Patented gene spread and other shenanigans
2 interesting pieces from CropChoice:
1.Federal judge's opinion shows understanding of patented gene spread
2.Monsanto's '435 patent: Now you see it, now you don't - Just what is Monsanto trying to hide?
1.Federal judge's opinion shows understanding of patented gene spread
by Robert Schubert
-- 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..."
Such a process makes public notice of the scope of the patented process impossible. The natural, spontaneous conversion of the man-made hemihydrate into its predecessor would, Gajarsa wrote, lead to inevitable infringement: "...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."
Gajarsa referred frequently to a distinction in patent law: Products or processes that humans create are patentable, while those of nature are not. The Supreme Court affirmed this in two cases -- Diamond v. Chakrabarty in 1980, and Pioneer Hi-Bred Int'l, Inc. v. J.E.M. Agric. Supply, Inc. in 2001.
On the one hand, paroxetine hemihydrate would qualify for a patent under Chakrabarty because humans created it. On the other hand, because of seeded laboratories, the original paroxetine anhydrate could, without human involvement, naturally convert itself into the hemihydrate. Such a natural process is unpatentable, according to the same case.
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 )
2.Monsanto's '435 patent: Now you see it, now you don't
by Robert Schubert
Just what is Monsanto trying to hide?
Patents are the cornerstone of the biotech revolution. Without them, there would be no profit or control. For years Monsanto, the St. Louis-based chemical and biotechnology corporation, has used the patents on its genetically engineered seed varieties as the legal basis for persecuting farmers.
But when Mississippi farmer Mitchell Scruggs recently questioned the validity of what is perhaps one of Monsanto's most valued patents in a lawsuit the company initiated, the presiding judge allowed it to remove the patent from the case. Monsanto wouldn't return calls or e-mails about this.
This '435 patent (No. 5,633,435) covers a gene that Monsanto engineered into canola, corn, cotton and soybeans. Armed with the gene, the crop plants are RoundUp Ready; they resist the glyphosate herbicide that Monsanto makes and markets as RoundUp. The technology allows farmers to spray RoundUp to kill weeds without harming the RoundUp Ready crops.
Monsanto sued Scruggs in September 2000 for infringing the '435 and other patents by saving seed he'd harvested from RoundUp Ready cotton and soybean plants and then sowing them the following season. Such practice violates the technology agreement requiring that farmers who choose to grow Monsanto's intellectual property must buy new seed every year from licensed dealers. (Monsanto itself doesn't sell seed, though its subsidiaries Asgrow, DeKalb and Hartz do.)
Scruggs denied the charges, but went further by attacking the validity and enforceability of '435 and four other patents. "We had the ‘435 patent in our sights," said Scruggs' lead counsel James L. Robertson, who practices law in Jackson, Miss.
In mid-May of 2002, Monsanto asked the Court to disregard everything Scruggs had done in the case up to that time, with one exception. "Monsanto was strangely silent regarding the ‘435 patent," Robertson said. "That was our first signal that Monsanto knew it had a problem."
Indeed, Monsanto's approach may be changing. In new saved seed lawsuits it has filed since 2003, the company hasn't mentioned this patent.
In the Scruggs case, court papers show that Monsanto first filed a motion to remove the patent from the lawsuit in July of 2002, supposedly to simplify matters. The request was denied in January 2003. Undaunted, Monsanto tried again the following December. This time it offered to dismiss all claims against Scruggs on the patent with prejudice and to promise -- in a binding covenant -- not to sue Scruggs again on '435. Monsanto initially filed these documents under seal, out of view of the public and the media. On June 16, the court agreed to Monsanto's motion for dismissal, ordered the company to repay Scruggs the money he'd spent on that portion of his defense, and unsealed the documents. However, Monsanto will maintain its infringement lawsuit on a second patent said to cover the RoundUp Ready trait product.
"Monsanto has been hammering farmers with this RoundUp Ready patent since 1998," Robertson said. "We’ve seen some 20 suits Monsanto has filed, citing the 435 patent as Count One. For at least five years, Monsanto has used the 435 patent to force farmers into costly settlements, preliminary injunctions and a few big damage awards, plus Monsanto’s attorney’s fees...The practice was particularly pernicious because of a doctrine holding that a patent upheld in one case is evidence of its validity in the next. For example, in January 2001 in the Scruggs case, Monsanto presented the 435 patent in Count One. Its expert told the Court how wonderful it was. Scruggs had no patent lawyer and no expert and got killed with a preliminary injunction. Three months later, Monsanto got a preliminary injunction hearing in April 2001 in St. Louis against Homan McFarling [another Mississippi farmer we've reported on recently; see http://www.cropchoice.com/leadstry.asp?recid=2540 ]. Monsanto presented the 435 patent again, just like in Scruggs, but added 'Judge, this patent has been upheld in Scruggs case, and you should consider that as evidence of its validity here' and on and on. When a farmer finally has the wherewithal to stand up and fight, Monsanto moves heaven and earth to get its important ‘435 patent out of the line of fire."
