Anthony L. Almada, B.Sc.10.01.02
Patents
Exploring the real significance of a patent.
ByAnthony L. Almada, B.Sc., M. Sc
“You, too, can enjoy pain-free living and vitality with DisJointa™. Be the talk of your family after taking the three-legged race at the annual reunion picnic. Leave your colleagues in a stupor after you say ‘I’m taking the stairs—see you in the board room,’ as they await the elevator to the corporate penthouse suite.”
—DisJointa’s formula is so unique it was granted a patent by the United States government. Take DisJointa and “dis” your tired, aching joints. DisJointa™—patented joint power!
Back in the early 1990s when I was directing R&D for KAL Nutritional Supplements—a target of Nutraceutical Corporation’s corporate consumptive behavior in the mid-1990s—I was mystified by the “buzz” surrounding what I consider to be the first botanical antioxidant of market significance—Pycnogenol®. I perused the available studies (both in English and in French—four years of high school français, merci beaucoup) and the patent invented by Pycnogenol’s poster child, Dr. Jack Masquelier. Absent were the human “proof of concept” studies that aligned with the claims offered both on-label and off-label. From anti-inflammatory to antioxidant par excellence (exponentially superior to vitamins C and E), this salutary solution was extolled. Woven into this mantra was a reference to U.S. patent 4,698,360, its market-relevant assignee being the non-eponymous Horphag.
Sifting through this patent (and stumbling over the numerous misspellings) one finds indicated therapeutic uses for Alzheimer’s disease, atherosclerosis, joint diseases and even multiple sclerosis. However, in absentia are any scientific data even hinting that said extract of pine bark actually has such therapeutic properties. Indeed, the very limited clinical research that does exist began to appear only several years later. This bubble-bursting exercise compelled me to generate my own mantra: A patent does not mean potent. For how many industrialists and consumers alike does a patent have a different, even contrary meaning?
Telescoping into a decade later I find the number of patents filed and issued without proof of concept data, both within the confines of NAFTA and overseas, to be staggering. Although it is not the burden of the patent examiners of respective countries to assess the efficacy or scientific validity (or safety) of inventions related to biologically functional ingredients or products, it is incumbent upon the licensees to undertake such fundamental tasks. However, since it is not required by patent law, or any other law of the land, innumerable “impotent” patents are filed and issued. Arguably the most egregious patents fitting this description are those invented by scientists and academics. Case in point: TV’s Dean of the Dermis, Dr. Nicholas Perricone, and his recent U.S. patents describing the use of olive polyphenols for treating skin diseases and conditions 6,437,004 and lipoic acid-containing cosmeceuticals for acne 6,365,623. The former lacks any proof of concept data (in vitro, animal or human), while the latter lacks randomized placebo-controlled trials.
For the marketing entity seeking to invalidate a competitor’s patent, the classical course of action is to seek a summary judgment declaring said patent’s claim(s) to be invalid (for one or more reasons). This is a costly and time consuming process involving Federal District and Circuit Courts. Alternatively, a creative strategy would be for the entity to sponsor an independent randomized controlled clinical trial evaluating the safety and efficacy of a presumed impotent patent’s claimed invention (herein a formula or composition). Including a non-infringing formulation of its own to compare head-to-head to the patented formulation would be ultra-strategic.
If the results come out against the patented invention, the proceeding tactical step would be to have the leader of the research study (an independent, economically non-conflicted researcher) present the results of the study at a national or international research conference. This would be orchestrated with dissemination of these results through the media (read press conference, press releases). If the alternate product is proven safe and effective two objectives have been met: de facto invalidation of the patented invention and validation of a superior product. Potency, of both biological and business persuasions, comes only with proof, not a patent.NW