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The Case for Patenting Medical Procedures

Published online by Cambridge University Press:  24 February 2021

Joel J. Garris
Joel J. Garris*
Affiliation:
University of Maine, Boston University School of Law
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Extract

In contrast to the few medical procedure patents granted in the three decades following the 1950s, patent attorneys now estimate that the Patent and Trademark Office (PTO) grants at least a dozen medical procedure patents each week. This growing trend heightened the medical community’s concerns that such patents may adversely affect the cost, quality, and patient accessibility of medical care. Additionally, attempts by physicians to enforce medical procedure patents against other physicians further increased these concerns. 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. 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. 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.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 22 , Issue 1 , 1996 , pp. 85 - 108
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1996

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References

1 For the purposes of this Note, medical procedure patents describe particular ways to perform medical procedures on patients. These patents claim only specific methods of using various devices. Additionally, this Note uses the words method and procedure interchangeably in referring to these types of patents. Examples of such patents include: a method of diagnosing heartbeat disorders, U.S. Patent No. 4,960,129; a method of treating arthritis, U.S. Patent No. 5,026,538; a method of administering insulin, U.S. Patent No. 5,320,094; and a method of treating diabetes, U.S. Patent No. 5,321,009. For a table listing various other medical procedure patents, see Noonan, William D., Patenting Medical and Surgical Procedures, 11 J. Pat. & Trademark Off. Soc'y 651, 655 (1995)Google Scholar [hereinafter Patenting Medical Procedures].

2 See Felsenthal, Edward, Medical Patents Trigger Debate Among Doctors, Wall St. J., Aug. 11, 1994, at B1, B6Google Scholar. Medical procedure patents “have been legal in the U.S. since the 1950s. But in the past doctors rarely applied for them, in part because they can be extremely difficult to enforce.” Id.

3 McCormick, Brian, Just Reward or Just Plain Wrong? Specter of Royalties from Method Patents Stirs Debate, Am. Med. News, Sept. 5, 1994, at 3, 3Google Scholar [hereinafter Just Reward]; McCormick, Brian, Restricting Patents: Bipartisan Bill Would Bar Ownership Claims for Medical Methods, Am. Med. News, Mar. 20, 1995, at 3, 3Google Scholar [hereinafter Restricting Patents].

4 Felsenthal, supra note 2, at B1; Patently Unwise: The Patenting of Medical and Surgical Techniques Is Wrong Way to Go, Am. Med. News, July 25, 1994, at 13Google Scholar [hereinafter Patently Unwise]; Squires, Sally, AMA Condemns Patents for Medical Procedures, Wash. Post, June 20, 1995, at A1, A1Google Scholar.

5 H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST file (Oct. 19, 1995) (appendix to the testimony of Dr. Frank Baldino, Jr., Biotechnology Industry Organization (BIO)) [hereinafter BIO Appendix]. The infringement suit that Dr. Samuel Pallin filed is apparently the first of its kind. Id. For a description of other ongoing attempts to enforce medical procedure patents, see PTO Assails Bills to Limit Patents on Medical Procedures, 50 Pal. Trademark & Copyright J. (BNA) No. 1250, at 737 (Oct. 26, 1995)Google Scholar (hereinafter PTO Assails Bills].

6 U.S. Patent No. 5,080,111, Method of Making Self-Sealing Episcleral Incision, Abstract.

7 Pallin v. Singer, No. 593CV202 (D. Vt. filed July 6, 1993).

8 See Squires, supra note 4, at A1.

9 AMA Speaks Out on Managed Care, UPI, June 14, 1994, available in LEXIS, Nexis Library, UPI File. The AMA is not alone in its position on medical procedure patents. At least four major specialty groups within the medical community oppose the practice of patenting medical procedures. Just Reward, supra note 3, at 3. For example, the American Academy of Ophthalmology opposes medical procedure patents. Hoskins, H. Dunbar Jr., Doctors Group Opposes Medical Method Patents, Wall St. J., Sept. 6, 1994, at A13Google Scholar (letter to the editor by Hoskins, M.D., Executive Vice President of the Academy).

10 McCormick, Brian, A Question of Ethics: Guidelines Address Method Patents, Role in Executions, Am. Med. News, July 3, 1995, at 3, 60Google Scholar [hereinafter Question of Ethics].

12 140 Cong. Rec. E1,754 (daily ed. Aug. 17, 1994).

13 H.R. 1127, I04th Cong., 1st Sess. (1995).

14 Id.

15 141 Cong. Rec. S15291 (daily cd. Oct. 18, 1995).

16 S. 1334, I04th Cong., 1st Sess. (1995).

17 Id.

18 U.S. Const. art. 1, § 8, cl. 8. Congress shall have the power “To 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.” Id.

19 35 U.S.C.A. § 154 (West Supp. 1995). The term of a patent lasts 17 years from the date granted or 20 years from the filing date of the patent application. Id.

20 In re Bergy, 596 F.2d 952, 973 (C.C.P.A. 1979).

21 35 U.S.C. § 101 (1994). The patent code protects “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Id.

22 Id. § 100(b). “The term ‘process’ means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.” Id.

23 Id. § 101.

24 Merges, Robert P., Patent Law and Policy 147 (1992)Google Scholar.

25 35 U.S.C. § 102(a) (1994). In establishing the conditions for patentability, § 102(a) provides that “[a] person shall be entitled to a patent unless the invention was known or used by others.” Id.

26 Merges, supra note 24, at 161.

27 Prior art is anything, such as relevant knowledge, use, publications, and patents, which pertains to, but predates, the invention described in the patent application. 35 U.S.C. § 102 (1994).

