PBR Staff Writer Published 23 March 2017
Biogen has won an intellectual property rights ruling over its multiple sclerosis (MS) drug candidate, Tecfidera following a favorable decision from the US Patent and Trademark Office’s Patent Trial and Appeal Board.
The patent case against Biogen for Tecfidera was filed last year by Coalition for Affordable Drugs led by hedge fund manager Kyle Bass.
Following the patent board’s ruling, Biogen will be in a position to ensure that Tecfidera will not have any competition from generic versions of the drug for four to five years, as reported by the Reuters citing Muzuho analyst Salim Syed.
The legal challenge put up by Bass was centered on the dosage of a key ingredient used by Biogen to develop the MS pill, Tecfidera.
The “514 patent” as it is called is based on a method where patients suffering from multiple sclerosis are dosed with Tecfidera every day with 480mg of certain fumarates that act as chemical intermediates.
Bass has been known for taking the legal route challenging various companies in order to remove their drug patents. He takes on patents which he feels were unfairly extended based on dosing schedules and thereby stopping affordable generic version of the drugs from being launched.
The verdict on Tecfidera’s intellectual property rights in the US comes two months after Biogen agreed to resolve a separate patent dispute with Forward Pharma over the same drug. For this, Biogen agreed to pay $1.25bn in a settlement and license agreement with the Danish biotech company.
Biogen will also pay royalties on the net sales of its multiple sclerosis drugs that use dimethyl fumarate as an active ingredient and are covered by a patent held by Forward Pharma.