Recent decision of Delhi High Court in the case of GILEAD PHARMASSET, LLC V. UNION OF INDIA & ANR

23rd February, 2015 - 7:46 am Categories: IP Practice in India News & Updates Patents pharma Section 3(D) 0 Comments

Recently, the Delhi high court on dated 30^th January 2015 set aside an order of the Deputy Controller of Patents and Designs. The impugned order rejected a patent to US drug maker Gilead for its hepatitis C drug “Sovaldi” on dated 13^th January 2015.

Facts of the case:

M/S GILEAD PHARMASSET, INC, USA, filed a patent application on 30/05/2003 in USA and the corresponding application was filed in India through PCT on 27/12/2005 vide application no. 6087/DELNP/2005 (“A (2’R)-2′-DEOXY-2’FLUORO-2′-C-METHYL NUCLEOSIDE”). Two Entities, NATCO Pharma Ltd. and Delhi Network of Positive People +IMAK filed applications for pre-grant opposition, under Section 25 of the Act on dated 13 March 2014 and 17 March 2014 respectively. On 13th January 2015, the Patent Office rejected Gilead’s Hepatitis C drug, sofosbuvir (Sovaldi) on the basis of it failing to clear Section 3(d) of Indian patent act 1970 which prevents evergreening of patents and provides that no new form of an existing substance shall be patented unless the new form is more effective than the old one. Being aggrieved by the order, the GILEAD filed the present writ petition under Article 226 of the Constitution of India.

Arguments advanced by the petitioner:

It was argued by the Counsel for the applicant that while passing the impugned order, Indian Patent Office (IPO) had taken recourse to the material and objections, which were placed on record by the applicants, who had filed their applications to oppose the grant of patent to the petitioner, under Section 25 of the Act. Further it was submitted that this aspect, was clearly demonstrable from the fact that, not only the grounds taken in opposition and documents cited were considered, while passing the impugned order, but even, the typographical errors contained in the applications, filed under Section 25 of the Act, got incorporated in the said order.

It was further contended that the once notice was issued to the petitioner for a hearing under Section 14 of the Act, to consider, whether to grant a patent as requested, IPO should also have heard the petitioner regarding objections raised in the application, under Section 25 of the Act. The learned counsel contended that, while documents in opposition filed by the entities, which had preferred applications under Section 25 of the Act were supplied, no opportunity, was given, to meet the objections raised by them.

Further it was submitted that the impugned order, had created a peculiar situation whereby, while it had returned a finding that the claims presented by the petitioner represented “novelty and inventive steps”, it sustained, the challenge, under Section 3 (d) of the Act, though the applicants, which had opposed grant of patent, had raised objections, on both counts.

Arguments advanced by the Respondent

On the other hand, the opponent contended that the exercise carried out by IPO under Section 14 and 15 of the Indian Patent Act, is quite different, from that, which IPO carries out while hearing applications filed under Section 25 of the Act. Further it was submitted that, while the material and/or objections filed by opponents, which had preferred applications under Section 25 of the Act, was supplied to the petitioner, IPO did not rely upon the same, while passing the impugned order.

Decision of the Hon’ble Court:

The hon’ble court observed that while petitioner’s request for a hearing under Section 14 of the Act was pending, two pre-grant oppositions were filed. Though, the documents filed by the opponents were supplied to the petitioner, no notice was issued to the petitioner with regard to the applications filed under Section 25 of the Act. Therefore, when hearing under Section 14 was finally granted to the petitioner on 24.07.2014, there was no clarity as to the extent and scope of objections, which it was required to meet while pressing ahead with its request for grant of patent. The petitioner, at best, would have prepared itself to rebut the objections raised in the FER. Further the court observed that combining S. 25 and the S. 14 proceedings, if Gilead would have been given an opportunity to be heard on both counts, it could have save not only time, effort but also have avoided the allegation of bias.

 The court accepted the Gilead’s claim and set aside the impugned order given by IPO and remanded for a fresh decision. The court also ordered IPO to fix a date of hearing both for Sections 14 and 25 proceedings and asked to send written communication to all concerned parties including the petitioner.

 Thus it would be interesting to see the decision by IPO after fresh consideration to the facts and circumstances in view of the fact that Gilead has already entered into license agreements with Generic companies of India for the drug “Sovaldi” as per the reported news in September 2014.

About the Author: Mr Sitanshu Singh, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:Sitanshu@khuranaandkhurana.com