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Supreme Court Denies Review in 101 Case But Will Review Section 271(f) Case

Despite the urgings of more than 20 amicus briefs, the Supreme Court on June 27, 2016, denied review of a Federal Circuit pa​nel decision that an important medical diagnostic method is ineligible for patent protection under 35 U.S.C. 101. Sequenom, Inc. v. Ariosa Diagnostics, Inc., U.S., No. 15-1182, 6/27/2016.

However, the Supreme Court granted review of a case on whether 35 U.S.C. §271(f)(1) is violated by providing a single component abroad which when combined with other components would induce infringement if combined in the United States. Life Technologies Corp. v. Promega Corp., U.S. No. 14-1538, 6/27/2016.

Sequenom Will Not Be Reviewed

Sequenom owns a patent for a process of detecting paternally-inherited fetal DNA in maternal blood samples and diagnosing possible birth defects without highly intrusive measures. A panel of the Federal Circuit affirmed a district court decision that the claimed method is patent-ineligible even though the invention revolutionized prenatal care. Applying the rule in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012), the Court explained that the method acts on natural phenomenon with well-understood, routine, and conventional steps.

While the Federal Circuit denied en banc review, particular judges expressed concerns for medical diagnostics under the current state of patent eligibility law. For example, Judge Dyk noted that the Mayo principles are important to a healthy patent system, but acknowledged that a too restrictive test reflected in some of the Mayo language may discourage development and disclosure of new diagnostic and therapeutic methods. “In my view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself,” he wrote.

Court Will Review 271(f) Issue in Promega

Promega is the licensee of a patent directed to a process for examining polymorphism in DNA samples, claiming a kit that includes a polymerizing enzyme, such as Taq polymerase, used to amplify the DNA sequences to obtain enough replicated sample for testing. Life Technologies supplied Taq polymerase abroad to be included in a kit for practicing the claimed process of amplifying DNA sequences to obtain enough replicated sample for testing.

Section 271(f)(1) makes it an infringement to supply or cause to supply “all or a substantial portion of the components of a patented invention” abroad for a combination that would induce infringement if do​ne in the United States. The Federal Circuit reversed a district court JMOL of non-infringement, finding that the quoted statutory phrase may be satisfied by a single component (here, the enzyme) that is important or central to the invention. 773 F.3d 1338 (Fed. Cir. 2014). According to the Court, without Taq polymerase, the genetic testing kit recited in the patent would be inoperable.

To read the Federal Circuit opinion in this case, click here; to read the cert. petition, click here​.

Other Supreme Court Orders

The Supreme Court also issued orders in the following cases:

  • Versata Development Group v. Lee, U.S., No 15-1145 (no appeal of decision to institute covered business method proceeding), cert. denied 6/27/2016.
  • Click-To-Call Technologies, LP v. Oracle Corporation, U.S., No. 15-1014 (inter partes review petition filed more than 1 year after petitioner was sued for infringement) cert. granted, vacated, and remanded for further consideration in light of Cuozzo , 6/27/2016.
  • Shukh v. Seagate Technology, LLC, U.S., No. 15-1285 (reputational harm may be enough for standing in inventorship challenge under 256), cert. denied, 6/27/2016.
  • Commonwealth Scientific and Industrial Research Organisation v. Cisco Systems, Inc., U.S., No. 15-1440 (damages did not sufficiently account for standard essential patent), cert. denied 6/27/2016.