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IN A major win for Indian pharma companies, the Delhi High Court (HC) has dismissed German drug major Bayer Healthcare’s attempt to stop the Drug Controller General of India (DCGI) from giving marketing approval to Indian company Cipla for the generic version of Bayer’s patented kidney cancer drug, Nexavar.

The HC also asked the German firm to pay Rs 6.75 lakh to the government and Cipla as legal cost.

Cipla joint MD Amar Lulla said, “It’s a fair, logical and historic decision and patients will benefit from the ruling.”

Bayer has hinted that it would challenge the court’s decision. “Bayer Healthcare is disappointed and disagrees with the court’s decision and will consider its legal options in this regard,” Aloke Pradhan, VP (corporate communications), Bayer Group India, said.

A decision favouring Bayer in the case would have given legal mandate to the demand of global pharma majors to withhold marketing approval to low-cost drugmakers for patented drugs, making it an entry barrier for Indian companies.

But the Delhi HC’s ruling allows companies to launch generic versions of patented drugs with the risk of paying damages, if found guilty of patent infringement.

Last November, the Delhi HC had prevented DCGI from giving marketing rights to Cipla for the generic version of Nexavar after Bayer alleged it would infringe upon its patent. It also said Cipla’s drug was spurious. In a 31-page ruling, the court said it cannot “conclude that unpatented drugs are spurious drugs”.

Other Indian cos to benefit

“THIS court is constrained to observe that the present litigation was what may be characterised as a speculative foray,” it ruled. The German firm got the patent for the drug (chemical name sorafenib tosylate) in India in March 2008. Indian patent laws provide the patent holder exclusive marketing rights for 20 years with no competition from generic low-cost companies. Cipla’s lawyer for this case, Pratibha Patil, said that the HC dismissed Bayer’s pleas because unpatented drugs are not spurious drugs and the company’s petition was an attempt to tweak public policy. Generic companies and health activists argue DCGI’s role is limited to regulating safety and efficacy of medicines and patent is a separate issue.

   But the global pharma lobby Organisation of Pharmaceutical Producers of India says patent enforcement is the responsibility of the government and allowing a violation is not the correct way to improve access to affordable modern medicines to the common people.

   Anand Grover, representing the Cancer Patients Aid Association in the case says the introduction of patent linkage system “would have seriously impacted the early entry of generic drugs into the market”. Now, this ruling will also strengthen the case of Indian companies, such as Hetero Drugs against US-based Bristol-Myers Squibb’s (BMS) engaged in a similar legal case. In a separate case, Cipla had also challenged Bayer’s patent for Nexavar. Mr Pradhan said Bayer “intends to defend the patent vigorously”. A favourable ruling will allow Cipla to sell its drug not only in India but also in countries where Bayer does not hold a patent. Nexavar, is one of Bayer’s most promising drugs, and expected to rake in $1 billion in annual sales.

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