In a great leap backwards for patenting life sciences, Magistrate Judge Cabell invalidated claims in a number of patents licensed to Oxford Immunotec that are directed to e.g., “A kit for diagnosing infection in a human host by, or exposure of a human host to, a mycobacterium that expresses [protein/antigen] ESAT-6 comprising a panel of eight [ESAT-6 peptide fragments] represented by SEQ ID NOS 1 to 8.” (U.S. Pat. No. 7,632,646).
The Report was issued on August 31, 2016, in Action No. 15-cv-13124-NMG in Oxford Immunotec, Ltd. v. Qiagen, Inc. et al.
Following the “breaking bonds does not a new compound make” approach taken in Myriad, (133 S.Ct. 2107), the Judge held that the small peptide subunits of ESAT-6 used in the claimed kits were patent-ineligible natural products. The Judge gave no weight to the fact that the Myriad decision was based in a large part on the fact that isolation of the BRCA genes preserved their information function, apart from their structure, and ignored the language in the decision that it was limited to holding that human DNA sequences are not patent-eligible. (“We merely hold that genes and the information they encode are not patent-eligible … simply because they have been isolated from the surrounding genetic material.” The Myriad Court also gave weight to the fact that the genes were not described in terms of their structure. Although this point has seen much debate, the sequences of the protein fragments in Oxford’s kits were fully set forth.
Although the Judge acknowledged that the isolated peptide fragments “perform differently than peptides contained in an intact ESAT-6 strand”, the Judge did not seem to realize that this could lead to the conclusion that the fragments were not natural products under the Mayo/Alice test. Instead, he continued to lean on Myriad, stating that “[i]t is undisputed that the peptides have not been changed beyond the act of isolation….their makeup is wholly based upon the structure of ESAT-6, which is naturally occurring.” The judge went on to find no inventive concept in the kit claims “which only describe the peptide panel itself.” Guess which case the Judge relied upon most heavily. Funky.
The claims to the in vitro diagnostic tests were found to arguably possess an inventive concept and so S.J. of invalidity was denied. Claim 1 of U.S. Pat. No. 8,507,211 reads as follows:
“A method of in vitro diagnosis of [TB] infection in a host, comprising:
(a)Keeping a population of T cells isolated from said host in contact with a peptide panel comprising one or more epitopes contained within [ESAT-6], and
(b) Detecting a recognition response by the T cells to the peptide panel.”
The judge stated that the court concludes “that the in vitro aspect of the plaintiff’s [TB] test is an ‘inventive concept’ because it improves on prior methods of detecting [TB] infection. It follows that the method claims, which describe the in vitro test, are potentially drawn to patentable subject matter.”
The Judge relied on Diehr—where the algorithm improved on existing technology—but the Judge described the law of nature discovered by Oxford so broadly that it is difficult to find an inventive concept that is not within the discovery itself: “Here, the plaintiff has discovered a law of nature—namely which specific peptides [‘natural products’ remember] are most likely to induce a recognition response by the T-cells of patients who have TB without creating false positive responses by the T-cells of those who have merely been vaccinated.” Kind of the Judge to credit elements of the invention that are not in all of the main claims – but we need all the help we can get these days to locate the ever elusive “more” that will get a diagnostic claim allowed.