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 Baos 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 persons 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, 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. Marys first aid instructor shared with his class that he had learned from his attorney-friend that Dr. Hindlicks 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 on each attempt to inhale. James, panicking at Sarahs 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 Sarahs skin is turning a grayish-blue as she struggles to breathe. Wanting to help, but recalling her first aid instructors admonition about using the Hindlick maneuver, she curses the fact that she is not a health professional, knowing that if she were, shed have immunity against Dr. Hindlicks 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. 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. The holding of the Court rendered clear that medical and surgical methods of treating the human body were not patentable processes. Until 1952, the Commissioners of Patents propounded the rule that the methods or modes of treatment [by] physicians of certain diseases are not patentable. The PTO simply rejected any claims attempting to patent a medical procedure. 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. Unarguably, the machine claim, alone, contained sufficient elements for patentability. 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. This ruling opened the door for medical process patents (medical procedure patents) and since that time medical process patents have been issued.
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. 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.
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. 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, a legislative melee  had induced a statutory amendment remedy.
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 worlds 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. Congress subsequently promulgated patent acts in furtherance of this power. The first was the Patent Act of 1790, 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. Finding this system increasingly problematic Congress provided, in 1836, a formal system of granting patents from applications reviewed by professional examiners. In 1952, Congress amended this law by clearly defining the requirements an inventor must meet to be granted a patent. These requirements are encoded in title 35 of the United States Code. 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 and the claim must meet the requirements of novelty, utility, and non-obviousness.
PART B The Requirements of Patentability
A patent, the right to exclusively use, promote, sell or license ones 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. These specification requirements are summarized as enablement, best mode, and written description. To be patentable, the application must be filed in a timely manner. But to make it through the Patent Office door, 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.
- Utility – 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. This has been interpreted to mean the invention must have practical utility.
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. Closely related to utility are the section 112 specification requirements: enablement, best mode, and written description. 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). The best mode requirement requires the inventor to set forth the best manner contemplated of carrying out his invention. All information necessary to practice the best mode must be disclosed. 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 inventors patent if the inventor knew of the best mode and didnt disclose it in the specification. Those who patent a medical procedure may not reserve their own private trade secret very best mode of practicing or using the invention.
The claim must state with definiteness the boundaries or scope of the utility of the invention claimed. 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. If the patent has been issued and challenged, the court is required to hold the patent invalid and inadvertently granted by the PTO.
- 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. The patent application or claim must teach something new; that is, something which is not available in the prior art. If the prior art itself, or an anticipation of prior art by an ordinary person skilled in the art evidences the invention, the claim lacks novelty and is not patentable. The details of novelty, as described in section 102, are meant to ensure that only new products and processes are patentable. Section 102 also delineates circumstances under which patents will not be granted. 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. 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.
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. 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. 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. 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. This experimental use exception may resurrect an otherwise dead claim.
- Non-obviousness – U.S.C. section 103
Section 103 of 35 U.S.C. requires that the invention be non-obvious to be patentable. If prior art would make the claimed invention obvious, the invention is not patentable. 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. 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.
- 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, the inventor must fully disclose and correctly teach the public how to make and use his invention. This is societys 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.
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. 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. 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. The patent applicant must disclose the invention fully, including any specific techniques or characteristics for best putting the invention into practice.
The requirement of definiteness of the claim delimits the boundaries or scope of the inventors patent rights. When a applicant fails to satisfactorily apprise the person of ordinary skill in the art of the scope of the invention, or where the applicants claim is broader in scope than is justified by the invention, the PTO is mandated to reject the patent application. If the PTO inadvertently grants the patent, the courts are required to invalidate the patent.
- 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. 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. 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. 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, and quoted Congressional committee reports demonstrating that Congress intended patentable subject matter to include anything under the sun made by man. Thus, the term process reasonably includes medical procedures.
PART C Reasons Favoring and Disfavoring Medical Process Patents
Proponents of medical process patents tend to center their arguments on economic bases. Perhaps the strongest economic argument supporting medical process patents springs from the incentive to invent theory. Medical process patents encourage invention by hedging the risk of private investment. In the absence of medical process patent protection, the argument goes, investors would lack an economic incentive to fund costly clinical research. Patent protection ensures that inventors profit by providing exclusive license fees and royalties. 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. 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 which do not require significant capital to develop.
The second economic rationale for patenting medical procedures comes from the incentive to disclose theory. This theory argues that, in the absence of patent protection, nothing requires inventors to publish, explain, teach, or otherwise disseminate their work. Disclosure is essential for the efficient development of science and technology because its publication requirement in the patent process prevents wasteful duplicative research. 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. But isnt 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. 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. 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 practitioners judgment. Medical process patents may limit or eliminate a patients access to new medical procedures. Patentees may charge any price for a license or royalty contract. 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 practitioners judgment in using a patented procedure. 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 hadnt 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 doesnt 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. 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. 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. 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. 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. 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.
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. The Clinton administration neither limited their comments to medical process patents, nor suggested how their concerns related to medical procedure patents. The Administrations comments appear to be without substance, but supportive of the ABAs opposition to the bill.
The executive director of the American Intellectual Property Law Association testified that there was no need for the legislation. 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. One could infer that Dr. Kirks 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. 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. 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. H.R. 3814 defined a medical procedure as a nonsurgical, nondiagnostic procedure for curing or preventing a disease, injury, illness, disorder, or deformity. 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. The second exception was for “a new use of a composition of matter or biotechnological process.” This bill should have satisfied the concerns of the biotechnology industry regarding H.R. 1127. Representative Ganskes testimony in support of the bill enumerated reasons for restricting medical process patents:
- Patient access to new surgical and medical procedure was being threatened by medical patents.
- Medical patents permit patent owners to charge monopoly prices and contribute to our Nations health care costs.
- Physicians have an obligation to share their knowledge and skill for the benefit of humanity.
- Medical patents are not necessary for the advancement of medicine.
- Europe, Canada, indeed 80 countries around the world already prohibit medical patents.
Further, Representative Ganske specifically stated that this bill would not prohibit patents on gene therapy or other similar procedures. The biotechnology industry nevertheless opposed the bill, claiming it would undermine the patenting of gene therapy treatments.
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. 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. S. 1334 would have operated by creating an infringement liability exception for medical professionals using patented medical procedures. S. 1334 was appropriately attacked as providing physicians special rights not available to the general public. Ultimately, S. 1334 did not pass. A similar bill introduced by Senator Frist on September 24, 1996, S. 2105, likewise died before making it to the House.
However, the substantive portion of S. 2105 became incorporated into H.R. 3610 as section 616 of that bill. During an all-night session of the House, H.R.3610 passed out of the House without ever having had a committee hearing. 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. 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. The President signed the bill that same evening creating an amendment to 35 U.S.C. section 287(c). 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.
PART E Conclusion
Amending section 287(c) greased organized medicines 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 gentlemens 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.
Lets 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, doesnt 287(c) apply to all citizens, rather than just licensed medical practitioners? Because all citizens werent squeaking at Congress. Section 287(c) merely quieted (greased) the squeaking licensed medical practitioners!
Too bad Sarah didnt choke in a restaurant in Canada or Great Britain. Neither of these countries allow medical method patents. Mary would have been free to use Dr. Hindlicks patented medical procedure without fear of infringement litigation.
In addition to Canada and Great Britain, virtually all other GATT (General Agreement on Tariffs and Trade) countries and NAFTA (North American Free Trade Agreement) member countries exclude patentability of diagnostic, therapeutic, and surgical methods for the treatment of humans or animals. Additionally, the European Community generally prohibits medical process patents. Evidently, the (bogus) concerns expressed by the American biotechnology industry are not shared by a multitude of other countries.
Shouldnt American citizens who are not licensed medical practitioners enjoy the same privileges as citizens in those countries? Isnt it time for us to join the other enlightened countries in the modern world and prohibit medical process patents?
 Dr. Hindlick is a hypothetical inventor of a medical procedure, requiring no product, which is useful to clear acute airway obstructions in humans.
 Stridor is a harsh vibrating sound heard during respiration in cases of obstruction of the air passages. Merriam-Websters Medical Dictionary, 664 Merriam-Webster, Inc., Springfield Mass., (1995).
 See Donald S. Chisum, Patents: A Treatise on the Law of Patentability, Validity and Infringement, 1.03(3), 1-70, (1996).
 Morton v. New York Eye Infirmary, 17 Fed. Cas. 879, 884 (S.D.N.Y. 1862).
 Donald S. Chisum, 1 Patents 1.03 (1995).
 Wendy W. Yang, Patent Policy and Medical Patents: Case for Statutory Exclusion from Patentability, 1 B.U. J. Sci. & Tech. L. 5 (1985). Medical procedure claims are referred to in patent language as medical process patents. Id.
