By James DeGiulio --
Roche Dodges Cobalt Invalidity Contention in Boniva Patent Suit
In a decision handed down earlier this week, the U.S. District Court for the District of New Jersey rejected Cobalt Pharmaceuticals' attempt to invalidate Roche's patent covering Boniva for incorrect inventorship. After Apotex and Cobalt filed Abbreviated New Drug Applications (ANDAs) for generic ibandronate, the active ingredient in Boniva, Roche filed suit against the generic drug manufacturers in September of 2007 for infringement of U.S. Patent Nos. 6,143,326, 6,294,196, 7,192,938, 4,927,814, and 7,410,957 (see "Court Report," September 30, 2007). Eventually, a total of six lawsuits were consolidated into two pretrial proceedings, and the claims relating to the '326, '196, and '938 patents were settled. In August, the District Court granted summary judgment in favor of Roche, finding that Apotex's ANDA literally infringes the '814 patent. The defendants maintain that the '814 patent is unenforceable due to inequitable conduct. On September 30, summary judgment was denied to both sides, and the case was sent to the jury. Roche successfully secured a preliminary injunction against Cobalt in November.
Cobalt asserted an affirmative defense for invalidity, arguing that one of the patents is invalid since the inventors listed are incorrect. However, on December 20, Judge Stanley Chesler found Cobalt's claim to be insufficient, and granted summary judgment for Roche. Citing Stark v. Advanced Magnetics Inc., Judge Chesler ruled that the law allows a patent filer to correct errors on a list of inventors, in some cases even when those errors were intentionally deceptive. However, Cobalt offered no evidence that Roche incorrectly listed inventors as a result of deceptive intent. Judge Chesler noted that there might be a better case for invalidation if deceptive intent had been established.
Novo Nordisk and Sandoz Settle Infringement Claims in Prandin Dispute
Novo Nordisk and Sandoz have reached a settlement in their dispute involving the patent covering Prandin, with Novo agreeing to drop two claims in exchange for Sandoz's admission that it infringed three other claims. The suit began in October 2009, when Novo sued Actavis for infringement of U.S. Patent No. 6,677,358 following Actavis' filing of 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 2009 (see "Court Report," November 15, 2009). 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 sought declaratory judgments of invalidity, noninfringement, and unenforceability due to inequitable conduct. They also sought injunctive relief and an award of treble damages for Novo's alleged Sherman Act violations arising from its patent misuse.
On December 16, Judge Paul G. Gardephe signed off on the settlement agreement, which stipulates resolution on all five claims of the '358 patent. Sandoz admitted its ANDA infringed claims 1, 2, and 4, and that any manufacture or sale of the generic drug would infringe claims 1 and 2. Novo agreed to drop allegations of infringement of claims 3 and 5, but reserved its right to pursue those infringement claims again if Sandoz amends its ANDA whereas infringement might be possible. The agreement can be found here.
Jury Finds That RyMed Infringes ICU Medical Valve Patents
After a jury found that RyMed had infringed two of ICU Medical's medical valve patents, RyMed Technologies vowed to challenge the verdict at an upcoming January bench trial. In a suit originally launched in July 2007 in the U.S. District Court for the District of Delaware, ICU Medical asserted that RyMed directly infringed U.S. Patent Nos. 5,685,866, 5,873,862, 5,928,204, and 6,572,592. ICU also alleged that RyMed induced others to infringe these patents through its medical valve products, which ICU asserted had no substantial noninfringing use. ICU further argued that all of RyMed's infringement had been willful. ICU sought an injunction, compensatory and treble damages with prejudgment interest, as well as costs and attorneys' fees. RyMed countered ICU's assertions, alleging that the patents are invalid and unenforceable for a number of reasons, including patent misuse and inequitable conduct. The '204 patent was eventually dropped from the suit.
On December 17, a jury concluded that two of the three patents asserted by ICU had been infringed. However, the jury was not persuaded that RyMed's infringement was willful. RyMed intends to file post-trial motions on the issue of literal infringement of the two patents, and will look to overturn the infringement findings at a bench trial set for January. The jury verdict form can be found here.
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