Posts Tagged: Food and Drug Administration


Federal Circuit Weighs in on Proper Venue in Hatch-Waxman Cases Under TC Heartland

Last week, the U.S. Court of Appeals for the Federal Circuit addressed a question of first impression regarding whether an act of patent infringement occurs in …
By IPWatchdog
5 months ago 1

Panelists Urge Americans to Trust IP, Trust Vaccines, Listen to Science in COVID-19 Debate

IPWatchdog’s most recent webinar focused on the role of IP in the development of the most promising vaccines to combat COVID-19 and included speakers from the …
By Eileen McDermott
7 months ago 2

FDA Issues Request for Comments on Modernizing Patent Listings in the Orange Book

On June 1, the Food and Drug Administration (FDA) published a notice in the Federal Register announcing that the agency was establishing a public docket for the receipt …
By Steve Brachmann
10 months ago 0

Sanofi Decision Presents Opportunities to Clear the Patent Thicket for Generic Pharmaceuticals

The U.S. Court of Appeals for the First Circuit has made brand companies think twice about creating patent thickets in the Orange Book by resuscitating an …
By Joel Wallace & Jason Harp
1 year ago 2

We Won’t Stop Coronavirus Without IP

The recent White House meeting with leaders from American pharmaceutical companies sought their help in solving the coronavirus that originated in Wuhan, China and is currently gripping …
By James Edwards
1 year ago 16

Responding to Criticism of ‘State Pharmaceutical Importation Programs Threaten Patients and Innovation’

A recent article by Dr. Kristina M. L. Acri née Lybecker highlighted her research about the fiscal workability of state pharmaceutical importation programs from two important …

Trusting Your Secrets to the Government

According to Merriam-Webster, the “Word of the Year for 2019 is “they” when used in the singular, typically to avoid ascribing a gender to the person being referred …
By James Pooley
1 year ago 0

Rare Diseases as A Strategic Springboard: Leveraging Orphan Drug Designations and Patent Protection for Increased Investment

Drug innovators are providing much needed focus on rare diseases and, at the same time, leveraging early-stage rare disease results to facilitate down-stream market entry in broad-spectrum …
By Jacob Moore & Julie Meigs
1 year ago 0

The Dark Side of Secrecy: What Theranos Can Teach Us About Trade Secrets, Regulation and Innovation

The spectacular failure of blood-testing firm Theranos is the subject of a riveting book, Bad Blood by investigative reporter John Carreyrou, and an engaging documentary, “The Inventor” …
By James Pooley
2 years ago 5

Don’t Ignore the Flashing Caution Lights in the Drug Pricing Debate

Trying to rationally address hot button issues in an election year is always a dangerous proposition. That's particularly true as we approach what promises to be one …
By Joseph Allen
2 years ago 1

India’s Patent Law is No Model for the United States: Say No to No Combination Drug Patents Act

The United States is on the brink of making changes to the U.S. patent law that would be modeled on India’s Patent Law. At a …

Rule Requiring Prescription Drug Price Disclosures in TV Ads Will Create Complex Lanham Act Enforcement Issues and First Amendment Implications

A Final Rule issued by the Centers for Medicare and Medicaid Services (CMS) on May 8 (the “Final Rule”) that requires direct-to-consumer (DTC) television advertisements for a prescription …

House Health Subcommittee Holds Fractious Hearing on Drug Pricing and Patent Protections

On the morning of Thursday, March 7, the House Ways & Means Committee’s Subcommittee on Health held a hearing titled Promoting Competition to Lower Medicare Drug Prices. The …
By Steve Brachmann
2 years ago 16

Examining the Truvada #BreakThePatent Debate: Gilead Responds

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure …
By Steve Brachmann
2 years ago 3

Patents in the Crosshairs During House Drug Pricing Debate

The opening salvo in what promises to be one of the hottest debates in the new Congress was fired January 29 during a day-long hearing in the House …
By Joseph Allen
2 years ago 28