Blow to another MNC as patent for GSK's drug revoked

Prices to come down, say patient associations

The Intellectual Property Appellate Board (IPAB) has revoked a patent granted to GlaxoSmithKline for its anti-breast-cancer drug Tykerb.

The drug’s global sales are estimated at £239 million, of which the Indian market accounts for one per cent.

The IPAB move is seen as jolt to another multinational pharma company in the country after the Supreme Court had in April rejected patent protection for Swiss major Novartis’ anti-cancer drug Glivec.

The IPAB decision came even as it upheld, citing innovative merit, a patent granted to GSK on lapatinib, the original compound of which Tykerb is the salt.

Earlier, GSK had cut prices of Tykerb by a third in India. The GSK Pharma stock on Friday slipped 2.8 per cent from its previous close to end the say at Rs 2,271 on the Bombay Stock Exchange.

In India, a strip of 10 Tykerb tablets costs Rs 3,600-4,000. A patient in an advanced stage of breast cancer is normally prescribed five tablets a day for one month. Experts say its high pricing has kept the drug’s sales low in the country.

IPAB’s decision came following a post-grant opposition to the Tykerb patents from Fresenius Kabi Oncology — the Indian unit of German healthcare group Fresenius SE — which said both molecules lacked innovation.

A GSK India spokesperson said the company was disappointed with the IPAB decision. “The ruling only relates to the lapatinib ditosylate salt patent in India and does not affect our basic patent for Tykerb or corresponding patents in other countries,” he added.

“We are studying the IPAB decision but maintain our belief in the inventiveness of the lapatinib ditosylate salt and will consider the possibility of taking further steps before the appropriate authorities to validate this,” the spokesperson said.

The corum of IPAB, comprising Chairman Justice Prabha Sridevan and Technical Member (Patent) D P S Parmar, ordered that the claimed invention of a salt variation of the drug, under Patent No IN221171, Lapotinib ditosylate, “is obvious and is hit by Section 3(d) and Patent No 221171 is revoked.” The revocation petiton was based on the ground of obviousness, insufficiency of description, non-patentability and non-disclosure under Section 8 of the Patents Act, 1970.

The country’s patient associations, on the other hand, have welcomed the IPAB decision. Y K Sapru, Chairman & CEO, Cancer Patients Aid Association, said: “In a majority of cases, one month’s treatment costs more than Rs 20,000. And, normally, the treatment needs to be had for a prolonged period. We are very happy with this decision. It will make the drug affordable and help save precious lives of thousands of cancer patients. Besides, this decision will set a good precedent against evergreening of older compounds the patents for which have expired.”

Similar to the rejection of Novartis’ patent on imatinib mesylate (Glivec), IPAB rejected GSK’s patent by applying the clause of Section 3(d) of 2005. According to section 3(d), inventions that are mere discoveries of a ‘new form’ of a known substance and do not result in increased efficacy, are not patentable.

Multinational companies, which have felt the heat through recent rejection of their patents, remain disappointed on the latest IPAB decision.

Tapan Ray, director-general, Organization of Pharmaceutical Producers of India (OPPI), the largest body for MNC drug makers in India, said: “Such incidents are indeed very disappointing. Revocation of patents, especially of globally acclaimed molecules, not only creates uncertainty and unpredictability in the intellectual-property (IP) ecosystem of a country but also invites doubts on its IP machinery. Such revocations in India, close on the heels of one another, further strengthen apprehensions of innovator companies and will not help patients, either.”

Last year, regulators had revoked patents granted to Pfizer Inc’s anti-cancer drug Sutent, Swiss major Roche’s anti-hepatitis C drug Pegasys, and Merck & Co’s asthma treatment aerosol suspension formulation.
BITTER PILLS FOR MNCs
Oct ‘12: Patent office revokes patent for Pfizer’s anti-cancer drug Sutent; IPAB holds decision
Nov ‘12: IPAB revokes Roche’s Indian patent on anti-hepatitis C drug, Pegasys
Nov ‘12: IPAB upholds patent office’s decision to deny patent protection to AstraZeneca’s anti-cancer drug Gefitinib
Dec ‘12: Patent office rejects Merck’s anti-asthma drug’s aerosol suspension formulation
Mar ‘13: IPAB upholds compulsory licence issued to Natco Pharma to make generic of Bayer’s anti-cancer drug Nexavar
Apr ‘13: SC refuses patent protection for Novartis’ anti-cancer drug Glivec