US appeals court invalidates patent for Teva's Copaxone, allowing launch of Novartis, Momenta's generic

A US appeals court ruled that Teva's patent covering a method for manufacturing the multiple sclerosis (MS) drug Copaxone (glatiramer acetate) is not valid, Momenta Pharmaceuticals announced Thursday. Momenta indicated that the decision will permit the launch of its FDA-approved generic version of the therapy Glatopa, which was developed with partner Novartis. Momenta CEO Craig Wheeler stated "we are very pleased with the Federal Circuit's decision to declare Teva's manufacturing process patent invalid once again."

Novartis' Sandoz unit announced the US launch of Glatopa, which it said has begun shipping to customers. "Sandoz, together with Momenta, is proud to announce the US market launch of a fully substitutable generic version of this important therapy," commented Peter Goldschmidt, president of Sandoz US.

The FDA cleared Glatopa in April for the once-daily treatment of patients with relapsing forms of MS. Wheeler noted that Glatopa will be the first generic version of Copaxone to reach the US market. Sandoz has yet to provide details regarding Glatopa's price.

The approval followed a US appeals court decision that had shortened the period of patent protection for Copaxone to 2014, from September 2015 originally. However, the Supreme Court later directed the appellate court to reconsider its ruling after determining it had used the incorrect approach in invalidating the patent.

In January 2014, Teva received FDA approval to launch a three-times-a-week formulation of Copaxone. While announcing its first-quarter results earlier this year, the Israeli drugmaker disclosed that it had converted about two-thirds of patients to the new formulation.

Meanwhile, the FDA last August accepted the application for a generic version of thrice-weekly Copaxone developed by Mylan and Natco Pharma. Commenting on the latest appellate court decision, Mylan CEO Heather Bresch said "we continue to remain very confident in our application for our generic version of Copaxone and look forward to bringing our product to market upon approval from the FDA."

Bresch also suggested the "ruling underscores concerns with Teva's ongoing financial prospects, as Teva's Copaxone franchise has historically been its largest and most significant revenue driver." In April, Mylan's board of directors unanimously rejected Teva's unsolicited takeover proposal valued at $82 per share, or approximately $40.1 billion.

For related analysis, see ViewPoints: Why delaying generic Copaxone remains key for Teva, despite the success of its 'switch' strategy.

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