E-mail this article to
yourself or a friend.
Enter address:


Federal judge's opinion shows understanding of patented gene spread

by Robert Schubert
CropChoice editor

(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.

"Paroxetine hemihydrate is presumably a synthetic compound, created by humans in a laboratory, never before existing in nature, that is nevertheless capable of 'reproducing' itself through a natural process...This crystalline compound raises a question similar to one that might arise when considering the invention of a fertile plant or a genetically engineered organism, capable of reproduction, released into the wild. Consider, for example, what might happen if the wind blew fertile, genetically modified blue corn protected by a patent, from the field of a single farmer into neighboring cornfields. The harvest from those fields would soon contain at least some patented blue corn mixed in with the traditional public domain yellow corn--thereby infringing the patent. The wind would continue to blow, and the patented crops would spread throughout the continent, thereby turning most (if not all) North American corn farmers into unintentional, yet inevitable, infringers. The implication -- that the patent owner would be entitled to collect royalties from every farmer whose cornfields contained even a few patented blue stalks -- cannot possibly be correct. The underlying question that engaged the district court, and that led it to develop numerous alternative holdings, is why this implication is incorrect. At oral argument, when faced with this hypothetical, SKB [SmithKline Beecham] expressed its belief that such a blue-corn patent would be 'very strong.' Such a belief is misplaced. The implicit concept of 'inevitable infringement' stems from the inevitable failure of the patent to provide public notice -- which, in turn, stems from the inherently unpatentable nature of the claimed subject matter...In short, patent claims drawn broadly enough to encompass products that spread, appear, and 'reproduce' through natural processes cover subject matter unpatentable under Section 101 -- and are therefore invalid."

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."


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.

  • Decision, United States Court of Appeals for the Federal Circuit, Case no. 03-1285, -1313, SMITHKLINE BEECHAM CORPORATION and BEECHAM GROUP, P.L.C. v. APOTEX CORP., APOTEX, INC., and TORPHARM, INC.,
  • Gajarsa concurring opinion, United States Court of Appeals for the Federal Circuit, Case no.03-1285, -1313, SMITHKLINE BEECHAM CORPORATION and BEECHAM GROUP, P.L.C. v. APOTEX CORP., APOTEX, INC., and TORPHARM, INC.
  • Interview, Peter DiMauro, Ph.D., the PatentWatch Project of the International Center for Technology Assessment,, (http://www.icta.org )

Related CropChoice story:
Mississippi farmer gets big break from appeals court in Monsanto biotech seed case... http://www.cropchoice.com/leadstry.asp?recid=2540