High Court Will Tackle Proper Enablement Standard

By Kevin E. Noonan –

Constituting something of a surprise, the Supreme Court on Friday, November 3rd granted Amgen's petition for certiorari on the second of the Questions Presented in its petition:

2.  Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art "to reach the full scope of claimed embodiments" without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial "'time and effort,'" Pet.App. 14a [emphasis added].

(The Court did not deign to consider the first Question, regarding whether enablement should be a question of law for the court, as it is under current Federal Circuit precedent, or a question of fact for the jury.)

This Question, and how the Court has been petitioned to address it, directly concerns the scope of disclosure necessary to satisfy the statutory requirements of 35 U.S.C. § 112(a), a question of particular importance for genus claims in pharmaceutical and biotechnology patents (see, D. Karshtedt, M. Lemley & S. Seymore, The Death of the Genus Claim,  35 Harv. J.L. & Tech. (forthcoming 2021) (rev. Apr. 19, 2021), 30 15 21 30 16 https://ssrn.com/abstract= 366801)*.

To recap, the petition was filed after en banc review was denied by the Federal Circuit after the Court affirmed the District Court's grant of JMOL below, overturning a jury's decision that the asserted claims were not invalid for non-enablement.  The case arose when Amgen sued Sanofi and Regeneron over sales of Praluent® (alirocumab), which allegedly competes with Amgen's Repatha™ (evolocumab) product; Amgen's asserted patents, U.S. Patent Nos. 8,829,165 ("'165 patent") and 8,859,741 ("'741 patent"), claim a genus of antibodies that encompass Praluent®.  As background, blood plasma contains low-density lipoproteins that bind cholesterol and are associated with atherosclerotic plaque formation.  Liver cells express receptors for LDL (LDL-R) wherein binding thereto reduces the amount of LDL cholesterol in blood and reduces the risk of plaque formation and cardiovascular disease.  PCSK9 (proprotein convertase subtilisin kexin type 9) is a molecule that binds to and causes liver cell LDL-R to be destroyed, thus reducing the capacity and effectiveness of the liver cell's ability to reduce serum LDL-cholesterol.  The antibodies at issue in this suit bind to PCSK9 and prevent PCSK9 from binding to LDL-R, preventing their destruction and resulting in lower serum cholesterol.  It is important to note that, while reciting the structure of the residues on PCSK9 (the antigen) that are bound by the claimed antibody, the claim does not recite any structural limitations of the antibody.  The only antibody characteristics recited as limitation are functional, i.e., the ability to bind (and not even specifically bind) to at least one of the recited PCSK9 residues and block PCSK9's interaction with the LDL-R.

The Federal Circuit's decision affirming the District Court's JMOL of non-enablement was based on its determination that "[t]he claimed antibodies are defined by their function: binding to a combinations of sites (residues) on the PCSK9 protein, in a range from one residue to all of them; and blocking the PCSK9/LDLR interaction."  The panel relied on its decision in In re Wands (and its famous "Wands factors"), the dispositive factor in the Court's decision being the amount of experimentation required to encompass the full scope of the claims at issue.  Calling In re Wands the Court's "go to" precedent, the opinion stated that while itself a monoclonal antibody case, "Wands did not proclaim that all broad claims to antibodies are necessarily enabled" because "[f]acts control."  The panel considered the facts (and the findings of invalidity) in more recent cases, including Wyeth & Cordis Corp. v. Abbott Laboratories, Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc.  In all these cases, of course, the Federal Circuit found that the claims were not enabled, due to the broad scope of embodiments the claims in these cases encompassed and the amount of undue experimentation required to satisfy the enablement requirement throughout its full scope.  The panel set forth its synthesis of the Federal Circuit's analysis regarding satisfaction of the enablement requirement arising from these cases:

What emerges from our case law is that the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short.  In particular, it is important to consider the quantity of experimentation that would be required to make and use, not only the limited number of embodiments that the patent discloses, but also the full scope of the claim.

This precedent is well grounded in the Federal Circuit's concern that a patentee must satisfy the quid pro quo of the patent grant, so that the specification supports its claims throughout their entire scope, whether on enablement or written description grounds.

