April 22, 2010
Meeting Ariad’s Written Description Requirement
Ariad Pharmaceuticals, Inc. v. Eli Lilly and Company, No. 2008-1248 (Fed. Cir. Mar. 22, 2010) (en banc)
In a much anticipated decision, the Federal Circuit issued an en banc decision addressing the scope of the “written description” requirement of 35 U.S.C. §112, first paragraph. At the court’s direction, the parties briefed two questions: whether §112, paragraph 1 contains a written description requirement separate from an enablement requirement; and, if yes, what is the scope and purpose of the written description requirement. The court received twenty-five amicus briefs, most of which (including a brief cited by the USPTO) advocated a separate written description requirement.
The court’s majority (9-2) reached the same result as the previous panel (reported at 560 F.3d 1366 (Fed. Cir. 2009)), finding the asserted claims of Ariad’s U.S. Patent 6,410,516 invalid for failure to meet the written description requirement. The court held that §112, paragraph 1, contains separate written description and enablement requirements. As to the purpose of the requirement, the court stated, “[R]equiring a written description of the invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described.” Slip op. at 26.
The court provided little in the way of specific guidance as to what constitutes sufficient disclosure, declining (in its words) to “set out any bright-line rules” Slip op. at 25. Rather, the court stated that “whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Slip op. at 24. The court stated that the level of detail required to support the written description requirement depends on the nature and scope of the claims and the complexity and predictability of the technology. The court stated that the sufficiency of written description is a question of fact.
Elsewhere in the opinion, the court articulated the test for sufficiency of written description as “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Slip op. at 23. The court admitted that “possession” is not an “enlightening” standard; “‘possession as shown in the disclosure’ is a more complete formulation.” Slip op. at 24. The court also stated that possession or reduction to practice outside the specification is not enough. “Rather, . . . it is the specification itself that must demonstrate possession.” Slip op at 25.
One focus of the court’s analysis was on whether claims meet the written description requirement simply by having been present in the application as filed. The court stated that, although original claims are part of the specification, they do not necessarily satisfy the written description requirement. The original claims define the invention, but do not describe the invention. “For example,” the court said, “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient o support a claim to a genus. Slip op. at 20. The court held that a claim to a genus, particularly one that defined the members of the genus by their function (like Ariad’s claims), “may simply claim a desired result, and may do so without describing species that achieve that result.” Id.
The court specifically stated that “a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement.” However, the court found that Ariad’s attempted constructive reduction to practice failed to satisfy the requirement. In particular, the inventors of the ’516 patent discovered a mechanism for the body’s immune response to infection. A transcription factor, NF-kB, is released from an inactive complex with a protein inhibitor, I-kB, so that it can bind to and activate certain genes, including cytokines, which can be harmful in excess. The specification states that it is possible to modify the activity of NF-kB by three mechanisms: adding an inhibitor molecule, an example of which was given as I-kB; with a decoy molecule that has a binding site for NF-kB, for which a table of sequences recognized by NF-kB in eleven genes was given; and by introducing a dominantly interfering molecule, describing a preferred embodiment as a truncated NF-kB molecule containing the binding domain but not the activating domain, “if the DNA binding domain and the DNA polymerase activating domain of NF-kB are spatially distinct in the molecule.” The patent claimed methods of reducing NF-kB activity by reducing binding of NF-kB to NF-kB recognition sites on genes.
The ’516 specification failed to support the claimed genus because it did not sufficiently disclose actual molecules belonging to the genus as of the adjudged effective filing date of April 21, 1989. Thus, although a figure disclosed the sequence of DNA that encodes I-kB, that figure was added in a continuation-in-part application in the chain in 1991. (The ’516 patent’s actual filing date was June 6, 1995.) It was not enough that one of ordinary skill in this art could have isolated natural I-kB; the court characterized disclosure of the first mechanism as “a vague functional description and an invitation for further research.” Slip op. at 33. Regarding the third mechanism, the dominantly interfering molecule, the specification had provided no specific molecule and had stated the method would work only “if the DNA binding domain and the DNA polymerase activating domain of NF-kB are spatially distinct in the molecule,” which the court viewed as an admission that the inventors did not know if, in fact, the two domains were spatially distinct, characterizing the disclosure as “ ‘just a wish, or arguably a plan’ for future research.” Slip op. at 35. Finally, the table of eleven genes with sequences recognized by NF-kB that might be used as decoy molecules for the second mechanism “does not answer the question whether the specification adequately describes using those molecules to reduce NF-kB activity. . . . [T]here is no descriptive link between the table of decoy molecules and reducing NF-kB activity.” Slip op. at 35-36. A publication in 1990 that reported using decoy molecules to reduce NF-kB activity could not show possession as of the 1989 priority date. Even were there a link to show possession of the decoy molecule mechanism, that would not have supported the generic claim to reducing NF-kB activity. Slip op. at 37.
Comment: The scope of the written description requirement has been the subject of much concern to many in the patent community, particularly in the pharmaceutical and biotechnology fields. The court’s decision in Ariad did little to assuage these concerns. Rather, the court acknowledged the impact on inventors in the life sciences, but refuted Ariad’s assertion that the written description requirement constituted a “super enablement” standard for chemical and biotechnology inventions. Slip op. at 26. The court also responded to concerns that the written description requirement disadvantages universities, stating, “Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.” Slip op. at 28.
The fact remains, however, that the written description requirement places major hurdles for inventors, companies, universities and their counsel in their pursuit of patents covering basic inventions (as opposed to “academic theories”) in new technologies. These hurdles are particularly difficult for smaller companies, as well as academic institutions; such entities have limited resources, are subject to pressures to expose technology for academic or commercial reasons (e.g., obtaining funding), or both. The court’s analysis in Ariad provides little solace or guidance in addressing these issues. (In addressing such concerns, the court notes that “This is no failure of the law’s interpretation, rather its intention.” Slip op. at 28.) The remedy, if one is to be had, is legislative. Thus, it remains clear that the pursuit of patents for inventions in the life sciences areas, in particular, requires potentially extensive technical work to define as many embodiments (whether real or prophetic) as possible prior to filing. There will be uncertainty in how many examples are needed to describe a genus and where such examples should be located in the genus space. Planning such work should be part of a comprehensive patent and business strategy for new technologies.