Basic patent law for the inventive endodontist
Michael J. Berkowitz, Esq., explains different patents and how they work
During the course of your professional practice, or in doing research in the field of endodontics, have you ever thought of a unique method for treating your patients or a device that would benefit your patients? Have you ever thought of a new product that would make life better for dentists or endodontists? If so, imagine how nice it would be if you could be paid for your ingenuity. The best way to capitalize on your creativity is to obtain a patent for your invention. Many endodontists and other medical and dental professionals have been doing this for years, and very successfully.
Endodontics has evolved and changed over the years. Great advancements in endodontics were made during the first part of the 20th century with the introduction of x-rays, more effective anesthetics, and a host of new root canal medicaments. These advances made endodontic treatment more predictable and more comfortable for the patient. Since that time, advancements have continued to make endodontics the simpler and less time-consuming process it is today. Instrumentation such as the Giromatic handpiece and later forms of rotary instruments for enlargement and debridement of canals have been developed and introduced. Nickel titanium has been incorporated into specialized endodontic files and high-torque handpieces. A natural latex material known as gutta percha became a favorite material for sealing and filling after root canal therapy. Ultrasonic units with specially configured tips and superbly accurate microchip computerized apex locators have totally changed the way endodontics and endodontic surgery are practiced. Improved visibility is now available with the advent of the endodontic microscope. Cone-beam imaging is proving a valuable tool for endodontic diagnosis and treatment. Today, the single-visit endodontic therapy concept is almost globally accepted, as it diminishes discomfort and improves results.
The art and science of endodontics has advanced considerably, and many of the foregoing advancements may have been protected by patents or other forms of intellectual property. This article discusses the basics on how to obtain a patent, as well as other issues commonly faced by endodontists with inventive ideas.
What is a patent?A patent is a document, issued by the federal government, granting to its owner a legally enforceable right to exclude others from practicing the invention described and claimed in the document. There are three types of patents available in the United States: (1) a utility patent, which covers the functional aspects of products and processes; (2) a design patent, which covers the ornamental design of useful objects; and (3) a plant patent, which covers a new variety of living plant. Each type of patent provides “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or importing the invention into the United States (See 35 U.S.C. 271[a]). It is important to mention that although a patent grants these “exclusive” rights, it does not grant the right to make, use, offer for sale or sell or import the invention. In other words, a patentee may not be permitted to make, use, offer for sale, or sell, or import his/her own invention if doing so would infringe on the prior patent rights of others. For example, many inventions are improvements of prior inventions that may still be covered by someone else’s patent. If an inventor takes an existing, patented mouse trap design, adds a new feature to make an improved mouse trap, and obtains a patent on the improvement, he or she can only legally build his or her improved mouse trap with permission from the patent holder of the original mouse trap, assuming the original patent is still in force. On the other hand, the owner of the improved mouse trap can exclude the original patent owner from using the improvement.
Patents protect certain categories of patentable subject matter. What counts as patentable subject matter is rather broad and includes articles of manufacture, compositions of matter, processes, devices, business methods, software, improvements on existing products, and many other things. In fact, one court described patentable subject matter as “anything under the sun made by man.” The term of the patent ends 20 years from the date of filing of the patent application. When a term ends, or the patent is held invalid, the right to exclude ends, and the public benefits from the technical advancement.
Since 2005, over 200 patents and published app-lications use the term “endodontic” or “root canal” in either the title or abstract sections of these documents. This demonstrates that endodontics is an active field of innovation, and inventors in this field understand the importance of protecting this innovation. Among these are patent documents covering an endodontic instrument for performing root canal therapy (US Pat. No. 7,806,690); a method of producing cut blades for instruments used in root canal treatment (US Pat. No. 7,785,174); an endodontic file with multi-tapered flutes (US Pat. No. 7,731,498); an interactive patient education system (US Pat. No. 7,658,611); a method for filling and sealing a root canal (US Patent No. 7,320,598); a root canal plugging apparatus for dental work (US Pat. No. 7,008,222); methods and kits for maxillary dental anesthesia by means of a nasal deliverable anesthetic (US Pat. No. 6,413,499); a method and apparatus for apical detection with complex impedance measurement (US Patent No. 5,759,159); a measuring device for the length of a root canal (US Pat. No. D601,262); and a non-biodegradable endodontic sealant composition (US Pub. No. 2010/0203482). The foregoing demonstrates that endodontists and other medical and dental professionals have already come to recognize the value of intellectual property as a means for protecting their inventions and generating revenue streams.
