Excerpted from The Biggest Legal Mistakes Physicians Make: And How to Avoid Them
Edited by Steven Babitsky, Esq. and James J. Mangraviti, Esq. (©2005 SEAK, Inc.)
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Physicians are natural problem-solvers, often highly creative ones. Solving problems in new and unexpected ways can result in inventions entitled to patent protection. Obtaining a patent, though, is an arcane and formidable process. Physicians who make mistakes in this area may miss chances to protect their inventions and to profit from them.
Mistake 1 Not Realizing That One Is an Inventor
The first step in the patenting process is to invent something. Invention, according to the patent laws, takes place in the mind, not in the laboratory: Physicians have invented something if they have formed in their mind the definite and permanent idea of the complete and operative invention as it would be applied in practice, a process the patent laws call “conception.” Either converting what one has conceived into a working prototype or describing the invention in a patent application filed with the U.S. Patent Office (the PTO) counts as “reduction to practice” in the patent laws. While a physician must reduce his or her invention to practice to obtain patent protection for it, conception makes the physician officially an inventor.
Action Step Physicians should be attuned to their own creative efforts so that they can recognize when they may have conceived something innovative. Documenting their work in a journal or lab notebook may help them appreciate their own conceptions and distinguish them from reductions to practice.
Mistake 2 Not Understanding Who Owns an Invention
If a physician invents something that becomes patented, that physician owns the rights that the patent conveys, no matter where he or she stands in the medical hierarchy. Others who co-conceive the invention are co-inventors and thus are co-owners of the patent. U.S. patent laws grant each co-owner full rights under the patent, including the power to license or sell those rights to others. Other contracts the physician inventor has signed or policies that bind the physician might obligate the physician, however, to transfer his or her rights of ownership to someone else, for example to an employer as a condition of employment or to a university by virtue of a faculty appointment.
Action Step Once physicians realize that they may have invented something, they should track down and review the agreements or policies that could affect their ownership interest. This may be a good time to obtain advice from an attorney experienced in patents and their ownership.
Mistake 3 Not Giving Credit Where It Is Due
Because inventing something gives the inventor an ownership interest in a patent to that invention, physician inventors should sort out who contributed what throughout the invention’s development. The process of developing a technology may involve many participants, not all of whom are inventors (see Mistake 1). Many members of a technology team may be listed as authors on a scientific paper describing an invention, but such authorship does not imply inventorship or any ownership interest in a patent covering the invention.
Action Step Physicians should identify the contributions of all team members early in the development of an invention, so that their proper roles can be recognized. Lab notebooks or other contemporaneous recordkeeping can be helpful in this process.
Mistake 4 Not Seeking Patent Protection for an Invention
By not seeking patent protection when appropriate, physicians may inadvertently give up the right to do so later. The U.S. patent laws specify what is patentable: The invention must be useful, novel (i.e., not already disclosed, in use, or on sale), and nonobvious (i.e., not apparent to others in the field based on the state of the art). These apparently straightforward terms have sufficient legal complexity that they may not be helpful to the physician inventor trying to figure out if an invention is patentable. Even if the invention appears patentable, the inventor may become intimidated by the process of seeking patent protection, thereby losing the opportunity for patenting.
Action Step Physicians who believe that they have invented something potentially patentable should seek advice promptly about whether to seek a patent. A temporary patent application, called a “provisional patent application,” can preserve a physician’s rights for a year while he or she decides whether to file a formal application.
Mistake 5 Publishing, Then Perishing
Inventive academic physicians face conflicting obligations: inform colleagues about their scientific discoveries, or protect their inventions under the U.S. and foreign patent laws. Publishing an article, posting an online abstract, presenting at a conference, or any other sort of public disclosure can eliminate foreign patent rights and can start a one-year time clock for filing a U.S. patent application. Physician inventors need to balance the importance of free academic communication against the unforgiving barriers that the patent laws impose on such disclosures.
Action Step Physicians should keep their discoveries and possible inventions to themselves until they have determined that they do not want to patent them or until they have applied for patent protection, even with a provisional patent application. If in doubt, they should keep quiet and obtain legal advice.
