Mylan ‘Likely To Win’ On US Tecfidera Challenge

Verdict In Litigation Is Expected By 20 June

09 Jun 2020

Mylan was shot down in February this year by the USPTO after challenging Biogen’s key US patent 8,399,514 protecting Tecfidera. However, the ANDA sponsor has been backed by Bernstein to prevail in separate district court proceedings, clearing a path to potential market entry years earlier than otherwise anticipated.

Gavels — Mylan is aiming to topple the sole Tecfidera patent in its path • Source: Shutterstock

Mylan has been backed to prevail in US district court patent-litigation proceedings with Biogen over key Tecfidera (dimethyl fumarate) intellectual property, opening the door for potential generic entry in the near term into a market worth almost $3.5bn last year.

The US generics player has been sued by Biogen in a court in West Virginia over method-of-use patent, 8,399,514 –...