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Mylan Wins Federal Circuit Ruling in Effort to Sell Generic Doryx

By Dyanna Quizon, Esq. on December 16, 2011 3:02 PM

Mylan, Inc. scored a victory in the U.S. Federal Circuit Court of Appeals in its battle to lift a ban prohibiting the company from selling a generic version of the antibiotic Doryx.

The Federal Circuit overturned a lower court’s decision to grant the ban while a patent-infringement suit against the company makes its way through the court process.

The antibiotic’s maker, Warner Chilcott, has argued that Mylan should not be allowed to make generic versions of the drug until its patent on a “stabilizing coat” expires in December 2022. Sales of the drug represents 6 percent of Warner Chilcott’s total revenue, with sales reaching $127 million in the first nine months of 2011.

Mylan, on the other hand, contends that the patent is invalid, and the Federal Circuit found that the district court judge did not thoroughly consider its invalidity defense, relying instead on disputed facts without holding an evidentiary hearing. The Court of Appeals would hear no excuses of "I have a six-to-eight-week trial ... and that has to get priority ... So I have no time the rest of this fall, certainly no time to do a preliminary injunction hearing" from the lower court judge.

In its decision, the Federal Circuit stated that the merits of Warner Chilcott's infringement claim "turned on a battle of experts." Because the judge refused to hold an evidentiary hitting pitting both sides' experts against each other and did not make any findings as to Mylan's invalidity challenge, the Federal Circuit held the district court abused its discretion and remanded the case for further proceedings.

This small victory doesn't mean Mylan's in the clear, however. The Federal Circuit recommended that the judge consider issuing a temporary order banning Mylan's copy given that the patent dispute may reach trial soon in recognition of the court's demanding schedule.

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