Patent Infringement: Cadila Healthcare, two others prohibited from launching Linagliptin Metformin Hydrochloride tablets

AHMEDABAD: In a major setback, three Gujarat based pharmaceutical companies including Cadila Healthcare, West Coast Pharmaceutical Works Ltd and Maan Pharmaceuticals Ltd have been temporarily prohibited from manufacturing and launching in the market Linagliptin tablet and Fixed Dose Combination (FDC) of Linagliptin and Metformin Hydrochloride tablet over patent infringement of a German Company, suggests a media report. The formulations are indicative of treating Type-2 diabetes.

The Commerical court has presently restricted the launch, make or sell of the said product by these drugmakers. The court has issued notices to all three companies and sought their replies by April 25.

The move comes in following a lawsuit filed by the German Pharma giant, Boehringer Ingelheim Pharma GmbH & Co KG. The matter originated after the company learnt via media reports about Cadila Healthcare seeking a tentative licence from the US Health Regulators to export the drug and getting a nod from the U.S Food and Drugs Administration (USFDA). In October 2018, Cadila had reportedly informed the Indian bourses about the same.

On learning this, Boehringer filed an application immediately under the Right to Information (RTI) Act to find out if the drug regulators had granted a license to the three Gujarat based companies to launch the diabetes medicine in the market.

Boehringer has claimed a patent on Linagliptin Metformin Hydrochloride tablets which was obtained from the Controller of Patents in January 2009 and October 2010. The company claimed that it holds the patent for Linagliptin, which is valid for the coming three years. The local companies have been asked to not manufacture even a generic version of the drug or any other product covered by the German company's patent.

Deliberating the case, the judge of the commercial court, Moolchand Tyagi, said that Boehringer Ingelheim has duly registered Linagliptin tablet and Fixed Dose Combination of Linagliptin + Metformin Hydrochloride tablets. The facts obtained under the RTI laws from the regulators of drugs disclosed that the drugmakers were about to launch the medicine, thus infringing on the patents of the German company.

According to TOI, the judge further said, "In my considered view, the plaintiff has a prima facie case in its favour and balance of convenience also lies in its favour. If the plaintiff is not granted ex-parte ad interim injunction, it would cause irreparable loss to the plaintiff and further, it will cause prejudice to the rights of the plaintiff. Further delay in granting protection would cause hardship and defeat the object of the suit."

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