FDA Law Blog 2.0


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

    Three years ago, as part of my FDA law class for my Regulatory Affairs degree program, I set out to write a series of blogs about biotech patent disputes and issues.  Before taking this core curriculum class, I found law particularly daunting and boring. I blindly followed the academician’s typical way of thinking: “why should I care if it’s not about publishing experimental science?”.  But that approach to thinking was leading me down a dead-end in life.  I was not heading anywhere just by publishing and working on my own niche area of academic science.  After 3 months of intensive discussions with my law professor and hours of digging through Hutt et al.’s Food and Drug law text book, I surprised myself and changed my perspective. I gained an appreciation for drug law and of a deeper understanding for the law profession with respect to how it fits into the life science industry.

    The series of blogs I wrote was based on a project our professor set for our class discussions.  For this scenario we had to become a subject matter expert for biotech law and give advice to small biotech firms who may be seeking to market their new drug products.  Every week we had to research a topic, write about it and present it in class.  I am going to republish and update my series of 10 blogs. Nowadays more than ever before, drug patents play an increasingly powerful role as drug companies begin to commercialize on an exponentially evolving universe of innovative disease treatments.

    Let’s begin with my original introduction to the blog series:
    When a company submits a new patent to the U.S. Patent and Trademark Office (USPTO) 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 the same time.  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 typically 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.

    This blog series is intended for researchers and scientists from small biotech companies who have or are about to file their first patent to gain some advice and knowledge about navigating the legal world.

    My first focus was on the little-known technology, CRISPR-Cas9 and the patent dispute between two parties.  In the subsequent blogs I dug into a variety of issues surrounding patent law such as patent protection length, brand companies gaming the Hatch-Waxman act, the importance of “obviousness” in gene patents and the scourge of patent trolls that haunt intellectual property.  This week I will begin again with the CRISPR patent dispute and all the updates to the saga.