727:
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
683:
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
648:
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
1020: (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.").
732:, 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
692:
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.
1143:
119:
624:
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.
1013:
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
724:
40:
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ruling thus is in keeping with earlier
Federal Circuit opinions on written descriptions, but ultimately its effect on biotechnology patents remains unclear.
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Text of Ariad
Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc opinion) is available from:
864:
1063:
1138:
1059:
Text of Ariad
Pharmaceuticals, Inc. v. Eli Lilly & Co., 560 F.3d 1366 (Fed. Cir. 2009) (panel opinion) is available from:
613:
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explain how others could replicate its work. Judge Rader in dissent felt that a lack of a more traditional patent concept,
719:
If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
716:
Whether 35 U.S.C. Sec, 112, paragraph 1, contains a written description requirement separate from an enablement requirement?
771:
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).
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On May 4, 2006, Lilly was ordered to pay ~$ 65 million in back royalties, and 2.3% royalties on future sales of the drugs
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773:"Identification of known drugs that act as inhibitors of NF-kappaB signaling and their mechanism of action"
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The lower court's opinion was controversial because many commentators felt that the scope of Ariad's
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Ariad v. Lilly: Federal
Circuit Grants En Banc Request to Challenge Written Description Requirement
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extremely detailed and precise description of the action embodiment of the invention itself.
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osteoporosis and prevention of breast cancer, and Xigirs(r) for the treatment of sepsis.
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Federal
Circuit order certified two narrow questions to be resolved by the appeal:
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Lourie, joined by Michel, Newman, Mayer, Bryson, Gajarsa, Dyk, Prost, Moore
901:"Brief video commentary on "written description" patent requirement case"
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Federal
Circuit three-member panel appellate ruling for Eli Lilly
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United States Court of
Appeals for the Federal Circuit cases
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Federal Circuit's en banc hearing again holds for Eli Lilly
1031:"Federal Circuit issues en banc opinion in Ariad v. Lilly"
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725:
United States Court of Appeals for the Federal Circuit
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United States Court of Appeals for the Federal Circuit
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Ariad Pharmaceuticals et al. v. Eli Lilly and Company
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court case regarding accusations of infringement by
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883:Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.
754:Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.
51:Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.
32:Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.
1033:. Intellectual Asset Management. Archived from
350:Patentability requirements and related concepts
818:
816:
562:
8:
903:. Washington Legal Foundation. May 4, 2010.
644:. Nuclear factor-kappa B (NF-kappaB) is a
632:The '516 patent was licensed by Ariad from
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993:from the original on September 27, 2015
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981:"Eli Lilly Wins Appeal in Patent Case"
965:: CS1 maint: archived copy as title (
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590:1336 (Fed. Cir. 2010) (en banc), is a
634:Massachusetts Institute of Technology
7:
1149:United States biotechnology case law
671:went far beyond what was covered or
373:Inventive step and non-obviousness
25:
627:
863:Holman, Chris (March 23, 2010).
612:to invalidate the patent for a
1159:2010 in United States case law
614:lack of sufficient description
1:
1154:United States patent case law
701:Ariad moved for a rehearing
608:. The Federal Circuit ruled
422:By region / country
193:Moore, joined by Prost, Linn
824:"A license to print money?"
675:in the patent itself. As a
1175:
890: (Fed. Cir. 2009).
761: (Fed. Cir. 2010).
479:By specific subject matter
789:10.1016/j.bcp.2009.12.021
430:Patent Cooperation Treaty
409:Sufficiency of disclosure
388:Person skilled in the art
358:Patentable subject matter
869:Holman's Biotech IP Blog
628:The '516 patent at issue
401:Other legal requirements
378:Industrial applicability
1139:Eli Lilly and Company
888:560 F.3d 1336
834:(6): 593. June 2006.
759:598 F.3d 1336
723:On 3 April 2009, the
606:ARIAD Pharmaceuticals
601:U.S. patent 6,410,516
259:Linn, joined by Rader
248:Rader, joined by Linn
152:William Curtis Bryson
82:1549 (Fed. Cir. 2009)
677:transcription factor
646:transcription factor
148:Haldane Robert Mayer
841:10.1038/nbt0606-593
642:Whitehead Institute
616:of the invention.
309:Procedural concepts
136:Paul Redmond Michel
986:The New York Times
777:Biochem. Pharmacol
664:NF-κB production.
414:Unity of invention
168:Kimberly Ann Moore
989:. April 3, 2009.
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172:Randall Ray Rader
156:Arthur J. Gajarsa
140:Alan David Lourie
16:(Redirected from
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783:(9): 1272–80.
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1039:. Retrieved
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995:. Retrieved
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949:. Retrieved
942:the original
930:available at
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865:"Pragmatism"
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342:Infringement
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176:Richard Linn
164:Sharon Prost
103:Case history
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620:before the
466:Netherlands
322:Prosecution
317:Application
231:Concurrence
220:Concurrence
209:Concurrence
113:F. Supp. 2d
1133:Categories
926:per curiam
740:References
730:enablement
640:, and the
487:Biological
327:Opposition
268:Patent law
96:U.S.P.Q.2d
80:U.S.P.Q.2d
1018:2008-1248
596:Eli Lilly
502:Insurance
436:Australia
393:Prior art
337:Licensing
332:Valuation
301:Criticism
296:Economics
273:Overviews
65:Citations
1041:April 4,
997:April 5,
991:Archived
961:cite web
850:16763570
807:20067776
604:held by
543:Glossary
538:Category
520:See also
507:Software
497:Chemical
257:En banc:
246:En banc:
235:En banc:
224:En banc:
202:En banc:
198:Majority
187:Majority
120:D. Mass.
1073:Findlaw
798:2834878
710:en banc
708:. The
704:en banc
673:enabled
662:inhibit
638:Harvard
636:(MIT),
622:en banc
610:en banc
456:Germany
383:Utility
368:Novelty
291:History
237:Gajarsa
57:Decided
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1016:,
924:Order
886:,
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757:,
660:which
658:Xigris
654:Evista
586:, 598
451:Europe
441:Canada
281:Patent
226:Newman
213:Panel:
191:Panel:
945:(PDF)
938:(PDF)
734:Ariad
681:NF-κB
461:Japan
446:China
432:(PCT)
122:2007)
94:; 94
78:; 90
37:Court
1043:2010
999:2009
967:link
953:2009
846:PMID
803:PMID
656:and
588:F.3d
215:Linn
111:529
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89:F.3d
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598:on
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