Regular readers of this Blog will recall that, in his guest post on the topic of exorbitant drug pricing, Zakir Thomas had alluded to Xtandi (enzalutamide), a wonder drug developed at the University of California, Los Angeles (UCLA) for fighting prostate cancer which is commercially sold in India by Astellas Pharma.
Noting how Astellas’ justification for the unaffordable cost of the drug viz. that it is commensurate with the cost of innovation and patient benefit is emblematic of the apathy that has come to characterize the worldview of most pharmaceutical giants, Mr. Thomas had argued that the pricing policy formulated by big pharma lacks a principled rationale.
Against this backdrop, the Indian Patent Office’s recent rejection of Pfizer’s application for the grant of a patent for Xtandi is a welcome development which could not have come at a more opportune time.
The drug is presently sold in India at a whopping 3.35 lakh per month by Japan’s Astellas Pharma, translating to roughly $180 or Rs. 11,000 per day, as Knowledge Ecology International notes.
This being the case, the Patent Office’s decision is likely to play an instrumental role in significantly bringing down the cost of the drug.
The rejection comes in the wake of a large array of pre-grant oppositions that were filed by such known stakeholders as Indian Pharmaceutical Alliance and BDR Pharmaceuticals Limited.
As a perusal of the IPO’s Order indicates, the grounds of opposition were, broadly, threefold: that the subject matter of the application was not novel; that it did not involve an inventive step; and it did not constitute an invention on account of, inter alia, being hit by Section 3(d).
On the issue of novelty, the Assistant Controller arrived at the conclusion that nothing in the prior art disclosed the structure of enzalutamide’s compound, inasmuch as the inventor was required to use appropriate substitutes in order to arrive at the claimed compound. Noting that such ‘picking and putting’ would make the invention novel, he rejected the argument of the opposing parties.
However, the application was rejected on two principal grounds: It lacked any inventive step and was hit by Section 3(d) and 3(e).
As regards the former, the Assistant Controller held that the claimed invention did not entail an inventive step over US patent 981 and 257, along with D1, a non-patented article, which were cited by opponent 1, inasmuch as it did not entail any non-obvious addition to the compounds envisaged by these documents. Further, claim 3 was found to be obvious in light of US Patent No. 578.
Similarly, since the invention lacked an inventive step and did not entail any material improvement in efficacy, it was also found to be hit by Section 3(d).
As Shreerupa Jha notes, this decision is consistent with India’s recent statement at the TRIPS Council, in which it urged all state parties to optimally use TRIPS flexibilities, transposed into their domestic statutes, in order to promote the robust growth of the generic industry.
Further, earlier this year, the Patent Office had granted a patent to Gilead for the hepatitis c drug, Sovaldi, which Prof. Basheer had strongly criticized on this Blog on the ground that the patent examiner had incorrectly applied Section 3(d) and had conflated the novelty and inventive step inquiries.
While the accurate appreciation and application of the law by quasi-judicial bodies is a desirable objective in all circumstances, its importance cannot be overemphasized in a situation where the decision of the authority is likely to have a material bearing on the health and safety of scores of patients in a very concrete way. Therefore, at a time when many stakeholders have lost confidence in the patent office’s ability to fully grasp the legal and technical issues that a patent application gives rise to, this decision can go a long way in undoing the damage that recent patent office decisions have caused.
In order to understand the full import of this development, it would be instructive to refer to the deleterious public health ramifications that have resulted from the patenting of Xtandi in the United States. At present, the drug costs a whopping $296 per day in the US, even though its research was largely funded by taxpayer-supported grants.
Earlier this year, a group of American senators, led by Bernie Sanders, had written a letter to the National Institute of Health and Department of Health and Human Services, urging them to consider overriding the patent on Xtandi to make it available at a more affordable price.
Explaining this move, Sanders had said that the United States Government “should use every tool available” for ending the era of pharmaceutical giants charging unconscionable prices.
In light of the fact that, if the transformative potential of this decision is fully realized, it is likely to result in Xtandi pills being made available at a paltry $2 per day in India, it would not be a hyperbole to hope that the decision will help end the era of unconscionable prices for good.
Not a good summary. There were five opponents in this case. Even obviousness summary by you is incorrect.
Again, all the five opponents argued on the basis of different documents / arguments, but documents cited by only one of the opponent was considered for refusing the application. Arguments /documents referred by all the other opponents has not been considered or discussed.
Hi Vishal,
Thanks for your comment. While there were undoubtedly five opponents, the gravamen of their claims was founded upon the 3 grounds that I delineated in the article. While other grounds of opposition were also raised, such as Sec. 25(1)(h), a perusal of the order indicates that the scope of the Assistant Controller’s inquiry was largely confined to these 3 main issues.
I would be curious to know why you think my obviousness/inventive step analysis is incorrect. While I would agree that the analysis is not as detailed as you may have been hoping for, the reason for that is that I wanted to examine the larger implications of the decision instead of dwelling too much on the intricacies of the holding.
Hi Rahul,
Please refer to para 12 i.e. Discussions On Grounds of Opposition (see order). More particularly para12.2 where Sec 25(1)(e) is discussed.
Ld. Controller specifically discussed D1 (a non-patent article) in combination with US patent 981 and 578 in a way as presented by opponent 1. Again, you would observe that it was only opponent 1 who cited these documents. Opponent 1 also attacked process claim 3 which was considered by the Controller [see para 12.2 (c)]. Ld. Controller finally concluded that “Claimed invention is lacking inventive step with reference to US’981 in combination with D1 AND US’981, US’257 in combination with D1.”
As mentioned earlier these documents were cited only by Opponent 1 but you missed to mention the name of opponent 1. Also there is apparent error in mentioning all the documents considered for inventive step.
I would appreciate if you could re-write the blog for your readers, as SpicyIP is being followed by many IP experts being a reliable source of information. A detailed summary is always welcomed!
Thanks Vishal. I have modified the relevant part of the article in order to capture the information that you alluded to.
We pride ourselves on our ability to consistently ensure that our analysis is factually and legally accurate, so constructive criticism is always welcome.