Pharmaceuticals - Trial Strategy Today

AI in Pharmaceuticals: From Discovery to Market

Complex Discovery

OCTOBER 19, 2024

Editor’s Note: Artificial intelligence (AI) is transforming the pharmaceutical industry, offering unprecedented opportunities to accelerate drug discovery, streamline clinical trials, and fortify intellectual property (IP) strategies.

Pharmaceuticals

Pharmaceuticals Discovery Government and Public Sector Chain Of Custody

Senate Judiciary Committee to Consider Bills Targeting Pharma Patents and Pricing

IP Watchdog

APRIL 2, 2025

Senate Judiciary Committee will convene an executive business meeting to consider several pieces of proposed legislation aimed largely at regulating patent-related activities in the pharmaceutical sector. government sources.

Pharmaceuticals

Legal Turmoil in the Pharmaceutical Industry: AbbVie, Purdue, and Beyond

Complex Discovery

JULY 12, 2024

Editor’s Note: In a legal confrontation that could significantly impact the pharmaceutical industry, AbbVie has petitioned the U.S. Adding to the legal drama, the pharmaceutical industry faces challenges in Mississippi, where U.S. has petitioned the U.S.

Pharmaceuticals

Pharmaceuticals Settlement Negotiations Litigation Mediation

Webinars

The Tech-Savvy Paralegals Playbook: How To Leverage AI

Uncovering The Hidden Connections: A Patent Family Survival Guide

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Debunked: USPTO Findings Should End False Pharma Patent Narratives

IP Watchdog

OCTOBER 28, 2024

Patent and Trademark Office (USPTO), whose “Drug Patent and Exclusivity Study” effectively debunks the false narratives and bogus statistics that have been levied against pharmaceutical patents with significant effect in recent years.

Pharmaceuticals

Pharmaceuticals Technology

Life Sciences Masters Panelists Say USPTO’s Controversial Anti-Pharma Rules are Unlikely to Progress

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

Pharmaceuticals Technology

The Law and Politics of Drug Price Controls and Pharmaceutical Innovation

IP Watchdog

JANUARY 21, 2025

My conversation this week with John White was much like any number of conversations we have had over the years over dinner or drinks. What prompted me to ask John to speak with us this week was an article he recently wrote, which we published on IPWatchdog.

Pharmaceuticals

Senate Judiciary Committee Advances Pharma Patent Bills IP Advocates Say are Backed by Faulty Data

IP Watchdog

APRIL 3, 2025

While many of these bills were hailed by committee members as strong steps toward reining in consumer drug prices, the perceived problems addressed by these bills have been fomented by controversial data reports, leading to questions as to whether these bills will achieve their intended cost reductions without negatively impacting the next generation (..)

Pharmaceuticals

CAFC Affirms District Court Holding for Generic, Says Later-Made Prosecution Statements Don’t Change Earlier Disclaimer

IP Watchdog

APRIL 8, 2025

Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Azurity Pharmaceuticals, Inc. affirming the District of Delawares ruling that Alkems generic drinkable antibiotic product did not infringe patent claims owned by Azurity Pharmaceuticals. Alkem Laboratories Ltd.

Brazilian Congress Debates Regulatory Data Protection for Pharmaceutical Products

IP Watchdog

JUNE 5, 2024

In May 2024, the Brazilian Senate Committee on Science, Technology, Innovation, and Informatics hosted two public hearings to discuss implementing Regulatory Data Protection (RDP) for pharmaceutical products of human use. The call for hearings (REQ 27/2023) was presented by Senator Izalci Lucas (Liberal Party).

Pharmaceuticals

Pharmaceuticals Healthcare Technology

Pharmaceutical Executive Pleads Guilty to Insider Trading | DOJ Press Release

Securities Docket

OCTOBER 9, 2024

A former executive of a global pharmaceutical company pleaded guilty today in federal in Boston to earning more than $250,000 by trading on material non-public information. Gupta worked as the Director of Strategy and Operations in the Boston office of a global pharmaceutical company (Company A). District Court Judge Julia E.

