ARTICLE
15 January 2024

USPTO Releases Examiner Guidance For The Amgen Enablement Decision

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Oblon, McClelland, Maier & Neustadt, L.L.P

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The USPTO today published its guidance to the examiners on the impact of the Amgen v. Sanofi,143 S. Ct. 1243 (2023), on USPTO practice.
United States Food, Drugs, Healthcare, Life Sciences
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The USPTO today published its guidance to the examiners on the impact of the Amgen v. Sanofi,143 S. Ct. 1243 (2023), on USPTO practice. The Guidance is basically steady as she goes but with the caveat that the enablement requirement and the Wands factors (In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)) apply across all technologies, noting the Court's reliance on cases involving the telegraph, incandescent lamp filaments and wood glue. The Guidance also noted that the post-Amgen Federal Circuit decisions had reaffirmed the continued validity of the Wands factors as consistent with Amgen, citingMedytox, 71 F.4th at 998- 999, Baxalta Inc, v. Genentech, Inc., 81 F.4th 1362 (Fed. Cir. 2023), and In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential).

A copy of the guidance is here.

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