IMMUNIZING THE MEDICAL PRACTITIONER “PROCESS” INFRINGER

    Greasing the Squeaky Wheel, Good Public Policy, or What?

 Weldon E. Havins, M.D., J.D.

  “We talk on principle, but we act on interest.”

Walter Savage Landor (1775-1864)

  “Lopez Baños and Romero Alpuente,” Imaginary Conversations, 1824-1853

            Recent changes our medical procedure patent laws have immunized only licensed medical practitioners against medical procedure patent infringement actions.  This preferential immunity thus makes likely situations exemplified in the following hypothetical.

At a quiet, mostly empty restaurant, a young couple, James and Sarah, enjoy an early Prime Rib steak dinner.  Sitting a few empty tables away, a business attired woman, Mary, enjoys her meal alone while she reads a novel.  Mary has just completed her workday as an insurance clerk.  She dreams of becoming an insurance lawyer someday when she had saved up enough money for law school.  Mary has a comfortable start on her savings plan but has a long way to go, especially considering the exorbitant tuition costs of law school these days.

Mary had recently completed a first aid class where a procedure to treat persons with upper airway obstruction was described, but not taught.  The procedure involved the application of a sudden compression of the upper abdomen in an upright person and was said to be very effective at forcibly expelling objects acutely obstructing a person’s upper airway.  The instructor discussed, but did not teach, the maneuver because the procedure had been patented.  The instructor explained that the inventor and holder of the patented medical procedure, Dr. Hindlick,^[1] had in the past brought at least one infringement action against a person who had used his patented procedure without his prior express approval. 

Dr. Hindlick advertised in national periodicals that he charged $1000 to use of his patented procedure, with prior approval.  Dr. Hindlick warned in the same advertisements that he charged $5000 for any non-approved infringing use of his patented procedure.  Mary’s first aid instructor shared with his class that he had learned from his attorney-friend that Dr. Hindlick’s medical procedure patent had been challenged in court, and that the patent had been found valid and enforceable.  Dr. Hindlick successfully argued that he had invented the procedure, timely filed a claim and received a Patent and Trade Office patent, and that had he right to protect his valid patent against infringers. 

The first aid instructor informed the students that if, however, the person using the procedure was a health care professional, the law provided immunity against infringement actions.  This exception, he reiterated, applied only to health care professionals.  If they used the procedure, they would subject to liability for patent infringement.

In the restaurant, James and Sarah banter away in cordial conversation.  Suddenly, to the horror of James, Sarah grasps her throat.  Her face contorts in alarm.  Coughing violently on every exhalation, she emits a high pitched screaming  stridor^[2] on each attempt to inhale.  James, panicking at Sarah’s obvious respiratory distress, screams for someone, anyone, to help Sarah.  His desperate, beseeching eyes fall upon Mary who has looked up from her novel, curious of the source of the commotion.  Realizing the emergency, Mary drops her novel to the floor and moves toward the now semi-comatose Sarah who has collapsed on the floor.  Mary walks past an increasingly lifeless young Sarah and positions herself along a side wall of the room while noting, with horror, that Sarah’s skin is turning a grayish-blue as she struggles to breathe.  Wanting to help, but recalling her first aid instructor’s admonition about using the Hindlick maneuver, she curses the fact that she is not a health professional, knowing that if she were, she’d have immunity against Dr. Hindlick’s infringement ploy.  Such is the dilemma our absurd contemporary law places upon ordinary citizens; utilize a useful medical procedure and subject yourself to an infringement action if the medical procedure is protected by a medical process patent.

Historically, medical and surgical procedures were not patentable.^[3]  For example, in 1862, in Morton v. New York Eye Infirmary, a New York Circuit Court rejected a patent on  a method of anesthetizing patients using inhalation of ether.^[4]  The holding of the Court rendered clear that medical and surgical methods of treating the human body were not patentable processes.^[5]  Until 1952, the Commissioners of Patents’ propounded the rule that “the methods or modes of treatment [by] physicians of certain diseases are not patentable.”^[6]  The PTO simply rejected any claims attempting to patent a medical procedure.^[7]  In 1952, the Patent Office Board of Appeals considered a challenge to a patent issued for a machine which forcibly injected medication through intact skin using a pressure jet mechanism.^[8]  Unarguably, the machine claim, alone,  contained sufficient elements for patentability.^[9]  The Court, however, focused on considerations of the utility of the “whole process” of injecting medication using a pressure jet, rather than the machine itself, and allowed a claim for a patent on the process of injection of medication through intact skin.^[10]  This ruling opened the door for medical process patents (medical procedure patents)^[11] and since that time medical process patents have been issued.^[12]

