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Patent Filing & Litigation

Intellectual Property Cases to Keep an Eye on in 2022

Intellectual property law watchdogs anticipate major decisions from the Supreme Court in 2022. Fast-evolving pharmaceutical and technology sectors have brought several key questions regarding patent law, fair use, and copyright law to lesser courts with the Supreme Court now preparing to answer them.

Amgen v. Sanofi

Big names like Sanofi yet again find themselves at the center of a legal battle with industry- and economy-wide implications. Amgen v. Sanofi has been taken up by SCOTUS after a US court of appeals recently invalidated Amgen’s pharmaceutical patent at the center of the case. The legal issue at stake is enablement requirements, as biotech firms continue to battle over whether chemical genuses can be patented.

These important pharmaceutical IP questions challenge whether or not structurally different but chemically similar organic materials with similar functional actions deserve patent protection, even when all their effects are not disclosed. SCOTUS is expected to again return to questions regarding whether naturally derived and isolated organic materials can qualify for patents and to what extent.

In this case, Sanofi argues that the functionality observed in Amgen’s drug Repatha isn’t enough to cover the entire drug class, which contains similar but alternate chemically structured organic substances that impact thousands of additional biological processes not disclosed. Amgen claims that its Repatha patent should cover the additional functionality not explicitly stated in its patent. If SCOTUS upholds the lesser court’s ruling, it could have the potential to effectively invalidate patents based on functionality.

The impact of Amgen v. Sanofi extends beyond the biotech industry and could have substantive practical implications, not the least of which is how any ruling will affect these patents’ lifecycles, their performance in managed pharmaceutical markets, and the effect these markets will have on consumers eager for generic alternatives in the marketplace.

Any future ruling could also impact the enablement doctrine more broadly, creating new limitation standards for biotech patents.

Case status: Motion granted: Time extended. Court is now scheduled to review in March 2022.

Axle v. Neapco

Next is American Axle and Manufacturing Inc. v. Neapco Holdings, which raises applications of Section 101 and the patent-eligibility of natural phenomena, in this case, those from physics and Hooke’s Law.

This case will essentially constitute a revisiting of Alice v. CLS Bank which originally defined the now seminal two-step patent eligibility criteria that sought to determine the difference between an unpatentable natural phenomenon and one that applies natural law to a patentable invention.

That two-step process, established in 2014, involves the court asking, first, if the patent claim contains natural phenomena and whether any additional “inventive concepts” enable a process that equates to significantly more than is offered by the phenomenon alone.

Axle is expected to warrant the court’s further delineation of these steps to help determine when natural phenomena are patentable.

Case status: As of May 2021, the acting Solicitor General has been invited to file a brief expressing the views of the US Government. The case was first docketed on January 5, 2021.

Warhol v. Goldsmith

Another series of cases—with one already decided and another currently under review by SCOTUS—has the potential to further define what constitutes fair use in the digital era.

In the 2021 case Google v. Oracle, SCOTUS determined that 11,500 lines of Oracle’s Javascript code could be fairly copied and put in commercial circulation due to the “purpose” of its reproduction, which sought to form the basis for an open-source Android programming platform. The courts deemed this application “transformative,” building upon its original use in a substantive way and therefore legitimate under current fair use laws.

Warhol v. Goldsmith is another fair use case that questions the limits of the doctrine, copyrighted artwork, and so-called transformative use. After the musician Prince’s death in 2016, questions arose surrounding the ownership of illustrations created by the late Warhol (and subsequently owned by the non-profit now managing his estate) in 1984, based on photographs taken by Goldsmith in 1981. Although Warhol’s illustrations appeared in Vanity Fair in 1984, the Goldsmith company was unaware of them until 2016. Vanity Fair credited Goldsmith in the 1984 publication.

Similar to Oracle’s Java code, at stake in Warhol v. Goldsmith are questions of an intellectual product’s purpose and how that relates to fair use. Warhol’s estate argues that the artist’s illustrations represent a transformative use of Goldsmith’s original photographs and therefore constitute fair use under the doctrine’s current standard. The 2021 Circuit Court’s original declaration was that the illustrations were not transformative, therefore violating the fair use doctrine. Unlike Google’s use of copied code, the disparate purpose of Warhol’s similar drawings was not enough to differentiate them from Goldsmith’s photographs.

Case status: Case has not yet been docketed at the Supreme Court level after a district court ruled in 2019 that Warhol’s illustrations did not constitute fair use.

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