Drug Regulation Innovation Patent

Grant of Patent to Gilead for Sovaldi Challenged in Delhi High Court


As our readers would recall, we had analyzed the Indian Patent Office’s decision to dismiss the multiple pre-grant opposition claims and consequently approve Gilead’s application for the grant of a patent for its hugely important Hepatitis C drug, Sovaldi, last week. The 58-page decision, which was issued by the Deputy Controller Rajesh Dixit, virtually amounted to a complete U-turn by the Patent Office which had rejected Gilead’s application for Sovaldi last January.

The decision came in for sharp criticism, not only because it is founded upon tenuous legal reasoning, but also because it is likely to erect substantial barriers to access to a drug, sans which it would be impossible to defuse a public health crisis which the World Health Organization has described as a viral time bomb.

Indeed, as Doctors without Borders noted in a statement, the ruling “will block a sustainable supply of key raw materials needed to produce the drug … and affect production by new suppliers.”

Against this discouraging backdrop, the decision of US-based Initiative for Medicines, Access & Knowledge (I-MAK) and the DELHI Network of Positive People (DNP+) to challenge the grant of the patent to Gilead for Sovaldi in the Delhi High Court could not have come at a more opportune time.

As the Economic Times notes, the central argument of the petitioners is that the Patent Office’s decision is “Contrary to the public interest, fails to assess the full scientific and legal evidence presented and ignores key Indian patent law and judicial precedents.”

Explaining the rationale for the writ petition, Tahir Amin, the Co-Founder and Director of I-MAK said that the decision is being appealed because it is “flawed, ignores the scientific facts and fails to uphold the standards of Indian patent law to ensure only new inventions are patented.”

While it remains to be seen how this appeal eventually pans out, there are at least 3 compelling reasons why the Patent Office’s decision is likely to be reversed by the High Court.

First, as Shamnad Sir has rightly noted, the Deputy Controller’s decision suffers from 3 key legal infirmities that are unlikely to be upheld by the High Court.

First, the judgment conflates the enquiry for ascertaining the novelty of the drug with the enquiry for assessing the existence of inventive step, by holding that the fact that the drug was not anticipated by prior art, coupled with the fact that Gilead arrived at the present formulation on the basis of extensive experimentation, is sufficient for demonstrating that the inventive step threshold has been duly met.

Second, the Deputy Controller’s assertion that the drug demonstrates an enhanced layer of efficacy is unsupported by a cogent chain of reasoning; his conclusion is especially suspect in light of the fact that he did not offer any reasons that prompted the Patent Office to adopt a radically different view from its January 2015 holding, in which it had come to the conclusion that the main compound in Sovaldi has essentially the same use in treating HCV infection as existing drugs.

Third, considering that Gilead’s application for the patenting of Sovaldi was not able to pass muster in China, Ukraine or Egypt, it is difficult to fathom how the Deputy Controller arrived at a completely different finding from the rulings of patent offices in similarly situated countries.

Second, as Ritvik has pointed out, there is a widely held belief amongst those in the know that Hardev Karar, the IPO official who rejected Gilead’s application last year, was forced to withdraw from the re-examination of Gilead’s application by those in the higher echelons of power, who were afraid that allowing Karar to examine the application might result in a similar result.

Further, in a development that can hardly be called a coincidence, Gilead’s application was rejected last year immediately before President Obama’s visit to India, and its application has now been approved just before Prime Minister Modi is scheduled to travel to the U.S. Therefore, one expects the High Court to take note of the manner in which crucial determinations that affect the lives of millions of patients are dictated by political considerations and are not grounded in a principled appreciation of the material on record.

Finally, the appeal will offer the High Court an opportunity to ensure that different agencies, that are tasked with the responsibility of fostering innovation while also ensuring affordable access to medicines, do not end up working at cross purposes with each other. More specifically, the Patent Office’s judgment under discussion directly flies in the face of the National Pharmaceutical Pricing Authority’s recent decision to bring Sovaldi within the price control regime by imposing a ceiling of Rs. 619 per tablet. Therefore, by overturning this decision, the High Court will not only be able to authoritatively reaffirm the standards that must be met for inventions to be patentable, but will also be able to make it amply clear to pharmaceutical companies that their clever ploys to exploit hapless patients cannot withstand legal scrutiny.

Rahul Bajaj

Rahul Bajaj is a fourth year law student at the University of Nagpur. His interest in intellectual property law began taking a concrete shape when he pursued Professor William Fisher's online course on copyright law in the second year of law school. Since then, Rahul has worked on a diverse array of IP matters during his internships. He is particularly interested in studying the role of intellectual property law in facilitating access to education.

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