Breaking News

The AMA’s Position on Medical Method Patents is Detrimental to Both Physicians and Patients

By Darin Gibby and Nathan Cassell

The American Medical Association (AMA) generally takes the position that patenting medical procedures is unethical, but this is completely at odds with nearly every other aspect of medicine which treats patents as the great driver of medical advancement.  Take, for example, the entire pharmaceutical industry, where every day patented drugs save millions of lives – arguably an order of magnitude more than any patented medical procedure.

Although well-intentioned, this prohibition on medical methods is based on a misunderstanding of patent law.  The unfortunate result is that physicians are deterred from making valuable contributions to the progress of medicine.  We believe the AMA Code should be updated so that physicians can ethically apply for medical method patents.  In this way, innovative physicians can ethically advance the medical arts by participating in the quid pro quo afforded by patent law, and at the same time fulfill their obligations to patients under the Hippocratic ideals of medical law.

 

The American Medical Association and the Ethics of Physician Patents

The AMA Code of Ethics was originally based on the work of Thomas Percival, an English physician.  In 1803, Percival wrote in his book “Medical Ethics” what may possibly be the earliest ethical guideline concerning physicians and their inventions.

“No physician or surgeon should dispense a secret nostrum, whether it be his invention, or exclusive property.  For if it be of real efficacy, the concealment of it is inconsistent with beneficence and professional liberality.  And if mystery alone give it value and importance, such craft implies either disgraceful ignorance, or fraudulent avarice.”  (Chapter II, Section XXII)

The AMA, upon their formation in 1847, promulgated the first Code of Medical Ethics in the United States.  With regard to the ethics of patents, the AMA expanded on Percival’s position and stated the following.

Equally derogatory to professional character is it, for physician to hold a patent for any surgical instrument, or medicine; or to dispense a secret nostrum, whether it be the composition or exclusive property of himself, or of others.  For, if such nostrum be of real efficacy, any concealment regarding it is inconsistent with beneficence and professional liberality; and, if mystery alone give it value and importance, such craft implies either disgraceful ignorance, or fraudulent avarice.”  (Ch. II, Art. 1, Sec. 4)

Over the course of several decades, however, the AMA’s position on the ethics of patenting medicine and surgical instruments evolved to the point where in 1971, the AMA no longer included medicine patents in the Code of Ethics, and surgical and diagnostic instrument patents were treated with a degree of ambivalence by characterizing them as “not unethical.”  Finally, by 1992 the AMA Code of Ethics affirmatively stated that both surgical and diagnostic patents were ethical.

History of AMA Position on Physician Patents

Medicine Surgical Instrument  Diagnostic Instrument Medical Procedure
1847 unethical Unethical
1903 unethical Unethical
1912 unethical Unethical
1971 not unethical not unethical
1992 Ethical ethical
1996 Ethical ethical unethical
2007 Ethical ethical unethical

 

Darin Gibby

The AMA’s Position on Surgical Instrument Patents

Yet the march toward acceptance for ethical medicine and instrument patents was not without conflict within the AMA.  For example, in 1876, James Marion Sims, M.D., President of the AMA and considered by some to be a visionary in the field of medical ethics, delivered the following comments at the Anniversary Address in Philadelphia:

A distinguished physician invents a galvanic cautery.  He has spent much time and a large amount of money perfecting his apparatus.  According to our Code, he cannot, he dare not, take out a patent for it as any other honest man could do, simply because he is a practicing physician.  But why should not the physician reap the reward due to talent and inventive genius as well as any other man?  Does the profession at large, or does the public, derive any benefit by this robbery of the inventor?  None whatever.  We simply compel him to give his invention, his time and labor, to enrich the instrument-maker.” (San Francisco Western Lancet, Journal of Practical Medicine and Surgery v. 5)

It would be decades before the AMA officially codified Sims’ prescient comments that a physician may ethically patent a surgical instrument.  Today, the AMA’s position is as follows.

Opinion 9.09 – Patent for Surgical or Diagnostic Instrument:  A physician may patent a surgical or diagnostic instrument he or she has discovered or developed.  The laws governing patents are based on the sound doctrine that one is entitled to protect one’s discovery.”

Hence, the AMA recognizes no diminishment in professionalism occasioned by a physician who may seek to obtain and enforce device and medicine patents, and considers such behavior to be consistent with the physician’s duty to promote the health and welfare of patients.