Scruggs certainly opposed the withdrawal of the ‘435 patent, but to no avail. "We had found major problems with the ‘435 patent. Monsanto’s extraordinary efforts to get it out of the case leave little doubt that the problems are serious," said Jager Smith, a Jackson, Miss. patent lawyer and a member of Scruggs' defense. "Monsanto appeared to be worried that even more problems will become publicly known if the case had gone forward with the ‘435 patent in it."
"The whole purpose of the patent system is to have a public record of patent claims, and it looks like Monsanto was trying to ‘hide the ball,’" said Gary Myers, who teaches intellectual property law at the University of Mississippi and consults the Scrugss legal team.
The Patent Act requires a patent applicant to disclose the best way to use the invention. But lawyers for Scruggs had pointed out in court filings that Monsanto’s ‘435 patent application had not disclosed that RoundUp herbicide cannot be sprayed on RoundUp Ready cotton crops after the fourth true leaf has emerged. However, in its Technology Use Guides, Monsanto does warn farmers that they can damage their RoundUp Ready crops if they spray RoundUp herbicide over the top after the fourth true leaf has appeared.
Monsanto provided the court a copy of an Application for Reissuance of the '435 patent dated July 18, 2003, Robertson said. His office checked periodically with the U.S. Patent and Trademark Office and was told it had no record of any such application to re-issue the application. Re-issue notice is supposed to be published in the PTO's Official Gazette, but it hasn't appeared there either.
This reporter called the PTO customer service line earlier this week about the matter and was told that indeed the re-issue application, numbered 10-622-201, was dated July 18, 2003. The official was curious as to why it's still in the pre-examination process. Like Robertson and his staff, I couldn't find the application on the PTO website or in the Official Gazette. I inquired at length about the matter in an e-mail to the patent office, but was told such questions couldn't be answered over e-mail.
Given all this, one might wonder why other farmers facing lawsuits didn't challenge the validity of this patent. Most likely because they don't have the money to hire the specialized lawyers and experts. But Monsanto's biotech competitors do. Why didn't they go after '435? "Maybe they figured if you can't knock out all of Monsanto's patents, what's the point," Robertson said. Instead, they all jumped into bed together. Witness the many cross-licensing agreements Monsanto has made -- DuPont/Pioneer in 2002, DowAgrosciences in 2002 and Bayer CropScience in 2003.
Indeed, Bayer has been trying to exploit the issue by advertising that farmers can spray over the top of its BXN herbicide resistant cotton product well past the fourth true leaf. BXN cotton is the only competing herbicide tolerant cotton trait product commercially available to farmers. BXN has a very small market share.
Not to be outdone, Monsanto has publicly announced that it is developing a new product -- RoundUp Ready Flex cotton -- that will not be subject to the fourth true leaf limitation. It probably won't be commercially available to farmers before 2006.
The Scruggs case is set for trial in U. S. District Court in Greenville, Mississippi beginning August 2, 2004.
For Court documents, contact:
Mr. Arlen B. Coyle
U. S. District Court
U. S. Courthouse
911 Jackson Avenue, Room 369
Oxford, Mississippi 38655-3622
Hon, W. Allen Pepper, Jr.
U. S. District Judge
U. S. Courthouse
305 Main Street, Room 329
Greenville, Mississippi 38701-4013
Source: James L. Robertson interview, court documents, and news release
Mississippi farmer gets big break from appeals court in Monsanto biotech seed case... http://www.cropchoice.com/leadstry.asp?recid=2540
Federal judge's opinion shows understanding of patented gene spread... http://www.cropchoice.com/leadstry.asp?recid=2560
Monsanto vs Homan McFarling: Judge Clevenger understands... http://www.cropchoice.com/leadstry.asp?recid=1175
Monsanto sees opportunity in glyphosate resistant volunteers, part 2... http://www.cropchoice.com/leadstry.asp?recid=1299