7 September 2017Americas

Forward Pharma files opening brief against PTAB Biogen decision

Forward Pharma has filed its opening brief in an appeal against a decision by the Patent Trial and Appeal Board (PTAB).

In March, the PTAB ruled that the claims of Forward Pharma’s patent application 11/576,871 were not patentable due to a lack of adequate written description.

The patent application covered a method of treating multiple sclerosis with a 480mg per day dose of dimethyl fumarate.

Biogen, the other party in the dispute, owns US patent number 8,399,514, which covers its drug Tecfidera (dimethyl fumarate).

Forward Pharma filed its opening brief with the US Court of Appeals for the Federal Circuit on Tuesday, September 5.

Biogen’s response is currently due October 16, 2017. Following that, Forward Pharma is allowed a reply brief, currently due October 30, 2017.

An oral argument is expected to be held before the Federal Circuit in late 2017 or early 2018.

“We continue to believe that our IP is strong and that we have presented compelling arguments to have the PTAB interference decision reversed,” said Dr Claus Bo Svendsen, CEO of Forward Pharma.

In January this year, Biogen and Forward Pharma entered into a settlement and licence agreement under which Biogen paid Forward Pharma $1.25 billion.

The licensing agreement gives Biogen an irrevocable licence to all IP owned by Forward Pharma.

Under the settlement, Biogen will also pay Forward Pharma royalties on net sales of Biogen products for the treatment of multiple sclerosis that are covered by Forward Pharma’s patent.

Biogen’s patent was also at the centre of a dispute with Kyle Bass’s Coalition for Affordable Drugs.

In March, the PTAB held that the coalition had failed to prove that US patent number 8,399,514 was obvious and therefore did not show that it was unpatentable.

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