The U.S. Supreme Court settled one of two key patentability issues affecting biopharma—without committing itself to a decision on the other—when its justices decided unanimously that Monsanto’s right to enforce its patents for genetically modified soybean seed extended beyond their initial sale.
A 75-year-old farmer from Indiana, Vernon Hugh Bowman, argued that Monsanto exhausted its rights once the first generation seed was sold by its original farmers as a commodity. The Supreme Court, however, upheld Monsanto’s intellectual property rights to the seed beyond an authorized sale over Bowman’s rights in growing multiple generations of the seed on his Knox County farm.
In ruling for Monsanto, the Supreme Court upheld two lower court decisions in the company’s favor. The U.S. District Court for the Southern District of Indiana, 686 F.Supp.2d 834 (S.D. Ind. 2009) awarded an $84,456 judgment against Bowman, affirmed by the U.S. Court of Appeals for the Federal Circuit, 657 F.3d 1341 (Fed. Cir. 2011).
“It’s not a sweeping case. But it could have been if it had been decided differently,” Erich E. Veitenheimer III, Ph.D., a partner with law firm Cooley LLP told GEN. “I don’t think there are any big surprises there. One would have thought that’s what they would have decided before the case got taken up.”
Gerry J. Elman, editor in chief of Biotechnology Law Report, a journal published by GEN publisher Mary Ann Liebert Inc., told GEN the Monsanto outcome will benefit the broader biopharma industry.
“The Court of Appeals for the Federal Circuit articulated a longstanding legal principle of what happens when you reconstruct a patented product from some material you got from the patentee, and something new, and found applicable here. Admirably, the Supreme Court has adopted that particular line of reasoning,” Elman said.
He added that the Monsanto decision aligned the court with its landmark decision in Diamond v. Chakrabarty, in which the justices decided 5–4 to uphold the patentability of human-made microorganisms as a valid new and useful “manufacture or composition of matter” under 35 U.S.C. § 101.
“That’s good news for the biotechnology community, along the line that Chakrabarty in 1980 was seen as good news in general for the biotechnology community,” said Elman.
However, Dr. Veitenheimer and another lawyer disagree that the case is as far-reaching as Chakrabarty, which sparked nearly three decades of Supreme Court decisions favorable to biopharma.
Thomas C. Meyers, a partner with law firm Brown Rudnick, noted that the court decided seed patentability in J. E. M. Agricultural Supply v. Pioneer Hi-Bred International 534 U. S. 124 (2001), where a majority found inventors could obtain patents on a seed or plant.
Not in dispute is that the industry’s hot streak abruptly ended last year, however, when the high court unanimously overturned two patents held by Nestle’s Prometheus Laboratories subsidiary for its methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases.
Prometheus sued in U.S. District Court in 2004, alleging that an announced (but never marketed) Mayo Medical Laboratories diagnostic test infringed two Prometheus patents. Mayo’s test measured the same metabolites as Prometheus’, but the former used different levels to determine toxicity of the two metabolites.