photo-teva-2
Photo: Courtesy of Teva
22 June 2015Americas

Teva’s Copaxone patent invalidated for second time

A US appeals court has for the second time invalidated a patent covering pharmaceutical company Teva’s multiple sclerosis drug Copaxone (glatiramer acetate).

In a 2-1 decision handed down on Thursday, June 18, the US Court of Appeals for the Federal Circuit invalidated the patent for the drug, which has faced competition from companies keen to market their own generic versions of it.

The dispute centred on Teva’s US patent number 5,800,808, which covers a process for manufacturing Copaxone’s active ingredient.

It was the second time the federal circuit has ruled on the patent, after its original decision to invalidate it in 2013 was reversed by the US Supreme Court in January this year.

The US Supreme Court said the appeals court, which reviewed the claims de novo, took the wrong approach. Instead, the Supreme Court said, the federal circuit should have applied the clearly erroneous standard.

But, assessing the case again, the federal circuit came to the same conclusion.

The court said: “A patent is indefinite ‘if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.’

“The patentee has failed to inform with reasonable certainty those skilled in the art about the scope of the invention,” the court added.

Teva had not responded to LSIPR’s request for comment at the time of publication, but we will update the story should the company get in touch.

However, a spokesperson told Reuters that it is “committed to pursuing all legal pathways, including seeking further appellate review.”

The ‘808 patent was due to expire in September 2015.

The judgment is the latest development in a dispute between Israel-based Teva and generic drug makers Sandoz and Mylan.

In 2013 the US District Court for the Southern District of New York ruled that Teva’s patent was valid.

Sandoz appealed against the decision to the federal circuit.

After reviewing the claim construction de novo, the federal circuit agreed with Sandoz and invalidated the patent.

Teva appealed against the decision to the Supreme Court, which then sent the case back to the federal circuit, prompting the latest judgment.

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More on this story

Americas
20 January 2015   The US Supreme Court has vacated an appeals court judgment that invalidated a patent covering Teva’s blockbuster drug Copaxone (glatiramer acetate).

More on this story

Americas
20 January 2015   The US Supreme Court has vacated an appeals court judgment that invalidated a patent covering Teva’s blockbuster drug Copaxone (glatiramer acetate).

More on this story

Americas
20 January 2015   The US Supreme Court has vacated an appeals court judgment that invalidated a patent covering Teva’s blockbuster drug Copaxone (glatiramer acetate).