Part II- Disentangling Infringement and Disclosure in Novo: Should we continue to Celebrate Novartis?
Yogesh Byadwal
Part II of the Novo v. Dr. Reddy judgement will shift the spotlight to prior claiming under sec. 64(1)(a). The inspiration to write this post came from a 2013 guest post by Darren Smyth, who was kind enough to have an hour long discussion with me on his post. The comments on that post, itself, are a trove of treasure with a long back-and-forth between Smyth and Prof. Basheer. In that post, Smyth, criticizing the Novartis v. UOI ruling, made a crucial point – “What the Supreme Court did was to confuse the examination of whether a patent is infringed with the examination of what that patent, as a document, discloses.”
For anyone following the DHC’s rulings on genus-species after 2020, as I explain below, the above statement rings truer than ever before. All of this started with a seemingly harmless statement in Novartis v. UOI- “there cannot be a vast gapbetween coverage and disclosure.” Did the SC equate coverage and disclosure? Or did it seek to narrow it, nevertheless keeping the distinction? The answer is not clear from the SC 2013 ruling.
The years since have seen the pervading shadow of this flawed reasoning cast upon most genus-species disputes in the DHC, even in the present dispute. As a result, Courts have continued to confuse infringement with disclosure and wrongly decided prior claiming, mostly invalidating patents owned by the Big Pharma. One could argue that this position furthers public interest and increases access to drugs. However, genus-species patenting has application in other fields of innovation like chemistry and biotechnology besides pharmaceuticals. Extending and applying this wrong reasoning will lead to absurd conclusions there too. Will that be in the public interest?
Covered is Disclosed: Novartis v. UOI
For a background on the Novartis case, please refer to this post. For this post, the focus is on the novelty analysis in that ruling and subsequently, the application of that analysis to the Novo vs Dr Reddy case at hand.
Novartis had argued that imatinib mesylate, although covered under the Zimmerman Patent, was not disclosed in an enabling manner. Coverage, in simple words, means that a product falls within the scope of the claims of the specification. If someone makes or sells that product, a claim for infringement of that particular patent can be made. However, it does not mean that the product was also disclosed i.e. it taught a POSITA to make it.
The SC, however, disagreed with this.
The relevant facts which the SC relied upon, among others, to reject novelty were the following-
- NATCO was blocked from marketing ‘Gleevec’ (which contained Imatinib Mesylate as the API) by Novartis asserting the Zimmerman patent (‘Genus’). The Court construed this as admission that the Genus patent covered as well as disclosed Imatinib Mesylate.
- Novartis, while seeking approval for Gleevec from FDA, stated that the API was covered by the Zimmerman Patent.
- Patent Term extension was sought for Zimmerman Patent citing the time it took for regulatory review of the drug Gleevec.
Smyth, in his post, criticized the Court’s reliance on the above facts to decide novelty of Imatinib Mesylate. Smyth argued that it is possible for a prior patent to cover elements of a later patent but nevertheless not disclose it i.e. enable a POSITA to make the later patent.
Why?
Smyth highlights that the analysis for ‘infringement’ and ‘disclosure’ is done with different comparators.
For infringement, ‘the comparison that is conducted is whether the alleged infringement reproduces all of the features of the claims.”
For disclosure, on the other hand, the comparison is of the claims of the later application with the disclosure of the prior document. As I wrote in this post, an invention stands disclosed only if the claims are “fairly based on the matter disclosed in the specification” i.e. enable a POSITA to make and use the invention.
Thus, it is perfectly reasonable to argue that the Zimmerman patent covered Gleevec i.e. imatinib mesylate but nevertheless did not disclose it. It is possible that Zimmerman does not provide teaching to make imatinib mesylate.
64(1)(a), which relates to prior claiming, states- “invention… claimed in a valid claim of earlier priority date” can be revoked. Sec. 10(5) states that every claim must be fairly based on the matter disclosed in the specification.
The above, when read together, lead to the conclusion that mere coverage in a claim is not sufficient to prove disclosure. It is also necessary to check whether the claim itself is disclosed or not. This position was observed in the recent DB Hoffman v. Natco.
Genus Patent and Disclosure
A counter argument, at this point, could be: if imatinib mesylate is not disclosed in Zimmerman but nevertheless covered, how does it even get patented in the first place? Shouldn’t it have been rejected for claiming something it did not disclose?
