- WRITTEN DESCRIPTION: ARIAD CHANGES NOTHING
- July 12, 2010
- Law Firm: Norris McLaughlin & Marcus, P.A. [incorporation phrase format]A Professional Corporation - Bridgewater Office
The Federal Circuit has now confirmed the existence of a written description requirement separate from the enablement requirement. The long-anticipated
en banc decision, with a large 9-2 majority, in Ariad Pharmaceuticals Inc. v. Eli Lilly and Co. was handed down by the Court of Appeals for the Federal Circuit (hereinafter “the Federal Circuit”) late last month, reaffirming its prior consistent precedent. The issue is of extreme importance, of course, because of the increasing number of lack of written description rejections being made by the Patent Office, particularly against chemical and biotechnology inventions. Indeed, at oral argument, the attorney for the Patent Office allegedly described as “high” the number of times the Patent Office rejects patent application claims as being enabled but not described.
¿B intracellular signaling. Ariad’s inventors discovered that NF-¿B intracellular signaling is implicated in certain diseases and, therefore, that reducing NF-¿B intracellular signaling could be beneficial in some treatment cases. Ariad applied for and obtained patent claims covering these discoveries. However,
¿B intracellular signal could actually be reduced. Ariad’s patent specification theorized three classes of molecules capable of reducing NF-¿B activity: specific inhibitors, dominantly interfering molecules and decoy molecules. Ariad’s patent specification did not have any specific examples of either of the first two classes of molecules, and, while exemplary structures were provided for the third class, there was nothing to indicate that these structures actually worked to reduce NF-¿B activity.
en banc, challenging the Federal Circuit’s interpretation of 35 U.S.C. § 112, first paragraph, specifically that this portion of the statute contains a written description requirement separate from the enablement requirement. Ariad’s petition was granted, with the Federal Circuit directing the parties to brief two questions:
(1) Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from the enablement requirement?
(2) If a separate written description requirement is set forth in the statute, what is the scope and purpose of that requirement?
35 U.S.C. § 112, first paragraph, reads in pertinent part as follows:
of the invention, and of the
, in such full, clear, concise, and exact
terms as to
enable any person skilled in the art to which it pertains, or with which
Ariad’s argument ¿ at least as the majority opinion recounts it ¿ was hypertechnical and internally inconsistent. Ariad answered Question (1) in the negative, i.e., that there was no written description requirement separate from the enablement requirement. Yet, Ariad conceded in response to Question (2) that there must be both a written description of the invention, and also a written description of the manner andprocess of making and using the invention. Thus, both Ariad and Lilly agreed that the statute by its terms requires a written description both of the invention and of the manner and process of making and using the invention. Either these are two separate requirements (written description and enablement), or it is a single requirement (written description) having two components (of the invention and of the process of making and using the invention). In either case, two different statutory requirements must be satisfied. Ariad’s main argument, thus, became a distinction without a distinction, which appeared to prejudice the court’s thinking against Ariad with respect to Question (2). Indeed, since Ariad had answered Question (1) in the negative, its answer to Question (2) became irrelevant when the Federal Circuit decided Question (1) in the affirmative.
Ariad would have been better served focusing on Question (2): What is the scope and purpose of the separate written description requirement? Having decided that its precedent compelled reading the statute to require a written description requirement separate from the enablement requirement, the Federal Circuit was further compelled to find some meaningful purpose for so requiring. For, as the Federal Circuit put it, “the rule of statutory construction [is] that Congress does not use unnecessary words.” According to the Court, if Congress had intended a written description congruent with enablement, Congress could have simply required “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.” Slip Opinion, page 11. The fact that Congress did not use this or equivalent language supports the Federal Circuit’s positions not only that Congress intended a separate written description requirement, but, also, that Congress intended the separate written description requirement to have some meaningful purpose apart from enablement.
