Law 360:
Law360, New York (August 18, 2010) -- Galderma Laboratories LP has launched a patent infringement suit against a Michigan pharmaceutical company and its Israeli unit for allegedly attempting to market a generic form of psoriasis-treating hair product Clobex.
Allegan, Mich.-based Perrigo Co. and subsidiary Perrigo Israel Pharmaceutical Ltd. intend to infringe two patents for clobetasol propionate shampoo (0.05 percent), known commercially as Clobex, as evidenced by an abbreviated new drug application filed with the U.S. Food and Drug Administration, Galderma complained Tuesday in the U.S. District Court for the Northern District of Texas.
The complaint, filed by Michael C. Wilson, Jamil N. Alibhai and Daniel E. Venglarik of Munck Carter LLP, lists one claim of patent infringement and includes demands for a permanent injunction and enhanced damages complete with costs and fees.
Galderma says it received a letter from Perrigo in July saying its ANDA included a Paragraph IV certification affirming the company's belief that Galderma's U.S. Patent Numbers 7,316,810 and 7,700,081 were invalid or not infringed by the proposed generic.
The plaintiff seeks a declaration that its patents are valid, enforceable and infringed, and that approval of Perrigo's ANDA must wait until after the patents-in-suit have expired.
Fort Worth, Texas-based Galderma holds marketing rights to Clobex under the FDA's approval of a new drug application for the product in February 2004. The company's Swiss arm, Galderma SA, owns the patents-in-suit.
The company in 2000 applied for a patent for a foaming composition for washing and treating hair and scalp based on an active principle. The U.S. Patent and Trademark Office granted the application, issuing the '810 patent in 2008.
The company applied for the '081 patent in 2006, with the patent issuing in April.
Perrigo is a generic-drug company that sells products at various chains, including Wal-Mart, CVS, Costco and Walgreens pharmacy stores, according to the complaint.
The latest suit is not the first Galderma has filed over patents for Clobex. The company in 2009 sued Paddock Laboratories Inc. over a related patent after Paddock submitted an ANDA for generic Clobex in its spray form.
The product is also sold as a lotion, according to Galderma.
As a shampoo, it is designed to reduce itching and flakes associated with psoriasis through a 15-minute application to the scalp.
The inventions claimed by the patents-in-suit are "essentially characterized in that [they] contain in an aqueous medium: at least an active principle selected among corticoids and retinoids, at least an anionic surfactant, at least an amphoteric surfactant, and a pro-penetrating agent," according to the USPTO.
Counsel for Galderma could not be reached by deadline Wednesday.
The patents-in-suit are U.S. Patent Numbers 7,316,810 and 7,700,081.
Galderma is represented by Munck Carter LLP.
Counsel information for the defendants was not immediately available Wednesday.
The case is Galderma Laboratories LP et al. v. Perrigo Co. et al., case number 4:10-cv-584, in the U.S. District Court for the Northern District of Texas.
--Additional reporting by Samuel Howard