District Court Sees through Misleading Allegations in PubPat Lawsuit against Monsanto

In a recent post, I pointed out similarities between "fabrications" regarding conditions at factories in China manufacturing Apple products, and the misinformation being promulgated regarding gene patents and agricultural biotechnology. Some prime examples of this sort of misleading information are evident, I think, in the lawsuit filed last year by the Public Patent Foundation against Monsanto. In a post on the case, I pointed out that the plaintiffs in the case seemed to lack standing, and that there seemed to be no basis for PubPat’s allegation that Monsanto had sued involuntary/inadvertent infringers, or that there was any reasonable likelihood that the plaintiffs (organic farmers and the like) would be sued for infringing Monsanto patents on recombinant crops.


Fortunately, the district court saw through the exaggerated allegations raised by the Public Patent Foundation in the lawsuit against Monsanto, and dismissed the case last February. The court's decision specifically addresses some of these unfounded assertions.

For example, the complaint alleges that certain plaintiff farmers and seed distributors were afraid that their crops and seeds would be contaminated by recombinant Monsanto products. In rejecting this argument, the court pointed out that none of the plaintiffs claimed that contamination had actually occurred in any of the crops they had grown or seeds they have sold.

The complaint further alleged that organic farmers risked losing their organic certification if their fields became contaminated by recombinant product, but the court found “no evidence in the record that any farmer has ever been decertified as organic by the U.S. Department of Agriculture National Organic Program (the “NOP”) because of seed contamination.” In fact, according to the NOP, “[o]rganic certification is process based, and as a result, “[i]f all aspects of the organic production or handling process were followed correctly, the presence of a detectable residues from a genetically modified organism alone does not constitute a violation of this regulation.”

The complaint also alleged that the plaintiff farmers risk being sued for patent infringement based on inadvertent growth of crops with Monsanto's patented traits. However, the court found that Monsanto had never filed a patent infringement suit against a certified organic farm or handling operation over the presence of patented traits in its operations. In fact, during oral arguments Monsanto stated that they had never sued the party who did not “want to make use of the traits that are manifested in [defendants’] transgenic products.” The court noted that Monsanto had expressly declared that it is not their policy “to exercise [their] patent rights where trace amounts of our seed or traits are present in [a] farmer’s fields as a result of inadvertent means.” The court went on to find that although the complaint “alleges without specification that defendants have accused certain non-intentional users of Monsanto’s seed of patent infringement and threatened them with [litigation, no] plaintiffs claim to have been so threatened.”

The complaint alleged that the organic farmers feel threatened by the fact that between 1997 and 2010 Monsanto filed 144 patent infringement lawsuits against farmers. However, the court found that plaintiffs had overstated the magnitude of Monsanto's patent enforcement, since this "average of roughly 13 lawsuits per year is hardly significant when compared to the number of farms in the United States, approximately two million."

The plaintiffs alleged that Monsanto had filed patent infringement lawsuits against other farmers who did not want to grow patented crops, citing specific examples where this had allegedly occurred, but the court found that this assertion was:

“belied by the decisions in the suits against the referenced individuals. See Monsanto Co. v. Parr, 545 F. Supp. 2d 836, 842-44 (N.D. Ind. 2008) (defendant intentionally induced others to infringe Monsanto’s patents); Monsanto Co. v. Nelson, No. 4:00-CV-1636, 2001 U.S. Dist. LEXIS 25132, at *2 (E.D. Mo. Sept. 10, 2001) (Monsanto alleged that defendants had intentionally saved and replanted second generation seed with patented traits in violation of their licensing agreement); Monsanto Can. Inc. v. Schmeiser, 2001 FCT 256 [120] (Can.) (finding that the defendant saved and planted seed “he knew or ought to have known was Roundup tolerant”).”

I found it particularly gratifying that the court addressed the widely held misperception that Percy Schmeiser, a Canadian farmer who took Monsanto to the Canadian Supreme Court (and lost) and became somewhat of a folk hero in the process, was an innocent victim whose fields were contaminated by Monsanto product. If you actually read the decisions from the Canadian courts, it is very clear that the court was convinced that Schmeiser had actively selected for and cultivated Monsanto Roundup ready seeds on his property without authorization and without paying any licensing fee (see my previous post).

The court was particularly critical of the Public Patent Foundation’s characterization of an attempt by Monsanto to reassure organic farmers that they would not be sued for inadvertent infringement as an "implicit threat" by Monsanto. The Public Patent Foundation had written a letter to Monsanto basically asking for a blanket immunity for all the plaintiffs against ever being sued for patent infringement, even if they did intentionally engage in infringing activity. Monsanto responded with a statement of its policy, which it had previously published in other venues:

“It has never been, nor will it be[,] Monsanto policy to exercise its patent rights where trace amounts of our patented seeds or traits are present in [a] farmer’s fields as a result of inadvertent means.”

Amazingly, the Public Patent Foundation characterized Monsanto's statement as an implicit threat, and as such the basis for declaratory judgment action.

