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The Supreme Court has misinterpreted or chosen to ignore legislative history in finding certain life sciences discoveries are patent ineligible, a law professor told a biotech conference March 28.
Jeffrey A. Lefstin, associate academic dean and professor of law at the University of California, Hastings College of the Law, said the court has tended to regard the inclusion of discoveries along with inventions in the U.S. Constitution as excess verbiage. But an examination of the legislative histories of the Patent Act and the plant patent law shows Congress has regarded discoveries as patent eligible since the beginning of U.S. patent law. “If you look at the history, it’s a different story than the Supreme Court tells us,” Lefstin said.
He said the Supreme Court’s recent decision in Mayo Collaborative Servs v. Prometheus Lab., Inc. finding a diagnostic method patent ineligible, and its denial of review in Ariosa Diagnostics, Inc. v. Sequenom, Inc., where the U.S. Court of Appeals for the Federal Circuit found it was bound by Mayo, “shows the court is done with this issue.” Noting the discussion the previous day at the conference on a proposal to amend 35 U.S.C. §101, the patent eligibility section of the patent law , Lefstin said, “I do think it’s time for legislation that amends the patent law. It’s the only way to go.”
The session was part of the BIO IP Counsels Committee Conference in Newport Beach, Calif.
The language that a patent can be granted to one who “invents” or “discovers” a composition, process or machine mirrors the “invention” and “discoveries” language of the Constitution and also dates back to the 1790 Patent Act Section 1, as well as to 19th century congressional revisions of the patent law, Lefstin said.
In 1930, Congress presented a clear example of congressional intent concerning discoveries when it said in the Plant Patent Act that the law applies both to the acts of inventing and discovery, Lefstin said.
The 1930 plant patent law said that in 1790, the term “inventor” had a dual meaning: One who creates and one who finds out. “Congress tells us inventors can be discoverers. The legislative history is quite clear,” he said.
A later plant patent lawsuit made congressional intent even clearer, Lefstin said. Ex parte Foster (1951) was about what could be protected as a plant mutant. The patent board found mere discovery of a plant can’t qualify as an invention. “But Congress said, ‘Yes, it can,’ ” and amended the plant statute in 1954 to clarify that seedlings found on cultivated land are patent eligible. “Congress stated that this was clearly its intent in 1930 that mutants, hybrids and seedlings discovered by persons engaged in agriculture should be patent eligible,” Lefstin said.
Congress also used the phrase “invention and discovery” in the Patent Act of 1952. Lefstin said, “Under congressional standards, when language is carried forward the original meaning applies.”
Lefstin also noted the definition of “process” in Section 100B, which was added in the Patent Act of 1952, to be a process, art or method that includes a new use of a known process, machine, manufacture, composition of matter or material. He cited commentary by Pasquale Joseph Federico, former head of the Patent Office and one of the movers of the 1952 legislation, that new uses arise when a known substance or a thing is discovered to have some previously unknown property. “This sounds like Sequenom, which was a discovery that maternal blood or plasma could be used to test for fetal abnormalities” that the Federal Circuit found to be patent ineligible, Lefstin said.
“Does it matter the Supreme Court has misinterpreted or ignored the legislative history?” Lefstin asked. “From a practical standpoint, if you’re trying to convince Congress to amend Section 101, it does matter. The patent system has traditionally protected discoveries, so with that in mind, it could be argued there is no reason to change the system. And it’s clear that the Supreme Court is entering into a time that it is restricting patent eligibility from what it has been in the past, engaging in a radical redefinition.”
Picking up on Lefstin’s statement that legislation may be the only alternative, Hans Sauer, Biotechnology Innovation Organization’s deputy general counsel for intellectual property, said even an amendment to the law wouldn’t necessarily change the Supreme Court’s radical redefinition mindset. He elaborated on comments made the day before by Kevin Noonan, a partner with McDonnell Boehnen, Hulbert & Berghoff LLP and Bloomberg BNA advisory board member, that the amendment should openly address the Supreme Court’s concerns about protecting medical research and physicians’ practice of law.
“We should say to the Supreme Court that it wasn’t that the court was wrong. We should say there is a protectionist role in Section 101, and this is what it is. And that is missing from the proposals we’ve seen so far.”
To contact the reporter on this story: John T. Aquino in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
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