IP Law Daily, PATENT—D. Del.: Mylan infringed Endo’s patent for migraine drug, (Jan 29, 2014)

By Peter Reap, J.D., LL.M.

Mylan Pharmaceuticals Inc. and Mylan, Inc. (collectively, “Mylan”) infringed Endo Pharmaceuticals Inc.’s U.S. Patent No. 5,464,864 (the “'864 Patent”) in connection with Mylan’s submission of Abbreviated New Drug Application (“ANDA”) number 202931, which sought the approval of the U.S. Food & Drug Administration (“FDA”) to market its generic ANDA Product prior to the expiration of the '864 patent, the federal district court in Wilmington, Delaware, has decided (Endo Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., January 28, 2014, Bumb, R.). However, Endo’s motion for attorney fees and costs was denied.

To secure approval for a new drug, an applicant may file a New Drug Application (“NDA”) that includes the number and expiration date of any patents that claim the drug or a method of using the drug if a claim of patent infringement could reasonably be asserted.

Endo filed suit alleging that Mylan has infringed and/or will infringe the '864 Patent,” together with its U.S. Patent Nos. 5,637,611 (the “'611 Patent”) and 5,827,871 (the “'871 Patent”) (collectively, the “King Patents”). On November 8, 2001, the FDA approved NDA No. 21-006 for Frova (frovatriptan succinate) oral tablets. Frova is used for the acute treatment of migraine attacks with or without aura in adults. Endo commercially markets Frova, which contains a compound chemically designated as (R)-(+)-3-methylamino-6-carboxamido-1,2,3,4-tetrahydrocarbazole monosuccinate monohydrate, known as frovatriptan monosuccinate monohydrate, as the active pharmaceutical ingredient.

The '871 and '611 Patents. Endo had asserted claims against Mylan relating to the '871 and '611 Patents in the current litigation, but midway chose instead to abandon them in favor of the '864 Patent. Hence, it was the court’s view that any further effort to pursue claims against Mylan related to the '871 and '611 patents, in this litigation, would be judicially estopped.

Endo now argued that the court erred because Endo was permitted to file the terminal disclaimer at any point in this litigation and that filing could not be deemed an admission of the merits of the double-patenting allegation. Although Endo was correct as to the legal effect of the terminal disclaimer, its arguments missed the point: the court based its decision not on the terminal disclaimer, but on the unequivocal statements of counsel signifying Endo’s intent to abandon its claims here.

Endo’s current position—”that its infringement claims against Mylan on the '611 and '871 Patents should have remained a part of this case”—was directly contradicted by the arguments made before the court during trial. Moreover, its current assertion that it has somehow maintained a consistent position all along troubled the court. Nonetheless, Endo abandoned its claims and was thus estopped from further pursuing claims against Mylan that were related to the '871 and '611 Patents in this matter, the court held.

The '864 Patent. Although Mylan disputed the claim construction adopted by the court, it conceded prior to trial that, under the court’s claim construction, Mylan infringed or would infringe the asserted claims of the King Patents. However, Mylan maintained that the King Patents are invalid under the doctrines of anticipation, obviousness, written description, and enablement.

Mylan failed to demonstrate by clear and convincing evidence that the '864 Patent is invalid as anticipated, obvious, or due to an insufficient written description or lack of enablement, the court ruled. Accordingly, the court entered judgment in favor of Endo and against Mylan.

Exceptional case. Endo sought costs and attorneys’ fees under 35 U.S.C. §285 “on the basis of Mylan’s litigation misconduct and unprofessional behavior.” The court stated that there was “no basis whatsoever” for holding that Mylan engaged in misconduct warranting an exceptional case finding under §285. Quite the contrary, both parties litigated this case vigorously, effectively, and in good faith, according to the court.

The case is No. 11-cv-00717 (RMB/KW).

Attorneys: Jack B. Blumenfeld for Endo Pharmaceuticals Inc. Richard L. Horwitz (Potter Anderson and Corroon, LLP) for Mylan Pharmaceuticals Inc.

Companies: Endo Pharmaceuticals Inc.; Mylan Pharmaceuticals Inc.

Cases: Patent DelawareNews