Universities War with Big Pharma

Image: Anne MacNamara Donald Young, a physician and biochemist at the University of Rochester Medical Center, spent three decades conducting research into steroids and protein production in cells. He and fellow researchers Michael K. O'Banion and Virginia D. Winn spent the last 10 of those years identifying the human gene responsible for coding the enzyme cyclooxygenase-2 (COX-2). They determined the mechanism by which the enzyme could be selectively inhibited, thus reducing inflammation and pain without unpleasant or dangerous side effects, such as gastrointestinal irritation and bleeding.1,2 Recognition for the Rochester researchers came in April 2000, when the three were named in a broad, pioneering patent that covers the method of activity of an entire class of popular drugs known as COX-2 inhibitors. The patent surprised the biotech and pharmaceutical industries; during the decade the team worked, patents had been granted to others for COX-2 inhibitors based on compositions of matter, rather than method.3 Those composition patents led to the development and marketing of two COX-2 blockbuster drugs-Celebrex and Vioxx. The very day the Rochester patent was granted, the university filed an infringement lawsuit against GD Searle & Co. (now Pharmacia) and Pfizer, which comarket Celebrex. (Patent claims against Merck, which holds the patent for Vioxx, have not been filed.) Rochester's "historic drug patent is likely to be the most lucrative in US history," the university boasted in an April 2000 news release, with royalty payments potentially totaling billions of dollars. Rochester officials weren't exaggerating. Both drugs are among the top-10 revenue-producing pharmaceuticals, and sales are steadily growing. Celebrex last year generated US sales of $3.1 billion for Pharmacia, while Vioxx took in $2.6 billion for Merck. A court victory for the university could lead to awards of from 10% to 20% of the royalties. A trial will likely begin early next year in US District Court in Rochester, NY. Motions were still being filed in July. Another broad-reaching patent was awarded in June to three major research institutions. The patent covers disease treatment methods drawn from the common NF-kB messenger pathway. One major lawsuit already has been filed. Some scientists fear that infringement worries will creep into academic labs, affecting research activities. How to Lick a Lawsuit Here are some tips from Kevin Noonan, an attorney with McDonnell, Boehnen, Hulbert & Berghoff in Chicago: Critical to winning a patent lawsuit is demonstrating that you invented first. Maintain a good lab notebook and keep up-to-date records. Have it signed and countersigned. If grad students and postdocs are involved, be sure the principal investigator (PI) reviews their labs books at least weekly. Give lab presentations regularly to keep everyone up to speed. Even if the presentations are informal, the PI should write them up, including copies of the gels, data, and printouts discussed. Be sure everyone in the lab understands his or her intellectual property ownership obligations to the lab, university, or research institution. THE COURT FOR COMPETITION As biotech and pharmaceutical drug companies compete to fill the drug pipeline, patent wars between academia and industry are likely to erupt more often. "Biotech patents have one of the highest rates of litigation, second only to medical device patents," says Jean O. Lanjouw, professor of economics at the University of California, Berkeley, and a senior fellow at the Brookings Institution in Washington, DC. In a study of nearly 14,000 patent cases filed between 1978 and 1999, she and colleague Mark Schankerman of the London School of Economics and Political Science found that one of every eight top biotech patents was the subject of an infringement lawsuit.4 "Biotech is a complicated industry," says Stephanie Ashe, senior manager of corporate affairs for Genentech, South San Francisco. "Lawsuits are just part of doing business." Cultural attitudes contribute to the rift between industry and academia. Most pharmaceutical companies license patents and pay royalties properly, but a few try to circumvent the law. Some companies "go to conferences, see the technology and think they can just take it, not expecting they have to get a license," says Gerald Dodson, a patent litigation attorney with Morrison & Foerster in Palo Alto, Calif. Their justification, he says, is based on the view that value is derived from developing and commercializing a product, not from doing the basic research. "They see it as free research. If it's discovered at a university, they think it's something they can take." Dodson, who represents the University of Rochester, claims this is exactly what happened in the Celebrex case. It was only after the Rochester scientists gave public and private presentations on their research that the pharmaceutical companies raced to develop the COX-2 inhibitors, he says. Mark Wolf, Pharmacia's director of corporate communications, declined to comment, saying the company does not discuss pending litigation. Previously, Pharmacia maintained that a staff scientist had discovered COX-2, but Wolf also declined to make available any of the scientists for interviews. Rochester's Young also declined to be interviewed. TESTIMONIES OF THE TACITURN Such reticence is not unusual. When patent disputes land in the courts, the scientists often find themselves in unknown territory peopled with lawyers, and defined by sworn depositions and lengthy trials. "It is a rare scientist who enjoys being deposed," says John W. Caldwell, an attorney with Woodcock Washburn in Philadelphia. "It is a rare scientist who does not begrudge the time spent away from the lab and the classroom." Dodson relates the experience of a senior investigator in the patent infringement lawsuit brought by the University of California, San Francisco, against Genentech over genetically engineered human growth hormone. "Even though he did not have to testify, he was deposed for 28 or 30 days in the case, grilled and harshly treated by the legal system," Dodson says. The researcher, who currently is head of a major department at Massachusetts General Hospital, did not wish to comment for publication. Understanding the unpleasantness of litigation, many universities and research institutions try to shield their researchers. "We try to isolate the investigators as much as possible and use their time valuably when needed to testify or give depositions," says Lita Nelson, director of the Technology Licensing Office at the Massachusetts Institute of Technology. "They're not usually the ones who make decisions or stay up nights worrying. They can worry if they want. We consult them, but we manage the work." At the University of Rochester, the Medical Center staff is handling the litigation against the pharmaceutical companies, Norris says. Litigation is a sign that the biotechnology industry is maturing. "Five or ten years ago, there was a land-grab among biotech companies and there were lots of opportunities," says Jonathan A. Barney, a patent attorney in Newport Beach, Calif. "Now, things are solidifying and companies are looking at market share and trying to hang on to what they have, or capture more of what they think they deserve, based on their patents," he says. "It's a sign that the industry is maturing, and biotech litigation will be on the rise." Ted Agres (tedagres@lycos.com) is a freelance writer in Washington, DC. References 1. D. Young et al., "Method of inhibiting prostaglandin synthesis in a human host," US Pat. 6,048,850, 2000. 2. M.K. O'Banion et al., "cDNA cloning and functional activity of a glucocorticoid-regulated inflammatory cyclooxygenase," Proceedings of the National Academy of Sciences, 89:4888-92, 1992. 3. R. Lewis, "Cox fighting," The Scientist, 14[11]:1, May 29, 2000. 4. J.O. Lanjouw, M. Schankerman, "Enforcing intellectual property rights: Suits, settlements, and the explosion in patent litigation," National Bureau of Economic Research, 2001. (http://papers.nber.org/papers/W8656)

Universities War with Big Pharma

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