IP Watchdog

SEPTEMBER 16, 2024

Last week, Patients for Affordable Drugs (“P4AD”) became the latest amicus to file a brief with the U.S. Court of Appeals for the Third Circuit in Bristol Myers Squibb Co. Becerra et al.

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Pharmaceuticals Manufacturing Litigation 64

IP Watchdog

NOVEMBER 6, 2023

Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Actelion Pharmaceuticals Ltd. Mylan Pharmaceuticals Inc. Today, the U.S. vacating an infringement judgment against Mylan in the Northern District of West Virginia.

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Evidence Pharmaceuticals Construction Litigation 105

IP Watchdog

AUGUST 24, 2022

On August 19, British brand name pharmaceutical firm GlaxoSmithKline (GSK) filed a brief with the U.S. Supreme Court opposing a petition for writ of certiorari filed by generic drugmaker Teva Pharmaceuticals. Teva’s petition appeals a decision by the U.S.

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IP Watchdog

JULY 23, 2024

After filing 13 lawsuits in 2023 claiming trademark infringement, deceptive trade practices, and false advertising related to the pharmaceuticals Ozempic and Wegovy, Novo Nordisk—a 100-year-old pharmaceutical company with its origins in Denmark—is once again making headlines.

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IP Watchdog

APRIL 29, 2024

The COVID-19 vaccine was quickly rolled out compared to other vaccines in the past and many pharmaceutical companies benefited financially. However, GSK contends their competitors, Pfizer Inc. and Pharmacia & Upjohn Co. LLC (collectively Pfizer) and BioNTech SE, BioNTech Manufacturing GMBH and BioNTech US Inc.

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IP Watchdog

JULY 13, 2023

Novartis is currently involved in a multi-district patent litigation campaign to block generic entrants for Entresto®, which is Novartis’ blockbuster heart medication. In the fall of 2022, Novartis went to trial on the validity of one of the asserted patents, U.S. 8,101,659 (“the ‘659 patent”).

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Technology Pharmaceuticals Construction Evidence 52

IP Watchdog

FEBRUARY 1, 2024

Department of Health and Human Services (HHS) made its initial offers to pharmaceutical companies pursuant to the Biden Administration’s Inflation Reduction Act of 2022 (IRA), which allows the U.S. Today, the U.S. Government to “negotiate” Medicare drug prices under a set framework based upon the amount of time a drug has spent on the market.

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InHouseBlog

APRIL 8, 2022

VP, Litigation & Employment Law , www.princetonlegal.com (Princeton, NJ). Senior Director, Compliance Risk Navigation , Regeneron Pharmaceuticals (Tarrytown, NY). Regulatory Litigation Attorney , Southern California Edison (Hybrid Remote). Director, IP Litigation , Inscripta, Inc. Legal Counsel , TuneIn (Remote).

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Real Estate Pharmaceuticals Litigation Technology 98

IP Watchdog

APRIL 1, 2024

Court of Appeals for the Federal Circuit (CAFC) ruled in a precedential decision authored by Judge Prost on Monday that certain claims of Janssen Pharmaceuticals Inc.’s

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Pharmaceuticals Litigation 52

IP Watchdog

JANUARY 24, 2023

Last week, Novartis Pharmaceuticals followed through on its September 2022 promise that it would appeal the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) June 2022 decision invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S.

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CaseFox

NOVEMBER 27, 2023

Over time, legal frameworks developed to address these concerns, forming the foundation for contemporary exposure litigation. High-profile incidents, such as Love Canal and asbestos-related diseases, prompted regulatory changes and a surge in environmental and occupational health litigation.

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Litigation Pharmaceuticals Expert Testimony Evidence 52

IP Watchdog

AUGUST 18, 2022

Court of Appeals for the Federal Circuit (CAFC) today affirmed a district court’s finding that Eagle Pharmaceuticals, Inc.’s s abbreviated new drug application (ANDA) does not infringe two patents owned by Par Pharmaceutical, Inc., In its third precedential patent decision this week, the U.S.

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Pharmaceuticals Litigation 72

IP Watchdog

OCTOBER 20, 2022

The People’s Vaccine Alliance, a coalition of over 100 organizations, issued a statement this week alleging that the pharmaceutical industry is attempting to tighten its control of the world’s pandemic response plans.

