In late March, the U.S. Court of Appeals for the Federal Circuit issued its en banc ruling in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. The issue in question – whether the patent statute requires patent applications to include a “written description” and what the scope of that requirement is – may seem esoteric even in the complex world of patent law. But the Federal Circuit’s en banc review attracted a slew of amicus brief, including one from Washington Legal Foundation.
WLF asked Howard W. Levine, head of the biotechnology/pharmaecutical group at the law firm Finnegan, Henderson, Farabow, Garrett & Dunner, LLP and a counsel to victorious Eli Lilly in Ariad, to explain the decision and its significance in 600 words or less. He effectively conveyed these very concise thoughts in a short video now available as part of WLF’s LegallyBrief video series (www.legallybrief.com). To view Mr. Levine’s video click here. The transcript of his commentary is below.At issue in Ariad v. Lilly were two of Lilly’s drugs, Evista(r) for the treatment of osteoporosis and prevention of breast cancer, and Xigirs(r) for the treatment of sepsis. Although these two drugs had been in development for years, Ariad demanded that Lilly pay it royalties in connection with Ariad’s patent (U.S. Patent No. 6,410,516). Lilly refused and after a trial in front of a jury, the jury awarded Ariad some 65 million dollars in damages.
A panel of three judges on the Federal Circuit reversed, holding that the claims at issue failed to satisfy the written description requirement. The written description requirement ensures that the inventor actually invented the claimed subject matter. In undertaking this analysis, the Federal Circuit examined the claims of Ariad’s patent and noted that the claims cover “the use of all substances that achieve the desired result of” inhibiting NF-κB activity. But, although the claims were extremely broad, the patent disclosed very little. The court stated, “The ’516 patent discloses no working or even prophetic examples of methods that reduce NF-kB activity, and no completed synthesis of any of the molecules prophesized to be capable of reducing NF-kB activity”
As such, the Federal Circuit explained that “Ariad chose to assert claims that are broad far beyond the scope of the disclosure provided in the specification of the ’516 patent.” And the Federal Circuit held the claims invalid under the written description requirement.
The case, however, did not end there. Ariad asked the entire Federal Circuit to consider en banc whether a written description requirement even exists. The court granted the petition and asked parties to respond to two questions:
1. Whether 35 U.S.C. § 112 even contains a written description requirement separate from enablement?
2. If so, what is the scope and purpose of the requirement?
After considering the text of the statute, and the applicable Supreme Court precedent, the Federal Circuit, in a 9-2 decision, agreed with Lilly that a separate written description requirement has always existed and is compelled by precedent. Further, the Court explained, “If the law of written description is to be changed, contrary to sound policy and the uniform holdings of this court, the settled expectations of the inventing and investing communities, and PTO practice, such a decision would require good reason and would rest with Congress”—not this Court.
In confirming the existing precedent, the Federal Circuit made several important observations about the written description requirement:
First, the court explained that the written description requirement applies to both original and amended claims. Second, the court stated
[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. [AND] Based on that inquiry, the specification must . . . show that the inventor actually invented the invention claimed.
Third, the court stated that the written description is a question of fact and depends on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”
In considering public policy, the court further explained:
Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. … That is no failure of the law’s interpretation, but its intention. …[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. … Claims to research plans . . . impose costs on downstream research, discouraging later invention. The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not ‘attempt[s] to preempt the future before it has arrived.’