April 5, 2018 — Pharmaceutical research into the human body's microbial ecosystem is "exploding" even though scientists and manufacturers working to develop drugs that may treat or cure diseases find it difficult to protect their time and investment through patent law, according to a guest speaker Monday at the University of Houston Law Center.
Associate Professor Rachel E. Sachs of the Washington University in St. Louis School of Law presented her work-in-progress, "The Uneasy Case for Patent Law," as part of the Law Center's 2018 Distinguished Speaker Series.
Her work deals with the intersection of patent and health law, and this particular project involves research on the human microbiome, a collection of helpful and harmful microbes — bacteria, fungi, viruses and other microorganisms — that live throughout the body. Research indicates great promise in developing drugs from the microbiome in treatment of gastro-intestinal diseases and other illnesses throughout the body.
Patent law has long promoted innovation in the pharmaceutical industry by protecting new drugs, making the time and expense of developing them worthwhile. She said so-called "small-molecule" drugs, which are developed through common technology and whose exact composition can be determined and easily reproduced, are readily protected by patent law, preventing any other company from manufacturing the drug.
Microbiome research is much more complex, she explained, often involving new technologies and several "families" of microorganisms, making it difficult to define compounds and processes to meet the requirements of patent law. Companies are relying more heavily on method claims and formulation patents, instead of traditional composition claims.
Companies are also relying on other protections such as the FDA 12-year exclusivity period; perhaps trade secret law would be a better choice, she added.
"There is a lot of activity and development," she concluded, "because companies have figured out a way to move forward even without traditional patent protection."