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Diagnostic Peptide Panels Patent-Ineligible?

September 20, 2016 – Oxford Immunotec Ltd. v. Qiagen, Inc. et al., pending in the U.S. District Court, D. Mass. (Case 1:15-cv-13124-NMG), likely has a long way to go before a final appellate decision is made, and could eventually end up before the Supreme Court. However, in an early motion in the case, U.S. Magistrate Judge Donald L. Cabell has extended the holding of Myriad1 (isolated genes and naturally-occurring fragments thereof are patent-ineligible products of nature) to find multiple isolated peptide fragments in a diagnostic panel patent-ineligible as well.

The six patents at issue included method claims directed to testing for the presence in a biological sample for the causative agent for tuberculosis, as well as kit claims directed to diagnostic panels of selected synthetic peptides corresponding to sequences from a particular antigenic protein on the microorganism. The invention thus allows for the in vitro diagnosis of TB.

In particular, the method claims are directed to the steps of combining the panel of peptides with a sample of the patient’s blood and detecting the reaction in vitro. This test is an improvement over the conventional TB test that requires injection of TB antigens under the patient’s skin (in vivo test) and waiting to see if there is a reaction, and/or culturing the microorganism from the patient’s sputum. It is of note that the analyte that is detected in the in vitro method of the invention, IFN-γ, is the product of a similar biological reaction as the prior art in vivo test, in that it measures the reaction of the patient’s T-cells to the elements of the protein to see if they have been sensitized to TB antigens; however, in the in vitro test of the invention, there is no necessity for the biological intermediate step of presentation to T-cells of the antigenic peptides by antigen-presenting cells as occurs in the prior art in vivo skin test.

The Defendants filed a joint motion to dismiss, predicated on their assertion that their affirmative defense of unpatentability of the claims would be dispositive of the case.

In his ”Report and Recommendation on Defendants’ Joint Motion to Dismiss” (filed August 31, 2016; http://patentdocs.typepad.com/files/report-and-recommendation-3.pdf), Judge Cabell applied the first part of the Mayo2 two-part analysis (as set forth in Alice3, citing Mayo) to hold that “[i]t is undisputed that the peptides have not been changed beyond the act of isolation” and that therefore “the isolated peptides are products of nature.” He also found that despite the significant differences between how the immune system reaction occurs in vitro and in vivo, the method claims were also drawn to the same law of nature, which was the production of IFN-γ by the patient’s T-cells.

The Magistrate then applied the second part of the Mayo analysis to determine whether the claims that encompass a law of nature contains an “inventive concept” such that the invention “amounts to significantly more than a patent upon the natural law itself.” With respect to the method claims, the judge found that there was a plausible reading of the method claims which involved an inventive concept, in that the method provides a “faster and more reliable method of diagnosing TB infection.” However, the judge further found that the kit claims directed to a panel of peptides were directed “merely” to products of nature, and were therefore not directed to patent-eligible subject matter. The judge dismissed Plaintiff’s infringement claims with respect to the kits, while allowing the case to go forward with respect to the method claims.

The decision questionably extends the holding of Myriad to encompass a panel of peptides as being patent-ineligible, and supports the argument by comparison to the mixtures of bacterial strains in Funk.4 Peptides of course are different from the DNA molecules which were the subject of the Myriad case, including whole genes and fragments, at least in that peptides have more than just an information function. In addition, in Myriad, the structures of the genetic sequences were arguably not described, whereas in Oxford, the specific sequences were expressly claimed. Still further, the properties of the isolated peptides in the diagnostic panel are different from the admixture of bacterial strains in Funk. The judge did not make a rigorous analysis of these important differences, in particular with reference to the detailed discussion of these issues in the Supreme Court’s holding in Myriad. Certainly, these issues are highly likely to be the basis for appeals of this decision, which will likely have a long appellate course before they are settled.

1. Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013)
2. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012)
3. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2355 (2014).
4. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 137 (1948).

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