CLARKSBURG – A New Jersey-based pharmaceutical company has sued Mylan over the drugmaker’s effort to win federal approval for a generic version of a treatment for plaque psoriasis.
Organon, Organon International GmbH and its Dermavant Sciences unit sued Morgantown-based Mylan Pharmaceuticals Inc. and Mylan Inc. August 31 in U.S. District Court for the Northern District of West Virginia, alleging a generic of VTAMA tapinarof cream would infringe nine of its patents.
Mylan’s Abbreviated New Drug Application No. 221179 seeks Food and Drug Administration approval to manufacture, market and sell a generic 1% tapinarof cream before the cited patents expire, according to the complaint.
VTAMA is Organon’s brand name for tapinarof cream, 1%, a topical medicine initially approved by the FDA in May 2022 for adults. The FDA later approved the drug in December 2024 for adults and children age 2 and older with atopic dermatitis, the complaint says.
The lawsuit says Mylan notified Organon in a July 22 letter it had filed an FDA application containing so-called Paragraph IV certifications. Such certifications assert that listed patents are invalid, unenforceable or would not be infringed by the proposed generic product.
Organon and Dermavant contend Mylan’s filing itself constitutes an artificial act of infringement under the Hatch-Waxman Act, which permits brand-name drug companies to bring patent litigation after a generic manufacturer seeks approval before patent expiration. The filing does not allege that an FDA-approved Mylan product is already on the market.
The plaintiffs allege the proposed generic product would contain 1% tapinarof and inactive ingredients designed to copy VTAMA’s formulation. They also allege Mylan represented its product would be bioequivalent to VTAMA, requiring it to demonstrate no significant difference in key active-ingredient, inactive-ingredient, structural and drug-release characteristics.
According to the complaint, Mylan’s proposed label would copy VTAMA’s labeling except that it would not seek approval for the atopic dermatitis indication. Organon and Dermavant argue the proposed label would encourage use that infringes patents covering methods of treatment for plaque psoriasis.
The complaint asserts infringement of nine U.S. patents, covering topical formulations, manufacturing processes for tapinarof and methods of using tapinarof to treat chronic plaque psoriasis:
The plaintiffs are asking the court to rule Mylan’s FDA application infringes the asserted patents and to delay the effective date of any FDA approval until the applicable patents expire.
They also seek preliminary and permanent injunctions barring Mylan and related entities from making, marketing, selling, distributing or importing the proposed generic product before the patents’ latest expiration dates, including any applicable extensions or exclusivity periods.
The plaintiffs further request damages if commercial sales occur before patent expiration, litigation costs and attorney fees. They contend the case should be deemed “exceptional” under federal patent law, a designation that can permit an award of attorney fees.
The plaintiffs are being represented by Steve Ruby and David Pogue of Carey Douglas Kessler & Ruby in Charleston and by Paul A. Ainsworth, Dennies Varughese, Deborah Sterling and Josephine Kim of Sterne Kessler Goldstein & Fox in Washington, D.C. The case has been assigned to U.S. District Judge Thomas S. Kleeh.
U.S. District Court for the Northern District of West Virginia case number 1:26-cv-00112
