By James DeGiulio --
Unigene Secures Ruling of Infringement against Apotex in Fortical Patent Suit
Unigene successfully reinstated an earlier 2009 opinion that its two patents for Fortical nasal spray were valid and infringed by Apotex, despite the defendant's argument that affirmative defenses and counterclaims were not addressed in the original order.
In 2006, Unigene and Upsher-Smith sued Apotex for infringement of U.S. Patent No. 6,440,392, after Apotex sought to make a generic version of the spray. During the course of the litigation, the patent was reissued as RE40,812 by the USPTO. In an August 2009 ruling, the plaintiffs were granted an injunction after the claim at issue was found to be valid and infringed. However, Apotex contended that certain affirmative defenses and counterclaims remained at issue, and the August opinion was vacated in October.
On July 6, Judge Robert Patterson Jr. of the U.S. District Court for the Southern District of New York reinstated his August 2009 order in its entirety, once again finding Claim 19, the claim at issue in both patents, was not obvious. Judge Patterson rejected Apotex's non-infringement arguments, noting that that Apotex had already conceded that its product would infringe Unigene's patents. The judge further rejected Apotex's invalidity and inequitable conduct claims, and separately pointed out the worry that Apotex might be using its stronger economic position and litigation pressures to induce Unigene into a settlement.
Judge Patterson's order can be found here.
Actavis, Sandoz Bring Inequitable Conduct Counterclaims against Novo Nordisk in Prandin Suit
Actavis and Sandoz filed their answer and counterclaims in their infringement suits with Novo Nordisk over the diabetes drug Prandin, claiming that Novo concealed clinical trial reports from patent examiners and provided the FDA with materially inaccurate and fraudulent use code descriptions for the asserted patent.
In October 2009, Novo sued Actavis for infringement of U.S. Patent No. 6,677,358 patent over an ANDA seeking approval to manufacture a generic version of Prandin (see "Court Report," November 8, 2009). The infringement suit over Sandoz's ANDA was filed in November. In Actavis and Sandoz's answer, filed on July 1 in the U.S. District Court for the Southern District of New York, the defendants seek declaratory judgments of invalidity, noninfringement, and unenforceability due to inequitable conduct. They also seek injunctive relief and an award of treble damages for Novo's alleged Sherman Act violations arising from its patent misuse.
Novo first attempted to obtain the at-issue patent in December 1999, but it was rejected as obvious over certain prior art. The patent eventually issued in January 2004, after the inventors submitted a study showing that repaglinide, the active ingredient in Prandin, when combined with a specific compound, produced a synergistic effect on patients with diabetes. However, according to Actavis and Sandoz, Novo neglected to disclose three additional clinical studies Novo conducted that showed directly conflicting results.
The defendant's answer and counterclaims can be found here.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at [email protected].
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