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Cipla Breached Patent Rights, Says Bayer

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German pharma major Bayer has charged that Indian generic drugmaker Cipla had breached its patent rights by slashing the price of a generic version of its patent-protected cancer drug Nexavar last week.

Bayer Pharma has not given its consent to Cipla to launch its generic Sorafenib (sold under the brand name Nexavar) and the company's decision to cut the price of the life-extending kidney and liver cancer drug "is a clear patent infringement," a Bayer spokesperson told PTI.

Bayer holds the patent for Nexavar till 2020 and it will "vigorously defend its patent within the available legal framework," the spokesperson said.

Cipla had slashed the prices by up to 76 per cent of its generic drugs, used in treating cancers of brain, lung and kidney. The price of 'Soranib' used for treating kidney cancer was cut by 76 per cent to Rs 1,710 "for a month's therapy", from Rs 6,990, Cipla had said in a statement.

The Delhi High Court is already dealing with a patent infringement suit filed by Bayer against the Indian company on March 15, 2010, in response to a decision of the Drug Controller General of India ( DCGI) to grant Cipla marketing authorisation for a generic version of Nexavar.

The next hearing to decide the course of the proceedings is scheduled for August 14, 2012, the spokesperson said.

Bayer Pharma also confirmed that it has launched a legal challenge to the compulsory licence issued by India in March this year to domestic drugmaker Natco Pharma to manufacture and sell a low-cost generic copy of Nexavar.

An appeal against the decision of the Controller General of Patents, Designs and Trademarks to grant a compulsory licence for Nexavar was filed with the Intellectual Property Appellate Board (IPAB) on May 4, it said in a press statement.

The order of the Indian patents office "damages the international patent system and endangers pharmaceutical research," the statement said.

"We will vigorously continue to defend our intellectual property rights, which are a prerequisite for bringing innovative medicines to patients."

The challenges faced by India's healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India's essential drugs list are not patented, Bayer said.

To facilitate access for patients to innovative treatments, Bayer has a Patient Access Programme in place since the launch of Nexavar in India in 2008, the statement said.

The Indian government invoked a trade rule of the World Trade Organisation (WTO) to issue the first compulsory licence to allow generic production of a patented drug to make it affordable to Indian patients.

The Trade Related Intellectual Property Rights (Trips) agreement under the WTO allows a government to grant compulsory licence to a domestic company to produce a generic version of a patented drug in "public interest".

The patent office had asked Hyderabad-based Natco Pharma to make available Nexavar to cancer patients a monthly dose of 120 tablets for Rs 8,800 rupees ($176) compared to Rs 2,80,000 ($5,500) charged by Bayer.

It also asked Natco Pharma to pay the patent-holder a six per cent royalty on the net sales of the cancer drug on a quarterly basis.

European medical relief and charity organisations have welcomed the Indian government's decision to issue the first compulsory licence for the generic production of a patent- protected drug.

They have said that such steps are necessary to make medicines not only for treating cancer, but also for HIV/AIDS and other diseases, affordable to the general public.

They pointed out that the current costs of Nexavar are unaffordable for many people even in Europe and without the support from national health services, many cancer patients would not have been able to receive the treatment.

(PTI)


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