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

by Dennis Crouch

Prof. Chris Holman recently characterized Amgen v. Sanofi as an “endorsement of the Federal Circuit’s current interpretation and application of the enablement requirement, and maintenance of the status quo.”  Although I largely align with Holman’s views, I note that the Supreme Court did not explicitly engage with Federal Circuit precedent. More specifically, the Court neither cited nor discussed any Federal Circuit or CCPA decision outside of case-specific historical documents.

The most recent enablement case invoked by the Supreme Court in Amgen is Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245 (1928). The Court also referenced several other historically significant enablement cases, including Wood 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 went to lengths to present O’Reilly v. Morse, 15 How. 62 (1854), as an enablement decision, even though in both Alice and Mayo, the court had labeled O’Reilly as an eligibility decision. The approach of Amgen echoes that of the Supreme Court’s 2010 Bilski decision, which advised a simple adherence to established precedents. The only non-Supreme Court decision that Amgen cites is Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813). Notably, Whittemore was adjudicated by Supreme Court Justice Joseph Story while on circuit duty.

In looking at the leading Supreme Court precedent case of Holland Furniture, it is telling that the Federal Circuit has invoked this case only twice – in both instances, for discussions regarding means-plus-function claim interpretation, not enablement. Nevertheless, Holland Furniture remains a crucial decision that precludes (a) genus claims built upon on the disclosure of a single species, as well as (b) genus claims that encompass inoperable species.  The case involved a patent covering starch-based glue.  The Supreme Court explained “an inventor may not describe a particular starch glue which will perform the function of animal glue and then claim all starch glues which have those functions, or even all starch glues made with three parts of water and alkali, since starch glues may be made with three parts of water and alkali that do not have those properties.”  Id.  The Federal Circuit’s failure to rely upon Holland Furniture likely stems from the fact that the case served as the foundation for Walker v. Halliburton that was later rejected by the 1952 Patent Act.

Elephants in the Room: The Federal Circuit has adjudicated numerous biotech enablement cases, providing nuanced analysis, none of which was cited or dissected by the Supreme Court.  Perhaps the simply have a tit-for-tat since the Federal Circuit so rarely cites the Supreme Court in enablement cases. The appellate court’s Amgen decision, for instance, cited many Federal Circuit opinions, but nothing from the Supreme Court.  In many ways, the two courts are simply talking past one another without disagreeing.

A critical case absent from the Supreme Court’s Amgen analysis is In re Wands, 858 F.2d 731 (Fed. Cir. 1988). In Wands, the Federal Circuit introduced a set of factual considerations to assess whether a claim is sufficiently enabled or would necessitate undue experimentation – a key factor is the amount of experimentation required.  In Amgen, these elements were handed to the jury for adjudication as mandated by the 7th Amendment. The jury in Amgen sided with the patentee, deeming the claims enabled. However, this pro-patentee verdict was overturned by the district court on JMOL, a decision subsequently affirmed by both the Federal Circuit and the Supreme Court. In its deliberation, the Supreme Court seems to reassess the Wands factors de novo without acknowledging the jury’s verdict. Intriguingly, the Supreme Court’s opinion finds substantial experimentation necessary, but does not even acknowledge the existence of a jury verdict, simply stating that “both the district court and Federal Circuit sided with Sanofi.” This omission marks a significant oversight by the Court.

While the Supreme Court’s decision in Amgen v. Sanofi seems to generally affirm the current approach of the Federal Circuit to enablement, it lacks any depth of engagement with the nuanced analysis often conducted by the Federal Circuit. In particular, the absence of reference to In re Wands and its eight-factor test, is a surprising omission. Even more disconcerting is the Court’s disregard for the jury’s verdict in the original Amgen trial, reflecting a potential underappreciation of the complexities of patent law and the factual determinations involved. It remains to be seen how this lack of engagement with Federal Circuit precedent may influence future patent law decisions.  Most likely, the Federal Circuit will continue its historic approach implicitly suggested by Prof Holman and continue to ignore the Supreme Court precedent on point.