Mylan wins UK court ruling related to Copaxone 40 mg/mL patent
Court finds all claims of Teva's patent relating to Copaxone invalid based on obviousness.
The UK's High Court of Justice has issued a decision in favour of Mylan and its European partner Synthon, finding all claims of Teva's patent EP (UK) 2 949 335 (EP 335) relating to Copaxone 40 mg/mL invalid based on obviousness.
This victory is yet another important milestone for Mylan, and this UK court decision only further increases Mylan's confidence in its ability to bring high quality, lower-cost generic versions of Copaxone to the multiple sclerosis community and patients around the world.
During the course of the last 8 years, Mylan has successfully overcome Teva's four waves of US patent litigation, eight Citizen Petitions, injunction proceedings in India, more than 15 regulatory challenges, patent litigations or commercial actions across Europe, and now the litigation in the UK, in addition to obtaining dismissal of Teva's suit against the FDA seeking to delay approval of the 20 mg/mL product. This positive ruling in the UK will further help pave the way for Mylan's future launches of Glatiramer Acetate Injection 40 mg/mL in certain European markets.
In addition, Mylan recently learned of Teva's latest action with the filing of an infringement action against Mylan's Irish subsidiary Mylan Teoranta in the High Court of Ireland alleging that Mylan's Glatiramer Acetate 40 mg/mL injection infringes two European patents. In fact, one of those patents is the same patent that was just invalidated today by the UK High Court of Justice and the counterpart to a U.S. patent that was previously held invalid by both the United States District Court for the District of Delaware and the Patent Trial and Appeal Board.
Related News
-
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance