News & Analysis as of

Inter Partes Review (IPR) Proceeding Patent Litigation Abbreviated New Drug Application (ANDA)

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Actavis Labs. FL, Inc. v. United States

Actavis Labs. FL, Inc. v. United States, Appeal No. 2023-1320 (Fed. Cir. Mar. 21, 2025) Our Case of the Week, in the words of its author, Circuit Judge Stark, “is not actually a patent case. It is, instead, a tax case.” In...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2024 #3

CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024) In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries

We are excited to share Sheppard Mullin’s inaugural quarterly report on key Federal Circuit decisions. The Spring 2023 Quarterly Report provides summaries of most key patent law-related decisions from January 1, 2023 to March...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Generic Restasis

On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan's RESTASIS® (Cyclosporine Ophthalmic Emulsion 0.05%) product for treatment of chronic dry eye. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc. (Fed. Cir. 2021)

There are some cases where the Federal Circuit makes its decision based on the eternal verities of patent law (insofar as there are any eternal verities in patent law).  One such decision arose earlier this month when the...more

Knobbe Martens

Federal Circuit Review - November 2021

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Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2021

University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) - In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to...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

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions: Amneal Pharm. LLC v. Almirall, LLC, 960 F.3d 1368...

Abbreviated new drug (ANDA) applicant Amneal petitioned for an inter partes review (IPR) of Almirall’s patent listed in the Food and Drug Administration’s (FDA) Orange Book for a prescription drug to treat acne. Almirall...more

McDonnell Boehnen Hulbert & Berghoff LLP

Biogen Int'l GmBH v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2020)

The written description requirement has had a twenty-five year renaissance, particularly in the chemical and biotechnology arts as a way of restricting claim scope to what an inventor has actually invented (see Regents of the...more

Jones Day

American Rule Applied to PTAB Attorney’s Fees

Jones Day on

In Amneal Pharmaceuticals LLC v. Almirall, LLC, the Federal Circuit recently found 35 U.S.C. § 285 did not authorize the Court awarding attorney’s fees for conduct occurring at the PTAB. No. 2020-1106, 2020 WL 2961939, at *2...more

Knobbe Martens

Standing to Appeal an Adverse IPR Decision Requires an Injury

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ARGENTUM PHARM. LLC v. NOVARTIS PHARM. CORP. Before Lourie, Moore, and Reyna. Appeal from the U.S. Patent and Trademark Office, Patent Trial and Appeal Board. Summary: A party lacks standing to appeal an adverse IPR...more

Troutman Pepper Locke

Article III Standing Strikes Again

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Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., Appeal No. 2018-2273 (Fed. Cir., April 23, 2020). Argentum and other petitioners filed IPRs against Novartis’ patent related to methods of treating...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2019 #3

PATENT CASE OF THE WEEK - HZNP Medicines LLC v. Actavis Laboratories UT, Inc., Appeal Nos. 2017-2149, et al. (Fed. Cir. Oct. 10, 2019) - In a lengthy decision following a bench trial, the Court addressed a matter of...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2019 #2

PATENT CASE OF THE WEEK - HZNP Medicines LLC v. Actavis Laboratories UT, Inc., Appeal Nos. 2017-2149, et al. (Fed. Cir. Oct. 10, 2019) - In a lengthy decision following a bench trial, the Court addressed a matter of...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - May 2019 #3

PATENT CASE OF THE WEEK - AVX Corporation v. Presidio Components, Inc., Appeal No. 2018-1106 (Fed. Cir. May 13, 2019) - Following an inter partes review upholding the patentability of certain challenged claims, the...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

Foley & Lardner LLP

Termination Of Product Development Precludes Standing To Appeal PTAB IPR Decision Upholding Patent

Foley & Lardner LLP on

In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast...more

WilmerHale

Federal Circuit Patent Updates - January 2019

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Barry v. Medtronic, Inc. (No. 2017-2463, 1/24/19) (Prost, Moore, Taranto) - Taranto, J. Affirming judgement of no invalidating public use of patents related to methods for correcting spinal column anomalies. Also...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

Jones Day

PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation

Jones Day on

In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds. Shortly thereafter, Novartis filed suit...more

Foley & Lardner LLP

The Hobson's Choice Of The Hatch-Waxman Integrity Act

Foley & Lardner LLP on

As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more

WilmerHale

Federal Circuit Patent Updates - April 2018

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01 Communique Laboratory, Inc. v. Citrix Online, LLC (No. 2017-1869, 4/26/18) (Newman, Mayer, Stoll) - Mayer J. Affirming plaintiff's motion for a new trial motion. The defendant did not improperly assert a “practicing...more

WilmerHale

Federal Circuit Patent Updates - February 2018

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Nalco Company v. Chem-Mod, LLC (No. 2017-1036, 2/27/18) (Moore, Schall, O'Malley) - O'Malley, J. Reversing district court's dismissal of patent claims for failure to state a claim. The district court's dismissal of direct...more

McDonnell Boehnen Hulbert & Berghoff LLP

District Court Allows Mohawk Tribe to Join ANDA Litigation, Finds Patents at Issue Invalid

In something of an anticlimax, Federal Circuit Judge William Bryson, sitting by designation on the bench of the U.S. District Court for the Eastern District of Texas, granted Allergan's motion to join the St. Regis Mohawk...more

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