October 1, 2023


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Supreme Courtroom’s Non-Engagement with the Federal Circuit in Amgen v. Sanofi

4 min read

by Dennis Crouch

Prof. Chris Holman just lately characterised Amgen v. Sanofi as an “endorsement of the Federal Circuit’s present interpretation and utility of the enablement requirement, and upkeep of the established order.”  Though I largely align with Holman’s views, I observe that the Supreme Courtroom didn’t explicitly have interaction with Federal Circuit precedent. Extra particularly, the Courtroom neither cited nor mentioned any Federal Circuit or CCPA choice outdoors of case-specific historic paperwork.

The newest enablement case invoked by the Supreme Courtroom in Amgen is Holland Furnishings Co. v. Perkins Glue Co., 277 U. S. 245 (1928). The Courtroom additionally referenced a number of different traditionally important enablement circumstances, together with Wooden v. Underhill, 5 How. 1 (1846); The Incandescent Lamp Patent, 159 U. S. 465 (1895); and Minerals Separation, Ltd. v. Hyde, 242 U. S. 261 (1916). The Courtroom went to lengths to current O’Reilly v. Morse, 15 How. 62 (1854), as an enablement choice, despite the fact that in each Alice and Mayo, the court docket had labeled O’Reilly as an eligibility choice. The strategy of Amgen echoes that of the Supreme Courtroom’s 2010 Bilski choice, which suggested a easy adherence to established precedents. The one non-Supreme Courtroom choice that Amgen cites is Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813). Notably, Whittemore was adjudicated by Supreme Courtroom Justice Joseph Story whereas on circuit obligation.

In wanting on the main Supreme Courtroom precedent case of Holland Furnishings, it’s telling that the Federal Circuit has invoked this case solely twice – in each situations, for discussions relating to means-plus-function declare interpretation, not enablement. Nonetheless, Holland Furnishings stays an important choice that precludes (a) genus claims constructed upon on the disclosure of a single species, in addition to (b) genus claims that embody inoperable species.  The case concerned a patent overlaying starch-based glue.  The Supreme Courtroom defined “an inventor could not describe a selected starch glue which can carry out the perform of animal glue after which declare all starch glues which have these capabilities, and even all starch glues made with three components of water and alkali, since starch glues could also be made with three components of water and alkali that wouldn’t have these properties.”  Id.  The Federal Circuit’s failure to depend upon Holland Furnishings probably stems from the truth that the case served as the inspiration for Walker v. Halliburton that was later rejected by the 1952 Patent Act.

Elephants within the Room: The Federal Circuit has adjudicated quite a few biotech enablement circumstances, offering nuanced evaluation, none of which was cited or dissected by the Supreme Courtroom.  Maybe the merely have a tit-for-tat because the Federal Circuit so not often cites the Supreme Courtroom in enablement circumstances. The appellate court docket’s Amgen choice, as an illustration, cited many Federal Circuit opinions, however nothing from the Supreme Courtroom.  In some ways, the 2 courts are merely speaking previous each other with out disagreeing.

A essential case absent from the Supreme Courtroom’s Amgen evaluation is In re Wands, 858 F.second 731 (Fed. Cir. 1988). In Wands, the Federal Circuit launched a set of factual issues to evaluate whether or not a declare is sufficiently enabled or would necessitate undue experimentation – a key issue is the quantity of experimentation required.  In Amgen, these parts have been handed to the jury for adjudication as mandated by the seventh Modification. The jury in Amgen sided with the patentee, deeming the claims enabled. Nevertheless, this pro-patentee verdict was overturned by the district court docket on JMOL, a choice subsequently affirmed by each the Federal Circuit and the Supreme Courtroom. In its deliberation, the Supreme Courtroom appears to reassess the Wands elements de novo with out acknowledging the jury’s verdict. Intriguingly, the Supreme Courtroom’s opinion finds substantial experimentation essential, however doesn’t even acknowledge the existence of a jury verdict, merely stating that “each the district court docket and Federal Circuit sided with Sanofi.” This omission marks a big oversight by the Courtroom.

Whereas the Supreme Courtroom’s choice in Amgen v. Sanofi appears to typically affirm the present strategy of the Federal Circuit to enablement, it lacks any depth of engagement with the nuanced evaluation typically carried out by the Federal Circuit. Specifically, the absence of reference to In re Wands and its eight-factor take a look at, is a stunning omission. Much more disconcerting is the Courtroom’s disregard for the jury’s verdict within the authentic Amgen trial, reflecting a possible underappreciation of the complexities of patent regulation and the factual determinations concerned. It stays to be seen how this lack of engagement with Federal Circuit precedent could affect future patent regulation choices.  Probably, the Federal Circuit will proceed its historic strategy implicitly instructed by Prof Holman and proceed to disregard the Supreme Courtroom precedent on level.

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