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Pharmaceuticals Manufacturing Technology Litigation 81

IP Watchdog

AUGUST 6, 2021

Court of Appeals for the Federal Circuit (CAFC) on Thursday underscored its October 2020 ruling that generic company, Teva Pharmaceuticals, was liable for induced infringement of GlaxoSmithKline’s (GSK’s) patent directed to a method of treating Congestive Heart Failure (CHF) using carvedilol.

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Pharmaceuticals Litigation 124

IP Watchdog

AUGUST 12, 2024

Teva Pharmaceuticals (2019), the Federal Circuit rejected Celanese’s contentions that statutory changes wrought by the America Invents Act (AIA) altered the on-sale bar such that sales of products manufactured by an undisclosed process would not invalidate patents claiming that process. Following the U.S.

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Pharmaceuticals Healthcare Manufacturing Technology 64

IP Watchdog

SEPTEMBER 30, 2022

Court of Appeals for the Federal Circuit (CAFC) earlier today upheld a Patent Trial and Appeal Board (PTAB) decision finding that Mylan Pharmaceuticals, Inc. In its third precedential patent opinion this week, the U.S. failed to show that certain claims of Merck Sharp & Dohme Corp.’s

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Pharmaceuticals Litigation 122

IP Watchdog

AUGUST 16, 2021

Court of Appeals for the Federal Circuit today issued two precedential decisions and one nonprecedential decision in cases involving Teva Pharmaceuticals and Eli Lilly, delivering wins and losses for each company.

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Pharmaceuticals Litigation 119

IP Watchdog

MARCH 30, 2023

Solicitor General on Wednesday filed an amicus brief with the United States Supreme Court advising it to grant Teva Pharmaceuticals’ petition for writ of certiorari relating to generic manufacturers’ liability for infringement through the use of “skinny labels” on generic drugs. The SG’s brief said that the U.S.

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Pharmaceuticals Manufacturing Litigation 115

IP Watchdog

JULY 25, 2023

Patent 9,593,066 cover methods of treating pulmonary hypertension and pharmaceutical compositions comprising treprostinil—Tyvaso is an inhaled solution formulation of treprostinil. Patent 10,716,793 and U.S. United Therapeutics also owns a new drug application (NDA) for Tyvaso, No. 022387.

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Pharmaceuticals Litigation 98

IP Watchdog

AUGUST 31, 2021

District Court for the Southern District of Florida ruled against plaintiff Vital Pharmaceuticals, Inc.’s In each of these opinions, the court noted the absence of survey evidence (or, in the Vital Pharmaceuticals case, the inadequacy of an “almost comically flawed” survey). On August 3, 2021, the U.S. On June 7, 2021, the U.S.

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Case Law Pharmaceuticals Evidence Litigation 126

IP Watchdog

JULY 21, 2022

Mylan Pharmaceuticals Inc. Last week, the U.S. Supreme Court received several amicus briefs filed in support of the petition for writ of certiorari filed in Biogen International GmbH v. If cert is granted, this case will ask the nation’s highest court to clarify the written description requirement under 35 U.S.C. §

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Pharmaceuticals Litigation 105

IP Watchdog

SEPTEMBER 22, 2022

Novartis Pharmaceuticals announced today that it will appeal the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) June decision invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S. Supreme Court, after the CAFC denied its request to rehear the case.

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Pharmaceuticals Litigation 119

IP Watchdog

MARCH 26, 2023

Sanofi, a case with the parties and 27 Amici, including the United States, weighing in on whether and how the Court should address the enablement requirement of Section 112 in the context of genus claims, and in particular, genus claims to antibodies in the pharmaceutical sciences.

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Jury Instructions Pharmaceuticals Litigation 78

IP Watchdog

MARCH 12, 2023

The brief responds to arguments raised both by rival pharmaceutical firm Sanofi and the U.S. Supreme Court in its appeal of the invalidation of its patent claims covering antibodies effective at blocking low-density lipoprotein (LDL) cholesterol receptors.

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Pharmaceuticals Litigation 98

IP Watchdog

JULY 29, 2021

Earlier today, the Senate Judiciary Committee held an Executive Business Meeting in which the Committee discussed and favorably reported four bills aimed at reducing prescription drug prices for consumers and curbing perceived abuses of the patent system by brand pharmaceutical companies.

