By Chris Holman
Much has been already been written about the Supreme Court’s recent decision in Amgen v. Sanofi, including Dennis’s prompt response. Speaking for myself, I read Amgen as an endorsement of the Federal Circuit’s current interpretation and application of the enablement requirement, and maintenance of the status quo. The enablement requirement is an important (and I would argue the primary) non-prior art-based doctrinal tool for policing claim scope, and as such it plays an important role in preventing inventors of pioneering inventions from laying too much claim to subsequent innovation.
As the Supreme Court observed in Amgen, although Sawyer and Man might have been the first to invent an electric lamp filament of “carbonized fibrous or textile material,” this achievement did not necessarily entitle them to a patent encompassing all electric lamps filaments constructed of this broadly defined class of material, including Edison’s subsequent, but apparently vastly superior, bamboo-based filament. Similarly, Samuel Morse’s invention of the telegraph did not mean he was allowed a patent encompassing any use of electricity “for marking or printing intelligible characters, signs, or letters, at any distance” (sounds like the internet). And in the realm of biopharmaceuticals, the discovery of an antibody capable of specifically binding a particular epitope does not necessarily justify a patent claim encompassing all antibodies specific for that epitope, including antibodies having different (or even superior) pharmaceutical function, a point raised by Sanofi in its briefing of Amgen.
For years, this has been Federal Circuit’s interpretation of the enablement requirement, which requires the scope of the patent’s disclosure to be “commensurate” with the scope of the claims. In Amgen the Supreme Court essentially paraphrased this long-standing standard, stating that “we understand [the Federal Circuit] to have recognized only that the more a party claims for itself the more it must enable. [T]hat much is entirely consistent with Congress’s directive and this Court’s precedents.”
At the same time, it has also long been understood that a patentee is not required to literally enable a person of skill in the art to make and use every embodiment falling within the scope of a patent claim in order to satisfy the enablement requirement. For example, it is uncontroversial that a patent claim broadly directed towards pharmaceutical compositions comprising a specified active ingredient is not invalid for lack of enablement simply because the claim encompasses improved formulations of that active ingredient (e.g., timed release or combination products) that are not literally enabled by the original patent. In many cases, such formulations are sufficiently innovative to justify their own patent, sometimes referred to as an “improvement patent.” I do not think that anything in Amgen should be interpreted as altering this fundamental understanding of the enablement requirement.
Over the last few years I have written quite a bit about the enablement requirement, particularly in the context of therapeutic antibodies and other pharmaceuticals. For those who might be interested, here are some links to those articles, along with a brief description of some of the points raised in those articles.
I will begin with two articles I co-authored with Professor S. Sean Tu, entitled Antibody Patents: Use of the Written Description and Enablement Requirements at the Patent & Trademark Office and Antibody Claims and the Evolution of the Written Description / Enablement Requirement. These articles report the results of an empirical study wherein we found that over the last couple of decades patent examiners faced with antibody claims have steadily increased the use of enablement and written description rejections, and have shifted from the issuance of broad, functionally-defined antibody claims (such as the claims struck down in Amgen) to narrower, structurally-defined claims (such as the sequence-based patent claims Amgen and Sanofi have obtained on their respective products, which the Federal Circuit and Supreme Court both pointed to with seeming approval).
In another article, Amgen v. Sanofi: The Supreme Court Takes up the Enablement Requirement in the Context of Therapeutic Monoclonal Antibodies, I offered some thoughts on Amgen prior to the Supreme Court deciding the case. The article summarizes some of the main arguments that were raised in Amgen’s successful petition for certiorari, as well as Sanofi’s brief in opposition and a number of amici curiae briefs filed by various interested parties, including the U. S. government’s brief recommending that the Court not grant certiorari.
Amgen’s petition for certiorari relied heavily upon a 2020 law review article entitled The Death of the Genus Claim (“Death”), which purports to document a dramatic shift in the Federal Circuit’s interpretation of the enablement and written description requirements that has rendered it nearly impossible to obtain a chemical genus claim that will withstand judicial scrutiny. Perhaps Death played some role in the Court’s decision to grant certiorari. In any event, I responded to Death with my own two-part article, entitled Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?, Parts I and II.
In Part I, I analyzed the judicial decisions upon which Death bases its claim, and explain why, in my view, the article does not substantiate its claim of a marked shift in the Federal Circuit’s interpretation and application of 112(a). In Part II, I push back against one particular assertion made in Death, i.e., the suggestion that patentees can circumvent the Federal Circuit’s purported heightened application of 112(a) to chemical genus claims by drafting broader claims that define chemical genuses solely in structural terms, without the inclusion of any functional limitations. Part II then reviews a substantial number of judicial decisions involving chemical genus claims, and finds little evidence of a pronounced change in the application of 112(a) to chemical genus claims over the time span which Death identifies as corresponding to a purported dramatic shift in the law.
In another article, The Enablement and Written Description Requirements Through the Lens of the Federal Circuit’s Actions (As Opposed to Its Words), I observe that, when applying patent law’s enablement and written description requirements to police the scope of chemical genus claims, there can at times be a marked divergence between what the Federal Circuit says the law is and what the court actually does. For example, although the Federal Circuit has repeatedly stated that a patentee must enable the “full scope” of a patent claim in order to comply with 112(a), that is clearly not literally true – rarely if ever does a patent enable every conceivable embodiment that would fall within the scope of a patent claim, a task that would be impossible in most (if not all) cases, given the open-ended nature of most patent claims. In Amgen, the Supreme Court expressly observed that “we review judgments of the lower courts, not statements in their opinions,” which I interpret as tacit recognition of the importance of focusing more on the actions of the Federal Circuit, as opposed to statements in the opinions that can sometimes be misleading when divorced from context.