‘Public interest demands easy, affordable access to anti-cancer drug’; Delhi High Court denies interim injunction to Bayer Healthcare for drug ‘Regorafenib’

Delhi High Court: In a case wherein the plaintiff, Bayer Healthcare LLC claimed an order of interim injunction against the defendant, Natco Pharma Ltd., based on the same patent (‘suit patent’), that covered and claimed a molecule, which was claimed to be a new chemical entity, which had been assigned an International Non-proprietary Name (‘INN’), “REGORAFENIB”, a Single Judge Bench of Navin Chawla, J.* opined that public interest would demand that large segments of population should have relatively easier and affordable access to an anti-cancer drug, which could be the difference between life and death for certain patients and taking into account the nature of the disease that the drug sought to provide relief from, affordability played a major role in its access to wide sections of the public. Therefore, the Court held that it would not be appropriate to injunct the defendant from selling the said product, especially when a credible challenge to the patent had been laid and the plaintiff had already enjoyed protection for its full term for the genus patent.

Background

The plaintiff was involved in research, development, manufacturing and marketing products for the prevention, diagnosis, and treatment of diseases. The plaintiff submitted that the suit patent was a valid and subsisting patent in India and had a term of 20 years from 22-7-2004. The suit patent was neither opposed in a pre-grant opposition nor in a post-grant opposition by any member of the public or interested party in India. The plaintiff further submitted that the counterparts of this patent had been granted in more than 80 countries, and in none of these jurisdictions had the patent been revoked or invalidated.

The plaintiff submitted that it had applied for and obtained an import license through its India affiliate, Bayer Pharmaceuticals (P) Ltd., on 1-7-2014, and had been selling REGORAFENIB under the brand name ‘STIVARGA®’ in countries like the United States, countries of the European Union, China and Japan, and was also selling the same under the brand names ‘NUBLEXA’ and ‘RESIHANCE’ in India since 2015. The plaintiff further submitted that these were oral, prescription anticancer medication approved by the US Federal Drug Administration (‘FDA’) for people with cancer such as colon or rectal cancer (‘CRC’). The plaintiff stated that REGORAFENIB worked not only by hindering the signals that tell cancer cells to multiply, thus, slowing the cancer from spreading to other parts of the body, but it was also effective in stopping the creation of new blood vessels that feed cancer cells. Thus, REGORAFENIB had increased the overall length of time of a patient’s life and had delayed worsening of the disease in patients. Therefore, the plaintiff sought interim injunction against the defendant from infringing the suit patent of the plaintiff.

The defendant submitted that the plaintiff had prior knowledge of the compound REGORAFENIB at the time of filing of genus patent. The defendant further submitted that at the time of filing, the genus patent captured numerous compounds under its formula, however, later during prosecution, many such compounds, including REGORAFENIB, were deleted by the plaintiff by amending the description of the genus patent. The defendant also submitted that this was done to claim compounds already disclosed in the genus patent. Thus, due to such deletion, the said compounds entered into the public domain and became publici juris. The defendant further claimed that REGORAFENIB being disclosed in the genus patent, which expired on 12-1-2020, thus, any corresponding protection to REGORAFENIB also expired on the same date, and therefore, no injunction could be granted against the defendant.

Analysis, Law, and Decision

The Court relied on B.P. Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511; F. Hoffmann-LA Roche Ltd. v. Cipla Ltd., 2009 SCC OnLine Del 1074, and opined that “the fact that the patent was old, that is, granted a long time back, and/or that there was no challenge to the same prior to its grant or thereafter, were not relevant circumstances, as there was no presumption on the validity of the patent. Further, the defendant, in opposition to the prayer for interim relief made by the plaintiff, was only to show vulnerability of the patent in question. The defendant was not to prove actual invalidity of the patent”.

The Court after relying on Novartis AG v. Union of India, (2013) 6 SCC 1; Astrazeneca AB v. Intas Pharmaceuticals Ltd., 2021 SCC OnLine Del 3746; and FMC Corporation v. GSP Crop Science (P) Ltd., 2022 SCC OnLine Del 3784, observed that “for obtaining grant of a patent, the applicant, in its application must succinctly describe the invention and its operation or use and the method by which it was to be performed. It must disclose the best method of performing the invention which was known to the applicant and for which he was entitled to claim protection and shall end with a claim or claims defining the scope of the invention for which protection was claimed. On expiry of the term of patent, the subject matter ‘covered’ by the said patent shall not be entitled to any protection”.

The Court noted that on an objection of the Controller, the plaintiff had deleted the reference to REGROFENIB from the complete specification and thereafter, the plaintiff had filed a divisional application, on which the defendant had claimed that the said application, had been rejected by the Indian Patent Office on 19-5-2022 for not meeting the criteria laid down in Section 2(1)(j) of the Patents Act, 1970 (‘Act’). Thus, this Court opined that the defendant had at least prima facie raised a credible defence and challenge to the suit patent under Section 64(1)(e) and 64(1)(f) of the Act.

The Court noted that the plaintiff had admitted that the suit patent was covered by the genus patent, though qualifying such admission by use of the word “technically”, whose term had admittedly expired, at least prima facie was not entitled to an interim order at this stage. Thus, the Court opined that the plaintiff had been unable to make out a prima facie case for grant of an interim injunction in its favour.

The Court opined that the public interest would also demand that such injunction be refused inasmuch as it was claimed that there was a huge disparity between the price of the product offered by the plaintiff and the defendant for a disease which was life threatening. The Court noted that the plaintiff was selling their product at the rate of Rs. 36,995 by importing the same into India, whereas the defendant was manufacturing the product in India and selling the same at a cost of Rs. 9,900. Thus, the Court observed that the defendant’s products were much cheaper than that of the plaintiff.

The Court opined that public interest would demand that large segments of population should have relatively easier and affordable access to an anti-cancer drug, which could be the difference between life and death for certain patients and taking into account the nature of the disease that the drug sought to provide relief from, affordability played a major role in its access to wide sections of the public. Therefore, the Court held that it would not be appropriate to injunct the defendants from selling the said product, especially when a credible challenge to the patent had been laid and the plaintiff had already enjoyed protection for its full term for the genus patent.

The Court disposed of the present application and directed the defendant that to maintain the balance of convenience, it should maintain complete accounts of manufacture and sale of the products with the subject patent, and file statement of account(s), on affidavit(s), on half yearly basis before this Court.

The matter would next be listed on 23-8-2023.

[Bayer Healthcare LLC v. Natco Pharma Ltd., 2023 SCC OnLine Del 3921, decided on 5-7-2023]

*Judgment authored by: Justice Navin Chawla

Advocates who appeared in this case :

For the Plaintiff: Pravin Anand, Dhruv Anand, Udita Patro, Swati Jain, Devinder Singh Rawat, Advocates;

For the Defendant: J. Sai Deepak, G. Nataraj, Avinash K. Sharma, Shashikant Yadav, Rahul Bhujbal, Harshita Agarwal, Garima Joshi, Advocates.