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Pharmaceuticals Manufacturing Litigation 122

IP Watchdog

AUGUST 7, 2022

recently in Novartis Pharmaceuticals Corp. But in Novartis Pharmaceuticals v. Talk about snatching victory from the jaws of defeat! That is precisely what the Federal Circuit did for HEC Pharm Co. Accord Healthcare Inc. 2021-1070).

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Pharmaceuticals Healthcare Litigation 78

IP Watchdog

SEPTEMBER 2, 2021

Court of Appeals for the Federal Circuit (CAFC) on Wednesday upheld a Delaware district court’s ruling that Belcher Pharmaceuticals Inc.’s In a precedential decision written by Judge Reyna, the U.S. s Chief Science Officer engaged in inequitable conduct, making its U.S. 9,283,197 unenforceable. Belcher brought the suit against Hospira, Inc.

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Pharmaceuticals Litigation 134

IP Watchdog

AUGUST 4, 2022

Court of Appeals for the Eleventh Circuit affirmed a district court’s ruling against Vital Pharmaceuticals, Inc. On Wednesday, August 3, the U.S. VPX) in the form of sanctions for violating its discovery obligations in a trade dress dispute with Monster Energy Company.

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Pharmaceuticals Discovery Litigation 72

IP Watchdog

JANUARY 21, 2022

A Policy Memo published by the Hudson Institute and authored by Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University has charged that some of the key data relied upon in the heated debate over the effects of pharmaceutical patents on drug pricing and access may be faulty.

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IP Watchdog

NOVEMBER 8, 2021

Mylan Pharmaceuticals Inc. On November 5, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Celgene Corp.

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Pleadings Pharmaceuticals Litigation 101

IP Watchdog

MAY 15, 2023

The Supreme Court also denied Teva Pharmaceuticals’ petition to review its appeal of the Federal Circuit’s “skinny label” induced infringement ruling over its generic version of carvedilol. Supreme Court issued an order list denying petitions for writ of certiorari filed to appeal several patent rulings, including a pair of 35 U.S.C. §

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Pharmaceuticals Litigation 80

IP Watchdog

APRIL 11, 2024

Court of Appeals for the Federal Circuit affirmed a district court’s final judgment that certain claims of several patents owned by Salix Pharmaceuticals for a drug used to treat irritable bowel syndrome (IBS) and other ailments were invalid as obvious. In a precedential decision authored by Judge Lourie, the U.S.

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Pharmaceuticals Precedent Litigation 59

IP Watchdog

APRIL 19, 2023

Supreme Court denied a petition for writ of certiorari filed by pharmaceutical developer Novartis seeking to overturn a decision on rehearing by the U.S. On April 17, the U.S. Court of Appeals for the Federal Circuit that invalidated patent claims covering the blockbuster multiple sclerosis (MS) treatment, Gilenya.

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Pharmaceuticals Litigation 72

IP Watchdog

JANUARY 20, 2022

In denying petitions from consumer tech giant Apple and generic pharmaceutical firm Mylan Laboratories, SCOTUS has ended the latest challenge to the PTAB’s NHK/Fintiv rule, which has raised the ire of many entities who have found the PTAB to be a very valuable backdoor towards patent invalidation outside of U.S. district court.

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Pharmaceuticals Litigation 111

IP Watchdog

MAY 10, 2023

Mylan Pharmaceuticals petitioned the PTAB for inter partes review (IPR) of all 18 claims in Sanofi’s drug injector pen patent. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision Tuesday that reversed a Patent Trial and Appeal Board (PTAB) decision invalidating claims of Sanofi’s U.S.

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Pharmaceuticals Litigation Technology 75

IP Watchdog

JANUARY 8, 2024

The FCA claim was brought by patent attorney Zachary Silbersher against Valeant Pharmaceuticals, predecessor to Canadian drugmaker Bausch Health.

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Pharmaceuticals Evidence Litigation 59

IP Watchdog

JANUARY 26, 2023

The pharmaceutical company launched the suit in the United States District Court for the District of Delaware. Bristol Myers filed a lawsuit Monday claiming AstraZeneca has infringed on a patent related to its Yervoy cancer drug.

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