Client Alert

On August 31, 2011, the Federal Circuit issued, after remand from the Supreme Court, its highly-anticipated decision in Classen Immunotherapies, Inc. v. Biogen IDEC, Nos. 2006-1634, -1649. In a 2-1 panel decision, the Federal Circuit held that two medical method patents were directed to patent eligible subject matter, but a third patent was not. This decision provides insight regarding how the Federal Circuit will consider the patent eligibility of medical methods in light of the Supreme Court’s previous decision in In re Bilski.

Background
The three patents at issue are based on the thesis that the schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders (such as diabetes, asthma, and cancer) and that immunization should be conducted on the schedule that presents the lowest risk with respect to such disorders. Two of the three patents (the ‘139 and ‘739 patents) recite a method where information on immunization schedules and the occurrence of chronic diseases is “screened” and “compared,” the lower risk schedule is “identified,” and the vaccine is “administered” on that schedule. The third patent (the ‘283 patent) recites a similar method where such information is reviewed and compared, but unlike the first two patents, the claims of the third patent do not include the step of administering a vaccine in accordance with the information learned by the claimed method.

In 2008, the Federal Circuit held that all three patents were directed to patent ineligible subject matter and were invalid under 35 U.S.C. § 101, because the claimed subject matter did not meet the so-called machine-or-transformation test. Two years later, however, in In re Bilski, the Supreme Court rejected the Federal Circuit’s rigid application of this test and clarified the standards for patent eligibility under § 101. 561 U.S. __ (2010). The Supreme Court then vacated the Federal Circuit’s 2008 Classen opinion and remanded the case to the Federal Circuit to reconsider the issue of patent eligibility in light of Bilski.

The Federal Circuit's Ruling
In contrast to its 2008 opinion, the Federal Circuit held that two of the three patents are directed to patent eligible subject matter. Specifically, the Court held that the claims of the ‘139 and ‘739 patents, which include the step of administering a vaccine in accordance with the preferred schedule, are not invalid under § 101 and are directed to patent eligible subject matter. According to the Court, “[t]hese claims are directed to a specific, tangible application” of an idea, rather than an idea alone.

On the other hand, the Court held that the claims of the ‘283 patent, which relate to the idea of collecting and comparing known information but do not require using this information for immunization purposes (such as by administering a vaccine), do not recite patent eligible subject matter. According to the Court, “methods that simply collect and compare data, without applying the data in a step of the overall method, may fail to traverse the § 101 filter.” While “the claims of the ‘139 and ‘739 patents require the further act of immunization in accordance with a lower-risk schedule, thus moving from abstract scientific principle to specific application,” “the abstraction of the ‘283 claim is unrelieved by any movement from principle to application.” As a result, the Court found the ‘283 patent was invalid under § 101.

Judge Moore, in a strong dissent, would have found all three patents were directed to unpatentable subject matter. In Judge Moore’s view, the patents all claim the scientific method itself and, as a result, are directed to an unpatentable, abstract idea.

Impact of the Decision
The Classen opinion highlights the distinction between medical method claims that are patent-eligible and those that are not. Companies and inventors that are considering asserting a medical method patent should give careful thought to which category their claims fall in before asserting the patent. On the flip side, companies accused of infringing a medical method patent should closely scrutinize the claims to see if they recite patent eligible subject matter under Classen. Finally, patent applicants should make a concerted effort to ensure their patent application includes claims that are focused on the application of an idea, rather than an idea itself.

If you have any questions or wish to discuss how this decision may impact your company, please contact your attorney at Brinks Hofer Gilson & Lione.

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This Client Alert is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. Brinks Hofer Gilson & Lione does not intend to create an attorney-client relationship by offering this information and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Brinks Hofer Gilson & Lione lawyer.