September 26, 2023

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 word that the Supreme Court docket didn’t explicitly have interaction with Federal Circuit precedent. Extra particularly, the Court docket neither cited nor mentioned any Federal Circuit or CCPA determination outdoors of case-specific historic paperwork.

The newest enablement case invoked by the Supreme Court docket in Amgen is Holland Furnishings Co. v. Perkins Glue Co., 277 U. S. 245 (1928). The Court docket 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 Court docket went to lengths to current O’Reilly v. Morse, 15 How. 62 (1854), as an enablement determination, regardless that in each Alice and Mayo, the court docket had labeled O’Reilly as an eligibility determination. The strategy of Amgen echoes that of the Supreme Court docket’s 2010 Bilski determination, which suggested a easy adherence to established precedents. The one non-Supreme Court docket determination that Amgen cites is Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813). Notably, Whittemore was adjudicated by Supreme Court docket Justice Joseph Story whereas on circuit responsibility.

In wanting on the main Supreme Court docket precedent case of Holland Furnishings, it’s telling that the Federal Circuit has invoked this case solely twice – in each cases, for discussions concerning means-plus-function declare interpretation, not enablement. However, Holland Furnishings stays a vital determination 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 Court docket defined “an inventor might not describe a selected starch glue which is able to carry out the perform of animal glue after which declare all starch glues which have these features, and even all starch glues made with three elements of water and alkali, since starch glues could also be made with three elements of water and alkali that shouldn’t have these properties.”  Id.  The Federal Circuit’s failure to depend on Holland Furnishings possible stems from the truth that the case served as the muse 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 Court docket.  Maybe the merely have a tit-for-tat because the Federal Circuit so hardly ever cites the Supreme Court docket in enablement circumstances. The appellate court docket’s Amgen determination, as an example, cited many Federal Circuit opinions, however nothing from the Supreme Court docket.  In some ways, the 2 courts are merely speaking previous each other with out disagreeing.

A crucial case absent from the Supreme Court docket’s Amgen evaluation is In re Wands, 858 F.second 731 (Fed. Cir. 1988). In Wands, the Federal Circuit launched a set of factual concerns 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 had 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 call subsequently affirmed by each the Federal Circuit and the Supreme Court docket. In its deliberation, the Supreme Court docket appears to reassess the Wands components de novo with out acknowledging the jury’s verdict. Intriguingly, the Supreme Court docket’s opinion finds substantial experimentation needed, 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 major oversight by the Court docket.

Whereas the Supreme Court docket’s determination in Amgen v. Sanofi appears to usually affirm the present strategy of the Federal Circuit to enablement, it lacks any depth of engagement with the nuanced evaluation usually performed by the Federal Circuit. Particularly, the absence of reference to In re Wands and its eight-factor check, is a stunning omission. Much more disconcerting is the Court docket’s disregard for the jury’s verdict within the unique 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 might affect future patent regulation selections.  Probably, the Federal Circuit will proceed its historic strategy implicitly instructed by Prof Holman and proceed to disregard the Supreme Court docket precedent on level.