Patent Office Agrees to Review Mylan’s Copaxone Challenge

Mylan scored a potential win from the U.S. Patent and Trademark Office when it agreed to review challenges to two patents on Teva’s blockbuster multiple schlerosis drug Copaxone.

By granting inter partes review, the Patent Trial and Appeal Board is acknowledging a reasonable likelihood that Mylan will prevail in showing the unpatentability of the ’250 and ’413 patents owned by Yeda Research and Development, which licenses Copaxone (glatiramer acetate) to Teva.

In this case, the board points to Mylan’s claims of obviousness about the 40 mg dosing regimen described in the patents, which calls for three injections over a seven-day period with at least one day between injections.

Mylan says it has filed another petition for review of a related patent, which the PTAB is expected to decide on soon.

Teva has been pushing for patients to switch from its original 20 mg daily treatment formulation to the 40 mg dose, as the 20 mg patents are set to expire Sept. 1.

Patents on the newer formulation, approved in January 2014, would be protected until 2030, unless Teva loses at trial. The PTAB scheduled a potential trial for May 2016.

The FDA accepted Mylan’s ANDA filing for its thrice weekly glatiramer acetate injection in August 2014.

Mylan believes it is among the first companies to file a substantially complete ANDA and expects to be eligible for 180 days of exclusive marketing upon FDA approval.

Other companies interested in marketing their own version of the injectable are Momenta, Sandoz and Dr. Reddy’s Laboratories (Generic Line, Sept. 10, 2014).

Mylan claims Copaxone 40 mg had U.S. sales of $2.6 billion in the last year.

Read the PTAB’s decisions to institute inter partes review here and — John Bechtel


$1,097 $847


Subscribe to Generic Line and save $250 off the regular one-year price of $1,097 — plus receive a FREE copy of our webinar,Success Strategies for Biosimilars Approval: A Roadmap to the 351(k) Application Process — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — Each issue provides you with links that support GEN's articles such as FDA guidances, warning letters, rules, full texts of proposed legislation and more.

FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.