Indian Court Nixes Bayer's Nexavar Patent Plea; Cipla Allowed To Market Generic Versions

MUMBAI - In a landmark decision that will further restrict multinational drug companies from introducing their internationally marketed brands in India, the Delhi High Court rejected German drug maker Bayer's plea to stop the Drug Controller General of India - the Indian drug regulator - from granting marketing approval to generic drug maker Cipla for kidney/liver cancer drug Nexavar (sorafenib).

The much awaited court decision also slapped a fine of 675,000 rupees ($14,062) on the German drug maker for legal costs to the government and Cipla. The full version of the verdict is expected to be published today.

Cipla Chairman Yusuf Hamied expressed satisfaction over the court ruling stating that Bayer's attempts to brand generic drugs as "spurious" has failed. "Cipla has been the lone fighter against attempts by multinational companies to create drug monopolies. More generic companies should come forward," he told PharmAsia News after the decision was made public.

Earlier, the Delhi High Court put on hold the generic drug approval on Bayer counsel's plea. The court in its earlier decision had said, "In case a license to market is granted to respondent [Cipla], the same would lead to multiplicity of proceedings besides it would lead to serious prejudice to the rights of the petitioner, who is the owner of the patent."

A Bayer India official was critical of the latest judgment and said the company will follow the next legal option available. "Bayer is disappointed and disagrees with the court's decision and will consider its legal options in this regard," he said hinting that the case will now go to a joint bench.

Cipla, Cancer Patients Aid Association and the Indian Pharmaceutical Alliance were jointly fighting the case against Bayer (Also see "Cipla Challenges Delhi Court’s Decision Restraining India’s Drug Controller From Granting Marketing Nod For Sorafenib" - Scrip, 13 Jan, 2009.).

Shamnad Basheer, a professor at Kolkata-based National University of Juridical Sciences said the much-awaited decision allows the drug regulators to carry on with their evaluation and approval process.

In one of his earlier blogs posted on Spicy IP, Basheer had said," If Bayer's argument were accepted, it would hit at the very essence of Bolar provision that is aimed at speeding up generic entry into the market and the availability of low cost drugs to the consumer."

Experts also opined that the Delhi court dismissed Bayer's pleas because unpatented drugs are not "spurious" as was made out to be by Bayer. With this, many more drug approvals can be speeded up while patent cases can continue to follow a different track in the courts.

Multinational companies - represented by the Organization of Pharmaceutical Producers of India - have argued that linking the regulatory process with patents is important to protect the rights of innovator drug companies. "It cannot be that the generic drug is approved even if the patents are in force. The two are contradictory points," an executive with a multinational company noted.

Health activists have clamored that allowing generic versions of costly anti-cancer drugs will save patients from expensive drugs. Cipla's generic version of Nexavar is expected to be priced at half of the innovator's prices.

Novartis' Glivec (imatinib) and Roche's Tarceva (erlotinib) have been challenged by Indian drug companies and health activists.

- Vikas Dandekar ([email protected])

[Editor's note: PharmAsia News will host a webinar Sept. 24 on the commercial and intellectual property implications in India after the patent of Novartis' Glivec was rejected for not demonstrating significantly enhanced efficacy.]