28 Id. § 102(a).

29 Id. § 102(b).

30 City of Elizabeth v. American Nicholson Pavement Co., 97 U.S. 126, 136 (1877).

31 Manville Sales Corp. v. Paramount Systems, Inc., 917 F.2d 544 (Fed. Cir. 1990) (finding that an invention mounted on a single light pole in a closed rest area on a highway was a sale for experimental purposes and did not constitute a sale sufficient to bar patent protection).

32 City of Elizabeth, 97 U.S. at 135-36. The general public incidentally derived a benefit from the use of the new and improved wooden pavement. Id. The Court held that such use was not a public use as long as the inventor engaged in good-faith testing and exercised control over the invention. Id.

33 35 U.S.C.A. § 103(a) (West Supp. 1995).

A patent may not be obtained ... if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.

Id.

34 Graham v. John Deere Co., 383 U.S. 1, 11 (1966).

35 Diamond v. Chakrabarty, 447 U.S. 303, 307 (1980).

36 See generally 35 U.S.C. §§ 100-103 (1994).

37 See supra notes 20-34 and accompanying text.

38 35 U.S.C. § 181 (1994).

39 Id.

40 The introduction of legislation banning medical procedure patents implicitly acknowledges that such inventions are patentable. See H.R. 1127, 104th Cong., 1st Sess. (1995); S. 1334, 104th Cong., 1st Sess. (1995). In addition, the granting of medical procedure patents confirms that medical procedures satisfy the patentability requirement that the invention is patentable subject matter. See supra notes 20-22 and accompanying text.

41 17 Fed. Cas. 879, 884 (S.D.N.Y. 1862) (No. 9,865).

42 Id. The legal basis for the decision in this case is unclear. 1 Donald S. Chisum, Patents § 1.03[3] (1995). The vague reasoning may be based on the failure of the invention to satisfy all or parts of the statutory requirements of novelty, utility, or obviousness. Id.

43 17 Fed. Cas. at 884.

44 Id.

45 1 Chisum, supra note 42, § 1.03[3].

46 New Decisions, 27 J. Pat. Off. Soc'y 797, 797 (1945)Google Scholar. Piles is another word for hemorrhoids. Webster’s Third New International Dictionary 1715 (1993).

47 New Decisions, supra note 46, at 798.

48 1 Chisum, supra note 42, § 1.03[3].

49 See, e.g., Ex parte Scherer, 103 U.S.P.Q. (BNA) 107 (Pat. Off. Bd. App. 1954).

50 Id. at 107.

51 Id. at 110; see Gregory F. Burch, Note, Ethical Considerations in the Patenting of Medical Processes, 65 Tex. L. Rev. 1139, 1147 (1987)Google Scholar.

52 Scherer, 103 U.S.P.Q. (BNA) at 110 (overruling Brinkerhoff to the extent that the decision “holds or implies that all medical or surgical methods are unpatentable subject matter merely be cause they involve treating the human body”).

53 Martin v. Wyeth, Inc., 96 F. Supp. 689, 689 (D. Md. 1951); Burk, Dan L., Patenting Trans- genetic Human Embryos: A Nonuse Cost Perspective, 30 Hous. L. Rev. 1597, 1632 (1993)Google Scholar; see 1 Chisum, supra note 42, § 1.03[3]. Because administrative agency decisions are subject to review in federal judicial courts, agency decisions do not provide precedents for these courts. See Finley, Lucinda M., Article III Limits on Article I Courts: The Constitutionality of the Bankruptcy Court and the 1979 Magistrate Act, 80 Colum. L. Rev. 560, 578-80 (1980)CrossRefGoogle Scholar.

54 Mastitis is an inflammation of the udder usually caused by an infection. Webster’s Third New International Dictionary, supra note 46, at 1391.

55 Martin, 96 F. Supp. at 695.

57 Id.

58 Id.

59 Based on shepardizing both of these cases, no subsequent cases rely on the reasoning of Martin or Scherer in determining if an invention is patentable subject matter. Similarly, litigation over medical procedure patents is minimal. H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST file (Oct 19, 1995) (written testimony of Dr. William D. Noonan) [hereinafter Noonan Testimony]. For example, Baxter Travenol Laboratories, Inc. v. Smith Laboratories, Inc. involved a patent on a medical procedure for injecting an enzyme into a herniated disc. 227 U.S.P.Q. (BNA) 67 (N.D. Ill. 1985). However, in determining the owner ship of this patent, the court did not address the validity of the patent. Id.

60 447 U.S. 303, 307(1980).

61 Burk, supra note 53, at 1633.

62 Chakrabarty 447 U.S. at 307.

63 Id.

64 Id. (quoting S. Rep. No. 1979, 82d Cong., 2d Sess., at 5 (1952); H.R. Rep. No. 1923, 82d Cong., 2d Sess., at 6 (1952)).

65 Id.

66 35 U.S.C. § 100(b) (1994). The definition of process includes methods. Id.

67 See supra note 40 and accompanying text.

68 Thomas, Kimberly, Patents; Rx for Debate, Detroit News, Sept. 19, 1994, at 1EGoogle Scholar.

69 35 U.S.C. § 154(a)(2) (1994). Recent amendments changed the patent term to extend from the date a patent issues until 20 years from the date of filing of the application for the patent. Id.

70 Dictionary of Medical Ethics 321 (A.S. Duncan et al. eds., 1981).

71 Question of Ethics, supra note 10, at 3.

72 As Doctors Patent Medical Procedures, Patients Pay, USA Today, June 19, 1995, at 10AGoogle Scholar.

73 Felsenthal, supra note 2, at B1.

74 Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 331 n.l (1945). The Supreme Court noted:

The purpose [of the patent system] is much deeper and the effect much wider than individual gain. It is the promotion of science and the advancement of the arts looking to the general welfare of the Nation that the patent laws hope to accomplish. The individual reward is only the lure to bring about this much broader objective.

