News & Analysis as of

Life Sciences Obviousness Hatch-Waxman

Axinn, Veltrop & Harkrider LLP

Vanda Swings for the Fences and Asks the Supreme Court to Heighten the Standard for Obviousness

Among the most established standards in patent law is that obviousness requires a motivation to combine the prior art with “a reasonable expectation of success.” The Federal Circuit alone has employed the “reasonable...more

Robins Kaplan LLP

Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd.,

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Case Name:  Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., No. CV 20-5426 (SRC), 2022 WL 17352334 (D.N.J. Dec. 1, 2022) (Chesler, J.)  Drug Products and Patent(s)-in-Suit: Duobrii® (halobetasol...more

Robins Kaplan LLP

Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc.

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Case Name: Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., No. 20-8966 (SRC), 2022 WL 17959811 (D.N.J. Dec. 27, 2022) (Chesler, J.) Drug Product and Patent(s)-in-Suit: Vyvanse® (1-lysine-d-amphetamine dimesylate); U.S....more

Robins Kaplan LLP

Arius Two, Inc. v. Alvogen PB Rsch. & Dev. LLC - Belbuca® (Buprenorphine)

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Case Name: Arius Two, Inc. v. Alvogen PB Rsch. & Dev. LLC, No. 2022-1394, 2022 WL 17828352 (Fed. Cir. Dec. 21, 2022) (Circuit Judges Chen, Clevenger, and Cunningham presiding; Opinion by Chen, J.) (Appeal from D. Del.,...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

Robins Kaplan LLP

Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc. Narcan® (Naloxone)

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Case Name: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 2020-2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022) (Circuit Judges Newman, Prost, and Stoll presiding; Opinion by Stoll, J.; Dissenting Opinion by...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.

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Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 18-cv-734, 2021 WL 5323737 (D.N.J. Nov. 16, 2021) (Cecchi, J.)  Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms., Inc.,

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Case Name: AstraZeneca AB v. Mylan Pharms., Inc., No. 2021-1729, 2021 WL 5816742 (Fed. Cir. Dec. 8, 2021) (Circuit Judges Taranto, Hughes, and Stoll presiding; Opinion by Stoll, J.; Opinion dissenting in part by Taranto, J.)...more

Robins Kaplan LLP

Auxilium Pharms., Inc. v. FCB I LLC

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Case Name: Auxilium Pharms., Inc. v. FCB I LLC, Civ. No. 20-16456, 2021 WL 2802537 (D.N.J. July 6, 2021) (Vazquez, J.) - Drug Product and Patent(s)-in-Suit: Testim® (testosterone gel); U.S. Patents Nos. 7,320,968 (“the ’968...more

Robins Kaplan LLP

Valeant Pharms Int’l, Inc. v. Mylan Pharms Inc.

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BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more

Robins Kaplan LLP

HZNP Medicines LLC v. Actavis Labs. UT, Inc.

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THE DISTRICT COURT’S FINDINGS REGARDING INDEFINITENESS, NON-INFRINGEMENT, AND NON-OBVIOUSNESS WERE AFFIRMED BY THE APPELLATE COURT. Case Name: HZNP Medicines LLC v. Actavis Labs. UT, Inc., No. 2017-2149, -2152, -2153,...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for December 2018?

This month we highlight two Federal Circuit obviousness-type double patenting decisions. CASES - Federal Circuit - Section 156 Patent Term Extension and Obviousness-Type Double Patenting - Novartis AG v. Ezra...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for August 2018?

This month we highlight a district court opinion from Judge Dyk, sitting by designation, denying a preliminary injunction in a brand-vs-brand litigation, and a lengthy district court opinion from Judge Bryson, sitting by...more

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