Pharmaceuticals

Pharmaceuticals Pleadings

GSK Argues Unusual Facts of Case Behind Teva’s SCOTUS Petition Limits CAFC’s Skinny Label Holding

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.

Pharmaceuticals

Pharmaceuticals Litigation

Bankrupting Big Pharma Isn’t a Solution

IP Watchdog

AUGUST 11, 2021

Believe it or not, a recent op-ed in the Washington Post written by Robin Feldman took the position that pharmaceutical companies should charge prices for their drugs that would surely guarantee that they go bankrupt.

Pharmaceuticals

Merck’s $8 Billion Cancer Vaccine Faces First US Jury Trial

Insurance Journal

JANUARY 27, 2025

is facing its first jury trial over claims the company wrongfully marketed its lucrative Gardasil cancer vaccine as safe, the latest high-stakes litigation for the pharmaceutical giant. Merck & Co. Lawyers for a Los Angeles woman will argue Monday that …

Pharmaceuticals

Pharmaceuticals Litigation

I-MAK Defends Integrity of Its Patent Data in Response to Tillis Letter

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

CAFC Again Says Teva Induced Infringement on Carvedilol, Assures Holding Narrowly Applies

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

Pharmaceuticals Litigation

IP News: Barks & Bites for Friday, March 21 | IPWatchdog

IP Watchdog

MARCH 21, 2025

This week in Barks & Bites: American pharmaceutical firm Johnson & Johnson announces $55 billion in U.S. by BOE Technology.

Pharmaceuticals

Pharmaceuticals Construction Litigation Technology

FTC’s 100-Patent Orange Book Challenge Creates Uncertainty for Pharma Patent Listings

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

What Recent Case Law Tells Us About the Importance of Consumer Surveys in Trademark Cases

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

Case Law Pharmaceuticals Evidence Litigation

CAFC Says Generic’s Public Statements Make Induced Infringement Claims Plausible

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

Pharmaceuticals Litigation

Sedgwick: Product Recalls Dropped in Q2 in 5 Key Industries

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

Automotive Pharmaceuticals

Teva Wins One, Loses Two at CAFC in Migraine Treatment Patent Cases

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

Pharmaceuticals Litigation

Supreme Court Rejects ‘Pharma Bro’ Shkreli’s Appeal of $64.6 Million Penalty

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

Federal Circuit Upholds Delaware Court’s Inequitable Conduct Analysis

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

Pharmaceuticals Litigation

CAFC Orders Review of Extrinsic Evidence to Determine Proper Limit of Claimed pH Range

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

Evidence Pharmaceuticals Construction Litigation

Novartis Asks SCOTUS to Rein in CAFC and Ninth Circuit Approach to Panel Rehearing Decisions

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

Pharmaceuticals Litigation

Organizations Tell USPTO Proposed 2025 Fees ‘Misuse’ Office’s Fee Setting Authority

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

Pharmaceuticals Manufacturing

Pharma Companies Fight it Out at High Court Over Whether CAFC Disregards Appellate Review Limits

IP Watchdog

NOVEMBER 13, 2024

The petition was filed on September 11, 2024, by Salix Pharmaceuticals and stems from an April 2024 precedential decision of the Federal Circuit affirming a district court’s final judgment that certain claims of several patents owned by Salix for a drug used to treat irritable bowel syndrome (IBS) and other ailments were invalid as obvious.

Pharmaceuticals

Pharmaceuticals Litigation

Tillis Wants More Info on I-MAK and Other Data Driving Anti-Patent Narratives Around Drug Pricing

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

Other Barks & Bites for Friday, March 7: Lashify Wins ITC Appeal on Economic Prong Analysis; CAFC Says Apple Did Not Violate Discovery Obligations at PTAB; and ParkerVision Files Reply Brief on Rule 36 Appeal at SCOTUS

IP Watchdog

MARCH 7, 2025

International Trade Commissions economic prong analysis for the domestic industry requirement of Section 337, finding that petitioners at the Patent Trial and Appeal Board have no self-executing discovery obligations to present evidence from parallel ITC proceedings, and more; strong global demand for AI chips buoys Broadcoms first quarter results; (..)