Id.

75 U.S. CONST. art. I, § 8, cl. 8.

76 United States v. Masonite Corp., 316 U.S. 265, 278 (1942).

77 See Felsenthal, supra note 2, at B1 (“Most physicians who hold so-called method patents appear to be more interested in licensing their techniques than restricting access.”). Even if some evidence existed to support the contention that physicians restrict access, a variety of remedies exist that remove potential barriers to accessing patented medical procedures. One option is to impose a compulsory licensing requirement for patented medical procedures. Burch, supra note 51, at 1166 (suggesting a compulsory license scheme to remedy the ethical concerns of patenting medical processes); see DeLaCruz, Cedric G., Do Patents Belong in Traditional Medicine?: Congress Considering Bills That Eliminate Protection, Legal Intelligencer, Nov. 2, 1995, at 9, 12Google Scholar. This licensing scheme would establish the level of royalties or licensing fees for patented medical procedures. Burch, supra note 51, at 1169. Another variation of this compulsory licensing scheme is to presume emergency use as a royalty free or royalty bearing license. From the Backwater to the Main Stream, As Corporate America Moves to Protect More of Its Property, Intellectual Property Laws Become Less Shrouded in Mystery, Ill. Legal Times, Dec. 1995, at 1, 17Google Scholar (suggestion by Attorney Richard J. Hoskins). Mandatory licensing provides physicians access to new procedures while providing inventors with a fair value for their invention. Burch, supra note 51, at 1169.

78 See Pallin, Samuel T., Patents Save Patients’ Money, USA Today, June 26, 1995, at 10AGoogle Scholar. Although Dr. Pallin received a patent for his method of making an incision during cataract surgery, he still uses his medical skills to provide free cataract surgery to those who cannot afford the operation. FYI, Phoenix Gazette, Apr. 5, 1993, at E1Google Scholar.

79 Pallin, supra note 78, at 10A.

80 Patenting Medical Procedures, supra note 1, at 656. Although a patent grants a limited monopoly to the inventor, this exclusive right is necessary to promote the progress of science. See supra note 74 and accompanying text.

81 H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST file (Oct. 19, 1995) (testimony of Dr. Charles D. Kelman, American Society of Cataract and Refractive Surgery) [hereinafter Kelman Testimony].

82 Ophthalmic Organizations Lead Patent Reform Drive, PR Newswire, Oct. 24, 1995Google Scholar, avail able in LEXIS, News Library, PRNEWS file (quoting Dr. Charles D. Kelman, president of the American Society for Cataract and Refractive Surgery); see H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST file (Oct. 19, 1995) (testimony of Dr. Jack Singer) [hereinafter Singer Testimony]. Dr. Singer claims that to avoid patent litigation, “the well advised physician will be driven to . . . withhold new and useful methods rather than sharing them freely for the benefit of patients.” Id.

83 For example, companies that do not seek patent protection for particular inventions may choose to protect their investment by considering the invention a trade secret. See Merges, supra note 24, at 960 (noting that the Uniform Trade Secrets Act covers inventions). In considering an invention a trade secret, companies must make reasonable efforts to maintain the invention’s secrecy. Unif. Trade Secrets Act § 1(4), 14 U.L.A. 438 (1990).

84 35 U.S.C. § 271(a) (1994). The statute regulates usage of a patented invention by providing that “whoever without authority makes, uses, or sells any patented invention, within the United States during the term of the patent therefor, infringes the patent.” Id.

85 Kewanee Oil Co. v. Bicorn Corp., 416 U.S. 470, 480 (1974).

86 See Thomas, supra note 68, at 1E (quoting Dr. M. Roy Schwarz, Senior Vice President of the AMA); Annas, George J., Surrogate Embryo Transfer: The Perils of Patenting, Hastings Center Rep., June 1984, at 25, 25-26CrossRefGoogle Scholar.

87 Thomas, supra note 68, at 2E. For example, patent protection is critical to the ability of the biotechnology industry to obtain funding for research. H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST file (Oct. 19, 1995) (testimony of Dr. Frank Baldino, Jr., Biotechnology Industry Organization (BIO)) [hereinafter Baldino Testimony]. Ernst & Young estimates that the biotechnology industry spent $7.7 billion on research and development during the fiscal year 1995. Id. (noting that the 1995 fiscal year is from July I, 1994 to June 30, 1995). Without patent protection, investors would not provide the necessary capital to fund this research. Id.

88 U.S. Patent No. 4,816,257; see also Annas, supra note 86, at 25.

89 Annas, supra note 86, at 25.

90 Id. at 25-26.

91 This opportunity for cost recovery complements the main objective of the patent system to promote scientific progress. See Sinclair & Carrol Co. v. Interchemical Corp., 325 U.S. 327, 331 (1945). Even the AMA recognizes that medical procedures requiring extensive research and development ‘“may never be made available to the public at all without the possibility of patent protection.’” H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST file (Oct. 19, 1995) (testimony of G. Lee Skillington, Office of Legislative and International Affairs, United States Patent and Trademark Office) (quoting the June 1995 report by the Council on Ethical and Judicial Affairs of the American Medical Association) [hereinafter Skillington Testimony].

92 Thomas, supra note 68, at 1E (quoting Dr. M. Roy Schwarz, Senior Vice President of the AMA).

93 Patently Unwise, supra note 4, at 13.

94 Id.

95 Dictionary of Medical Ethics, supra note 70, at 210.

96 Felsenthal, supra note 2, at B1 (quoting Lonnie Bristow, President-Elect of the AMA).

97 Dictionary of Medical Ethics, supra note 70, at 210 (quoting the Hippocratic Oath: "Nor will I give a woman a pessary to procure abortion.”).

