Today, the Federal Circuit finally released its long-awaited opinion in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. In a 9-2 decision, the court chose to follow Judge Lourie’s interpretation of the statute from his earlier opinions in Enzo and Rochester in holding that the statute does include a written description requirement separate from the enablement requirement.
As noted previously, the statute as written is not a model of clarity and has been subject to multiple interpretations.
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The court, in an opinion written by (surprise, surprise) Judge Lourie, opens its opinion by noting that even Ariad seems to argue that the statute has two requirements. First, the inventor must describe what the invention is. Second, he must describe how to make and use it. Of course some might argue that it is the claims that describe what the invention is.
The court seems to argue that the statute is not ambiguous and that its interpretation is clear from the language (even Judge Gajarsa who joins that majority disagrees with that).
History and Stare Decisis
Next, the court argues that the Patent Act has historically contained a separate written description requirement. Congress knew this when it enacted the 1952 Patent Act.
The court next turns to stare decisis and argues that Supreme Court precedent going back to the 1850’s dictates the outcome in this case. Most recently, the Supreme Court acknowledged the written description requirement in Festo:
[T]he patent application must describe, enable, and set forth the best mode of carrying out the invention. These latter requirements must be satisfied before issuance of the patent, for exclusive patent rights are given in exchange for disclosing the invention to the public. What is claimed by the patent application must be the same as what is disclosed in the specification; otherwise the patent should not issue. The patent also should not issue if the other requirements of § 112 are not satisfied.
According to the court, a separate written description requirement is not inconsistent with the purpose of a patent’s claims.
Claims define and circumscribe, the written description discloses and teaches.
The Patent Act in § 132 also contains a prohibition against adding “new matter” to a patent application or claims during prosecution. “New matter” generally refers to disclosure that was not in the original application as filed.
Albeit in dicta, the court indicates that § 132 is a mere “examiner’s instruction.” By this, the court means that the new matter prohibition is not a basis on which a patent may be invalidated. Instead, § 132 is merely for use during prosecution of the patent. Section 112’s written description requirement, on the other hand, can be used as a basis for invalidating an issued patent.
The court seemed to have a bit of difficulty in articulating the test for whether a patent has complied with the written description requirement. The court referred to the inquiry as a question of fact.
[T]he 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.
The inquiry sounds suspiciously similar to the enablement requirement that varies depending on the context. The court did note that the description requirement does not require actual examples or reduction to practice.
Ariad argued that universities and others that conduct basic research will be disadvantaged by this new rule. The court responded that the Patent Act was not intended to grant patents to new academic theories, but rather to applications of such research.
Judge Newman (normally a dissenter) joined the court’s opinion, but also wrote separately “because the real issue of this case is too important to be submerged in rhetoric.” She argued that rather than focusing on the statute that the policy of patents is better served with a separate written description requirement. Such a requirement preserves the quid pro quo of the patent system: in return for a patent, the patentee must provide a written description of the invention.
Judge Gajarsa filed a concurring opinion where he argued that the text of the statute “is a model of legislative ambiguity.” He believes that reasonable people can differ on the statutory language, but in the end it comes down to much ado about nothing. He cites several empirical studies that conclude that a separate requirement will have little effect on patents.
Judge Rader filed a dissenting opinion. He argued that the statutory language is perfectly clear and does not contain a written description requirement separate from the enablement requirement. Next, he argued that the only time a written description requirement was previously discussed by the courts, it was in the context of whether a patent was properly supported by a parent application.
Judge Rader argued that the issue is really about claim construction. If the court would not interpret claims more broadly than they are described in the specification, there would be no need for a separate written description requirement.
Judge Linn also dissented. He argued that the only purpose of a written description has been to police new matter issues. There is no need for a separate requirement as the enablement requirement adequately meets the needs of the patent system.
Judge Linn further criticized the court’s test for the written description requirement. If it is an objective test, it should be a legal rather than factual inquiry. The test seems to be too similar to the enablement requirement to justify a separate test.
Judge Linn completely disagreed with the court’s reading of prior patent statutes and Supreme Court opinions as setting forth a separate written description requirement. Finally, he argued that it does not make sense that the original claims of a patent application can violate the written description requirement. By definition, they are a part of the original description.
Lesson From the Court
The court provides another lesson on application drafting in this case. It is important that all claims be supported by the specification. The PTO will generally enforce this issue for new claims (new matter). For original claims, the easiest way to accomplish this is to include the actual claim langauge in paragraph form in the specification itself.