Research tool patents debated

The US Supreme Court heard arguments this week from both sides of a 10-year debate that essentially pits the interests of the research tool industry against those of drug developers.The case tests the limits of an imprecise federal law, which states that researchers conducting experiments reasonably related to new drug approvals do not have to pay licensing fees to use proprietary products. One side argues that if extended to cover too many experiments, the exemption could hurt the research tool industry, which depends on licensing fees. However, as it stands, those fees may be limiting drug development, the opponents note.The debate has divided the life sciences industry, with large pharmaceutical companies and patient advocates lending support to drug developers and tool makers throwing their hats in the ring for the research tool industry.If the Supreme Court sides in favor of the drug developers, intellectual property rights to research tools would be "basically useless," argued Richard Berman, who heads Washington, DC, law firm Arent Fox's prescription drugs group and has no connection to the case.The debate stems from a series of experiments conducted by David Cheresh and his colleagues in the 1990s. Cheresh received a grant and different peptide sequences from German pharmaceutical company Merck—unrelated to the international US-based firm Merck—to determine if any peptide groups blocked an integrin important for tumor angiogenesis. However, some of those peptide groups were patented by Integra, based in New Jersey. Integra sued Merck, winning $15 million in a California court.Merck appealed, arguing that they didn't have to pay licensing fees because their work fell under an exception: As long as experiments are reasonably related to new drug applications to the US Food and Drug Administration (FDA), the law allows scientists to use patented technologies without paying a license. The exception was designed to enable generic drug makers to test products under patent, so they can sell generics the moment the patent lifts. Merck has now brought the case before the US Supreme Court, which is expected to rule by the summer.Numerous large pharmaceutical companies have voiced their support for Merck's position, as has the American Association of Retired Persons (AARP). In turn, Integra has received support from groups that make research tools, who argue that without patent protection, the industry won't survive.Cheresh said that although the research tool industry may be affected by a ruling in Merck's favor, the needs of drug developers should come first. Using Integra's technology, the researchers produced a cancer drug called cilengitide, now in phase 2 trials. If he had had to wait until Integra's patent expired, so would cancer patients who are now taking the drug, argued Cheresh, who recently moved from the Scripps Research Institute to the University of California, San Diego. "It's a lose–lose situation for the public, for the scientists," if the court rules for Integra, he told The Scientist.However, if the government acted only in patients' interests, they would abolish patents altogether, to allow generic drug makers to provide everyone with cheaper drugs, argued attorney Berman. Since that won't happen, he said, it's not clear why the government should make an exception in this case.Furthermore, if research tool makers can't recoup costs through licensing fees, companies may be less willing to develop new, more effective tools, which could hurt both scientists and patients down the road, added Berman. If the court rules in favor of Merck, the research tool industry "is not really a profitable enterprise," he said.John Van Amsterdam, a molecular biologist and senior attorney at the Boston firm Wolf Greenfield, who does mostly biotech patent work and also has no connection to the case, said that the situation is no different from one in which a lab buys a polymerase chain reaction tool from a company licensed to sell it. This arrangement occurs frequently, he noted, and given how much pharmaceutical companies spend on developing drugs, an extra amount for licensing fees is a "drop in the bucket." A ruling for Merck would be "more of a burden" for research tool makers, Van Amsterdam said.However, Sarah Lenz Lock, an attorney at AARP, who attended Wednesday's Supreme Court arguments (April 20), said that the group opposes anything that adds to the cost of prescription drugs. AARP is "very concerned about the access to and development of new drugs, and wants to speed that along," she said. Lock told The Scientist that the Supreme Court appeared "skeptical" of Integra's argument that since some of Cheresh's Merck-funded experiments involved animals, not humans, they were too early to be related to new drug approvals. Merck, in turn, argued that the FDA requires both human and animal experiments before okaying a new drug.Berman said that if the Supreme Court forces Merck to pay licensing fees to Integra, this will not have a major impact on most scientists. But if scientists are being paid by a pharmaceutical company to produce new products, they should know who made the tool they're using. "And if it's somebody else's, shouldn't they profit from it?" Berman asked.Tim Murphy, partner at the Boston firm Bromberg & Sunstein, said the courts clearly need to strike a balance between the interests of tool makers and drug developers. "The system is broken if researchers feel they have to call a lawyer every time they do an experiment," Murphy noted.

Research tool patents debated

Supreme Court appeal could limit licensing income for research tool makers

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