Posts Tagged: clinical trials


Blockbuster Restasis Patent Goes Down at Federal Circuit a Victim of Rule 36

Without any explanation, analysis or justification, Chief Judge Prost, and Judges Reyna and Hughes affirmed the decision of colleague Judge Bryson. A patent to a blockbuster drug …
By Gene Quinn & Steve Brachmann
12 months ago 23

Avoiding drug development clinical trials from being an invalidating public use

The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the …
By Theodore Chiacchio
2 years ago 4

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 …

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 …

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
4 years ago 5

Distorting Innovation: Fixed Patent Terms and Underinvestment in Long-term Research

Drugs for the treatment of late-stage cancers are less expensive to develop, in part because late-stage drugs extend patients’ lives for a shorter period of time such …

The Need for Regulatory Data Protection in the TPP: Why Australia’s Got it All Wrong

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe …