By Brenna Legaard, JD, and Robert N. Lyman, JD
A general understanding of patent law is key
Surgeons are prolific inventors. They are smart, understand how things work, and are focused on solving problems. In our practice as patent attorneys with many surgeon-clients, we have found that surgeon/inventors frequently test their devices before consulting a patent attorney. They want to know if their inventions work and whether the substantial cost of getting a patent will be worth it. The problem is that they can permanently lose their rights to a patent during this testing period if they do not take appropriate steps.
Consider two hypothetical surgeon-inventors. Both invent a novel implantable medical device. Dr. Smith, unsure of its effectiveness, uses it on several consenting patients to test it and discover possible improvements, documenting the results according to accepted clinical procedures.
Dr. Jones, however, promptly begins selling both the design and copies of the device to her colleagues for use on their patients.
If Dr. Jones doesn’t hurry to a patent attorney, she will lose all rights to a patent in a year. So far, however, Dr. Smith probably faces no deadlines at all. What is the difference and what does it mean to you?
Rules governing patents
The Patent Act contains no deadline for filing a patent on your invention so long as you do not publish about it, use it in “public,” or offer to sell it. Doing any of these things starts a 1-year clock; if you do not file a patent application within that year, you lose all rights to a patent.
Publication means describing the invention in “printed” form anywhere in the world. Publication could be as simple as a Web page featuring drawings, or as formal as an article in a peer-reviewed journal. Publication also includes blueprints or design specifications made widely available, as Dr. Jones did. Depending on the circumstances, disclosing a research proposal to an institutional review board (IRB) for approval can also be considered publication.
“Public use” means virtually any nonexperimental use of a novel device inside the United States. A medical implant is in public use if the patient leaves the operating room. Even a novel surgical tool, which itself stays within a doctor’s office, is in public use if its products—healthy patients—are permitted to venture into public.
Placing an invention “on sale” requires only a bona fide commercial offer to sell an invention that is “ready for patenting.” An invention is “on sale” if you offer to sell it—even if you don’t have any inventory or the manufacturing capacity required to make good on the offer.
The experimental use exception
The experimental use exception enables you to evaluate the new device without starting the clock. Although not all experimentation counts as “experimental use,” guidelines do exist.
For example, when you operate on a patient using a new device, you should follow up especially carefully. Do not permit others to participate in experiments unless they are employees or so closely associated with your practice that they may fairly be called co-inventors. Do not send your invention to other doctors to try.
Good recordkeeping is also essential, because genuine experiments are aimed at confirming that a device works or discovering improvements, two things that are impossible to prove without records. Changes or improvements to the device will tend to support a finding of experimentation, but they must be incorporated into the patent or they will not count.
Legitimate experiments might not qualify as “experimental use” under the patent law. For instance, the U.S. Food and Drug Administration might require that a novel plastic implant be tested to determine if it is hypoallergenic. Although certainly experimental in nature, this is not “experimental use” under the patent law unless the plastic itself is the subject of the patent. If the design, rather than any particular material, is being patented, experimentation ends when the design is proven.
Dr. Smith is clearly engaged in experimentation, given that he has used the device on only a few patients with whom he follows up diligently, and has kept careful records. Dr. Jones is selling copies of her invention to others with no attempt to maintain control.
Charging for use
Patents have a limited lifespan and the courts frown on attempts to extend those limits by early commercial exploitation. Thus, commercial sales of an invention start the 1-year clock ticking. But because the patent system recognizes that it may be necessary to test an invention in the real world and to recoup costs, “experimental sales” are possible. Such sales must be “incidental to the primary purpose of experimentation” rather than profit-oriented. Thus, an experimental sale of a device that is otherwise “ready for patenting” must be a noncommercial sale.
The other requirements of experimental use (such as regular inspection and record keeping) must also be present. In at least one case, an orthodontist who charged a regular professional fee for the fitting of a novel dental appliance was held by a court to be engaged in experimentation, and similar logic might apply to a surgeon. Because of the exchange of money in a sale, however, experimental sale is riskier than uncompensated experimental public use.
Dr. Smith may have started his 1-year clock ticking if he charged his patients for his services. Because all the indications of experimentation are present, however, he can probably protect himself from the on-sale bar.
Dr. Jones has sold her device commercially to other doctors; this is definitely not experimental use, and she will have to hurry to a patent lawyer if she wants to protect her idea.
Follow these best practices
If you have a new idea, you should first talk to a patent attorney—even before you decide whether to file for a patent. A patent attorney can offer guidance as to how to develop your idea and what deadlines you may face.
Second, consider delaying publication of ideas and results.
Third, do not sell an invention except in the very limited context of using it on a paying patient. Do not sell your device to other surgeons.
Fourth, be sure to carefully document any experiments conducted, whether on live patients or in other media, such as cadavers. If you seek IRB approval for an experimental use, be especially diligent in your record keeping. Maintain physical control over your invention to the extent practicable. Proper clinical protocols and thorough documentation will go a long way to show that your work was a true experiment.
Finally, tell your patent lawyer everything there is to know. As medical professionals, you should be well aware of the consequences of failing to reveal relevant facts. Patents issued based on erroneous information may be invalid, and if the concealment was intentional rather than accidental, the patent will be unenforceable. Your lawyer can tell you what impact your activities may have had on your rights. But your lawyer can only give good advice if he knows the entire history of the device’s conception, testing, publication, and sale, so hold nothing back.
Brenna Legaard, JD, is a partner at Chernoff, Vilhauer, McClung & Stenzel (Portland, Ore.), which specializes in intellectual property law including patent prosecution, licensing, and litigation relating to patents, trademarks, copyrights, and trade secrets. Robert N. Lyman, JD, is an associate with the same firm.