98 See Planned Parenthood v. Casey, 112 S. Ct. 2791 (1992); Roe v. Wade, 410 U.S. 113 (1973).

99 See Dictionary of Medical Ethics, supra note 70, at 210. “The function of disclosure historically has been to get patients to agree to what the doctors wanted. In ancient Greece, patients’ participation in decision-making was considered undesirable, since the doctor’s primary task was to inspire confidence.” Furrow, Barry R. et al., Health Law: Cases, Materials and Problems 322 (2d ed. 1991)Google Scholar.

100 Dictionary of Medical Ethics, supra note 70, at 210-11 (The “Hippocratic tradition[’s] . . . emphasis on secret knowledge . . . ha[s] no universal application.”).

101 See, e.g., Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

102 See Dictionary of Medical Ethics, supra note 70, at 210 (The Hippocratic Oath includes a provision “to look upon [a teacher’s] children as [one’s] brothers”).

103 King, Lester S., The ‘Old Code’ of Medical Ethics and Some Problems It Had to Face, 248 JAMA 2329, 2331 (1982)CrossRefGoogle ScholarPubMed (citing 1847 AMA Code of Ethics, ch. II, art. iv, para. 1). See H.R. 1127 and II. R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST file (Oct. 19, 1995) (testimony of Dr. Samuel L. Pallin, Medical Director, Lear Eye Clinic) [hereinafter Pallin Testimony]. Dr. Pallin claims that the 1953 Code of Ethics for the AMA stated that it is un ethical for physicians to “receive remuneration from patents on . . . surgical instruments, appliances, and medicines.” Id. (quoting the 1953 Code of Ethics for the AMA). But see Patenting Medical Procedures, supra note 1, at 655. Recognizing the need for protection to recover the expense of research, the AMA Judicial Council issued an Official Opinion in 1948 stating that “it no longer considered medical patents necessarily unethical.” Id.

104 1992 Code of Medical Ethics: Annotated Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association § 9.09 (1992) [hereinafter 1992 Code Of Medical Ethics].

105 Id.

106 See id. § 9.08.

107 Id.

108 See King, supra note 103, at 2331.

109 1992 Code of Medical Ethics, supra note 104, § 9.08.

110 Just Reward, supra note 3, at 3, 32.

111 Eisenberg, Rebecca S., Proprietary Rights and the Norms of Science in Biotechnology Research, 97 Yale L.J. 177, 184 (1987)CrossRefGoogle ScholarPubMed (stating that “[u]pon publication, the scientist’s observations enter the public domain”).

112 Restricting Patents, supra note 3, at 3; Thomas, supra note 68, at 2E.

113 Restricting Patents, supra note 3, at 3 (quoting Dr. John Glasson, Chair of the AMA’s Council on Ethical and Judicial Affairs).

114 Wendy W. Yang, Note, Patent Policy and Medical Procedure Patents: The Case for Statutory Exclusion from Patentability, 1 B.U. J. Sci. & Tech. L. 5, ¶ 40 (1995)Google Scholar, available in LEXIS, Lawrev Library, BUJSTL File; see Eisenberg, supra note 111, at 181-84.

115 Eisenberg, supra note 111, at 217.

116 Id. at 216.

117 35 U.S.C. § 112 (1994) sets forth the disclosure required in a patent application:

The specification shall contain a written description of the invention, and of 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 and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Id.

118 Restricting Patents, supra note 3, at 3; Bowman, Lee, Physicians Stake Claims to their Art of Healing, S.F. Examiner, July 16, 1995, at B1, B7Google Scholar.

119 Bowman, supra note 118, at B7. In contrast to journals which normally involve subscription fees, federal law requires the PTO to “maintain, for use by the public, paper or microform col lections of United States patents, foreign patent documents, and United States trademark registrations arranged to permit search for and retrieval of information.” 35 U.S.C.S. § 41(h)(2)(i)(1) (1995). Federal law prohibits the PTO from imposing any fee directly for the use of such collections. Id. Additionally, the PTO must make full access of automated search systems available to the public. Id. § 41(h)(2)(i)(2). Although the PTO may impose a reasonable fee for use of such automated search systems, free access is available for purposes of education, training, and financial hardship and public interest exceptions allow a waiver of such fees in individual cases. Id. § 41(h)(2)(i)(3).

120 For patent disclosure requirements, see supra note 117; Restricting Patents, supra note 3, at 3.

121 Restricting Patents, supra note 3, at 3 (quoting Dr. Pallin’s patent attorney, James Longacre).

122 See Kelman Testimony, supra note 81.

123 There are “numerous reports of information and papers withheld due to disputes over credit or fears of helping a research competitor at a crucial moment.” Bowman, supra note 118, at B7. Additionally, Dr. Pallin claims that “[t]here are many frustrated physicians with ideas who aren't able to get them published, either because the journals are overwhelmed with submissions or because there are political pitfalls you must navigate around before you can get published.” Rhein, Reginald, BIO, AMA Clash over Bill to Shield Health Pros from Suits over Procedures, Biotech. Newswatch, Nov. 20, 1995, at 5Google Scholar (quoting Dr. Pallin).

124 Just Reward, supra note 3, at 32.

125 Id.

126 Stodghill, Ron II, First, Do No Harm. Then, Get a Patent, Bus. Wk., July 24, 1995, at 86Google Scholar.

127 Just Reward, supra note 3, at 32.

128 Id.

129 Id.

130 Greengard, Samuel, Doctors of Invention: Inspiration—and a Lot of Perspiration—Help Physician-Inventors Build a Better Device, Am. Med. News, Feb. 8, 1993, at 27, 29Google Scholar. Despite this potentially large source of income, virtually all of the members of the American College of Physician Inventors claim that money is not their primary motivation for inventing. Id. Instead, they enjoy the creative process and are pleased to help advance the practice of medicine. Id.

