In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court held invalid under § 101 patent claims that were directed to isolated genes that could be used to test for increased risk of breast cancer. While the Court found that discovery of the genes was important and useful, “separating [the] gene from its surrounding genetic material is not an act of invention.” 133 S.Ct. 2107, 2117 (2013). In holding the patent invalid, the Court emphasized that the patent claims covered the genes themselves, rather than methods that involved the genes, suggesting that method claims might be patentable under § 101. Id. at 2120.
Recently the Magistrate Judge in Oxford Immunotec Ltd., v. Qiagen, Inc., took the next step suggested by Myriad and found that while patent claims directed to a test kit for tuberculosis, claiming 8 peptides from the naturally occurring ESAT-6 antigen, were invalid under § 101, claims to a diagnostic method that used those peptides to detect tuberculosis plausibly described an inventive concept, and hence, should not be invalid under § 101. Report and Recommendation, Case No. 15-CV-13124 at p. 11-12 (D. Mass. Aug. 31, 2016).
The Magistrate Judge applied the two step Mayo test and found under step one that claims to both the test kit and diagnostic method were drawn to a law of nature: “ESAT-6, a naturally occurring protein, and the human immune system’s naturally occurring response to ESAT-6.” Id. at 7. Step two of Mayo required the court to search for an inventive concept, i.e., a combination of elements “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law.” Id. at 10. According to the court, the test kit claims lacked an inventive concept because they were limited to the peptides without additional elements. Id. at 12. The test method, however, included an inventive concept because it required that the test be performed in vitro, which distinguished it from prior art tuberculosis tests performed on the skin of live patients. Id. According to the court, the patented method was “more convenient, less dependent on a physician’s subjective interpretation of results, and more accurate” than the prior art skin tests.
Takeaway: The Magistrate Judge’s Recommendation in Qiagen is a fair application of the Supreme Court’s analysis in Myriad. It suggests that appropriate method claims can rescue inventions based on laboratory discoveries that might otherwise be invalid under § 101, if the claims include steps that show a difference from competitive prior art methods.