The court totally rejected this flawed logic, declaring it "objectively unreasonable for plaintiffs to read [the language of Monsanto statement] as a threat." The court also stated that,

"[i]ndeed, plaintiffs’ letter to defendants seems to have been nothing more than an attempt to create a controversy where none exists. This effort to convert a statement that defendants have no intention of bringing suit into grounds for maintaining a case, if accepted, would disincentivize patentees from ever attempting to provide comfort to those whom they do not intend to sue, behavior which should be countenanced and encouraged. In contrast, plaintiffs’ argument is baseless and their tactics not to be tolerated.”

It bears noting that critics of Myriad Genetics have repeatedly complained that Myriad should make an explicit statement that the company promises not to sue entities that infringe its BRCA patents in the context of research or non-commercial testing. But I've always maintained that Myriad is rightly concerned that such a statement could be used against them. Here we see a perfect example of this, with the Public Patent Foundation using Monsanto's attempt to reassure inadvertent infringers that they will not be sued as a weapon against Monsanto.

The district court in this case, fortunately, rejected the argument, and noted that public policy dictates that companies such as Monsanto should be encouraged to provide such reassurance, not punished, and that the Public Patent Foundation's tactic of using the statement against Monsanto is "not to be tolerated." But with all the advocacy groups out there gunning for Myriad, is it any wonder the company would be reluctant to open itself up to the negative unintended consequences of an explicit statement of immunity for some infringers?

Organic Seed Growers and Trade Association Et al. v. Monsanto: The Public Patent Foundation Takes on Agricultural Biotechnology

The Public Patent Foundation (PubPat), housed at the Cardozo School of Law in New York, is probably best known to readers of this blog for its role in the challenge to Myriad gene patents in AMP v. PTO (PubPat is co-counsel, along with the ACLU). PubPat has brought a number of other "public interest" actions against other patents, including reexamination of some of the key University of Wisconsin embryonic stem cell patents.

On March 29 PubPat took on agricultural biotechnology, filing a declaratory judgment action in the Southern District of New York against Monsanto, on behalf of a large contingent of plaintiffs, including agricultural member organizations, farms and farmers, and seed companies. The plaintiffs are primarily, but not entirely, organic, and all have purportedly have disavowed the use of genetically modified seed.

The primary contention of the plaintiffs is that they "are increasingly being threatened by transgenic seed contamination despite using their best efforts to avoid it." The allege that Monsanto "has aggressively asserted [its patents] against literally hundreds of farmers, including those farmers who became contaminated by Monsanto's transgenic seed through no fault of their own." They have asked the court to declare a long list of Monsanto patents invalid, unenforceable, and not infringed, and that Monsanto would not be entitled to any remedies against the plaintiffs even if found to infringe a valid and enforceable patent.

Interestingly, I was talking with someone who works for Monsanto recently and he mentioned that to his knowledge the complaint had never been served upon Monsanto. I checked PACER on June 1, and the docket indicates that PubPat has yet to file notice that the complaint was served on Monsanto, even though the complaint was filed more than two months ago (March 29). For comparison, in the Myriad case notice of service on the plaintiffs was filed within one month after the complaint was filed.

Do the Plaintiffs Have Standing?

Perhaps the biggest stumbling block for PubPat will be establishing that any of the plaintiffs have standing to bring suit (a big issue in the Myriad lawsuit). The standing of the plaintiffs seems even more problematic in this case, since the plaintiffs all avow that they are doing everything they can to avoid infringing Monsanto's patent, and there appears to be no evidence that Monsanto has ever filed suit against an involuntary/inadvertent infringer. The complaint filed by PubPat makes this allegation, but does not document a single example of a case where a party was sued for infringement that was involuntary. The closest it comes is a reference to a 2008 segment of the CBS Evening News, which the complaint alleges described an incident in which farmers (Mr. and Mrs. Runyon), "who never intended to use transgenic seeds," were threatened with a patent infringement suit (but apparently never sued).

The complaint also alleges that Monsanto has litigated patent infringement claims against other farmers who did not want to be contaminated by transgenic seeds, including notably Percy Schmeiser. Schmeiser has become something of a folk hero, a Canadian farmer who was sued by Monsanto for patent infringement in a case that was eventually decided by the Canadian Supreme Court. Critics of Monsanto in the popular media routinely point to Schmeiser as an example of a honest Canadian farmer sued by corporate villain Monsanto for patent infringement that was completely involuntary and inadvertent, while failing to note that the Canadian courts found unambiguously that Schmeiser’s infringement was in fact voluntary, and that he went out of his way to collect and plant transgenic seed incorporating the patented Monsanto trait. Here are some excerpts from the Canadian Supreme Court decision [Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34, [2004] 1 S.C.R. 902]:

The remaining question was how such a pure concentration of Roundup Ready Canola came to grow on the appellants’ land in 1998. The trial judge rejected the suggestion that it was the product of seed blown or inadvertently carried onto the appellants’ land . . .

Invoking the concepts of implied licence and waiver, the appellants argue that this Court should grant an exemption from infringement to “innocent bystanders”. The simple answer to this contention is that on the facts found by the trial judge, Mr. Schmeiser was not an innocent bystander; rather, he actively cultivated Roundup Ready Canola.

