WASHINGTON _ The U.S. House of Representatives on Tuesdayhanded the biotechnology industry a victory by passing a bill that willmake it easier for biotech firms to patent novel processes and protectthem from foreign competition."We're thrilled," said Lisa Raines, vice president for governmentaffairs for Genzyme Corp., of Cambridge, Mass. "This bill is veryimportant for the biotechnology industry."The bill, which has taken five years to emerge from committee andreach the House floor, passed without significant opposition in a two-thirds voice vote. Since the Senate has already passed its own versionof the law, the two measures must be reconciled before PresidentClinton can sign them into law.Both remaining steps are viewed largely as formalities. Theadministration has in the past expressed strong support for the measure."Foreign piracy of U.S. technology through exploitation of a legalloophole such as this should not be tolerated," Clinton aide MichaelKirk told BioWorld Today when the bill was introduced in May.The legislation (HR 4307) would change the way that the U.S. Patentand Trademark office grants patents for processes.Currently, inventors cannot stop foreign firms from importing itemsmade from a process that depends upon a substance patented in theU.S. _ unless the inventors hold a patent on the process itself.Unless processes are protected by patents, a foreign manufacturer maytake patented components offshore, process them using the U.S. firm'sunpatented technique, and then export the finished product back intothe U.S. without fear of being prosecuted for infringement.Further complicating matters, Raines said, is a 1985 court ruling, whichlabeled genetic engineering processes as "obvious" _ meaning that,because genetic engineering techniques have been used to make a widevariety of products, the engineering process itself is not sufficientlyinventive to warrant patent protection.As a result, the patent office will grant patents for components of abiotechnology product, such as a DNA sequence vector or a host cell,but not for the process it uses to combine those components into amarketable product.The new law would eliminate the requirement that companies provetheir process is "nonobvious," which means that virtually all geneticengineering processes would be viewed as significant enough towarrant patenting, even if a similar process has been used before.Raines said that sponsors of the House bill had hoped that the Senatewould simply vote on the House version of the bill, eliminating theneed to reconcile the two versions now in hand. "The House bill isbroader and better drafted," she said. "It's also simpler."Raines said the Senate version is narrowly confined to thebiotechnology industry, a focus that forced the bill's authors to try toproduce a definition of biotechnology that would hold up despite futureadvances that could change the biotech industry _ and interpretationof the law _ in unpredictable ways.In contrast, the House bill broadly covers industrial processes inbiotechnology and other industries, minimizing the likelihood thatfuture changes in biotechnology would render the law unenforceable.Unfortunately for legislative strategists, Raines said, an unrelatedcopyright measure was tacked onto the House version of the bill beforepassage. "We hope that won't be an obstacle but that does present amore complex situation in the Senate than we expected," she said. n
-- Steve Sternberg Special To BioWorld Today
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