AbbVie, Merck and Allergan have filed a patent infringement lawsuit against other biopharmaceutical companies, accusing the defendants of attempting to submit a generic version of the plaintiffs’ migraine medication Ubrelvy without authorization.
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Attorneys with McCarter & English and Finnegan, Henderson, Farabow, Garrett & Dunner filed the lawsuit on behalf of AbbVie, Merck Sharp & Dohme and Allergan Pharmaceuticals International in the U.S. District Court for the District of New Jersey. The plaintiffs alleged that the defendants, Aurobindo USA, out of East Windsor, New Jersey, along with Aurobindo Pharma and Apitoria, corporations in India, allegedly infringed on U.S. Patent Nos. 10,117,836 (’836 patent), 11,717,515 (’515 patent), 11,857,542 (’542 patent), and 11,925,709 (’709 patent), according to the complaint.
Aurobindo recently sought Food and Drug Administration approval of an abbreviated new drug application, seeking approval to allegedly market generic versions of the plaintiffs’ Ubrelvy, or ubrogepant, oral tablets in 50 mg and 100 mg dosage forms. Aurobindo’s new drug application, number 219088, has allegedly been submitted prior to the expiration of the patents-in-suit relating to the Ubrelvy tablets, according the plaintiffs.
The plaintiffs also claim they received a notice letter from Aurobindo representing that Aurobindo’s new drug application contains a paragraph IV certification, alleging that the claims of the ’836 patent are invalid, unenforceable or will not be infringed by Aurobindo’s generic products, the complaint said.
AbbVie further contends that it hasn’t received a notice of paragraph IV certification regarding Aurobindo’s new drug application number 219088, for the ’709 patent, but believes Aurobindo’s notice letter and the information contained, as well as regulatory requirements, demonstrate that it has infringed on the ’709 patent.
“Aurobindo’s Notice Letter does not state or otherwise indicate that Aurobindo submitted a Paragraph IV certification for the ’096, ’210, ’545, and ’448 patents, each of which is listed in the FDA Orange Book for UBRELVY (ubrogepant) oral tablets, 50 mg, 100 mg,” the complaint said. “Accordingly, on information and belief, Aurobindo submitted a Paragraph III certification for ’096, ’210, ’545, and ’448 patents, and informed the FDA that it would not launch at least before December 23, 2033.
“Aurobindo’s purpose in submitting ANDA No. 219088 and a Paragraph IV certification is to market Aurobindo’s generic products before the expiration of the ’836 patent. Aurobindo intends to market Aurobindo’s generic products before the expiration of the ’515, ’542, and ’709 patents,” the complaint said, claiming that the plaintiffs still have not received access to Aurobindo’s new drug application.
Counsel for AbbVie, Allergan and Merck allegedly attempted to negotiate with counsel for Aurobindo in an attempt to reach an agreement on reasonable terms of confidential access to Aurobindo’s new drug application, but were unable to reach an agreement.
The complaint brings claims for infringement and declaratory judgment regarding the four patents, and requests permanent injunctions enjoining Aurobindo from manufacturing, using, offering for sale or selling the generic products, as well as enjoining it from seeking, obtaining or maintaining approval of the ANDA until the involved patents expire.
The plaintiffs’ attorney, Jose L. Linares of McCarter & English in Newark, declined to comment.
Aurobindo and Apitoria did not immediately respond to a request for comment.
Attorneys have not yet appeared for the defendants.
