socio-economic and technological development.[15]

(iii) Article 27(2) allows a State to restrict the patentability of inventions on various grounds such as, threat to human life or health.

(iv) Article 30 of Trips provides that the WTO members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with the normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, provided that the legitimate interests of third parties have been taken into consideration.

(v) Article 31 lays down a list of provisions applicable in all situations where the law of a WTO Member country permits use of the subject-matter of the patent without authorisation of the patent-holder.[16]

TRIPS and Patent Exclusions

The Patents Act should interpret the concept of exclusions from patentability through the literal rule of interpretations. The literal rule always suggests the human right dimension to the exclusions. The ideals of public health and social welfare in consonance with advancement in technology enshrined in the Constitution is given due importance.

(i) Compulsory Licensing

With the introduction of a product patent regime in 2005 for pharmaceuticals and the consequent increase in patent scope thereof, concerns of compulsory licensing have assumed a great significance in India.[17] Compulsory licensing is defined generally as the granting of a licence by a Government to use a patent without the patent-holder’s permission.[18] Compulsory licence is an involuntary contract between a willing buyer and an unwilling seller imposed or enforced by the law.[19] The TRIPS agreement allows compulsory licensing as part of the agreement’s overall attempt to strike a balance between promoting access to existing drugs and promoting research and development into new drugs. But the term “compulsory licensing” does not appear in the TRIPS agreement. Instead, the phrase “other use without authorisation of the right holder” appears in the title of Article 31. Compulsory licensing is only part of this since “other use” includes use by Governments for their own purposes. Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking into account the legitimate interests of third parties.[20] Compulsory licensing is when a Government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself. It is one of the flexibilities in the field of patent protection included in the WTO’s agreement on intellectual property — the TRIPS.[21]

The effort of the Government of India to provide a National IPR Policy in 2016 has provided an impetus in enabling “strong and effective IPR laws, which balance the interests of rights owners with larger public interest”.[22]

Further, amendment of 2017 enlarges the scope of compulsory licence as, if any developing country needs to turn to the option of compulsory licensing to produce needed affordable pharmaceuticals, producers overseas can step up and supply that need, even if a compulsory licence is needed in that country.  It is therefore a compulsory licence especially for production in one country, for export, to meet the public health needs of one or more other countries.[23] The rational justifying the idea of compulsory licence is that, patent so granted should not impede protection of public health and should act as an instrument to promote public interest in the sectors of vital importance for socio-economic and technological development of the nation. Patents are granted to make the benefit of the patented product at a reasonable price that is affordable to a large section of public. To access the benefits of patent compulsory licence can be granted.

(ii) Indian Legislation

Provisions related to the grant of compulsory licence in India are prescribed under Sections 82-94 (Chapter XVI) of the Patents Act, 1970, and Rules 96-102 (Chapter XIII) of the Patents Rules, 2003.[24] The Controller of Patents can issue compulsory licence under the following situations: compulsory licence under Section 84; licensing of related patents under Section 91; special provision for compulsory licences on notifications by Central Government under Section 92; and, compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances under Section 92-A.

It is to be noted that Natco case[25] has pioneered a revolution in Indian pharmaceutical industry on working of patents and established a consonance between TRIPS and domestic laws. It has showcased that all the developing countries including India can use the TRIPS flexibility effectively to provide healthcare to public and also fulfil the constitutional obligation of right to life as envisaged under Article 21. Further, even the Bombay High Court agreed with the findings of the Controller General of Patents and the Tribunal regarding compulsory licensing under Section 84 of the Patents Act.

Other applications for compulsory licensing has also been filed, however, they were rejected by the Controller. One such application was filed by BDR Pharmaceuticals to manufacture the generic version of anti-cancer drug Dasatinib, patented by Bristol-Myers Squibb in India.[26] Further, in 2015, Lee Pharma filed an application for seeking the grant of a compulsory licence for manufacturing and selling the drug Saxagliptin used in the treatment of type II diabetes mellitus. Both applications were rejected as they failed to convince the Controller of Patents to make a prima facie case for the grant of compulsory licensing.[27]

Although the comparative study[28] concludes that compulsory licensing provisions in India are fully TRIPS compliant. However, compulsory licences are conceptually oxymoronic and fundamentally problematic.[29] Till date, only one compulsory licence has been granted in India. The prime reason that can be attributed for such restricted usage of flexibilities is the procedural complexities. The paper version of the concept is very overwhelming but the actual construction is in the hands of the patent office. To further strengthen the compulsory licensing provisions in India, there is a need of policy formulations.  A detailed guideline must be issued by Indian Patent office.

