Patents are often described as government-granted monopolies. This description is somewhat misleading because the term monopoly implies that the monopolist is the sole producer of the goods or services. What a patent conveys is the right to exclude others from making, using, importing, selling, or offering for sale the patented product or process.

A patentee need not make or use its own product or process, and sometimes it is forbidden from selling its patented product as, for example, where the patented drug has not been approved by the FDA. Although companies that do not make or use their patented product or process usually license the technology to others who will. U.S. law, in contrast to many other countries, does not require them to do so.

An increasingly common business model is the “patent holding company” whose sole activity is bringing lawsuits for patent infringement. Even where a patent owner chooses to license its technology, there is no limit on the amount that may be charged for a licensee, and it is not uncommon for drug or device makers to charge exorbitant licensing fees where there is a great demand for its patented technology.

Because clinicians are not typically engaged in the manufacture or sale of pharmaceuticals or devices, they may believe that the patent system affects them only indirectly, such as through the increased cost of patented medical supplies and equipment. This belief is, unfortunately, increasingly incorrect as the number of patented medical procedures mount. Medical procedure patents (sometimes referred to as “medical process” patents), cover the types of activities clinicians regularly engage in, such as diagnosing a disease or condition. As less news coverage has been directed toward medical process patents than to pharmaceutical patents, you may surprised to find that you regularly infringe patents without knowing it.

In 2005, the U.S. Supreme Court decided to address the validity of these types of patents in the case LabCorp v. Metabolite Industries Inc. (No. 04-607) The patent at issue in LabCorp was a method of diagnosing whether a patient may have a deficiencies of two vitamins, folate (folic acid) and cobalamin (Vitamin B12), by measuring the level of the amino acid homocysteine in bodily fluids and noticing that high homocysteine levels may indicate vitamin deficiency.

The patentee did not claim to have invented any new way to test for homocysteine or analyze the results of a homocysteine test beyond stating that high homocysteine levels “correlates” to deficiency of folic acid and B12. The patent was merely on the mental process of reading test results and concluding whether a patient was likely or unlikely to be deficient in these vitamins.

Patients not Patents Inc. (patientsnotpatents.com) submitted a friend-of-the-court brief arguing that allowing patents on the mental steps of diagnosis would undermine the doctor-patient relationship by creating an environment in which medical practitioners could discuss test results with a patient without justifiably fearing a lawsuit for patent infringement.(1) The Court, without comment, ultimately decided that it should not have agreed to hear the case in the first place.

The emphasis in the U.S. patent system on exclusionary rights, particularly when it involves medical process patents such as the one at issue in the LabCorp case, flies in the face of the medical community’s tradition of openness and sharing of knowledge. For primarily this reason, and in response to a practitioner’s filing of an infringement lawsuit based on his patent for a sutureless ophthalmic surgery procedure, the American Medical Association passed a resolution stating that it is unethical for a doctor to obtain a patent on a medical procedure.

Congress assuaged the medical community’s fears somewhat by passing a law preventing enforcement of medical procedure patents against healthcare professionals in certain situations, although the law did not declare invalid or prevent the issuance of new patents on medical procedures.(2)

Several caveats in the law, however, limited its usefulness. First, the law immunized doctors only for performing “medical activities,” defined as “the performance of the medical or surgical procedure on the body.” A practitioner may therefore still be liable for infringing a patent on a method of diagnosis, such as the one at issue in LabCorp, because courts are not likely to consider diagnosis as an activity performed “on the body.” Additionally, the exemption only applies to patents having an effective filing date on or after Sept. 30, 1996. Because patent term is generally 20 years from the date of filing, the exemption will not provide full protection for medical practitioners until 2016.

Consider, for example, U.S. Patent 4,960,129 that concerns a method for diagnosing cardiac dynamical dysfunction using heartbeat interval data. The patent as written would be infringed by a doctor who concluded that a patient had cardioventilatory phase locking by comparing the patient’s ventilatory cycle with the patient’s heartbeat.(3) This patent was filed Dec. 5, 1988, so it remains in force as of publication of this article, and medical practitioners would not be immune from an infringement lawsuit because the patent application was filed before 1996. Additionally, the method of diagnosis described in the patent does not involve the performance of a medical or surgical procedure “on the body.”

The need to bar medical method patents becomes even clearer when you consider the issue of indirect infringement.
Suppose that after reading this article, you say to a colleague, “You know, I just read about how out-of-control our patent system is. A doctor actually got a patent just for noting that a linear correlation between heartbeat rate and the phase of ventilator cycle in a patient with cardioventilatory phase locking. You might want to keep that in mind the next time you suspect phase locking.” That comment could lead to you getting sued for inducing another to infringe a patent.

Similarly, if you have a teaching position or are putting together a poster for a conference, and you include in your outline the method described in the patent and suggest that the attendees or students make use of this knowledge, you may be facing a lawsuit for inducing infringement, even if your audience never intended to violate a patent. Even if your audience never makes a dime off of the information you presented, a court may order you to pay “reasonable royalties” to the patent owner, and it is difficult to estimate how much that will cost you.

The accompanying articles in this issue describes litigation that arose over similar conduct, which demonstrates that the need for patent reform is not merely an academic or theoretical, but a real-world issue affecting the health profession. Patients not Patents has recently launched a program to prohibit the granting of patents on medical processes. Tax-deductible contributions may be made at patientsnotpatents.com. VTN

1 www.patientsnotpatents.org/documents/amicus_pnp.pdf
2 35 U.S.C. § 287.
3 The patent claims “A method for determining the presence of cardioventilatory phase locking in a subject, comprising the steps of: (a) acquiring data representing the respective time intervals between successive heartbeats of said subject; (b) concurrently acquiring data representing the phase of the ventilatory cycle of said subject related to said heartbeat interval data; (c) determining whether said data acquired in steps (a) and (b) are substantially linearly correlated at substantially the same point in the ventilatory cycle of said subject over a discrete period of time; whereby the existence of said substantial linear correlation is indicative of cardioventilatory phase locking.”

Jeffrey Light is founder and executive director of Patients not Patents Inc. Light holds a law degree from Georgetown University Law Center and master and bachelor degrees from Brandeis University in biochemistry. He is licensed as a registered attorney by the U.S. Patent and Trademark Office and licensed to practice law in Washington, D.C. Light has had articles on patent law published in both the American Bar Association’s “The Tax Lawyer” and the University of Chicago-Kent’s “Intellectual Property Journal.” He may be contacted at 202-277-6213.