131 Eisenberg, supra note 111, at 181.

132 See H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST File (Oct. 19, 1995) (testimony of Donald R. Dunner, Chair, Section of Intellectual Property Law, American Bar Association) [hereinafter Dunner Testimony]. Id. Mr. Dunner claims that it is “unfair to single out one area of creativity—the creation of new and improved medical procedures—and deny rewards to those creators while providing them to all others.” Mr. Dunner also claims that such a result would also be counterproductive because it goes against the underlying premise of the patent system—a system that has enabled the United States to achieve world leader ship in scientific and technological development. Id.

133 See Singer Testimony, supra note 82 (“The medical profession’s culture of openness offers a virtual gold mine of free information for opportunistic physicians to claim ownership of variations of procedures developed by others.”).

134 See Kelman Testimony, supra note 81. In support of his legislation to ban medical procedure patents, Representative Ganske analogizes this abuse to “put[ting] the cherry on top of the whipped cream and . . . seeking a patent on the entire banana split.” H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST File (Oct. 19, 1995) (testimony of Representative Ganske) [hereinafter Ganske Testimony].

135 Kelman Testimony, supra note 81.

136 35 U.S.C. § 102 (1994); see supra notes 25-32 and accompanying text.

137 35 U.S.C.A. § 103 (West Supp. 1995); see supra notes 33-34 and accompanying text.

138 35 U.S.C. § 302 (1994). “Any person at any time may file a request for reexamination by the Office of any claim of a patent on the basis of any prior art cited under the provisions of section 301 of this title.” Id. Section 301 limits the prior art that may be cited to those “patents or printed publications which that person believes to have a bearing on the patentability of any claim of a particular patent.” 35 U.S.C. § 301 (1994). On written request, the identity of a person requesting a reexamination is kept confidential. Id.

139 35 U.S.C. § 282 (1994); 35 U.S.C.A. § 271(a) (West 1984 & Supp. 1995), amended by Pub. L. No. 103-465, tit. V, §§ 533(a), 534, 108 Stat. 4988, 4990 (1994) (defining infringement as: "Except as otherwise provided in this title, whoever without authority makes, uses, or sells any patented invention, within the United States during the term of the patent therefor, infringes the patent.”).

140 35 U.S.C. § 282 (1994). For example, the medical community and Dr. Singer view Dr. Pallin’s patented procedure as merely a simple addition to existing procedures. See Kelman Testimony, supra note 81; Singer Testimony, supra note 82. If this claim is accurate, Dr. Singer may success fully assert a defense to the alleged infringement by providing evidence of the prior art. See 35 U.S.C. §282(1994).

141 See, e.g., Felsenthal, supra note 2, at B1.

142 Id.; see Singer Testimony, supra note 82 (claiming that “physicians have an ethical obligation not to place additional financial burdens on their patients”).

143 See Singer Testimony, supra note 82. The American Society of Cataract and Refractive Surgery claims that granting medical procedure patents will increase health care costs due to the imposition of four different types of associated expenses: royalties to use a patented procedure, costs of searching the Patent Office’s files to avoid infringement liability, costs of applying for a patent, and legal fees used to defend against infringement actions. Kelman Testimony, supra note 81.

144 Patently Unwise, supra note 4, at 13.

145 Pallin, supra note 78, at 10A.

146 Felsenthal, supra note 2, at B1.

147 U.S. Patent No. 5,080,111, Method of Making Self-Sealing Episcleral Incision, Abstract.

148 Id. Astigmatism is a condition that leads to blurred vision in the patient. Webster’s Third New International Dictionary, supra note 46, at 134.

149 Bowman, supra note 118, at B1.

150 See Stodghill, supra note 126, at 86-87.

151 Thomas, supra note 68, at 1E.

152 U.S. Patent No. 5,320,094, Method for Administering Insulin, Abstract.

153 Felsenthal, supra note 2, at B1.

154 See, e.g., Gostin, Lawrence O., Health Information Privacy, 80 Cornell L. Rev. 451, 512 (1995)Google ScholarPubMed. Medical records are confidential because such records contain information obtained from a confidential relationship. Id. "Most states recognize a common law duty of confidentiality" in the physician-patient context. Id. at 508. Although there is some statutory protection for the confidentiality of medical information, a disclosure of information in good faith for a legitimate purpose may not result in the imposition of liability. Furrow et al., supra note 99, at 310-11.

155 Roach, William H. Jr. And the Aspen Health Law Center, Medical Records and the Law 2 (2d ed. 1994)Google Scholar. The physician or hospital that created the record owns the record subject to the patient’s interest in the information it contains. Id. at 95.

156 Burch, supra note 51, at 1154.

157 See Felsenthal, supra note 2, at B1. In emphasizing the difficulty of enforcing patents in light of these privacy concerns, George Annas, a health-law specialist at Boston University, asks “What are you going to do, stop people on the street and ... get them to show you their scar?" Id. at B6.

158 Roach, supra note 155, at 95. The general exceptions to the rule of confidentiality include disclosures required by the Freedom of Information Act, state and federal reimbursement regulations, review boards such as peer review organizations (PROs), state reporting statutes, and law enforcement. Id.

159 See 42 U.S.C. § 1320c-3(a)(7)(C) (1994). The PRO program primarily focuses on utilization and quality control of medical services provided to Medicare beneficiaries. See Furrow et al., supra note 99, at 767.

160 42 C.F.R. § 476.120(a) (1994). Roach, supra note 155, at 124.

