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May 2013

Biotechnology News

Patent rights and biotech seeds

The Supreme Court of the United States (SCOTUS) heard arguments on February 18, 2013, on a case involving patent infringement with respect to genetically engineered (GE) soybeans. Seed producer Monsanto Co., St. Louis, Missouri, sued Vernon Bowman, an Indiana farmer who is receiving legal backing from a number of academics and pro bono attorneys, and two nonprofit organizations, the Center for Food Safety and Save Our Seeds.

A decision on the case is not anticipated until June or July of 2013, but reports of the hearing, discussed below, point to the favorable reception by the justices of the arguments presented by Monsanto.

Members View inform ButtonMonsanto initiated its suit against Bowman in 2007, arguing that he had planted the offspring of its patented GE soybean—which had been bioengineered to resist the herbicide Roundup—in contradiction to the contract that Monsanto makes its seed purchasers sign, agreeing not to replant the original seeds’ progeny.

Farmers have a long tradition of saving seeds for replanting. Some have replanted Roundup Ready soybeans anyway and thus have violated the contracts with Monsanto they had to sign in order to purchase and plant these beans. According to the Center for Food Safety (CFS), the company has sued farmers 144 times as of January 13, 2013, prevailing in the 11 cases that went to trial. More than 400 farmers in 27 states were involved.

Bowman’s approach was different. Instead of replanting Roundup Ready soybeans that he himself had grown, in 1999 he bought commodity beans from the local elevator to plant for a risky late-season crop on which he didn’t want to spend much money. He reasoned that many of these commodity beans, which are typically sold as animal feed, would be Roundup Ready, especially in light of the fact that 90% of the soybeans grown in the United States are Roundup Ready. And he was correct—they did resist Roundup when he applied that herbicide to his second-crop beans.

Bowman continued to plant seed harvested from his initial second-crop sowing in later years. He also supplemented his second-crop planting supply with periodic additional purchases of commodity seed from the grain elevator. In summary, he did not purchase the second-crop seed from Monsanto and he did not sign a contract with the company for those seeds.

When Monsanto learned of Bowman’s activities, which he had made no effort to hide, it sued, arguing that the company “retained rights even though there was no agreement specific to that transaction”. Bowman contended that the doctrine of patent exhaustion (the termination of a patent owner’s rights to control the use of patented product or a process used for making that product) allowed him to do what he wanted with products he had obtained legally. However, the district court agreed with Monsanto and fined Bowman $84,456. The appellate court concurred in 2011, saying that the seed from the planting was a “newly infringing article.” The case then went to the Supreme Court in December 2011 on a request for a writ of certiori (request for re-examination of actions of an inferior appeals court), and the request was granted in October 2012.

SCOTUS hearing
Twenty-three amicus curiae briefs (amicus curiae: friend of the court. Thus, a brief presented by someone interested in influencing the outcome of a lawsuit but who is not a party to it) were filed for this hearing, representing organizations such as the National Farmers Union; the Automotive Aftermarket Industry Association; Agilent Technologies; the Biotechnology Industry Organization; Pioneer Hi-Bred International, Inc.; and the American Soybean Association.

The justices considered the case for only 70 minutes, which USA Today said indicated that SCOTUS was strongly in favor of Monsanto’s argument. The New York Times pointed out that Monsanto’s lawyer, Seth P. Waxman, a former US solicitor general, “was allowed to talk uninterrupted for long stretches, which is usually a sign of impending victory”.

Justice Sonia Sotomayor said Bowman could not make his case on the doctrine of patent exhaustion. “The exhaustion doctrine permits you to use the goods that you buy. It never permits you to make another from that item you bought”. Justice Stephen Breyer said, “[Y]ou cannot make copies of a patented invention.”

Chief Justice John Roberts asked, “Why in the world would anyone spend money to improve the seed if as soon as they sold the first one anybody could grow more” at no extra cost? (Chicago Tribune, February 20, 2013).

Justice Elena Kagan pointed out the case could present an opportunity for SCOTUS to clarify its position on conditional sales of patented products.

According to InsideHealthPolicy, several justices emphasized that “the court has never heard a patent exhaustion case specifically involving self-replicating technologies.”

The implications of this case go beyond seed production. For example, BSA/The Software Alliance, which represents companies such as Apple and Microsoft, said in its amicus brief that a decision against Monsanto might “facilitate software piracy on a broad scale” if buyers were free to copy software after a first use.

Entities in the biotechnology field also are watching the outcome of the case. Issues regarding technologies as disparate as stem cells, live vaccines, transgenic animals, DNA used for research or medical treatment, regenerative medicine, and other genetically modified products besides soybeans could be affected by the outcome of this hearing.

On the other hand, the Automotive Aftermarket Industry Association, which represents makers of replacement auto parts, sided with Bowman in its amicus brief, arguing against restricting how patented products are sold and resold.

The journal Nature pointed out that if the outcome of this hearing is in favor of Bowman, Monsanto and other companies dependent on self-replicating technologies will be forced to revisit technologies that can short-circuit copycat proliferation of their work. One possibility would be to create GE plants that generate sterile seeds (so-called terminator technology). A second might be to engineer the seeds so that they can grow into new plants that do not pass along the benefits of the engineered trait to the next generation of seeds. A third could be to put the gene that has been beneficially altered under the control of a switch that must be activated by a proprietary chemical, one that the seed producers would sell to the farmers each year along with their seeds.

Nature reports that Monsanto is not currently researching these techniques, and that other companies hope they will not have to do so.


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