Evolving U.S. intellectual property law continues to impact many industries, including the technology and pharmaceutical sectors, with 2022 promising to be no different.
The U.S. Supreme Court will have a significant role to play in the coming year. On the patent front, it will decide whether to review the U.S. Court of Appeals for the Federal Circuit’s decision in American Axle, a case which could potentially expand patent- ineligible subject matter to include certain conventional methods of using mechanical devices
A second case, now seeking Supreme Court review, Amgen v. Sanofi could have implications in the biotech and pharma space with regard to the ability to protect chemical genuses.
Copyright law is also evolving, with U.S. appellate courts trying to apply the Supreme Court’s Google v. Oracle decision addressing fair use in more traditional copyright settings.
Will the Supreme Court Rein in its Patent-Eligibility Doctrine?
The limits of Section 101 and subject-matter eligibility remains a hot and controversial issue. Since the Supreme Court’s 2014 decision in Alice, federal district courts and the Federal Circuit have struggled to determine the best approach to satisfy Alice’s two-part test. Fortunately, the Supreme Court has indicated a willingness to revisit this area in the context of American Axle & Manufacturing Inc. v. Neapco Holdings.
Here, the Federal Circuit held claims relating to a method of manufacturing a shaft assembly of a drive-line system were merely an application of a natural law. Specifically, the claims require “tuning a mass and stiffness of at least one liner,” and inserting the liner into a drive shaft such that it damps certain vibrational modes.
The Federal Circuit found this to be a simple application of Hooke’s law, despite American Axle’s protests that properly tuning the liners required far more. In a fiery dissent, Chief Judge Kimberly Moore rejected the majority decision as an expansion of Section 101 law, and questioned whether the majority’s position should instead be based on enablement.
Chief Judge Moore wrote: “We cannot convert § 101 into a panacea for every concern we have over an invention’s patentability[.]”
In May, the Supreme Court invited the solicitor general to submit a brief relating to the petition for certiorari in the case, indicating they may be willing to once again visit the issue and provide additional guidance.
Are Genus Claims Using Functional Language Effectively Invalid?
A string of recent Federal Circuit decisions, including most recently Amgen v. Sanofi, have relied on a lack of enablement in holding that functionally defined genus claims are invalid.
In Amgen, the patent used functional language to claim a class of antibodies that bind to a particular region on a specific protein, which encompasses potentially millions of currently unknown antibodies. In contrast, only a few hundred antibodies that could fit within the scope of the claims were known at the time of the patent filing.
In finding the claims not enabled, the Federal Circuit held the claims were far broader than the associated disclosures, and undue experimentation would be necessary to identify undisclosed embodiments encompassed by the claims. The court relied less on disclosure of how to identify these embodiments or the “representative number” of disclosed examples (as in past decisions) and more on the absolute number of possible embodiments that may fall within the scope of the claims.
Amgen now argues in its petition for Supreme Court review that the Federal Circuit has created a new, more restrictive test for enablement of genus claims with functional limitations. Supreme Court review of the decision could impact the pharma and biotech industries, while also potentially impacting the enablement doctrine more broadly.
Transformative Use and the ‘Purpose’ of a Work
In Google v. Oracle the Supreme Court found Google’s use of 11,500 lines of declaring code was fair use, focusing in large part on the “purpose” of the use. But as recent circuit court opinions have shown, determining the “purpose” may be more difficult in artistic works than in software.
In The Andy Warhol Foundation v. Goldsmith, the Second Circuit held in March that courts “should not assume the role of art critic” before taking on that very role in determining whether Andy Warhol’s use of a photograph of the musician Prince was a fair use in creating a series of artwork featuring the musician.
While the Supreme Court was concerned with the purpose of the use of Google’s software code, the Second Circuit noted that “purpose is perhaps a less useful metric where, as here, our task is to assess the transformative nature of works of visual art that, at least at a high level of generality, share the same overarching purpose (i.e., to serve as works of visual art).”
Determining the purpose of software code may be a simpler task than determining the purpose of visual artwork, and despite the Second Circuit’s rejection of “the state or perceived intent of the artist,” the circuit was forced to consider both the purpose of Warhol’s art as well as the substantiality of similarities—both highly subjective indicia—in determining whether the artwork was transformative of the underlying photograph.
The distinction between visual art and software code, and the ease of determining the purpose of one compared to the other, bears monitoring. The Warhol Foundation’s petition for a writ of certiorari may lead to the Supreme Court clarifying whether these different works must be analyzed differently.
With these significant developments in IP law, 2022 is shaping up to be a potentially significant year.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Dorothy R. Auth is head of Cadwalader’s Intellectual Property Group in New York. She coordinates global IP enforcement, licensing, and procurement strategies for clients in industries including biotechnology, pharmaceutical, and medical devices, as well as consumer products, computers, and financial services.
Howard Wizenfeld is a special counsel in Cadwalader’s Intellectual Property Group in New York. He handles complex patent litigation primarily in the electrical engineering, telecommunications, and computer science fields, and has handled litigation in the biotechnology, pharmaceutical, and chemical sectors.
David (Dash) Cole is an associate in Cadwalader’s Intellectual Property Group in New York. His practice focuses on patent litigation and counseling, trademark registration and enforcement, trade secrets, licensing, opinions, and due diligence investigations.