Almost since its inception in 1982, the Federal Circuit has found that “meaningful purpose” to be to ensure “possession” of the invention, and
Ariad reaffirms this principle. The possession requirement is a particularly powerful weapon in the Patent Office’s rejection arsenal, especially against broad, generic patent claims being sought for basic inventions. According to the Federal Circuit, “the test for sufficiency [of the written description] is 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 Opinion, page 23. Where the patent claims a genus, “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Slip Opinion, page 21. Rather, “a sufficient [written] description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id.
ipsis verbis support in the original specification for what an applicant claimed, and, further, that original claims constituted their own written description. Even the Federal Circuit’s attempts to point to passages in Supreme Court precedent as supporting a possession doctrine are not persuasive, as the decisions in these cases could easily be accredited to the failure of the applicant to provide an enabling disclosure rather than some failure to prove possession in the context of written description.
but its intention (emphasis added).” Id. The Federal Circuit explained, “[p]atents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. * * *. Requiring a written description requirement 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.” Id.
¿B activity was fatal to Ariad’s case. As noted above, Ariad’s patent specification disclosed three classes of molecules theoretically capable of reducing NF-¿B activity, but did not describe any particular molecules of two of the three classes and, while it described structures of the third class that might be capable of reducing NF-¿B activity, did not indicate that these structures would actually work to reduce NF-¿B activity.Likely, the case will be appealed to the Supreme Court, and the hope is that the court will take the case on and provide some meaningful guidance.
Intellectual Property Law Alert provides information to our clients and friends about current legal developments of general interest in the area of intellectual property. The information contained in this Alert should not be construed as legal advice, and readers should not act upon such without professional counsel.
Copyright © 2010 Norris McLaughlin & Marcus, P.A
In the meantime, continued great care will need to be taken in drafting patent specifications in order to win broad claims from the Patent Office. While inventors, always mindful of peer review, often loathe presenting anything other than scientific work actually performed, the fact remains that a patent specification is not a scientific, peer-reviewed article, but instead is a legal document. Moreover, the value of that legal document depends very little on the actual invention behind the document, and every bit on the invention described in that document, whether the invention described accurately reflects the actual invention or not. That having been said, the applicable rules of practice and, indeed, the Federal Circuit itself sanction the use of prophetic examples. “Prophetic examples are routinely used in the chemical arts, and they certainly can be sufficient to satisfy the written description requirement.” Slip opinion, page 35. In chemical cases, patent practitioners need to make greater use of prophetic examples to “fill out” sparse disclosures. Although this is more difficult to do in biotechnology cases because of the difficulty of predicting whether one macromolecule will behave similarly to another, once the active sites are discovered, prophetic examples should likewise be employed in biotechnology cases.
Ultimately, Ariad’s failure to identify in its original patent application a sufficient number of species or specific details about molecules that could be used to reduce NF-
Ariad also objected that the possession doctrine unfairly disadvantages universities, and provides an unfairly high hurdle to clear when attempting to patent basic research. The Federal Circuit was unsympathetic, noting “the patent law has always been directed to the ‘useful Arts.’” Slip Opinion, page 28. While noting that “[m]uch university research relates to basic research, including research into scientific principles and mechanisms of action, and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered,” the Federal Circuit countered “[t]hat is no failure of the law’s interpretation,
The Federal Circuit’s reliance on its own precedent to support the possession doctrine is especially unsatisfying. Ariad is correct that historically the written description requirement was satisfied by
it is most nearly connected, to make and use the same * * * (emphasis added).”
manner and process of making and using it
“The specification shall contain a written description
Ariad sued Lilly in the United States District Court for the District of Massachusetts. After a jury trial culminating in a finding of infringement, a panel of the Federal Circuit held Ariad’s asserted patent claims invalid for lack of written description. Ariad then petitioned the Federal Circuit for rehearing
Ariad’s patent application contained a paucity of examples exemplifying how the NF-
By way of background, Ariad brought suit against Lilly, alleging infringement of Ariad’s patent related to interference of NF-