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Working to amend the patent law is an option for the biopharma industry, but so is learning what the U.S. Supreme Court wants, biopharma attorneys said.
Congressional amendments to patent law might ensure that biological and diagnostic method claims the Supreme Court has held to be patent ineligible would be eligible for patenting, attorneys speaking at a session of the BIO International Convention in San Diego said. The court’s decisions are already hurting venture capital funding of start-up biopharma companies, they said.
David J. Kappos, a partner at Cravath Swaine & Moore LLP, New York, and former director of the U.S. Patent and Trademark Office, said of the situation for biopharma patent attorneys today, “People have said things will settle down and get better. Things aren’t getting better. We’re in a leaky life raft.”
Jeffrey Lamken, a partner at MoloLamken LLP, Washington, suggested that attorneys “work to amend the patent law, and that’s something that should at least be tried. But as attorneys, we should also draft our patent claims, prepare our briefs, and argue our cases with our minds on the Supreme Court’s concerns behind their decisions. And perhaps, our efforts will percolate up so that the court will see how our claims work within the law and why what we’ve been arguing for so long has been so important to us.”
The Supreme Court’s 2012 decision in Mayo Collaborative Servs. v. Prometheus Lab., Inc. and 2013 decision Assn’ for Molecular Pathology v. Myriad Genetics rendered the patent claims ineligible under court-determined exceptions to patent eligibility.
In Mayo, the court found that diagnostic patent claims for administering dosages of drugs were patent ineligible as reciting a law of nature. In Myriad, the court concluded that claims for naturally occurring DNA segment associated with breast and ovarian cancer were patent ineligible as products of nature.
Kappos gave an example of the situation today. The University of Michigan faculty made discoveries observing macular degeneration that led to claims for a treatment. The university licensed its patent rights to a start-up, which submitted claims to the PTO. The agency rejected the diagnostic method claims as patent ineligible under Mayo because the methods merely observe bodily functions. “The company will likely abandon its application, which could leave the claims subject to copying,” Kappos said.
Robert Stoll, a partner at Drinker Biddle & Reath, Washington, and former commissioner of patents for the PTO, noted that three organizations have released proposals to amend 35 U.S.C. §101, the patent eligibility section of the U.S. patent law: the Intellectual Property Law Owners Association, the American Bar Association, and the American Intellectual Property Law Association (AIPLA).
Stoll said he prefers the AIPLA proposal, which he helped write. “We need to narrow it to one proposal,” he said. “I am not optimistic that legislation will be passed any time soon, but I think it still should be introduced. It will give the Supreme Court a little pause, having them think Congress may rework patent law.”
Stoll advised attorneys not to stop filing patents for claims for biological products or diagnostic methods. “The law is changing every day. Keep your application pending until it changes your way,” he said.
Lamken identified some common themes in the high court decisions.
“One thing the Supreme Court doesn’t like is people messing with its precedents. They seem to be saying: ‘Follow our cases, don’t invent new formulae.’ And also, there is a sense the court is feeling the patent system is overheated and needs to be calmed down.”
The court’s May 2017 decision in TC Heartland LLC v. Kraft Foods Grp. Brands, which affects court venue for patent cases, is an example of overheating, Lamken said.
In that case, Kraft claimed the more flexible venue practice adopted by the U.S. Court of Appeals for the Federal Circuit facilitated forum shopping, where litigants file suit in a court where they expect a favorable outcome. The company noted almost half of patent cases—including those on patent eligibility—are heard in the U.S. District Court for the Eastern District of Texas .
“TC Heartland argued 28 U.S.C. 1391(c) provides a definition of residency ‘for all venue purposes,’” Lamken said. “Justice [Clarence] Thomas, however, concluded in the [high] court’s opinion that particular statute didn’t apply to patent cases. It appears the court didn’t like it that patent cases were concentrated in specific geographic areas.”
Lamken noted that in its most recent opinions, the Federal Circuit is trying to make sense of the high court’s precedents. “We have to be in it for the long haul,” he said. “We need to work to change the Supreme Court’s mind, and it will take time. Attorneys can also consider using other avenues to protect their clients’ interests, such as contract law and the Defend Trade Secret Act.”
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To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
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