22 CASE REPORT


LSIPR Newsletter 02:13


INDIA: THE SUNITINIB CASE


Sugen’s patent for anti-cancer drug sunitinib has been revoked by the Indian Patent Office. Ranjna Mehta-Dutt and Swarup Kumar at Remfry & Sagar explain the details of the matter.


In October 2007, Sugen Inc was granted a patent for anti-cancer drug sunitinib (Patent No. 209251) by the Indian Patent Office (IPO). In September, 2012, this patent was revoked by the IPO on grounds of obviousness in a post- grant opposition proceeding filed by Cipla. Te patentee challenged this decision by filing a writ petition before the High Court of Delhi primarily claiming that principles of natural justice were not followed since the opposition board’s recommendations were not supplied to it for rebuttal.


During the pendency of the writ, the Delhi High Court granted an order restraining Cipla from marketing a generic version of sunitinib, against which Cipla appealed at the Supreme Court. Te Supreme Court in November 2012, liſted the injunction against Cipla and directed the Controller to dispose the post- grant opposition aſter giving both parties an opportunity to present submissions on the joint recommendations of the opposition board.


Accordingly, fresh hearings were conducted by the Controller of the IPO eventually leading to


the issue of a decision revoking the patent of Sugen Inc.


What are the issues at stake in the case?


Tere were primarily two issues:


(1) Whether the invention claimed in Patent No. 209251 was obvious or not in view of the documents cited by Cipla during the post grant opposition; and


(2) Whether appropriate information in accordance with the requirements of Section 8 of the Patent Act was disclosed by the patentee or not.


What did the Controller decide?


Te Controller upheld the recommendations of the opposition board that the invention claimed in the patent did not involve inventive step and was obvious to a person skilled in the art in view of cited prior art.


To elaborate, it was held that invention claimed was obvious in view of documents


Life Sciences IP Review


D1 (US5886020), D2 (WO9850356) and D3 (WO9961422). Interestingly, all the three cited documents are in the name of Sugen, Inc. The Controller observed that teaching of D1 and D2 could be modified to introduce the polar group Z taught by D3 to formulate a compound which does not possess the (alkyl) group but retains the protein tyrosine kinase inhibitory activity. The Controller also relied upon the fact that the compounds disclosed in D1, D2 and D3 were used for treatment of the same category of disease as the impugned patent.


On the second issue, the Controller held that the patentee had fulfilled its duty to furnish all the information required under Section 8. On the allegation by the opponent that many details/documents were not furnished to the IPO, the Controller held that “Te details cited by the opponent are from the World Intellectual Property Organization (WIPO) website and espacenet which is freely available to the Controller and Examiner.” Terefore, this ground for revocation was not maintainable.


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