Given the issues of standing, one has to wonder why PubPat has chosen the declaratory judgment route to challenge Monsanto's patents. After all, PubPat asserts that Monsanto has aggressively asserted its patents against "literally hundreds of farmers," including farmers whose only offense was to have their crops contaminated by Monsanto's seed. In the Myriad case, the ACLU and PubPat were forced to assemble a group of plaintiffs and file a declaratory judgment action, because for years Myriad has disappointed its critics by never suing anyone for infringing its gene patents. But that is not the case with Monsanto, which I believe has filed patent infringement suits against farms numbering in the hundreds.

Why isn't PubPat defending one of these farmers that has already been sued? This would give PubPat the opportunity to challenge the Monsanto's patents, without any issue of standing. Perhaps they find it is preferable to conduct "public interest litigation" on behalf of recruited plaintiffs rather than actual defendants potentially liable for damages.

In fact, at least one farmer is currently before the Federal Circuit arguing one of the legal theories raised in the PubPat complaint, i.e., that "Monsanto's patent rights in transgenic seed exhaust upon the authorized distribution by Monsanto to its customers." In 2009, a district court in the Southern District of Indiana rejected this very argument in Monsanto v. Bowman, citing earlier Federal Circuit decisions in Monsanto v. Scruggs and Monsanto v. McFarling. Mr. Bowman argued unsuccessfully that he should not be held liable for infringement based on the use of "commodity" soybean seed he had purchased and that inadvertently included seed containing the patented Roundup Ready trait. The district court decision indicates that Mr. Bowman argued the case as a pro se defendant, but the appeal briefs being filed with the Federal Circuit this year indicate that he is currently being represented by Frommer Lawrence & Haug LLP.

Below, I briefly address some of the arguments raised in the PubPat complaint, including moral utility, exhaustion and inadvertent infringement.

Moral Utility

Historically, US law had a doctrine of moral utility, under which a patent could be found invalid if the claimed invention lacks sufficient social or moral use. The doctrine traces its origin to a statement by Justice Story in the 1817 Lowell v. Lewis decision to the effect that inventions that are "injurious to the well-being, good policy, or sound morals of society" are unpatentable. Examples provided by Justice Story included "a new invention to poison people, or to promote debauchery, or to facilitate private assassination."

Although technically still on the books, the doctrine of moral utility has generally been considered moribund in the US since the 1999 Federal Circuit decision in Juicy Whip v. Orange Bang, which essentially held that patent law is not the appropriate legal vehicle for addressing questions of morality. I think this is the proper approach. For example, I would rather not have the patent office deciding whether or not a gambling invention is patentable based on the morality or social utility of gambling. A patent does not confer any positive right to practice in invention, only the right to exclude others from practicing it, so the patent would in no way shields the patent owner from anti-gambling laws, which is the more appropriate way to address morality or social concerns associated with gambling.

European patent law, on the other hand, explicitly provides that inventions that are "immoral and against the public order" are patent ineligible. The European High Court is currently considering a case challenging the patent eligibility of embryonic stem cells based on allegations that the use of viable human embryos in the industrial process of producing cultured embryonic stem cells is immoral. The Court's advocate general has in fact put forth such a position, as discussed recently on the Patent Docs blog.

I cannot imagine PubPat prevailing on this theory. The doctrine of moral utility has generally been considered pretty much irrelevant after Juicy Whip, but even if the doctrine still has some teeth, there is a wealth of data supporting the benefits of transgenic crops, which explains why they have been so widely adopted in the US, and increasingly throughout the world. The PubPat complaint goes to great lengths reciting a host of alleged evils of agricultural biotechnology, and asserts that transgenic crops have failed to provide any benefits, citing authorities such as England's Prince Charles, but I think this flies in the face of a wealth of evidence going the other direction.

Patent Exhaustion

As mentioned above, PubPat alleges that Monsanto's patent rights in transgenic seeds are exhausted by their first authorized sale, presumably relying on the Supreme Court's 2009 Quanta decision. This was one of the main concerns that I raised regarding Quanta, i.e., the potential for the decision to preclude the ability of biotechnology companies to adequately enforce patents covering products capable of self-replication.

Prior to the Supreme Court deciding Quanta, the Federal Circuit held in Monsanto v. Scruggs (2006) that patent exhaustion did not shield from infringement liability a farmer who saved and replanted patented seeds without Monsanto's authorization because (1) the initial sale from Monsanto was not an “unrestricted sale” and (2) the second generation of seeds were never “sold.” Scruggs filed a petition for certiorari with the Supreme Court, which was denied. The case was remanded to the district court, where Scruggs moved for reconsideration in light of the Supreme Court's decision in Quanta. The district court denied the motion, but certified the issue for interlocutory appeal to the Federal Circuit, to resolve the question of whether the Federal Circuit's decision regarding patent exhaustion in Monsanto v. Scruggs was still good law in view of Quanta. But in 2009 the Federal Circuit exercised its discretion and declined to decide the interlocutory appeal, advising Scruggs to appeal the issue after the district court issues a final decision or injunction.

