Swiss company Actelion moves US court against Natco Pharma over generic of its patented drug

Hyderabad: Swiss pharma company Actelion Pharmaceuticals Ltd has filed a petition in a US court alleging that Natco Pharma and its US partner Syneos Health LLC are attempting to come out with a generic version of its patented drug Tracleer (Bosentan) tablets for oral suspension (dispersible tablets) of 32 mg.

In the petition on May 28, Actelion alleged that the Indian drugmakers proposed generic Bosentan 32 mg will infringe upon the patent and requested the court to pass an injunction order against manufacturing, importing and selling that drug in the USA.

Bosentan is a prescription medicine used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) in adults and children of three years of age and older.

The US arm of Actelion urged the US court to grant a preliminary and permanent injunction enjoining the defendants, their officers, partners, agents, servants, employees, parents, subsidiaries, affiliate corporations and other business entities from making, using, selling, offering to sell, marketing, distributing, or importing into the United States the Natcos copycat version of Bosentan 32 mg, before the expiry of the patent.

It also sought damages or other monetary relief, including pre-judgment and post-judgment interest, if the defendants engage in the commercial manufacture, use, sale, offer to sell, marketing distribution, or import of the proposed generic version of Bosentan 32 mg, before the expiry of the patent.

Actelion Pharmaceuticals is the lawful owner with all right, title and interest of the Tracleer (Bosentan) tablets for oral suspension (dispersible tablets) of 32 mg, the petition said.

On April 16, Natco Ltd had informed the plaintiff that it had submitted to the FDA the Abbreviated New Drug Application(ANDA) for Bostenan tablets for oral suspension of 32 mg, the petition said.

Actelion is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Under paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiry of patents related to the brand-name drug that the generic seeks to copy.

According to pharma analysts, patent infringement cases are not uncommon for generic drugmakers in USA and the lawsuit would not have any implications on the performance of the company.