Patent

Delhi HC Seeks Explanation for Denial of Xtandi Patent


The Delhi High Court passed a pertinent order on 2nd March, 2017 in the case of The Regents of the University of California v. Union of India (read the order here).

While the order does not go into details, and merely directs the counter-affidavit to be filed within four weeks, media reports indicate that the Court has asked the Centre to explain on what basis the Indian Patent Office rejected the University’s patent application for Xtandi, their prostate cancer drug. Justice Sanjeev Sachdeva reportedly questioned the decision as follows: “How does the official (of patent office) substantiate his order? What is the evidence based on which he passed the order?” We’re not very sure of the accuracy of this statement, as it is not mentioned in the order, and will have to wait till the next date of hearing for more clarity on the actual court proceedings.

The University claims to have invented Xtandi, a drug used in the treatment for prostate cancer, (read our previous posts on this drug here), and to have secured patents in over 50 jurisdictions since 2007. Xtandi is sold in India by Japan’s Astellas Pharma, reportedly at INR 3.35 lakh per month. The University filed a patent application for the same in 2007, which was rejected in November last year. (Read Rahul’s post here, and the IPO order here.) The application was rejected following a number of pre-grant oppositions filed by stakeholders including the Indian Pharmaceutical Alliance, and BDR Pharmaceutical International Pvt. Ltd. The application was rejected on two primary grounds: that it lacked inventive step, and was hit by Sections 3(d) and 3(e) of the Patents Act.

Media reports indicate that the present writ petition was filed by the University on the ground that the IPO did not consider evidence that they had submitted, and it was contested that the application be remanded for consideration of the same. This appeal by way of a writ petition is one of the two routes that aggrieved parties can take in such a situation, the other being an appeal to the IPAB, followed by a Special Leave Petition to the Supreme Court. The integral difference between the routes, as I’m given to understand – is that the present route allows the applicant the additional review of the IPO decision.

The IPO’s grant of a patent to Gilead’s Sovaldi was similarly challenged at the Delhi High Court in May, 2016. However, it was here argued that the IPO decision was “contrary to public interest”, and failed to assess the full scientific and legal evidence presented, as well as ignored precedent on the matter. This petition is yet to be concluded.

We will have a clearer picture on this petition when a more detailed order is released. However, it should be kept in mind that this challenge should not go beyond the merits of the order passed by the IPO, and should confine itself to the order itself. Moreover, the patentability of this drug should not be based on the question of its arguably exorbitant price, and must be decided independent of that fact.

Image from here.

Inika Charles

Inika is a fourth year student at National Law University, Jodhpur, and is on the founding Board of Editors of the Journal of Intellectual Property Studies. She has a strong interest in Intellectual Property, and is fascinated with the intersection of IP with Technology and Media law. Annoyingly insistent that you pronounce her name right, (Eye-nika); she's an avid football fan, and is very appreciative of dark humour and Game of Thrones theories. You can contact her at [email protected], or on Twitter: @inikacharles

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