Ariad v. Lilly

Ariad v. Lilly is a United States court case in which Eli Lilly was found to have infringed U.S. Patent 6,410,516 held by Ariad Pharmaceuticals (licensed from Massachusetts Institute of Technology (MIT), Harvard, and the Whitehead Institute). 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.[1]

The case is controversial because the scope of Ariad's patent's claims is viewed by some as going far beyond what is enabled in the patent. 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.

The Federal Circuit has granted Ariad's motion for a rehearing en banc.[2] The en banc Federal Circuit order[3] certifies two questions to be resolved: a. Whether 35 U.S.C. Sec, 112, paragraph 1, contains a written description requirement separate from an enablement requirement? and b. 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 threw out the verdict against Eli Lilly by ruling that the Ariad patent was invalid because it had failed to adequately describe the invention or explain how others could replicate its work.[4][5]

References

  1. ^ "A license to print money?". Nat. Biotechnol. 24 (6): 593. June 2006. doi:10.1038/nbt0606-593. PMID 16763570. 
  2. ^ Ariad v. Lilly: Federal Circuit Grants En Banc Request to Challenge Written Description Requirement, http://www.patentlyo.com/patent/2009/08/ariad-v-lilly-federal-circuit-grants-en-banc-request-to-challenge-written-description-requirement.html
  3. ^ Order per curiam, available at, http://www.cafc.uscourts.gov/opinions/08-1248ebo.pdf
  4. ^ "Eli Lilly Wins Appeal in Patent Case". NYTimes.com. 2009-04-03. http://www.nytimes.com/2009/04/04/business/04drug.html. Retrieved 2009-04-05. 
  5. ^ 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, 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.”).