Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.

Ariad Pharmaceuticals et al. v. Eli Lilly and Company, 598 F.3d 1336 (Fed. Cir. 2010) (en banc), is a United States court case regarding accusations of infringement by Eli Lilly on U.S. Patent 6,410,516 held by ARIAD Pharmaceuticals. The Federal Circuit ruled en banc to invalidate the patent for a lack of sufficient description of the invention. Amici briefing before the en banc panel was intensive, with 26 separate briefs filed, and the final decision has been heavily discussed by legal commentators. Its ultimate impact on biotechnology patents remains to be determined.

The '516 patent at issue

The '516 patent was licensed by Ariad from Massachusetts Institute of Technology (MIT), Harvard, and the Whitehead Institute. Nuclear factor-kappa B (NF-kappaB) is a transcription factor that plays a critical role in many cell functions including embryonic and neuronal development, cell proliferation, apoptosis, and immune responses to infection and inflammation.^[1] Defendant Lilly was manufacturing two drugs accused of infringing the '516 patent: Evista(r) for the treatment of osteoporosis and prevention of breast cancer, and Xigirs(r) for the treatment of sepsis.

On May 4, 2006, Lilly was ordered to pay ~$65 million in back royalties, and 2.3% royalties on future sales of the drugs Evista and Xigris which inhibit NF-κB production.^[2]

The lower court's opinion was controversial because many commentators felt that the scope of Ariad's patent's claims went far beyond what was covered or enabled in the patent itself.^[3] As a transcription factor, NF-κB regulates over 300 genes, and NF-κB-controlled pathways are relevant to many human diseases. As many as 200 marketed drugs have mechanisms of action that may affect the NF-κB pathway.^[2] Lilly's defense is termed by some as the "Lilly written description" doctrine, as it entails the need for an extremely detailed and precise description of the action embodiment of the invention itself.

Federal Circuit three-member panel appellate ruling for Eli Lilly

On appeal, a three-member panel of the Federal Circuit overturned the lower court ruling, and invalidated the '516 patent. The basis of the ruling was that the '516 patent did not have a sufficient "written description" of the patented invention.^[4]

Federal Circuit's en banc hearing again holds for Eli Lilly

Ariad moved for a rehearing en banc'.^[5] The en banc Federal Circuit order^[6] certified two narrow questions to be resolved by the appeal:

• Whether 35 U.S.C. Sec, 112, paragraph 1, contains a written description requirement separate from an enablement requirement?
• If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

On 3 April 2009, the United States Court of Appeals for the Federal Circuit again approved throwing out the verdict against defendant Eli Lilly. Rather than address whether Eli Lilly had infringed the patent, the Federal Circuit ruled that the Ariad patent was invalid. Essentially, the court ruled that the patent failed to adequately describe the invention in its patent or explain how others could replicate its work.^[7][8] Judge Rader in dissent felt that a lack of a more traditional patent concept, enablement, would be sufficient to invalidate the patent. In Judge Rader's view, the use of traditional tests to determine whether a patent is enabled by its descriptions solved the appellate court's problematic analysis more definitively and predictably. The impact of the Ariad ruling thus is in keeping with earlier Federal Circuit opinions on written descriptions, but ultimately its effect on biotechnology patents remains unclear.^[9]

References

1. Miller SC, Huang R, Sakamuru S, Shukla SJ, Atten-Rmaos MS, Shinn P, Van leer D, Leister W, Austin CP, Xia M (1 May 2010). "Identification of known drugs that act as inhibitors of NF-kappaB signaling and their mechanism of action". Biochem. Pharmacol. 79 (9): 1272–80. PMID 20067776.
2. "A license to print money?". Nat. Biotechnol. 24 (6): 593. June 2006. doi:10.1038/nbt0606-593. PMID 16763570.
3. Holman, Chris. "Pragmatism". Holman's Biotech IP Blog.
4. "Brief video commentary on "written description" patent requirement case". Washington Legal Foundation.
5. Ariad v. Lilly: Federal Circuit Grants En Banc Request to Challenge Written Description Requirement
6. Order per curiam, available at, "Archived copy" (PDF). Archived from the original (PDF) on 2010-05-27. Retrieved 2009-12-18.
7. "Eli Lilly Wins Appeal in Patent Case". NYTimes.com. 2009-04-03. Archived from the original on September 27, 2015. Retrieved 2009-04-05.
8. Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research, and The President and Fellows of Harvard College, V. Eli Lilly and Company, ["Archived copy" (PDF). Archived from the original (PDF) on 2009-04-24. Retrieved 2009-04-09. 2008-1248] (United States Court of Appeals for the Federal Circuit 2009-04-03) (“Because we hold that claims 80, 95, 144, and 145 of the ’516 patent are invalid for lack of written description, we need not address infringement or the other validity issues on appeal.”).
9. "Federal Circuit issues en banc opinion in Ariad v. Lilly,". Intellectual Asset Management. Retrieved April 4, 2010.