UCB, Inc. v. Mylan Techs. Inc.

Neupro® (rotigotine)

March 8, 2024

GENERICally Speaking: A Hatch-Waxman Bulletin

Case Name: UCB, Inc. v. Mylan Techs. Inc., Civ. No. 22-cv-216 (D. Vt. Mar. 8, 2024) (Reiss, J.)

Drug Product and Patent(s)-in-Suit: Neupro® (rotigotine); U.S. Patents Nos. 8,246,979 (“the ’979 patent”) and 8,246,980 (“the ’980 patent”)

Nature of the Case and Issue(s) Presented: Neupro is a transdermal patch indicated for the treatment of Parkinson’s’ disease and restless leg syndrome. On March 24, 2017, UCB filed a complaint in the District of Delaware, alleging that Mylan’s ANDA infringed five patents, including the 979 patent and the 980 patent.

On July 16, 2019, UCB filed an infringement action in the District of Vermont alleging infringement of two pop-up, Neupro patents. The District of Delaware action was thereafter transferred to Vermont. The parties attempted to negotiate a resolution, but reached an impasse as UCB was only willing to issue a covenant not to sue on the drug products then described in Mylan’s ANDA, whereas Mylan wanted the covenant to apply to its current ANDA product “including any amendments and/or supplements thereto.” The parties eventually filed a stipulation of dismissal with only UCB’s language on May 13, 2020.

On October 27, 2022, Mylan submitted a major amendment to its ANDA and sent UCB notice with a paragraph IV certification. The paragraph IV certification alleged non-infringement because the changes to the ANDA did not “alter the infringement analysis” and thus, according to Mylan, the covenant not to sue still applied. In response, UCB filed suit and obtained a 30-month stay of approval of Mylan’s ANDA. Mylan moved for partial summary judgment, arguing that UCB breached the covenant not to sue and sought a declaration that it did not infringe the 979 and 980 patents.

Why UCB Prevailed: Mylan first argued that the covenant not to sue covered modifications and supplements to the product that was the subject to the parties’ prior settlement. The court disagreed and found that the covenant not to sue applied only to Mylan’s ANDA product as described as of the date of settlement on May 27, 2020.

Mylan next argued that the covenant not to sue applied unless the changes to the ANDA “altered the infringement analysis with respect to the 979 and 980 patents.” The court agreed and found that because UCB was both the drafter of the stipulation and because this language created a condition subsequent to the covenant not to sue, then UCB possessed the burden of proving that Mylan’s ANDA product in fact had changed. Thereafter, the court found that there was a fact issue regarding whether Mylan changed its ANDA product in such a way that altered the court’s infringement analysis. As a result, it denied Mylan’s motion for summary judgment.

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