Amgen Denied Petition To Rehear Enablement Requirements For Biotech Patents

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On June 21, 2021 the Court of Appeals for the Federal Circuit ( CAFC) denied a petition filed by Amgen, Inc., (Amgen) to rehear enablement requirements in a patent disclosure.[1] “Enablement” refers to a requirement that a patent application must describe how to make and use a claimed invention.[2] The purpose behind this requirement is to make the invention available to the public in a meaningful way by describing the claimed invention in such terms that one skilled in the art can make and use it.[3]

Amgen’s first argument was that the CAFC had created a new test for enablement.[4] The CAFC however disagreed with this argument, stating that since the passage of the Patent Act of 1870, a patent applicant must enable one’s invention, regardless of the type of invention.[5] The CAFC went on to specify that chemical inventions can be enabled by providing actual or constructive examples such as compounds that have been prepared or discovered.[6]

The CAFC went on to explain further that enablement is required even for generic claims to biological materials.[7] Similarly to chemical compounds, biological compositions should be described constructively to enable the full scope of the claims.[8]

Amgen then argued that the CAFC’s decision on enablement would hamper innovation and extinguish investment in drug discovery.[9] The CAFC disagreed with this point, explaining that one cannot gain exclusivity over an invention without disclosing how to make and use the invention.[10]

Lastly, Amgen argued that the CAFC should overrule case law that considers enablement to be a question of law.[11] However, the CAFC stated that it was bound by precedent dating back to before the establishment of the CAFC.[12] Due to this, Amgen made no compelling reason as to why the treatment of enablement as a question of law should be changed.[13]

This case highlights the importance of ensuring one’s claimed invention is described in sufficient detail to enable one to be able to make and use the claimed invention. Inventions where this is not possible may be better protected with other forms of protection such as trade secrets. Working with patent counsel can aid in formulating a robust patent strategy that takes key considerations into account.

Learn more about Biotech and Intellectual Property here: Biotech & IP: Getting Started, Biotech and IP: Financing and Strategy

[1] http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.ORDER.6-21-2021_1792946.pdf

[2] https://www.uspto.gov/web/offices/pac/mpep/s2164.html

[3] Id.

[4] http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.ORDER.6-21-2021_1792946.pdf

[5] Id.

[6] Id.

[7] Id.

[8] Id.

[9] Id.

[10] Id.

[11] Id.

[12] Id.

[13] Id.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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