Posts Tagged: fda


Courts Answer Key Questions Over the Reach of the BPCIA

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal …

Biologics Applicant Must Give Post-Approval Notice to Reference Product Sponsor

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would …

FDA approval of Teflaro puts Allergan’s portfolio of anti-infectives into focus

Treatments for infectious diseases is one area where Allergan is looking to buoy its fortunes in the coming years. The first quarter of 2016 was a strong one …
By Steve Brachmann
1 month ago 0

IP Protection Critical for BioPharma Given Number, Cost and Complexity of Clinical Trials

Biopharmaceutical innovation is difficult, expensive, time-consuming, and risky. More so now than ever. A 2014 study by Tufts University’s Center for the Study of Drug Development calculated …
By Dr. Kristina Lybecker
2 months ago 9

Federal Circuit Affirms Doctrine of Equivalents Analysis Using Appropriate Hypothetical Claim

The Federal Circuit held that it is not the case that a patent must spell out a claim element’s function, way, and result, for the doctrine …

A look at treatments for hepatitis C, America’s top infectious disease killer

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss …
By Steve Brachmann
2 months ago 1

Clinical Trials and Tribulations: Why IP Protection is Critical to the Future of Biologic Medicine

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the …
By Dr. Kristina Lybecker
3 months ago 3

Acorda Therapeutics v. Mylan Pharmaceuticals May Not be the Last Word on Personal Jurisdiction in ANDA Cases

The Federal Circuit held that Mylan Pharmaceuticals, Inc. (“Mylan”), a generic drug manufacturer, was subject to specific personal jurisdiction in Delaware because Mylan had filed an abbreviated …

The Evolution of Food Safety: HOF Inventors John Silliker and Welton Taylor tamed Salmonella

The 2016 inductee class for the National Inventors Hall of Fame includes two microbiologists whose contributions to the field of food safety have helped to keep many foodborne …
By Steve Brachmann
5 months ago 0

Free Drugs: Bernie Sanders and the end of drug patent exclusivity

The Medical Innovation Prize Act of 2007, submitted by Senator Bernie Sanders (D-VT), would have effectively done away with patent rights for pharmaceutical drugs approved by the Food …
By Gene Quinn
6 months ago 41

Illicit pharmaceutical drug sales find a home on Twitter

Twitter’s popularity has not only benefited the legitimate side of the pharmaceutical industry. A study released in December, supported by both the Global Health Policy Institute …
By Steve Brachmann
6 months ago 0

Phase 3 trial starts for treatment for peanut allergy

It is estimated that more than 30 million people in the United States and Europe have a food allergy, and more than five million people in the United …
By Gene Quinn
7 months ago 5

Tech News Roundup: Bezos and Musk Square Off, LED ‘Li-Fi’ Internet and VTech Data Breach

Our latest Tech Round-Up here on IPWatchdog takes a brief glance at many of the stories which have caught our attention in recent days. As he often …
By Steve Brachmann
8 months ago 0

The future of agricultural pest control is biopesticides, IoT insect monitoring systems

The Internet of Things has been lauded as a potential boon for crop production, including pest control. Automated IoT pest control systems have been developed by Spensa …
By Steve Brachmann
10 months ago 0

Pharmaceutical greed makes Martin Shkreli public enemy #1

On August 10th, the rights to sell Daraprim were bought from Impax Laboratories Inc. (NASDAQ:IPXL) of Hayward, CA, by Turing Pharmaceuticals, a privately held company with …
By Steve Brachmann
10 months ago 11