 Becton-Dickinson v. Scherer, 106 F. Supp. 665 (E.D. Mich. 1952) (where the court held that processes are patentable even if they consist of medical or surgical methods which involve treatment of the human body).
 For the purposes of clarity, in the language of the U.S. Code, Title 35, a patent on a medical procedure is legally characterized as a patent on a medical process. Thus, the legal term medical process patent is equivalent to the more generically understood term medical procedure patent. 35 U.S.C.A. 100.
 Susan H. Adelman, An Earful About Why Lawyers Support Process Patents, 38 Amer. Med. News 34, 35-36 (1995).
 Reid G. Adler & Kate H. Murashige, Biomedical Product Patent Protection Essential to High Tech Economy, Legal Backgrounder, Feb. 2, 1996 (in Lexis news library, WLF file).
 Pallin V. Singer, 36 U.S.P.Q.2d 1050 (D. Vt. 1995). See also, U.S. Court in Vermont Declares Patent Claims on Surgical Procedure Invalid and Unenforceable, AHLA Health Law Digest, 1-2, West Group ed. (1998).
 Lee Bowman, Physicians Stake Claims to the Art of Healing: Courts will rule on Patents, While Medial Societies Denounce Them an Unethical, Harmful, S.F. Examiner, July 16, 1995, at B-1.
 Pallin v. Singer, 1996 W.L. 274407 (D. Vt.)(where, via consent decree, the action was dismissed with prejudice and all patent claims were declared invalid). Was the PTO in error in issuing the patent? A PTO rejection of Pallins claim would appear to have avoided the wrenching controversy that ensued.
 The following bills (to be discussed insubstantial detail) were introduced to remedy the concerns generated by Pallin v. Singer: H.R. 1127, 104th Cong. (1995); H.R. 3814, 104th Cong. (1996); S. 1334, 104th Cong. (1995); and S. 2105, 104th Cong. (1996). As result of H.R. Conf. Rep. No. 104-863 (1995), the statutory amendment to 35 U.S.C. 287(c) were codified from Pub. L. No. 104-208 (1996), 110 Stat. 3009 (1996).
 H.R. 3610, 104th Cong. (1996) and codified in 35 U.S.C. 287(c) stating, inter alia, that, with respect to a medical practitioners performance of a medical activity that constitutes an infringement …[an action for infringement]… shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity. 35 U.S.C. 287(c) further defines the term medical activity to mean performance of a medical or surgical procedure on a body, but does not include the use of a patented machine, manufacture, or composition of matter in violation of such patent. This would appear to mean, in abridged language, that a medical practitioner is liable for infringement when the medical activity involves a patented product.
 U.S. Const., Art. I 8, cl. 8 (1789).
 Patent Act of 1790, ch. 7, 1 Stat. 109-112 (1790).
 See generally, Robert P. Merges, Commercial Success and Patent Standards, Economic Perspectives on Innovation, 76 Cal. L. Rev. 803 (1988).
 35 U.S.C.A. 100 et. seq. (West 1992 and Pocket Parts 1998).
 1952 Patent Act Committee Reports per Nancy Vensko, Biotechnology Law class (1999).
 35 U.S.C. 101, 102, 103 (West Supp. 1998).
 35 U.S.C. 112 (West Supp. 1998).
 U.S.C. 102 (generally providing a one year period from the time of reduction to practice to file an application with the Patent and Trade Office).
 S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H.R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952) (wherein both the Senate and House Committee Reports intended patentable subject matter under section 101 to include anything under the sun that is made by man….). Id.
 35 U.S.C. 101.
 Brenner v. Manson, 383 U.S. 519, 529-30 (1966) (holding that, unless the invention is developed to the point of specific benefit in its current form, the patent should not be issued).
 Guidelines for Examination of U.S. Patent Applications for the Utility Requirement, USD Biotechnology Class syllabus, MPEP 706.03 [A].
 35 U.S.C. 112.
 Operability in section 112 has the same meaning as utility in section 101; that is, practical usefulness. See In re Brana, 51 F.3d 1560, 1569 (1995). The statute requires that the medical procedure works in a way to solve the problem it was designed to solve; there is no requirement to explain how or why the medical procedure works. Robert P. Merges, Patent Law and Policy 36 at 147 (1992).
