American Journal of Law & Medicine

The case for patenting medical procedures.

I. INTRODUCTION

In contrast to the few medical procedure patents(1) granted in the three decades following the 1950s,(2) patent attorneys now estimate that the Patent and Trademark Office (PTO) grants at least a dozen medical procedure patents each week.(3) This growing trend heightened the medical community's concerns that such patents may adversely affect the cost, quality, and patient accessibility of medical care.(4) Additionally, attempts by physicians to enforce medical procedure patents against other physicians further increased these concerns.(5) One of the more widely publicized patented medical procedure cases involves an infringement suit over a patent for a method of making self-sealing episcleral incisions during cataract operations.(6) On July 6, 1993, Dr. Samuel Pallin filed a lawsuit against fellow opthalmologist Dr. Jack Singer, accusing Dr. Singer and his clinic of performing hundreds of cataract operations using the patented procedure.(7) The medical community views this case as an illustration of the problems that may arise in patenting medical procedures because Dr. Pallin's suit restricts Dr. Singer's use of a procedure that benefits patients.(8)

In June 1994, the American Medical Association's (AMA) House of Delegates addressed these concerns and voted to "rigorously condemn the patenting of medical and surgical procedures and work with Congress to outlaw this practice."(9) A year later, the AMA's Council on Ethical and Judicial Affairs issued a report announcing that "it is unethical for physicians to seek, secure or enforce patents on medical procedures."(10) The AMA based this policy on the potential for patents to limit patient accessibility to new procedures.(11)

In response to concern over the potential for medical procedure patents to increase health care costs,(12) Representative Greg Ganske, a Republican from Iowa, introduced the Medical Procedures Innovation and Affordability Act, House Bill 1127, on March 3, 1995.(13) This proposed legislation would ban the issuance of patents on medical procedures unless such procedures are necessary components of a patentable machine or device.(14) In response to concerns that this House proposal might deny patent protection for biotechnology companies, Senator Bill Frist, a Republican from Tennessee, introduced a counterpart bill of the same name, Senate Bill 1334, on October 18, 1995.(15) The Senate Bill creates an infringement liability exemption for patients, medical professionals, and health care entities using patented medical procedures.(16) However, this exemption does not apply to use by persons engaged in commercial activities.(17)

This Note examines the advantages and disadvantages of granting patent protection to medical procedures. Part II of this Note focuses on the present status of medical procedure patents. It examines the statutory requirements for obtaining a patent and discusses the applicable case law. Part III discusses the issues surrounding the patenting of medical procedures. These issues include patient and physician accessibility to patented procedures, the traditions of the medical profession, the potential royalties associated with patented procedures, and various ethical considerations. Part IV analyzes the House and Senate Bills by focusing on the proposed language, international perspective, and precedential value of the legislation. Part V recommends that the legislative efforts to ban the granting of medical procedure patents should not continue. Finally, Part VI concludes that the medical community should consider the full scope of the issues raised by medical procedure patents before advocating a ban on such patents.

II. PRESENT STATUS OF MEDICAL PROCEDURE PATENTS

A. United States Patent Code

The Constitution explicitly grants Congress the power to promote scientific progress by granting exclusive rights to inventors.(18) The patent code implements this policy by granting an inventor the exclusive right to make, use, or sell the invention for a limited term.(19) To obtain patent protection, an invention must satisfy four requirements. First, the invention must be the kind the patent code protects.(20) The patent code provides protection to any process(21) and includes method within the definition of process.(22) The second requirement for obtaining a patent is that the invention must be useful.(23) This requirement ensures that the patented invention contributes to scientific progress.(24) The third requirement for patentability is novelty.(25) To obtain a patent, the inventor must introduce a new invention into society.(26) If the invention is already available to the public in the prior art(27) before the date of invention, patent protection is not available.(28) However, an inventor may describe the invention in a publication or allow public use of the invention without the risk of losing patent protection so long as such events do not occur more than one year prior to the patent application date.(29) Public use for longer than one year may occur by application of the experimental use doctrine.(30) Although this doctrine presents a subjective standard that the inventor engaged in good-faith testing of the invention, the relevant case law allows sales for experimental purposes(31) and incidental benefits to the public.(32) The last requirement, non-obviousness, ensures that a substantial difference exists between the "new" invention and the current methods in practice.(33) The purpose of the non-obviousness requirement is to prevent the granting of patents for inventions that are obvious to a person reasonably skilled in the particular art.(34)

These requirements establish broad guidelines for the patentability of any invention.(35) The text of the patent code does not provide any explicit requirements for obtaining medical procedure patents because the patent code does not employ a categorical approach. Inventions are not patented based on their inclusion or exclusion in a particular category or field of application.(36) Instead, inventions receive patent protection by satisfying the general statutory requirements.(37) The only exception to this approach is for inventions that may "be detrimental to the national security," such as fissionable material or weapons systems.(38) These types of inventions are not patentable.(39) At present, there is no such categorical exclusion for medical methods. Based on the broadly worded text of the patent code, a medical procedure, just like any other invention, may receive a patent as long as the medical procedure satisfies the statutory requirements. The applicable case law also supports the conclusion that medical procedures may receive patent protection.