In its petition for certiorari, Amgen's argument regarding the second Question Presented was that it was contrary to ancient Supreme Court precedent, citing Mowry v. Whitney, 81 U.S. 620, 644-645 (1871); The Telephone Cases, 126 U.S. 1, 536 (1888); Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916); Schriber-Schroth Co. v. Cleveland Tr. Co., 305 U.S. 47, 57 (1938); and Universal Oil Prods. Co. v. Globe Oil & Refin. Co., 322 U.S. 471, 484 (1944).  Amgen argued that the Federal Circuit's standard for statutorily compliant enablement, what it termed cumulative disclosure that reached the full scope (even to the most remote corners of the claimed invention), is "a standard of its own devising" that is "impossible to satisfy" citing the Karshtedt paper.  This standard requires the claims to be enabled throughout their full scope even if there is no evidence that there is any particular species that would require undue experimentation to achieve, Amgen argued.  The proper standard, according to Amgen, consistent with the statutory text, the history of how enablement has been considered, and Supreme Court precedent, is disclosure sufficient to be able to make and use the invention, which does not require disclosure throughout entire scope of the claim.  "The Federal Circuit identified no reason why patent validity should depend on the cumulative effort required to ferret out every conceivable implementation of the invention," Amgen argued in its petition, asserting that the requirement was contrary to Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916).  The test creates an impossibility that prevents a patentee from protecting her invention because a claim can be avoided by an infringer who makes a minor (structural) change, according to Amgen.  And as a consequence, "[t]he Federal Circuit routinely lays waste to innovative patents that juries upheld at trial" by imposing its test, according to the petition.

The Solicitor General presented the government's views that the Court should not grant certiorari in this case.  The SG's brief argued that this case is not an appropriate vehicle for Supreme Court review (being limited to its narrow factual predicate) and that Amgen is wrong in its legal arguments because what must be enabled is the invention (which necessitates disclosure throughout its full scope).  The brief in particular cited Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465, 476 (1895), wherein the Court rejected the proposition "that one, who had discovered that a certain fibrous or textile material answered the required purpose, should obtain the right to exclude everybody from the whole domain of fibrous and textile materials."  And with regard to Amgen's reliance on Minerals Separation, the SG stated that the principle enunciated in that case was merely that "the need to tweak an invention to accommodate differing circumstances—without changing the basic principles on which the invention operates—does not render a patent claim invalid for lack of enablement," which is not the situation in this case.

As always, it is impossible to discern the Court's reasoning for granting certiorari, particularly when it is against the recommendations of the SG.  (The last patent case where these circumstances arose was in LabCorp v. Metabolite; in that case the Court ultimately decided certiorari had been improvidently granted and after oral argument dismissed the writ.)  Here the Court will wade into a question that involves balancing the scope of genus claims and their preclusive preemptive effect on future development of related but not expressly disclosed species, on one hand, and the need for a patentee of an invention capable of a multiplicity of (relatively) minor structural changes to be able to protect her invention from trivial infringers, on the other hand.  One alternative to restricting the scope of genus claims can be appreciated by recognizing that the law leaves room for others to patent independently non-obvious (and not expressly disclosed) species falling within the scope of a claimed genus (thus protecting future innovation while permitting the genus patentee to protect against infringers).  The doctrine of equivalents provides perhaps a less certain but not entirely toothless weapon against trivial changes in undisclosed species claims (e.g., substituting a valine for a leucine in the amino acid sequence of a claimed protein).  It is undoubtedly the case that the briefing in this case will provoke a broad range of amici curiae on both sides of the question, and ultimately that the Court will have the opportunity to stimulate the patent community on an issue that isn't subject matter eligibility under Section 101.  Which in some ways is in itself blessing (at least until the decision is rendered).

*Sadly, the first author, Professor Dmitriy Karshtedt, died recently and suddenly; see D. Kass, "'Brilliant' GW Law Patent Scholar Dmitriy Karshtedt Dies at 45," IPLaw 360 November 2, 2022.