Courting disaster for American innovation


“Based on the legal errors inherent in the Circuit Court’s decision and the chilling effect these errors will have if they remain the law of the land, it would be an invaluable service to law and innovation if the decision were cancelled.”

The only president to have obtained one, Abraham Lincoln knew of the vital role that patents have played in the scientific and technological innovations that have spurred American growth and prosperity since the founding of the republic.

Lincoln cited the development of patent laws—along with the invention of writing and the discovery of America—among the most important events in world history. Patents have “special value…in facilitating all other inventions and discoveries,” he said in an 1858 speech. To give inventors exclusive use of their inventions for a limited time,” added fuel from the burning interest of genius in the discovery and production of new and useful things.

What was true a century and a half ago remains true today. But a recent decision by the United States Court of Appeals for the Federal Circuit threatens to stem the fire and limit inventions of the future. Last August, a three-judge Circuit Court panel struck down Sloan Kettering’s patent for his CAR-T cancer immunotherapy and reversed the $1.2 billion awarded to Sloan Kettering and his partner and licensee. proprietary, Juno Therapeutics, after a jury trial found Kite Pharma infringed the patent. The tribunal, in bench, refused to reconsider the decision.

An unenforceable regime

I consulted Juno Therapeutics during the Federal Circuit proceeding, but anyone concerned about the law and scientific innovation should be concerned about the decision. If upheld, the ruling would impose significant hurdles on intellectual property protection and the future of biopharmaceutical innovation, which is growing rapidly and poised for major breakthroughs in the treatment of common diseases like cancer.

At its core, patent law contains plain language about what inventors must disclose to obtain “exclusive” rights: it simply requires that a patent disclose the invention and the manner and process of making and using it. with enough detail to allow skilled craftsmen to both make and use it.

But the Circuit Court has placed an enormous new burden on inventors that goes far beyond what Congress has put into patent law, requiring inventors to demonstrate “possession” of “the full scope of the invention.” claimed”, including both “known and unknown” embodiments. . Sloan Kettering would have to spend years manufacturing and testing “millions of billions” of antibody fragments – a conventional prior art component of the new therapy – when those resources can be better deployed in groundbreaking research on the cancer.

The Circuit Court produced an unenforceable legal regime, particularly for biopharmaceutical inventions, where variability is the name of the game for just about any conventional component that could be used in a new drug or other invention. I joined the previous underlying, Ariad. But this new decision transforms from Ariad flexible analysis that accounts for science in an extremely rigid, legalistic and harmful rule that ignores science.

Most worrying, however, is that it threatens to remove the incentives for innovation from the patent system. By requiring extensive, unnecessary and costly testing – making patents more difficult and less valuable to obtain – the ruling makes research institutions and companies less likely to devote resources to cutting-edge technologies, thus delaying or preventing medical miracles entirely. what Americans expect.

This “possession” doctrine has never been endorsed by the Supreme Court. In fact, the modern court has never even addressed the statutory text at issue in this case, much less the precise question at the heart of this litigation: whether the written description required by patent law requires anything other than a description of the invention and how to make and use it. The Court has already been asked to consider similar issues, but has declined to do so.

The Supreme Court should intervene

In June, Juno Therapeutics and Sloan Kettering filed a subpoena certiorari asking the Supreme Court to review the case. Highlighting concern over the impact on innovation, St. Jude’s Children’s Research Hospital, Albert Einstein College of Medicine, University of Texas MD Anderson Cancer Center and Fred Hutchinson Cancer Center were among the signatories of five amicus briefs filed last month in support of Supreme Court review.

In light of the CAR T-cell decision, it’s time for the highest court in the land to directly address this elementary part of patent law and replace the Circuit Court’s view with a more close to the language of the law and supportive, non-destructive, of innovation. This case is a particularly attractive vehicle for such scrutiny because of the patently illogical terms on which the Circuit Court relied to invalidate the patent.

Based on the legal errors inherent in the Circuit Court decision and the chilling effect these errors will have if they remain the law of the land, it would be an invaluable service to law and innovation if the decision were overturned. .

Like Lincoln, the Founding Fathers believed that patents were important enough to the future of the nation to merit an explicit place in the Constitution. Article 1, Section 8, Clause 8 states that Congress shall have power “to promote the progress of science and useful arts, securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries” .

More than a century of legal precedent and the explicit intent of Congress would be respected by a rejection of the Circuit Court’s decision. The Supreme Court should follow the stated intent of Congress and that of the Constitution. It will “promote the progress of science and useful arts” by restoring the proper incentives for inventors to continue to provide their medical miracles to the American people through the protection of patent issuance.

Paul R. Michel served on the United States Court of Appeals for the Federal Circuit from 1988 to 2010 and served as Chief Justice from 2004 to 2010. He consulted with Juno Therapeutics during Federal Circuit proceedings.


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