 35 U.S.C. 112
 Brian P. OShaughnessy, The False Inventive Genius: Developing a New Approach for Analyzing the Sufficiency of Patent Disclosure Within the Unpredictable Arts, 7 Fordham Intell. Prop. Medic & Ent. L. J. 147, 160 (1996).
 A claim is an introductory, one sentence statement of the definition of the invention for which patent rights are requested. See generally, John W. Schlicher, Patent Law: Legal and Economic Principles 7.02.
 John W. Schlicher, Patent Law: Legal and Economic Principles 7.02 (1)(a) (1996).
 See generally, Herbert Schwartz, Patent Law & Practice, 48-74 (2nd ed. 1995) (generally excellent discussion of the requirements of patentability).
 See generally, In re Baxter Travenol Labs, 21 U.S.P.Q.2d 1281 (1991).
 Id. The section 102 novelty requirement is not met if the invention is anticipated. That is, if all the elements of the claim are identically disclosed in a single prior art reference, there is no novelty and the application must fail. If the patent has been issued, the patent may be challenged on the basis of anticipation. If anticipation is established by a preponderance of objective evidence presented by those skilled in the art, the patent will be invalidated.
 35 U.S.C. 102.
 35 U.S.C. 102(b).
 See Sinskey v. Pharmacia Ophthalmics, Inc., 25 U.S.P.Q.2d 1290 (1992).
 35 U.S.C. 103.
 Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966) (wherein the Supreme Court elucidated a four step test to determine the obviousness or non-obviousness of a claimed invention:
- determine the scope and content of the prior art;
- ascertain the differences between the claimed invention and the prior art;
iii. resolve the level of skill of one of ordinary skill in the art; and
- determine the obviousness of the subject matter against the background of the first three steps.
 Gore v. Garlock, 721 F.2d 1540, 1548 (Fed. Cir. 1983) (holding that a claim must be evaluated as a whole when determining non-obviousness or obviousness under section 103).
 Herbert Schwartz, Patent Law & Practice at 60 (2nd ed. 1995) (detailing prior art to include:(1) printed publications or patents from anywhere in the world that were published or issued before the applicant’s date of invention,
(2) prior use/knowledge occurring in the U. S. before the invention date,
(3) a United States patent application that subsequently issued and was filed before the applicant’s date of invention, and
(4) another’s invention made in the United States and was not abandoned, suppressed, or concealed before the invention date of the invention in question.
 35 U.S.C.A. 154 (West Supp. 1998).
 35 U.S.C. 261.
 35 U.S.C. 112, para. 1.
 University of California v. Eli Lilly & Co., 43 U.S.P.Q.2d 1398, 1404 (1997); Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (1997).
 Chemcast Corp. v. Arco Industries Corp., 16 U.S.P.Q.2d 1033, 1036 (1990) (wherein Court stated that all information necessary to practice the best mode, whether characterized as manufacturing data, customer requirements, or trade secrets, must be disclosed). See also, Scripps Clinic v. Genetech, Inc., 18 U.S.P.Q.2d 1002, 1012 (1991).
 Chemcast, 16 U.S.P.Q.2d at 1036-37.
 Robert P. Merges, Patent Law and Policy 39 at 516.
 John W. Schlicher, Patent Law: Legal and Economic Principles 7.01(1)(a).
 35 U.S.C. 101 (1952).
 35 U.S.C. 100(b).
 Cochrane v. Deener, 94 U.S. 780, 788 (1876) (wherein the U.S. Supreme Court stated that a process is a mode of treatment of certain materials to produce a given result. It is an act or series of acts, performed upon the subject matter to be transformed and reduced to a different state or thing.).
 Diamond v. Chakrabarty, 447 U.S. 303, 307 (1980).
 Id. (quoting S. Rep. No. 1979, 82nd Cong., 2d Sess., at 5 (1952); and H.R. Rep. No. 1923, 82nd Cong., 2d Sess., at 6 (1952)).
 35 U.S.C. 100(b) (1994).
 Beata Gocyk-Farber, Patenting Medical Procedures: A Search for a Compromise Between Ethics and Economics, 18 Cardozo L. Rev. 1527, 1537 (1997).
 Brian McCormmick, Restricting Patents: Bipartisan Bill Would Bar Ownership Claims for Medical Methods, Am. Med. News, Mar. 20, 1995, at 3; Susan Hershberg, An Earful About Why Lawyers Support Process Patents, Am. Med. News, Sept. 11, 1995, at 35.
