“One would think that a topic as fundamental, well-established, and frankly simplistic as the written description requirement would not present any difficulty for supposed learned judges of the Federal Circuit. Unfortunately, that assumption would be incorrect.”
The written description requirement is really the backbone of the quid pro quo between the public and the patent applicant. In exchange for information about an invention, society is willing to grant the applicant a patent, which conveys exclusive rights for a limited period of time to what is claimed, not described. But the description provided in the specification must demonstration that the applicant really has an invention in the first place and what the boundaries of that invention are—this is the written description requirement in lay terms.
In legalese, the written description requirement, dating back to The Telephone Cases, 126 U.S. 1 (1888), has required enough description so that the invention is described with “sufficient clearness and precision to enable those skilled in the matter to understand [the invention].” And more recently, the Supreme Court reiterated that “Section 112 requires only a written description of the invention… in such full, clear, concise, and exact terms as to enable any person skilled in the art… to make and use the same.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).
The critical aspect of the written description requirement, as with virtually every other analytical aspect of patent law, is that the invention is considered through the eyes of one of skill in the relevant subject matter. This obviously makes sense; if the invention relates to a sophisticated area of computational neurobiology, do we really care whether an aeronautical engineer who specializes in aerodynamics and propulsion understands the nuances of the invention? No. The law only cares whether one of skill in the subject area of the invention understands the description.
A New and Impossible Standard
One would think that a topic as fundamental, well-established, and frankly simplistic as the written description requirement would not present any difficulty for supposed learned judges of the Federal Circuit. Unfortunately, that assumption would be incorrect. Recent cases in the life sciences area, however, suggest a higher level of disclosure is being required by some judges of the Federal Circuit. Indeed, such a high level of disclosure that the standard cannot possibly be met if what the court has stated is applied literally as a test moving forward.
As difficult as it is to believe, the Federal Circuit has actually said that inventors must convey both “known and unknown” aspects of the invention in order to satisfy the written description requirement. Indeed, according to the Federal Circuit in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330 (Fed. Circ. 2021), to demonstrate possession and satisfy the written description requirement found in 35 U.S.C. 112(a), the inventors needed to convey that they possessed both “known and unknown” aspects of the claimed invention. But how can an inventor describe something that is unknown? And where does “possession” come into play when that term and concept is not even mentioned in the statute? Juno Therapeutics has petitioned the Supreme Court to take up this case.
Of course, this “known and unknown” standard of disclosure to satisfy the written description requirement is idiotic and cannot be what the law requires. Not only is it illogical to require an inventor to disclose that which they don’t know in order to obtain a patent, which is obviously impossible, but this standard—if it is in fact a standard—fundamentally violates the underpinning of the law of obviousness. The Federal Circuit correctly explained that which is unknown cannot be obvious in Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A. DE C.V., 865 F.3d 1348 (Fed. Cir. 2017). This issue arises in the area of obviousness due to the fact that examiners will from time to time reject claims as being inherently obvious, so there is a well-established understanding that “[o]bviousness cannot be predicated on what is unknown.” In re Rijckaert, 9 F.3d 1531 1531, 1534 (Fed. Cir., 1993) (citing In re Spormann, 363 F.2d 444, 448 (CCPA 1996)). And if what is unknown cannot make a claimed invention obvious, unknown aspects of an invention have no rightful bearing on written description.
Will SCOTUS Restore Sanity?
Meanwhile, the U.S. Supreme Court has also been petitioned by Biogen, asking the Court to consider whether the written description must disclose data that demonstrates the claimed invention is “effective” and emphasize the claimed invention by singling it out. This petition follows a contentious decision of the Federal Circuit in March, and the denial of a petition for panel rehearing and rehearing en banc. Dissenting from the Federal Circuit’s rehearing denial were Chief Judge Kimberly Moore and Circuit Judges Alan Lourie and Pauline Newman, who argued that Biogen’s written description disclosed every claim limitation in the patent. The dissent contended that the rest of the Federal Circuit introduced extraneous considerations into the Section 112 written description analysis, which they of course did.
Hopefully the Supreme Court will bring some sanity to this important area of law.
Join Us Live
If you are interested in this issue, please join us October 25-26 for Life Sciences 2022, which is a part of the IPWatchdog Masters™ series of live and in-person events. A panel of experts will discuss written description requirement, the tension between the statute and Supreme Court interpretation, how the Federal Circuit case law is evolving, what this means for the future of innovation, and what applications can and should do to respond. See also the full Agenda.
Image Source: Deposit Photos