One of their patented pharmaceuticals is Copaxone, and Teva have filed suit against four companies – Novartis’ Sandoz unit, Mylan, Momenta Pharmaceuticals and India’s Natco Pharma – alleging infringement of patents for best-selling drug Copaxone.
The generics firms claim that Teva’s patent for Copaxone (glatiramer acetate) are invalid.
The US District Court for the Southern District of New York refused to issue a summary judgment in the case, requiring a trial to take place.
Meanwhile, some analysts suggest that the outcome of the court case could be unimportant because there are serious questions about the ability of the generics companies to prove that their products are equivalent to the branded Copaxone. Bioequivalence is difficult in this instance since Copaxone is a complicated molecule, with a poorly understood mechanism of action and no validated biomarkers for its efficacy.
In this regard, we note that Teva has repeatedly asked the US Food and Drug Administration (the FDA) to refuse to approve any abbreviated New Drug Application for a “purported generic version” of Copaxone, given the “inability to establish acceptable ‘sameness’ of the active ingredients” in the drug. To date, all the petitions have been rejected.
Consequently, the US Food and Drug Administration (FDA) may require a fairly extensive clinical trials programme for any generic version and the patent will anyway lapse in 2014.
A verdict in the case is not expected for several months.