NATCO Pharma Faces Infringement Claim by Taiho over Cancer Drug

Natco Pharma is again in news and surprisingly for nearly same pharmaceutical field. Taiho Pharmaceutical, a Japanese pharmaceuticals company and its group company have moved a US court against Natco Pharma, alleging that the Indian drug maker was attempting to come out with a generic version of its cancer medicine ‘Lonsurf,’ before expiration of its patent.

In a petition filed in the District Court of Delaware on December 30, Taiho alleged that the Indian drug maker’s proposed generic Lonsurf (trifluridine and tipiracil) will infringe the patent and sought the court to pass an injunction order against manufacturing, importing and selling that drug in the US.

Taiho Oncology, Inc. sells and distributes Lonsurf in the United States, while Taiho Pharmaceuticalis the owner of all the right, title, and interest of the patent.

As per Taiho Oncology, Natco infringes the patent on Lonsurf drug at least on six counts although Natco has explained themselves by informing the Japanese drug major that its ANDA will not infringe the patents through ‘Paragraph IV notice letter.’ Under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration ofpatentsrelated to the brand-name drug that the generic seeks to copy.

In India, Natco has won a case for a cancer drug ‘Nexavar’ in 2013 against Bayer where the Intellectual Property Appellate Board (IPAB) upheld the grant of compulsory licence (CL) to the Hyderabad-based Natco Pharma Limited, to produce and market Nexavar, the patented cancer drug of multinational pharma major Bayer Corporation. The order has paved the way for reduction in the prices of costly life saving drugs.

Such practices are fairly common in pharmaceutical field and does not hamper sales of generic drugs or company itself, as per experts in domain. Meanwhile, Natco Pharma in a filing with bourses said it believes that it was one of the first ANDA filers for the product and could be eligible for 180 days exclusivity under certain circumstances.

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