News & Analysis as of

Standing Article III 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

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

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On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...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

Jenner & Block

Client Alert: Access to Mifepristone Still Standing for Now, but Questions Remain

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On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...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

Quarles & Brady LLP

Federal Court Deals Blow to FDA’s Compounding MOU

Quarles & Brady LLP on

On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...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

King & Spalding

U.S. District Court Overturns HHS Interpretation of Final Rule that Permitted Sponsors of Certain Drug and Device Trials to Avoid...

King & Spalding on

If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...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

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

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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

Kilpatrick

Notes from RICO Class Action Wars Against Pharmaceutical Companies

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Takeaway: There are two ways to beat a class action – defeat class certification or defeat the class claims on the merits. Individual RICO actions tend to be complex and expensive to defend, and they increase a defendant’s...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

McDonnell Boehnen Hulbert & Berghoff LLP

Momenta Pharmaceuticals, Inc. v, Bristol-Myers Squibb Co. (Fed. Cir. 2019)

The Federal Circuit has on several occasions taken the opportunity to address (and in doing so, flesh out) the requirements for Article III standing to appeal an adverse determination in a post-grant review proceeding...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

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Year End Review: A Look Back…A Look Ahead

Bass, Berry & Sims PLC on

Perhaps the single most appropriate word to describe the current state of the civil and criminal healthcare fraud enforcement environment is uncertainty. From changes in personnel and policy at the highest levels of...more

Bradley Arant Boult Cummings LLP

First Circuit Restricts Class Certification of Classes Containing Uninjured Persons

In recent years, courts have reached divergent conclusions about the circumstances in which a damages class containing uninjured persons can be certified. Although there is some room to debate what constitutes injury, it is...more

Pierce Atwood LLP

In re Asacol Antitrust Litigation: Article III Standing In Multi-State Class Actions

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In his October 17th post, Josh Dunlap describes in detail the First Circuit’s landmark ruling in In re Asacol Antitrust Litigation concerning classes that include uninjured members. ...more

Carlton Fields

No Injury, No Problem?: The First Circuit Weighs In On Certification Where Absent Class Members Lack Harm

Carlton Fields on

In Tyson Foods, the Supreme Court declined to resolve the issue of whether a class may be certified if it contains members who were not injured and have no legal right to damages. ...more

Goodwin

Federal Circuit Orders Momenta to Show Cause in ORENCIA IPR Appeal

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As we have previously reported, Momenta appealed a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product. On October 1, 2018, Momenta informed the Court...more

Goodwin

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

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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

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