Federal Circuit releases two interesting decisions

This week the Federal Circuit released two interesting decisions relevant to the generic pharmaceuticals sector.

The first decision was covering filing of an ANDA for Divalproex Sodium [Depakote (R) from Abbott] by NuPharm with help from Apotex, who had earlier been injuncted from filing of an ANDA for Depakote.

Apotex had earlier filed an ANDA against this drug and in 2001, the Distric Court granted a summary judgment of validity and infringement to Abbott for its patents. Abbott then tried to design around the patents and got NuPharm to file the ANDA. This action was held as contempt by Judge Posner in an October 2006 proceeding. Apotex took this contempt matter to the Federal Circuit which upheld the district court's decision to hold a contempt proceeding as well within its discretionary authority, notwithstanding any provisions in (or not in) the Hatch-Waxman Act, and affirmed the revised injunction against Apotex.

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The next decision is for moexipril hydrochloride [Univasc (R)]. In this case, the Patent owner was not impleaded and it was therefore argued that Schwarz Pharma [exclusive licensee] lacked standing to bring the appeal because Warner-Lambert, the patent owner, did not appeal the district court's judgment.

The Federal Circuit determined that "when a patentee joins an exclusive licensee in bringing a patent infringement suit in a district court, the licensee does not lose standing to appeal even though the patentee does not join in the appeal," explaining that the reason for requiring joinder in the district court (to avoid subjecting the alleged infringer to multiple actions) does not exist on appeal.