Breaking News: Gilead Wins First Round, as Sovaldi Patent Oppositions Dismissed!

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:

  1. 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.
  2. 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!

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11 thoughts on “Breaking News: Gilead Wins First Round, as Sovaldi Patent Oppositions Dismissed!”

  1. According to my view puzzling decision given by Delhi High court, should patent office of India rethink on the legal training of officers and its qualification.

  2. According to my view puzzling decision given by Delhi High court, should patent office of India rethink on the legal training of officers.

  3. Shamnad, Please do not be too harsh on Dixit or his field of expertise, How come a lone IPAB Technical member decides matters pertaining to all technology under the sun! Now, Parmar is gone too ( bot that he was great)…just pray who will come and take that position!

    On Section 3(d)- additional data have been allowed to be presented by Courts separately.. It does not have to be necessarily disclosed in the spec- which in most cases is not practical. However, I agree with you that the reasoning should have been clear on the point of comparison and how he attributed enhanced efficacy to the claimed compound.

    1. Shamnad Basheer

      You’re right. I was a bit harsh on him initially in my email message to subscribers. I tempered down a bit while posting to the blog. But am still appalled at the way in which the section 3(d) argument was dealt with. If he thought that section 3(d) was wholly inapplicable (since the earlier known substance [from Merck’s patent] was not really a “derivative” or that it was an “imaginary” compound (as he called it, borrowing liberally from the Gilead submissions filed before him), then he should have stated so explicitly and left it at that. And not ventured out and still held that there was an “added layer of efficacy”. Efficacy when compared with what? And even his labelling of the prior known compound (in Mercks prior art patent) as “imaginary” and not “enabled” is hugely problematic. How did he arrive at this factual finding–for you can’t simply state that something is not enabled just because a party to your proceeding (in this case Gilead) says so. He has to reason out and make a factual finding on this count (based on expert testimony etc) that this prior known substance (listed as one of the embodiments in Mercks’ patents) was not enabled. And cannot therefore be considered for section 3(d). Unfortunately, no reasoning at all on this count!

      His inventive step analysis is even more problematic. For he essentially does a “novelty” framework analysis here, holding that since there is no mention of flourination in any of the prior art documents cited, this alleged invention is “inventive” or non obvious. But if the precise “flourine” (2 down position) was in fact mentioned explicitly in a prior art document, then this would go to “novelty”-i.e. the claimed compound would be fully and completely anticipated! He says that a person skilled in the art would not be able to obtain this claimed compound without experimentation. But mere experimentation does not confer inventive step. Rather all it does (if the experimentation qualifies as “undue”) is to take it out of the anticipation challenge and vest it with “novelty”.

      More worryingly, the Controller also states that the opponent has not been able to demonstrate that the allegedly “imaginary” compound in the Merck patent works as stated and therefore qualifies as a known substance? Why should the opponent have to prove this? The burden of proof for section 3(d) is on the patent applicant; not the opponent! Sadly all this was lost on the Controller, leaving huge gaping holes in the decision. Making this a sitting duck for an appeal. Also on the technical expertise front, I believe he has a chemistry background. And reading the decision also suggested to me that he had some degree of proficiency in the underlying science. Wish I could say that about the law or his powers of reasoning. But hopefully with more such cases thrown his way and with more legal/judicial training, we will see better from him in the future. I don’t mean him any ill will. And perhaps he is a mere pawn in a larger issue of institutional malaise where we simply don’t have enough resources at the office and leave our officers without significant legal or judicial training. And burden them with a huge case load! But then again, this is a hugely important case for public health and to have it reasoned so poorly makes ones blood boil! For this is a decision that will ultimately impact the lives and well being of several thousand patients and the future of the innovation ecosystem as well (given that this is one drug that has finally woken up US law makers to go after drug pricing!). All in all, a wasted opportunity for developing and clarifying patent law jurisprudence.

  4. S Mauria ICAR

    I think I read that this patent case was rejected in China. Somebody may compare the grounds of its acceptance here in India and its rejection in China; and draw some good conclusions.

    1. Shamnad Basheer

      Thanks Dr Mauria. Unfortunately, as I understand the Chinese decision is not a reasoned one. Just a very short order. But I could be wrong.

  5. Hello Shamnad sir,

    I would like to speak to you regarding the Gilead case. I am currently working as a company analyst for The Economist Intelligence Unit. I am working on an analytical piece on this case and its possible ramifications for the common man. I would be highly obliged if you could agree to provide your valuable insight for the same.

  6. Hello Shamnad sir,

    I am a companies analyst working for The Economist Intelligence Unit. I am a former business journalist who also does freelancing work. I was working on an analytical piece focusing on Gilead’s patent approval. I would be highly obliged if you could provide your valuable insight into the possible ramifications of this decision on the common man and what kind of precedent does this case set for other contenders in near future.
    Kindly let me know if you are willing to speak to me or write to me through emails.

  7. Its surprising that without checking the background of Dr Dixit, question has been raised on his degrees and competency to handle patent matters. Dr. Dixit has done his Ph.D. from University of Rajasthan in 1988 and LL.B. from Meerut University (Lloyd College of Law) few years back. He has has undergone judicial training from NLU, Delhi.
    He is working in Patent Office since November 1999.

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