Although rarely enforced, physicians have obtained medical process patents mainly to claim credit for a medical procedure invention, without expectations of royalties or other compensation.^[13]  While medical process patents have been controversial since Sherer, the debate on these patents reached a critical mass threshold in 1994 when Samuel Pallin, an ophthalmic surgeon holding a medical process patent on a sutureless cataract surgery incision, brought an infringement action against Jack A. Singer, another ophthalmic surgeon using the patented incision on his own cataract surgery patients.^[14]

This case excited heated debate over the issue of whether or not medical procedures should be patentable, in large part, because it was the first medical process infringement action brought by one physician against another.^[15]  The proponents of medical process patents supported the patent holder, Dr. Pallin, while the opponents sympathized with the defendant alleged infringer, Dr. Singer.  By the time the case was resolved,^[16] a legislative melee ^[17] had induced a statutory amendment “remedy.”^[18]

This paper will comment on the derivation, purpose, and effectiveness of this legislative remedy.  Part A of this paper will discuss the legal basis for the public policy of granting exclusive rights to use, promote, or sell an invention.  Part B will delineate the requirements for patentability, including: utility, novelty, non-obviousness, specification requirements, and patentable subject matter.  Part B presents some arguments favoring and disfavoring medical procedure patents.  Part D discusses the attempts at legislating a remedy for the perceived deficiencies in the law permitting a Pallin v. Singer case.  Part E will conclude with personal observations and a call for the United States to join the world’s other modern economic powers by rejecting medical process patents.

      PART A     The Legal Basis for Patents

Article I, section 8, clause 8 of the United States Constitution grants Congress the power to make laws which 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.^[19]  Congress subsequently promulgated patent acts in furtherance of this power.  The first was the Patent Act of 1790,^[20] also known as the “1790 Act.”  Congress replaced this unworkable act in 1793 with a statute which provided for formal registration of writings and inventions.^[21]  Finding this system increasingly problematic Congress provided, in 1836, a formal system of granting patents from applications reviewed by professional examiners.^[22]  In 1952, Congress amended this law by clearly defining the requirements an inventor must meet to be granted a patent.^[23]  These requirements are encoded in title 35 of the United States Code.^[24]  Section 101 of the code provides, in part, that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title.”  Generally, to be patentable, the subject matter must be patentable^[25] and the claim must meet the requirements of novelty, utility, and non-obviousness.^[26]

      PART B     The Requirements of Patentability

A patent, the right to exclusively use, promote, sell or license one’s own invention, is available to a person meeting all the requirements of patentability.  Among the most important of these requirements are those of utility, novelty, non-obviousness.  The patent application specification must contain a written description of the invention along with the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the use of the invention.^[27]   These specification requirements are summarized as enablement, best mode, and written description.  To be patentable, the application must be filed in a timely manner.^[28]  But “to make it through the Patent Office door”,^[29] the subject matter must be patentable.  The theme of this paper revolves around the question of whether human medical procedures should be patentable subject matter. 

1.  Utility^[30]  -  35 U.S.C. section 101

A patent is available only if the subject matter of the patent is useful.  The invention must provide some social benefit or utility and work in a way that solves the problem it was designed to solve.  In 1966, the U.S. Supreme Court ruled that the government may not grant a patent unless the invention has a specific social benefit.^[31]  This has been interpreted to mean the invention must have practical utility.^[32]

Since 1994, the Guidelines for Examination of U.S. Patent Application for the Utility Requirement state that if any credible utility would be apparent to one of ordinary skill in the art, section 101 is satisfied.^[33]  Closely related to utility are the section 112 specification requirements: enablement, best mode, and written description.^[34]  Section 112 requires that the patent contain an enabling disclosure describing the mechanical steps to use, for example, the medical procedure (in addition to a requirement that the medical procedure be recognized as operable^[35]).  The best mode requirement requires the inventor to set forth the best manner contemplated of carrying out his invention.^[36]  All information necessary to practice the best mode must be disclosed.^[37]  A medical procedure patent may be invalidated if the inventor intentionally or deliberately fails, as established by clear and convincing evidence, to disclose the best mode.  Even accidental concealment of the best mode is a basis for invalidating the inventor’s patent if the inventor knew of the best mode and didn’t disclose it in the specification.^[38]  Those who patent a medical procedure may not reserve their own private “trade secret” very best mode of practicing or using the invention.^[39]

