The following is excerpted from an October 20, 2011 Mylan press release available on its website:
Dey Pharma L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL), today confirmed that the U.S. Patent and Trademark Office (PTO) has issued Reexamination Certificates for two patents related to Perforomist® (Formoterol Fumarate) Inhalation Solution 20 mcg/2mL vial thereby confirming the validity of these patents. Sepracor, now known as Sunovion Pharmaceuticals, requested the PTO to re-examine these patents, which now has been completed.
Mylan Chairman and CEO Robert J. Coury commented: "We are pleased that the successful re-examination of these patents is complete as this only further strengthens our confidence in the intellectual property protecting our Perforomist product as well as our combination product currently in development. We are very excited about continuing to build on our brand division, Dey, which is and will continue to be an important growth driver for Mylan."
In addition to the two re-examined and granted patents, Dey owns five other relevant patents, giving it a total of seven U.S. patents which it believes are infringed by Sunovion's Brovana® product. In addition, Dey believes that Teva's Formotorol Fumarate product, which is the subject of an Abbreviated New Drug Application (ANDA) pending before the FDA, infringes several of Dey's U.S. patents. Mylan intends to vigorously defend its intellectual property in the pending patent litigations against Sunovion and Teva. The terms of the patents protecting Perforomist extend into 2021.
Read the full press release here.
In other Mylan news, on October 19, 2011 it announced it , "has entered into a settlement agreement with Warner Chilcott resolving litigation related to Femcon® Fe Chewable Tablets, known generically as Norethindrone and Ethinyl Estradiol Tablets USP (Chewable), 0.4 mg/0.035 mg and Ferrous Fumarate Tablets USP (Chewable), 75 mg (28-Day Regimen). This medication is an oral contraceptive. Pursuant to the settlement agreement, the pending litigation has been dismissed and Mylan may begin to market and sell a generic version of Femcon Fe upon receipt of final product approval from the U.S. Food and Drug Administration. Additional details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission."