Connetics Files Patent Infringement Lawsuit Against Agis, a Wholly-Owned Subsidiary of Perrigo Company
Connetics Corporation (Nasdaq:CNCT), a specialty pharmaceutical company focused on dermatology, announced today that it has filed a patent infringement lawsuit under paragraph IV of the Hatch-Waxman Act against Agis Industries (1983) Ltd. (“Agis”), a wholly-owned subsidiary of Perrigo Company, in response to Agis’s submission to the U.S. Food and Drug Administration (FDA) of an abbreviated new drug application (ANDA) for a generic version of clobetasol propionate foam, 0.05%. Connetics markets the drug product under the brand name OLUX(R) (clobetasol propionate) Foam 0.05%.
Connetics’ patent infringement lawsuit, filed today in the U.S. District Court for the District of New Jersey, requests, among other things, that any approval of the Agis ANDA not be effective until after the expiration on March 1, 2016 of Connetics’ U.S. Patent No. 6,126,920 covering corticosteroids delivered in foam. This action formally initiates the patent enforcement process under the Hatch-Waxman Act.
About OLUX
OLUX Foam is a super high-potency topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas.
About the Paragraph IV Process
In 1984 Congress enacted the Hatch-Waxman Act to establish a streamlined approval process for the FDA to use in approving generic versions of previously approved branded drugs, while also providing enhanced intellectual property protection for the substantial investment in research and development made by the innovators of new drug therapies. Under the Hatch-Waxman Act, for each patent listed in the Orange Book for the relevant branded drug, an ANDA applicant must certify one of the following claims: (1) that such patent information has not been filed; (2) that such patent has expired; (3) that the proposed drug will not be marketed until expiration of the patent; or (4) that either the proposed generic drug does not infringe the patent or the patent is invalid, otherwise known as Paragraph IV certification.
If an ANDA applicant files a paragraph IV certification, the Hatch-Waxman Act requires the applicant to provide the patent holder with notice of that certification and provides the patent holder with a 45-day window, during which it may bring suit against the applicant for infringement. If patent litigation is initiated during this period, the FDA may not approve the ANDA until the earlier of (1) 30 months from the patent holder’s receipt of the notice of certification or (2) the issuance of a court decision finding the patent invalid or not infringed. If the patent is found to be infringed by the filing of the ANDA, the FDA may not approve the generic product until the patent expires.
About Connetics
Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. Connetics has branded its proprietary foam drug delivery vehicle VersaFoam(R). The Company’s marketed products are OLUX(R) (clobetasol propionate) Foam, 0.05%, Luxiq(R) (betamethasone valerate) Foam, 0.12%, Soriatane(R) (acitretin) capsules and Evoclin(TM) (clindamycin) Foam, 1%. Connetics is developing Velac(R) (a combination of 1% clindamycin and 0.025% tretinoin) Gel, for treating acne, Desilux(TM) (desonide) VersaFoam-EF, 0.05%, a low-potency topical steroid formulated to treat atopic dermatitis, Primolux(TM) (clobetasol propionate) VersaFoam-EF, 0.05%, a super high-potency topical steroid formulation to treat atopic dermatitis and plaque psoriasis and Extina(R), a foam formulation of the antifungal drug ketoconazole. Connetics’ product formulations aim to improve the management of dermatological diseases and provide significant product differentiation. In Connetics’ marketed products, these formulations have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information about Connetics and its products, please visit www.connetics.com.
Press Release Code: (CNCT-G)