The claim must state with definiteness the boundaries or scope of the utility of the invention claimed.^[40]  If the claim fails to state the scope of the invention, or claims a broader scope than the invention justifies, the PTO is required to refuse to grant the requested patent.^[41]  If the patent has been issued and challenged, the court is required to hold the patent invalid and inadvertently granted by the PTO.^[42]

2.  Novelty  -  35 U.S.C. section 102

The subject matter of patent - process, machine, manufacture, or composition of matter -must disclose something that is new or “novel”.^[43]  The patent application or claim must teach something new; that is, something which is not available in the prior art.^[44]  If the prior art itself, or an anticipation^[45] of prior art by an ordinary person skilled in the art evidences the invention, the claim lacks novelty and is not patentable.^[46]  The details of novelty, as described in section 102, are meant to ensure that only new products and processes are patentable.^[47]  Section 102 also delineates circumstances under which patents will not be granted.^[48]  Perhaps the most common reasons for patent denials are found in section 102(b) which provides that an invention may not be publicly used or offered for sale in the United States, or patented or published anywhere, more than one year prior to the date of filing the application for a U.S. patent.^[49]  Whether a patent application will be denied under section 102 as prior art will depend on considerations of the following: prior printed publications, prior public use of the invention, prior public knowledge, prior patent applications in the U.S., and prior invention of the subject matter of the patent by another party.^[50]  

As relates specifically to medical procedure patents, if an inventor publicly uses the invention in the U.S., offers the invention for sale in the U.S.,  or patents or publishes the invention anywhere more than one year before filing for a PTO patent, a patent may not be issued.^[51]  A medical procedure inventor has only one year from the time he or she offers the invention for sale, or publicly demonstrates, or uses the invention in the U.S., to file for a patent.^[52]  Filing the patent application just one day after the statutorily permitted one year period, will result in rejection of the application, or invalidation of the erroneously issued patent when the breach of the one year period becomes known.^[53]  A medical procedure inventor may successfully contest this strictly construed rule if the inventor can prove that the use of the patent was for refining the invention, or assessing the value of the invention in consideration of the time and expense of filing an application.^[54]  This “experimental use” exception may resurrect an otherwise dead claim.

3.  Non-obviousness  -  U.S.C. section 103

Section 103 of 35 U.S.C. requires that the invention be non-obvious to be patentable.^[55]  If prior art would make the claimed invention obvious, the invention is not patentable.^[56]  Whether an invention is patentable over the prior art depends on whether the subject matter of the claim, taken “as a whole,” is or would have been obvious to a person of ordinary skill in the prior art at the time of the filing for the patent.^[57]  In contrast to novelty, a patent may be denied if an invention is obvious to one skilled in the art on the basis of more than one prior reference.^[58]

4.  Patent Application Specification - 35 U.S.C. section 112

In exchange for the grant of a patent which provides the inventor the exclusive right to make, use, or sell his invention for a period of twenty years,^[59] the inventor must fully disclose and correctly teach the public how to make and use his invention.  This is society’s quid pro quo for the granting the inventor the rights associated with patenting.  In practice, patent holders generally use the patent  themselves or license the invention in exchange for royalties.^[60]

The standards for disclosure are set forth in section 112 of the U.S.C. in the descriptive portion of the patent application known as the specification.^[61]  The specification must contain a written description of the invention that enables an ordinary person skilled in the prior art to make and use the invention.^[62]  Moreover, the specification must describe the best mode of making and using the invention contemplated by the inventor at the time of filing the application.^[63]  The patent applicant must disclose the invention fully, including any specific techniques or characteristics for best putting the invention into practice.^[64]

The requirement of definiteness of the claim delimits the boundaries or scope of the inventor’s patent rights.^[65]  When a applicant fails to satisfactorily apprise the person of ordinary skill in the art of the scope of the invention, or where the applicant’s claim is broader in scope than is justified by the invention, the PTO is mandated to reject the patent application.^[66]  If the PTO inadvertently grants the patent, the courts are required to invalidate the patent.^[67]