Thus, the question of whether the Federal Circuit decision in Monsanto v. Scruggs regarding patent exhaustion of transgenic seeds survives Quanta has yet to be resolved. The Federal Circuit could address the issue in Monsanto v. Bowman, or perhaps in the PubPat lawsuit if it goes forward.

Inadvertent Infringement

At a doctrinal level, for me perhaps the most interesting argument raised by PubPat is that the plaintiffs are not liable for infringement because any infringement would be involuntary and inadvertent, the result of contamination by transgenic seed used by other farmers. To my knowledge, this issue has never been directly addressed by the courts, and as a practical matter I doubt that Monsanto has sued farmers for legitimate good-faith but inadvertent infringement. As noted above, the PubPat complaint does not appear to identify any specific occurrence of this, and the widely propagated story that Schmeiser was a good-faith inadvertent infringer is contrary to the findings of the Canadian courts.

But how would a court deal with involuntary and inadvertent infringement if the issue ever did arise? It is well-established that, as a general matter, patent infringement is a matter of strict liability, i.e., intent is not an element of patent infringement. However, I am convinced that a court faced with a true case of inadvertent infringement would find some doctrinal loophole to shield the alleged infringer from liability. However, there is to my knowledge no specific doctrinal defense addressing the issue.

For example, in Monsanto v. Schmeiser, the Canadian Supreme Court indicated that if Schmeiser’s infringement had been inadvertent he would not have been liable for infringement, because under such circumstances his mere possession of patented seeds would not lead to a presumption that he had "used" the seeds in an infringing manner.

In the US, the issue of inadvertent infringement was addressed in the fascinating case of SmithKline Beecham v. Apotex, 403 F.3d 1331 (2005), which involved allegations that a generic drug manufacturer would not be able to produce a non-infringing generic drug without inadvertently producing an infringing polymorph of the drug, thus involuntarily infringing the patent. At the district court level, the decision was written by Judge Posner, a famous judge on the Seventh Circuit Court of Appeals, sitting by designation for this case as a district court judge. Judge Posner noted the policy concern attendant to holding an inadvertent infringer liable for patent infringement, and spent a great deal of time grappling with the question of how existing patent doctrine could be interpreted in a manner to arrive at the outcome, i.e. no liability for inadvertent infringement.

Here is an excerpt from Judge Posner's opinion in SmithKline Beecham v. Apotex, 247 F.Supp.2d 1011 (2003):

The reason for excusing the alleged infringement in this case is not that Apotex stole only a little hemihydrate from SmithKline. It stole nothing from SmithKline. It doesn't want hemihydrate, and it derives no value from the hemihydrate that it unavoidably creates and “sells.” If it made hemihydrate deliberately, or if it took advantage of 100 percent conversion to obtain a product that had hemihydrate's superior handling characteristics, that would be theft and it would be nonsense to point out that paroxetine is only 10 percent of the pill by weight. But if the person sitting next to me at dinner spills his soup on my sleeve, I am not a thief even though I cannot remove the stain.

On appeal, the Federal Circuit rendered the question of inadvertent infringement moot by invalidating the SmithKline patent for inherent anticipation. However, in a concurring opinion Judge Gajarsa addressed the issue of inadvertent infringement, in a manner that would probably resonate with PubPat and other opponents of patents on transgenic seeds. Judge Gajarsa essentially advocated a position that the issue of inadvertent infringement could be dealt with in situations such as this by recognizing that any product capable of being "spread and reproduced by natural processes" is patent ineligible under 35 USC 101. I think this assertion is incorrect, and would be inconsistent with the Supreme Court's decision in Diamond v. Chakrabarty, which explicitly found genetically modified living organisms to be patent eligible.

Nevertheless, here are some excerpts from Judge Gajarsa’s concurrence:

The asserted breadth of Claim 1 makes sense only under the erroneous belief that patents may protect products spread and reproduced by natural processes, directly contradicting our well established understanding of the limits imposed by section 101. Given current scientific trends, such a belief could easily lead to misdirected research investments, to inappropriately issued patents, and to a widespread in terrorem effect crippling entire industries whose artisans learn that even their best efforts to respect patent rights may not save them from liability as inadvertent, inevitable infringers. As the district court recognized, the notice function of patents is meaningless in such an environment, SK II, 247 F.Supp.2d at 1028. The lack of suitable notice could easily chill innovation, inquiry, experimentation, and commercial development. The patent law does not sanction the concept of inevitable infringement.
. . .

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.FN7 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.

FN7. Although intent is not a factor in determining infringement, public notice is required as a predicate to the validity of a patent. Jurgens v. CBK, Ltd., 80 F.3d 1566, 1570 n. 2 (Fed.Cir.1996). The hypothetical causes unavoidable infringement even in situations where the public would, in good faith, want to avoid infringing.

At oral argument, when faced with this hypothetical, SKB 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.