How do I get a patent? In the United States, the first step to obtaining a US patent is to file a patent application with the US Patent and Trademark Office (USPTO). The application undergoes rigorous examination by a representative of the USPTO known as a patent examiner. The patent examiner’s job is to decide whether the invention comports with criteria for patentability and whether the format and content of the patent application complies with requisite formalities. The application process commonly involves back-and-forth arguments and negotiations between the patent examiner and the patent attorney who represents the applicant/inventor. On average, it takes about 2 to 3 years for a patent to issue after the application has been filed. Some patent applications never ultimately issue as patents, either because the invention is not patentable or because the inventor simply gives up after the patent examiner has rejected the application multiple times. Patents generally expire 20 years from the date of filing. Once a patent expires, it is in the “public domain,” i.e., its owner can no longer stop anyone from making, using, or selling the patented invention.
Is my invention patentable?Patents are only granted for (1) useful, (2) novel, and (3) non-obvious inventions. A useful invention is one that has practical utility and that works for its intended purpose. An invention is novel if it does not exist in the “prior art.” Prior art is virtually any publicly available written information, such as that found in patents, journal articles, textbooks, technical treatises, advertisements, etc. Prior art can also be actual products that have been publicly used or sold. Thus, if your invention was described in a medical journal, or is already on the market, it is not novel. Non-obviousness is tricky and is often the greatest hurdle to overcome in obtaining a patent. Even if your invention is novel, your patent application may be rejected if your invention is deemed to be “obvious to a hypothetical person of ordinary skill” in the relevant technical/scientific discipline. Due to the elusive nature of that inquiry, it can be difficult to tell whether an invention is obvious under the law. Patents have been granted for some seemingly simple inventions, yet rejected for very complicated inventions. Therefore, if your invention passes the novelty test, don’t necessarily conclude that it is obvious only because it is simple.
If I work for a university or an academic hospital, do I own my invention, or does the university or hospital own it?
The general rule is that the inventor owns the patent for his or her invention. If you are in private practice, you ordinarily own the rights to your invention. However, often, especially for professionals who are employed by universities or hospitals, the general rule may not apply. The two most common situations in which you would not own the patent for your invention because of an employment relationship are: (1) due to express assignment; or (2) you are considered hired to invent. If you are employed by, or otherwise affiliated with a health entity, e.g., hospital, group practice, etc., check your employment contract. Universities and academic hospitals usually have specific intellectual property (IP) rights provisions in their physician employment contracts or reference these provisions as part of their policies and procedures manual. If none of these apply, the next question is whether you are considered hired to invent. This is a bit of a grey area, as it depends on the nature of your practice. For example, if your practice is purely clinical, then you are arguably not “hired to invent.” On the other hand, if you are primarily engaged in research, especially at a university hospital, you may be hired to invent. Determining early on who owns the rights to an invention is important. Why? For one, you do not want to spend money to patent an invention that does not belong to you. Moreover, hospitals will often pay for costs associated with obtaining a patent and commercializing your invention. Many hospitals have IP policies that reward doctors with royalties for their patented and commercialized ideas. Such policies often create win-win situations for doctors and hospitals. You should check your employment contract and your employer’s IP policy before spending your own money to obtain a patent.
Is getting a patent worth it?This depends on your goals and your budget. A patent is arguably the strongest and most comprehensive IP protection. However, patents should not be sought on a whim. Before you rush to file a patent application, you should weigh the costs of obtaining a patent against the benefits of having one. In terms of benefits, you should do a market analysis to assess the value of having the legal right to stop others from making, using, or selling your invention. You also may want to investigate the relevant prior art to determine whether your invention is patentable. Such an investigation, known as a “prior art search,” is never foolproof, but it is nevertheless helpful and can save money in the long run. In terms of costs, the process of obtaining a patent is not cheap. Expect to pay no less than $7,000-$10,000 for the preparation and filing only of a patent application—more if the invention is very complex. Because patents are rarely granted on applications as filed, the final patent grant is usually the product of back-and-forth negotiations between the inventor’s attorney and the patent examiner. Thus, it should be expected that costs for ultimately obtaining a patent will exceed initial filing costs. The costs (and feasibility) of enforcing the patent also needs to be considered. Because a patent confers exclusionary rights, it may be worthless without the ability to enforce those rights. Enforcement may require litigation against infringers or alternative dispute resolution. Patent litigation is a game for players with deep pockets. Any decision to patent must include an assessment of whether the patentee can afford to enforce the patent.
