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Federal judge's opinion shows understanding of patented gene spread by Robert Schubert (Monday, May 17, 2004 -- CropChoice commentary) -- Someone in the federal judiciary finally has taken note of the issues surrounding the self-replication of patented processes in nature. This is a concern that farmers and scientists have observed with the spread of genetically modified organisms in crops.
The similarity between those organisms and a synthetic compound were noted by Judge Arthur J. Gajarsa of the U.S. Court of Appeals for the Federal Circuit in his April 23 opinion in SmithKline Beecham Corp. v. Apotex Corp. This distinction in patent law deserves emphasis: Products or processes that humans create are patentable, while those of nature are not. The Supreme Court affirmed this in Diamond v. Chakrabarty in 1980. On the one hand, SmithKline Beecham's paroxetine hemihydrate would qualify for a patent under Chakrabarty because humans created it. On the other hand, it could, because of seeded laboratories, reproduce itself. Such a natural process is unpatentable.
Questions for the future In the prefatory remarks to his opinion, Judge Gajarsa wrote what could be interpreted as a responsibility of courts judging cases involving patents to look at whether they should have been awarded in the first place. Given his lengthy discussion of the unpatentability of SmithKline's hemihydrate and the hypothetical blue corn, one might wonder whether Gajarsa was laying the groundwork for questioning existing patents on genetically modified seeds? After all, why couldn't a judge view farmers' fields as the factories and labs that are, according to many biotech skeptics and some supporters, becoming seeded, through a variety of vectors, with patented traits? And if that is true, will farmers growing patented -- and not necessarily genetically modified -- soybeans, corn, canola, wheat and other commodity crops become "inevitable infringers" who have no way of knowing the scope of the patents seeded in their fields? With this opinion, Gajarsa is "testing the waters," said Peter DiMauro, Ph.D., director of the PatentWatch Project at the International Center for Technology Assessment . "While he has gone through a circuitous route to find the SmithKline Beecham patent invalid under section 101 of patent law, I don't think his reasoning or concerns would lead to him to want the GMO patents invalidated, but rather for judges to find exemptions to infringement." Note: DiMauro is a patent expert, but he's not a lawyer. The Project can be found on the Web at http://www.icta.org . Even if more judges at the district and appellate court level were to read and consider Gajarsa's reasoning, that wouldn't do much in the short term to help farmers who are having to defend themselves against a biotechnology or seed company. "Now, does this [decision] mean that American farmers are protected from accusations of patent infringement for plants containing patented genes from stray pollen," DiMauro said. "Heck no! We are not even close to such a just situation. However, the Gajarsa opinion ought to inform other judges and policy makers that the problem can exist, and that the solution is not a strict literal enforcement of draconian patent laws, but, rather, an equitable application of flexible patent laws, either the laws we have now or ones legislated in the future." Background: In the early 1980s, SmithKline Beecham sought to improve paroxetine hydrochloride (PHC) anhydrate, created nearly a decade earlier. From this antidepressant compound company researchers crystallized paroxetine hydrochloride (PHC) hemihydrate, which contains a water molecule making for easier packaging. A patent was awarded in 1988, and the British pharmaceutical maker began marketing it as Paxil in 1993. In 1998, a company called Apotex wanted to process the original PHC anhydrate (no water molecule) to sell as a generic antidepressant. That's where the problems started. SmithKline Beecham sued Apotex that year in the U.S. District Court for the Northern District of Illinois for infringing its patent. The company argued that Apotex would not be able to produce the original PHC anhydrate without making at least some of the patented version.
Indeed, the district court found that the hemihydrate SmithKline created in 1984 has spread -- seeded itself -- to more and more manufacturing environments, including those of Apotex. Under normal climactic circumstances in a seeded environment, at least some of the original anhydrate will convert spontaneously into the patented hemihydrate crystals. The lower court decided the patent was valid, but that Apotex was not liable for infringement because its production process had resulted in small, commercially insignificant amounts of hemihydrate. Failing to limit the scope of the patent language would, the judge reasoned, lead to inevitable infringement. SmithKline Beecham appealed the ruling to the U.S. Court of Appeals for the Federal Circuit. The three-judge panel differed with the lower court by saying that any amount of hemihydrous PHC produced, whether commercially viable or not, infringes the patent. The appellate judges also ruled that the clinical trials SmithKline had performed constituted a prior public use, which meant the compound already existed in the public domain. Based on that, they ruled the patent invalid. In his concurring opinion, Judge Gajarsa wrote that SmithKline's patent was invalid not because it covered subject matter that had been used prior, but because it was not patentable under section 101 of patent law in the first place (35 U.S.C. 101). "I was very heartened to see Judge Gajarsa say this because it does lend credibility to the fact that patents on self-reproducing organisms can have inherent problems and can't be treated like manufactured articles such as a toaster that doesn't reproduce itself," said DiMauro at the PatentWatch Project.
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