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21 September 2020BiotechnologyMuireann Bolger

Biogen loses another battle over MS drug patent

In a blow for biotechnology company, Biogen, a US federal judge has ruled that its lone surviving patent on multiple-sclerosis drug Tecfidera (dimethyl fumarate) should remain invalid because the matter had already been resolved by another court.

Following a decision handed down by Judge Maryellen Noreika at the US District Court for the District of Delaware, on Wednesday, 16 September, Biogen has failed in its bid to revive the patent.

Biogen had hoped to overturn a ruling by a district court in West Virginia on June 18, which held that the Tecfidera patent, US number 8,399, 514, which was due to expire in February 2028, should never have been issued.

In the decision, which clears the way for generic drug companies to produce and market generic versions of the treatment, Judge Noreika held that the West Virginia court had been correct in its ruling that the Biogen patent on a Tecfidera dosing regimen was “invalid because it did not sufficiently describe the claimed invention”.

Last month, Mylan launched its generic version of Biogen’s drug, the first generic of any multiple sclerosis treatment in an oral solid dosage form available to patients in the US.

In the June ruling, the court found the specification of the Biogen patent to be overly broad. Mylan provided a convincing expert witness who testified that the Biogen patent would not direct a person of ordinary skill in the art (POSA) towards a 480mg/day dose of dimethyl fumarate (DMF).

Biogen, was unable to provide a clear written specification in its arguments, and instead relied upon testimony from the inventor, but the court ruled that this was “not sufficient”.

This latest ruling is a major setback for Biogen, which relied on Tecfidera for almost a third ($4.4 billion) of its 2019 sales.

Biogen's total IQVIA sales in the US for the 12 months ending June 30, 2020, were approximately $3.79 billion for Tecfidera.

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Americas
23 March 2017   A Biogen patent covering the drug Tecfidera has been upheld by the Patent Trial and Appeal Board, after a challenge from Kyle Bass’s Coalition for Affordable Drugs.
Americas
23 June 2020   Mylan has succeeded in having a key Biogen patent covering multiple sclerosis drug Tecfidera invalidated by a US federal court.
Americas
29 September 2020   The US Court of Appeals for the Federal Circuit has sided with EMD Serono and Pfizer over the invalidation of a multiple sclerosis drug patent, in a defeat for biotech company Biogen.

More on this story

Americas
23 March 2017   A Biogen patent covering the drug Tecfidera has been upheld by the Patent Trial and Appeal Board, after a challenge from Kyle Bass’s Coalition for Affordable Drugs.
Americas
23 June 2020   Mylan has succeeded in having a key Biogen patent covering multiple sclerosis drug Tecfidera invalidated by a US federal court.
Americas
29 September 2020   The US Court of Appeals for the Federal Circuit has sided with EMD Serono and Pfizer over the invalidation of a multiple sclerosis drug patent, in a defeat for biotech company Biogen.