Federal Circuit Affirms Validity of Ortho-McNeil’s Patent On Epilepsy Drug Topomax

Holding:

In this appeal, the Court of Appeals for the Federal Circuit permanently enjoined defendant generic drug maker from infringing plaintiff’s patent relating to the anti-convulsive drug topiramate. Specifically, the Federal Circuit held that the term “and” found in an independent claim of the patent should be construed as “or.” Under such proper construction, the claim covers topiramate. The Federal Circuit likewise sustained the district court’s finding of non-obviousness of patent at issue. In particular, the record showed powerful unexpected results of anti-convulsive activity of topiramate. Plaintiff similarly demonstrated skepticism of experts and copying – other respected sources of objective evidence of non-obviousness – as well as commercial success. On the basis of this finding, the Federal Circuit sustained the district court’s ruling that plaintiff’s patent on epilepsy pharmaceutical was valid and enforceable.

Detailed Summary:

Patent (‘006 patent) at issue relates to Topiramate, a drug that is distributed by plaintiff Ortho-McNeil Pharmaceutical, Inc. (“plaintiff”) as Topomax.  It is a significant epilepsy drug that was formulated during a search for new anti-diabetic drugs. On the other hand, defendant Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (“defendant”) are generic drug makers that had sought to manufacture and market a generic version of this patented drug. Under the Hatch-Waxman Act. 21 U.S.C. § 355,  defendant filed an ANDA (Abbreviated New Drug Application) with the FDA (Food and drug Administration) with a paragraph IV certification asserting that plaintiff’s ‘006 patent…

More Updates