This section 101 problem therefore brings us full circle, back to the impossibility of public notice. Under normal circumstances, inventors other than the patentee will understand how to avoid infringing a patent by avoiding the claimed product. Because products, such as our hypothetical blue corn or SKB's paroxetine hemihydrate, that can be “made” through a natural process of spontaneous conversion imply inevitable infringement, no combination of claim language and written description could possibly teach even one skilled in the art how to avoid infringement. It is unsurprising that a requirement considered so trivial for most patentable products that we are content to let it remain implicit, namely a lesson in infringement avoidance, is effectively impossible for subject matter unpatentable under section 101. 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.

It will be interesting to see how the PubPat challenge to Monsanto, and the patenting of Arab cultural biotechnology in general, plays out.

Briefs Filed by Petitioner and His Amici in Bowman v. Monsanto

In Bowman v. Monsanto, the Supreme Court will have the opportunity to address the extent to which the doctrine of patent exhaustion applies to progeny of patented recombinant seeds. For background on the case, see this previous post.

Here are links to briefs recently filed by petitioner Bowman and his amici, with some brief commentary:

Petitioner (Vernon Bowman) argues that an authorized sale of recombinant seeds exhausts patent rights in progeny seeds that were not themselves the subject of an authorized sale. He bases this argument on a theory that subsequent generations of seeds are "embodied” in the first-generation authorized seeds.  Bowman is apparently attempting to leverage the Supreme Court's questionable use of the term "embodies" with respect to method patents in Quanta.  He also argues that production of progeny seeds does not constitute "making" the seeds because the use of genetically modified seeds inherently results in the production of progeny seeds. Bowman contends that contract law provides adequate remedies to owners of patents on self-replicating technologies.

Center for Food Safety argues that extending patent exhaustion to progeny seeds will benefit farmers by curtailing Monsanto's patent enforcement actions targeting farmers. The Center also claims that extending the patent exhaustion doctrine in this way will benefit scientific research and innovation in agriculture, and lower the cost of farming. The Center further contends the Federal Circuit's decision is contrary to Quanta, and reiterates petitioner's argument that producing progeny seed constitutes use of the patented seed, not making it, and hence falls within the scope of patent exhaustion. The amici voice is concerned that farmers whose fields have been "contaminated” by Monsanto's patented seeds could be subject to infringement lawsuits.

The American Antitrust Institute argue that the Federal Circuit's decision is contrary to Supreme Court precedent, particularly Quanta, and departs from long-standing Congressional patent policy.  They warn that the Federal Circuit's decision "portends dangerous unintended consequences" for other industries, particularly the computer software industry. They suggest that Monsanto should learn from the software industry, and engage in "effective product differentiation and efficient third-degree price discrimination" in order to counter the threat posed by the ease with which their products can be replicated. They contend that Monsanto could have avoided its need to rely on patents by not working with soybean seeds and other inbred seed lines, and confining their activities to hybrid seeds (i.e., corn) that do not produce true copies of themselves. Somewhat surprisingly, the Institute suggests that Monsanto "could have developed its ‘terminator’ gene, which would have rendered progeny seeds sterile." “Terminator” is a pejorative term for Genetic Use Restriction Technology (GURT), highly controversial technology that Monsanto pledged not to use in 1999.

The Automotive Aftermarket Industry Association et al. are concerned that affirmance of the Federal Circuit's decision weakens the patent exhaustion doctrine. This brief was filed on behalf of companies that market automotive replacement parts and refurbished inkjet cartridges.

Knowledge Ecology International essentially argues that effective patent protection is not necessary for self-replicating genetically engineered crops, because "a plethora of alternative mechanisms to patent regimes exist to reward research and development."  For example, they argue that an inventor "can still protect his investment through contractual agreements governing post-sale uses” (while at the same time acknowledging that contract law would not have helped in this case, due to a lack of privity between Bowman and Monsanto).  The plethora of alternative mechanisms includes "sui generis systems of rewards or cash innovation inducement prizes," which KEI characterizes as "viable alternatives to the patent system."  They voice concern that "even plants exhibiting the genetically modified trait found in the wild as a result of cross-pollination, would fall under the patent rights the patent holder.)

The Public Patent Foundation expresses concern that under the Federal Circuit's ruling, "contaminated farmers are infringers," and "Monsanto's customers routinely make and sell new infringing articles." In a previous post, I discussed a lawsuit that the Public Patent Foundation has filed against Monsanto on behalf of a variety of groups including associations of organic farmers.

 

 

 

Bowman v. Monsanto: An Important Case for Agricultural Biotechnology

The Supreme Court recently granted certiorari in Bowman v. Monsanto, an important case for agricultural biotechnology. If the Supreme Court decides to overrule the Federal Circuit's decision in favor of Monsanto, it could seriously impact the ability of agricultural biotechnology companies to recoup their investment in developing traits for seeds that farmers can harvest and replant, such as soybeans.

