By Larry Storer

There are 80 countries that prohibit medical method or procedure patents. Only the United States and Australia allow this type of invention to be patented. The U.S. Patent and Trademark Office (USPTO) is so patent-friendly that foreign doctors come from their countries to patent their procedures here. Of the 100 patents a month granted by USPTO, about half go to foreign doctors.

The WMA “considers that the patenting of medical procedures is unethical and contrary to the values of professionalism that should guide physicians' service to their patients and relations with their colleagues.”  The WMA noted the differences between medical procedures and medical devices, concluding that the patenting of medical devices is acceptable;

            For 161 years, the American Medical Association (AMA) has also taken a strong position opposing medical and surgical procedure patients, stating that they are unethical and contrary to the philanthropic nature of the physician’s practice, which is a tradition expressed in the Hippocratic oath. The oath mandates that every physician must teach the craft of medicine "without fee or covenant."

            Code of Medical Ethics, Rule E-9.095 (V, VII) states: The patenting of medical procedures poses substantial risks to the effective practice of medicine by limiting the availability of new procedures to patients and should be condemned on this basis. Accordingly, it is unethical for physicians to seek, secure or enforce patents on medical procedures.

            The AMA’s position is that defining best medical knowledge and practice should occur through introduction and vetting at public lectures, collegial training, group discussion and publication in the profession’s peer-reviewed journals.

Patenting methods of treatment conflict with most of these goals according to doctors. The association of patents with patent medicines, for example, undermined medical credibility, and the purpose of patents was clearly trade regulation, profit and market control. Allowing doctors to patent medical methods has led to increased litigation with the resulting increase in the cost of the medical procedures and supplies. 

            The American College of Phlebology (ACP) position is that it would be inappropriate for the ACP to have a position on medical method patents, according to Executive Director Bruce Sanders;

 “We don’t have resolutions, statements or positions on medical method patents or the litigation around them,” Sanders said. “The ACP is a 501(c) nonprofit organization and our mission and purpose is education and research. It is not within our purview to have formal statements of support or non-support on the issue.”

AMA position

At the 2006 Annual Meeting of the American Medical Association, the House of Delegates adopted Resolution 1, “Trademarks, Patents, Copyrights, and Other Legal Restrictions on Medical Procedures.” This resolution requested the Council on Ethical and Judicial Affairs (CEJA) to study and evaluate whether there was an ethical difference between the use of patents for medical procedures and the use of various other legal devices to limit access to new medical procedures, a term that includes medical techniques and technical maneuvers. According to the AMA, the resolution also asked CEJA to study and evaluate whether to affirm Opinion E-9.095, “Patenting of Medical Procedures,” or to amend it to prohibit the use of other means, in addition to patents, to limit access to medical procedures.

The resulting report, issued June 1996 and based on the report “Ethical Issues in the Patenting of Medical Procedures,” (adopted November of 2007)  focuses primarily on trade secrets and confidentiality agreements because of the limited application that copyright or trademark law could have on medical procedures, including medical techniques.

Until the middle of the 20th Century, the Code of Medical Ethics contained a prohibition on the patenting of medical devices. The original 1847 edition of The Code of Ethics of the American Medical Association provided that “Equally derogatory to professional character is it, for a physician to hold a patent for any surgical instrument, or medicine….” Similarly, in 1903, 1912, and 1947, the AMA reaffirmed the prohibition against patents on surgical instruments, appliances, and medicines.

The AMA began to recognize the benefits of allowing physician-inventors to retain rights in inventions and the policy was revised to allow patents for devices by the mid-1950s, and later to allow for certain patents related to human genes. Notably, the opinion permitting patents on devices did not mention procedure patents. In fact, Opinion E-9.08, “New Medical Procedures,” added in the mid-1980s, provided that physicians should share knowledge, an indication that the medical profession remained somewhat ambivalent regarding the restrictions entailed by patents.

