IP Watchdog

MARCH 9, 2022

The Initiative for Medicines, Access & Knowledge (I-MAK) has responded to a letter it received from Senator Thom Tillis (R-NC) in January asking the organization to address claims that its data on the effects of pharmaceutical patents on drug pricing is faulty. I-MAK’s view is that the U.S.

Pharmaceuticals 126

Pharmaceuticals 126

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.

Pharmaceuticals 124

Pharmaceuticals Litigation 124

IP Watchdog

NOVEMBER 9, 2023

On October 7, the Federal Trade Commission (FTC) sent letters to 10 pharmaceutical companies notifying them of the agency’s intent to challenge allegedly improper patent listings in the U.S. Food and Drug Administration’s (FDA) Orange Book.

Pharmaceuticals 122

Pharmaceuticals 122

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.

Case Law 126

Case Law Pharmaceuticals Evidence Litigation 126

IP Watchdog

JULY 5, 2024

Federal Trade Commission (FTC) a blow when it issued a preliminary injunction against the agency's proposed ban on noncompete agreements; the company behind President Trump’s shoe line filed a lawsuit accusing counterfeiters of trademark and copyright infringement; the FTC is set to start an investigation into Teva Pharmaceuticals after it refused (..)

Pharmaceuticals 69

Pharmaceuticals 69

IP Watchdog

JUNE 25, 2024

Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision today reversing a district court’s grant of Hikma Pharmaceuticals’ motion to dismiss Amarin Pharma, Inc.’s s complaint against it for induced infringement.

Pharmaceuticals 111

Pharmaceuticals Litigation 111

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Court of Appeals for the Federal Circuit today issued two precedential decisions and one nonprecedential decision in cases involving Teva Pharmaceuticals and Eli Lilly, delivering wins and losses for each company.

Pharmaceuticals 119

Pharmaceuticals Litigation 119

Insurance Journal

SEPTEMBER 3, 2024

decreased across the automotive, consumer product, food and drink, medical device and pharmaceutical industries in the second quarter, according to a new report from Sedgwick. Product recalls in the U.S. Sedgwick’s U.S. Recall Index found the 788 recalls across those …

Automotive 115

Automotive Pharmaceuticals 115

IP Watchdog

JANUARY 19, 2023

Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) today jointly held an all-day listening session featuring speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies who weighed in on the relationship between patents and affordable access to medicines.

Evidence 128

Evidence Pharmaceuticals 128

Insurance Journal

OCTOBER 7, 2024

Supreme Court declined on Monday to hear former pharmaceutical company CEO Martin Shkreli’s challenge to a $64.6 million financial penalty imposed by a judge after he raised a lifesaving drug’s price by more than 4,000%. The justices turned …

Pharmaceuticals 102

Pharmaceuticals 102

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.

Pharmaceuticals 134

Pharmaceuticals Litigation 134

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.

Pharmaceuticals 124

Pharmaceuticals Litigation 124

IP Watchdog

FEBRUARY 1, 2022

Just over one week ago, Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University published a Policy Memo with the Hudson Institute charging 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.

Pharmaceuticals 122

Pharmaceuticals 122

IP Watchdog

JUNE 5, 2024

Chamber of Commerce’s Global Innovation Policy Center (GIPC), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Council for Innovation Promotion (C4IP) are among a number of organizations that have recently submitted comments on the U.S.

Pharmaceuticals 113

Pharmaceuticals Manufacturing 113

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.

Evidence 105

Evidence Pharmaceuticals Construction Litigation 105

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.

Pharmaceuticals 122

Pharmaceuticals Manufacturing Litigation 122

IP Watchdog

APRIL 5, 2022

Patent and Trademark Office (USPTO) to once again voice his concerns about several sources advancing data on the effects of pharmaceutical patents on drug pricing. On Friday, April 1, Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S.