161 See Roach, supra note 155, at 124. Confidential information also includes the identification of the practitioner and the health care institution. Id. However, by giving advance notice to practitioners and institutions, a PRO may disclose such confidential information. Id. at 125. In certain situations, a PRO may disclose this information without providing advance notice. Id. In contrast, numerous state statutory requirements do not even distinguish confidential information from the scope of disclosure. Id. at 134. For example, communicable disease reporting laws require the disclosure of the patient’s name and other identifying information. Id. (citing Ala. Code §§ 22- 11 A-l to -11A-73 (1995); Fla. Stat. Ann. § 384.21-384.34 (West 1993 & Supp. 1996); Haw. Rev. Stat. §§ 325-1 to-4 (1991)).

162 42 C.F.R. § 476.115(b) (1994).

163 Numerous health databases already exist for a variety of medically related information. Gostin, supra note 154, at 464. For a detailed discussion of the benefits of such databases including “the ability to enhance consumer choice, improve the quality of health services, assess system performance, improve administrative efficiency, facilitate research, and safeguard public health,” see id. at 471-84.

164 A computer program designed to detect improper medical reimbursement claims already exists. Using standardized codes for medical procedures, the program detects cases in which a single medical procedure is improperly billed as a series of procedures. GMIS, Inc. v. Health Payment Rev., Inc., No. 94-576, 1995 U.S. Dist. LEXIS 1201, at *3-4 (E.D. Pa. Jan. 24, 1995). The U.S. District Court for the Eastern District of Pennsylvania found the computer program to be patentable subject matter. Id,; see Computer Programs Are Patentable Subject Matter, 4 Health L. Rep. (BNA) No. 8, at D31 (Feb. 23, 1995).

165 See 35 U.S.C. § 271(a) (1994) (“[W]hoever without authority makes, uses or sells any patented invention ... infringes the patent.”).

166 140 Cong. Rec. E1754 (Aug. 17, 1994). On August 14, 1994, Representative John Bryant of Texas spoke of the possible barrier to access that occurs when the PTO grants patent protection to medical procedures. Id. The Congressman also stated that such patents would increase health care costs and undermine the traditional medical incentive system of publication. Id.

167 Restricting Patents, supra note 3, at 3.

168 Id. Claiming that the net effect of medical procedure patents is “bad,” Representative Wyden stated that most physicians and patients “will pay through the nose" while “a handful of physicians are profiting enormously.” PTO Assails Bills, supra note 5, at 737 (quoting Rep. Wyden).

169 H.R. 1127, 104th Cong., 1st Sess. § 2 (1995). Section 2, Limitation on Issuance of Patents states:

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, the patent on such machine, manufacture, or composition of matter may claim such technique, method, or process.

Id.

170 Id.

171 H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST File (Oct. 19, 1995) (opening statement of Representative Carlos Moorhead) [hereinafter Moorhead Statement].

172 Bill Tracking Report for H.R. 1127, 104th Cong., 1st Sess., Mar. 27, 1996, available in LEXIS, Legis Library, BLTRCK File. While most of the cosponsors joined in sponsoring the Bill during the summer of 1995, a total of 17 cosponsers joined since the October 19, 1995 hearing. Id.

173 141 Cong. Rec. S15291, S15292 (Oct. 18, 1995). While introducing this Bill, Senator Frist stated that the legislation would “limit the enforcement of medical method patents against physicians, while preserving the rights of the biotechnology industry.” Id.

174 S. 1334, 104th Cong., 1st Sess. (1995); see, e.g., PTO Assails Bills, supra note 5, at 737.

175 S. 1334, 104th Cong., 1st Sess. § 2 (1995). Section 2 of the Bill proposes amending 35 U.S.C, § 271 to add the following new subsection:

For any patent issued on or after the effective date of this subsection, it shall not be an act of infringement for a patient, physician, or other licensed health care practitioner, or a health care entity with which a physician or licensed health care practitioner is professionally affiliated, to use or induce others to use a patented technique, method, or process for performing a surgical or medical procedure, administering a surgical or medical therapy, or making a medical diagnosis.

Id.

176 Id. Section 2 provides:

This section does not apply to the use of, or inducement to use, such a patented technique, method, or process by any person engaged in the commercial manufacture, sale, or offer for sale of a drug, medical device, process, or other product that is subject to regulation under the Federal Food, Drug, and Cosmetic Act of the Public Health Service Act.

Id.; see, e.g., PTO Assails Bill, supra note 5, at 737.

177 On January 30, 1996, Senator Frist added Senator Helms of North Carolina and Senator Craig of Idaho as cosponsors of S. 1334. 142 Cong. Rec. S559 (daily ed. Jan. 30, 1996). On February 20, 1996, Senator Frist also added Senator McCain of Arizona as a cosponsor. Bill Tracking Report for S. 1334, 104th Cong., 1st Sess., Feb. 20, 1996, available in LEXIS, Legis Library, BLTRCK File.

178 See supra discussion part III; see also Kelman Testimony, supra note 81; DeLaCruz, supra note 77, at 9 (stating that the AMA, the American Society of Cataract and Refractive Surgery, the American Urological Association, the American Academy of Opthalmology, and the Association of American Medical Colleges support the current Bills).

179 Kelman Testimony, supra note 81 (commenting that even some of H.R. 1127’s sponsors favor the Senate version). At the congressional hearing, Representative Ganske testified that Representative Wyden and he were willing to amend the Bill to make it as narrow as possible so as not to limit the growth of the biotechnology industry. Ganske Testimony, supra note 134. In referring to the Senate Bill, Ganske viewed the Bill as reflecting discussions he conducted with members of the biotechnology industry. Id.

180 See supra discussion part III.

181 Id.

182 Method of use patents protect developments of new uses of compositions of matter. Baldino Testimony, supra note 87 (claiming that method of use patents are quite common in the biotechnology industry).

183 See, e.g., id. "H.R. 1127 is an over-broad response to the ethical problem of procedure patents in medicine. It would eliminate patent protection for new uses of unpatentable compounds or compositions.” Noonan Testimony, supra note 59.

