Complaint filed by Noven Pharmaceuticals against Mylan Technologies for Patent Infringement

October 28, 2015 – Plaintiffs, Noven Pharmaceuticals, Inc., filed a Complaint in the United States District Court for the District of Delaware against Defendants Mylan Technologies Inc., Mylan Pharmaceuticals Inc., Mylan N.V., and Mylan Inc. alleging patent infringement. The patents at issue are U.S. Patent No. 6,210,705, entitled “Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate,” U.S. Patent No. 6,348,211, entitled “Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate,” U.S. Patent No. 8,632,802, entitled “Device for transdermal administration of drugs including acrylic polymers,” and U.S. Patent No. 9,034,370, entitled “Device for transdermal administration of drugs including acrylic polymers.”

Plaintiffs hold New Drug Application No. N021514 for the manufacture and sale of Methylphenidate Transdermal System, which the Plaintiffs sell in the United States under the registered trademark DaytranaTM. Plaintiffs’ product is covered by the ’705, ’211, ’802, and ’370 Patents. Defendants have filed ANDA No. 206497 seeking FDA approval to market and sell generic a Methylphenidate Transdermal System. Plaintiffs claim that the Defendants’ submission of ANDA No. 206497 and its Paragraph IV certification seeking FDA approval to commercially manufacture, use, sell, offer to sell, or import the generic product prior to the expiration of the ’705, ’211, ’802, and ’370 patents constituted patent infringement under 35 U.S.C. § 271. The case has been filed in the District of Delaware and is captioned: Noven Pharmaceuticals, Inc. v. Mylan Technologies Inc. et. al., DED-1-15-cv-00979.

By: David G. Varghese