Mistake 6 Not Getting Advice Early
The U.S. and foreign patent laws are highly specialized. Many of the mistakes already mentioned—along with others—can be avoided if the physician obtains good legal counsel at the outset. A valued resource for academic physicians is the university’s technology transfer office, where licensing professionals work with inventors to obtain proper patent protection and to arrange the commercialization of their technologies.
Action Step A patent attorney or a patent agent can advise physicians about their invention and the patenting process. Physicians who are faculty members may be able to obtain advice from their institution’s technology transfer office, and those physicians may have an obligation to inform that office of any inventions they create.
Mistake 7 Not Pitching in With the Paperwork
Doctors are generally allergic to paperwork, and the patent world is paperwork intensive. Still, there are at least two good reasons to be directly involved in the paperwork part of patenting an invention. First, physician inventors know their invention better than anyone else and are therefore likely to be the best at describing it to the PTO, using words or diagrams as necessary. Even if that description is not the final one, they can provide key technical information for the patent attorney who is writing the application. Second, physician inventors know their field, so they can tell which features of their invention are importantly different from the work others have done, work that is collectively termed the “prior art.” Physician inventors may even decide to research the field ahead of time to see if others have disclosed or patented something similar. A good place to start searching for other patents and published applications relevant to a physician’s invention is the PTO database (at www.uspto.gov).
Action Step Physicians should take a hands-on role in the paperwork necessary to patent their invention. They will obtain better patent protection that way, and the process will be more economical.
Mistake 8 Not Reading the Fine Print
For many doctors, legal documents are nothing but fine print that they do not want to read. But doctors ignore such documents and the contents of those documents at their peril. For example, physician inventors will encounter certain legal documents during the patenting process that they are required to read, understand the contents of, and state officially to the PTO that they have done so. In addition, certain legal documents (e.g., consulting agreements, licenses, and assignments) can affect a physician’s ownership interests in an invention or a patent. Inventors who do not read these documents before signing them may be giving up important rights they could have bargained for had they just been aware of those rights. Physician inventors also become bound by what they have signed in such commercial agreements. Breaching an agreement’s term can have severe economic consequences not offset by the liability insurance that doctors traditionally carry.
Action Step Physician inventors must read legal documents before signing them, making sure they understand what the documents mean and how the documents obligate them. An attorney familiar with the patenting and commercialization process can be a useful ally in this regard.
Mistake 9 Misunderstanding One’s Patent Rights
Physician inventors might assume that having a patent allows them to make, use, sell, and offer for sale the invention it covers, but they would be wrong. A patent is a negative right, preventing others from practicing someone’s invention. It is not a positive right that allows the inventor to practice it himself or herself. Others may hold patents that prevent a physician inventor from making or using his or her own invention. These patents, called blocking patents, might be extremely broad, pioneering ones that cover the entire technical field, or they might cover an essential component of a physician’s invention. In either case, no one is able to commercialize his or her invention without dealing with blocking patents. It may be necessary to obtain a license from whoever holds them, or it may be necessary to modify the commercial product to design around the blocking patents.
Action Step An issued patent sets forth in its claims precise and technical statements of what the patent covers. This is where to look in order to figure out whether a third-party patent covers an invention. By searching for issued U.S. patents that could cover his or her invention and then examining their claims, the physician can determine whether any blocking patents may present problems. The searchable PTO patent database (at www.uspto.gov) is a useful tool for this investigation.
Mistake 10 Not Anticipating the Future
After a physician’s creativity has produced an invention and the physician has been able to patent it and even to reap some commercial benefit from it, that creativity should not stop there. The physician should try looking into a scientific crystal ball to figure out how the invention might evolve and to identify potential opportunities. The more the physician can anticipate, the more possible gains he or she can capture in agreements the physician negotiates. By not anticipating the future, the physician may be missing opportunities that only he or she could identify.
Action Step Physician inventors should keep their creativity engaged throughout the patenting process, projecting how they or others might develop the technology. That way, they may be able to capture these ideas in a separate patent application or to structure an agreement for commercializing the present invention so that they retain control over how they develop it in the future.
Physicians who make the mistakes described in this section may miss their chances to protect their inventions and profit from them.
Sharon Webb, MD, PhD, Esq.
Peer reviewed by:
Stephen G. Charkoudian, Esq.
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