A "pure" medical or surgical procedure is a medical diagnostic procedure or treatment, or a method or process, where the "invention" is independent of the use of a medical device and drug. For more than a century these medical and surgical methods and processes for diagnosing and treating disease in both people and animals were not considered patentable. In 1952, Congress changed the patent law, adding to the list of subject matter which could be patented, of "new and useful processes." At the time, the clear legislative intent was to codify existing policy, not change it, and "pure" medical and surgical methods and processes were still not considered patentable.
Since 1952, however, the U.S. Patent and Trademark Office has been routinely issuing method or process patents for purely medical and surgical procedures not associated with any drug or medical device (hereinafter referred to as "Medical Procedure Patents"). Until recently, such patents were rarely enforced. During the past decade, however, the holders of some of these Medical Procedure Patents have actively sought to enforce them, and during the last few years, the number of Medical Procedure Patents has dramatically increased.
There are several compelling ethical and legal reasons for prohibiting the patenting of medical and surgical methods and processes.
1. Is it unethical for an orthopaedic surgeon to patent a medical and surgical procedure which is performed independent of a drug or device?
2. Does the granting of these Medical Procedure Patents pose a serious threat to medical advancement, medical education, and/or patient care?
3. Should the U.S. Patent and Trademark Office place a moratorium on the granting of these Medical Procedure Patents?
4. Should Congress amend federal law to prohibit the patenting of medical and surgical procedures which are performed independent of a drug or device?
The training of new physicians and continuing medical education for practicing physicians are based on the free sharing and passing on of knowledge, methods, and procedures. Since it is in the patent holder's interest to keep an "invention" a secret until the patent is granted, Medical Procedure Patents actually discourage doctors from sharing medical information openly. In addition, the enforcement of Medical Procedure Patents is a strong disincentive for physicians to share the results of their professional experiences and/or independent discoveries of similar existing methods with their colleagues, since this sharing may identify themselves for a potential target for infringement suits. Thus, the granting of Medical Procedure Patents undermines the process of peer review, evaluation, and critical appraisal of medical innovation within the medical profession.
It is possible for the medical community to reach an untenable situation, where all medical schools, and all medical and surgical societies or other entities providing medical education would be prohibited from teaching certain procedures or would have to pay a licensing fee to the inventor before teaching a course that includes the patented method. The cost of medical education also will increase if medical schools are required to pay royalties to patent holders to teach patented surgical and medical techniques. This serves as an additional disincentive to utilize Medical Procedure Patents.
Medical Procedure Patents unreasonably interfere with the practice of medicine and the physician-patient relationship. Enforcing such Medical Procedure Patents may compromise patient confidentiality since all procedures will have to be recorded. Also, patients may be denied access to certain procedures, and their choice of physicians may be restricted to only those doctors who are paying royalties to the original "inventor" of the process. Granting Medical Procedure Patents will adversely affect the quality of care, impede medical technology, and contribute to the increasing cost of health care.
In sum, Medical Procedure Patents impede the advancement of medicine, curtail academic access, compromise peer review, place unreasonable limits on the research community, directly interfere with the education of new physicians, and interfere with the physician-patient relationship and the quality of medical care provided to the patient. Under these circumstances, the patenting or protection of "pure" medical procedures or techniques is unethical. This position is consistent with the American Medical Association Report of the Council on Ethical and Judicial Affairs on the Patenting of Medical Procedures.
No medical method or procedure is really "new" or innovative. Instead, every advancement in medicine, and in medical methods or procedures builds on existing knowledge. Sufficient "prior art" exists in almost every instance where the U.S. Patent and Trademark Office has granted a Medical Procedure Patent. Seen in this light, the U.S. Patent and Trademark Office should not have even granted these patents. The consensus in the medical community is that no medical process is really new. Every method innovation is largely based on "prior art." Also, there is the real possibility of expensive litigation over whether a Medical Procedure Patent should have been granted in the first place. Such litigation has already occurred in this country and serves to increase the cost of health care generally.
The U.S. Patent and Trademark Office does not have the staff or expertise to identify "prior art." Moreover, most medical methods and procedures have not been patented, and consequently, the Patent and Trademark Office is ill-equipped to determine whether a process is new. In most instances, these medical and surgical processes have existed for years, and have been transferred from teacher to student through practice seminars, actual "hands-on" training, and through the medical literature. Therefore, the U.S. Patent and Trademark Office should place a moratorium on the granting of these Medical Procedure Patents until such time as it is able to more efficiently and effectively determine "prior art," and whether a Medical Procedure Patent application should be granted.
The consensus of the world community has been to ban these Medical Procedure Patents. More than 80 countries throughout the world expressly prohibit Medical Procedure Patents, including most European countries. The European countries and the United States are cosignatories of international trade agreements ensuring reciprocity, and for the U.S. to be in full compliance with these agreements, it should prohibit Medical Procedure Patents.
Because of the concerns raised by the medical community, in the 104th Congress, Rep. Greg Ganske, MD (R-Iowa) and Rep. Ron Wyden (D-Ore.) introduced a bill, HR 1127, to amend the current patent law to prohibit the patenting of medical and surgical procedures.
Consistent with the Code of Ethics and the Principles of Medical Ethics in Orthpaedic Surgery, and the American Medical Association's Report of the Council on Ethical and Judicial Affairs on the Patenting of Medical Procedures, the American Academy of Orthopaedic Surgeons asserts that it is unethical for orthopaedic surgeons to seek, secure, or enforce patents on medical and/or surgical procedures.
The granting of Medical Procedure Patents poses a serious threat to medical advancement, medical education, and patient care, as well as contributes to the spiraling costs of health care.
The granting of Medical Procedure Patents conflicts with the American Academy of Orthopaedic Surgeons' mission to promote and foster the provision of cost-effective, high quality medical care.
The U.S. Patent and Trademark Office should cease granting any more Medical Procedure Patents for medical and surgical procedures until such time as it takes to institute adequate safeguards to determine that there is no "prior art," rather than forcing physician defendants to prove "after the fact" that a Medical Procedure Patent should not have been granted.
The American Academy of Orthopaedic Surgeons supports HR 1127, legislation introduced by Rep. Greg Ganske, MD (R-Iowa) and Rep. Ron Wyden (D-Oregon) to amend the current patent law to prohibit the patenting of medical and/or surgical procedures, and urges that this legislation be approved by Congress and signed into public law by the President.
Legal and Ethical References
Applicable provision of the Principles of Medical Ethics in Orthopaedic Surgery. "IV. The orthopaedic surgeon must continually strive to maintain and improve medical knowledge and make relevant information available to patients, colleagues and the public."
Applicable provision of the Code of Ethics."IV.A.
The orthopaedic surgeon must continually strive to maintain and
improve medical knowledge and skill, and should make available
and colleagues the benefits of his or her professional attainments."
American Medical Association. Report of the Council on Ethical and Judicial Affairs, Patenting of Medical Procedures (Informational Report), June 1995.
U.S. Constitution, Art. 1, Section 8, cl. 8. Congress has the power to "promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."
35 U.S.C. 1101. Any "new or useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may be patented."