On Wednesday in the District of Delaware, Biogen Inc. and affiliates filed a complaint against Teva Pharmaceuticals Development Inc., alleging infringement of the Biogen patents covering drug Vumerity.
According to the filing, pharmaceutical company Biogen holds New Drug Application No. 211855 for multiple sclerosis (MS) drug Vumerity. Generic drug manufacturer Teva submitted Abbreviated New Drug Application (ANDA) No. 214206 seeking Food and Drug Administration (FDA) approval for delayed-release diroximel fumarate capsules, the generic version of Vumerity. Vumerity is covered by U.S. Patent Nos. 8,669,281, 9,090,558, and 10,080,733, of which plaintiffs Alkermes Pharma Ireland Ltd. and Biogen Swiss Manufacturing GmbH are the assignee and licensee, respectively, according to the complaint. The patents all are set to expire Sept. 20, 2033, according to the FDA’s approved drug patent database, the Orange Book.
In a Feb. 2 letter, Teva notified the plaintiffs that it had submitted its ANDA and asserted that Biogen’s claims of the patents-in-suit would be “invalid, unenforceable, and/or not infringed” by Teva’s ANDA product.
The plaintiffs disagreed, contending that Teva’s ANDA product would infringe on the Vumerity patents. According to the complaint, Teva should have known about the patents-in-suit because of the patents being listed in the Orange Book.
“Notwithstanding this knowledge,” the complaint said, “Teva continues to assert its intent to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Teva’s ANDA Product.”
According to the plaintiffs, Teva filing its ANDA was “tightly tied, in purpose and planned effect, to the deliberate making of sales in Delaware” of the generic MS drug, conduct that would purportedly cause “irreparable injury” to the plaintiffs.
The plaintiffs are seeking judgment that Teva’s alleged conduct is infringing and an enjoinment of Teva and its affiliates from manufacturing, selling, marketing, and distributing the ANDA product before the patents-in-suit expire, and monetary damages, among other relief.
Morris, Nichols, Arsht & Tunnell LLP is representing the plaintiffs.
