Continuing the discussion on the Delhi High Court’s DB judgment in Risdiplam case, Part II of the post by Dr. Victor Vaibhav Tandon discusses the Court’s finding on the “Person in the Know” yardstick to assess obviousness and the comeback of public interest in high stakes pharma patent cases. Dr. Tandon is an academician turned lawyer, with the law firm Saikrishna and Associates. He continues to teach patent law- rather sporadically- at ILI and ISIL. The views expressed herein are strictly personal. He was not involved in any of the cited matters in any manner, except the FMC CTPR disputes, one of which is cited in the judgment. Alternative views and corrections, if any, are welcome. His previous posts can be accessed here.
Part II: Genus-Specie Disputes: Thoughts on the Risdiplam Division Bench Judgment
By Dr. Victor Vaibhav Tandon
To my understanding, at least, for inventive step, the person skilled in the art is not to be equated with the inventor. That will produce erroneous results, since to the inventor, everything would be obvious, and it would be akin to being a judge in one’s own cause. The person skilled in the art is an external hypothetical construct.
Additionally, this person skilled in the art is not of ordinary skill since the Indian Act does not use any prefix like ‘ordinary’ or ‘average’ while describing the person skilled in the art for the inventive step test. Any judgment or argument based on the Person Ordinarily Skilled in the Art (POSITA or PHOSITA standard of the U.S.) in the Indian context is therefore erroneous in my understanding (this is an aspect Ashwini Siwal and I had explored in some detail here. Interestingly, before the Single Judge, the patentee had consistently argued basis the POSITA standard.
In the context of genus-species disputes, where the inventors are the same for both the genus and species patents, Dapa DB had suggested a new standard for person skilled in the art. It essentially said that the test of inventive step then has to be from the perspective of a ‘person in the know’ to determine “whether the inventor, while writing the first patent, knew of the invention claimed in the subsequent patent”. This implies that when determining the inventive step of a species patent, the inventor of a genus patent (who also happens to invent the species patent) would have readily known how to modify the Markush formulations in order to reach the species patent. This ‘person in the know’ is then essentially intrinsic and not a hypothetical construct, but a real human being, the inventor. Siwal and I had previously called this approach “extra-statutory”, while advocating stringent standards for determining inventive step.
This time around, the Risdiplam DB agreed with Dapa DB and agreed with the single judge that the Risdiplam specie patent was obvious since the inventors of the genus and the specie patent were the same and could have easily made the substitution in the genus structure to arrive at the specie compound. Of course, it helps that the single judge and the DB in Risdiplam also otherwise note the suit patent to be obvious from the yardstick of the person skilled in the art.
The Yardstick that Launches a Thousand Questions
One could wonder though, is the ‘person in the know’ yardstick here to stay in the context of genus-species disputes, where the inventors (or most of them, if not all) of the genus and species patents are the same? Does this permanently convert the external hypothetical construct of a person skilled in the art to an internal real-inventor yardstick in genus-species disputes?
One could justify it. After all, as the Dapa DB noted, “The words ‘Markush’, ‘Genus’, ‘Species’, do not find mention in the Patents Act”. If the law permits such concepts to remain, by adoption or because of the patent office’s practices, can it permit bending the person skilled in the art standard to a ‘person in the know’ standard?
Does ‘Public Interest’ Make a Comeback?
The Risdiplam DB notes that “the whole raison d’être, behind providing for obviousness from prior art as a defence against infringement, is to prevent the inventor from evergreening the invention”. The bench then goes on to note that,
“In the case of drugs and pharmaceutical products, this principle acquires a superadded and predominant element of public interest. If patents relating to essential and life-saving drugs are permitted to be evergreened, the drug may forever remain outside the public domain and available only for the original inventor to exploit, which could result in calamitous and incalculable public harm”.
One couldn’t help but notice the undertones of the anti-evergreening clause, section 3(d) and the pleasant comeback of ‘public interest’. However, the appeal bench did not say anything more on the aspect of public interest. Devvrat Josh and I had deliberated on this public interest aspect previously in this piece.
Where from Here? And a Lingering Sense of Déjà vu
Of course, Risdiplam DB was merely a decision in relation to Roche’s request for interim injunction. There is the possibility of an appeal to the Supreme Court from the Risdiplam DB judgment. And since the suit patent will expire in May 2035, there is the possibility of a trial and a post-trial final determination. Of course, each future case would be fought on its own facts. Perhaps the same arguments will occur ad infinitum. Or perhaps the apex court might have something to say.