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Patent owners are increasingly heading to court — and losing when they get there. At least that’s what Finnegan, Henderson, Farabow, Garrett & Dunner concluded in a report it prepared on biotech patent trends and released at the BIO 2004 conference held recently in San Francisco. The firm found that out of 37 pharmaceutical and biotech cases appealed to the Federal Circuit U.S. Court of Appeals in 2003, lower courts favored accused infringers over patentees by a margin of 2 to 1. Since the data takes into account only those cases pursued to appeal, it does not provide a full picture of patent litigation. Even so, “This seems to say that the public has a problem with patents, and I personally think that’s a dangerous thing,” says Arie Michelsohn, a partner in Finnegan’s Washington, D.C., office and editor of the report. The Federal Circuit affirmed the lower court decisions 56 percent of the time in biotech cases and 82 percent of the time in pharmaceutical disputes. The authors of the Finnegan report also found that the explosive growth in biotech patenting in the 1990s appears to be leveling off. Michelsohn noted that biotech patents increased eight times the rate of other types of patents between 1993 and 2001. While companies are receiving fewer biotech and pharmaceutical patents, they are going to court more often to battle over them. The report says there has been a steady increase in litigation, particularly cases involving pharmaceuticals, over the past five years. The report did not provide statistics on the number of lawsuits that have been filed. The current level of litigation may reflect the jump in patenting a few years ago, says Michelsohn, who adds that it can take up to 10 years from the time a patent issues until legal disputes arise. In another trend, the report notes that the private sector has been acquiring more biotech patents compared to universities and the U.S. government. In 2003, universities, institutes and other nonprofits were assigned just 20 percent of nucleic acid patents, one of the primary types of biotech patents, according to the report. Finnegan’s study got some attention at the BIO conference, which drew more than 14,000 attendees. The firm sponsored the IP breakout sessions at the event, kicking off the first session with a panel discussion of its report. Stephen Kunin, deputy commissioner for patent examination policy at the U.S. Patent and Trademark Office, offered explanations for some of the trends. The decline in biotech patents is in part due to budget restrictions at the PTO, which prevented the agency from hiring more examiners, Kunin said in a subsequent interview. The sector also lost financial momentum after the technology boom went bust. “The shift in the economy and the drying up of some venture capital and the lessening in the amount of federal dollars through grants to universities” helped slow patent activity, Kunin said. These factors also influenced the shift in patent ownership from universities to the private sector, he said. The PTO put a further brake on biotech patenting when it issued guidelines in 2001 requiring applicants to provide more data on the genes they were seeking to patent. The guidelines “made it harder to get a patent, so fewer were issued,” said Kunin. Brenda Sandburg is a senior writer at The Recorder , where she covers developments in patent law and other intellectual property matters.

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