Patent Baristas

In Ariad v. Eli Lilly & Co., the Court of Appeals for the Federal Circuit set out a split decision on a case addressing patent validity and enforceability issues where Lilly contends that the asserted claims of US 6,410,516 are invalid for including non-statutory subject matter, for being obtained through inequitable conduct, and are unenforceable due to prosecution laches.

Lilly argued, and of course Ariad disputed, that the claims cover unpatentable naturally-occurring phenomena, that Ariad withheld critical documents from the patent examiner not only to get the patent issued but to avoid the risk of losing 13 years of patent term.

Earlier, Eli Lilly lost in District Court after a jury decided that the ‘516 patent was valid and infringed by Lilly’s sale of Evista® and Xigris® and awarded Ariad approximately $65 million in back royalties and a 2.3 percent royalty on future U.S. sales of Evista and Xigris until the patent’s expiration in 2019.  Ariad Pharmaceuticals et al. v. Eli Lilly and Company.

Ariad petitioned for rehearing en banc, challenging the court’s interpretation of 35 U.S.C. § 112, first paragraph, as containing a separate written description requirement.  The en banc court looked at whether § 112, first paragraph, contains a written description requirement separate from the enablement requirement and, if so, the scope and purpose of that requirement.

The Federal Circuit has now reaffirmed that § 112, first paragraph, contains a written description requirement separate from enablement and held the asserted claims of the ’516 patent invalid for failure to meet the statutory written description requirement.  Ariad Pharma v. Eli Lilly (08-1248).

The ‘516 patent claims methods based on the discovery of a naturally-occurring biological pathway, the NF-kappaB pathway. While Ariad contends that the patent covers all means for modulating the NF-kappaB pathway, Lilly’s contention is that it discovered the drugs in question, Evista and Xigris and disclosed their medicinal properties years before the patentees’ scientists made their discovery.

This case raises the question of if a researcher discovers a drug without ever knowing the drug acts on a patented pathway or before the pathway is understood, does that constitute infringement? If the drug was acting on the pathway before the pathway was discovered, does the existence of the drug invalidate the patent on the pathway by rendering it not “new“? This could give rise to a number of conflicting patents.

The inventors of the ’516 patent discovered that if the transcription factor NF-κB’s activity could be reduced, it could ameliorate the symptoms of diseases that trigger NF-κB activation – similar to how aspirin can reduce a fever without actually treating the underlying infection.

The asserted claims include language for methods that include a single step comprising reducing NF-κB activity in cells. The district court determined that “reducing NF-κB activity” means “decreasing the function of NF-κB to act as an intracellular messenger that regulates transcription of particular genes, in response to certain stimuli.”

Ariad argued that § 112, first paragraph, does not contain a written description requirement separate from enablement. Ariad argued that the statute contains two description requirements: “Properly interpreted, the statute requires the specification to describe (i) what the invention is, and (ii) how to make and use it.” Thus, according to Ariad, in order to enable the invention, the specification must first identify “what the invention is, for otherwise it fails to inform a person of skill in the art what to make and use.” Yet Ariad argued that this first step of “identifying” the invention applies only in the context of priority (i.e., claims amended during prosecution; priority under 35 U.S.C. §§ 119, 120; and interferences) because original claims “constitute their own description.”

Lilly argued that two hundred years of precedent support the existence of a statutory written description requirement separate from enablement and that the statute requires, first, a written description of the invention and, second, a written description of how to make and use the invention so as to enable one of skill in the art to make and use it. Lilly claimed that this separate written description requirement applies to all claims—both original and amended—to ensure that inventors have actually invented the subject matter claimed.

Section 112, first paragraph, reads as follows:

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.

Ariad parses the statute as follows:

The specification shall contain:

[A] a written description of the invention, and of the manner and process of making and using it,

[B] 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 . . .

Ariad asserts that the written description requirement serves a single purpose: enablement.

Lilly disagreed, arguing that § 112, first paragraph, contains three separate requirements as follows:

“The specification shall contain a written description of the invention, and”

“The specification shall contain a written description . . . 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”

“The specification . . . shall set forth the best mode contemplated by the inventor of carrying out the invention.”

The Federal Circuit took the separate route:

We agree with Lilly and 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]. 35 U.S.C. § 112, ¶ 1 (emphasis added). On this point, we do not read Ariad’s position to be in disagreement as Ariad concedes the existence of a written description requirement. See Appellee Br. 2 (“Under a plain reading of the statute, a patent specification . . . must contain a description (i) of the invention, and (ii) of the manner and process of making and using it.”). Instead Ariad contends that the written description requirement exists, not for its own sake as an independent statutory requirement, but only to identify the invention that must comply with the enablement requirement.

Finally, a separate requirement to describe one’s invention is basic to patent law. Every patent must describe an invention. It is part of the quid pro quo of a patent; one describes an invention, and, if the law’s other requirements are met, one obtains a patent. The specification must then, of course, describe how to make and use the invention (i.e., enable it), but that is a different task. A description of the claimed invention allows the United States Patent and Trademark Office (“PTO”) to examine applications effectively; courts to understand the invention, determine compliance with the statute, and to construe the claims; and the public to understand and improve upon the invention and to avoid the claimed boundaries of the patentee’s exclusive rights.

Our Favorite Quote:

The term “possession,” however, has never been very enlightening. It implies that as long as one can produce records documenting a written description of a claimed invention, one can show possession. But the hallmark of written description is disclosure. Thus, “possession as shown in the disclosure” is a more complete formulation.

Everyone’s Two Cents:

Judge Newman added:

Basic scientific principles are not the subject matter of patents, while their application is the focus of this law of commercial incentive. The role of the patent system is to encourage and enable the practical applications of scientific advances, through investment and commerce.

Judge Gajarsa concurred:

Contrary to the representations of the Patent Office and the opinions of members of this court, I do not believe that this issue has a significant, practical impact. … The empirical evidence confirms my belief that written description serves little practical purpose as an independent invalidity device and better serves the goals of the Patent Act when confined to the priority context.

Judge Rader, with Judge Linn joining, dissented-in-part and concurred-in-part:

The Constitution of the United States gives Congress, not the courts, the power to promote the progress of the useful arts by securing exclusive rights to inventors for limited times. Art. I, § 8, cl. 8. Yet this court proclaims itself the body responsible for achieving the “right balance” between upstream and downstream innovation. … In rejecting that statutory balance in favor of an undefined “written description” doctrine, this court ignores the problems of standardless decision making and serious conflicts with other areas of patent law.

Judge Linn, with Judge Rader joining, dissented-in-part and concurred-in-part:

While the parties offer vigorous arguments about the grammar of § 112, paragraph 1, the only reasonable interpretation is the one offered by Ariad, both because it conforms to the long-recognized purpose of the statute in policing new matter violations and because it tethers the “written description of the invention” to an understood standard: “such full, clear, concise, and exact terms so as to enable.” Lilly remarks that statutes do not necessarily specify their own tests, and that “the legal standards for applying them are developed by courts over time.” Lilly’s Br. 28. Although this might be true generally, Congress did provide such a legal standard in this statute, and the majority’s creation of a separate, additional requirement—with a poorly defined standard—is unnecessary and ill advised.