5.  Subject matter patentability - Process

In order to be patentable, the invention must be either a process, machine, manufacture, composition of matter, or an improvement thereof.^[68]  Patents are generally divided into product or process patents.  The term “process” means a process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.^[69]  A process differs from other classes of subject matter in that it does not constitute an entity, but rather consists of a step or series of steps designed to lead to a useful result.^[70]  Under this broadly worded text, a medical procedure, just like any other invention, may receive a patent as long as the medical procedure satisfies the statutory requirements.  In upholding a patent on genetically engineered bacteria, the U.S. Supreme Court stated that the patent laws would be given wide scope^[71], and quoted Congressional committee reports demonstrating that Congress intended patentable subject matter to include “anything under the sun made by man.”^[72]  Thus, the term “process” reasonably includes medical procedures.^[73]

      PART C     Reasons Favoring and Disfavoring Medical Process Patents

Proponents of medical process patents tend to center their arguments on economic bases.^[74]  Perhaps the strongest economic argument supporting medical process patents springs from the “incentive to invent” theory.^[75]  Medical process patents encourage invention by hedging the risk of private investment.^[76]  In the absence of medical process patent protection, the argument goes, investors would lack an economic incentive to fund costly clinical research.^[77]  Patent protection ensures that inventors’ profit by providing exclusive license fees and royalties.^[78]  This argument seems problematic in the face of the lack of reliable empirical data establishing that the patent system promotes the development of science and technology.^[79]  At the least, this theory would apply only to medical processes requiring extensive clinical research.  It is difficult to imagine how this argument would apply to so-called “pure” medical processes^[80] which do not require significant capital to develop.

The second economic rationale for patenting medical procedures comes from the “incentive to disclose” theory.^[81]  This theory argues that, in the absence of patent protection, nothing requires inventors to publish, explain, teach, or otherwise disseminate their work.^[82]  Disclosure is essential for the efficient development of science and technology because its publication requirement in the patent process prevents wasteful duplicative research.^[83]  Without the disclosure requirement, this theory posits that a medical practitioner would likely withhold his new medical procedure from the public in pursuit of a self-created monopoly.^[84]  But isn’t the exact same risk created when the medical practitioner receives a patent and demands exorbitant licensing fees?  The main difference, apparently, is that the patent holder is granted a monopoly for twenty years.  Absent the fear of infringing a patent, it seems very likely that another practitioner would develop the same or a similar medical procedure.  Then, another practitioner would likely develop a further improvement in the medical procedure and promote it to his or her credit.  Thus, keeping a non-patented medical procedure secret in this system would only benefit a physician-inventor for a very short time.

A third economic advantage of medical process patents comes from the “incentive to innovate” theory.^[85]  A doctor-patent holder has an interest in assuring the safety and long term success of the procedure since his profits will thereby be maximized by extended licenses and royalty contracts.^[86]  Therefore, medical process patents should be available to further development by the patent holder.

The ethical arguments opposing patenting medical processes involve restricted access to medical procedures and the adverse effects of patented processes on a medical practitioner’s judgment.  Medical process patents may limit or eliminate a patient’s access to new medical procedures.  Patentees may charge any price for a license or royalty contract.^[87]  Conceivably, a very useful new medical procedure could be excluded from the market, or be made available on an extremely limited and expensive basis for twenty years.  If restricted in its availability, a clearly superior medical procedure could nevertheless become the standard of care for treatment of a particular condition.  Medical practitioners would be compelled to pay the demanded price or risk being subject to a medical malpractice liability claim for breach of the duty to practice at the level of the standard of care.  Using the medical procedure without paying would subject the medical practitioner to an infringement action.

Similarly, patenting medical procedures may affect a medical practitioner’s judgment in using a patented procedure.^[88]  If the medical practitioner has paid the price for the right to use the procedure, will he or she use it (when it may not be the best current procedure) just to recover the costs of the investment?  Will the practitioner not use the procedure because he or she hadn’t paid for the right to use it and use an inferior procedure which has not been subject to a patent?  Will a practitioner avoid using what may be the best procedure simply because he or she doesn’t know if the procedure is patented, and he or she wants to avoid an infringement lawsuit?

