Some Physicians and Surgeons Seek to Apply Patents to Techniques
Product patents for medical devices and drugs are common. However, the U.S. Patent and Trademark Office only rarely granted patents for medical and surgical procedures before 1954. Since that time only a very limited few hadbeen granted. More recently, the number of patents issued for medical procedures has reached as many as 15 or more per week.
A medical procedure is considered a procedure for the purpose of treatment or diagnosis of a human or animal condition, whether or not the condition is in fact a definable medical disease. Method patents (the term used for these types of patents) have included in the past such things as combining drugs and vitamins to treat cancer, administering insulin, transferring surrogate embryos, determining the gender of a fetus using ultrasound equipment, grafting skin, and diagnosing and treating heart problems.
The analogy that comes to mind is the concept of being able to patent a dance – say the twist or waltz – such that every time anyone performed those dances, or danced those dances, they would have to pay a fee to the patent holder. This concept is on its face, “patently” absurd, to say the least. So we can see the problem with so called method patents quite clearly.
Patent Opponents
The medical profession has considered patents on medical inventions as contrary to the nature of the physician’s practice. Almost 80 foreign countries, including Canada, Britain, and most nations in Europe, currently ban medical procedure patents.
The American Medical Association (AMA) House of Delegates voted in 1994 to oppose the practice of medical and surgical procedure patents as unethical. The patent system (as applied to procedures or techniques), to the extent it keeps new procedures secret for long periods of time and limits free access to information that improves patient care, conflicts with the principles of the Hippocratic Oath, which calls upon physicians to share their expertise freely and to teach their colleagues for the benefit of patients, according to the AMA Board of Trustees,. The House of Delegates viewed the method patent trend as contrary to the medical tradition of an open exchange of information without the expectation of financial reward and expressed concern that it might have a chilling effect on medical practice and education.
The cost to society of granting medical method patents would appear to clearly surpass any perceived benefits. The controversy in the medical arena is the grant of patents — not for the drugs or equipment a doctor uses — but the actual steps he or she takes to diagnose or treat a patient. Physicians used to teach students and colleagues their procedures for free, and some still do. With an enforceable method patent, they could charge for the privilege of using them on patients, and even refuse to license the procedures or prevent others from using them at all.
European law, in contrast to other jurisdictions, notably the U.S., concerns the restrictive practice relating to patent claims for medical methods. According to Art. 53 (c) of the European Patent Convention, patents shall not be granted for methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body.
A 1996 law exempts medical practitioners from liability for infringement of patents for medical and surgical procedures issued after enactment of the law. Shielded from liability are medical practitioners licensed by a state to provide medical and/or surgical procedures, those acting under the direction of such a person, and health care entities affiliated with such a person, including nursing homes, hospitals, universities, medical schools, health maintenance organizations, group medical practices and medical clinics. Public Law 104-208, signed by President Clinton on September 30, 1996, denies patent owners the right to enforce patents covering medical or surgical procedures that do not involve patented drugs or devices. Patents on medical and surgical procedures performed on a human body, organ cadaver, or even on an animal used in medical research or instruction relating to the treatment of humans, are now unenforceable.
Suffice it to say that we believe that medical patents must be limited to new developments in chemistry and pharmacology (drugs and medications) as well as medical and surgical equipment (devices). No procedure or method in medicine should be able to be patented for financial gain. Also, we believe that medical and surgical procedure or method patents are not in the best interests of patient care and that they stifle and limit the spread of new ideas and concepts. That some physicians still try to find a way around this is disappointing and blot on the profession . . . jomaxx and obi jo
Patents on Medical Procedures and The Physician Profiteer – http://library.findlaw.com/2004/Sep/19/133572.html
Ethical Issues in the Patenting of Medical Procedures – http://www.ama-assn.org/ama1/pub/upload/mm/369/ceja_1a95.pdf
Patent infringement liability changes – http://www.physiciansnews.com/law/1097meyers.html
Germany: G1/07: EPO Enlarged Board Rules on Methods of Surgery – http://www.mondaq.com/article.asp?articleid=98352
EPO clarifies patentability of diagnostic methods – http://www.lexology.com/library/detail.aspx?g=95d083f2-38db-49e6-b7b6-0ad4a511bfc0
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