Posts Tagged: Food and Drug Administration


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
2 months 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
3 months 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 …
By Shabbir Imber-Safdar
5 months ago 22

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
6 months 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
6 months 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
8 months 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
9 months 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
1 year 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
1 year 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
1 year ago 28

Petitioner Has Standing to Appeal PTAB Decision Where Litigation is Inevitable

Altaire filed two complaints against Paragon: (1) alleging a breach of the non-disclosure clause of the Agreement, and (2) seeking declaratory judgment that the ‘623 patent was invalid. Paragon, in …

Hatch-Waxman Litigation: 60 Percent Increase in ANDA Lawsuits from 2016 to 2017

In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (…
By Steve Brachmann
2 years ago 0

Mary Engle Pennington: The Mother of Modern Food Preservation

The preservation of food and beverage products for safe consumption despite extended shelf lives at grocery stores is a major global industry. Both consumers and companies have …
By Steve Brachmann
2 years ago 0