Patent Litigation in India has come a long way from the days of process patents. Pharmaceuticals, chemicals and food processes were only patentable after the Ayyangar Committee’s report which envisaged patents geared towards welfare economics. The Patents (Amendment) Act of 2005 created product patent regime for the above categories – giving rise to a spate of litigation.
Novartis’ “Gleevec” was the first drug denied patentability under Section 3(d) of the amended Patent Act, which makes mere discovery of new forms of known substances non-patentable without enhancement of existing efficacy. Novartis’ case is before the Intellectual Property Appellate Board (IPAB).
The Board commenced hearing Novartis’ appeal challenging the Indian Patent Office’s rejection of its patent application for the beta-crystalline form of imatinib mesylate (Gleevec).
Another facet of Indian patent litigation was revealed when courts started factoring in public policy concerns regarding access to drugs and public health, though limiting their reach to life saving medicines. F. Hoffman-La Roche filed an infringement suit against Cipla for infringing its patent on “Tarceva”. Cipla counter-claimed the patent was invalid. The court observed that a balancing of convenience in cases involving life saving drugs would factor in imponderables such as the likelihood of injuring unknown parties and potentially denying them remedies. While the plaintiff was not entitled to an ad-interim injunction, the court directed the defendant to maintain faithful product sales accounts and file quarterly accounts, as well as authenticate its annual sales figures presented in court. The court said the measure was to provide an equitable balancing of interests.
The denial of a patent application entitled “Pharmaceutical composition” and filed by Boehringer Ingelheim Pharmaceuticals, is significant because it points towards submission of data relating to therapeutic effect showing enhanced efficacy over known substances to overcome the bar of Section 3(d). The invention relates to a pediatric suspension of “Nevirapine Hemihydrate”. A pre-grant opposition was filed by the Indian Network for People Living with HIV/AIDS and Positive Women Network in response to the publication of the application. It was concluded that no data existed to compare the therapeutic effect of the known substance and claimed substance.
The patent row over “Valganciclovir” – again between Roche and Cipla – refers to the significance of patent review. Awarding Roche the Valganciclovir patent without giving a pre-grant opposition hearing (based on the Madras High Court’s decision to set aside Roche’s patent grant) violated Section 25 of the Patent Act of 1970 (as amended in 2005). The court ordered the re-hearing of the pre-grant opposition.
An ex parte ad interim order granted to Bristol-Myers Squibb by the Delhi High Court against Hetero Drugs underscores the interplay between patent status and drug regulation. Along with restraining the defendants from dealing directly or indirectly in any product infringing the plaintiff’s patent, the order directed plaintiffs to make out a case to the Drug Controller General of India (DCGI) for breach of its patent for which the defendant sought approval. Another suit, awaiting adjudication on linking regulatory approval of generic medicines with their patent status, is that of Bayer against the Indian government and the DCGI.
The Bayer case will purportedly have a huge impact on medicine accessibility and generic drug production as it may encourage patent holders to approach courts to prevent or delay marketing approval of affordable versions of patented drugs. Linking regulatory approval of drugs with their patent status essentially entails the Controller General denying approval to a generic applicant if that product is already patented in India and the patent has not expired.
Globally, industries have a preference for knowledge-based assets such as patented technology rather than physical infrastructure. The need for ever newer technology means patents are a vital intellectual property resource.
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Lex Orbis Intellectual Property Practice
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