Supplement Perspectives
patent

The Wrinkles of Research and Intellectual Property

“Don’t employ a lawyer as an inventor” and reinvesting in research are just two lessons from Dr. Vladimir Badmaev the CEO of American Medical Holdings Inc.

Patents and patent-pending status are much sought-after additions to a dossier of nutritional supplements and functional foods. Conversely, the intellectual property on nutritional and food products is fast becoming a commodity by popular demand where the mission of science derived from invention that is secured by a patent is often lost in translation.

In many instances writing a patent is requested by the company as a part of preparing a product dossier, rather than a “eureka” finding from the scientific research on the product. As a consequence of the product-centric-at-all-costs philosophy, writing a patent is often deferred to a patent attorney rather than the inventor. As a result many patents are technically correct scripts acceptable to the patent office but without true merit of an invention. The costly decision on the part of a corporate entity to employ a lawyer as an “inventor’ weakens the purpose of product patenting and ultimately the product offering.

These challenges to patent-supported supplements and functional foods can be resolved by a sound research program with the understanding that such research may or may not result in a viable patent application. The truth is that there is no successful nutritional enterprise that would not agree with and consent to a substantial risk of failure investing in research of promising product, and that the research results short of a “eureka” factor cannot be translated into a patent application. Fortunately, the results from the studies that do not support the expectations of the nutritional product can and should be used to revise the study protocol and gain corporate experience to develop useful and cost-effective research programs for the future products.

The successful IP program first has to admit the inconvenient truth that many companies sponsor and support nutritional research that is predictable or provide expected end-point outcome. Such research long-term often leads to theories and trends that ultimately are debunked by follow-up research and hardly can provide grounds for the innovative findings leading to a valid patent. In fact, many nutritional trends that go from “Green Light” to “Red Light” confirm that currently practiced research in support of nutritional products and patents is often short-sighted and not sound. Of course, the pharma companies are not free from that fallacy, often acquiring boom-to-bust nutritional companies without sound examination of the scientific evidence behind the product inclusive of patents, e.g. acquisition of resveratrol or hoodia research and IP.

Next the preclinical and/or clinical research conducted by nutrition companies have to recognize the different dynamics than that of clinical trials designed and conducted by pharma companies; this is mostly due to budgetary constraints. Because of budgetary limitations, the initial research needs to focus on practical, narrow research goals, and depending on the preliminary research outcome, expand the specific topic of the study or possibly explore additional related topics.

For example, a weight loss nutritional compound may initially be tested to find out whether body fat to lean body mass ratio is favorably altered in the course of several weeks' intake of the compound. The next step could evaluate the degree and dynamics of body weight loss as well as metabolic function parameters—e.g. blood lipids, blood sugar homeostasis, and inflammatory indices like c-reactive protein. Perhaps most importantly, safety of the compound has to be established prior to initiating a clinical study for efficacy.

Pre-clinical and clinical research should start with baby steps, nevertheless, it has to be well-designed, meeting the criteria of sound scientific research ready for publication in a peer-review and PubMed listed journals. The outcome of any such study has to be evaluated by an independent panel of researchers who can issue their opinions about the biological potential and innovative value of such a compound.

Conducting multi-center studies with the nutritional product is probably the best insurance policy against falling into the trap of an insufficiently researched product. The multi-center studies can be initiated by generating a strategic interest of academic centers that often run research programs aligned with the research theme of the nutritional product. Also, the initial success does not release the company from repeating and perpetual continuation of the research of the product. This is a rare occurrence that nutritional companies have a habit of continuously reinvesting into research of the product. There is never enough evidence in research data to support an existing and successful product. In fact, the reinvestment can increase value of the IP investment and return on the product.

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