At the 1995 Annual Meeting of the House of Delegates, amid growing concern for the effect that procedure patents would have — especially in light of increasing numbers of these patents and lawsuits seeking enforcement — CEJA submitted a report entitled “Patenting of Medical Procedures.” This report laid out the basis for prohibiting the patenting of medical procedures and concluded that the best interest of patients and the profession militated against allowing such patents.

The corresponding Opinion E-9.095, “Patenting of Medical Procedures,” prohibits procedure and technique patents because such patents pose “substantial risks to the effective practice of medicine by limiting the availability of new procedures to patients and should be condemned on this basis.  Principle V of the AMA’s Principle of Medical Ethics, which lays out physicians’ ethical responsibility to contribute to and share scientific knowledge, is the foundation of this opinion. Preventing the dissemination of knowledge for financial gain or fame can have a negative effect on patients and would contravene Principle VIII.

U.S. patent law allows for the patenting of medical procedures. Essentially, “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” may be patented. However, in 1996, Congress passed legislation that protects medical practitioners and related entities from claims of infringement in specified circumstances. This provides limited protection for physicians and hospitals in the clinical use of patented medical procedures.

Trade Secrets and Medical Procedures

Protection for the discovery of a new medical procedure or improvement of an existing procedure is not limited to patents. Trade secret law, including contractual arrangements to prevent the dissemination of knowledge under what is known as a confidentiality agreement, can also be employed to limit the dissemination of new medical knowledge.

Trade secret law is based primarily on state law rather than a comprehensive federal act. It can be used to protect the same information as patent law — such as a device, procedure, or method of use — but it does not require the public disclosures that patents do. Essentially, if the person maintaining the trade secret can keep it out of the public knowledge, he can prevent another from using the subject of the trade secret. If the trade secret is made known through improper means, such as corporate espionage or a departing employee violating a confidentiality agreement, the person holding the trade secret may pursue damages for violation of this right and still be able to prevent the use of any information gained through the improper disclosure.

The responsibility to prevent disclosure rests with the holder of the trade secret. If the holder inadvertently releases information that others can rightfully discover, the trade secret will no longer exist. Additionally, if another person discovers the same device or procedure through legitimate means and makes that information publicly available, the trade secret will cease to exist.

The primary difference between a patent and a trade secret is that the public disclosure of a trade secret destroys legal protection, while the publicly available disclosure of the subject matter of a patent is required. Additionally, a patent lasts for a definite time while a trade secret lasts as long as there is a protected secret.

The Code of Medical Ethics contains policy that speaks to inhibiting the spread and use of medical knowledge. Opinion E-9.08, “New Medical Procedures,” presents a strong rationale for disallowing the use of trade secrets to protect medical procedures.

It states that “Physicians have an obligation to share their knowledge and skills and to report the results of clinical and laboratory research.”  Moreover, “The intentional withholding of new medical knowledge, skills, and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and society and is to be condemned.”

It could be said that trade secrets fall under this opinion, because their purpose is “intentional withholding” for “personal gain.” However, Opinion E-9.08 does not explicitly address this legal means. Likewise, Opinion E-9.095, “Patenting of Medical Procedures,” discusses the hindrance of dissemination of medical procedures, but is narrow in scope and does not address any legal theory other than patents. It provides that “The patenting of medical procedures poses substantial risks to the effective practice of medicine by limiting the availability of new procedures to patients and should be condemned on this basis.”

The justification for designating medical procedure patents as unethical is that dissemination of new medical knowledge will be inhibited, thus harming patients who might have benefited from the patented procedure.

This reasoning is even stronger for trade secrets: the end result of maintaining a trade secret is limited dissemination or none at all. Like patents, the holder of a trade secret can choose permissible uses of a procedure; unlike patents, the public can be prevented from obtaining the knowledge for future innovations. This limitation on medical knowledge presents additional dangers to patients by preventing others from reviewing or testing the procedure for safety and efficacy. VTN