Posts Tagged: "clinical trials"

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.

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.

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.

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.

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 States and Europe have peanut allergy, including more than two million children. Bouyed by success in earlier rounds of FDA testing, Aimmune Therapeutics, Inc. (NADSAQ: AIMT) announced earlier today that it has enrolled the first patient in the pivotal Phase 3 PALISADE trial of its lead product candidate, AR101 for the treatment of peanut allergy. Previously, the Food and Drug Administration (FDA) has granted AR101 Breakthrough Therapy Designation status, and in September 2014 the FDA gave AR101 fast track designation even before Phase 2 clinical data was available.

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 that clinical trials are concluded more quickly. This means that such drugs require less time to research, develop, test and bring to market than drugs that treat earlier stage cancers, providing the innovator with a longer effective patent life. In essence, less research and development investment is directed toward drugs that treat patient groups requiring lengthy clinical trials, those with longer commercialization lags… It’s worthwhile to ask whether a ‘one-size-fits-all’ patent policy is optimal. How we can think creatively about patent protection in an effort to incentivize the innovation we want and push the frontiers of modern medicine.

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 and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.