Christopher Cowles comments on SCOTUS Amgen-Sanofi decision

19 May 2023 | Applicable law: US | 5 minute read

Christopher Cowles' thoughts on the recent U.S. Supreme Court decision appeared in Bloomberg Law, IP Law Daily, and Law360. 

A lower court ruling invalidated two Amgen patents aimed at reducing LDL cholesterol levels, and the Supreme Court unanimously upheld the decision in a recent ruling. Amgen alleged that its patents were infringed upon by a similar drug developed by Sanofi SA and Regeneron Pharmaceuticals, Inc. Amgen went on to argue, unsuccessfully, against enablement, the requirement that patents be capable of replication by a skilled professional. Antibody patents, until recently, appeared to be held to a different standard. Christopher Cowles noted to Bloomberg Law that when such treatments first emerged in the 1990s, the US Patent and Trademark Office was more permissive of broad patent claims that protected a whole category of antibodies that could perform a listed function. 

Speaking on the subject with Law360, Chris said that beginning in the late 1990s, the U.S. Patent and Trademark Office began allowing patents on antibodies that were described as binding to a specific antigen without further explanation, creating an exception that let antibody patents be defined in terms of their function in a way other patents cannot. He acknowledged that practice has largely ended, and antibody patents are now commonly written in more detail following earlier court rulings. "I see this as sticking a final fork in that antibody exception," he said. Chris went on to tell Bloomberg Law that the Supreme Court's decision corrects this "glaring outlier" and that it "makes sense to harmonize the rest of biology with the antibody space." 

Speaking with IP Law Daily on the decision, Chris agreed that it “confirms the Court's hostility to Amgen's assertion that Amgen's identification of a ‘sweet spot’ in the naturally-occurring PCSK9 protein entitled Amgen to monopoly protection of the full scope of all antibodies encompassed by the composition-of-matter claims of Amgen's '165 (US Patent No. 8,829,165) and '741 (US Patent No. 8,859,741) patents.” 

While Amgen argued enablement of such a broad range of antibodies, Chris pointed out that “Sanofi counsel’s characterization of both the law (enablement requires that a skilled artisan would be able to make and use the claimed invention, without reliance upon undue experimentation) and the science (notably referring to an expert Declaration penned by Sir Gregory Winter) respectively undermined Amgen's assertions regarding the predictability of the genus of antibodies claimed, thereby highlighting the lack of enablement of Amgen’s disputed claims.”

According to Chris, the impact of the Court’s ruling today “should be one of harmonizing USPTO patentability standards in the antibody therapeutic space with literally all other areas of biologic therapeutics—including nucleic acids therapeutics—in a long-overdue acknowledgement of the unpredictability of development of safe and effective biologics in all such areas of research and development.”

You can read more at the following links. Please note that a subscription may be required:

'In Amgen-Sanofi Decision, High Court Sticks to Patent Law Script,' Bloomberg Law

'U.S.: High Court Affirms Federal Circuit's Narrow Enablement Approach,' IP Law Daily

'Justices Clamp Down on Broad Patents in Amgen Decision,' Law360

You can also read Chris' initial comments on the US Supreme Court hearings for this case here on our website

This document (and any information accessed through links in this document) is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.


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