Mylan Violated Patent for Acne-Drug Oracea, Judge Rules
Mylan Pharmaceuticals Inc., a generic drugmaker, violated one of four patents related to the acne drug Oracea, a judge ruled.
U.S. District Judge Leonard P. Stark in Wilmington, Delaware said today he’ll wait to decide whether to bar Mylan from selling a generic version of Oracea, as requested by Galderma Laboratories LP. A temporary ban will remain in place, Stark ruled.
“Galderma is entitled to some relief,” Stark wrote in his opinion. Still, he said, he will delay imposing any permanent restrictions on Mylan until after hearing from both sides “given that neither party prevailed in the entirety of its position.”
Mylan has regulatory approval to sell the medicine, which is used to treat acne rosacea and is known by its active ingredient doxycycline monohydrate. In July 2010, Stark ordered Mylan not enter the market for the drug until he ruled on Galderma’s patent-infringement claims.
Galderma is seeking an extension of that order until the patent expires in 2027.
In 2009, Galderma, the Research Foundation of State University of New York, an New York University sued Mylan claiming it infringed at least four patents related to Oracea.
Patent Upheld
Stark told both sides to submit arguments on the request, since the only patent that was upheld -- for a once-daily formulation of tetracyclines -- was issued after his July 2010 order.
The other patents, which Stark said weren’t infringed, relate to dosage forms. The judge also ruled that two of the patents are invalid because they aren’t different enough from earlier inventions.
Galderma, which specializes in dermatology drugs, was created in 1981 as a joint venture between Switzerland’s Nestle SA (NESN), the world’s largest food company, and France’s L’Oreal, the biggest cosmetics maker, according to its website.
Michael Laffin, a spokesman for Canonsburg, Pennsylvania- based Mylan, didn’t immediately return an e-mail seeking comment.
The case is The Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc., 09CV184, U.S. District Court, District of Delaware (Wilmington).
To see the patents, click: 7,211,267; 7,232,572; 5,919,775; and 5,789,395.
To contact the reporter on this story: Steven Church in Wilmington, Delaware, at schurch3@bloomberg.net.
To contact the editor responsible for this story: John Pickering at jpickering@bloomberg.net.
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