(iii) Doha Declaration and Public Health

As regards to the flexibilities various Governments extended their difficulty in interpreting these flexibilities and are also unsure of the boundary of protection of the rights. A large part of these flexibilities and right and obligations of the nations were settled at the Doha Ministerial Conference in November 2001. In the main Doha Ministerial Declaration of 14-11-2001, WTO member Governments stressed that it is important to implement and interpret the TRIPS Agreement in a way that supports public health by promoting both access to existing medicines and the creation of new medicines i.e. without obstructing the research and development. It emphasises that the TRIPS agreement should not restrict the nations to make legislations according to their socio-economic status. They have freedom to act in furtherance of their public health. TRIPS agreement posed a serious threat upon the developing nations as to the impediment caused by it on implementation of measure to promote access to affordable medicines in the interest of public health. While acknowledging the role of intellectual property protection “for the development of new medicines”, the Declaration specifically recognises concerns about its effects on prices.[30] “Doha Declaration”, which affirmed that public health took precedence over private patent rights, and reaffirmed the rights of Governments to use inbuilt WTO public health safeguards and other available measures to gain access to cheap medicines.[31] The Declaration also refers to the exhaustion of intellectual property rights, and therefore addresses the question of a member’s right to allow parallel imports. The Declaration makes it clear that the Trips agreement’s provisions on exhaustion in effect, leave each member free to establish its own regime without challenge but subject to the general TRIPS provisions prohibiting discrimination on the basis of a person’s nationality.[32]

It can be noted that, the TRIPS agreement and the Doha Declaration represent an attempt at the international level to achieve the sensitive task of balancing the need for providing incentives for research and development on the one hand and the need to protect public health interests of making access of drug reality, on the other. Despite having such mechanism the plight of developing countries is not solved. It is pertinent to note that many developing nations choose to issue the same, since it could be perceived as indifference towards intellectual property rights and thereby seriously weakening trade relations with other nations and might discourage investors.[33] It is a well-known fact that developing countries have strict patent regime much flexible in granting compulsory licensing, due to no or minimal incentives. Developed countries have no incentive to issue compulsory licence for exports. Such obstacles are rendering these flexibilities granted by TRIPS inaccessible.

Section 3(d), Patents Act, 1970: A Check on Evergreening

According to the WHO Report 60% of the essential life saving drugs manifests incremental innovations[34] which thereby enhances the need to encourage pharmaceuticals to invest more in innovation and to motivate investment in pharmaceutical industry; companies need to be rewarded with efficient patent protection. However, India places itself in quite different pedestal as reflected in Novartis AG v. Union of India[35] decision. India incorporated Section 3 of the Patents Act, 1970 which limits the scope of subject-matter eligible for patents which are not “inventions” within the meaning of Indian Patents Act. Section 3(d) was enacted primarily to prevent “evergreening” as it specifically rejects the patents for the mere discovery of a new form of known substance unless such product manifests significant enhanced therapeutic efficiency over the original and known substance. Section 3(d) does not allow patent protection for the mere discovery of any new form of known substance unless it enhances the efficacy of the original substance. It also acts as a bar on the new use patents by stipulating that mere discovery of any new property or new use of a known substance would not be patentable.

The term “evergreening” has not been defined in Patents Act, 1970 but this patent strategy consists of securing patents on minor, more often trivial, modifications of existing pharmaceuticals products or process in order to indirectly extend the period of patents protection over previously patented compounds.[36] It is an improper extension of life of patent beyond 20 years without actually being benefiting the pharmaceutical sectors. It is argued that, Novartis has attempted to do so by applying patent for beta form of the compound.

