Selected Papers
Patent Law Amendment Provides Swift Relief for US Doctors
By Warren D. Woessner and Michael A. Dryja*
Originally Appearing in IP Worldwide Magazine, March/April 1997
It became law inconspicuously, as a small part of an omnibus appropriation bill. It was intended to make only one tiny change in US patent law. But things may not work out that way. The Ganske compromise legislation was intended only to protect doctors and other medical practitioners against a certain type of patent infringement suit. However, the law is causing worry for many in the software and computer industries. And it raises disturbing questions about the future of America's whole patent law. The original version of the bill,1 introduced in March 1995, would have banned the issuance of patents claiming "pure" medical procedures, such as methods of making incisions for cataract or open heart surgery. However, the bill's language was so broad that it would also have banned patents on new uses for known compounds and many diagnostic assays. The Ganske bill thus faced strong opposition from groups such as the Biotechnology Industry Organization, the American Bar Association and the American Intellectual Property Law Association, and the bill did not become law. The Ganske bill was revived, in very different form, as Section 616 of the 1996 omnibus appropriation bill,2 and it became law in late 1996. The new Ganske compromise law no longer attempts to curtail patentable subject matter. Instead, the compromise legislation amends 35 U.S.C. Section 287 by adding a subsection (c) that exempts from the definition of patent "infringement" a medical practitioner's performance of a "medical activity" on a human or a laboratory animal. Rather than banning patent protection for medical procedures, the Ganske compromise legislation establishes that any such patents are not infringed when the patented procedures are performed under certain situations by certain classes of individuals.3
No worries for doctors
Section 287(c) contains many exemptions which effectively limit the term "medical activity" to "pure" surgical procedures or diagnostic procedures not involving drugs or reagents to accomplish the end result. For example, medical activities do not include the use of a patented machine, manufacture or composition of matter, or "the patented use of a composition of matter."4 The term, "patented use of a composition of matter" includes a diagnostic method in which an unpatentable composition of matter "directly contributes to achievement of the claimed method." One example would be an assay for cancer based on the discovery that a known, unpatentable antibody can detect a marker protein for the cancer. On the other hand, a claim to a surgical procedure that incidently involves use of a drug such as a disinfectant or anesthetic, that is not responsible for accomplishing the end result, would remain an exempted "medical activity." The term "medical activity" does not include the "practice of a process in violation of a biotechnology patent."5 The legislative history for this section defines "biotechnology patent" as one claiming a "biotechnological process" as defined in 35 U.S.C. Section 103(b) or claiming a process of making or using biological materials which have been manipulated ex vivo at the cellular or molecular level.6 The term "medical activity" does not include activities related to the commercial development, manufacture, sale, importation of a machine or compound, or the provision of pharmacy or clinical laboratory services, unless the clinical lab services are performed in the physician's office.7 The effect of new Section 287(c) on the medical community is likely to be minimal. There are only a relatively small number of patents that have issued on "pure" surgical procedures. Thus, even before the Ganske compromise law was passed, doctors employing the surgical procedures of others had little reason to fear being sued for patent infringement, because so few of the procedures were actually patented. Now, of course, doctors can put their infringement concerns completely to rest when in the operating room. The main result of the Ganske compromise law is that doctors and their associated health care facilities will not have to pay royalties for the value added to their practices and business when they use any patented surgical procedures.
Controversy continues
The passage of Section 287(c) is not likely to end the debate on the appropriateness of extending patent protection to surgical procedures. Many in the medical community have taken the view that these procedures amount to an intangible "art" of the practice of medicine, which should be passed on freely within the medical community to ensure that patients receive the best possible quality of care. Just as basic medical knowledge taught in medical school is not patentable, these individuals argue, so too surgical procedures should not be patentable. These individuals note that there is no "fair use" exception to patent law. Even the recitation of a patented surgical procedure in a medical text book or a seminar is a potential infringement.8 Some patent practitioners, economists and other academics counter that the advancement of surgical procedures is no different than the advancement of other technologies, which is encouraged by the availability of full patent protection. A surgeon or researcher who invents a surgical procedure should receive patent protection as an incentive to continue inventing and discovering, just as the inventor of a better mouse trap is entitled to receive a patent for the fruits of his or her labor. Otherwise, the argument runs, the surgeon or researcher may determine that the costs incurred in conjunction with perfecting a new or improved surgical procedure are not worth the benefits that they may receive. Such surgeons or researchers may elect not to make their techniques public, or may even decide to forego inventing altogether. Furthermore, obtaining knowledge of medical innovations is seldom "free," as evidenced by medical school tuition or the cost of continuing medical education programs. Some therefore argue that it would not be unreasonable for physicians to pay some additional patent license fees for access to cutting-edge technologies.