Prior to agricultural biotechnology, there was little incentive to invest in the development of improved seeds, since farmers have historically been able to save and replant second-generation seeds, preventing seed innovators from recouping the value they create in their seeds. The exception has been hybrid corn, which cannot be saved for replanting without losing beneficial characteristics of the hybrid, effectively forcing farmers to buy new seed each year. This natural technological restriction on seed saving encouraged investment by seed companies such as Pioneer in the development of improved strains of hybrid corn.

In the 1990s scientists at USDA and Delta Pine Land, a cotton biotechnology company subsequently purchased by Monsanto, developed genetic use restriction technology (GURT). GURT allows for the production of seeds that germinate and produce second-generation seeds, but those second-generation seeds are sterile. In effect, this would allow a seed company like Monsanto to impose a technological restriction on the ability of farmers to save and replant seeds, analogous to the inherent restriction on the replanting of hybrid corn. It would also allay concerns that genetically modified crops might escape into the environment and cause environmental harm. However, anti-biotechnology activists learned of GURT and dubbed it "Terminator" technology, and made it a public relations disaster for agricultural biotechnology, and particularly Monsanto. Agricultural biotechnology companies like Monsanto have not used GURT in their products, but have instead relied upon patents to prevent farmers from saving and replanting seeds. In 1999, Monsanto pledged not to use GURT in its products.

Instead, Monsanto has relied upon patent and contract law to prevent replanting of second-generation patented seeds. Basically, purchasers of seeds containing a patented Monsanto trait, such as Roundup Ready soybean, are required to sign a contract agreeing not to save second-generation seeds for replanting. Farmers are of course able under the contract to harvest the seeds for use as food or feed. A number of farmers challenged the enforceability of this system on a variety of grounds, but in 2002 and 2006 the Federal Circuit issued decisions upholding the validity of the arrangement in Monsanto v. McFarling and Monsanto v. Scruggs, respectively. In those cases, the farmer saved and replanted seeds harvested from their own fields, which the Federal Circuit held to constitute infringement of Monsanto's patents.

In 2008, the Supreme Court's decision in Quanta v. LG Electronics cast some doubt on the ability of Monsanto to use patents to prevent replanting of second-generation seeds. In Quanta, the Supreme Court overturned the Federal Circuit's decision that patent owners could place conditions on sales, and held that the authorized sale of a patented product exhausts patent rights in the product. Arguably, Quanta could be interpreted as precluding Monsanto from claiming patent rights in the progeny of seed that had been the subject of an authorized sale, as discussed in a previous post.

In Monsanto v. Bowman, the Federal Circuit held that even post-Quanta Monsanto was not barred by the first sale doctrine from enforcing its patents against farmers who save and replant second-generation seeds. Vernon Bowman is a soybean farmer, and for years he has purchased and planted Roundup Ready soybean, and signed the agreement not to replant. However, he later began purchasing commodity soybeans from a grain elevator that he knew probably were Roundup Ready, planting those seeds, and then harvesting and replanting some of the second-generation seeds grown in his field. He apparently believed that since he did not sign agreement with respect to commodity seeds he was not barred from replanting them. He sprayed the soybeans twice during the season with Roundup, demonstrating that not only did he know that the seeds are Roundup Ready, but also that he was using the glyphosate-resistance properties of the plants.

The Federal Circuit rejected Bowman's argument that his activities were protected by the first sale doctrine. The court held that his purposeful planting and growing of the second-generation seeds constituted more than simply "using” the patented seed, but impermissibly "making" patented product in violation of Monsanto's patent.

In his petition for certiorari, Bowman argues that the ability to make second-generation seed is an inherent characteristic of seeds, and that his natural and foreseeable use of the seeds to produce second-generation seeds is permitted under the first sale doctrine, regardless of whether he sells the seed for use as feed or replants it.

The US solicitor general was invited to file Amicus brief in the case, and did so, advising the Supreme Court not to grant certiorari. The solicitor general agreed with Monsanto and the Federal Circuit that the first sale doctrine under Quanta does not extend to second-generation seed.  The Federal Circuit and solicitor general recognize that the interpretation of the first sale doctrine advocated by Bowman would severely limit the ability of biotechnology companies like Monsanto to recoup their sizable investment in developing agricultural traits.

The grant of certiorari is presumably cause for great concern to Monsanto and other agricultural biotechnology companies selling patented seed that can be saved and replanted. In recent years, when the Supreme Court has granted certiorari in patent cases it has tended to reverse the Federal Circuit, for example in Prometheus, Quanta, KSR, Bilski and Festo.  Because the Federal Circuit is generally the only Court of Appeals to decide patent cases, Supreme Court normally does not accept patent cases to resolve split between the circuits. The fact that it took the case suggests to me that at least some Justices question the Federal Circuit's decision in Monsanto v. Bowman. Of course, that does not necessarily mean the Court will reverse. For example, in LabCorp v. Metabolite (2006) the Supreme Court dismissed a petition for certiorari as improvidently granted, although three of the justices filed a dissent indicating they would have decided the case and overruled the Federal Circuit's decision.

