Patented_gene_spread_and_other_shenanigans

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> Subject::_Patented_gene_spread_and_other_shenanigans

> " GM_WATCH " <info

> Mon, 26 Jul 2004 22:55:17 +0100

 

>

> GM WATCH daily

> http://www.gmwatch.org

> ------

> " ...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. " (item 1)

>

> 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

> CropChoice editor

> http://www.cropchoice.com/leadstry.asp?recid=2560

>

> -- 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. "

>

> 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.

>

> Sources:

> 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

> CropChoice editor

> http://www.cropchoice.com/leadstry.asp?recid=2634

>

> 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.

>

> -end-

>

> For Court documents, contact:

> Mr. Arlen B. Coyle

> Clerk

> U. S. District Court

> U. S. Courthouse

> 911 Jackson Avenue, Room 369

> Oxford, Mississippi 38655-3622

> Tele: 662-234-1971

>

> 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

>

> Related stories:

>

> 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