[SpicyIP] - Delhi High Court Risdiplam DB Judgement: A Few More Thoughts
Bharathwaj Ramakrishnan
[The post is co-authored with Praharsh Gour with research assistance from Vikram Nanda.]
The Delhi High Court’s recent Risdiplam DB judgement refused to interfere with the Single Judge’s order rejecting Roche’s interim injunction application against Natco. It was alleged by the Swiss Pharma manufacturer that Natco infringed its Risdiplam patent- IN 334397 (Suit Patent). The decision, passed by a bench comprising Justice C Hari Shankar and Justice Ajay Digpaul, will enable access to affordable orphan drugs for the treatment of Spinal Muscular Atrophy (SMA), which is reportedly sold at INR 6 lakhs per bottle. While the judgement brings relief to SMA patients across the country, it has also reignited the debate concerning genus and species patents. Dr. Victor Vaibhav Tandon wrote a two-part post on this development (here and here), focusing mainly on the coverage-disclosure dichotomy and ‘Person in the Know’ yardstick for assessing obviousness. Taking the discussion forward in this post, we’ll look at some additional implications of DB’s observations on the Indian Patent regime.
Since the 2013 Supreme Court’s ruling in Novartis v. UoI, courts have been trying to respond to these two crucial questions: Whether a patentee can claim patent protection over a single compound covered in both genus and species patents? Can a compound be “covered” within the broad Markush claims of the genus patent and still not be “disclosed” (enabling the person skilled in the art to make/ use the invention) within the specification, allowing the patentee to file for a subsequent species patent? After a set of DB orders in Natco v. Novartis (2024) (covered by Shivam here and Dr. Tandon here) and Astrazeneca v. Intas (2021) (covered by Adyasha here), it was somewhat clear that there cannot be more than one patent over one compound, and that there are no gaps between coverage and disclosure.
Deciding against letting the sleeping dogs of the coverage-disclosure dichotomy lie, the Risdiplam DB has nudged towards an affirmative interpretation in response to the latter question. We say nudge, because the DB merely stated that AstraZeneca requires reconsideration, without disturbing the precedent. The DB did, however, make some choice observations on the Single Judge’s conclusions concerning a credible challenge by Natco against the validity of Roche’s Risdiplam patent on grounds of novelty (Section 64(1)(e)). Part I of Dr. Tandon’s nicely covers the DB’s observations on coverage and disclosure and interested readers can refer to it for the necessary background. Here, we’d like to take the discussion forward to understand and assess the Risdiplam observations in light of Section 53(4) and Section 64(1)(e).
A False Equivalence?
In para 19.7.4, DB observes “Section 64(1)(e) is, however, predicated on prior claiming. This would, in its turn, entail prior disclosure”. This observation by the DB bench is odd. It seems to have conflated a challenge under prior claiming (Section 64(1)(a)) with a challenge under prior publication (Section 64(1)(e)). In para 19.10 again, the Court seems to conflate Section 64(1)(a) and Section 64(1)(e). One might ask, why is this important or relevant? It is important because, firstly, Justice Hari Shankar while sitting singly in FMC Corporation v. Best Corp Sciences (FMC) (2021) had painstakingly, in excruciating detail, attempted to clarify the scope of both Section 64(1)(a) and Section 64(1)(e) (refer to para 12.11 and 13.5) and treated both the objections as distinct correctly appreciating the legislative scheme. Thus, it is surprising that the Division Bench, without any explicit reason, even when it had approvingly quoted FMC, had also deviated from it without any explanation. It is doubly puzzling when, in the present case, the genus patent is not an Indian Patent but a foreign patent. This is relevant, since Section 64(1)(a) requires, among other things, prior claiming to take place in a “complete specification of another patent granted in India”. This conflation of two different objections under Section 64, at least to our minds, raises serious doubts about the observations made by the Division Bench in general with regard to Section 64(1)(e).