 

Nathan Cassell

The AMA’s Position on Medical Method Patents

Historically, medical procedure patents may not have been as well-known as medicine and instrument patents.  All of that changed in 1993 when Dr. Samuel L. Pallin filed suit against Dr. Jack A. Singer for patent infringement.  The lawsuit is believed to be the first of its kind, where one surgeon sued another surgeon over a patent, and it sparked a public furor.  In 1996, the court held that Pallin’s asserted patent claims were either invalid or not infringed.

Although Dr. Pallin’s patent was defeated in court, some were disturbed by the notion that a physician could own rights to a medical method.  Perhaps more importantly, many objected to the idea that a physician could be sued for treating a patient.

In response, the AMA Code of Ethics was revised in 1996 to state the following:

Opinion E-9.095 Patenting Of Medical Procedures: 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 reiterated this position in 2007 when the Code was amended to also include a prohibition against trade secrets and confidentiality agreements which conceal medical procedures.

 

The AMA Relies Upon Several Myths to Support the Ban on Medical Method Patents

When the AMA declared medical method patents unethical in 1996, they provided a litany of reasons for doing so.  For example, the AMA stated:

Medical process patents have been possible since the early 1950’s but were rarely issued until recently.  The fact that medicine advanced rapidly from World War II to the late 1970’s despite the absence of medical process patents undermines the central claim that economic incentive is needed to induce innovation in the realm of medical procedures.” [Council on Ethical and Judicial Affairs, Report 1-A-95]

This statement is problematic in many ways.  First, it ignores the incentives provided by other types of patents (e.g. pharmaceutical, device) which helped medicine advance during this period.  Second, it is improper to measure the ethical value of a patent by the amount of innovation it generates.  Third, by the early 1950’s, medical process patents had in fact been possible for over a century.

 

Medical Method Patents Under US Law

We may never know which patent contained the earliest medical method claim.  Sadly, in 1836 a fire destroyed the U.S. Patent Office, including the records for approximately the first 10,000 patents, wiping out almost 50 years of patent records.  Although some of these patents have since been recovered through other sources, over 7,000 of them remain missing.  Perhaps some of those lost patents include claims for treating smallpox, tuberculosis, cholera, or other medical conditions of the times.

As evidenced in the following representative sample, the Patent Office issued several medical method patents following the 1836 fire.

  •  US 4,347 (Swett, 1845) Method of administering medicated vapors
  • US 4,818 (Morton, 1846) Method of administering ether
  • US 46,570 (Maxwell, 1865) Method of treating burns
  • US 58,034 (Fouilloux, 1866) Method of treating rheumatism
  • US 61,063 (Gregory, 1867) Method of administering oil for treating disease
  • US 97,613 (Déclat, 1869) Method of treating croup
  • US 506,449 (Silsbee, 1893) Method of treating disease with electricity
  • US 622,922 (Horton, 1899) Method for administering therapeutic electricity
  • US 1,547,369 (Dick, 1925) Method of administering scarlet fever antitoxin
  • US 2,008,526 (Wappler, 1932 ) Method of treating tissue with high-frequency electric current
  • US 2,098,295 (Kettering, 1933) Method of applying high frequency field to create a fever
  • US 2,322,245 (Lockhart, 1943) Method of injecting hypodermic liquid beneath the skin

One brief yet notable exception to the Patent Office’s longstanding position of issuing medical method patents occurred in 1883.  The head of the Patent Office (Edgar M. Marble, Commissioner from 1880 to 1883) stated that medical method patents deceptively lead the public to believe a claimed therapy will produce the desired result in all cases.  Hence, the Commissioner found that medical methods are not patent eligible subject matter (Brinkerhoff decision of 1883).

Although this was a single isolated decision by only one Commissioner, and neither his predecessors nor his successors held the same official position, the 1883 Brinkerhoff decision would resurface at the Patent Office over half a century later.

Robert Scherer filed a patent application in 1949 for a therapeutic injection method.  The patent examiner in charge of reviewing Scherer’s application decided to reject the application, alleging that methods of treating the human body were ispo facto ineligible for patenting.

Scherer appealed the examiner’s rejection, and in 1954 the Patent Office Board of Appeals convened an augmented panel of eleven judges to resolve the issue.  In a 10‑1 decision, the Board found that despite any suggestion to the contrary by the Brinkerhoff decision, medical methods are indeed eligible for patenting.  Scherer’s application went on to issue as US Patent No. 2,704,542.

