Netherlands-incorporated Mylan (Nasdaq: MYL) has received another boost in its aim to market a generic version of Teva Pharmaceutical Industries’ (NYSE: TEVA) multiple sclerosis (MS) treatment Copaxone (glatiramer acetate) 40mg/mL.
The US Patent and Trademark Office (PTO) has ruled in favor of Mylan by invalidating another of the Israeli company’s patents for the big-selling drug.
This comes after the PTO’s Patent Trial and Appeal Board (PTAB) last week found Teva’s first two Copaxone patents unpatentable in Mylan’s inter partes review challenge.
Mylan’s chief executive Heather Bresch said: “Through significant investment in research and development and by challenging these invalid patents, we are working to bring a more affordable generic alternative of Copaxone to market.
“Challenging patents is just one of the ways that Mylan helps to ensure patient access to medicines. In the last few years alone, Mylan’s patent challenges have allowed earlier access to generic competition for brand products equating to nearly $20 billion in annual brand sales product and reducing more than 60 years of patent life that otherwise could have blocked generics from entering the market.”
On August 15, the PTAB found Mylan’s petition against a fourth Copaxone 40mg/mL patent ineligible for post-grant review for procedural reasons.
However, Mylan believes that the three favorable rulings undermine that patent as well so the company will proceed with pursuing all avenues to challenge that.
Copaxone 40mg/mL had US sales of approximately $3.3 billion for the 12 months ending June 30 this year, according to IMS Health.
Teva has announced its intention to appeal against the rulings to the US Court of Appeals for the Federal Circuit, with chief executive Erez Vigodman saying that the company was “prepared to defend the full suite of our intellectual property through the PTAB and the US courts regardless of the time required.”