The Impact of Price Controls and Biologics on the Future of U.S. Pharmaceutical Innovation and Investment
IP Watchdog
JUNE 8, 2025
Over the last several years the pharmaceutical industry has come under increased pressure.
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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.
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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.
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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.
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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.
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 (..)
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FTC Renews Campaign to Remove ‘Junk’ Inhaler and Device Patents from Orange Book Listings
IP Watchdog
MAY 22, 2025
Yesterday, the Federal Trade Commission (FTC) sent a series of seven warning letters to several pharmaceutical companies renewing the agencys challenge to dozens of patent listings in the U.S. Food & Drug Administrations (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book.
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 (..)
CAFC Affirms Moderna’s Win, Holding Alnylam Narrowly Defined ‘Branched Alkyl’
IP Watchdog
JUNE 4, 2025
in its ongoing patent battle with Alnylam Pharmaceuticals over mRNA-based COVID-19 vaccine technology. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court's finding of noninfringement in favor of Moderna, Inc.
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).
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.
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.
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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.
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 …
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International IP Index Warns EU Efforts to Weaken Pharma IP Could Cause Investment to Migrate
IP Watchdog
APRIL 16, 2025
While this years IP Index marked little movement among the top nations for IP legal frameworks, leaving the United States as the top nation overall for yet another year, stronger IP protections in Middle Eastern countries and efforts to weaken IP protections for pharmaceuticals in the EU and U.S.
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.
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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.
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Judge Hughes Again Calls Out CAFC’s Overly Rigid Article III Analysis for Pharmaceutical Cases
IP Watchdog
MAY 7, 2025
Sun Pharmaceutical Industries, Ltd. Today, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Incyte Corp. dismissing Incytes appeal from post-grant review (PGR) proceedings at the Patent Trial and Appeal Board (PTAB) for lack of Article III standing.
Durbin, Tillis Reintroduce Bill on USPTO-FDA Collaboration
IP Watchdog
MARCH 26, 2025
Senate Democratic Whip Dick Durbin (D-IL), Ranking Member of the Senate Judiciary Committee, and Senator Thom Tillis (R-NC), as well as Senators Chuck Grassley (R-IA), Chairman of the Senate Judiciary Committee, Chris Coons (D-DE), and Peter Welch (D-VT) this week reintroduced a bill titled The Interagency Patent Coordination and Improvement Act, which (..)
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.
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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.
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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 …
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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.
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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.
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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 …
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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.
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Bayer Seeks Roundup Settlement, Explores Monsanto Bankruptcy: Reports
Insurance Journal
MAY 20, 2025
The German pharmaceutical … Bayer is preparing a plan to settle some of its mass lawsuits over Roundup weedkiller in Missouri, and may also seek bankruptcy for its Monsanto unit if the effort fails, the Wall Street Journal reported, citing sources.
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.
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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.
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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.
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.
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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; (..)
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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.
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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.
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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
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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 …
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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.
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.
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.
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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.
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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.
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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 …
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.
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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. §
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