Pharmaceuticals 126

Pharmaceuticals 126

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

Pharmaceuticals 122

Pharmaceuticals Litigation 122

IP Watchdog

OCTOBER 29, 2024

During IPWatchdog’s Life Sciences Masters program, which is taking place this week from Monday to Wednesday, panelists on the one hand breathed a sigh of relief that certain rule proposals considered most destructive to the industry seem unlikely to move forward, but on the other, lamented the overall negative tenor of the public debate around pharmaceutical (..)

Pharmaceuticals 103

Pharmaceuticals Technology 103

Insurance Journal

NOVEMBER 14, 2024

A jury has awarded the city of Baltimore $266 million in damages in its suit against pharmaceutical firms McKesson and AmerisourceBergen for their part in the city’s opioid epidemic. With the jury award, the city has notched another win for …

Pharmaceuticals 103

Pharmaceuticals 103

IP Watchdog

APRIL 3, 2023

The Information Technology and Innovation Foundation (ITIF) is hosting an event on the downfall of Japan’s pharmaceutical industry. This week in Washington IP news, Congress is out of town thanks to a state work period, but there are still several interesting events related to the IP world.

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Pharmaceuticals Technology 59

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.

Pharmaceuticals 104

Pharmaceuticals Litigation 104

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.

Pleadings 110

Pleadings Pharmaceuticals Litigation 110

IP Watchdog

FEBRUARY 2, 2023

The key data being questioned is that of the Initiative for Medicines, Access & Knowledge (I-MAK), an advocacy organization that has become a “principal, go-to source” for data on the number of patents and patent applications covering pharmaceutical innovations.

Pharmaceuticals 119

Pharmaceuticals Technology 119

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.

Pharmaceuticals 119

Pharmaceuticals Litigation 119

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.

Manufacturing 111

Manufacturing Pharmaceuticals Technology Litigation 111

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. §

Pharmaceuticals 105

Pharmaceuticals Litigation 105

IP Watchdog

AUGUST 14, 2021

In the Report, the Committee pointed out the “challenges in strengthening the country’s IPR regime, the related procedural and substantive constraints, legal aspects and other issues, such as low awareness of IPR, counterfeiting and piracy, IP financing, and IPRs in agriculture and pharmaceutical sector, etc.”.

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Pharmaceuticals Technology 130

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.

Pharmaceuticals 115

Pharmaceuticals Manufacturing Litigation 115

IP Watchdog

OCTOBER 24, 2022

Two major trade organizations representing global vaccine manufacturers are officially backing a proposal submitted to the G20 and G7 countries in July that they claim offers practical solutions for future pandemics to avoid the inequities that have been highlighted by the COVID-19 pandemic.

Manufacturing 113

Manufacturing Pharmaceuticals Technology 113

IP Watchdog

MAY 12, 2023

This week in Other Barks & Bites: AI inventorship comments due, the United States Patent and Trademark Office (USPTO) seeks nominations to two advisory committees; Oprah’s company settles a trademark dispute with a podcast; and high-profile pharmaceutical company CEOs testify before the Senate on insulin prices.

Pharmaceuticals 102

Pharmaceuticals 102

IP Watchdog

APRIL 22, 2024

Vanda Pharmaceuticals filed the petition following the U.S. Supreme Court today denied a petition for certiorari seeking clarification from the Court on the proper standard for a showing of obviousness.

Pharmaceuticals 104

Pharmaceuticals Evidence 104

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.

Pharmaceuticals 81

Pharmaceuticals Manufacturing Technology Litigation 81

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.

Pharmaceuticals 111

Pharmaceuticals Litigation 111

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.

Pharmaceuticals 98

Pharmaceuticals Litigation 98

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.

Pharmaceuticals 72

Pharmaceuticals Litigation 72

IP Watchdog

MAY 8, 2023

This week in Washington IP news, both houses of Congress are busy with hearings that touch on subjects relevant to IP. Both the Senate and House will be holding hearings on two hot-button issues: semiconductor supply chains and prescription drug pricing. Elsewhere, the USPTO is holding an AI inventorship listening session on the West Coast.

Pharmaceuticals 69

Pharmaceuticals 69