In our previous post on the Risdiplam saga, we had mentioned that Roche has filed an SLP before the Supreme Court. Earlier today, the SC dismissed this SLP with instructions to the High Court that it shall endeavour to dispose of the suit expeditiously. Roche raised the usual arguments on rare diseases, that very few companies invest in them, and that they came up with this drug after a lot of research. And stated that they were able to come up with the current suit (species) patent, which has not been annulled anywhere in the 62 jurisdictions. They submitted that in all other countries, they have patents on both genus and species. They also pointed out that there are no pre- or post-grant oppositions against the patent.
On the coverage-disclosure dichotomy, they argued that while ‘wide gaps’ cannot be present, some gap between the two can be there. The issue of dichotomy between the two concepts has been discussed by Bharathwaj and me here, and by Dr. Victor Vaibhav Tandon here. The DB’s observation in its judgement, apprehending some gap between coverage and disclosure, might have given a fresh boost in support of Roche’s argument. However, as argued in the two posts above, the DB’s observations fail to take into account some key provisions of the Patents Act, which rule against any gaps between coverage and disclosure. On the ‘person in the know’ test, Roche argued that the test is nowhere to be found, and rather the test is of PSITA i.e. Person Skilled in the Art. My own take on this is that this is a situation of – riffing off the meme – Modern Problems require Modern Doctrines”. Genus Patents, Markush Claims, and Species Patents are not found in the Indian Patents Act, and courts find themselves dealing with disputes on these terms now and then. Thus, it would be only fair to have a suitable yardstick to measure inventive steps within these foreign concepts, and this is where the concept of “Person in the Know” comes into the picture. More on this here.
Roche also tried arguing that public interest should not be used to defeat the patentees’ rights here. This tryst with public interest, with innovators opposing it while the generics using it as a defence against interim injunctions, is not new and has seen numerous interpretations (also see here) over the years, with Courts siding with different arguments in different stages.
As to what the Supreme Court held today – the Court was not inclined to interfere with the findings of the High Court, as it was an interim matter and the findings are concurrent in both the Single Judge and DB orders. The Court also refused to put an embargo on the export of Natco’s generics but directed that the High Court shall endeavour to dispose of the suit expeditiously.
We still await the copy of the order and shall update the post once we get access to it.
Thanks to Akshat Agrawal for the live updates on the Court’s proceedings and to Swaraj for his inputs on the post.