A genus patent, which at times covers more than a million/billion compounds, are not required to disclose each any every compounds therein. Patent Office’s “guidelines for examination of patent applications in the field of pharmaceuticals” state that Markush claims are “drafted to obtain a wide scope of protection encompassing a large number of compounds whose properties might not have been tested.” The Manual requires the applicant to only “disclose best representatives, as known to the applicant, of the possible embodiments.” It does not require disclosure of every embodiment possible.
Why?
Lemley et al., in this paper, highlight that it is impossible for a patentee to identify and test every species falling in the genus. A genus claim is valid as long as it meets ‘commensurability’ i.e. enough information is provided by the patentee that a POSITA can identify species that work and provide teaching to make those species without undue effort. It is possible that some embodiments do not work or are not reachable. However, this will not render the genus invalid as long as enough of the genus works as described.
Deciding Novelty in Genus-Species
Various DHC judgements, since Novartis, have quoted the observations of Novartis that there cannot be a vast gap between coverage and disclosure with approval. In doing so, however, they have perpetuated the same error of confusing infringement analysis with disclosure. Let me list out some judgements and the facts they relied upon to reject novelty of the species patent-
- Hoffman v. Roche (SB) (Risdiplam Drug)- Relied upon patent term extension sought for the Genus patent citing Risdiplam; b. Listing of Risdiplam in Orange Book mentioning the Genus Patent; c. Letter by USPTO to FDA that Risdiplam was covered by the Genus patent.
- Astrazeneca v. Intas– Relied on simultaneous assertion of Genus and Species patent to allege infringement as admission that the compound is not only covered but also disclosed in the genus patent.
- Boheringer v. Vee Excel (Linagliptin )- Relied on a. Statement by the Plaintiff in Canada that sale of Linagliptin infringes both genus patent and species patent; b. Form 27 of both genus and species which were directed towards working of the same drug i.e. Linagliptin
- Astrazeneca v. P. Kumar (TICAGRELOR)- Relied on a. Form 27 of both genus and species being directed towards working of the same drug; b. assertion of genus patent to block infringement of the drug.
- Bayer Healthcare v. NATCO Pharma (REGORAFENIB)- Relied on a. Patent Term Extension for the Genus patent citing Regorafenib; b. Mention of Regorafenib in Orange Book being covered by the Genus patent; c. Admission that Genus patent would be infringed if someone sold Regorafenib.
There are other judgements too but for our purposes, the above seems sufficient to make the point. Courts, as recently as 2025, still are amenable to accept that assertion of genus patent to block infringement is admission of disclosure. DHC continues to confuse and collapse the analysis of infringement and disclosure while deciding novelty. For instance, how does identical Form 27s for the genus and species patent indicate admission of disclosure? It is perfectly possible that a drug is covered by both the patents but not disclosed in the genus.
Various judgements by Justice Hari Shankar, however, have rejected the notion that coverage is the same as disclosure. These judgements have been covered on the blog.
Most recently, Justice Hari Shankar reiterated this position in Hoffman v. Natco (Risdiplam) judgement (DB) where he observed that-
“It is only if the claim in the species patent is disclosed in the genus patent, that Section
64(1)(e) would apply…..infringement requires only coverage whereas invalidity requires disclosure, and coverage by itself does not necessarily imply disclosure.”
The Court rejected the view that mere coverage of the embodiment in a genus, ipso facto, leads to disclosure. It laid down that the analysis for infringement and invalidity is different i.e. coverage decides infringement whereas disclosure decided novelty.
In my opinion, this view correctly lays down the law.
Present Dispute
In the present case, there is a separate section where the Judge discusses whether the species was disclosed in the genus i.e. if the genus enabled the POSITA to reach the genus. This is the correct approach and perfectly in sync with my argument. I have much appreciation that the judge went into a detailed discussion on this aspect.
However, after that, the Judge goes into a needless discussion of Form 27 and Patent Term Extension.
The Court relied on Form 27s for the genus and species patent which were identical and mentioned ‘Semaglutide.’ This, as per the Court, is evidence of the fact that semaglutide was claimed in the genus patent. Further, while seeking extension for the genus patent in foreign jurisdiction, the Plaintiff had cited the drug semaglutide.
The above is an indication that the Judge, despite discussing enabling disclosure, hasn’t completely disentangled infringement from disclosure. The criticism I levelled above, thus, extends to this judgement too.
Being a law student myself, Novartis v. UOI continues to be taught in classrooms for clarifying the scope of section 3(d) (which, too, is arguable). However, in my experience, the discussion on coverage and disclosure is completely absent. Given its bearing on the present disputes, primarily revolving around essential drugs, it is important that this aspect too is highlighted and taught. Then, it can be left to the students to decide whether Novartis, in its entirety, should be celebrated.
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