News & Analysis as of

Patent Litigation Standing Pharmaceutical Industry

Knobbe Martens

Speculative Plans Are Insufficient to Establish Standing in PTAB Appeals

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INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, INC. - Before Moore, Hughes, and Cunningham. Appeal from the Patent Trial and Appeal Board. Speculative plans for potentially infringing activity are insufficient to...more

Jones Day

Federal Circuit: Plans for Future Activity Created a Substantial Risk of Future Infringement

Jones Day on

Restem filed a petition for inter partes review of U.S. Patent No. 9,803,176, directed to stem cells obtained from umbilical cord tissue and isolated through a two-step process to create a specific cell marker expression...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.

Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., Appeal No. 2023-2357 (Fed. Cir. June 4, 2025) In this week’s Case of the Week, the Federal Circuit affirmed a final judgment that Moderna’s mRNA-based COVID-19 vaccine did...more

McDermott Will & Emery

No Article III Appellate Standing Under the Sun

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit dismissed Incyte’s appeal of a Patent Trial & Appeal Board decision, holding that a disappointed validity challenger lacked appellate standing to challenge the Board’s final...more

Robins Kaplan LLP

Association for Accessible Medicines v. Bonta

Robins Kaplan LLP on

Case Name: Association for Accessible Medicines v. Bonta, Civ. No. 2:20-cv-01708-TLN-DB, 2021 WL 5853431 (E.D. Ca. Dec. 9, 2021) (Nunley, J.) - Drug Product and Patent(s)-in-Suit: N/A - Nature of Case and Issue(s) Presented:...more

Knobbe Martens

Federal Circuit Review - November 2021

Knobbe Martens on

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

Troutman Pepper Locke

Article III Standing Strikes Again

Troutman Pepper Locke on

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

Alston & Bird

Patent Case Summaries

Alston & Bird on

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

McDermott Will & Emery

Mootness on Appeal from PTAB

The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing...more

Foley & Lardner LLP

Court Dismisses Biosimilar Petitioner's IPR Appeal For Lack of Standing

Foley & Lardner LLP on

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., the Federal Circuit dismissed Momenta’s appeal from an adverse IPR decision for lack of standing after Momenta suspended its potentially infringing biosimilar...more

WilmerHale

Federal Circuit Holds Petitioner Lacks Standing to Appeal Inter Partes Review Decision

WilmerHale on

On February 7, 2019, in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, the Federal Circuit dismissed an appeal brought by a petitioner in an inter partes review (IPR) for lack of standing and mootness because...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Dismisses Momenta IPR Appeal for Lack of Standing and Mootness After Momenta Abandons Orencia® Biosimilar

Last week, the Federal Circuit issued its long-awaited opinion in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, slip op. (Fed. Cir. Feb. 7, 2019). ...more

Troutman Pepper Locke

Sometimes the Patent Office Has the Last and Only Word

Troutman Pepper Locke on

The Federal Circuit just issued a decision that confirms its stance on Article III standing for appeals from inter partes reviews (IPRs), making it tougher for unsuccessful IPR petitioners to obtain judicial review of U.S....more

Jones Day

Appellate Standing Not Precluded By Inability To Maintain Hatch-Waxman Suit

Jones Day on

Mylan Pharmaceuticals, Inc. petitioned for inter partes review (IPR) of U.S. Patent No. 6,858,650 (the “‘650 Patent”), which is owned by UCB Pharma GmbH (“UCB”) and is directed to chemical derivatives of a drug for treating...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

Goodwin

Momenta Contends ORENCIA IPR Appeal Is Not Moot

Goodwin on

On October 23, 2018, we previously reported that the Federal Circuit ordered Momenta to show cause as to why Momenta’s appeal of a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to...more

Goodwin

BMS and Momenta File Additional Letters Regarding Standing in Orencia IPR Appeal

Goodwin on

As we reported here, Momenta is appealing a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”), which relate to BMS’s Orencia® (abatacept) product. Momenta has not yet filed an...more

Patterson Belknap Webb & Tyler LLP

Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar...

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing...more

Goodwin

Massachusetts District Court Denies Motion to Dismiss in Janssen v. Celltrion

Goodwin on

The United States District Court for the District of Massachusetts has denied Celltrion’s motion to dismiss the action for lack of standing. As we previously reported, Celltrion argued that certain co-owners of the ’083...more

Hogan Lovells

Hogan Lovells ITC Section 337 Monthly Highlights

Hogan Lovells on

The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. ...more

Robins Kaplan LLP

Apotex Inc. v. Alcon Research, Ltd.

Robins Kaplan LLP on

Case Name: Apotex Inc. v. Alcon Research, Ltd., No. 16-3145-WTL-MJD, 2017 U.S. Dist. LEXIS 27016 (S.D. Ind. Feb. 27, 2017) (Lawrence, J.). Drug Product and Patent(s)-in-Suit: Pataday® (olopatadine); U.S. Patents Nos....more

McDonnell Boehnen Hulbert & Berghoff LLP

Phigenix, Inc. v. ImmunoGen, Inc. (Fed. Cir. 2016)

Can any petitioner appeal a Board's final written decision from an inter partes review or post grant review proceeding? Contrary to the language of 35 U.S.C. § 141(c) which permits any party "who is dissatisfied with" the...more

Sheppard Mullin Richter & Hampton LLP

Post-Grant Review Roils Patent Litigation Waters

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

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