Posts Tagged: Food and Drug Administration


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
23 days 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
1 month 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
7 months 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
8 months 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
8 months 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
1 year 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

Distribution Agreement Considered a Commercial Offer and On-Sale Bar

The Federal Circuit reiterated that the on-sale bar does not exempt commercial agreements between a patentee and its supplier or distributor. It is the commercial character of …

IP Strategy is a Tricky Balancing Act for Pharmaceuticals

The 20 years of protection afforded by a patent is intended to promote innovation by allowing inventors a chance to recoup development costs and derive a profit from …
By Shai Jalfin
2 years ago 2

Supreme Court of Canada rules on Promise Doctrine in favor of Pharma Patent Owners

The Supreme Court of Canada issued a ruling in AstraZeneca Canada Inc. v. Apotex Inc., which gives patent owners a far greater ability to protect their intellectual …
By Steve Brachmann
2 years ago 1

The FDA process, patents and market exclusivity

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and "exclusivity" separately. "Exclusivity" refers to exclusive marketing rights granted by the …

Senate passes 21st Century Cures Act, President Obama expected to quickly sign bill into law

Earlier today, by a vote of 94 to 5, the United States Senate overwhelmingly passed the 21st Century Cures Act. Having passed in the House, the Cures Act now …
By Gene Quinn
3 years ago 6