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

Amgen v. Sanofi: A Groundbreaking Patent Decision

When the U.S. Supreme Court handed down its decision in Amgen, Inc. v. Sanofi in May 2023, it sent a seismic shock through the patent world. The ruling, which invalidated Amgen’s patents due to a lack of enablement, particularly rattled the chemical and biotech sectors. The consensus was that this decision 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.

USPTO’s Response to the Amgen Decision

Fast forward a few months, and the U.S. Patent and Trademark Office (USPTO) has now issued eagerly awaited patent examiner guidance that takes into account the implications of the Amgen decision. Interestingly, it appears that the decision may have a more muted impact on the examination of chemical and biotech patent applications than initially anticipated.

The USPTO Guidance

The new guidance instructs USPTO personnel to “continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable” when considering if utility patent claims are enabled. 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 foster 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), in ex parte appeals and post-issuance proceedings. Importantly, it does not seem to signal a significant departure from existing guidance for analyzing the patentability of chemical and biotech patent applications.

The Amgen Decision

While the guidance does not signal a significant departure from current guidance, it’s worth revisiting the unanimous Amgen decision. This ruling is still likely to influence examination with respect to the enablement issue. Furthermore, Courts will be guided by the Amgen precedent when dealing with the enablement issue during litigation.

In Amgen, 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 “specification may call for a reasonable amount of experimentation to make and use a patented invention” and “[w]hat is reasonable in any case will depend on the nature of the invention and the underlying art.”

Justice Neil Gorsuch, author of the opinion, provided the basic principle of enablement: “If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” Therefore, “[t]he more one claims, the more one must enable.”

The Court ultimately found that the specification failed to enable all that it claimed, even if 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 a person of skill in the art reading the specification that tries to make every antibody claimed in Amgen’s patents would have to engage in an undue amount of experimentation. The Court held that the courts below had correctly found the Amgen patents to be invalid for lack of enablement.

Conclusion

While the new guidance does not signal a significant shift in the approach USPTO personnel should use when examining chemistry and biotech patent applications, the Amgen decision is bound to have some impact on examination and litigation with respect to enablement. Therefore, innovators working in technologies where enablement is an issue—particularly in the chemical and biotechnology arts—should collaborate with practitioners who are well-versed in the nuanced issues of enablement. This will provide the best likelihood of success in obtaining patents that will withstand validity challenges based on the Amgen precedent.