Protecting inventions is complex, costly, crucial

In protecting your intellectual property (IP), patents are only part of the picture, according to experts. Other options include copyrights, trademarks and good old-fashioned business secrets.

Know your "why"

Before beginning the development process, said Las Vegas-based dermatologist Candace Spann, M.D., you must understand the "why" behind your product. "Your 'why' is the reason you're doing this. It's something you feel passionately about. You recognize a deficit or niche that needs help, and you commit yourself to this 'why,'" she told attendees at Cosmetic Surgery Forum (Las Vegas, 2014).

READ: Dermatologists in the United States

As part of your marketing story, "The 'why' is something you'll say over and over, so it must be something you believe." In the case of her ReTress product line, launched in late 2014, "The 'why' was that women with thinning hair have been largely ignored. And unfortunately, I was one of those women." When she started scouring remedies, "Everything was developed for men. And women's hair loss is different. It's not caused by dihydrotestosterone, as every other product on the market suggests. It's caused by inflammation, excessive shedding and decreased blood flow to the scalp, among other factors." Ultimately, she developed a drug-free product that's now available in nearly 100 stores and online.

NEXT: Be patient

Be patient

"Patenting is a very challenging process, at least for me," said Rhett Drugge, M.D., a Stamford, Connecticut-based dermatologist and cosmetic surgeon who has a patent for total immersion photography (Melanoscan). A patent can spring from a doctoral thesis – and can require as much work, he said.

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"From the inventor's perspective, patenting is an explication of what you have to an audience, so that they can see it as novel and new. And don't expect your patent to be accepted" on the first attempt. "It may take five years from the patent application to receipt of the patent," which is promptly published, essentially giving your recipe to potential competitors.

Additionally, "Before you patent, think about how many failures you'll experience before you get it right. Especially in the medical device world, there's a lot of opportunity for failure." However, he said, failures point the path toward success. He failed three times en route to developing a device worth patenting.

Embrace the process

Reasons to patent something include the fact that this process requires you to keep abreast of what's being developed in your chosen area, by searching in places such as google.patents.com, said Dr. Drugge. "It's a great starting place to learn about how your possible idea or invention fits in the context of the greater knowledge base. After all, society's benefit from your getting a monopoly via a patent is that you're going to confer a lot of knowledge on society. Conversely, people who have done patents are teaching you what they've done. Even if you don't go on to develop a patent, you should be an avid reader of patents in your area of expertise."

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From a practical standpoint, Carl Thornfeldt, M.D., said that in his experience, "Probably the biggest advantage of filing patents is that as I looked at other technologies, I could really understand how they were put together. That allows us to see better ways to do things." He is a Fruitland, Idaho-based private practitioner, founder and CEO of Episciences, Inc., and holder of 15 U.S. patents.

NEXT: Understand your patent rights

Understand your patent rights

Patents have driven America's pharmaceutical-industry dominance, said Dr. Thornfeldt. Dr. Drugge added that although he considers patents worthwhile in many instances, their protection has limits.

For starters, said Kevin C. Smith, M.D., a board-certified dermatologist in Canada (Niagara Falls, Ontario) and the United States, patents confer negative rights. "A patent allows you to stop someone else from using your invention, but does not actually give permission for you to use the invention. There are many other patents out there. For you to use your invention, you may have to use several other people's inventions and IP. You may have to obtain agreements from them" to do so.

Among patent types, Dr. Thornfeldt said, "Composition of matter patents are the most powerful." Broadly applicable, a composition of matter patent applies to a novel mixture or chemical combination of materials, various online sources say.

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Dr. Smith also encouraged attendees to consider use patents, which cover new applications of existing inventions. "Dermatologists do that a lot. We make observations about existing drugs which have new uses, and away we go."

Use patents can grow from a notion as simple as using Bag Balm (Vermont's Original, LLC) to help bald men grow hair, Dr. Smith said. Likewise, "140 conditions are now treated with Botox (onabotulinum toxin A, Allergan). Many of those are subject to use patents," held by Allergan or the application's originator. Therefore, Dr. Smith said, "If you think you have a new use for botulinum toxin, for example, write up your idea and observations in as much detail as possible. Search the medical literature, then get advice from a patent attorney, which can cost you $1,000 to $10,000," which is tax-deductible.

NEXT: Read the fine print

Read the fine print

Any IP-related agreement you sign can come back to bite you, said Dr. Smith. These include nondisclosure, consulting, industrial secrets and clinical-trial agreements, all of which may be written more broadly than one expects. "In one extreme case, an agreement would have had me sign over all my rights to any IP I created in the future, which was ridiculous."

Dr. Thornfeldt added that he sometimes tussles with universities over IP. If any aspect of a development project – even a miniscule assay – is done on university property, he explained, a university may demand half of the patent rights, "Even though you did 99.8 percent of the work." Accordingly, Dr. Smith advised young dermatologists and dermatology residents to immediately start keeping a central file that includes a copy of every IP agreement they sign. That way, "If your patent attorney wants to review these 15 years from now, they can see whether or not you signed away some of your rights."

Prepare to spend time and money

Dr. Thornfeldt said his first U.S. patent cost $110,000; since then, the cost has more than doubled. "Even once you get your patent," added Dr. Drugge, "you have to pay to maintain it" and most likely defend it court.

"The real killer is policing – and going into the national and international courts," said Dr. Thornfeldt. "It's amazing how much we spend chasing down companies that are using our technologies without any kind of agreements."

Furthermore, said Dr. Drugge, up to half of patents are allowed to lapse because the ideas they protect no longer hold value. "A patent may be superseded by another invention. So patents are a very high-risk zone. A very small minority of them actually create commercial value for their inventors."

Other methods of protecting intellectual property that Dr. Drugge said are more widely used by business leaders include the following:

• Trademarks – Dr. Spann said that because the Food and Drug Administration considers drug-free ReTress a beauty product, "I was advised by three different patent attorneys to trademark ReTress, because in the beauty industry, patents can be easily circumvented." As with patents, she said, securing a trademark was a costly, grueling process. As such, "Be prepared to make a large infusion of your own money. Investors are going to want a large portion of your company in exchange for very little money. So decide what you're comfortable with, and stick to your guns. In the beginning, somebody offered me $100,000 for 70 percent of the company. No thanks." Once your company starts growing, she added, "There will be a time when you'll need some help from investors. So if you give away all of your company in the beginning, you won't have anything to offer investors later."

• Copyright – This protection lasts 70 years after the copyright author's death, said Dr. Drugge, versus 20 years from issuance date for patents. Dr. Thornfeldt added, "You can prolong your patent by filing a one-year provisional patent, which costs less than $1,000, or prolong protection every 18 months by filing a continuation in part (CIP) patent." Adding new data and technology also can extend patents. "For example, we found that one of the key inhibitors in the pigmentation pathway also plays a role in inflammation, and we're now able to add anti-inflammatory data and more clinical studies" to extend one of his company's patents.

Less formal but still widely used means of protecting IP include keeping proprietary secrets and achieving superior sales and service in one's chosen market, added Drs. Drugge and Thornfeldt.

Dr. Thornfeldt is the inventor of the Epionce skincare line and a shareholder in Episciences, Inc. Dr. Drugge is inventor of the Melanoscan device. Dr. Spann is creator of the ReTress product line. Dr. Smith reports no relevant financial interests.

NEXT: References

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