In a previous post, I’d promised to bring a more detailed analysis of the problematic patent decision in the Sovaldi (Sofosbuvir) post, wherein Gilead won a hard fought patent battle against some 8 odd opponents. Apart from the rather thin analysis on section 3(d) which I highlighted, the Deputy Controller also appears to have conflated the novelty and inventive step test frameworks. Essentially, he’s imported the “novelty” test framework into the “non obvious” or inventive step analysis. Or pioneered a rather “novel” frame for assessing whether the claimed invention is “non obvious’ or “inventive”.
Novelty vs Inventive Step (Non-Obviousness)
To save my time and yours, let me simply reproduce what I’d written in response to a comment received on the earlier post:
“You’re right. I was a bit harsh on him (Rajesh Dixit, the Deputy Controller) 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 Merck’s 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 fluorination in any of the prior art documents cited, this alleged invention is “inventive” or non obvious. But if the precise “fluorine” (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”.
Section 3(d) and Burden of Proof
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.”
Amendment Without Notice to Opponents
Apart from the above, the Deputy Controller also permits Gilead to amend their patent specification at the last minute without notifying the opponents, a ground that has been taken up in a writ challenge by IMAK and others who’ve challenged the problematic patent decision.
Merck vs Gilead: Whose Drug is it Anyway?
Meanwhile across the shores, a very interesting development is spewing. As some may be aware, the key prior art relied on by opponents to challenge Gilead’s patent application is a published patent by Merck. Merck sued Gilead (claiming that Sovaldi infringes upon this patent) and won in the US (at least at the initial stage, with the jury awarding Merck 200 million dollars, after the patent was found to be valid. Gilead conceded on the issue of infringement). It now turns out that Gilead has submitted evidence that this patent by Merck may have been built upon confidential disclosures by Pharmasset researchers to a Merck scientist. A judge found prima facie merit in this contention by Gilead and permitted them to bolster this claim by submitting additional evidence. Remember that the Sovaldi patent initially belonged to Pharmasset which was then taken over by Gilead. More on this in the next post. Stay tuned.