Biogen settles in Tecfidera patent case
- As predicted by some analysts, Forward Pharma settled with Biogen on their patent dispute regarding the active ingredient for the blockbuster multiple sclerosis drug Tecfidera (dimethyl fumarate).
- In exchange for an irrevocable license to all intellectual property, Biogen will pay Forward $1.25 billion as well as royalties.
- The agreement is subject to approval by Forward shareholders and a meeting is set for Feb. 1. Approximately 77% of shareholders have already agreed to vote in favor of the deal.
The two companies have been battling it out in court over the intellectual property associated with the 480mg dose of oral dimethyl fumarate, the active compound in Tecfidera.
The litigation is still ongoing through the Patent Trial and Appeal Board (PTAB), the U.S. Court of Appeals for the Federal Circuit, the European Patent Office, and the Technical Board of Appeal and the Enlarged Board of Appeal. A decision is expected on March 17.
This settlement allowed Biogen to hedge its bets — even though most analysts anticipated a successful outcome for the big biotech.
In this instance, Biogen will pay $1.25 billion upfront, but the level of royalties will be dependent on the interference proceeding hearing decision. The royalty rate could range from 1% to 10%, and could increase to as high as 20%, depending on the outcome.
Tecfidera is one of Biogen’s most successful products. The drug got off to a strong start, hitting blockbuster status early in the launch, but has hit a few speed bumps in recent quarters.
Sales growth for the drug slipped after some safety concerns cropped up and the company recently nixed a direct-to-consumer ad campaign which failed to boost the drug as much as hoped.
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