Posts Tagged: "clinical trials"

Report: U.S. Leadership in Biopharma R&D to Plummet Post-Price Controls

The U.S. Chamber of Commerce released a report today predicting that proposals by the Biden Administration to impose price controls on certain pharmaceuticals will reduce the number of clinical trials “by thousands across all categories of research examined and by up to 75% in some therapeutic areas,” eventually turning the United States into a “research desert.” The report comes on the heels of a Federal Register Notice last week that proposed a framework for expanding the use of march-in rights under the Bayh-Dole Act to circumstances in which qualifying drugs are priced too high.

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 like Restasis, which has over $1.4 billion in annual sales in the United States, deserves greater consideration than a once sentence disposition that simply says: “Affirmed.”… It is one thing to use Rule 36 to dispose of an appeal that should never have been brought relating to an invention of modest or no commercial success. But there is something fundamentally arrogant about using Rule 36 to finally strike a fatal blow to a patent covering a blockbuster drug responsible for more than $1.4 billion in annual sales in the United States. And given that the district court judge was Judge Bryson, the lack of an opinion only raises further questions.

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 use of a claimed invention in connection with carrying out clinical trials will constitute an invalidating public use. Patent applications are typically filed early on in the process of developing and commercializing a pharmaceutical drug product. One reason for this approach is to secure the earliest possible filing date thereby pre-dating as much would-be prior art as possible. Such would-be prior art, however, is not limited to that published or otherwise emanating from others but also includes time bars such as the public use bar. The circumstances under which clinical trials involving administration of a drug product that occur prior to the critical date may constitute an invalidating public use is a murky area of the law and courts’ decisions in this area are highly dependent on the facts of the case before them.

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 that a mere one in eight (11.8%) of all drugs that enter clinical trials are ultimately approved by the U.S. Food and Drug Administration. The drug development gamble appears to be getting riskier. A report released on May 25th by the Biotechnology Innovation Organization (BIO), the biotechnology industry’s national trade group, finds that fewer than one in ten (9.6%) of drugs that enter clinical trials will gain approval by the U.S. Food and Drug Administration.

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 recently negotiated Trans-Pacific Partnership (TPP) Agreement to protect biologic medicines are disappointing… As clinical trials become increasingly costly, these costs are increasingly born by the biopharmaceutical industry. A recent study from the Johns Hopkins Bloomberg School of Public Health calculates that the biopharmaceutical drug and medical device industry now funds six times more clinical trials than the federal government.