By James DeGiulio --
Otsuka Abilify Patent Found Valid and Enforceable
In 2007, Otsuka sued several defendants, including Teva, Apotex, and Sandoz, after the defendants filed Abbreviated New Drug Applications (ANDAs) for aripiprazole, which Otsuka claimed infringed U.S. Patent No. 5,006,528. The cases over individual ANDAs were consolidated in the U.S. District Court for the District of New Jersey. The defendants did not contest Otsuka's claim of infringement, arguing instead that the '528 patent was invalid due to obviousness and obviousness-type double patenting over Otsuka's U.S. Patent No. 4,734,416. They also argued that the patent was unenforceable due to inequitable conduct. In August, Otsuka went to trial with Teva, Barr and Apotex, with the other defendant generics agreeing to be bound by the District Court's decision.
On November 15, Judge Mary L. Cooper ruled that the '528 patent is valid and enforceable, and enjoined the defendants from marketing generic Abilify until Otsuka's patent expires on April 20, 2015. Weighing the obviousness of three chemical substitutions, Judge Cooper first rejected the defendant's notion that a person of ordinary skill must possess all of the attributes of a multi-member chemistry research team. Several pieces of prior art were considered, and though these references disclosed the structure of the active ingredient in Abilify, the references did not teach its use as an antipsychotic. Judge Cooper also found that the defendants did not show by clear and convincing evidence that a person of ordinary skill in the art would have selected the particular lead compound. An extensive analysis of secondary considerations was also included in the opinion. On the issue of inequitable conduct, the Judge found that two declarations that the defendants argued were materially misrepresented to the U.S. Patent and Trademark Office did not rise to the requisite level to render the '528 patent unenforceable. Judge Cooper's Opinion can be found here.
Lilly's Alimta Patent Found Valid
Eli Lilly enjoyed a victory in its patent dispute over the chemotherapy treatment Alimta following a ruling which upheld the validity of Lilly's U.S. Patent No. 5,344,932. The decision prevents defendants Teva and APP Pharmaceuticals from producing generic versions of Alimta until July 2016.
In June 2008, Lilly and Princeton University, which owns the '932 patent, brought suit against Teva and APP for patent infringement, seeking to block them from marketing 500 mg doses of generic Alimta. In November 2008, Lilly filed another suit against Teva over the 100 mg dose of the drug. The three suits were consolidated in the U.S. District Court for the District of Delaware for discovery and trial purposes. The case has been at trial since early November.
On November 15, Judge Gregory M. Sleet issued a bench ruling for the trustees of Princeton University and Lilly, which holds an exclusive license to the '932 patent. The trial ended with Judge Sleet entering judgment in Lilly's favor, upholding the patent's validity.
Stryker's Challenge of USPTO Ruling in Bone Screw Interference Struck Down
Stryker Spine was unsuccessful in its attempt to force the USPTO to define two allegedly distinct inventions in Stryker's patent for spinal fixation devices. The decision came in an interference proceeding involving Stryker, Biedermann Motech GmbH, and DePuy Spine.
In December 2005, the USPTO issued U.S. Patent No. 6,974,460, covering spinal fixation devices, to Stryker. Biedermann had previously filed U.S. Application No. 10/763,431 in January 2004, and filed a request for a declaration of interference in July of that year. During the course of the interference, Biedermann filed a motion to redefine the interference, arguing that the first count of the interference included two separate inventions that were patentably distinct. In April 2008, the USPTO rejected this contention, concluding that the two inventions were not distinct. Following this rejection, Stryker filed suit in the U.S. District Court for the District of Columbia, seeking a declaratory judgment that the separate claims at issue in the interference were directed to two separate and distinct inventions, and thus should be two counts. In February, the District Court denied Stryker's motion for summary judgment, ruling that the issue of whether the board erred by failing to redefine the interference count must proceed to trial.
On November 15, Judge Colleen Kollar-Kotelly entered judgment in favor of defendants Biedermann Motech GmbH and DePuy Spine, finding that the BPAI did not err in declaring a single interference count encompassing both claimed inventions. The Judge heard expert testimony from both sides, and concluded that the inventions were not patentably distinct. Since all of Stryker's remaining claims in the interference were contingent upon the redefined interference, Judge Kollar-Kotelly endered judgment for the defendants and dismissed the action. Judge Kollar-Kotelly's opinion can be found here.