No US court has ever held a claim to be ineligible for patenting on the basis that it recited a medical method.  There is sometimes a misunderstanding, however, about the difference between patent eligibility and patentability. Generally speaking, patent eligibility is pertains to the what types of subject matter may be patented at all, whereas patentability pertains to whether an invention is novel or nonobvious in view of the prior art.  It is important to recognize that patent eligibility and patentability are approached under two entirely different standards of review.  For example, in 1862 the Morton patent mentioned above (US 4,818) was found to be unpatentable in view of prior art.  The court did not hold, however, that Morton’s invention was ineligible for patenting because it claimed a medical method.

Ultimately, Congress has the primary authority for deciding what types of subject matter are eligible for patenting.  Under a Constitutional mandate, Congress has described four subject matter classes.  Specifically, 35 U.S.C. 101 broadly indicates that any process, machine, manufacture, or composition of matter is eligible for patenting in the U.S.  Since the original Patent Act was passed in 1790, Congress has never enacted legislation to make medical methods ineligible for patenting.

 

Recent Legal Developments which Impact Medical Method Patents

When the AMA initially declared a prohibition on medical method patents in 1996, another concern at the time was that a physician could use a patent as a way to keeping a medical method secret.  In 2000, however, the patent laws were revised so that patent applications are now published on the USPTO website 18 months after filing.  This is part of the quid pro quo inherent in the patent system, whereby the free flow of information and advancement of technology is incentivized in exchange for a limited term of protection for the patent holder.  In practice, many biomedical innovators submit their findings for publication in peer reviewed journals at the same time they file a patent application on the invention.

The AMA was also concerned about the detrimental impact on the patient community if physicians could be prevented from performing patented treatment or research methods.  However, in 1996 Congress passed legislation giving physicians immunity for practicing a medical method patent.  As a result, doctors now are free to infringe upon medical method patents, without having to worry if they will be dragged into court for doing so.  The law was passed over 15 years ago, and we are aware of no instance to date where a physician has been found liable for infringing a medical method patent.  Put simply, the physician immunity law is working as intended.

Some may question the economic value of medical method patents in view of the immunity law.  Yet in reality, biomedical scientists, engineers, and other innovators routinely pursue medical process patents on their inventions, and such patents are enforceable against corporate entities which would seek to induce physicians to infringe them.  There is no reason why physicians should not be on a level playing field with other innovators in the medical field.

 

The AMA’s Position on Medical Method Patents is Inconsistent, Archaic, and Should be Reconsidered

We believe that the AMA’s position on medical methods patents should be aligned with its position on medicine and device patents.  Certainly from a legal standpoint, there is no difference in patent eligibility between medicine, device, and medical method inventions.

Further, the medical ethics community has questioned the propriety of the AMA’s disparate treatment of method patents.  For example, in 1999, Eliot Freidson, a noted medical sociologist, wrote:

[T]he code’s condemnation of patenting medical procedures […] does not sit well beside its approval of patenting surgical or diagnostic instruments.”  (Baker et al, The American Medical Ethics Revolution, p. 139; 1999).

From a historical perspective, the AMA has shown a propensity to treat specific types of physician patents with initial caution, followed by eventual recognition.  This is a reasonable approach, and in any organization, new ideas are often approached in a cautious manner at the outset, and then later incorporated into through adaptation.  Somewhat ironically, this is true even at the Patent Office, which deals with inventions on a daily basis. For example, the Patent Office was originally skeptical of one of the most ground breaking inventions in history, that of manned flight.  After toiling decades to develop their flying machine, the Wright brothers were met with initial resistance by the Patent Office.  Similarly, Chakrabarty’s first attempt to patent an oil-consuming microbe was flatly denied by the Patent Office.  Today, however, the Patent Office routinely grants patents in the aeronautical and biotechnology fields.

Likewise, it is now time for the AMA to recognize that physicians can ethically pursue medical method patents.  The conditions in 1996 which originally compelled the AMA to consider medical method patents as unethical are no longer relevant.  Hence, the AMA’s prohibition is archaic, logically inconsistent, detrimental to physicians and patients, and should be reconsidered.

###

Darin Gibby is a partner in Kilpatrick Townsend’s Denver office.  Mr. Gibby’s practice focuses on protecting a wide variety of technologies in the medical field, including surgical devices and procedures, drug delivery systems and patient monitoring equipment. You can reach Darin at: dgibby@kilpatricktownsend.com.

Nathan Cassell is an associate in Kilpatrick Townsend’s Denver office.  Mr. Cassell’s practice focuses on patent prosecution and counseling in the field of biomedical technology. You can reach Nathan at: ncassell@kilpatricktownsend.com.

 

 

Leave a Reply

Your email address will not be published. Required fields are marked *