Discovery

Discovery Pharmaceuticals Evidence

Senate Judiciary Committee Advances Legislation to Reduce Drug Prices, Rein in Pharma Industry Practices

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

Pharmaceuticals Manufacturing Litigation

Tillis Renews Request to FDA and USPTO for Independent Assessment of I-MAK Patent Data

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

CAFC Affirms Merck’s Win at PTAB over Mylan Challenge to Diabetes Treatment Claims

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

Pharmaceuticals Litigation

Jury Awards Baltimore $266 Million in Damages After Opioid Trial

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

This Week in Washington IP: What the United States Can Learn from the Downturn in Japan’s Pharmaceutical Industry, IP as a Business Strategy, and Increasing Equity through Federal Policy

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.

Pharmaceuticals

Pharmaceuticals Technology

Federal Circuit Affirms Dismissal of Celgene’s Hatch-Waxman Suit Against Mylan, Clarifying Venue and Pleading Requirements

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.

Pharmaceuticals

Pharmaceuticals Pleadings Litigation

In Response to Questions Signaling Major Changes to Patent System, Commenters Ask USPTO: ‘Where’s Your Data?’

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

Pharmaceuticals Technology

Novartis to Appeal CAFC’s ‘Unprecedented’ U-Turn in Ruling on Multiple Sclerosis Drug Claims to SCOTUS

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

Pharmaceuticals Litigation

Public Nuisance Claims Denied by Ohio Supreme Court in Opioid Case

Insurance Journal

DECEMBER 12, 2024

COLUMBUS, Ohio (AP) The Ohio Supreme Court ruled last Tuesday that the state’s product liability law prohibits counties from bringing public nuisance claims against national pharmaceutical chains as they did as part of national opioid litigation, a decision that …

Pharmaceuticals

Pharmaceuticals Court Rules Litigation

GSK Says Pfizer Infringed Five Patents Relating to Comirnaty COVID Vaccine

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

Manufacturing Pharmaceuticals Technology Litigation

Amicus Filings in Biogen v. Mylan Urge SCOTUS to Eliminate Uncertainty in Drafting Patents to Satisfy Written Description Requirement

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

Pharmaceuticals Litigation

U.S. Government Sides with Teva in Skinny Label SCOTUS Fight

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

Pharmaceuticals Manufacturing Litigation

Parliamentary Committee Report Outlines Policy Changes to Improve Indian IP Regime

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.”.

Pharmaceuticals

Pharmaceuticals Technology

Other Barks & Bites for Friday, May 12: Intel and OpenSky Kill VLSI Patent; AI Inventorship Comments Due; and Pharma CEOs Testify on Insulin Prices

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

British Columbia Can Mount Opioid Class Action, Canada’s Top Court Says

Insurance Journal

DECEMBER 2, 2024

The province of British Columbia can bring a class action lawsuit against pharmaceutical companies for opioid harms on behalf of multiple governments across Canada, the country’s Supreme Court ruled on Friday. In 2018, BC sued more than 40 drug manufacturers, …

Pharmaceuticals

Pharmaceuticals Manufacturing Court Rules Litigation

AI in Pharmaceuticals: From Discovery to Market

Senate Judiciary Committee to Consider Bills Targeting Pharma Patents and Pricing

Webinars

Trending Sources

Legal Turmoil in the Pharmaceutical Industry: AbbVie, Purdue, and Beyond

Webinars

Debunked: USPTO Findings Should End False Pharma Patent Narratives

Life Sciences Masters Panelists Say USPTO’s Controversial Anti-Pharma Rules are Unlikely to Progress

The Law and Politics of Drug Price Controls and Pharmaceutical Innovation

Senate Judiciary Committee Advances Pharma Patent Bills IP Advocates Say are Backed by Faulty Data

