Ariad Pharmaceuticals et al. v. Eli Lilly and Company, 598 F.3d 1336 (Fed. Cir. 2010)[1] (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 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.[2] 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.[3]
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.[4] 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.[3] 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 Lillyedit
On appeal, a three-member panel of the Federal Circuit overturned the lower court ruling, and invalidated the '516 patent.[5] The basis of the ruling was that the '516 patent did not have a sufficient "written description" of the patented invention.[6]
Federal Circuit's en banc hearing again holds for Eli Lillyedit
Ariad moved for a rehearing en banc'.[7] The en banc Federal Circuit order[8] 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.[9][10] 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.[11]
Referencesedit
^Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010).
^Miller SC, Huang R, Sakamuru S, Shukla SJ, Atten-Rmaos MS, Shinn P, Van leer D, Leister W, Austin CP, Xia M (May 1, 2010). "Identification of known drugs that act as inhibitors of NF-kappaB signaling and their mechanism of action". Biochem. Pharmacol. 79 (9): 1272–80. doi:10.1016/j.bcp.2009.12.021. PMC2834878. PMID 20067776.
^ ab"A license to print money?". Nat. Biotechnol. 24 (6): 593. June 2006. doi:10.1038/nbt0606-593. PMID 16763570.
^Holman, Chris (March 23, 2010). "Pragmatism". Holman's Biotech IP Blog.
^Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 560 F.3d 1336 (Fed. Cir. 2009).
^"Brief video commentary on "written description" patent requirement case". Washington Legal Foundation. May 4, 2010.
^Ariad v. Lilly: Federal Circuit Grants En Banc Request to Challenge Written Description Requirement
^Order per curiam, available at, (PDF). Archived from the original (PDF) on May 27, 2010. Retrieved December 18, 2009.{{cite web}}: CS1 maint: archived copy as title (link)
^"Eli Lilly Wins Appeal in Patent Case". The New York Times. April 3, 2009. from the original on September 27, 2015. Retrieved April 5, 2009.
^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.").
^. Intellectual Asset Management. Archived from the original on March 1, 2014. Retrieved April 4, 2010.
External linksedit
Text of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 560 F.3d 1366 (Fed. Cir. 2009) (panel opinion) is available from:CourtListenerFindlawLeagleGoogle Scholar
Text of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc opinion) is available from:CourtListenerLeagleGoogle Scholar
March 14, 2024
ariad, pharmaceuticals, lilly, ariad, pharmaceuticals, lilly, company, 1336, 2010, banc, united, states, court, case, regarding, accusations, infringement, lilly, patent, held, ariad, pharmaceuticals, federal, circuit, ruled, banc, invalidate, patent, lack, su. Ariad Pharmaceuticals et al v Eli Lilly and Company 598 F 3d 1336 Fed Cir 2010 1 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 Ariad Pharmaceuticals Inc v Eli Lilly amp Co CourtUnited States Court of Appeals for the Federal CircuitFull case nameAriad Pharmaceuticals Inc v Eli Lilly amp Co DecidedMarch 22 2010Citation s Panel Opinion 560 F 3d 1366 90 U S P Q 2d 1549 Fed Cir 2009 En banc Opinion 598 F 3d 1336 94 U S P Q 2d 1161Case historyPrior history529 F Supp 2d 106 D Mass 2007 Court membershipJudge s sittingPaul Redmond Michel Alan David Lourie Pauline Newman Haldane Robert Mayer William Curtis Bryson Arthur J Gajarsa Timothy B Dyk Sharon Prost Kimberly Ann Moore Randall Ray Rader Richard LinnCase opinionsMajorityPanel Moore joined by Prost LinnMajorityEn banc Lourie joined by Michel Newman Mayer Bryson Gajarsa Dyk Prost MooreConcurrencePanel LinnConcurrenceEn banc NewmanConcurrenceEn banc GajarsaConcur dissentEn banc Rader joined by LinnConcur dissentEn banc Linn joined by Rader Contents 1 The 516 patent at issue 2 Federal Circuit three member panel appellate ruling for Eli Lilly 3 Federal Circuit s en banc hearing again holds for Eli Lilly 4 References 5 External linksThe 516 patent at issue editThe 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 2 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 kB production 3 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 4 As a transcription factor NF kB regulates over 300 genes and NF kB controlled pathways are relevant to many human diseases As many as 200 marketed drugs have mechanisms of action that may affect the NF kB pathway 3 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 editOn appeal a three member panel of the Federal Circuit overturned the lower court ruling and invalidated the 516 patent 5 The basis of the ruling was that the 516 patent did not have a sufficient written description of the patented invention 6 Federal Circuit s en banc hearing again holds for Eli Lilly editAriad moved for a rehearing en banc 7 The en banc Federal Circuit order 8 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 9 10 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 11 References edit Ariad Pharmaceuticals Inc v Eli Lilly amp Co 598 F 3d 1336 Fed Cir 2010 Miller SC Huang R Sakamuru S Shukla SJ Atten Rmaos MS Shinn P Van leer D Leister W Austin CP Xia M May 1 2010 Identification of known drugs that act as inhibitors of NF kappaB signaling and their mechanism of action Biochem Pharmacol 79 9 1272 80 doi 10 1016 j bcp 2009 12 021 PMC 2834878 PMID 20067776 a b A license to print money Nat Biotechnol 24 6 593 June 2006 doi 10 1038 nbt0606 593 PMID 16763570 Holman Chris March 23 2010 Pragmatism Holman s Biotech IP Blog Ariad Pharmaceuticals Inc v Eli Lilly amp Co 560 F 3d 1336 Fed Cir 2009 Brief video commentary on written description patent requirement case Washington Legal Foundation May 4 2010 Ariad v Lilly Federal Circuit Grants En Banc Request to Challenge Written Description Requirement Order per curiam available at Archived copy PDF Archived from the original PDF on May 27 2010 Retrieved December 18 2009 a href Template Cite web html title Template Cite web cite web a CS1 maint archived copy as title link Eli Lilly Wins Appeal in Patent Case The New York Times April 3 2009 Archived from the original on September 27 2015 Retrieved April 5 2009 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 Federal Circuit issues en banc opinion in Ariad v Lilly Intellectual Asset Management Archived from the original on March 1 2014 Retrieved April 4 2010 External links editText of Ariad Pharmaceuticals Inc v Eli Lilly amp Co 560 F 3d 1366 Fed Cir 2009 panel opinion is available from CourtListener Findlaw Leagle Google Scholar Text of Ariad Pharmaceuticals Inc v Eli Lilly amp Co 598 F 3d 1336 Fed Cir 2010 en banc opinion is available from CourtListener Leagle Google Scholar Retrieved from https en wikipedia org w index php title Ariad Pharmaceuticals Inc v Eli Lilly 26 Co amp oldid 1175138534, wikipedia, wiki, book, books, library,
