Federal Circuit Hands Personalized Medicine Patent Holders New Tool for Enforcement

06 September 2012 Personalized Medicine Bulletin Blog

If two or more actors jointly perform a patented method, is the claim infringed ? Late last week, in Akamai Technologies, Inc. v. Limelight Networks, Inc., and McKesson Technologies, Inc. v. Epic Systems Corp., __ F.3d __ (Fed. Cir. 2012), the Federal Circuit said yes, infringement can be found under 35 U.S.C. § 271(b) if a party induced others to act with him or induced others to perform all elements of the claim. In an en banc opinion, the court overruled its prior precedent which held that in order for a single party to be liable for induced infringement, a single entity must perform all elements of the claim. See BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007). The court in Akamai reasoned that a party who knowingly induces others to engage in acts that jointly practice the steps of a patented method – and those others perform those steps – has had precisely the same impact on the patentee as the party who induces the same infringement by a single infringer.

Application to Personalized Medicine

The case is important to diagnostic method patents and personalized medicine because it is not uncommon for two or more parties to collectively perform all elements of a single diagnostic claim. For example, personalized medicine method claims that would be performed by two or more actors can relate to determining if a patient is likely to develop a disease:

1. A method of determining the increased likelihood of having or developing rheumatoid arthritis in a patient, comprising the steps of:

obtaining a serum sample from a patient;

contacting the serum sample with an anti-IgM XYZ antibody; and

determining that the patient has rheumatoid arthritis or an increased likelihood of developing rheumatoid arthritis based upon the increased binding of the anti-IgM antibody to IgM rheumatoid factor in the serum sample.

In the above method, one party such as a laboratory technician, would normally obtain the serum sample from the patient and transfer the sample to a clinical laboratory for the “contacting” step with the anti-IgM XYZ antibody. Under the Akamai holding, a party that knowingly required the sampling from the patient and testing of the sample would be liable for infringement.

With certain caveats, the Federal Circuit’s Akamai decision provides another cause of action for the enforcement of patented methods when two or more actors jointly perform the claim. For example, to prove induced infringement under 35 U.S.C. § 271(b), the patentee must prove that the accused infringer possessed specific intent to encourage another’s infringement, and that actual practice or use of the claim occurred. In addition, the Federal Circuit explicitly stated that joint or divided infringement does not apply to direct infringement liability under 35 U.S.C. § 271(a).

Finally, Akamai may not be the last word on the issue. Six of the eleven Federal Circuit judges joined in the majority opinion. Judge Linn, joined by four judges, strongly dissented indicating he would have instead followed BMC Resources, supra. Judge Newman opined that joint liability for two or more actors should have been extended to direct infringement (35 U.S.C. § 271 (a)) as well. In light of the disparate views of the Federal Circuit judges, one or more parties may choose to appeal to the US Supreme Court.

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