I can’t quite remember exactly how I met Dr. Andy Clark, but it may very well have been at a class reunion. Andy’s wife, Linda McGillen Clark, and I have known each other since we were in Mrs. Martha Mongtomery’s second grade class at North Side School in Johnson City, Tennessee.

Linda and Andy have been married for 34 years, having met on a blind date. The Clark’s are members of Munsey Memorial United Methodist Church and were married there. They are the proud parents of Shelley, and proud grandparents of Shelley’s infant daughter, Clark Elizabeth Patterson.

W. Andrew (Andy) Clark, PhD, RD is a Professor of Clinical Nutrition and Associate Dean of Research for the College of Clinical and Rehabilitative Health Sciences at ETSU. Dr. Clark received his BS in Animal Science from Colorado State University, MS in Animal Science and Agricultural Biochemistry from the University of Delaware and his PhD in Nutrition from North Carolina State University (1980). He has held academic positions at South Dakota State University (1980–1983) and ETSU (2002 — present) and had an 18-year tenure at Eastman Chemical Company (1983–2001) with assignments in Research, Strategy, Technical Service, Sales and Marketing. Dr. Clark is the co-inventor of AquADEKs developed during his time with Yasoo Health Inc. (2001–2003) and is currently the Chief Technology Officer for RTD Neutraceuticals LLC which just recently launched their first product, Lavengel (lavengel.com). You may also know Andy as the killer rhythm guitar player for Bag a’ Cats, Tri-Cities hottest party band (now retired).

I learned an awfully lot when I first read Andy’s blog. I bet you will, too, unless you are an attorney. Thank you, once again, Dr. Andy Clark, for the below blog:

You have come up with a great idea for a new product and are ready to take on the world but have you thought about how you are going to protect your product from competitors and copycats?

Most entrepreneurs have a limited budget and spend the majority of their time and money on the development of their product, manufacturing process, quality control and preliminary marketing concepts but do not appropriate the time or money for protecting the intellectual property (IP) of their invention or product identity.  The reasons for not pursuing IP protection may seem valid at the onset of your project.  You may be short on cash and attorney fees for IP protection are expensive or you’re not sure if the market for your product is going to materialize and a number of other seemingly valid reasons.  Kathy Caprino, a senior contributor for Forbes magazine, has two great statements regarding intellectual property.

• “If you do not protect your intellectual property proactively and early, you might have to protect it defensively later.”

• “Register your copyrights on written works, including computer codes, screenplays, and artwork, and register them early.”

I agree with Ms. Caprino on the need to make protection of IP a significant focus of your product launch strategy.  In this blog I want to describe the IP options available to entrepreneurs or established businesses.

Trade Secret – A trade secret is different from doing nothing at all to protect your invention.  As the inventor you must do everything within your control to keep your invention a secret.  This means that you have to limit access to your manufacturing facility to employees only, employees must sign non-disclosure agreements as a requirement of their employment, vendors need to sign non-disclosure agreement to be a supplier to your company and you need to limit the number of people in your inner circle who know the trade secret.  Many companies have a grand opening day where they invite the community and potential customers to “show off” their new state of the art facility.  During a time in my career when I served as a liaison between Eastman Chemical Company and Harvard Business School I learned about a study that analyzed who shows up at grand opening days of new manufacturing facilities.  The study demonstrated that the list included an alarming number of competitors who wanted to see firsthand what you have and learn how they can compete with you.  Don’t open the door and invite competitors into your house to steal your invention. Some companies do an excellent job of protecting trade secrets.  The formula for Coca Cola (the original Coke) is a trade secret and is locked away somewhere safe in Atlanta, GA and has not been disclosed in any patent or other documents available to the public.  That isn’t to say that numerous formulation chemists have not worked diligently to reverse engineer the formula.  Many people claim that Walmart’s Coke knock off version is pretty darn close while Coke purists defend the original formula.  The point is that maintaining a trade secret is hard work and if someone is able to reverse engineer your product you better have a strong trademark, branding or market presence to survive.