B. Medical Procedures and the Applicable Case Law

Although the case law does not explicitly address the patentability of medical procedures, proponents and opponents of granting medical procedure patents view medical procedures as patentable subject matter.(40) Early patent decisions, however, viewed granting patents for medical procedures as improper. In 1862, in Morton v. New York Eye Infirmary, the New York Circuit Court rejected a patent on the method of anesthetizing patients by administering ether.(41) The court denied patent protection because the invention was a discovery of a new effect for the well-known process of inhaling ether.(42) The Morton court concluded that such discoveries were patentable only in combination with a means of operation or other type of embodiment for utilizing the new effect.(43) However, the natural functions of an animal," such as inhaling, could not constitute any part of this requisite combination.(44) This language "spawned the notion that medical and surgical methods of treating the human body were not patentable processes."(45)

In Ex parte Brinkerhoff, the Commissioner of Patents relied on the language in Morton and rejected a patent claim for a method of treating piles.(46) The Commissioner established a broad rule against the patentability of medical methods by stating that "the methods or modes of treatment of physicians of certain diseases are not patentable."(47) The Commissioner based the rationale for excluding medical methods on "the uncertainty that any medical method will achieve the desired result."(48)

Subsequent decisions of the Patent Office, however, rejected Brinkerhoff's exclusion of all medical treatment methods from patentability.(49) in Ex parte Scherer, the Board of Patent Appeals approved a patent for a method of injecting medicaments by a pressure jet.(50) The Board found that the uncertainty-of-results rationale in Brinkerhoff did not justify a categorical refusal of all patents for medical methods.(51) The Board expressly overruled Brinkerhoff to the extent that the decision held that medical procedures were unpatentable.(52)

However, opponents of patenting medical procedures view Scherer as only a decision within the Patent Office and rely mainly on the court decision in Martin v. Wyeth, Inc.(53) In invalidating a patent for a method of administering medicine for the treatment of mastitis(54) in dairy herds, the Martin court raised ethical and public interest concerns about the patenting of medical methods.(55) The court stated that "[t]he professional ethics of doctors and surgeons are more consistent with the widespread use of their medical and surgical discoveries for the benefit of mankind than in obtaining a monopoly to control their discoveries for personal commercial advantage."(56) The Martin court concluded that a public interest existed in ensuring that new medical discoveries were available to all patients.(57) However, the court did not base the rejection of the patent on this public interest notion. Instead, the court invalidated the claims because they constituted "merely the application of an old and well-known device to a new use."(58) Because subsequent case law has not directly addressed the issue of the patentability of medical procedures, courts have yet to adopt the rationale in either Scherer or Martin.(59)

The Supreme Court decision in Diamond v. Chakrabarty(60) provides indirect support for the proposition that medical procedures are patentable.(61) In upholding a patent on a human-made, genetically engineered bacterium capable of breaking down crude oil, the Court deferred to the plain congressional intent "that the patent laws would be given wide scope."(62) The majority reasoned that Congress demonstrated its intent by employing broad, general language in drafting the patent code.(63) The majority also relied on Committee Reports which demonstrated that "Congress intended statutory subject matter to include anything under the sun that is made by man."(64) In deferring to Congress, the Court emphasized that the policy contentions surrounding the patenting of living organisms should be addressed to the political branches of government.(65) Following the logic of Chakrabarty, the term process, used in the patent code to define patentable subject matter, would receive a wide scope that would encompass medical procedures.(66) Consequently, the relevant case law supports the present view that medical procedures are patentable.(67)

III. DISCUSSION OF THE ISSUES SURROUNDING PATENTING

MEDICAL PROCEDURES

A. Accessibility

A leading criticism of medical procedure patents focuses on the possibility that granting patents may restrict patient access to medical care.(68) The nature of the patent system provides support for this contention. A patent grants the inventor the exclusive right to make, use, and sell the invention in the United States for a definite period of time.(69) Essentially, a patent gives the patentee a limited monopoly on the newly created technique.(70) If the patentee chooses to restrict access to the new invention, physicians will not be able to provide all possible treatments to patients. The AMA views the potential for patents to limit the availability of new procedures as unethical.(71) Additionally, doctors who are unable or unwilling to risk legal action may refuse to use patented procedures on patients.(72) Dr. Pallin's infringement suit against Dr. Singer demonstrates the legal risk associated with using a patented procedure without obtaining a license or paying a royalty.(73)

The response to this accessibility concern derives its support from the underlying objectives of the patent system. The long-recognized main objective of the patent system is to promote the progress of science.(74) The Constitution explicitly states this objective in delegating to Congress the power to establish the patent system.(75) The individual reward to inventors "is secondary and merely a means to that end" of promoting the scientific progress.(76) Based on the objectives of the patent system, patents are necessary to encourage development of new medical methods. Physicians do not apply for medical procedure patents to restrict access to these inventions. There is no evidence to justify the medical community's concerns that physicians will restrict access to their medical procedures.(77) For example, Dr. Pallin wants to license his procedure for making an incision(78) and the requested royalty of four or five dollars per operation is not exorbitant when compared with the overall cost of the operation.(79)

The medical community misinterprets the patent system's basic premise that restricted access to medical procedures may be a necessary precondition for advancing such inventions.(80) The American Society of Cataract and Refractive Surgery views medical procedure patents as having a chilling effect on the dissemination of new ideas.(81) The Society claims that if medical procedure patents are enforced, "doctors would operate in secrecy, behind closed doors so that their `methods' would not be stolen by an observer."(82) However, the absence, not the presence, of patent protection encourages such secrecy.(83) In the absence of patent protection, other doctors may freely use any new medical procedure encountered in the medical field. Consequently, a doctor who chooses to protect his investment in developing a new procedure will practice the procedure in secret to prevent this widespread use. …

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