In 1995, when Congress attempted legislative relief of medical process patents controversy, these questions and arguments were raised.  Was it the economic arguments that appeared sufficiently persuasive to defeat several bills, or was the legislative agenda controlled by other considerations?  An abbreviated review of pertinent legislative history follows.

      PART D     Legislative Sausage - the Medical Process Patent Amendment

In March of 1995, Representative Ganske introduced the Medical Procedure Innovation and Affordability Act, H.R. 1127.^[89]  The bill proposed to prohibit the issuance of patents “for any invention of a method or process for performing a surgical or medical procedure, administering a surgical or medical therapy, or making a medical diagnosis.”^[90]  Excepted from the prohibition were patents issued for techniques, methods, or processes performed as a necessary component of a machine, manufacture, or composition of matter.^[91]  Organized medicine supported this bill; the ABA and the biotechnology industry opposed this bill, criticizing the bill as vague and overly broad because it did not define the meaning of “surgical or medical procedure, surgical or medical therapy, or making a diagnosis.”^[92]  The biomedical industry, which relies on patents to protect their investments in developing products, expressed concern about the lack of definition of “medical therapy,” which they believed might have threatened their industry.^[93]  Another criticism leveled at the bill was that doctors would be compelled to deceive the PTO by keeping secret the inventive aspect of a discovery by obtaining a patent for an instrument capable of performing the medical procedure.^[94]

These criticisms defy reason.  The biotechnology industry simply could have offered an amendment to define “medical therapy” so that their capital investments would not be threatened.  Second, a doctor-inventor patenting an instrument and the integral medical process critical to the utility of that instrument would be granted patent protection because the bill excepted medical processes essential to the utility of the patented product.  Hence, there would not be a motive to maintain secret information regarding the use of the instrument. 

The Clinton administration testified on H.R. 1127 declaring that excluding surgical and medical procedures from patentability was not the proper way to address the concerns surrounding medical patents.^[95]  The Clinton administration neither limited their comments to medical “process” patents, nor suggested how their concerns related to medical procedure patents.^[96]  The Administration’s comments appear to be without substance, but supportive of the ABA’s opposition to the bill.

The executive director of the American Intellectual Property Law Association testified that “there was no need for the legislation.”^[97]  Dr. Kirk dismissed the bill with the sweeping conclusion that, the “underlying concepts of H.R. 1127 [were] so failing in merit that all of the technical problems [were] not worth addressing.”^[98]  One could infer that Dr. Kirk’s disdain of H.R. 1127 was so great that the bill did not deserve the dignity of a rational comment.

Mr. Baldino, the biotechnology industry lobbyist, finally argued that the bill would be detrimental to biotechnology firms because it would eliminate the incentive to develop new uses for available products.^[99]  This argument seems particularly spurious because new uses of patented products would promote greater sales of the protected products, thereby benefitting the biotechnology industry patent holders.  If anything, the non-availability of medical process patents proposed by H.R. 1127 would likely encourage creative medical practitioners to find additional uses for the patented product because there would be no apprehension of an infringement action.  The notion that these companies wish to retain the rights to bring infringement actions against those who find new uses for patented products seems short-sighted and against self-interest.

During the sessions final House debates, Representative Ganske offered an amendment to H.R. 1127 in the form of  an amendment to appropriations bill, H.R. 3814.^[100]  This bill contained the same essential features as H.R. 1127, but instead defined surgical procedure as a “treatment for curing or preventing disease, injury, illness, disorder, or deformity by operative methods, in which human tissue is cut, burned, or vaporized by the use of any mechanical means, laser, or ionizing radiation, or the penetration of the skin or body orifice by any means.”^[101]  H.R. 3814 defined a medical procedure as a “nonsurgical, nondiagnostic procedure for curing or preventing a disease, injury, illness, disorder, or deformity.”^[102]  The bill made two exceptions to the prohibited issuance of medical process patents.  The first exception was for a procedure performed by or as a necessary component of a patentable machine, manufacture, or composition of matter.^[103]  The second exception was for "a new use of a composition of matter or biotechnological process."^[104]  This bill should have satisfied the concerns of the biotechnology industry regarding H.R. 1127.^[105]  Representative Ganske’s testimony in support of the bill enumerated reasons for restricting medical process patents:

1.  Patient access to new surgical and medical procedure was being threatened by         medical patents.

2.  Medical patents permit patent owners to charge monopoly prices and                       contribute to our Nation’s health care costs.