184 See, e.g., H.R. 1127 and H.R. 2419: Hearings Before the Subcomm. on Courts and Intellectual Property of the House Judiciary Comm., 104th Cong., 1st Sess. (1995), available in LEXIS, Legis Library, CNGTST File (Oct. 19, 1995) (testimony of Michael K. Kirk, Executive Director, American Intellectual Property Law Association) [hereinafter Kirk Testimony].

185 H.r. 1127, 104th Cong., 1st Sess. (1995).

186 See id.; BIO Appendix, supra note 5. Similarly, the phrase surgical procedures is subject to widely different interpretations even among physicians. Id.

187 BIO Appendix, supra note 5. BIO analyzes each of these types of inventions and provides explicit examples where patent protection may be denied for various biotechnology inventions. Id. For example, gene therapy appears to fall within the scope of “administering a medical therapy.” Id. A process of using hyaluronic acid to reduce postsurgical adhesions may fall within the scope of “surgical procedures" and thus prevent the developing company from recovering the millions of dollars spent in development. Id. Additionally, the prohibition against procedures for “making a medical diagnosis" would cripple the medical diagnostics industry. Id.

188 See Kirk Testimony, supra note 184 (viewing the exemption as one of many technical flaws in H.R. 1127); Baldino Testimony, supra note 87.

189 See Kirk Testimony, supra note 184. If the machine is patentable, claims to the procedure are of no added value because an infringer will be liable for the unlicensed use of the machine. Baldino Testimony, supra note 87.

190 Baldino Testimony, supra note 87. The immunity approach “in no way lessens our concerns with imposing a statutory restriction on medical or surgical procedure patents.” Kirk Testimony, supra note 184.

191 See S. 1334, 104th Cong., 1st Sess. (1995); see also Baldino Testimony, supra note 87 (expressing concern that biotechnology competitors may utilize infringing products and procedures with impunity).

192 Noonan Testimony, supra note 59.

193 The Due Process Clause of the Fifth Amendment limits the federal government from allowing differential treatment of certain classes of people. U.S. Const, amend. V. The Due Process Clause serves as a counterpart to the Equal Protection Clause of the Fourteenth Amendment which restricts state action. Boiling v. Sharpe, 347 U.S. 497 (1954). The Supreme Court applies the same standards of review under cither constitutional provision. See id.; United States R.R. Retirement Bd. v. Fritz. 449 U.S. 166, 174-79 (1980). The Senate Bill distinguishes physicians from all other patent infringers. S. 1334, 104th Cong., 1st Sess. (1995). Because this classification docs not constitute a suspect class, rational basis review will apply. See City of Cleburne v. Cleburne Living Center, Inc., 473 U.S. 432, 439-47 (1985) (holding that retarded persons are not a suspect class and applying rational basis review). This standard upholds a law if the law is rationally related to a legitimate governmental interest. Id. Due to the deferential nature of rational basis review, the Senate Bill will probably survive such a constitutional challenge. See Fritz, 449 U.S. at 179.

194 U.S. CONST, art. 1, § 8, cl. 8.

195 Id.

196 See generally id.

197 Dunner Testimony, supra note 132.

198 Id.

199 See supra notes 35-39 and accompanying text; Pallin Testimony, supra note 103; Dunner Testimony, supra note 132.

200 Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980); see supra notes 35-37 and accompanying text.

201 35 U.S.C. § 181 (1994).

202 Restricting Patents, supra note 3, at 21 (quoting patent attorney James Longacre).

203 See id.; Baldino Testimony, supra note 87. “One has a difficult time ... in analogizing a method of making a surgical incision to a method of making an atomic weapon.” BIO Appendix, supra note 5; see also PTO Assails Bills, supra note 5, at 738 (referring to a comment by Donald Dunner that medical procedures are not so unique as to require an exemption from the patent system).

204 See Burch, supra note 51, at 1166 (commenting on the possibility of excluding medical processes from patent protection).

205 Pirkey, Louis T. & Barber, William G., Treaties Bring Changes to U.S. Trademark Law and Practice, 22 AIPLA Q.J. 509, 510 (1994)Google Scholar.

206 United States Department of State, Fact Sheet: Protection of Intellectual Property Rights, Mar. 7, 1994, available in LEXIS, Intlaw Library, DSTATE File. “Estimated losses to U.S. owners of intellectual property rights from ... illegal activities amount to billions of dollars each year.” Id.

207 Id.

208 Agreement on Trade-Related Aspects of Intellectual Property Rights, Including Trade in Counterfeit Goods, Final Act Embodying the Results of the Uruguay Round of Trade Negotiations, Apr. 15, 1994, art. 27, 33 I.L.M. 1, 83-111 (1994) [hereinafter TRIPS Agreement].

209 United States Department of State, supra note 206. Other agreements that involve strengthening intellectual property rights include the North American Free Trade Agreement and various agreements developed through the World Intellectual Property Organization. Id.

210 Paragraph 1 of Article 27 states that “patents shall be available for any inventions, whether products or processes, in all fields of technology.” TRIPS Agreement, supra note 208, at para. I; see Dunner Testimony, supra note 132.

211 TRIPS Agreement, supra note 208, at para. 3; Kirk Testimony, supra note 184.

212 TRIPS Agreement, supra note 208, at para. 3(a).

213 The European Patent Convention explicitly excludes “methods for treatment of the human or animal body" from the scope of patent protection. Burch, supra note 51, at 1163 (citing Article 52(4), European Patent Convention (Munich 1973) as amended Dec. 21, 1978, O.J. Comm. 3 (1979)). As early as 1914, British courts denied patent protection to methods of medical treatment. Id. (citing C & W’s Application, 31 R.P.D. & T.M. Cas. 235 (1914)). Codifying this long- established principle, the United Kingdom Patents Act of 1977 provides that procedures for treating humans are not patentable. Id. (citing United Kingdom Patents Act, 1977, pt. I, at l(1)(c) (Eng.)); see id. (citing Eli Lilly & Co.’s Application, 1975 R.P.D. & T.M. Cas. 438, 438 (“It has long been established that claims to methods of medical treatment should not be accepted.”)).

