On Monday in the District of Delaware, EPI Health LLC and Allergan Inc. filed a complaint against a United Kingdom-based generic pharmaceutical company, alleging that the defendant’s product infringes on plaintiffs’ product Rhofade.
According to the complaint, pharmaceutical marketing company EPI Health markets and sells Rhofade, a rosacea treatment, which drug manufacturer Allergan brought to the market in 2017. Rhofade is covered by United States Patent Nos. 7,812,049; 8,420,688; 8,815,929; 8,883,838; 9,974,773; 10,335,391; and 10,751,325, some of which are owned by EPI Health and some by Allergan. The U.S. Patent and Trademark Office issued the earliest patent-in-suit in 2010 and the most recent in 2020, the complaint detailed.
Perrigo UK FINCO Ltd. Partnership, the defendant, notified the plaintiffs by letter on Feb. 23 that it had submitted Abbreviated New Drug Application (ANDA) No. 211942 seeking Food and Drug Administration (FDA) approval for oxymetazoline cream, the generic version of Rhofade. Perrigo claimed in its letter that the plaintiffs’ patents covering Rhofade are “invalid, unenforceable, and/or will not be infringed” by Perrigo’s ANDA product — although, the complaint claimed, Perrigo failed to provide the full formula of its generic product apart from the active ingredient.
The plaintiffs noted that Perrigo offered them confidential access to parts of its ANDA, as long as they accepted certain “terms and conditions” set by the defendant, which the plaintiffs deemed “unreasonable.”
“The Perrigo Offer unreasonably restricted the ability of counsel to seek the opinions of Allergan’s or EPI Health’s employees and outside experts,” the complaint asserted. “The Perrigo offer also unreasonably would have prevented Plaintiffs from incorporating and relying on confidential information in this Complaint.”
According to the plaintiffs, the restrictions that Perrigo placed on access to its ANDA violates U.S. code governing drug applications for approval, which says a confidential access offer “shall contain such restrictions as to persons entitled to access, and on the use and disposition of any information accessed, as would apply had a protective order been entered for the purpose of protecting trade secrets and other confidential business information.”
The complaint contended that the plaintiffs “will suffer substantial and irreparable harm” if Perrigo is not enjoined from marketing and selling its ANDA product before the patents-in-suit expire.
EPI Health and Allergan are represented by Morris, Nichols, Arsht & Tunnell LLP.