“USPTO Guidance and Amgen Decision: Implications for Chemical and Biotech Patent Applications”

Unraveling the Impact of the Amgen Decision on the Patent Landscape

When the U.S. Supreme Court handed down its verdict in Amgen, Inc. v. Sanofi (Amgen) in May 2023, the patent world was left reeling. The decision, which invalidated Amgen patents due to a lack of enablement, sent shockwaves through the chemical and biotech sectors. It was widely anticipated that this ruling would make it more challenging for life sciences companies to secure broad patents claiming an entire genus of compounds, such as antibodies, that perform a specified function. However, the recent guidance issued by the U.S. Patent and Trademark Office (USPTO) suggests that the impact of the Amgen decision might not be as severe as initially feared.

The USPTO Guidance: A Beacon of Clarity?

The USPTO’s much-anticipated guidance on the Amgen decision has finally arrived. The guidance instructs USPTO personnel to continue using the In re Wands factors to determine whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable. These factors include the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make and use the invention based on the content of the disclosure.

The aim of this guidance is to ensure a consistent analysis and treatment of the enablement requirement of U.S. patent laws by USPTO employees. It applies to re-examination proceedings by the Patent Trial and Appeal Board (PTAB), ex parte appeals, and post-issuance proceedings. Interestingly, the guidance does not seem to signal a significant departure from the existing guidance for analyzing the patentability of chemical and biotech patent applications.

Dissecting the Amgen Decision

While the USPTO guidance does not indicate a major shift in the patent examination process, it’s worth revisiting the Amgen decision itself. The unanimous ruling by the Supreme Court is still likely to influence the examination process, particularly with respect to the enablement issue. Furthermore, courts will likely use the Amgen precedent when dealing with enablement issues during litigation.

In the Amgen case, the Supreme Court ruled that claims drawn to a genus of monoclonal antibodies, though functionally claimed, were invalid for lack of enablement. The Court clarified that the patent’s specification must describe the invention in such terms that one skilled in the art can make and use the claimed invention. Justice Neil Gorsuch, the author of the opinion, emphasized that the more one claims, the more one must enable.

The Court found that the specification failed to enable all that it claimed, even allowing for a reasonable degree of experimentation. The Court held that the specification’s description of how to make 26 examples was insufficient to fully enable the full breadth of the claims. The Court concluded that the Amgen patents were invalid for lack of enablement.

Conclusion: Navigating the Post-Amgen Patent Landscape

While the new USPTO guidance does not signal a significant departure from the current approach to examining chemistry and biotech patent applications, the Amgen decision is bound to have some impact on patent examination and litigation with respect to enablement. Innovators working in technologies where enablement is an issue—particularly in the chemical and biotechnology sectors—should collaborate with practitioners well-versed in the nuanced issues of enablement. This will increase their chances of obtaining patents that can withstand validity challenges based on the Amgen precedent.