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IP: The (new) patent eligibility of medical methods

Congress and the courts try to balance patent rights with “law of nature”

In my previous article, we discussed the balances presently being made in the implementation of the American Invents Act (AIA). As stated in that article, the nature of the bargain struck often depends on your perspective.

Last month, we saw the Supreme Court genuinely struggle with finding the right balance as to the patent eligibility of medical methods relative to the laws of nature in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In attempting to fashion a solution that would remain technologically neutral, the court recognized that the “practical effects” of such rules “may differ from one field to another.”

Many in the biotechnology and pharmaceutical industries can surely identify at least one group for whom the practical effects of Mayo differed, and the court recognized that not everyone would be satisfied with the decision. As the court intimated in Bilski v. Kappos and stated even more clearly in Mayo, if you don't like what we have done, take it up with Congress (“And we must recognize the role of Congress in crafting more finely tailored rules where necessary”).

So, how would that look? If Congress were to try to come to grips with the issue of patent eligibility, what might they propose? Or even more narrowly, what might happen if Congress tried to come to grips with the patent eligibility of methods relating to medical diagnosis and treatment?

Actually, we don't have to blindly speculate on the answer to that question because nearly two decades ago, Congress did wrestle with the patent eligibility of medical methods. A bill was introduced to:

preclude the issuance of a patent 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.

Powerful parties lobbied on both sides of the question—many doctors and the American Medical Association lobbied against patent eligibility, while the biotechnology and medical device industries lobbied for patent eligibility. Sound familiar?

We all know that Congress did not remove methods of medical treatment and diagnosis from the Patent Act in 1995. What might not be as well known is that Congress did pass a law that attempted to strike a balance on the issue of medical methods. In the end, no one got everything they wanted, but everyone received something.

For doctors and their related healthcare entities (e.g., hospitals, clinics, HMOs, group medical practices, etc.), Congress provided immunity from liability and injunction. This immunity was then subject to several exceptions, to address the concerns of the biotechnology and medical device communities. For instance, the doctor’s immunity for medical activity did not cover use of a patented medical device. Another exception retained liability for “practice of a process in violation of a biotechnology patent."

Still, setting aside whether Congress has already acted on this issue, a further question arises: Would future Congressional action necessarily resolve the issue any better than Mayo did? The answer unfortunately may be an unqualified maybe.

To begin, laws regarding patent eligibility may well be easier to articulate than apply, such that any clarity obtained by a statement that medical methods (or business methods, or software) are or are not patent eligible may be illusory.

Take, for example, the European system where “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body,” “methods for doing business,” and “programs for computers” are not patentable subject matter. None of these categories are completely off limits. There are patent strategies that permit the patenting of methods or programs that a lay person might justifiably think falls outside of the scope of patentable subject matter.

So it might have been with the bright-line business method exception proposed by the dissenters in Bilski. Rather than asking whether something was so abstract as to be an unpatentable idea, we might have been asking what makes something a “method of doing or conducting business.” So might it be with a prohibition on patent eligibility of medical methods of treatment and diagnosis, or any statement specifically ensuring the patent eligibility of such methods, for that matter.

What congressional action might do is return the issue of patent eligibility to its role as a threshold question separate and apart from patentability as determined relative to the prior art. At present, Mayo appears to suggest that patent eligibility requires a review and analysis of the prior art—are the steps of the method (apart from the excised law of nature) conventional both individually and in combination, or are they unconventional?

While patent eligibility should be required for patentability, the cases do not support the conclusion that patent eligibility requires patentability. Consequently, congressional action may permit a refocusing of the patent eligibility analysis.

Of course, even if we are willing to wait for Congress to provide us with legislation, the wait might be lengthy. When Congress finally passed the patent reform bill last year, the legislation had been five to 10 years in the making. Even then, passage came only after some of the more controversial provisions had been removed.

Given the strength of opinion on both sides of this issue, it seems unlikely that the patent-eligibility standard will be addressed overnight.

The views in this article are those of the author, and not of Marshall, Gerstein & Borun LLP or its clients. The contents of this article are not intended as, and should not be taken as, legal advice, legal opinion, or any other advice. Please contact an attorney for advice on specific legal problems.

Contributing Author

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Paul Craane

Paul Craane is a partner at Marshall, Gerstein & Borun LLP in Chicago, Illinois. For nearly twenty years, Paul has been prosecuting patent...

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