The Food and Drug Law Blogs


    In recent months I have been studying for a degree in Quality Assurance and Regulatory Affairs in pharmaceutical drug development. While at first glance regulatory affairs may seem like a tedious subject to study, especially for a basic research scientist involved in cutting edge academic research, it turns out that courses taught in the curriculum can be a perfect complement for any biomedical scientist wishing to pursue a career in industry.  Regulatory affairs in drug development is a science in and of itself, dealing with the study of various paths a drug manufacturer can/should navigate in order to develop a drug from preclinical testing to clinical trials to postmarket research.  All the while companies must coordinate with contract research organizations, institutional review boards, hospitals, health care providers, patients and of course the Food and Drug Administration. I am taking one of the core course modules this summer, which is Food and Drug Law. As part of the course I must write a weekly blog about an aspect of food and drug law that I find fascinating and make a presentation about the theme at the end of the semester. I have decided to focus my theme on drug law patents and the most current topics concerning that field. I thought it would be a good idea to simply post up my blog assignment onto my website for each week. So in the following blog entries, you will find essays concerning my reviews about drug patent laws as well as legal issues concerning the FDA.

    Why have I chosen to write about drug patents? My explanation begins in the introduction:

      Food, Drug and Biological patent disputes in the 21st Century

    New innovations happen all the time in the biomedical sciences field and new drugs are being developed at a faster rate than ever before. When a company submits a new patent to the U.S. Patent and Trademark Office and it gets approved, it is the responsibility of the sponsoring company to submit the patent information to the FDA’s database of Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange Book” within 30 days (21CFR314.53).  However, since multiple companies and laboratories are often tackling the same problems with the same available resources, similar patents are often filed by different parties at similar times.  Furthermore, the FDA itself does not review drug patents since the Agency’s statute only requires the publication of patent information.  With patent rights for drugs usually lasting 20 years (with the exception of Title II of the Hatch-Waxman Amendments of 1984) and with time taken for drug development sometimes lasting over 10 years, it is natural for sponsors to scrupulously guard a patent in order to make good on financial returns once the drug can be marketed.  Thus in our current landscape of technological innovation and financial competition it is not hard to see how patent disputes can often arise between rival companies.