 Gregory R. Burch, Note, Ethical Consideration in the Patenting of Medical Processes, 65 Tex. L. Rev. 1139 (1987).
 George J. Annas, Surrogate Embryo Transfer: The Perils of Patenting, 14 Hastings Center Rep. 25 (1984).
 Susan Hershberg, An Earful About Why Lawyers Support Process Patents, Am. Med. News, Sept. 11, 1995, at 37.
 See Rebecca S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. Chi. L. Rev. 1017 (1989).
 Pure process patents are those that do not involve a product as a critical element of the medical procedure. An example of a pure process patent is U.S. Patent No. 4,986,274 held by Dr. John Stephens who received a patent on a method of “reading an ultrasound image to determine the gender of a fetus in the first trimester of pregnancy.” The procedure involves a common sense identification of male and female genitalia: penis =male; no penis = female (not rocket science!). So self‑evident is the process that one physician commented that Dr. Stephens holds “a patent for telling the difference between the right hand and the left hand.” Yet, Dr. Stephens is a patentee of the procedure and plans to restrict its usage by limiting licenses for the next seventeen years. Hearing on H.R. 1127 and H.R. 2419 Before the House Subcomm. on Courts and Intellectual Property of the House Comm. on the Judiciary, 104th Cong. 1st Sess., at *5 (testimony of Charles D. Kelman, M.D., American Society of Cataract and Refractive Surgery).
 Ward S. Bowman, Jr., Patent and Antitrust Law 13 (1975).
 Eisenberg, 56 U. Chi. L. Rev. at 1029.
 Brian McCormick, restricting Patents: Bipartisan Bill Would Bar Ownership Claims for Medical Methods, Amer. Med. News, Mar. 20, 1995 at 3.
 Eisenberg, 56 U. Chi. L. Rev. at 1037.
 William D. Noonan, Patenting Medical and Surgical Procedures, 77 J. Pat. & Trademark Off. Society 651, 653 (1995).
 See Gregory F. Burch, 65 Tex. L. Rev. 1139 (1987) (noting that prices of licenses and royalty contracts are not subject to governmental regulation).
 Timothy J. McCoy, Biomedical Process Patents, 13 J. Legal Med. 501, 507 (1992).
 H.R. 1127, 104th Cong. (1995). The Medical Procedures Innovation and Affordability Act in pertinent part provides:
On or after the date of the enactment of this Act, a patent may not be issued for any invention or discovery of a technique, method, or process for performing a surgical or medical procedure, administering a surgical or medical therapy, or making a medical diagnosis, except that if the technique, method, or process is performed by or as a necessary component of a machine, manufacture, or composition of matter or improvement thereof which is itself patentable subject matter, the patent on such machine, manufacture, or composition of matter may claim such technique, method, or process.
 Medical Procedures Innovation and Affordability Act: Hearings on H.R. 1127 Before the Subcomm. on Courts and Intellectual Property of the House Comm. on the Judiciary, 104th Cong. 134 (1995).
 Id. (see statement of Mr. Baldino). Also see, Joel Garris, The Case for Patenting Medical Procedures, 22 Am. J. Law & Med. 85, 100-04 (1996).
 Id. (see statement of Mr. Baldino).
 Hearings on H.R. 1127 (testimony of G. Lee Skillington).
 Hearings on H.R. 1127 (testimony of Dr. Kirk).
 Hearings on H.R. 1127 (testimony of Mr. Baldino).
 H.R. 3814, 104th Cong. (1996).
 See H.R. 3814, 104th Cong. (1996). See also, 142 Cong. Rec. H8030 (stating that Dr. Ganske offered House Bill 3814).
 Hearings on H.R. 1127 (testimony of Mr. Baldino).
 142 Cong. Rec. H8254, at H8277 (daily ed. July 24, 1996)(statement of Rep. Ganske).
 Bill with PTO Finding and Patent Reform on Medical Procedures is Signed in Law, Pat. Trademark & Copyright L. Daily (BNA), Oct. 7, 1996, at D5. If the biotechnology industry really had been concerned about the bills restriction on gene therapy patents, the industry could have offered an amendment to the bill specifying an exception for gene therapy patents.
 See H.R. 3814(a).
 S. 1334, 104th Cong. (1995).
 142 Cong. Rec. S11,845, at S11,846 (daily ed. Sept. 30, 1996) (letter from Dr. Kirk of the American Intellectual Property Law Association criticizing the physician immunity provision of S.1334).
