Teva Comments On Mylan Paragraph IV Filing For COPAXONE

Teva Pharmaceutical Industries (Teva) has commented on the abbreviated new drug application (ANDA) containing a Paragraph IV certification for Copaxone (glatiramer acetate injection), filed by Mylan Pharmaceuticals. Teva has filed a lawsuit against Mylan Pharmaceuticals, Mylan Incorporation and Natco Pharma Limited for patent infringement in the US District Court for the Southern District of New York.

Reportedly, Teva received Mylan’s Paragraph IV certification notice referring to Teva’s US Patents, which cover the chemical composition of Copaxone, pharmaceutical compositions containing it, and methods of using it. These patents are listed in the FDA Orange Book and extend through May 24, 2014.

However, Teva remains committed to defending its Copaxone intellectual property rights against infringement wherever they are challenged and intends to pursue all relevant regulatory avenues via the FDA. Teva’s lawsuit has been filed within the 45-day period provided under the Hatch-Waxman legislation. The lawsuit triggers a stay of FDA approval for the Mylan ANDA until the earlier of the expiration of a period of 30 months and a district court decision in its favor, and is also subject to the expiration of any exclusivity rights that may attach to earlier filed ANDAs.

The company has said that Copaxone is a highly-complicated product to develop and manufacture, and given the inability to fully characterize the active ingredients of Copaxone. Teva has serious doubts about any generic applicant’s ability to demonstrate conclusively that the composition of its product is identical to that of Copaxone.

Teva contends that any company that files an application for any glatiramoid substance, via an ANDA or 505(b)(2) application, should conduct full-scale, placebo-controlled clinical trials with measured clinical endpoints in MS patients to establish safety, efficacy and immunogenicity in this patient population. Internal research at Teva has indicated that even minor changes in the synthetic process and/or molecular weight distribution of a glatiramoid can have severe ramifications on the safety and mechanism of action of the product.