The 2013 judgment of Novartis AG v. Union of India[37] has a major implication in shaping the Indian legislation regarding patent protection. The Novartis pronouncement was made after considering many socio-economic factors. The Supreme Court upheld the intent of the legislature behind Section 3(d) of Patents  Act by providing strict and narrow interpretation of test mentioned therein. As mentioned by the Supreme Court that Section 3(d) was introduced to prevent evergreening, to provide access to the life saving drugs and to discharge their constitutional obligation of providing good healthcare to its citizens.[38] This shows that external economic and social factors are a priority for India.  But this pharmaceutical based specific test of therapeutic efficacy has brought various uncertainties. It is pertinent to note that, more uniform standard also provides a more predictable system for multinational pharmaceutical companies and allows them to invest in research and development aimed at addressing the health needs in developing countries. In 2003, WHO reported that more than 50% of the population in Asia and Africa did not have access to essential drugs.[39] Many factors contribute to this problem of limited access. One of the prime reasons could be the inadequate production and inadaptability to the specific local conditions that can be addressed if multinational corporations have the right incentives, such as patent protection for incremental pharmaceutical innovations in the developing country. The concern of high price of drug is also one of the facets but can be tackled by alterative measures like compulsory licensing.

Remaining Challenge

However, a subsequent study manifested that Section 3(d) has not been effectively utilised in preventing secondary patents from being granted.[40] It has also been noticed that there has been many inconsistencies in the way the “Novartis standard” is dealt with by the Patent Office.[41] Despite the fact that Section 3(d) is useful, it appears that Section 3(d) is being deliberately ignored by the Patent Controller’s office. As a result, it is not being applied correctly always.[42] Further, patent office has provided with unfettered discretion to devise its own policy for determining what constitutes significant enhancement of therapeutic efficacy and goes no further while defining what “therapeutic efficacy” actually means.

Conclusion

In developing countries like India, the way healthcare is organised has created condition for the gross violation of fundamental rights. The principal of justice is being violated when majority of the population do not have access to basic minimum healthcare. The coming future of public health in India largely depends upon the way pharmaceuticals industry responds to the TRIPS agreement. Manufacture of the patented product or application of the patented process in a local industry is generally called as “local working of patent”. Inventive activity  should result in innovation, which thereby leads to the development of technology as well as the industrial and economic welfare which is possible only through local working of patented inventions.

The monetary interest of big players in the drug industry remains under a constant threat to the access of life saving drug at moderate prices in India. Innovation and patent are two sides of the same coin. Innovations should be for serving the humanity especially in the field of medicine and patents should not have only one objective to amass profit.

Suggestions

(i) While recognising its international obligations, each country should shape its patent law according to its socio-economic needs and objectives including public health.

(ii) Moulding patent regulations to improve access to medicines, particularly by the poor is an important public health objective.

(iii) A health sensitive legal regime should allow Governments to act efficiently in cases of emergency, including epidemic crisis.

(iv) Government should create a framework for pharmaceutical patenting, especially regulating the accessibility of life saving drugs.

(v) Flexibilities of compulsory licence should be exercised in reality in developing and least developed nation. Easy process must be formulated for the grant of compulsory licensing.

(vi) Parallel import of some essential life saving drugs should be permitted.

With such reforms we can optimistically foresee a picture where picture people are walking out of the shadow of the incurable disease into the sunshine, singing merrily with smiles, on the green meadows, in refreshing woods or on the breezy beach.


 †  Fourth-year student, National University of Study and Research in Law, Ranchi.

[1]  Bishwanath Prasad Radhey Shayam v. Hindustan Metal Industries, (1979) 2 SCC 511: AIR 1982 SC 1444.

[2]  Kaur A., Chaturvedi R., Compulsory Licensing of Drugs and Pharmaceuticals: Issues and Dilemma, Journal of Intellectual Property Rights, 2015, Vol. 20, 279-287.

[3]Cecilia Oh, Trade-Related Aspects of Intellectual Property Rights and Pharmaceuticals, available at <https://www.globalpolicy.org/component/content/article/209/43854.html> (last accessed on 15-9-2018).

[4]  L.M. Singhvi and Jagadish Swarup (2006), Constitution of India, Vol. 1, Modern Law Publications, (2nd Edn. p. 1100).

[5]  All India Drug Action Network v. Union of India, (2011) 14 SCC 479.

