Patent Office refuses Eli Lilly's application for anti-cancer drug

Pemetrexed, under the brand name Alimta, is currently used to treat non-small cell lung cancer, according to reports

The Patent Office has refused to grant patent for a crystalline form of Eli Lilly's cancer drug Pemetrexed, in favour of the pre-grant opposition filed by three pharma firms - Fresenius Kabi Oncology Ltd, Cipla Ltd and Glenmark Pharmaceuticals Ltd.

The opponent companies filed the pre-grant opposition on the grounds that the claimed invention was anticipated by prior publication, there is prior public knowledge or use, obviousness and lack of inventive steps and that it is not an invention within the meaning of the Patent Act, 1970, among others.

The order, however, says that Eli Lilly did not respond to the opposition filed by the other pharma firms or attend the hearing held by the Patent Office and later informed that it is not pursuing the application.

"In the light of the statement and technical explanations provided by the opponent during hearing and analysis of the same provided as above, I decide that the claimed 'invention' although novel does not involve inventive step and also not patentable under section 3(d) of the 'Act. Therefore, I accept the representation filed by opponent under Section 25(1) & Rule 55(1) and refuse the grant of patent....," said the order issued by Soumen Ghosh, Assistant Controller of Patents & Designs, Patent Office.

The hepta-hydrate form has been claimed as more stable form with respect to solvent content (acetone / water) as required for the preparation of the pharmaceutical formulation along with other ingredients.

The company sells drug Pemetrexed under the brand name Alimta, for non-small cell lung cancer which said to be not responsive to many other medicines. According to a report of Reuters in June 25, 2015, Alimta posted sales of $2.79 billion globally during 2014.

Eli Lilly has filed the national phase application on June 24, 2002, of an international application, with the Patent Office, Kolkata, which was published in the Journal of the Patent Office, on March 11, 2005. The First Examination Report (FER) was issued on November 11, 2005, on which the company filed a reply on May 2, 2006 along with amendment of claims.

The application was examined in the amendment stage and was in order as per the opinion of earlier controller. But the application was finally not granted and no patent number was granded, says the order.

Meanwhile, opposition was filed for the application and the same controller had communicated the notice of opposition to the applicant, following which the application was re-allotted.

While the notice of opposition was sent to Eli Lilly, the the company did not file any reply statement and while the opponent companies appeared for the hearing, the patent applicant did not appear for the hearing and later informed through e-mail that the company is not interested in pursuing the instant application, said the order.