Supporters of Bowman argue that they Federal Circuit's decision will end the long-standing practice of farmers saving and replanting seeds, and of grain elevator selling commodity seeds. They point out that today most of the soybeans collected by grain elevators and sold as commodity seeds contain the patented Roundup Ready trait, since most farmers are planting Roundup Ready soybeans. However, in this case Bowman clearly knew that the seeds he planted were Roundup Ready, since he sprayed the fields repeatedly with Roundup, which he would not have done if he thought he had planted non-glyphosate resistant seeds. I very much doubt whether Monsanto has sued any farmer who bought commodity seeds that happened to include the Roundup Ready trait, but who did not take advantage of the patented trait by using Roundup on his fields. Such a case of inadvertent infringement would clearly raise substantial policy issues, but those are not the facts of this case.

If the Supreme Court reverses the Federal Circuit and holds that companies like Monsanto cannot use their patents to prevent replanting a second-generation seeds, it would be analogous to interpreting the first sale doctrine in copyright as permitting anyone who buys a CD or DVD to make unlimited copies and sell those copies. Clearly the first sale doctrine does not go that far in copyright, and I don't think it should go that far in patent law with respect to self-replicating technologies like seeds. I don't think a farmer who innocently plants commodity seeds that happen to contain the patented Roundup Ready trait, and who does not take advantage of that trait by using Roundup on his fields, should be liable for patent infringement. But I don't think a farmer should be able to take advantage of the first sale doctrine to purposely acquire and grow patented seeds, benefit from the Roundup ready characteristics by using Roundup on the crops, and then use the first sale doctrine as a defense.

If the Supreme Court sides with Bowman in this case, I'm not sure what Monsanto and other agricultural biotechnology companies will do. They might have to alter their licensing practices, as discussed in a previous post. Perhaps they will have to reconsider the use of GURT or some other technological solution in lieu of patents.

Quanta and Agricultural Biotechnology

In previous posts, I have discussed why it is important for agricultural biotechnology companies to be able to prevent farmers from saving genetically modified seeds for replanting, and the potential for Quanta to limit the ability of companies to enforce such post sale restrictions under the patent laws. To the extent Quanta prohibits enforcement of these restrictions by means of patent infringement actions, the value of many agricultural biotechnology patents could be severely eroded, which could in turn negatively impact an industry that has historically relied heavily on patents. I think most people, even those who argued in favor of the Supreme Court overruling the Federal Circuit approach to patent exhaustion, as exemplified by the Mallinckrodt and Braun decisions, would agree that enforceable post sale restrictions are important in the context of agricultural biotechnology. Concerns with the impact of the Court's decision on ag biotech is evidenced by some of the questions asked by Justice Kennedy during oral arguments, as well as a footnote in the Solicitor General's amicus brief stating that the Court has never ruled on the question of whether patent exhaustion applies to copies of a self replicating patented product, and that this question was not implicated by Quanta. In the amicus brief it filed recommending denial of cert in McFarling v. Monsanto, the Solicitor General expressed the view that patent exhaustion should not apply with respect to the progeny of patented seeds.

It appears to me that the ability of agricultural biotechnology companies to enforce these important restrictions under the patent laws has not been severely impacted by Quanta. At least, I hope this is the case. For one thing, I think that a court faced with the question would side with the Solicitor General, and find that patent exhaustion does not apply to copies made from a self replicating patented invention, particularly when the invention is a genetically modified seed. I don't think anything in Quanta would preclude such a determination, and for public policy reasons the courts would side with the innovator in a case raising the issue. I also think drawing such a line between a purchased patented product and a copy of the product would be entirely consistent with Microsoft v. AT&T, the 2007 Supreme Court decision which made an analogous distinction between software and copies of software. In Microsoft, the Court held that while software made in the US can constitute a component of a patented invention originating from the US for purposes of 271(f), copies of the software made outside the US do not originate from the US and hence cannot form the basis for infringement under 271(f).

Another element of Quanta that will facilitate the enforcement of post sale restrictions in agricultural biotechnology is the Court's endorsement of the rule announced in its General Talking Pictures decisions. As I noted in my last post, General Talking Pictures, when read in combination with other Supreme Court patent exhaustion precedent such as Univis and Quanta, creates what the solicitor General has described as an anomalous outcome which “allow[s] a patentee to achieve indirectly - through an enforceable condition on the licensee - a limitation on use or resale that the patentee could not itself impose on a direct purchaser.” Under General Talking Pictures, I think that agricultural biotechnology companies will be able to impose post sale restrictions through licensee seed companies, and enforce violations of those restrictions under the patent laws.

The facts of General Talking Pictures appear to be right on point in this regard. Recall that in that case the patent owner licensed a manufacturer to sell the product only to private users, not to commercial users. Because sales to commercial users were not authorized by the patent owner, patent exhaustion did not apply and the patent owner was permitted to sue commercial users for patent infringement, even though the seeds were purchased from licensee. If we tweak the facts only slightly, substituting seed saving farmers for commercial users, it seems clear that if a patent holding biotechnology company licenses seed companies to sell seed only for use in the production of food and a farmer saves and replants seeds, under General Talking Pictures the patent owner will not be barred from bringing suit under the patent laws. As I understand it, a company like Monsanto generally does not sell seed directly to farmers, but rather licenses seed companies to produce and sell seeds incorporating the patented technology. In a case where the patent owner is selling seeds directly to farmers, Quanta might prompt a patent owner to structure its business such that sales are made through a licensee so as to avoid patent exhaustion.