Side effects for software
Surprisingly, the Ganske compromise legislation may not affect the medical community as much as the software community. Many in the software and computer industries are understandably concerned about the law's effect on their patent acquisition efforts. Does the new Section 287(c) infringement exemption apply to patent claims directed towards a software or computer invention that is medically related (e.g., a diagnostics or medical imaging software invention)? The answer seems to depend on the patent claim. Section 287(c) defines medical activity as "the performance of a medical or surgical procedure on a body." Thus insofar as a software or computer system is not a "medical or surgical procedure," Section 287(c) should not cover claims specifically directed to the system. Enforceable claims can therefore be obtained for software inventions that are cast as system, device, or apparatus claims, without the need to expend undue attention studying the vagaries of Section 287(c). Such claims are easily identified by their preambles and would include claims beginning with, for example: "a computerized system for diagnosing heart disease"; "a computer having software running thereon to inform a medical diagnosis related to cancer"; or "a medical imaging device."
Questionable methods
The question remains as to whether Section 287(c) applies to computer or software inventions when they are protected by method claims. The archetypical medical software method claim recites the steps of acquiring medical data from a patient, converting and inputting the data to a computer, conducting various analyses on that data by the computer, and outputting a diagnosis or other suggested course of action for performance on the patient. Does such a method claim encompass "medical activity" as defined by Section 287(c)? The answer is unclear. If a method claim directed to a medical software invention includes one or more steps for the performance of a course of action as suggested by the computerized analysis of previously acquired patient data, then Section 287(c) may control the claim. Such a claim for the performance of a course of action may be construed to be a "medical or surgical procedure on a body" because a medical practitioner is told what to do. Then, under section 287(c), the patentee could not successfully seek damages against a medical practitioner who utilizes the patented claim without authorization. Because one cannot know for sure whether the US courts will interpret Section 287(c) to encompass method claims for software or computer-related inventions, such claims should be carefully couched in language that does not recite application of a medical procedure on a body. A prudent practitioner would thus draft a method claim that has a step to "provide a diagnosis as suggested by the computerized analysis," instead of a claim that has a step to "perform a diagnosis as suggested by the computerized analysis." Performing a diagnosis on a patient may constitute a medical procedure on a body within Section 287(c), while providing a diagnosis for later or possible performance on a patient is far less likely to be seen as a medical procedure on a body. Moreover, a method claim that includes a step of providing a diagnosis, instead of performing a diagnosis, should be sufficient to protect against misappropriation of the invention.
Dangerous precedent
Regardless of the effects of Section 287(c) on the software and medical communities, a far larger issue is whether Section 287(c) is a harbinger of other amendments to US patent law. Remarkably, the patent laws of the US have remained largely unchanged since their modern incarnation in the Patent Act of 1952. The primary revisions to this Act have only set out to correct minor technical issues and to make the patent laws of the United States consistent with various international treaty obligations. Substantively, the patent laws have been changed little, if at all, by Congressional action. The Ganske compromise legislation may represent a turning point in the way US patent law will evolve. Rather than waiting for the courts to gradually settle the issue on a case by case basis, opponents of surgical procedure patents convinced Congress to change the law, even though few surgical procedure patents had issued and even fewer cases had been brought. This compares unfavorably to other hot spots in patent law, such as the fight over patent protection for computer software, which has instead been battled over the past thirty years in courts up to and including the US Supreme Court. This slow, judicial procedure has allowed for practical experience to shape the patent protection afforded computer software over time. Although the current state of computer software patent law is far from perfect, most would agree that it is in a much better position that if Congress had acted precipitously when the issue was first raised in the late 1960s. The fear is that other industries, having had their appetites whetted by the medical community's success in amending Section 287(c), will push other amendments to the patent system through Congress. Rather than staying a largely simple and eloquent body of law, the patent system may become as inconsistent and convoluted as the United States tax code, which is frequently amended by Congress to cater to special interests. If this were to happen, everyone stands to lose -- except patent attorneys, who would then have to spend more time (at the expense of their clients) to sort through an ever-growing and increasingly convoluted body of law. One can only hope that the Ganske compromise legislation will remain an exception, not the rule.
(1) H.R. 1127.
(2) P.L. 104-208.
(3) The law exempts both medical practitioners and "related health care entities."
(4) 35 U.S.C. § 287(c)(2)(A)(ii).
(5) Id. § 287(c)(2)(A)(iii).
(6) Cong. Rec. 9/28/96 H1186566. This latter part of the definition seems redundant. Biological materials that have been manipulated ex vivo -- including cultured cells, DNA, proteins and viruses -- are "compositions of matter," the patented uses of which are independently excluded from the scope of medical activity. 35 U.S.C. § 287(c)(2)(A)(i).
(7) 35 U.S.C. § 287(c)(3)(A).
(8) Of course, certain individuals could be exempt from liability under Section 287(c).
* Dr. Woessner, Ph.D., is head of the biotechnology and chemical practice groups of the Minneapolis firm of Schwegman, Lundberg & Woessner. Mr. Dryja is an associate with the firm.
Copyright 1997, The New York Law Publishing Company. All Rights Reserved. Used with Permission.
