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Patents Sandoz Prescription Drugs

Hogan Lovells

Sandoz v Bayer: Ethical issues and determining obviousness for patents in the UK

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The English High Court has held that a patent relating to a once-daily dosing of an active ingredient was invalid for lack of inventive step over prior art posters presented to the public at conferences. The decision has been...more

Venable LLP

The First Prolia® / Xgeva® Biosimilar Approvals in the U.S.

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On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more

Robins Kaplan LLP

Amgen Inc. v. Sandoz Inc. Otezla® (Apremilast)

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Case Name: Amgen Inc. v. Sandoz Inc., Nos. 2022-1147, 2022-1149, 2022-1150, 2022-1151, 2023 WL 2994166 (Fed. Cir. Apr. 19, 2023) (Circuit Judges Lourie, Cunningham, and Stark presiding; Opinion by Lourie, J.) (Appeal from...more

Smart & Biggar

PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Refuses to Reconsider Its Panel Decision Finding No Common Ownership of Immunex’s Enbrel Patent

Last week, the Federal Circuit denied Sandoz’s petition for an en banc rehearing of its precedential July 1st panel decision upholding two of Immunex’s patents covering Enbrel®... ...more

Robins Kaplan LLP

Allergan Sales, LLC v. Sandoz. Inc.

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Case Name: Allergan Sales, LLC v. Sandoz. Inc., Nos. 2017-1499, 2017-1500, 2017-1558, 2017-1559, 2017 U.S. App. LEXIS 26312 (Fed. Cir. Dec. 22, 2017) (Circuit Judges Moore, Mayer, and Hughes presiding; Opinion by Hughes, J.)...more

Robins Kaplan LLP

Millennium Pharms., Inc. v. Sandoz Inc.

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Case Name: Millennium Pharms., Inc. v. Sandoz Inc., Nos. 2015-2066, 2016-1008, -1009, -1010, -1109, -1110, -1283, -1762, 2016 U.S. App. LEXIS 12702 (Fed. Cir. July 17, 2017) (Circuit Judges Newman, Mayer, and O’Malley...more

Robins Kaplan LLP

Teva Pharms. USA, Inc. v. Sandoz Inc.

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Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc., Civ. No. 17-275(FLW), 2017 U.S. Dist. LEXIS 78002 (D.N.J. May 23, 2017) (Wolfson, J.)....more

Mintz - Intellectual Property Viewpoints

Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more

BakerHostetler

The Federal Court Reverses a Hindsight Reconstruction of An Important Pharmaceutical Invention

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In Millennium Pharmaceuticals v. Sandoz, the Federal Circuit reversed the district court’s holding of obviousness of certain claims of Millennium-owned U.S. Patent No. 6,713,446 (the ‘446 patent), finding that the district...more

Robins Kaplan LLP

Allergan Sales, LLC v. Sandoz, Inc.

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Case Name: Allergan Sales, LLC v. Sandoz, Inc., No. 12-cv-207-JRG, 15-cv-347-JRG, 2016 U.S. Dist. LEXIS 135088 (E.D. Tex. Sept. 30, 2016) (Gilstrap, J.) - Drug Product and Patent(s)-in-Suit: Combigan® (brimonidine...more

Robins Kaplan LLP

Pfizer Inc. v. Sandoz Inc

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Case Name: Pfizer Inc. v. Sandoz Inc., C.A. No. 13-1110-GMS, 2016 U.S. Dist. LEXIS 52762 (D. Del. Apr. 20, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate); U.S. Patents Nos....more

Robins Kaplan LLP

Spectrum Pharms., Inc. v. Burwell

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Case Name: Spectrum Pharms., Inc. v. Burwell, No. 15-5166, 2016 U.S. App. LEXIS 10095 (D.C. Cir. June 3, 2016) (Circuit Judges Griffith, Cavanaugh, and Wilkins presiding; Opinion by Griffith) (Appeal from D.D.C., Lamberth,...more

Robins Kaplan LLP

Millennium Pharms., Inc. v. Sandoz Inc.

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Case Name: Millennium Pharms., Inc. v. Sandoz Inc., Civ. No. 12-1011-GMS (consolidated), 2015 U.S. Dist. LEXIS 110099 (D. Del. Aug. 20, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Velcade® (bortezomib); U.S....more

Robins Kaplan LLP

Merck Sharp & Dohme Corp. v. Sandoz Inc.

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Case Name: Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 3:12-cv-03289-PGS-LHG, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug. 27, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Emend® (fosaprepitant...more

K&L Gates LLP

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

K&L Gates LLP on

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

Robins Kaplan LLP

Allergan, Inc., v. Sandoz Inc.

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Case Name: Allergan, Inc., v. Sandoz Inc., Civ. No. 2014-1275, 2015 U.S. App. LEXIS 13616 (Fed. Cir. Aug. 4, 2015) (Circuit Judges Lourie, Linn, and Hughes presiding; Opinion by Lourie, J.) (Appeal from E.D. Tex., Schneider,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015)

Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more

Robins Kaplan LLP

Spectrum Pharms., Inc. v. Burwell

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Case Name: Spectrum Pharms., Inc. v. Burwell, Civ. No. 15-631 (RCL), 2015 U.S. Dist. LEXIS 73218 (D.D.C. May 27, 2015) (Lamberth, J.) - Drug Product and Patent(s)-in-Suit: Fusilev® (levoleucovorin); N/A - Nature of...more

Robins Kaplan LLP

Insite Vision Inc. v. Sandoz, Inc.

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Case Name: Insite Vision Inc. v. Sandoz, Inc., 783 F.3d 853 (Fed. Cir. Apr. 9, 2015) (Circuit Judges Prost, Newman, and Linn presiding; Opinion by Linn, J.) (Appeal from D.N.J., Cooper, J.) - Drug Product and...more

McDonnell Boehnen Hulbert & Berghoff LLP

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

Mintz - ML Strategies

Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery...

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On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more

Foley & Lardner LLP

Biosimilars Can Sit Out Patent Dance, But May Have To Wait Out Second Exclusivity Period

Foley & Lardner LLP on

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Tackles Claim Construction Review under New Standard

The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.) - On June 18, 2015, the Federal Circuit handed down...more

McDermott Will & Emery

Motivation to Combine Reviewable for Clear Error - Insite Vision Inc. v. Sandoz, Inc.

Reviewing the district court’s framing of the obviousness inquiry and determination of no motivation to combine for clear error, the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s determination...more

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