Ariad v. Lilly
Encyclopedia
Ariad v. Lilly is a United States
court case in which Eli Lilly
was found to have infringe
d 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.
The case is controversial because the scope of Ariad's patent's claim
s 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. The en banc Federal Circuit order 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.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
court case in which Eli Lilly
Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States...
was found to have infringe
Patent infringement
Patent infringement is the commission of a prohibited act with respect to a patented invention without permission from the patent holder. Permission may typically be granted in the form of a license. The definition of patent infringement may vary by jurisdiction, but it typically includes using or...
d held by Ariad Pharmaceuticals (licensed from Massachusetts Institute of Technology
Massachusetts Institute of Technology
The Massachusetts Institute of Technology is a private research university located in Cambridge, Massachusetts. MIT has five schools and one college, containing a total of 32 academic departments, with a strong emphasis on scientific and technological education and research.Founded in 1861 in...
(MIT), Harvard, and the Whitehead Institute
Whitehead Institute
Founded in 1982, the Whitehead Institute for Biomedical Research is a non-profit research and teaching institution located in Cambridge, Massachusetts, USA....
). 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
Enzyme inhibitor
An enzyme inhibitor is a molecule that binds to enzymes and decreases their activity. Since blocking an enzyme's activity can kill a pathogen or correct a metabolic imbalance, many drugs are enzyme inhibitors. They are also used as herbicides and pesticides...
NF-κB.
The case is controversial because the scope of Ariad's patent's claim
Claim (patent)
Patent claims are the part of a patent or patent application that defines the scope of protection granted by the patent. The claims define, in technical terms, the extent of the protection conferred by a patent, or the protection sought in a patent application...
s 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. The en banc Federal Circuit order 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.