3.  Physicians have an obligation to share their knowledge and skill for the benefit       of humanity.

4.  Medical patents are not necessary for the advancement of medicine.

5.  Europe, Canada, indeed 80 countries around the world already prohibit                    medical patents.^[106]

Further, Representative Ganske specifically stated that this bill would not prohibit patents on gene therapy or other similar procedures.^[107]  The biotechnology industry nevertheless opposed the bill, claiming it would undermine the patenting of gene therapy treatments.^[108]

Unfortunately, H.R. 3814 contained a fatal flaw.  H.R. 3814 would operate by eliminating PTO funding for issuance of medical process patents, but only for one year.^[109]  Not purporting to solve the underlying medical process patent controversy, H.R. 3814 passed the House, but died in the Senate.

When H.R. 1127 appeared moribund, Senator Bill Frist, a thoracic surgeon, introduced S. 1334, entitled the “Medical Procedures Innovation and Affordability Act,” which neither limited the issuance of medical procedure patents nor restricted funding for the granting of such patents.^[110]  S. 1334 would have operated by creating an infringement liability exception for medical professionals using patented medical procedures.^[111]  S. 1334 was appropriately attacked as providing physicians special rights not available to the general public.^[112]  Ultimately, S. 1334 did not pass.  A similar bill introduced by Senator Frist on September 24, 1996, S. 2105,^[113] likewise died before making it to the House.^[114]

However, the substantive portion of S. 2105 became incorporated into H.R. 3610 as section 616^[115] of that bill.^[116]  During an all-night session of the House, H.R.3610  passed out of the House without ever having had a committee hearing.^[117]  Linked to H.R. 4278 as a conference report, voting out H.R. 3610 obliged the Senate to vote on the bill package without amendment.^[118]  On September 30, the Senate passed H.R. 4278, containing the provisions of H.R. 3610 which was, essentially, a copy of the now defunct S. 2105.^[119]  The President signed the bill that same evening creating an amendment to 35 U.S.C. section 287(c).^[120]  This section of the patent law deprives owners of medical process patents of the right to sue for damages or seek injunctive relief when their patents are infringed by licensed medical practitioners engaging in medical activities.^[121]

      PART E     Conclusion

Amending section 287(c) greased organized medicine’s squeaky wheel.  Section 287(c) statutorily immunized licensed medical practitioners from infringement of medical process patents.  Section 287(c) did not affect the biotechnology industry because the patenting of medical processes survived unmolested.  The patent attorneys’ financial outlook seems even brighter since real or imagined ambiguities of 287(c) will be litigated for years to come.

But in an overall sense, all this legislative maneuvering amounted to “much ado about nothing.”  Section 287(c) merely formalized the status quo in existence prior to the Pallin v. Singer infringement action.  Prior to Pallin, medical practitioners did not sue one another for patent infringement.  Section 287(c) merely statutorily recognizes that gentlemen’s understanding.

Are there any real losers from this legislation?  Remember our hypothetical choking Sarah from the beginning of this paper?  She died.  Not being a 287(c) immunized licensed medical practitioner, Mary feared an infringement action from Dr. Hindlick if she used his patented medical procedure to help Sarah. 

Let’s take another no so hypothetical example.  Many air carriers have purchased portable automatic cardiac defibrillators which are intended to be used by their flight attendants when a passenger has a suspected heart attack.  Surely the cardiac defibrillators are patented.  Is the medical process of placing the defibrillator on  a heart attack victim or the medical process associated with the operation of the defibrillator patented?  If so, is the non-medical practitioner operator of the portable defibrillator going to be subject to an infringement action?  It is ridiculous that non-medical practitioner thrust into this situation should be concerned with the possibility of an infringement lawsuit.

Why then, doesn’t 287(c) apply to all citizens, rather than just licensed medical practitioners?  Because “all citizens” weren’t squeaking at Congress.  Section 287(c) merely quieted (greased) the squeaking licensed medical practitioners!

Too bad Sarah didn’t choke in a restaurant in Canada or Great Britain.  Neither of these countries allow medical method patents.^[122]   Mary would have been free to use Dr. Hindlick’s patented medical procedure without fear of infringement litigation.