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Obviousness Appeals Pharmaceutical Industry

White & Case LLP

Federal Circuit Limits the Application of Obviousness-Type Double Patenting for Patents in the Same Family

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On August 13, 2024, a three-judge panel of the Court of Appeals for the Federal Circuit issued a decision, authored by Judge Lourie, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the...more

Goodwin

The Appeals Review Panel’s In Re Xencor Decision: The USPTO Provides Its Position on Written Description and Means-Plus-Function...

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On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more

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

Mind Your Ps and Qs, and Your PTAs Too

Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more

Smart & Biggar

Federal Court of Appeal upholds invalidity of fampridine patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Biogen and a cross-appeal by Taro from a decision of the Federal Court... dismissing two actions by Biogen under the Patented Medicines (Notice of Compliance)...more

Knobbe Martens

Identical Elements Are Not Required for the Presumption of Obviousness Based on Overlapping Ranges

Knobbe Martens on

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC - Before Lourie, Chen, and Cunningham. Appeal from the Patent Trial and Appeal Board. Summary: Presumption of obviousness based on overlapping ranges applied where a...more

Smart & Biggar

Federal Court of Appeal upholds decision finding Seedlings' LifeCard patent invalid and not infringed by Pfizer’s EpiPen

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On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedling’s appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings' LifeCard...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

Goodwin on

On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

McDermott Will & Emery

Equivalent Disclosure Used to Satisfy Written Description Requirement

McDermott Will & Emery on

Invoking a newly minted equivalent disclosure doctrine, a panel of the US Court of Appeals for the Federal Circuit found that the written description requirement of § 112 was satisfied in the interest of arriving at a...more

Knobbe Martens

A “Substantially Equivalent” Disclosure May Satisfy the Written Description Requirement

Knobbe Martens on

NALPROPION PHARMACEUTICALS, INC. v. ACTAVIS LABORATORIES FL, INC. Before Prost, Lourie and Wallach. Appeal from the U.S. District Court for the District of Delaware. Summary: A “substantially equivalent” disclosure may...more

Alston & Bird

Patent Case Summaries

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A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board....more

Knobbe Martens

Grunenthal GMBH v. Alkem Laboratories Limited

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Before Judges Reyna, Taranto, and Chen. Appeal from the U.S. District Court for the District of New Jersey. Summary: There may be no reasonable expectation of success in producing a specific polymorph of a compound when...more

Smart & Biggar

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal

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As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (ODV) succinate products (Pfizer’s PRISTIQ) until expiry of...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Decision Clarifies When an ANDA Filer May Appeal an Adverse IPR Ruling

In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...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

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

Smart & Biggar

Rx IP Update - August 2018

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Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed - On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Schwabe, Williamson & Wyatt PC

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

In Sanofi v. Watson Labs., the Circuit affirms a determination of induced infringement of one patent and direct infringement of another, thus assuring Sanofi another 12 years of exclusivity as to its Multaq® atrial...more

Schwabe, Williamson & Wyatt PC

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

In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more

Foley & Lardner LLP

Court Rejects Theory Of Derivation Based On FDA Requirement

Foley & Lardner LLP on

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more

Smart & Biggar

RX IP Update - January 2017

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Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more

Smart & Biggar

Rx IP Update - November 2016

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Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genzyme Petitions Federal Circuit for Rehearing in Genzyme Therapeutic Products, Inc. v. Biomarin Pharmaceutical, Inc.

Many of the complaints from patent holders over the PTO's inter partes review process under the Leahy-Smith America Invents Act (codified in pertinent part at 35 U.S.C. §§ 311-319) stem from how the Office has implemented...more

McDermott Will & Emery

The Doctrine of Obviousness-Type Double Patenting Maintains Its Vitality

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Abbvie Inc. v. Kennedy Institute of Rheumatology Trust - Addressing whether the doctrine of obviousness-type double patenting is still viable, and, if so, whether it served to invalidate a later-issued and expiring...more

McDermott Will & Emery

A Compound Is Obvious Where Only Minor Changes to a Prior Art “Lead Compound” Are Required to Make the Claimed Compound

Bristol-Myers Squibb Co. v. Teva Pharms USA, Inc. - Addressing the obviousness of a claimed compound where a person of skill would need to make only minor changes to a lead compound to arrive at the claimed invention,...more

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