GlaxoSmithKline loses cancer drug patent in India

MUMBAI: MNCs, which often complain about India’s stringent patent regime, have finally started using law to their own benefit. On Friday, the Intellectual PropertyAppellate Board (IPAB) revoked the patent for UK drug major GlaxoSmithKline’s (GSK) anti-cancer drug Tykerb in its salt form. The court said that the drug failed to show significant improvement in the efficacy.

The Indian subsidiary of German drugmaker Fresenius Kabi moved the IPAB challenging the patent of lapatinib and lapatinib ditosylate salt, the key ingredient in Tykerb. The IPAB upheld the patent for lapatinib, but shot down the salt version of the ingredient.

Tykerb is used in the treatment of breast cancer and costs 4,160 for 10 tablets. The IPAB used the Novartisjudgement as a benchmark to quash the patent for the salt form, citing Section 3d of the Indian Patents Act 2005, which deems any incremental innovation non-patentable.

“As regards the S.3 (d) bar, the respondent’s own statements and the expert’s affidavit demonstrate that this invention cannot be held to have enhanced therapeutic efficacy,” the IPAB said.

“We are pleased that the Intellectual Property Appellate Board (IPAB) in India has upheld our basic patent for the lapatinib compound, the active ingredient in Tykerb,” a GSK spokesperson told ET.

“We are, however, disappointed that the IPAB has revoked our expiring patent for the lapatinib ditosylate salt. This latter 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,” it further added.

GSK has said that it still believes that the patent for the salt is valid and will consider appealing the case. The patent for Tykerb is valid till 2019, the company said.

This judgement comes at a time when India’s patent laws are being severely criticised by MNCs which have been thwarted in their attempts to launch their patented drugs in India by the IPAB. The board has used Section 3 (d) of the Act to declare some drugs as not meeting the standards of the Act.


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