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No. 71 OPINION filed for the court by Lourie, Circuit Judge; Chen, Circuit Judge and Cunningham, Circuit ...

Document Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., 22-2153, No. 71 (Fed. Cir. Apr. 11, 2024)
IRENA ROYZMAN, Kramer Levin Naftalis & Frankel LLP, New York, NY, for amici curiae Regeneron Pharma- ceuticals, Inc., Ocular Therapeutix, Inc. Also represented by CHRISTINE WILLGOOS; PAUL BRZYSKI, Washington, DC.
Rather, it contends that even if the asserted combination of refer- ences effectively discloses the claimed 1,650 mg/day dos- age, there remains insufficient evidence to support a finding of a reasonable expectation of success in using that particular dosage amount.
Although we have rejected the idea that “efficacy data [are] always required for a reasonable expectation of suc- cess,” OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375, 1385 (Fed. Cir. 2019), we are hesitant to conclude as a gen- eral matter that the disclosure of a Phase II clinical trial SALIX PHARMACEUTICALS, LTD. v.
In Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966), the Supreme Court set forth the background against which obviousness is to be assessed: “Under § 103, the scope and content of the prior art are to be determined” SALIX PHARMACEUTICALS, LTD. v.
The court noted that “[i]t is not a simple matter to determine whether an ANDA applicant has successfully carved out language from a label to turn infringement into non-infringement” and that what Norwich sought in its Rule 60(b) motion “would essentially be a second litigation” following final judgment.
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Conformis, Inc. v. Medacta USA, Inc.

Docket 1:19-cv-01528, Delaware District Court (Aug. 15, 2019)
Judge Richard G. Andrews, presiding
Patent
DivisionWilmington
FlagsCLOSED, LEAD, PATENT
Cause35:271 Patent Infringement
Case Type830 Patent
Tags830 Patent, 830 Patent
Plaintiff Conformis, Inc.
Defendant Zimmer Biomet Holdings, Inc.
Defendant Zimmer, Inc.
...
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NantKwest, Inc. et al v. Merck KGaA et al

Docket 3:19-cv-01266, California Southern District Court (July 10, 2019)
Judge M. James Lorenz, presiding, Magistrate Judge Michael S. Berg
Contract - Other
DivisionSan Diego
Flags., SEALDC
Cause28:1332jd Diversity-Declaratory Judgement
Case Type190 Contract - Other
Tags190 Contract, Contract, Civil, Other, 190 Contract, Contract, Civil, Other
Plaintiff NantKwest, Inc.
Plaintiff Brink Biologics, Inc.
Defendant Merck KGaA
...
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No. 54 Judgment

Document Baxalta Incorporated v. Genentech, Inc., 22-1461, No. 54 (Fed. Cir. Sep. 20, 2023)
Motion for Judgment
United States Court of Appeals for the Federal Circuit
Appeal from the United States District Court for the District of Delaware in No. 1:17-cv-00509-TBD, Circuit Judge Timothy B. Dyk.
THIS CAUSE having been considered, it is
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No. 53 Opinion

Document Baxalta Incorporated v. Genentech, Inc., 22-1461, No. 53 (Fed. Cir. Sep. 20, 2023)
Using routine techniques, the inventors screened the candidate antibodies from the four fusion experiments to determine whether the antibod- ies bind to Factor IX/IXa and increase procoagulant activ- ity, as claimed.
As the Supreme Court recently reaffirmed in Amgen Inc. v. Sanofi, “the specification must enable the full scope of the invention as defined by its claims,” allowing for “a reasonable amount of experimentation.” 598 U.S. 594, 610–12 (2023).
The Court rea- soned Amgen’s roadmap “merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies—calling on scientists to create a wide range of candidate antibodies and then screen each to see” which practice the claims.
In an attempt to distinguish Amgen, Baxalta argues the hybridoma-and-screening process disclosed in the ’590 patent does not require trial and error but instead predict- ably and reliably generates new claimed antibodies every time it is performed.
We do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors.4 In light of the foregoing, we hold the ’590 patent fails to teach skilled artisans how to make and use the full scope of claimed antibodies without unreasonable
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Precedential OPINION

Document Baxalta Incorporated v. Genentech, Inc., 22-1461 (Fed. Cir. Sep. 20, 2023)
Using routine techniques, the inventors screened the candidate antibodies from the four fusion experiments to determine whether the antibod- ies bind to Factor IX/IXa and increase procoagulant activ- ity, as claimed.
As the Supreme Court recently reaffirmed in Amgen Inc. v. Sanofi, “the specification must enable the full scope of the invention as defined by its claims,” allowing for “a reasonable amount of experimentation.” 598 U.S. 594, 610–12 (2023).
The Court rea- soned Amgen’s roadmap “merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies—calling on scientists to create a wide range of candidate antibodies and then screen each to see” which practice the claims.
In an attempt to distinguish Amgen, Baxalta argues the hybridoma-and-screening process disclosed in the ’590 patent does not require trial and error but instead predict- ably and reliably generates new claimed antibodies every time it is performed.
We do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors.4 In light of the foregoing, we hold the ’590 patent fails to teach skilled artisans how to make and use the full scope of claimed antibodies without unreasonable
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General Electric Company et al v. Lighting Science Group Corporation

Docket 1:19-cv-05365, New York Southern District Court (June 7, 2019)
Judge Denise L. Cote, presiding
Patent
DivisionFoley Square
FlagsCLOSED, ECF, PATENT-PILOT
Cause35:0001 Establishment of PTO
Case Type830 Patent
Tags830 Patent, 830 Patent
Plaintiff General Electric Company
Plaintiff Consumer Lighting (U.S.), LLC
Plaintiff Current Lighting Solutions, LLC
...
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Gentex Corporation v. Galvion Ltd., et al.

Docket 1:19-cv-00921, Delaware District Court (May 17, 2019)
Judge Maryellen Noreika, presiding
Patent
DivisionWilmington
FlagsCLOSED, PATENT
Cause35:1 Patent Infringement
Case Type830 Patent
Tags830 Patent, 830 Patent
Plaintiff Gentex Corporation
Defendant Galvion Ltd.
Defendant Galvion Inc.
...
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Lighting Science Group Corp. v. General Electric Company et al

Docket 1:19-cv-00806, Delaware District Court (May 1, 2019)
Judge Leonard P. Stark, presiding.
Patent

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In re Ex Parte Application of Kokusai Electric Corporation

Docket 3:19-mc-80056, California Northern District Court (March 5, 2019)
Magistrate Judge Elizabeth D. Laporte, presiding.
Statutory Actions - Other

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Vestcom New Century LLC v. I.D. Images LLC et al

Docket 1:19-cv-00600, Illinois Northern District Court (Jan. 29, 2019)
Honorable Harry D. Leinenweber, presiding.
Patent

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No. 39

Document Baxalta Incorporated v. Genentech, Inc., 22-1461, No. 39 (Fed. Cir. Feb. 8, 2023)

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Hewlett Packard Enterprise Company v. Chrimar Systems, Inc.

Docket IPR2019-00033, Patent Trial and Appeal Board (Oct. 4, 2018)

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No. 15

Document Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., 23-1952, No. 15 (Fed. Cir. Dec. 16, 2024)

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No. 21

Document Baxalta Incorporated v. Genentech, Inc., 22-1461, No. 21 (Fed. Cir. Sep. 15, 2022)

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