Hyderabad:
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 Pharmaceutical is the owner of all the right, title, and interest of the patent.
The Japanese company sought the court to pass an injunction order enjoining Natco from attempting to manufacture or sell Lonsurf in the US.
Earlier in November, 2019, through a letter to Taiho, the Indian drug maker notified that it submitted ANDA (abbreviated new drug application) to the US FDA seeking approval to engage in commercial manufacture and sell the generic version in America prior to the expiration of the patents-in-suit, the petition said.
Taiho further alleged that Natco’s proposed ANDA violates the Lonsuf’s patents on six counts.
Natco informed 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 of patents related to the brand-name drug that the generic seeks to copy.
A senior official of a city-based pharmaceutical company said patent infringement cases in the US are not uncommon for generic drug makers and the lawsuit will not have any implications on the performance of the copycat makers.
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.
Lonsurf has recorded sales of USD 150 million for the year ending December 2018 in the US market, it said quoting marker reports.