CAFC Affirms District Court Holding for Generic, Says Later-Made Prosecution Statements Don’t Change Earlier Disclaimer

Brazilian Congress Debates Regulatory Data Protection for Pharmaceutical Products

Pharmaceutical Executive Pleads Guilty to Insider Trading | DOJ Press Release

GSK Argues Unusual Facts of Case Behind Teva’s SCOTUS Petition Limits CAFC’s Skinny Label Holding

Bankrupting Big Pharma Isn’t a Solution

Merck’s $8 Billion Cancer Vaccine Faces First US Jury Trial

I-MAK Defends Integrity of Its Patent Data in Response to Tillis Letter

CAFC Again Says Teva Induced Infringement on Carvedilol, Assures Holding Narrowly Applies

IP News: Barks & Bites for Friday, March 21 | IPWatchdog

FTC’s 100-Patent Orange Book Challenge Creates Uncertainty for Pharma Patent Listings

What Recent Case Law Tells Us About the Importance of Consumer Surveys in Trademark Cases

CAFC Says Generic’s Public Statements Make Induced Infringement Claims Plausible

Sedgwick: Product Recalls Dropped in Q2 in 5 Key Industries

Teva Wins One, Loses Two at CAFC in Migraine Treatment Patent Cases

Supreme Court Rejects ‘Pharma Bro’ Shkreli’s Appeal of $64.6 Million Penalty

Federal Circuit Upholds Delaware Court’s Inequitable Conduct Analysis

CAFC Orders Review of Extrinsic Evidence to Determine Proper Limit of Claimed pH Range

Novartis Asks SCOTUS to Rein in CAFC and Ninth Circuit Approach to Panel Rehearing Decisions

Organizations Tell USPTO Proposed 2025 Fees ‘Misuse’ Office’s Fee Setting Authority

Pharma Companies Fight it Out at High Court Over Whether CAFC Disregards Appellate Review Limits

Tillis Wants More Info on I-MAK and Other Data Driving Anti-Patent Narratives Around Drug Pricing

Other Barks & Bites for Friday, March 7: Lashify Wins ITC Appeal on Economic Prong Analysis; CAFC Says Apple Did Not Violate Discovery Obligations at PTAB; and ParkerVision Files Reply Brief on Rule 36 Appeal at SCOTUS

Senate Judiciary Committee Advances Legislation to Reduce Drug Prices, Rein in Pharma Industry Practices

Tillis Renews Request to FDA and USPTO for Independent Assessment of I-MAK Patent Data

CAFC Affirms Merck’s Win at PTAB over Mylan Challenge to Diabetes Treatment Claims

Jury Awards Baltimore $266 Million in Damages After Opioid Trial

This Week in Washington IP: What the United States Can Learn from the Downturn in Japan’s Pharmaceutical Industry, IP as a Business Strategy, and Increasing Equity through Federal Policy

Federal Circuit Affirms Dismissal of Celgene’s Hatch-Waxman Suit Against Mylan, Clarifying Venue and Pleading Requirements

In Response to Questions Signaling Major Changes to Patent System, Commenters Ask USPTO: ‘Where’s Your Data?’

Novartis to Appeal CAFC’s ‘Unprecedented’ U-Turn in Ruling on Multiple Sclerosis Drug Claims to SCOTUS

Public Nuisance Claims Denied by Ohio Supreme Court in Opioid Case

GSK Says Pfizer Infringed Five Patents Relating to Comirnaty COVID Vaccine

Amicus Filings in Biogen v. Mylan Urge SCOTUS to Eliminate Uncertainty in Drafting Patents to Satisfy Written Description Requirement

U.S. Government Sides with Teva in Skinny Label SCOTUS Fight

Parliamentary Committee Report Outlines Policy Changes to Improve Indian IP Regime

Other Barks & Bites for Friday, May 12: Intel and OpenSky Kill VLSI Patent; AI Inventorship Comments Due; and Pharma CEOs Testify on Insulin Prices

British Columbia Can Mount Opioid Class Action, Canada’s Top Court Says

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