In Ariad v. Eli Lilly & Co. (08-1248) (a top 10 case for 2009), 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.

evistabottlesEarlier, Eli Lilly and Company lost a jury trial in the U.S. District Court of Massachusetts in the case of Ariad Pharmaceuticals et al. v. Eli Lilly and Company. The Jury decided that ‘516 patent was valid and infringed by Lilly’s sale of Evista® and Xigris® and awarded the plaintiffs 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.

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.”

To satisfy the written description requirement, an applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.  In other words, the applicant must ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,’ and demonstrate that by disclosure in the specification of the patent.” (quoting Vas-Cath Inc. v. Mahurkar).

The same is true for both process claims and composition claims. Where the specification provides only constructive examples in lieu of working examples, it must still describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention. Of course, what is adequate depends upon the context of the claimed invention with courts looking at “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.”

Lilly argued that the asserted claims are not supported by written description because the specification of the ’516 patent fails to adequately disclose how the claimed reduction of NF-κB activity is achieved. The parties agree that the specification of the ’516 patent hypothesizes three classes of molecules potentially capable of reducing NF-κB activity: specific inhibitors, dominantly interfering molecules, and decoy molecules. Lilly contends that this disclosure amounts to little more than a research plan, and does not satisfy the patentee’s quid pro quo as described in Rochester.

Ariad turned around and said that Lilly’s arguments fail as a matter of law because Ariad did not actually claim the molecules.  According to Ariad, because there is no term in the asserted claims that corresponds to the molecules, it is entitled to claim the methods without describing the molecules. The Federal Circuit, however, felt that Ariad’s legal assertion was wrong-headed:

In Rochester, we held very similar method claims invalid for lack of written description. Id. (holding patent invalid because “Rochester did not present any evidence that the ordinarily skilled artisan would be able to identify any compound based on [the specification’s] vague functional description”); see also Fiers v. Revel, 984 F.2d 1164, 1170–71 (Fed. Cir. 1993) (holding a claim to a genus of DNA molecules not supported by written description of a method for obtaining the molecules); cf. Eli Lilly, 119 F.3d at 1567–68 (holding claims to a broad genus of genetic material invalid because the specification disclosed only one particular species). Ariad attempts to categorically distinguish Rochester, Fiers, and Eli Lilly, because in those cases, the claims explicitly included the non-described compositions.

Ariad’s attempt to distinguish these cases is unavailing. Regardless of whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods, and Ariad admits that the specification suggests only the use of the three classes of molecules to achieve NF-κB reduction. Thus, to satisfy the written description requirement for the asserted claims, the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-κB activity so as to “satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.” Capon, 418 F.3d at 1357.

judge-linnCircuit Judge Linn, concurring, wrote that:

I write separately to emphasize, as I have before, my belief that our engrafting of a separate written description requirement onto section 112, paragraph 1 is misguided. … As I observed in University of Rochester, section 112, paragraph 1 requires no more of the specification than a disclosure that is sufficient to enable a person having ordinary skill in the art to make and use the invention.”

I note that the written description requirement does separate mischief in this case. Because the court relies upon this requirement to reverse the district court, it does not reach the important enablement issue raised by Lilly. … We have long held that in order to survive the enablement requirement, the specification “must describe the manner and process of making and using the invention so as to enable a person of skill in the art to make and use the full scope of the invention without undue experimentation.” … To my knowledge, however, we have not specifically addressed this requirement in relation to the type of claims at issue here—that is, claims written broadly enough to cover any method for achieving a particular result. It may be, as Lilly argues, that such a claim can never be valid, since the specification cannot enable unknown methods. Cf. In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983) (rejecting “single means” claim, as such claims “cover[ ] every conceivable means for achieving the stated result”). This is an important issue that we have left unresolved. It is an issue that we would have been compelled to reach had the case been decided on enablement grounds, a basis found in section 112, instead of on written description grounds, a separate basis not justified under that section or any other provision of the Patent Act.

Look for more discussion from the courts on what is (or is not) required for a written description.

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    […] While not specifically antibody-related, the CAFC found that Ariad’s patent on methods of modulating the NF-kB pathway is invalid. […]