PITTSBURGH — Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.
The U.S. District Court for the Southern District of New York denied Teva’s motion for a summary judgment finding no inequitable conduct in relation to Copaxone (glatiramer acetate).
Inequitable conduct is when the maker of a branded drug did not properly complete its application when filing for a patent for the drug. When a generic drug maker wishes to gain early entry for its version of the branded drug, it can file an approval application with the Food and Drug Administration that contains a paragraph IV certification, an assertion that the patent is invalid, enforceable or won’t be infringed, based on a finding of alleged inequitable conduct.
A trial in which Mylan will defend its assertion of inequitable conduct will begin on July 11.