Newswise — The fight against Alzheimer disease rallies warriors of many sorts—families caring for afflicted loved ones, scientists toiling late nights in the lab to unravel disease mechanisms, advocates lobbying for research funding, companies sponsoring clinical trials, participants volunteering their time. And don’t forget lawyers. For better or worse, they, too, play their part in the war against AD. A string of recent lawsuits filed against the use of well-established AD mouse models and other tools is keeping patent attorneys busy as it saps research time and dollars—again.
Researchers may recall a legal battle that erupted in the late 1990s between Elan Pharmaceuticals, Inc., headquartered in Dublin, Ireland, and the Mayo Foundation for Medical Education and Research. Elan sued the Minnesota-based nonprofit, alleging that its use and distribution of Tg2576 mice infringed two company patents on transgenic animals expressing amyloid precursor protein (APP) with the Swedish mutation. Mayo made a counterclaim that Elan’s patents were invalid, touching off a protracted legal seesaw that included a U.S. District Court’s dismissal of the case, Elan’s appeal of the ruling, and an eventual agreement that restored the use of the transgenic models and other AD research tools by both parties in 2004.
Though this five-year court drama appeared to end on a promising note, a controversial U.S. patent that helped fuel those proceedings continues to stir up trouble even today. Issued in 1995, this patent covers certain genetic sequences of human APP with the Swedish mutation (APPswe), i.e., nucleotide substitutions that change the lysine at codon 670 and methionine at codon 671, and that cause early-onset familial AD. In 1996, the Mayo Foundation secured a license for this and related patents when it began breeding and distributing Karen Hsiao Ashe’s Tg2576 mice, which overexpress APPswe (Hsiao et al., 1996). The license agreement helped convince a district court judge in San Francisco nearly a decade ago that Elan’s patents on APPswe mice were invalid since they covered technology anticipated by the earlier APPswe patent Mayo had been allowed to use.
This patent was issued to the Alzheimer’s Institute of America (AIA), based in Kansas City, Kansas, and is set to expire in 2012. The patent lists just one inventor—Michael Mullan, who heads the Roskamp Institute and Archer Pharmaceuticals, both in Sarasota, Florida. As a doctoral student in John Hardy’s lab at Imperial College, London, who finished his dissertation at the University of South Florida, Tampa, Mullan was part of the collaboration that discovered the APP Swedish mutation.
Now in its final years of life, this AIA patent, along with several others Mullan was granted and sold to AIA, is back at the center of heated litigation. In a lawsuit filed in February and amended in March 2010 in the Northern District of California, AIA is suing Elan and six other parties for infringement of patents on APPswe and its use in mice, cells, and other research tools. The other defendants include Eli Lilly and Company, Indianapolis, Indiana; AnaSpec, Inc., Fremont, California; Immuno-Biological Laboratories, Inc., Minneapolis, Minnesota; Phoenix Pharmaceuticals, Inc., Burlingame, California; American Peptide Company, Inc., Sunnyvale, California; and The Jackson Laboratory, Bar Harbor, Maine. AIA alleges that Elan and Lilly have used AIA-patented technology in their AD research and drug discovery efforts. The lawsuit cites several company-owned U.S. patents (e.g., Elan’s 7,553,831 and 7,514,408; Lilly’s 7,585,885) that describe the use of assays, cell lines, and animal models including the APP Swedish mutation. The other named companies face infringement charges related to their sale of APPswe-containing peptide sequences and other reagents.
For the full story, please visit the Alzheimer Research Forum web site:http://www.alzforum.org/new/detail.asp?id=2472
The Alzheimer Research Forum (www.alzforum.org), founded in 1996, is the web's most dynamic scientific community dedicated to understanding Alzheimer disease and related disorders. It is an independent nonprofit organization supported by grants and individual donations. The web site does not endorse any specific product or scientific approach.
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