The Unaddressed issue of Section 53(4)
The Division Bench’s observations with respect to Astrazeneca raise some additional interpretive concerns with respect to Section 53(4). The Section, in no uncertain terms, states that upon expiry of a patent, subject matter “covered” by an expired patent shall not be entitled to “any protection”. It has to be clarified that it was not strictly necessary for the Division Bench to discuss Section 53(4) since it would not apply to the facts of the case, as I will explain below. Yet its observations on the coverage-disclosure dichotomy and AstraZeneca seem to be of a general nature and not limited to the facts of the case. Yet such observations do not take into account Section 53(4). In light of Section 53(4), if a compound is “covered” by a genus patent, would it not prevent any subsequent species patent from subsisting after the expiry of the initial genus patent? Thus, even if one accepts the Division bench’s observations on the coverage-disclosure gap, the species patent cannot outlast the genus if it can be shown that the compound(s) covered and disclosed in the species were previously merely covered by the genus. Hence, species patents that tend to have a later priority date from the genus cannot outlast the genus and are invalid by the operation of Section 53(4).
Yet Section 53(4) comes with its own riders. A combined reading of Section 2(m) and Section 53(4) means that the patent discussed in Section 53(4) is limited to a patent granted under the Patents Act, 1970. This means that the scope of Section 53(4) is very limited and gets triggered only when a granted India genus patent subsequently either expires or ceases to exist due to non-payment of renewal fee. This means that the scope of Section 53(4) is very limited and gets triggered only when a granted Indian genus patent subsequently either expires or ceases to exist due to non-payment of renewal fee.
We have seen courts decide disputes based on this interpretation as well. A Single Bench of the DHC in Bayer HealthCare v. Natco Pharma (2023) rejected a plea for an interim injunction based on Section 53(4). Bayer, in its plaint, had admitted that the domestic genus patent (which had expired at the time of the litigation) “technically covered” the compound in dispute, Regorafenib. This admission, in the eyes of the Court, that the genus patent covered the chemical compound, was sufficient, among other things, to deny Bayer its interim relief against Natco, where the suit patent, which was asserted against Natco, was a species patent.
Thus, accepting the DB’s reasoning would leave one in an absurd position with respect to Section 53(4) and disclosure coverage gap, where an expired indian genus patent would leave the species patent vulnerable in an interim proceeding, while an expired foreign genus would not render a subsequent Indian species patent granted in India vulnerable. This is because the disclosure coverage gap, as advocated by the Division Bench, if accepted, would protect such an expired foreign genus and an Indian species pair from a disclosure = coverage style argument, but not an Indian species with an expired Indian genus due to Section 53(4). This position, in our view, shows the limits of the disclosure coverage gap advocated by the DB. It creates arbitrary additional protection for a certain set of patent pairs over others, which rationally does not make sense.
Public Interest and Policy Levers:
As was discussed at the start of this post, the ruling allows Natco to sell an affordable version of the drug (reportedly at Rs. 15,900 per bottle). The price of the generic would be 97% cheaper than what has been offered by Roche. But as pointed out by Sabeeh, the price of a single bottle could be as less as Rs. 99. Dr Barber, on whose research Sabeeh had relied on, had further argued that Risdipalm is an example of a low-cost (cheaper to manufacture) and high price (priced at a higher rate to the consumer) drug. She had also argued that Risdipalm, being a small-molecule drug with a less complex manufacturing pipeline, was an ideal candidate for generic and local manufacturing. Hence, Risdipalm is an ideal candidate to be manufactured and distributed at the behest of the government to SMA patients at a very cheap and affordable rate. In this blog, at various instances (see here and here), bloggers have highlighted levers under the Patents Act, like government use and CL provisions, that can be utilised by the Government to facilitate access to SMA patients. SMA patients had also filed a writ petition before the Kerala High Court seeking directions to be issued to the Government of India to exercise its powers under the government use and CL provisions. Yet the Government of India chose to file an SLP before the Supreme Court, arguing that it would create “unsustainable financial burden”, reflecting a lack of desire or intention to utilise government use and CL provisions available to the Government under the Patents Act. Hence, when a resemblance of relief did come for SMA patients, it is depressing to note that relief came from the actions of a private company, not from the Government, whose responsibility is to protect the health and livelihood of its citizens.
Postscript:
It has been reported now that Roche has moved to the Supreme Court against the Division Bench order. CJI has allowed for the urgent listing of the matter. The matter as per news reports, is to be listed on 16 or 17th October.
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