214 Patenting Medical Procedures, supra note 1, at 664 n.36 (citing Examination Guidelines for Patent and Utility Model in Japan, Japanese Patent Office, Tokyo, 1994—chapter 1, page 3).

215 Fiorito, Edward G., The WIPO “Basic Proposal" for Harmonization of Patent Laws Viewed from the U.S. Practitioners Point of View, 19 AIPLA Q.J. 24, 38 (1991)Google Scholar. At the June 1990 meeting of the World Intellectual Property Organization, 44 developing countries requested a number of exceptions, including medical methods, to the proposed allowance of patents in all fields of technology. Id.

216 See Kelman Testimony, supra note 81. During the congressional hearings on H.R. 1127, Representative Moorhead suggested that the United States’s commitment to international patent law required the country to join with other nations in banning medical procedures. PTO Assails Bill, supra note 5, at 738.

217 See Kirk Testimony, supra note 184; Noonan Testimony, supra note 59. “'Our government has taken a hard line with other nations to be more expansive in honoring patents. It would be hard to argue that at the same time we move to restrict patent protections for our own innovators.*" Restricting Patents, supra note 3, at 21 (quoting patent attorney James Longacre).

218 Additionally, the present legislative proposals are more restrictive than foreign law, placing domestic industries at a disadvantage. Noonan Testimony, supra note 59; see PTO Assails Bills, supra note 5, at 738. Some suggest that the absence of such legislation will provide the United States a stronger bargaining position in harmonization negotiations because allowing medical procedure patents could potentially be sacrificed in return for maintaining other aspects of United States patent law. Noonan Testimony, supra note 59. Noonan believes that the international harmonization effort may eventually bring about the elimination of medical procedure patents, rendering the present controversy moot. Patenting Medical Procedures, supra note 1, at 664.

219 Patently Unwise, supra note 4, at 13.

220 See supra notes 103-09 and accompanying text.

221 BIO Appendix, supra note 5.

222 Id. "Any group which perceives that a class of patents will have a deleterious impact on that group and/or its members can rush to Congress, requesting that laws be passed which prohibit the issuance of such patents.” Id. By passing these Bills, interest groups will utilize them as precedent “to effectuate changes to the law which benefit those groups, irrespective of the damage caused to our Nation’s patent system and our innovators who use this system.” Id.

223 Stammer, Larry B. & Hotz, Robert Lee, Faiths Unite to Oppose Patents on Life Forms, L.A. Times, May 18, 1995, at A1, A21Google Scholar. Responding to this group’s concerns, Senator Mark Hatfield, a Republican from Oregon, has introduced a bill to prohibit the patenting of genetically engineered animals in every session of Congress since 1987. DeLaCruz, supra note 77, at 9.

224 “The patent de jour is now ‘surgical procedures.’ Tomorrow it may be procedures for treating disorders of the heart or AIDS.” BIO Appendix, supra note 5.

225 See supra notes 84-91 and accompanying text.

226 Moorhead Statement, supra note 171 (“[T]he burden of proof is on the proponents of the legislation to demonstrate the need for it.”). The medical community “ha[s] not been able to establish the need for such legislation, other than for purely philosophical reasons.” Kirk Testimony, supra note 184. Furthermore, the proposed legislation represents an attempt “to legislate a resolution to a dispute within the medical community.” BIO Appendix, supra note 5.

227 See Patenting Medical Procedures, supra note 1, at 657 (comparing the present controversy involving medical procedures to disputes over the patenting of transgenic animals and human gene sequences).

228 Id.

229 Id.

230 See, e.g., Skillington Testimony, supra note 91. “[The bill] was entitled ‘A bill amending the statutes relating to patents, relieving medical and dental practitioners from unjust burdens imposed by patentees holding patents concerning methods and devices for treating human diseases, ailments, and disabilities.’” Patenting Medical Procedures., supra note 1, at 654 (citing H.R. 12451, Mar. 12, 1902). The bill “prohibited patents on any ‘art of treating human disease ... or upon any device adapted to be used in the treatment of human disease or disability, or attached to the human body and used as a substitute for any lost part thereof, or upon any art of making such device.’” Id.

231 Patenting Medical Procedures, supra note 1, at 654.

232 Skillington Testimony, supra note 91.

233 See generally supra part III.

234 See Skillington Testimony, supra note 91.

235 The PTO suggests an administrative approach to addressing the issues surrounding the patenting of medical procedures. Opthatmalic Organizations Lead Patent Reform Drive, PR Newswire, Oct. 24, 1995, available in LEXIS, Nexis Library, PRNEWS File. In testifying before Congress, G. Lee Skillington offered to conduct hearings to develop actions that the PTO could take to solve the problems the proponents of the Bills identified. Skillington Testimony, supra note 91. These hearings may change the PTO’s approach to reexamining existing medical procedure patents and observing the non-obviousness requirement for medical procedure patent applications. Id. This administrative approach presents a better solution than the proposed legislation because it avoids the introduction of a categorical exception into the patent system. See supra notes 199-204 and accompanying text. However, these administrative efforts appear unnecessary because the PTO imposes exacting standards on medical procedure applications. Dunner Testimony, supra note 132. The fact that patent applications for medical procedures are subject to “very exacting requirements ... is demonstrated by the fact that their success rate is only about half that of applications for conventional mechanical and electrical patents.” Id.