By Dr. Victor Vaibhav Tandon
There was a sense of déjà vu. On 1st April 2013, the Indian Supreme Court had refused Novartis’ application for beta-crystalline form of Imatinib Mesylate as it failed the threshold bar of section 3(d) of the Patents Act (Novartis I see here). And more than a decade later, on 24th April 2024, a Division Bench (DB) of Delhi High Court overturned a single judge’s decision, thus rejecting Novartis’ request for interim relief against Natco Pharma in relation to Eltrombopag Olamine (IN 233161), basis, inter-alia, section 3(d) (Novartis II see here). In doing so, the DB- it is hoped- settled some aspects of genus-species patent disputes. It will be interesting how big pharma- the patentees- respond to this development, an aspect explored later in this piece.
One could, simplistically, observe that Novartis I related to patentability (patent eligibility for purists), while Novartis II relates to an infringement action. But a deeper dive would lead one to agree with another DB of Delhi High Court (see Vifor v. MSN here), which has clarified that the tests/ standards of novelty applicable at stage of patentability and those for determining infringement cannot be different. Both at stage of grant (patentability) and while deciding infringement, the language of claim remains unaltered, and claims and specification do not change hues at the two stages, but remain static.
The interlude between Novartis I and Novartis II had seen another DB of Delhi High Court rule against AstraZeneca and deny its request for interim relief in relation to Dapagliflozin- see decision (Dapa DB). Patentees had consistently sought to distinguish Dapa DB from other genus-species disputes by arguing that AstraZeneca had asserted both genus and species patents therein- and that therefore Dapa DB was factually so different from every other genus-species dispute as to have no applicability to any other genus-species case at all! By such a simplistic strategic tweak, every patentee could avoid the albatross of the Dapa DB from being hung around its neck; until Novartis II DB had to state the obvious: “the fundamental question involved in both cases is whether a patentee can claim protective rights in respect of the same compound as covered under two product patents: one, a broad claim covering several compounds with an essential core, claiming to possess therapeutic value, and the second a specific claim, in respect of the compound in question”. Those familiar with genus-species disputes would recognize that the former is the genus patent and the latter is the species patent. Holding this, Novartis II aligned itself with Dapa DB, and went on to hold, inter-alia,
An interesting aspect of genus-species disputes is that neither the arguments nor the conclusions are new. In fact, even the questions and context are not new. For example, the following are passages from Novartis I and Dapa DB respectively- cases that some would argue are as different as Sun and Moon- but the law, the questions and the answers thereto are not different:
Excerpt from Novartis IExcerpt from Dapa DBIt would be apparent at once, from a reading of the above passages (and the judgments in general), that the patentees’ arguments have always proceeded on the basis that the genus covers but does not disclose the species, that patentee of the genus or anyone else could invent the species from the genus, but if someone else was to do so, such person would need approval from the holder of the live genus patent. Of course, in a high stakes battle, patentees and generics will not cede ground and both will re-agitate the same script ad infinitum. But with two Division Benches- and several single judges- of Delhi High Court now holding firmly against patentees/ big pharma, where do we go from here.
Firstly, big pharma could do what it has been doing for more than three decades with great effect- lobbying, right from the time of inclusion of TRIPS within the fold of WTO (this is too well researched and documented to be repeated herein) to the Special 301 Reports of US Trade Representative, which retains India on its priority watch list, and curiously notes in its 2024 edition that,
Excerpt from Pg. 56 from the ReportThat US and big pharma always had problems with Indian Section 3(d) and compulsory licensing are an open secret. But for the special report to specifically state that US wants to monitor the situation regarding Form 27/ patent working requirements makes matters a bit too obvious (even when we accept that it is indeed US’s business to be concerned about patent laws of every other country!). For a hard-hitting and radical view of things in this context, see here. It will be interesting to see, if, and how, big pharma captures the narrative on genus-species disputes and pushes for reform(!) of section 3(d) and may be section 53(4) itself.
Secondly, and the signs of this are already there- patentees could venture to other High Courts, forum shifting to get interim reliefs- including ex-parte orders (not a bad legal strategy at all, to be fair). For those familiar with genus-species disputes, Boehringer Ingelheim had approached the Himachal Pradesh High Court with unprecedented success (including, initially ex-parte orders) in relation to Linagliptin and Linagliptin + Metformin. It then came to Delhi High Court, only to suffer a refusal of interim relief (see here) with the Delhi High Court noting that “With the greatest respect, the aforesaid observations of Himachal Pradesh High Court are at variance with the findings of the Supreme Court in Novartis (supra) and the judgment of the Division Bench in AstraZeneca (supra). With due respect, I am not in agreement with the aforesaid view taken by the Himachal Pradesh High Court.” Interestingly the single judge in this matter was also part of the Dapa DB.
Most recently, Boehringer again secured interim relief against generics in relation to Empagliflozin on 30th May 2024, from the Himachal Pradesh High Court (see decision here). Interestingly, the same bench decided both the empagliflozin dispute and the earlier linagliptin dispute at the HP High Court. Obviously, Delhi High Court’s decisions hold mere persuasive value for other High Courts, and where facts are different, application of the same legal principles may lead to different results. Importantly, will other patentees follow in the footsteps of Boehringer, and explore other forums? And will the genus-species conundrum eventually reach the Indian Supreme Court?
It will be critical for the health of Indian patent jurisprudence to avoid a scenario where lobbying or forum shifting is allowed to lead to dilution of rigours and nuances of Indian jurisprudence. Further, it will be prudent to have some amount of consistency in application of tests as well as the interpretation of those tests- including what exactly is the credible challenge that a defendant must raise at the interim stage and whether there should be any place for public interest at all in patent jurisprudence (for development of law relating public interest in relation to pharmaceutical patent infringement and grant of interim reliefs, see the blog post here).
This author at least tends to believe that public interest must have some role to play in matters of interim relief in pharmaceutical patent law- because even where commercial entities are involved, there is a third stakeholder- the consumer or the public whose right to affordable healthcare may be demonstrably involved in patent matters. However, divergent views have come from benches within the Delhi High Court on place of public interest in context of interim reliefs in pharmaceutical/ agro-chemical patent litigation. The Himachal Pradesh High Court has noted in its Empagliflozin decision that “a commercial rival against whom there is an allegation of infringement of patent cannot be allowed to raise the plea of public interest” since there were checks and balances in Patents Act “to cater” to public interest. Hence, there is a need for some consistency of law in this area, as noted above.
And benches across the country will perhaps have to be alert- it is accepted within doctrine of separation that courts cannot enter the domain of legislation and policy making- but interpretation of law can be an important tool to steer jurisprudence in certain intended directions. The classic example is of constitutional law- where upon a conversation between Justice Frankfurter and B.N. Rau, ‘due process of law’ was dropped from Article 21, only for the concept to make an entry via Maneka Gandhi v. Union of India. However, not every interpretation and not every borrowing of alien concepts from other jurisdictions would turn out to be beneficial!