District Court Rules Against Teva in Copaxone Patent Lawsuit

January 31, 2017
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Teva said it plans to appeal a district court decision that invalidated several of the company’s Copaxone patents.

Teva suffered a blow on Jan. 30, 2017 after a United States District Court in Delaware invalidated several of the company’s patents for Copaxone (glatiramer acetate injection) 40 mg/mL, the company’s blockbuster multiple sclerosis treatment. In

, Teva alleged infringement on four Copaxone method-of-use patents ’250, ‘413, ‘776, and ‘302 by five of six abbreviated new drug application (ANDA) filers.

The district court decision opens Copaxone 40 mg/mL up to generic competition. In a 2017 financial outlook, Teva said it did not expect the drug to face competition in the US this year; however, it did note that the entry of two AB-rated generic competitors in February 2017 could reduce revenues for Copaxone by $1.0 billion to $1.2 billion.

Heather Bresch, CEO of Mylan, one of the defendants in the suit, called the decision a “positive step” in Mylan’s efforts to bring generic versions of Copaxone to market. In a statement, Mylan said it believes it is one of the first companies to file an ANDA containing Paragraph IV certification for a three-times-per-week glatiramer acetate injection.

An appeal on the horizon?

Teva has already said that it has plans to appeal the court’s decision. Despite this announcement, Umer Raffat, an analyst at Evercore ISI, said in a note to investors that there may not be any hope in the appeals process. “Both IPR and district court have been unfavorable…and both rulings don’t appear to leave much room for ambiguity,” he noted.

Raffat pointed to inconsistencies between testimony and Teva’s Gala protocol, saying this supports the idea that the company was aware of the rush to patent a “more tolerable” version of the drug. He continued, “The court sees the '250, '413, '302, and '776 patents as nothing more than ‘life-cycle management’-an attempt to continue to monopolize a multi-billion dollar market for a blockbuster drug.” Bloomberg reports the Teva’s shares fell to the lowest in more than a decade following the district court’s decision.

Source: Teva, Mylan, US District Court of Delaware, Evercore ISI