News & Analysis as of

Obviousness Hatch-Waxman Patent Litigation

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 18th, 2:00 pm PDT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 12th, 12:00 pm GMT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Fish & Richardson

Middle District of North Carolina Finds Public Interest Favors Granting Preliminary Injunction

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On December 27, 2023, Chief Judge Catherine Eagles of the U.S. District Court for the Middle District of North Carolina granted a motion for preliminary injunction by Natera Inc. enjoining NeoGenomics Laboratories Inc. from...more

Akin Gump Strauss Hauer & Feld LLP

In Wake of In re Cellect, District Court Interprets Safe Harbor Statute and Finds Patent Not Invalid for Obviousness-Type Double...

The District Court for the District of Delaware recently held on summary judgment that a patent with 2,295 days of combined patent term adjustment (PTA) and patent term extension (PTE) was not invalid for obviousness-type...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

Robins Kaplan LLP

Tris Pharma, Inc. V. Teva Pharms. Usa, Inc., Quillichew Er® (Methylphenidate)

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Case Name: Tris Pharma, Inc. v. Teva Pharms. USA, Inc., Civ. No. 20-5212 (KM)(ESK) (D.N.J. Aug. 16, 2022) (McNulty, J.)  Drug Product and Patent(s)-in-Suit: QuilliChew ER® (methylphenidate); U.S. Patents Nos. 9,545,399 (“the...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

Akin Gump Strauss Hauer & Feld LLP

Discussion of Inventors’ Path in Expert’s Obviousness Opinion Warrants Partial Exclusion in Bench Trial

In the weeks preceding a recent Hatch-Waxman bench trial, a district court excluded portions of an expert’s opinion on obviousness that addressed internal documents and inventor testimony concerning the “inventors’ path” to...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

Haug Partners LLP

No Clear Error to Find Lack of Written Description for a Method of Treatment Patent Despite Separate Disclosures of the Drug,...

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Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....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

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...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

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Reverses District Court Anticipation Decision Combining Two Prior Art References

The Federal Circuit reversed a decision from the District Court for the District of Delaware invalidating three patents on anticipation grounds, finding the district court improperly relied on disclosures from multiple...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

Robins Kaplan LLP

Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc.

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PLAINTIFF’S DISCLAIMER OF CLAIMS FOUND INVALID BY THE PTAB MOOTED ANY CONTROVERSY BEFORE THE APPELLATE COURT ASSOCIATED WITH THAT PATENT, AND A SECOND PATENT-IN-SUIT WAS NOT INVALID BECAUSE THE DISTRICT COURT DID NOT ERR IN...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2019 #3

PATENT CASE OF THE WEEK - Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories, FL, Inc., Appeal No. 2018-1221 (Fed. Cir. Aug. 15, 2019) - This week’s Case of the Week focuses on issues relating to written...more

Jones Day

Polymorph Patent Not Invalid as Obvious

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The Federal Circuit upholds the validity of a patent covering a polymorphic form of a chemical compound. The United States Court of Appeals for the Federal Circuit recently held in Grünenthal Gmbh v. Alkem Labs. Ltd. that...more

Knobbe Martens

Federal Circuit Review - February 2019

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PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more

Robins Kaplan LLP

UCB, Inc. v. Accord Healthcare, Inc.

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Case Name: UCB, Inc. v. Accord Healthcare, Inc., Fed. Cir. Nos. 2016-2610, 2016-2683, 2016-2685, 2016-2698, 2016-2710, 2017-1001 (Fed. Cir. May 23, 2018) (Circuit Judges Prost, Bryson, and Stoll presiding; Opinion by Stoll,...more

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