 S. 2105, 104th Cong. (1996).
 142 Cong. Rec. S12,023 (daily ed. Sept. 30, 1996).
 Public Law 104‑208 section 616 provides:
Section 287 of title 35, United States Code, is amended by adding at the end the following new subsection:
(c) (1) With respect to a medical practitioners’s performance, of a medical activity that constitutes an infringement under section 271 (a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.
(2) for the purposes of this subsection:
(A) the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a bio‑ technology patent.
(B) the term “medical practitioner” means any natural person who is licensed by State to provide the medical activity described in subsection (c) (1) or who is acting under the direction of such person in the performance of the medical activity.
(C) the term “related health care entity” shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.
(D) the term “professional affiliation” shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.
(E) the term “body” shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.
(F) the term “patented use of a composition of matter” does not include a claim for a method of performing a medical or surgical procedure on a body that recites that use of a composition of matter where the sue or that composition of matter does not directly contribute to achievement of the objective of the claimed method.
(G) the term “State” shall mean any state or territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(3) This subsection does not apply to the activities of any person, or employee or agent of such person (regardless of whether such person is a tax exempt organization under section 501(c) of the Internal Revenue Code), who is engaged in the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition *1564 of matter or the provision of provision of pharmacy or clinical laboratory, services (other than clinical laboratory services provided in physician’s office), where such activities are:
(A) directly related to the commercial development, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician’s office), and
(B) regulated under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Clinical Laboratories Improvement Act.
(4) This subsection shall not apply to any patent issued before the date of enactment of this subsection.
Pub. L. No. 104‑208, 616, 110 Stat. 3009 (1996).
 H.R. 3610, 104th Cong. (1996).
 See 142 Cong. Rec. S11,815, at S11,816 (daily ed. Sept.30, 1996) (statement of Mr. Lott).
 Pub. L. No. 104-208, 110 Stat. 3009 (1996).
 35 U.S.C. 287(c)(1). Section 287(c)(1) states that:
With respect to a medical practitioner’s performance, of a medical activity that constitutes an infringement under Section 271 (a) or (b) of this title, the provisions of Sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.
Section 287(c)(2)(A) defines the term “medical activity” to mean “performance of a medical or surgical procedure on a body,” but does not include:
(i) the use of a patented machine, manufacture, or composition of matter in violation of such patent,
(ii) the practice of a patented use of a composition of matter in violation of such patent, or
(iii) the practice of a process in violation of a biotechnology patent.
 Reginald Rhein, BIO, AMA Clash over Bill to Shield Health Pros from Suits Over Procedures, Biotechnology Newswatch, Nov. 20, 1995.
 Beata Gocyk-Farber, Patenting Medical Procedures: A Search For A Compromise Between Ethics and Economics, 18 Cardozo L. Rev. 1527, 1565 (1997). (Countries Prohibiting Medical Method Patents:
Europe: European Patent Convention Countries
Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Liechtenstein
Spain, Sweden, Switzerland, United Kingdom
Other European Countries
Channel Islands (Jersey and Guernsey), Croatia, Cyprus, Czech Republic, Finland,
Gibraltar, Israel, Macedonia, Norway, Slovakia, Slovenia, Vatican City, Yugoslavia (Serbia and Montenegro)
North America: Canada, Mexico,
South America: Brazil, Chile, Colombia, Ecuador, Falkland, Venezuela
Asia: Brunei, China, Hong Kong, India, Indonesia, Japan, Malaysia, Mongolia, Singapore
Solomon Islands, Sri Lanka, Taiwan, Thailand, Vietnam, Republic of Vanuatu,
Africa: Benin, Bophuthatswana, Burkina Faso, Cameroon, Central African Republic,
Ciskei, Congo, Gambia, Ghana, Guinea, Ivory Coast, Kenya, Lesotho, Mali, Mauritania, Niger, Senegal, Sierra Leone, Somali Republic, South Africa, Swaziland, Tanzania,
Tchad, Togo, Transkei, Uganda, Venda
Other: New Zealand, St. Helena, Saudi Arabia, Southern Yemen‑Aden,
Central America: Barbados, Cayman Islands, Costa Rica, Cuba, Guatemala).
 Agreement on Trade Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments -Results of the Uruguay Round, vol. 31.
 European Patent Convention, Oct. 5, 1973, art. 52(4), 1 B.D.I.E.L. 986, as amended by Decision of the Administrative Council of the European Patent Organization, Dec. 21, 1978.