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6 February 2020Big PharmaEdward Pearcey

Biogen fights off Mylan’s Tecfidera patent challenge

US multinational biotechnology company Biogen has successfully defended multiple sclerosis treatment Tecfidera from a patent challenge brought by generic and specialty pharma company Mylan.

Biogen shares surged to over $346 immediately after the decision was announced, having dipped to £$334 earlier in the day.

The Patent Trial and Appeal Board ( PTAB) upheld the validity of its patent on Tecfidera (dimethyl fumarate), rejecting Mylan’s calls that it should be invalidated on the grounds of obviousness.

Tecfidera is a disease modifying drug (DMD) for the treatment of relapsing remitting multiple sclerosis, generally characterised by relapses that last at least 24 hours.

Mylan had filed an inter partes review seeking to remove the last remaining Tecfidera patent. However, the Netherlands-based company did not “demonstrate, by a preponderance of the evidence, the unpatentability of the claims” it had challenged, the PTAB found.

Mylan argued that the active ingredient in Tecfidera (dimethyl fumarate) and its effects had been commonly known for years, and the dosage form was predictable.

Biogen argued that its trials showed a variation of the effects for different dosage levels, revealing that the effects of the drug were, in fact, not predictable.

In 2019, Tecfidera earned over $4.4 billion for the US drugmaker, almost a third of its global sales. Biogen’s 2019 revenues grew 7%, driven by “growth in all core business areas”, according to its latest financial results.

According to media reports, Mylan is considering filing an appeal with the PTAB, and is currently challenging the Tecfidera patent in Southern District Court of West Virginia. It continues to argue that Biogen’s patent is invalid.

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More on this story

Americas
9 July 2020   In the high stakes world of life sciences, the strength of a company’s IP portfolio can determine the value of a corporate transaction, argue Jonathan Harris and Nisan Zaghi of Axinn, and Ian Lodovice of Biogen.
Americas
19 March 2020   Biogen and the University of Zurich have accused New York-based Creative Biolabs of unlawfully selling copies of Biogen’s aducanumab antibody.
Americas
23 June 2020   Mylan has succeeded in having a key Biogen patent covering multiple sclerosis drug Tecfidera invalidated by a US federal court.