In a potential victory for Alzheimer’s disease research, a federal court ruling issued Wednesday, 2 May 2012, knocked the wind out of patent litigation that has long scuttled distribution of mice with a mutant gene that causes early-onset AD.

The Alzheimer’s Institute of America, Inc. (AIA) of Kansas City, Kansas, sued Avid Radiopharmaceuticals and the University of Pennsylvania, Philadelphia, in November 2010, claiming the parties infringed AIA’s patents on transgenic mice that express the amyloid precursor protein with the Swedish mutation (APPswe). The patents list Michael Mullan of Roskamp Institute, Sarasota, Florida, as the inventor. However, in the recent trial, the jury found AIA’s allegations invalid on two separate grounds (see Memorandum Opinion). First, Mullan was not the sole inventor of the APPswe mutation claimed in the patents. Furthermore, Mullan did not, in fact, own the patent rights he assigned to AIA in July 1992, about a month after filing the APPswe patent application.

On the first issue, the U.S. Court for the Eastern District of Pennsylvania determined that John Hardy, then of Imperial College London, U.K., co-invented the Swedish mutation, since he and Mullan had collaborated all along in the work leading to the mutation’s discovery. Mullan came to Hardy’s lab in 1988 as a Ph.D. student, and the two relocated Hardy’s AD research lab to the University of South Florida in Tampa. Mullan moved to Tampa in late 1991 to set up the lab, and Hardy joined him in 1992.

The second issue, ownership, was more complex. Because Mullan was employed by USF at the time the Swedish mutation was identified, APPswe patent ownership should have gone to USF, unless the university knowingly waived its rights, according to Florida state law. “Knowingly” is key here. Mullan and Hardy did get the university to sign such a waiver. However, the waiver was ineffective per Florida state law, the jury found, because the scientists did not disclose their Swedish mutation work, i.e., the invention. “Avid argues that Imperial owned the rights to the inventions because Mullan was a student and employee of Imperial when the inventions were conceived,” U.S. District Judge Timothy Savage wrote in the Memorandum Opinion. “Avid asserts that in either case, Mullan owned no rights to the inventions, and thus had no rights to assign to AIA. Therefore, so Avid argues, AIA has no standing to bring a patent infringement action for the patents in suit.” The jury agreed with Avid on both points.

As for the APPswe patents at stake, the book has not yet formally closed. While the Pennsylvania Court has entered final judgment, AIA will have the opportunity to appeal the jury’s findings, and plans to do so. “For almost 20 years, AIA has been and continues to be the record owner of title to the Swedish mutation patents,” Brian Sexton of the AIA Foundation wrote in an e-mail to ARF. “Michael Mullan’s inventive contribution to the discovery of the Swedish mutation and the resulting invention was not disputed in the litigation and remains unchallenged. Per its policy, AIA will not comment further on pending litigation, other than to state that it remains ongoing in the trial court and will likely continue in the U.S. Court of Appeals for the Federal Circuit.” That process will take many months, maybe as much as a year.

Nevertheless, the possibility of AIA prevailing in its appeal is “extremely unlikely,” said an attorney for one of seven parties the AIA sued in its earlier APPswe patent case filed February 2010 (see ARF related news story). “For AIA to get an effective reversal, [the Court of Appeals] would have to reverse both parts of the jury’s findings. That will be very difficult.”

The Avid/Penn ruling should provide grounds for dismissal of ongoing AIA APPswe lawsuits. “The jury finding means that AIA lacks standing. It cannot pursue these claims,” the attorney told ARF. One of those ongoing suits was filed by the AIA in June 2009 against Oklahoma Medical Research Foundation (OMRF), Oklahoma City, and the biotech company CoMentis of South San Francisco, on similar APPswe patent infringement allegations. “In light of the jury’s verdict and judgment in the Penn case, if AIA does not dismiss the [OMRF/CoMentis] case voluntarily, we expect to move the court to dismiss the case,” said Eric Walters at the San Francisco office of Davis Wright Tremaine LLP, who represents CoMentis.

The only other ongoing litigation is against Elan and Eli Lilly and Company, which acquired Avid in late 2010 and therefore managed the Avid case. Jackson Laboratory (JAX)—a nonprofit institute in Bar Harbor, Maine, that maintains and distributes APPswe transgenic mouse strains to AD researchers—was named with Elan, Lilly, and others in the February 2010 lawsuit. The JAX case was dismissed last summer, and all other parties have settled (see ARF related news story). One question raised by the recent court finding is that defendants in previous suits brought by AIA who have chosen to settle may now consider suing AIA on the argument that AIA never had standing to bring infringement claims on a patent it did not own. The patents at the center of this controversy expire next year.—Esther Landhuis.

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References

Other Citations

  1. ARF related news story

External Citations

  1. Alzheimer’s Institute of America, Inc.
  2. Memorandum Opinion

Further Reading