FDA Approval and Patent Protection of Medical Marijuana: What Would It Take?

For many, the concepts of FDA Approval and patent protection may seem oddly out-of-place in a discussion of medical marijuana. Upon further examination, however, they are directly related—and give us an insight into the challenging nature of the medical marijuana industry.

Many patients, support organizations, and medical professionals look forward to the day the FDA approves a new drug application for medical marijuana. This would allow patient healthcare plans to pay for the drug and allow physicians to legally write prescriptions. First, of course, the U.S. government would need to declassify marijuana—currently a Schedule I narcotic.

Among other requirements; the FDA would need to review the results of a detailed, pre-approved clinical trial. This trial could potentially cost millions of dollars and require several years. Such a trial would likely have at least three separate study phases covering topics such as:

  • Identifying the tested drug as a single strain of marijuana
  • Listing the anticipated benefits and defined end-points
  • Confirming safety, efficacy, and dosing using collected data

The developing company would have to identify something new, unique, and innovative to submit a patent application for medical marijuana. These might include an exclusive plant strain with accompanying breeders’ rights, a continuous (versus batch grow) method, or an automated harvest-drying-extraction-infusion process.

So why does someone not fund such a trial? To be honest, there is no current return on investment. Considering that skilled growers might easily reproduce the genetic strain once the cannabinoid composition was revealed, forecasted ROI would be dismal. With this in mind, a company would only fund such trials if they were guaranteed the period of marketing exclusivity that comes with the receipt of a U.S. patent.

A British company, GW Pharmaceutical has done just that. They have received multiple patents from the United States Patent and Trademark Office for unique discoveries related processes such as the chemical method of drug administration and extraction under pressure. They are targeting multiple diseases with their cannabinoid compositions but have yet to obtain marketing approval from the FDA on various trials.

Ultimately, only time will tell if other medical marijuana companies—and their investors—will prove willing to take on and succeed against such a formidable challenge.

My name is Richard F. Newmiller. I have over 20 years of Pharmaceutical Industry experience.  I am presently a Management Consultant supplying Engineering and project management services with a unique background that includes corporate, contractor, designer and owner perspective.

I also teach a training course for the Center for Professional Innovation and Education (CfPIE), The Regulated Medical Marijuana Business - An Educational Seminar from Concept to Product Sale, that provides a comprehensive overview for growers, owners, designers, engineers, investors, regulators, and lenders.


Tags: FDA , Medical Marijuana , Patent Protection