News & Analysis as of

Obviousness Hatch-Waxman Generic Drugs

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

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

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

Auxilium Pharms., Inc. v. FCB I LLC

Robins Kaplan LLP on

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

Robins Kaplan LLP

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

Robins Kaplan LLP on

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.

Robins Kaplan LLP on

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

McDermott Will & Emery

Polymorphic Patent Survives Obviousness Challenge

McDermott Will & Emery on

In a Hatch-Waxman case involving patents directed to a polymorphic compound for a treatment for polyneuropathic pain, the US Court of Appeals for the Federal Circuit affirmed a district court finding that a patent was not...more

Knobbe Martens

Federal Circuit Review - February 2019

Knobbe Martens on

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

Knobbe Martens

Amerigen Pharmaceuticals v. UCB Pharma GMBH

Knobbe Martens on

Federal Circuit Summary - Before Lourie, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: A generic pharmaceutical company had standing to appeal the Board’s decision in an IPR that claims of a...more

Knobbe Martens

Orexo AB, Orexo US Inc., v. Actavis Elizabeth LLC

Knobbe Martens on

Federal Circuit Summary - Before Newman, Hughes, and Stoll. Appeal from the United States District Court for the District of Delaware Summary: Objective indicia of nonobviousness cannot be dismissed merely because all...more

Robins Kaplan LLP

UCB, Inc. v. Accord Healthcare, Inc.

Robins Kaplan LLP on

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

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Merck v. Hospira, the only precedential case decided this week, a majority of the panel affirms a determination of obviousness, noting that despite the objective indicia supporting patentability, the claimed process was...more

McDonnell Boehnen Hulbert & Berghoff LLP

Galderma Laboratories, L.P. v. Tolmar, Inc. (Fed. Cir. 2013)

When does a prior art disclosure of a concentration range of a medicament render obvious the use of a species that falls within that range, when that same use was also known in the prior art? After all, common sense should...more

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