By David Gornish, Esq.
Increasing numbers of physicians are finding that it literally pays to be patent savvy. Physicians unfamiliar with patent law would be doing themselves a favor to learn the basics, as it is never known when that “eureka” moment might come. In the United States there has been a recent surge in patent issuance due in part to the recognition that intellectual property (IP) protection can be a highly lucrative investment. People are, by and large, patent savvier than they used to be – and that needs to include physicians as well.
Although practicing physicians are first and foremost dedicated to patient care, increasing numbers are also taking on the role of innovators. Through patent protection, many physicians are reaping the rewards of their ingenuity. Some physicians affiliated with hospitals are named as inventors on royalty-generating patents, and are personally receiving a cut of the cash. Other physicians, including those not affiliated with hospitals, are discovering novel and marketable solutions to problems they encounter during the course of their practices. Many have obtained patents for their inventions, thereby establishing an additional source of revenue. Still, others have formed innovative medical device companies, attracting investors by creating a strategic patent portfolio.
Although a patent can be quite valuable, the path to obtaining one is arduous and fraught with complexities. This article provides a general overview of the patent process and highlights some issues particularly germane to physicians.
What is a Patent?
A patent is a temporary grant by the government giving its owner the legal right to stop others from making, using, or selling an invention. A patentable “invention” can be a new product or process, or improvement of an existing product or process.
As soon as a patent application is filed with the United States Patent and Trademark Office (USPTO), the invention that it covers is considered “patent pending.” This status does not give rise to any particular legal rights; however it still has many practical advantages, such as warding off possible infringers and giving clout when dealing with investors and potential licensees.
Criteria for Patentability
Once filed, the application undergoes rigorous examination to determine whether it complies with three main criteria: it must be (1) useful, (2) novel and (3) non-obvious.
A “useful” invention is one that has practical utility and that works for its intended purpose. Establishing that an invention is useful is typically the easiest hurdle to overcome. “Useful” certainly does not mean perfect, and can often be established with a minimal showing.
For mechanical devices, usefulness is often apparent based on patent drawings and descriptions. An actual prototype of a mechanical device is not needed to establish that it is useful. For other inventions, however, usefulness is less visually apparent. For example, recitation of a chemical formula for a compound does not establish that it has any particular practical medical utility. However, basic test data in the patent application can be sufficient to establish that such an invention is useful.
An invention is “novel” if it does not exist in the “prior art,” which includes publicly available written information or products that have been publicly used or sold. Often, before filing a patent application, the inventor will search the prior art, either through the USPTO’s website (www.uspto.gov), or public databases of medical literature, such as PubMed, to see if his or her idea is novel.
“Non-obviousness” is tricky and is often the greatest hurdle to overcome in obtaining a patent. Even if novel, a claimed invention may be rejected if it 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 ones. An invention can pass the non-obviousness test even if it is simple, and conversely it is not necessarily given that it will meet the requirement only because it is complex.
Often, a patent examiner initially rejects at least some of the applicant’s claims, usually based on at least one of the foregoing criteria for patentability. It is then up to the applicant to respond to rejections by amending the application and/or arguing that the invention is patentable. If the first response does not overcome the examiner’s rejections, the process may be repeated until a patent is ultimately granted, or the applicant abandons the application. On average, the time between filing an application and issuance of a patent is about two to three years, and a patent generally expires 20 years after the initial application date.
What to Watch Out For
There are many benefits and reasons for physicians to publish their research and ideas in medical journals, but there can be a downside to publishing from a patent perspective. “Prior art” includes (among other things) any publication describing an invention that was published more than one year before filing a patent application covering the invention. This means, for example, that a published article authored by an inventor can potentially be used to negate patentability of the inventor’s own invention.
Although the United States provides a one-year grace period between publication and filing for a patent, the patent laws of most foreign countries have no grace period at all. Thus, even if an article is published immediately before filing for a patent, most foreign countries would consider that publication to be “prior art,” which could preclude a patent from being obtained in those countries. Consequently, it is often best to file a patent application before publishing inventive ideas.
Physicians’ own actions can potentially preclude patentability of an invention in two additional ways, namely, by (1) publicly using the invention more than one year before filing for a patent, and (2) selling or offering to sell the invention more than one year before filing for a patent. One should be particularly careful regarding public use, as the law does not require a high level of publicity in order for such use to be regarded as “prior art.” Even though the United States permits a one-year grace period in which to file a patent application, it is still prudent to file a patent application before selling, offering to sell or publicly using the invention.
Who Owns the Patent?
Questions regarding ownership rights to an invention are best addressed prior to preparation of a patent application. If physicians have their own medical practices and develop inventions, they would normally own the rights to the inventions. If, however, they work for a hospital, chances are that the hospital would own the rights to any inventions they come up with. Most likely, there is an employment contract provision or an explicit hospital policy to the effect that IP developed by doctors during the course and scope of employment would belong to the hospital.
The flip side of the coin is that most hospitals financially reward inventor-physicians by giving them a percentage of royalties earned from their commercialized inventions. Moreover, hospitals usually cover the costs involved in patenting and commercializing inventions that they believe have merit. The cost of preparing and filing a patent application is typically in the $7,000 to $10,000 range – possibly more. Moreover, since patents are rarely granted on applications as filed, the costs involved in the entire process usually exceed, sometimes significantly, initial filing costs. Therefore, it is extremely important to check employment contracts and hospital IP policies before spending personal funds to pursue patent protection. If non-hospital-associated physicians will be spending their own money to obtain patent protection, they should compare the costs involved against the estimated commercial potential of their inventions.
Surgical Procedures and Other Methods of Treatment
Another area of particular interest to physicians is the patentability of medical methods, e.g., surgical procedures or methods of treatment (including new uses of existing drugs). In the United States, medical methods are patentable subject matter. The apparent catch-22 is that medical method patents cannot be enforced against doctors or hospitals. Naturally, the question arises as to what value a medical method patent has if it cannot be used to stop the very people likely to infringe.
The quick answer is that, while direct infringers (i.e., doctors) are shielded from liability for infringing medical method patents, indirect infringers (e.g., companies) are not. For example, where medical device companies or pharmaceutical companies design or promote their products specifically to be used in patented procedures or methods of treatment, the companies could be considered indirect infringers. Such companies may be inclined to purchase a license from the patent owner.
Patients of the Patents
Just as patients should be informed about proper nutrition and be aware of behaviors that are hazardous to their health, so should physicians understand the basic legal framework in which their inventive ideas can be protected. There needs to be a general understanding to identify potentially patentable ideas, spot red flags and avoid common pitfalls. However, once they have developed an invention, even if it is not necessarily “perfect” or complete, they are well advised to protect their interests by consulting with qualified patent professionals.
Obtaining a patent, even for a spectacular idea, is a formidable task. Success is more likely to come to physician inventors who understand the criteria for patentability, avoid prematurely publicizing their ideas, clear up ownership issues early on, and who are prepared to be in it for the long haul.
David Gornish, Esq., is an associate with Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd. in Philadelphia, Pa.