A case decided a last month by eleven judges of the U.S. Court of Appeals for the Federal Circuit[1] — the “Supreme Court of Patent Law” as it is often called – illustrates a fatal mistake that can be made while preparing a patent application (especially in chemical- and biological-related technologies). The case involved Ariad Pharmaceuticals accusing Eli Lilly’s Evista® and Xigris® pharmaceuticals products of infringing one of its patents.
U.S. patent law requires that a patent application contain: “[1] a written description of the invention, and [2] of the manner and process of making and using [the invention so] as to enable any person skilled in the art to which it pertains … to make and use the same.”[2] The first requirement is often referred to as the “written description” requirement, and the second requirement is often referred to as the “enablement” requirement.
The purpose of the written description requirement, as explained by the court, is to: “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification. It is part of the quid pro quo of the patent grant and ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.”[3]
What is the test for meeting the written description requirement? Well, there are no bright-line rules. The level of detail required to satisfy the requirement varies depending on the nature and scope of the claims, and on the complexity and predictability of the relevant technology, including such factors as “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.”[4]
In the Ariad case, after a trial, a jury found that Eli Lily’s products did infringe Ariad’s patent. The appeals court, however, overturned the verdict. It found that Ariad’s patent claimed methods encompassing a genus of materials achieving a stated useful result, but the specification did not disclose a variety of species that accomplish the result. Thus, the patent was invalid for failing to meet the written description requirement by describing only a generic invention that it purports to claim – even though the enablement requirement was met. So, how can one fall into this trap? After all, how can your chemical- and biological-related patent application enable any person skilled in the art to which it pertains to make and use the invention, but not have a written description of the invention!?
With respect to the chemical arts, the court explained that “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result.”[5]
With respect to the biological arts, the court explained, that there can be a case where the specification discusses only compound A. This might very well enable one skilled in the art to make and use compounds B and C. Any claims to compounds B and C, however, would be invalid for lack of written description. This is because the requirement ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function.
This brings us to the rationale for the somewhat harsh result in Ariad? The court answered that: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of ‘invention’—that is, conceive of the complete and final invention with all its claimed limitations—and disclose the fruits of that effort to the public.”[6]
Thus, the lesson for small and medium enterprises (SMEs) – especially those working in the biological and chemical-related technologies – is to work closely with your patent attorney to make sure that your submitted patent application not only enables someone in your field to “get it,” but that you do not cut corners while rushing to file on-the-cheap and actually fail to have a written description of what you invented. Otherwise, years later, that issued patent will end up being just an expensive piece of useless paper!
[1] Ariad Pharmaceuticals v. Eli Lilly and Company, 2008-1248 (Mar. 22, 2010).
[2] 35 U.S.C. § 112, ¶ 1.
[3] Id. at 29 (internal citations omitted).
[4] Id. at 24 (internal citations omitted).
[5] Id. at 20 (internal citations omitted).
[6] Id. at 28 (internal citations omitted).