Depending on the nature of your invention and your business, you may want to consider alternative (and perhaps less costly) ways to protect your intellectual property. For example, some inventions can be protected as trade secrets. A trade secret is any commercially valuable information (including how to make a product or how to perform a process) over which the owner takes reasonable steps to keep secret. One successfully kept trade secret is the formula for Coca Cola®. Depending on the circumstances, trade-secret protection may be less expensive than obtaining patents. And, unlike patents, trade secrets can theoretically last forever (as long as they are kept secret). On the other hand, trade-secret protection only stops others from improperly obtaining and using your trade secret, such as by stealing it from your files or by divulging it to someone else in breach of a confidentiality agreement. This means that if someone else independently makes the same invention—or even reverse engineers your invention—trade-secret protection cannot help you. Furthermore, you cannot have a patent and a trade secret covering the same invention—you must choose between the two. You should weigh the pros and cons of trade-secret protection versus patent protection before obtaining a patent.
Is there anything I can do to jeopardize my ability to get a patent? YES! BE CAREFUL! There are several things you can do to jeopardize the “novelty” and hence patentability of your own invention. If more than 1 year before the filing date of your patent application you: (1) publicly use your invention, (2) sell or offer to sell your invention; or (3) publish your invention in a printed publication (e.g., a medical journal), you are no longer entitled to a patent. If this sounds harsh, consider that the United States gives you this 1-year grace period, whereas most foreign countries have an absolute novelty bar, i.e., you automatically lose the right to obtain a patent once you publicly use/sell/publish your invention any time prior to filing for a patent. Do not depend on the 1-year grace period if there is a chance that you will be seeking foreign patents.
Points to keep in mind(1) File a patent application as soon as is reasonably possible. Once you have filed, you will not lose your patent rights if you subsequently publicly use or sell or publish your invention. (2) Be very careful about public use. Even some “secretive” uses can be considered “public use,” e.g., using a method of medical treatment on a patient, even where the patient does not know exactly what you did. (3) Before you publish, make sure that you will not be unknowingly relinquishing potential patent rights. (4) Patentable utility (in contrast with, e.g., FDA safety and efficacy requirements) is a low standard and often does not require extensive testing, much less public use and experimentation. Thus, try to file for a patent before doing any public testing. That said, to the extent you feel you must engage in a public use prior to filing for a patent (e.g., conducting clinical trials), you may be able to convince the patent examiner that your public use does not preclude novelty because it was necessary in order to establish patentable utility. The “experimental use exception” is not rock solid (do not depend on it to save the day), but in certain situations, it may be all you have to avoid a patent-barring public use. Some guidelines to follow include: (a) To the extent testing can effectively be done privately, do it privately; (b) Have written confidentiality agreements with those involved in the testing; (c) Maintain detailed records of the progress of experiments; (d) Conduct or control testing yourself, to the extent possible; (e) Conduct as few tests as possible; (f) The testing must be technical in nature—testing marketability is not “experimental use”; and (g) The public use should not be for profit.
If I get a patent, how can I make money from it? A patent is literally a piece of property. Like any other type of property, some patents are more valuable than others. To the extent that the exclusive rights over your invention conferred by your patent have commercial value, you can do one of three things with your patent: (1) You can assign (i.e,. sell) it to another person or company, e.g., for a lump sum, installments, or a combination. (2) You can license it to someone else. If you license your patent, you still own it, but you are contractually bound to permit the licensee to exercise certain rights in the patented invention. In exchange, the licensee usually pays you a royalty, e.g., percentage of sales over specified increments of time. (3) You can choose neither to assign nor license it. You can keep it all to yourself and use it to give value to your business by preventing competitors from selling your invention.
What is a nondisclosure agreement?In advance of disclosing your invention to someone else, such as a potential licensee, it is important to obtain from that person an executed nondisclosure agreement. By using a nondisclosure agreement, you can ensure that your invention stays secret—or have legal recourse if the invention is misappropriated or disclosed to the wrong parties. A nondisclosure agreement (or a confidentiality agreement) is a contract in which the parties promise to protect the confidentiality of secret information that is disclosed during a business transaction.
If you have questions about this article or its contents, please contact Michael J. Berkowitz, Esq., at (215) 567-2010 x132 or
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. The content of this article is intended for informational purposes only and is not to be understood as giving legal advice or opinion.
BioMichael Berkowitz is a partner with the firm of Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd., in Philadelphia. He focuses his practice on all aspects of Intellectual Property law, including federal and state litigation, appeals, patent and trademark prosecution, licensing, and client counseling. Registered to practice as a patent attorney before the US Patent and Trademark Office, Mr. Berkowitz has represented clients before the US Trademark Trial and Appeal Board and the US Patent and Trademark Office Board of Patent Appeals and Interferences. Mr. Berkowitz is a leader in a number of professional and community organizations. In 2007, he was elected to the Board of Governors of the Philadelphia Bar Association and currently co-chairs its Intellectual Property Committee. Before becoming an attorney, Mr. Berkowitz worked for 5 years as an engineer with the Space Systems Division of the General Electric Company.