Ariad v. Lilly
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''Ariad Pharmaceuticals et al. v. Eli Lilly and Company'', 598
F.3d The ''Federal Reporter'' () is a case law reporter in the United States that is published by West Publishing and a part of the National Reporter System. It begins with cases decided in 1880; pre-1880 cases were later retroactively compiled by We ...
1336 (Fed. Cir. 2010) (en banc), is a
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...
court case regarding accusations of infringement by Eli Lilly on held by
ARIAD Pharmaceuticals ARIAD Pharmaceuticals, Inc. was an American oncology company, now part of Takeda Oncology, which was founded in 1991 by Harvey J. Berger, M.D. and headquartered in Cambridge, Massachusetts. ARIAD engaged in the discovery, development, and commer ...
. 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 The Massachusetts Institute of Technology (MIT) is a private land-grant research university in Cambridge, Massachusetts. Established in 1861, MIT has played a key role in the development of modern technology and science, and is one of the ...
(MIT),
Harvard Harvard University is a private Ivy League research university in Cambridge, Massachusetts. Founded in 1636 as Harvard College and named for its first benefactor, the Puritan clergyman John Harvard, it is the oldest institution of higher le ...
, and the
Whitehead Institute Whitehead Institute for Biomedical Research is a non-profit research institute located in Cambridge, Massachusetts, United States that is dedicated to improving human health through basic biomedical research. It was founded as a fiscally indepen ...
. Nuclear factor-kappa B (NF-kappaB) is a
transcription factor In molecular biology, a transcription factor (TF) (or sequence-specific DNA-binding factor) is a protein that controls the rate of transcription of genetic information from DNA to messenger RNA, by binding to a specific DNA sequence. The fu ...
that plays a critical role in many cell functions including embryonic and neuronal development, cell proliferation, apoptosis, and immune responses to infection and inflammation. 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 Raloxifene, sold under the brand name Evista among others, is a medication used to prevent and treat osteoporosis in postmenopausal women and those on glucocorticoids. For osteoporosis it is less preferred than bisphosphonates. It is also used t ...
and Xigris which inhibit NF-κB production. 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. As a
transcription factor In molecular biology, a transcription factor (TF) (or sequence-specific DNA-binding factor) is a protein that controls the rate of transcription of genetic information from DNA to messenger RNA, by binding to a specific DNA sequence. The fu ...
, 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. 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.


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

Ariad moved for a rehearing '' en banc. The ''en banc'' Federal Circuit order 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 The United States Court of Appeals for the Federal Circuit (in case citations, Fed. Cir. or C.A.F.C.) is a United States court of appeals that has special appellate jurisdiction over certain types of specialized cases in the Federal judiciary of ...
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. 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.


References


External links

* * {{DEFAULTSORT:Ariad V. Lilly Eli Lilly and Company United States Court of Appeals for the Federal Circuit cases United States biotechnology case law United States patent case law 2010 in United States case law