Moreover, the Federal Circuit's LGE decision (the subject of appeal in Quanta), along with earlier decisions like Mallinckrodt and Braun, suggest that the Federal Circuit generally disfavors a strong patent exhaustion doctrine that cannot be overridden by an agreement between the patent owner and purchaser to limit post-sale uses. For example, prior to Quanta, the Federal Circuit was confronted with Supreme Court precedent that on its face seemed to mandate patent exhaustion in all cases where a patented product was the subject of an authorized sale. Nevertheless, the Federal Circuit circumvented this precedent by holding that the doctrine only applies to product claims, not method claims, and even then only when the post sale restriction independently violates some other law or policy, such as patent misuse or an antitrust violation. When faced with a new fact patterns implicating patent exhaustion, the Federal Circuit might well read Quanta in a similarly narrow fashion, thereby limiting its impact, particularly with respect to self replicating products. This sort of circumvention will be facilitated by Quanta’s failure to directly address Mallinckrodt, or any other Federal Circuit decisions relating to patent exhaustion other than LGE.

NPR Retraction of Story on Apple Factories Provides Insight into the Mentality behind Attacks on Gene Patents and Agricultural Biotechnology

On March 16, the popular National Public Radio (NPR) program This American Life (TAL) was forced to retract statements made during an episode that aired in January alleging abuse of workers at Chinese factories manufacturing products for Apple. The explanation provided by “monologist” Mike Daisy, source of the "significant fabrications" reported on the TAL program, provide some insight I think into the mentality behind the flood of misinformation that has been promulgated with respect to gene patents and agricultural biotechnology, and which unfortunately has found its way into the courts and Congress.

TAL admits to having excerpted the fabricated story from "The Agony and The Ecstasy of Steve Jobs," a one-man show that Mike Daisey had been performing across the country, and which is currently in production at the Public Theater in New York. In a press release, TAL says it first learned Daisey had fabricated parts of his story when another public radio program, Marketplace, tracked down Daisey's interpreter, who disputed parts of Daisey's monologue. After being caught lying, Daisey apologized to NPR, explaining that:

“I’m not going to say that I didn't take a few shortcuts in my passion to be heard. [] My mistake, the mistake I truly regret, is that I had it on your show as journalism, and it's not journalism. It's theater.'"

Daisey's rationalization of his lies reminds me a lot of the response of an author after I reviewed his book entitled "Who Owns You? The Corporate Gold Rush to Patent Your Genes", and pointed out some of the numerous inaccuracies in the book regarding patent law in general, and gene patents in particular. In the book, the author characterized himself as an intellectual property attorney, but when he was unable to refute the many inaccuracies in his book that I pointed out in my review, he dismissed them, and asserted that it did not matter because he had approached the issue as a philosopher, rather than as a lawyer or scientist; very reminiscent of Daisey's explanation that his report on NPR was "theater," not journalism.

The problem is, these people target a lay audience largely unfamiliar with the subject matter they cover, and push forward their work as evidence allegedly supporting their position. It would be one thing if Daisey had explained to his NPR audience that he was merely engaged in theater, or if the author of "Who Owns You?" had explained that his book was nothing more than philosophical ponderings, with no grounding in fact. But that is not how they present their work, and unfortunately their works can play an important role in motivating others (including judges and members of Congress) to take action.

For example, according to NPR the TAL piece featuring Daisey made him "Apple's chief critic and it also inspired a Change.org petition that collected more than 250,000 signatures demanding that Apple better the working conditions at the factories.” Books like "Who Owns You?” have no doubt played a role in shaping the current widespread antipathy toward gene patents.

I also found it interesting that Daisey characterizes his fabrications about Apple factories as "shortcuts in [his] passion to be heard." I suspect that this sort of mentality might explain the bending of reality routinely engaged in by the opponents of gene patents and agricultural biotechnology. They are convinced that gene patents and genetically engineered crops endanger society, and that companies like Myriad Genetics and Monsanto are evil, and will seemingly say anything in their passion to be heard. Like Daisey, they do not appear to be bothered by specific facts, and are willing to take shortcuts around the truth in seeking to eliminate these evils from the world.

The disturbing thing is that there is so much incentive for people to propagate these myths. People like Daisey clearly love being in the spotlight, and the more sensational he can make his reports of condition Apple factories, the more people he will have listening. NPR reported that this episode of TAL had the largest audience that show had ever achieved, and that Daisey became the most prominent critic of Apple factories because of the coverage. Unfortunately, I think there are also incentives at play, particularly in academia and with respect to advocacy groups such as the ACLU and Public Patent Foundation, for making overblown and sensationalistic allegations on hot button issues such as gene patents and agricultural biotechnology.