A federal appeals court on Wednesday upheld an earlier court ruling that generic-drug maker Mylan Laboratories Inc. (MYL) didn't infringe a patent for a Johnson & Johnson (JNJ) incontinence drug, and that the patent was invalid.
The ruling could clear the way for the launch of generic versions of oxybutynin to treat over-active bladders, which J&J sells under the brand Ditropan. Patent Attorney Database
The appeals court also upheld an earlier ruling of invalidity in a similar patent fight over Ditropan between J&J and another generic drug maker, Impax Laboratories Inc. (IPXL).
J&J, the New Brunswick, N.J., health-care conglomerate, had sued Mylan, Pittsburgh, in 2003 claiming patent infringement after Mylan applied for regulatory approval to sell a generic version of oxybutynin.
A year ago, a federal court in West Virginia ruled in favor of Mylan, finding that Mylan wasn't infringing the patent and that the patent was invalid.
J&J appealed that ruling, and on Wednesday the U.S. Court of Appeals for the Federal Circuit in Washington upheld the ruling. The appeal in the Mylan case was heard together with an appeal of the earlier Impax ruling.
Julie Keenan, a spokeswoman for J&J's Alza unit, which was the plaintiff in the litigation, declined to comment on whether the company would appeal the case further or what the expected financial impact of a generic launch would be.
Keenan did say Mylan has tentative Food and Drug Administration approval to market oxybutynin and is awaiting final approval.
In December 2005, Mylan reached an agreement with J&J under which J&J would supply certain doses of the drug to Mylan, and license the patent, pending the outcome of the appeal.
Representatives for Mylan and Impax couldn't immediately be reached.
Mylan shares rose 53 cents, or 2.6%, to $20.85 Wednesday. Impax shares rose 40 cents, or 6.7%, to $6.40. J&J was off 31 cents at $64.
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