Holdings Corporation Vs Granules India Limited with respect to a patent dispute relating to Ruxolitinib (used for the treatment of myelofibrosis, a rare disorder of the bone marrow). Incyte Holdings Corporation, the patent holder, had sued Granules India Limited alleging that the latter infringed their patent by manufacturing and listing on Pharmacompass its version of Ruxolitinib (Pharmacompass serves as a global pharmaceutical product database for manufacturers and sellers of pharmaceutical products).
The dispute was on the infringement of the patent for Ruxolitinib, marketed under the brand name of 'JAKAVI' in India and elsewhere. The settlement was recorded after Granules India told the court that its conduct was only research-related, and it was clearly within the Bolar-type exemption under Section 107A of the Indian Patents Act, 1970.
Section 107A and Its Issues
Section 107A of the Patents Act, 1970, is commonly referenced in patent litigation with generic manufacturers, because it provides a shield for the research and regulatory use of patented pharmaceutical drugs. Section 107A(a) allows for the manufacturing, using, or selling of a patented invention strictly for obtaining regulatory approvals like for a generic version of a patented pharmaceutical drug once the patent has expired. It is often called a "Bolar-type exemption" based on the American case Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc. that established exemptions for generic drug manufacturers to prepare their product for market once a patent expires.
Nonetheless, Section 107A has been condemned by critics as being extremely broad or uncertain. Critics highlight the vagueness about certain points such as: the timing of the use of PVXs/PVIs for research or regulatory use, the liability of third-party active pharmaceutical ingredient (API) suppliers, and whether stockpiling a drug should be permitted. Just like stockpiling, Section 107A does not have guidance for generic manufacturers in relation to whether they can produce large quantities of a patented drug prior to patent expiry and be able to market that once the patent expires.
A report by Confederation of Indian Industry (CII) emphasises that Section 107A aims to foster innovation and ensure generic competition post-patent expiry, but its broad language and lack of precise definitions can lead to misuse and undermine patent holders' rights.
Bayer and the Limits of Section 107A
The case of Bayer Corporation v. Union of India and Bayer Intellectual Property GmbH v. Alembic Pharmaceuticals Ltd. further clarified the scope of Section 107A. In a judgment of the Delhi High Court on whether Alembic Pharmaceuticals' export of Bayer's drug Rivaroxaban for non-commercial purposes fell within the scope of Section 107A. The court emphasised that the intent behind the use of the patented invention was necessary in determining whether the exception applied. If the use was for research or regulatory purposes, as opposed to commercial exploitation, Section 107A would apply.
However, in the Incyte vs. Granules case, it was seen that disputes could still arise when the intent behind the use of the patented drug was questioned. Granules India's explanation that its listing was for regulatory purposes aligns with the Bolar exception, but the timing and specific activities involved in seeking regulatory approval remain open to interpretation.
The Ruling
The Delhi High Court granted Incyte''s application for an ex-parte interim injunction restraining Granules from manufacturing, stocking up on, or selling products containing Ruxolitinib pending further proceedings. The interim injunction was intended to prevent commercial infringement while the matter was considered. The court also issued an order permitting the appointment of a local commissioner to inspect the premises of Granules and seize infringing products.
Conclusion
The resolution of the infringement dispute between Incyte and Granules India show the difficulties inherent in interpreting and applying Section 107 A of the Patents Act of India. This provision is meant to promote innovation and allow entry for generics but it has some vague language and leaves unanswered questions on matters of stockpiling and the role of third-party suppliers, both of which allow for ambiguity.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
