WASHINGTON _ Unless Congress changes the draft legislation thatwould implement the General Agreement on Tariff and Trade (GATT)treaty, biotech firms may bring new drugs to market only to find theircoveted patent protection ticking away, said industry officials whohave launched a drive to change the proposed law.The new legislation, expected to come to a vote as early as mid-July,would provide protection for 20 years beginning on the date that patentapplications are filed. It represents a marked shift from current patentlaw, which starts the clock ticking on the date the patent is issued andprotects patent holders for 17 years.Those two words, filed or issued, could mean millions of dollars _ orperhaps even survival _ to a start-up biotech firm, which may spendhalf of the 20-year life of the patent in the application process. Theaverage period that a biological patent could be pending is a decade,according to the Biotechnology Industry Organization (BIO).David Beier, vice president for government affairs for Genentech Inc.,of South San Francisco, Calif., said most patent recipients working infields with established science, accepted precedents and reams of case-law, "will wind up with as much of a term as they have today, orlonger."That's not necessarily the case in the science of biotechnology, Beiersaid."A simple biotech application can take three to five years in the patentoffice, which is 50 percent longer than other types of patentapplications," he said. "If you get into a dispute over who inventedsomething first, it can take an exceedingly long time."The BIO this week sent a letter to U.S. Trade Representative MickeyKantor to complain that the legislation could "seriously disadvantageour industry." On Tuesday several representatives of leading biotechfirms _ including Genentech, Sandoz Pharmaceuticals Corp., andSchering-Plough Corp. _ met with Patent Commissioner BruceLehman to express their concerns.A U.S. trade official, who has closely tracked the GATT and TRIPSprocess, said that the government is not opposed to making the changesthe biotech industry is seeking."This proposal is not new, it has been out there for a while," said theofficial who has agreed to speak only on the condition his name wouldbe withheld. "We took biotech's silence on this as a sign that there wasno problem. But there is room for change. Whether they ultimatelyprevail is another matter having to do with the merits of their position.Patent office statistics indicate that the average time needed to obtain apatent is 18 months _ but the time can vary dramatically depending onwhether the invention is a new mousetrap or a promising newgenetically engineered vaccine.Adriane Antler, a patent attorney with the firm of Pennie & Edmonds,in New York, said that biotech research often does not immediatelyproduce the kind of evidence that patent examiners view as the basisfor awarding a patent.For instance, the Supreme Court has ruled that an invention, to bepatentable, must meet a standard of immediate, practical utility.Problems arise, Antler said, because the standard of proof fortherapeutic utility has come to mean statistically significant,reproducible human studies or, at the very least, animal trials thatprovide evidence of the invention's usefulness."Patent claims are often filed years before the necessary experimentaldata is generated," Antler said. "If you wait too long, publications onthe subject will appear and you may lose the right to a patent."Further complicating matters, she said, the Supreme Court has alsoruled that substances cannot be patented if their sole "utility" rests inresearch into their potential usefulness.Underpinning the current controversy was the desire a decade ago toimprove the patent protection accorded to intellectual property.GATT, and the related Agreement on Trade Related Aspects ofIntellectual Property Rights (TRIPS), were viewed as obvious startingpoints. The TRIPS agreement became the impetus for a movement toextend patent protection to 20 years and to "harmonize" internationalpatent law by changing the U.S. standard for proof of intellectualproperty rights _ being the "first to invent" a product _ to theinternational standard of being "first to file" for a patent.But the parallel efforts split apart. The harmonization effort died. Onlythe push to extend the patent period to 20 years survived.The changes will not go into effect until after the GATT treaty isratified by Congress, a process which involves passage of the enablinglegislation, which was introduced into the Senate about six months agoby Sen. Dennis DeConcini, (D-Ariz.). and into the House two weeksago by Rep. William Hughes, (D-N.J.).Carl Feldbaum, BIO president, said that the organization is trying tochange the language of the legislation before it passes Congress. Theproposed change states that patent protection should begin on the dateon which the patent is issued and end 17 years later. The term shall notrun for less than 20 years from the date on which the patent applicationwas filed in the U.S.If that effort fails, the group will step up its efforts to amend thelegislation. n

-- Steve Sternberg Special to BioWorld Today

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