After a long and tortuous set of proceedings involving the Indian patent office and the Delhi high court, the final decision in the Sovaldi opposition case just issued. The Deputy Controller handed down a clear victory to Gilead, dismissing the various contentions raised in the various oppositions that had been filed against the patent application (as noted in an earlier post, about 7-8 oppns were filed by different parties).
I’ve taken only a quick look at the order by the Deputy Controller, Rajesh Dixit and must say that the decision is not an easy read. Making out the case again (and letting me trumpet out my pet peeve again) that in view of the serious quasi judicial nature of the patent office, it’s officers must be given compulsory legal training. And not just training to boost up their legal proficiency. But to bolster their adjudicatory competence. For mere legal proficiency (gained by long years of study/practice of the law) is not sufficient to vest one with adjudicatory competence,
The present decision leaves much to be desired in terms of its reasoning and clarity of thought/presentation. In fact, the reasoning on section 3(d) is so thin and waif like it would make Kate Moss look obese.
Section 3(d) Analysis: Slim and Shaky?
Here is how the learned Controller decided that this present patent application did not attract section 3(d):
“The patent application provides comparative activity and toxicity data in mice and monkey. Further, additional comparative activity data has been filed during the examination of the patent application. These data have been relied during the hearing. Further, applicant also argued that the medicine prepared from the compounds claimed in the present invention has resulted in breakthrough treatment of HCV infection and the medicine is approved in many countries including USA and India. I am satisfied that the claimed compound has an added layer of enhanced efficacy.”
If all it takes to demonstrate enhanced efficacy is regulatory approval (as the controller appears to indicate) then all Pharma drugs will pass muster. No point even applying section 3(d)! More worryingly, the Controller fails to appreciate that section 3(d) and efficacy are to be judged as on the date of filing of the patent application. In other words, the key issue for determination under section 3(d) is: at the time of filing the patent application, did the applicant demonstrate (through the patent specification) that the claimed compound is more efficacious than a previously known compound? Often times, the compound for which a patent is applied is made into a drug (and regulatory approval procured) much later. So to use the factum of approval to justify a demonstration of efficacy is thoroughly flawed!
Further the Controller speaks about “comparative data” without spelling out what is the point of comparison? What data is being compared? What is the substance under comparison? Recall in the Novartis Glivec case, one of the key issues was precisely this: what prior art substance must one compare the patented compound against when making a section 3(d) assessment?
Seems like a good appeal has just been handed down on a platter. Just the same way the IPO had done earlier when it first ruled (after having copied verbatim portions of Natco’s opposition brief) that this very same (alleged) invention was not patentable!
Adjudicatory Competence at “Quasi Judicial” Patent Office
Here are some quick questions for readers in the know:
- Does Rajesh Dixit (the present controller who issued this decision) have the necessary legal competence to adjudicate this case? A law degree? Legal training? This goes back to an issue I’ve been raising about vesting an important office such as the patent office with the requisite adjudicatory competence.
- On the technical side, I assume Dixit has a science/technical degree closely aligned with the technology under dispute (bio-chemistry, pharmacology or even chemistry or biology)?
I know that demanding more qualifications from patent office personnel is asking for the moon, given how the office struggles to attract even basic talent. Not to mention the pathetic policies in place that deny patent office personnel even the right to a basic shot at time bound promotions, a point I reflect upon in this post here.
But then, given the global importance of cases such as this for the future of innovation and public health, these hard questions must be asked. And relevant policies designed to attract more competent people to the fold and vest them with the necessary legal/adjudicatory competence, not to mention adjudicatory independence! Given the continuing US pressure on India to toe the patent line and rescript it in line with western industrial interests, one wonders if any pressure was brought to bear on the present Controller. Particularly so, since the patent office followed this curious practice of partitioning the various oppositions (without even permitting one opponent to sit through proceedings of the other opponent) and closed what are essentially public hearings from the eyes of the outside world.
Though in all fairness, I must say that Controller Dixit”s ruling on novelty was fairly robust (holding that the prior compounds cited by the opposition did not anticipate or disclose Gileads’ claimed compound). Unfortunately his take on inventive step and section 3(d) was poorly reasoned.
More later when I’ve assessed the decision more fully. Stay tuned!