Will the Supreme Court Save Biopharma from CAFC Enablement Insanity?

The United States Supreme Court is soon poised to decide the fate of the enablement requirement, and the patent community is collectively holding its breath, wondering if the Court will strike a deathblow to the biopharmaceutical industry—simultaneously making all patents harder to get and even easier to challenge than they already are. The Supreme Court does not have a strong track record of objectively getting patent issues correct, at least not from a pro-innovation standpoint, although the Justices and their supporters likely would disagree. The undeniable truth, however, is that since the Supreme Court issued its decision in eBay v. MercExchange, virtually every decision of consequence to the patent system has made patent rights weaker and patents themselves easier to successfully challenge.

Although the Supreme Court declined to hear Juno v. Kite,  it is hard not to hear the echoes from the Federal Circuit’s inexplicable and stupefying written description law in the wind. In what is as difficult to write as it is to say or hear, the Federal Circuit has actually ruled that to satisfy the written description requirement, patent applicants must disclose both what they know and what they do not know. This requirement to disclose what is known and what is unknown is not just recklessly ignorant, it is not just illogical, but it is the precise type of standard that causes right thinking individuals to legitimately ask whether the Federal Circuit really understands not only what is at stake, but whether they understand anything at all. It should not need to be said, but it is an impossible standard to require patent applicants to disclose what they don’t know. The Federal Circuit might as well require patent applicants to levitate; that would be as achievable a standard as disclosing what one does not know.

A Federal Circuit Favorite—Departure from Established Law

In the Amgen case, the same thought processes that led the Federal Circuit to say that both that which is known and that which is unknown needs to be disclosed bleed over into the enablement issues that are properly before the Supreme Court. At the core is the position that if one has invented broadly, and achieved an important foundational advance, it is simply not appropriate to claim everything that has been invented. The result is broad claims are held invalid, with only narrow claims being upheld,  which will necessarily result in only small, incremental innovation. As with written description, if an applicant has to describe and enable all that is known and unknown, it will mandate disclosure of either hundreds or thousands or tens of thousands of examples, or a finding that not all of the embodiments are properly enabled by the applicant regardless of what one of skill in the art understands.

Until the Federal Circuit’s recent departure from established law, as illustrated in its decision in Amgen, the law of enablement was clear and rather uncontroversial. The patent applicant was required to provide enough information in the application to allow one of relevant skill in the technical field to both make and use the invention without undue experimentation. In Amgen,  the Federal Circuit set a new course for enablement by conflating the basic question “can one of skill in the art make and use the invention” with the caveat  “without undue experimentation” to “reach the full scope” of the claim. Previously, undue experimentation was found when after great effort and significant investment those of skill in the art were unable to make and use the invention. That, however, is not this case.

Descriptions of inventions in a patent application have never been required to be blueprint-level detail. If this requirement that each and every antibody must be specifically disclosed is upheld, that will change. If every embodiment must specifically be disclosed and specifically be taught, regardless of what one of skill in the art would understand based upon reading the disclosure, patent disclosures will necessarily need to all have engineering-level detail instead of enough information to teach one of skill in the art. This would be an enormous departure from existing law, and it would instantly invalidate many hundreds of thousands of patents, if not virtually every patent still in force, which would suddenly become legitimately challengeable under this “super enablement” standard.

Diving Deeper into Amgen

On pages 11-15 of Amgen’s opening brief, the teachings of Amgen’s patents are comprehensively described. The patents include 26 antibody examples and detailed instructions for generating additional antibodies within the genus, which Amgen has referred to as the “roadmap.” If you look at the patents, they are almost 400 pages in length and they come with a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4. Amgen’s expert testified that the patents are a “rich handbook,” providing “a wealth of information” about the claimed antibodies. Appx. 3910(763:1-12). He also testified that skilled artisans following the patents’ roadmap “would be certain to make all” the antibodies across the claims. Appx. 3909 (762:10-20), 3908 (757:12-14).

Sanofi-Regeneron argued that four antibodies—its own Praluent (alirocumab) and third-party PCSK9 antibodies from Merck (1D05) and Pfizer (J16)—could not be made using the patents’ disclosures. Resp.C.A.Br. 11-15. Unfortunately for Sanofi-Regeneron, the jury rejected that argument. And not only was that argument rejected, it was rejected because it was not only unbelievable but because it was directly rebutted: Amgen’s expert explained in detail how the patents’ roadmap produces each of those four antibodies. Appx. 3909 (760:2-21).

Neither the Federal Circuit nor Sanofi-Regeneron identified any actual antibody that required undue experimentation to make using the patents’ teachings. At least as the term “undue experimentation” has historically been used up to this point in patent history. What the Federal Circuit seems to be doing, however, is creating a new caveat to the requirement that those of relevant skill in the art be able to make and use the invention; namely, that the entirety of the invention be capable of being made and used within a reasonable amount of time. This has never been what the enablement requirement has mandated, and it is a gross bastardization of the undue experimentation caveat. Simply stated, there is no credible evidence or argument before the Court that the complete and full nature of the disclosed invention was not fully enabled. That it might take some time to make every antibody within the genus does not and should not mean that undue or any other level of experimentation is required.

The mere fact that it takes time and routine effort to make and use additional examples of the invention cannot equate to undue experimentation. The Federal Circuit was wrong, and the decision must be overruled or else there will be an end to the patenting of groundbreaking, pioneering innovations. That would be significant, and tragic, because it would lead to incentives and investments moving away from fundamental, foundational innovation to discrete, small, incremental innovations that can be protected.

Unlikely Amici

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