News desk | ILLINOIS
CHAMPAIGN, Ill. – A new paper co-authored by a University of Illinois at Urbana-Champaign lawyer who studies intellectual property protection for advanced biotechnology argues for common ground in patent claims involving antibodies, the backbone of modern bioscience.
Antibodies are a $145 billion annual market – an amount that is expected to nearly double by 2026, making the patents covering them among the most valuable intellectual property in the patent system. But those patents are being revoked due to a recent change by the United States Court of Appeals for the Federal Circuit to strengthen two areas of patent law — enablement and written description — that are ill-equipped to do about the molecular complexity of antibodies, said Jacob S. Sherkow, a law professor and affiliate at the Carl R. Woese Institute for Genomic Biology in Illinois.
Sherkow’s co-author is Mark A. Lemley of Stanford Law School.
“Given the improvement in antibody science as well as the advancement of our understanding of the genetic diversity of antibodies, the federal circuit’s sweeping change in antibody patenting law seems simply ill-suited,” he said. Sherkow said.
Describing a complex molecule as an antibody atom-by-atom, which is the equivalent of what the doctrinal change in the Federal Circuit would force those seeking patent protection to do, would be like “describing an F-15 fighter jet through all its nuts and bolts.” bolts”. said Sherkow.
“The production of immune receptors, for example, is a semi-random and galactically expansive process. It produces antibodies that are strikingly different in structure and function,” he said. “All of this means that there is no good way to make claims about antibodies that would pass the current court tests. Science does not easily allow what the court is asking for.
Sherkow and Lemley said that an older form of patent protection—means-plus-function and equivalent-infringement claims—would better grant inventors effective control over true substitutes without giving them the power to block improvements by competitors.
“Claiming means plus function is a way to define a new invention by how it works, but with limitations,” Sherkow said. “You can make a fairly broad claim, but you only get the exact thing that you describe in your patent. So you can use broad and expansive language, but you also have to describe, basically, all the ways it works, and you are limited only to this description.
The change in Federal Circuit case law is a legitimate reaction to the long-standing practice of claiming antibodies in functional terms, which can lead to overbroad patents that stifle future innovation, much like what s passed into the software industry in the 1980s and 1990s. But applying the current reinvigorated written description of the Federal Circuit and activation requirements to antibodies and their chemical structure does not fit well with the underlying science , Sherkow said.
“As they’re applied to antibodies, there’s a growing concern that we’re not getting those incentive structures right, although that’s a difficult balance,” he said.
If the economics of intellectual property focuses on balancing a need for protection beyond literal invention and the possibility of improvements, means-plus-function claims represent a step in a more doctrinally and economically sensible, Sherkow said.
“It’s about making sure we’re doing enough to encourage the development of therapeutic antibodies and antibodies for other applications such as COVID-19 testing, but also making sure we don’t allow researchers and antibody developers to become much broader. patents to which they are reasonably entitled, given the underlying science of the antibodies,” he said.
With hundreds of billions of dollars at stake, the implications of intellectual property protections for antibodies will likely be revisited in the U.S. Supreme Court’s upcoming term in Amgen Inc. v. Sanofi, Sherkow said.
“Just to further underscore the importance of this issue, when Amgen v. Sanofi came before the Supreme Court in April, the court did not simply make a positive or negative decision as to whether it would hear the case.. He thought it was such a big case that he asked for a memorandum from the United States Solicitor General, which is usually the signal the court sends for the most important cases and those that most involve the workings of government,” Sherkow said.
“I imagine we will have the Solicitor General’s opinion by the end of this month, if not next month. Generally, when the Solicitor General recommends that the Supreme Court take up a case, it does so. And at least since 2005, just about every patent case that the Solicitor General has recommended the court take, the court has granted certiorari. So this is an important question that we will probably hear a lot about soon.
The article will be published by the Yale Law Journal.