[6]  People’s Union for Democratic Rights v. Union of India, (1982) 3 SCC 235.

[7] Report on the revision of the patent law, Rajagopal Ayyangar Committee, September 1959,  available at <http://nopr.niscair.res.in/bitstream/123456789/2027/1/JIPR%2013%285%29%20414-423.pdf>  (last Accessed on 1-10-2018).

[8]  Overview: the TRIPS Agreement, available at <https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm> (last accessed on 19-9-2018).

[9]  Ida Madieha Azmi and Rokiah Alavi, TRIPS, Patents, Technology Transfer, Foreign Direct Investment and the Pharmaceutical Industry in Malaysia, 4 Journal of World Intellectual Property, 2001 at 948.

[10]  Pradeep Agrawal and P. Saibaba, Trips and India’s Pharmaceutical Industry, 36 Economic and Political Weekly, 2001 at 37-87.

[11]TRIPS and Pharmaceutical Patents, available at   <https://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf>.

[12]  Agrawal, Pradeep and P. Saibaba, TRIPS and India’s Pharmaceuticals Industry, Economic and Political Weekly, Vol. 36, No. 39, 2001, pp. 3787-3790.

[13]  Janice M. Mueller, The Tiger Awakens: The Tumultuous Transformation of India’s Patent System and the Rise of Indian Pharmaceutical Innovation, (2007) 68 U Pitt L Rev 491.

[14]  Ibid.

[15]  Art. 8 TRIPS.

[16]  Abhayraj Naik, Pharmaceutical Patents and Healthcare, 2 Socio-Legal Rev. 46 (2006).

[17]The “Compulsory Licence” Regime in India: Past, Present and Future, available at <https://www.researchgate.net/publication/228173575_The_’Compulsory_Licence’_Regime_in_India_Past_Present_and_Future> (accessed 25-9-2018).

[18]  Review of TRIPS, Int’l Trade Daily News (BNA) (Int’l Trade Rep.) at D7 (9-6-1999).

[19]  Arnold J.G., International Compulsory Licensing: The Rationales and the Reality, IDEA, The Journal of Law and Technology, 1993; 33(2): 349.

[20]  Art. 30 TRIPS.

[21]Compulsory Licensing of Pharmaceuticals and TRIPS, available at  <https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm> (last accessed on 14-9-2018).

[22]  Objective 3: Legal and Legislative Framework of the National Intellectual Property Rights (IPR) Policy, <http://dipp.nic.in/English/Schemes/Intellectual_Property_Rights/National_IPR_Policy_08.08.2016.pdf>.

[23]  Ibid.

[24]  The Patents Act, 1970 (39 of 1970) [as amended by Patents (Amendment) Act, 2005 (15 of 2005)]

[25]  Bayer Corpn. v. Union of India, 2014 SCC OnLine Bom 963.

[26] BDR Pharmaceuticals International Pvt. Ltd. v. Bristol-Myers Squibb Company. CLA No. 1 of 2013, available at http://ipindia.nic.in/iponew/Order_30October2013.pdf (last accessed on 16-10-2018).

[27]  Lee Pharma Ltd. v. AstraZeneca AB, CLA No. 1 of 2015, available at <http://ipindia.nic.in/writereaddata/Portal/News/33_1_2-compulsory-license-application-20jan2016.pdf> (last accessed on 15-10-2018).

[28]  Compulsory Licensing of Pharmaceutical Patents in India: A Research Study, European Journal of Pharmaceutical and Medical Research,  2016, 538, available at <http://shodhganga.inflibnet.ac.in/bitstream/10603/130490/19/19_annexure.pdf> (last accessed on 26-9-2018)

[29]  Daniel R. Cahoy, Breaking Patents, 32 Mich. J. Int’l L. 461, 462 (2010).

[30]  Health Security and National Strategy Under the Patents Regime: Issues and Concern, CNLU LJ (6) (2016-17) 80.

[31]  For a scathing analysis of the actual US response to the mandate laid down at Doha, see, US Bullying on Drug Patents: One Year after Doha (Oxfam International Briefing Paper, 2002), available at: <http://www.oxfam.org/eng/pdfs/pp021112bullyingpatents.pdf> (last accessed on 15-9-2018).

