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En banc Federal Circuit reaffirms written description requirement is separate from enablement

March 24, 2010
Post by Blog Staff

Monday the Federal Circuit released its en banc opinion in Ariad Pharmaceuticals, Inc. v. Eli Lily & Co., where the court addressed whether 35 U.S.C. § 112 has a written description requirement separate and apart from the enablement requirement. A substantial majority of the court (10 judges) joined in the majority opinion, with two judges dissenting. As summarized by the court:

We . . . read the statute to give effect to its language that the specification "shall contain a written description of the invention" and hold that § 112, first paragraph, contains two separate description requirements: a "written description [i] of the invention, and [ii] of the manner and process of making and using [the invention]."

The Federal Circuit analyzed several old Supreme Court cases, and concluded that the Supreme Court, while not specifically calling this requirement a "written description" requirement, has consistently held that an inventor must do more than simply enable one in the art to make and use the invention claimed, but also must describe what the invention is.

This decision is not unexpected, and leaves intact the Federal Circuit's jurisprudence on the subject. In fact, one of the grounds for retaining the requirement is that forty years of case law has held such a requirement exists, and inventors have relied upon the requirement over the course of that time. The court was reluctant to upset the settled expectations of the patent community. The court also declined to set forth a rule where original claims always meet the written description requirement, noting:

Although many original claims will satisfy the written description requirement, certain claims may not. For example, 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 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.

More detail of the en banc decision after the jump. Click here for our post regarding the original panel decision, which has much of the factual background of the invention at issue. Click here for a discussion of court's decision to grant en banc review, including the questions presented.

The court also attempted to elaborate further on the applicable test for whether the written description requirement is met (internal citations omitted):

[T]he hallmark of written description is disclosure. Thus, "possession as shown in the disclosure" is a more complete formulation. Yet 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. . . . For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including "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."
. . .
There are, however, a few broad principles that hold true across all cases. We have made clear that the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement. Conversely, we have repeatedly stated that actual "possession" or reduction to practice outside of the specification is not enough. Rather, as stated above, it is the specification itself that must demonstrate possession. And while the description requirement does not demand any particular form of disclosure, or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement.

The court also acknowledged the written description requirement is frequently an issue for biotechnology inventions, noting the problem was "particularly acute" in this field. The problem most frequently in such cases is:

Such claims merely recite a description of the problem to be solved while claiming all solutions to it and, as in Eli Lilly and Ariad's claims, cover any compound later actually invented and determined to fall within the claim's functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention.

Or, stated a different way, and quoting the Supreme Court in Brenner v. Manson:

Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. “[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion."

After reaffirming these principles regarding the written description, the court noted there was no reason to disturb the analysis or conclusions of the panel decision under review, so the en banc court adopted that analysis as its own.

Judge Newman offered "additional views," largely dedicated to highlighting the overarching issue in the case, which in her mind is the issue of patenting "basic scientific research." She notes that researchers built upon the basic discovery outlined in the patent at issue here and actually developed products that achieved the goals of the patent. However, the problem with the patent was that it was filed too soon, after the theory was viable but before working products were produced. As she states: "Although the content varies, the threshold in all cases requires a transition from theory to practice, from basic science to its application, from research plan to demonstrated utility."

Judge Gajarsa filed a concurring opinion, noting § 112 is ambiguous, and while reasonable people may disagree on its interpretation, the majority's interpretation is reasonable, and therefore acceptable. He also cites studies showing the relative infrequency with which the written description issue comes up in courts and at the BPAI.

Judge Rader filed an opinion dissenting on the written description issue, in which Judge Linn joined. According to Judge Rader, the statute is not ambiguous, and the "creation" of the written description requirement by the Federal Circuit is simply wrong. Regarding the language of § 112, Judge Rader states:

This language, while cumbersome, is unambiguous. It says that the written descriptions of the invention and of the manner and process of making and using the invention are both judged by whether they are in such full, clear, concise, and exact terms as to enable a person skilled in the art to make and use the invention. The reason for a description doctrine is clear: to ensure that the inventor fully discloses the invention in exchange for an exclusive right. The test for the adequacy of the specification that describes the invention is also clear: Is the description sufficient to enable a person of ordinary skill in the art to make and use the claimed invention? Nowhere does the paragraph require that the inventor satisfy some quixotic possession requirement.

Judge Rader observes that the "description" requirement had previously only been used to determine priority. He also argues that the requirement is at odds with other fundamental patent law concepts.

Judge Linn also authored a separate opinion dissenting in part and concurring in part, in which Judge Rader joined. He touches on some of the same statutory construction arguments as Judge Rader. He also points out the majority, while acknowledging the "possession of the invention" test is not helpful, fails to elucidate a viable alternative test:

I credit the majority for acknowledging that the "possession" test "has never been very enlightening" and for attempting to clarify that "possession as shown in the disclosure" should be an "objective inquiry into the four-corners of the specification." Maj. Op. at 23-24. Yet, given the court’s concern for public notice, the opinion fails to set the boundaries for compliance with its separate written description test. Commentators have noted our use of variable and confusing vocabulary to delineate the test: that the specification demonstrate "possession," that the inventor "invented what is claimed," or that a person of ordinary skill be able to "visualize or recognize" the claimed subject matter. Donald S. Chisum, 3 Chisum on Patents § 7.04[1][e] (2009). Today, the majority confirms the notion that the specification must show that the inventor "actually invented the invention claimed," Maj. Op. at 23, but then says that "actual 'possession' or reduction to practice outside of the specification is not enough," id. at 25. If the specification's four corners control—not the inventor’s subjective beliefs or activities—then an "actually invented" standard should be irrelevant. Moreover, § 112, paragraph 2 already requires separately that the claims, once issued, objectively claim "the subject matter which the applicant regards as his invention."

He also rejects the majority's contention that Supreme Court precedent supports the majority's viewpoints, arguing the written description requirement was created from whole cloth by the Feder


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