Patent –   A patent is awarded by the US Patent and Trademark Office if there is sufficient evidence that the invention is novel and is not obvious to someone with ordinary skill in the art (subject matter).  The patent examiner will exam the prior art (other patents and disclosed intellectual property) and determine if the patent application is novel, has utility (useful from a practical standpoint and operable), non-obvious and enablement (patent application contains a specific written description of the invention that allows anyone skilled in the art to make and use the description in order to make and use the invention).  The historical purpose of the patent system was to encourage the development of new inventions and disclosure of the new invention.  This allows other inventors to “learn from your patent” and expands the development of other new ideas (inventors spring boarding from your patent) which helps the nation maintain scientific prominence.  In return for disclosing your intellectual property, the government grants a temporary monopoly to practice your invention. There are 3 types of patents.  Design patents are issued for new, original, and ornamental design and last for 14 years.  Plant patents are issued for the discovery or invention of new and distinct asexually reproducing plants and can last for 20 years.  Utility patents are the most common type of patents and can be related to “computer software, investment strategy, medical equipment, tools, chemical compositions, genetically altered life forms, and improvements” (https://www.justia.com).   Utility Patent life is no longer than 20 years from the date of the patent application and no shorter than 17 years from the date of issuance.

It took us a little over 2 years to convert our research about Lavengel® (lavengel.com) into a utility patent.  On February 9, 2021 our patent application, “Topical gel compositions for the treatment of Staphylococcal infections” was granted and gives us a monopoly to practice our art (invention) until May 17, 2039.  The cost of a utility patent is typically between $12,000 and $15,000 in patent attorney and filing fees and in addition you are required to pay patent maintenance fees at years 3, 7 and 11 after the patent issuance.  Just because you have a patent does not mean that no one will try to utilize your invention for their own product.  You need to defend your patent by sending potential patent infringers a “cease and desist letter” threatening them with a lawsuit if they continue to violate your patent.  A large company can violate your patent and then “paper” you with attorney letters forcing you to have your patent attorney respond to their letters creating a huge expense which you may not be able to sustain.  A great example of this is a 2008 movie called “Flash of Genius”, about Robert Kearns, a Wayne State University professor who obtained numerous patents for his invention of intermittent windshield wipers and his battle with General Motors.

Copyright and Trademarks – A copyright is a protection of your “artistic, literary or intellectually created works (novels, music, software code, photographs, painting that are original and exist in a tangible medium such as paper, canvas, film or digital format” (www.uspto.gov).  Rebecca copyrights her blog and that gives her the exclusive right to reproduce, distribute and display her and/or her contributors creative works.  Individuals can not copy or exploit the creation (blog) without her permission.  A copyright is indicated by the symbol © being placed at the end of your work.

Trademarks are a word, phase, design or combination that identifies your goods or services from your competitors.  According the USPTO you become a “trademark owner as soon as you start using your trademark with your goods or service.  You establish rights in your trademark by using it, but those rights are limited, and they only apply to the geographic area in which you’re providing your goods and service.” (www.uspto.gov).  A trademark is indicated by adding the symbol ™ after the word, phrase or design you are protecting.  If you want to have a stronger trademark you need to register the trademark with the US Patent and Trademark Office (USPTO) and this keeps others from using your trademark in an industry similar to yours.  Our product, Lavengel® is a registered trademark and can not be used by anyone else in a topical skin care market segment however, someone who owns a hotel that is surrounded by lavender plants could name and register their business as the Lavengel Inn and would not be subject to violating our registered trademark.

Conclusion – I firmly believe that you need to be intentional in protecting your intellectual property and creative works in order to give your business a chance to grow exponentially and without impedance from copycats and thieves.  Each business is different in how they plan to protect their intellectual property.  A patent may not be the best option for many businesses and if you are not granted a patent you may still have attorney fees exceeding $10,000 with no tangible property.  Entrepreneurs need to determine what their exit strategy will be for their business.  Are you willing to sell your business or merge with competitors or do you want your business to be a sustainable family run small business?  I do know that if your business is successful you will create more value in your business (e.g. – sales price) if you have received a patent protecting your intellectual property with time left on the patent.  Go out there and be creative and entrepreneurial and intentionally budget and plan for how you are going to protect your intellectual property and creative works.

Request:  We have good anecdotal data that Lavengel® is effective in treating acute and chronic radiation dermatitis that results from radiation treatment for breast and head and neck cancers.  We are currently writing a grant proposal to NIH for funding to prove Lavengel’s® efficacy in treating radiation dermatitis in a clinical trial but not all grant applications are funded (only about 5% at NIH).  If you know of someone who is going through radiation therapy for one of these cancers let them know that we will supply them with a free tube of Lavengel® in return for their assessment of how Lavengel® worked in treating their radiation dermatitis (radiation burn).  Contact me at Andy@Lavengel.com or text me at 423-676-5541.

Copyright, June 3, 2021 by Dr. Andy Clark and Rebecca Henderson.