Mylan ‘Likely To Win’ On US Tecfidera Challenge

Verdict In Litigation Is Expected By 20 June

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 –...

More from Legal & IP

Henlius And Organon Sued In US Over Plans To Market Perjeta Biosimilar

 
• By 

Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.

UPC Imposes Wide Cross-Border Injunction On Zentiva In Ofev Patent Clash

 
• By 

The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.

UK Decision Opens Up Competition On Forxiga

 
• By 

Generic dapagliflozin rivals to AstraZeneca’s Forxiga are now free to hit the UK market after the country’s Supreme Court lifted the final barrier preventing launch, allowing off-patent firms access to a market worth hundreds of millions of pounds annually.

Sandoz Rushes To Fill Gap After German Court Revokes Xarelto Patent

 
• By 

Germany’s Federal Patent Court has invalidated Bayer’s key patent covering once-daily use of Xarelto (rivaroxaban), paving the way for Sandoz to launch a generic version. Bayer is considering an appeal.

More from Generics Bulletin

Alvotech Focuses On Value Over Volume As Sales Continue To Grow

 
• By 

As Alvotech announced first-half results that outpaced expectations, the biosimilars developer’s management explained that the firm was targeting value and product margin over market share and volumes.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By 

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.