[32]Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2, available at <http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_Tripse.htm> (last accessed on 14-9-2018).

[33]  5(d), Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2, adopted on 14-11-2001, available at <http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_Tripse.htm>, last accessed on 23-9-2018).

[34]  White & Case LLP and Dua Consulting, The Value of Incremental Pharmaceutical Innovation: Benefits for Indian Patients and Indian Businesses, Coalition for Innovation, Employment and Development June 2009, p. 4.

[35]  (2013) 6 SCC 1.

[36]  ICTSD, WHO, UNCTAD, Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective — A Working Paper (2006).

[37]  (2013) 6 SCC 1.

[38]  Id. 92-93, para 17.

[39] World Health Organisation (2004), The World Medicines Situation Report, available at <http://apps.who.int/medicinedocs/en/d/Js6160e/9.html#Js6160e.9> (last accessed on 16-10-2018).

[40]  Patralekha Chatterjee, Five Years After the Indian Supreme Court’s Novartis Verdict, available at  <http://www.ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-verdict> (last accessed on 20-10-2018).

[41]  Dr Feroz Ali , Pharmaceutical Patent Grants in India: How our Safeguards Against Evergreening have Failed, and Why the System Must be Reformed, available at <https://www.accessibsa.org/media/2018/04/Pharmaceutical-Patent-Grants-in-India.pdf> (last accessed on 20-10-2018).

[42]  Supra 34.

Case BriefsHigh Courts

Delhi High Court: While deciding the issue that whether persons having genetic disorders can be discriminated against in the context of health insurance, the Bench of Prathiba M. Singh, J., held that right to avail health insurance is an integral part of the Right to Healthcare and the Right to Health, as recognised in Art. 21 of the Constitution, therefore discrimination in health insurance against individuals based on their genetic character, in the absence of appropriate genetic testing and the laying down of intelligible differentia is unconstitutional.

The plaintiff took a medi-claim insurance policy of Rs. 5 lakhs for himself and his family from the Defendant Company. The policy was renewed continuously without break till 10th September, 2012. The plaintiff suffers from Hypertrophic Obstructive Cardiomyopathy (HOCM). He was hospitalised on 23rd January, 2004 and 27th February, 2006 and his claims for the said periods have been honoured and payments were made by the Insurance Company. The Plaintiff was again hospitalised for treatment on 27th November, 2011. He made a claim for an amount of Rs.7, 78,864/- with the defendant. The claim however was rejected on the ground that genetic diseases are not payable as per the policy genetic exclusion clauses. The plaintiff contended that the exclusion of genetic disorders was not part of the initial policy which was availed by him but was added as part of the `Exclusions’ in a later policy document, without specific notice to him and hence the said exclusions do not bind him. Per contra, the stand of the defendant was that HOCM is a genetic disorder which is clearly excluded and hence the claim cannot be entertained.

Examining the contentions, the Bench framed the issue regarding the legality of the exclusion based on genetic disorders. The Court examined at length the meaning of genetic disorders noting that genes pass on several positive characteristics; they could at times be responsible for some abnormal medical conditions which are passed on from one generation to another which are termed as genetic disorders. The Court noted that in order to exclude genetic disorders from insurance claims, there has to be genetic testing Without doing genetic testing and prescribing what is the kind of genetic disorder which is excluded, applying a general exclusion would lead to arbitrariness. The Court also deemed it fit to analyze the global position on the subject and noted that eventhough there is lack of uniformity in the nature of regulation, the unanimous opinion appears to be that discrimination based on genetic heritage and disposition is contrary to human rights and in the context of insurance, exclusions relating to genetic disorders is heavily regulated. With the aforesaid observations, the Court held that the broad exclusion of genetic disorders is not merely a contractual issue between the insurance company and the insured but spills into the broader picture of Right to Health. It was also observed that there is an urgent need for a proper framework to prevent against genetic discrimination as also to protect collection, preservation and confidentiality of genetic data. Insurance companies are free to structure their contracts based on reasonable and intelligible factors which should not be arbitrary and exclusionary. [United India Insurance Co. Ltd. v. Jai Prakash Tayal, 2018 SCC OnLine Del 7415, decided on 26.02.2018]