In the general chaos that has resulted from the Supreme Court's recent forays into trying to delineate the proper standards for patent subject matter eligibility (AMP v. Myriad Genetics, Mayo Collaborative Labs v. Prometheus), there is occasionally an inkling of the method behind this particular brand of jurisprudential madness. That method, of course, is the Court's intuition that if it provides the broad counters of eligibility (as incoherent as they might be) the district courts and USPTO will provide the details that result in a reasonable standard. (It is too much to hope for that the Court believes the Federal Circuit will provide much useful input in this regard, a determination that the appellate court has gone a long way to justify in decisions like In re BRCA1- and BRCA 2-based Hereditary Cancer Test Patent Litigation and Ariosa v. Sequenom.) One example of that glimmer may be found in a decision by the District Court of Georgia affirming the advice of a special master that the District Court deny defendant's motion to dismiss based on failure to recite patent-eligible subject matter, in MiMedx Group, Inc. v. Liventa Bioscience, Inc.
The case arose in the context of patent litigation over U.S. Patent No. 8,709,494; claim 1 is representative:
1. A dehydrated, laminated tissue graft consisting essentially of one or more washed and/or substantially cleaned amnion layers and one or more washed and/or substantially cleaned chorion layers, wherein at least one of the amnion layers contains its fibroblast cell layer, and further wherein the amnion layer and the chorion layer are directly laminated to each other.
The Court (District Court Judge Mark H. Cohen) appointed Sumner Rosenberg (Of Counsel, Mercer Thompson LLC) as a special master pursuant to Fed. R. Civ. P. 53. The Special Master submitted a Report and Recommendations to Judge Cohen on a variety of issues, one of which was Liventa's Motion for Summary Judgment of Invalidity under 35 US.C. § 101 (and MiMedx's cross-motion for Summary Judgment that the claims of its patent-in-suit recited patent-eligible subject matter). The Special Master recommended that the Court deny Liventa's motion and grant MiMedx's motion and the Court affirmed after de novo review, unpersuaded by Liventa's objections. The Special Master concluded:
In the present case, merely separating the amnion from the chorion and using the amnion layer as a graft is analogous to the DNA gene [which the Court held was not patentable] in [Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013)] being separated from its surrounding genetic material. On the other hand, the claimed tissue graft where the amnion and chorion layers are cleaned (i.e. having substantially all of the blood clots and the spongy/connective tissue removed) and laminated together absent such spongy/connective tissue [is] analogous to the cDNA [which the Court held was patentable] in Myriad. The tissue grafts as claimed are indeed "something new" and that is sufficient to find they are not products of nature.
Liventa in its objections had argued that the Special Master erred in making his determination based on whether there was "something new" recited in the claim rather than that the claimed subject matter was "markedly different" from naturally occurring placental tissue. Defendants analogized the invention to what was claimed by the patentee in Funk Bros. Seed Co. v. Kalo Inoculant Co. in support of this argument. The District Court disagreed, finding that the Special Master had followed the Supreme Court's Mayo and Alice Corp. Pty. Ltd. v. CLS BCank Int'l decisions, using the Federal Circuit's two-part test as set forth in Rapid Litig. Mgmt. Ltd. v. CellzDirect. Inc. Relevant to the eligibility standard, the District Court opined (in agreement with MiMedx) that "'[m]arkedly different' is far from a mandated standard of analysis" for making subject matter determinations under § 101. This phrase came from the Supreme Court's Diamond v. Chakabarty decision as being "sufficient, but not [] necessary" for showing subject matter eligibility (emphasis in opinion). Moreover, the District Court understood that this phrase from the Chakrabarty decision was never used again until it was quoted in the Myriad decision for distinguishing the Chakrabarty decision. The Federal Circuit, for its part, has used the phrase only in its In re Roslin Institute (Edinburgh) decision, again using it as sufficient but not necessary condition for patent eligibility. Significant to the District Court was the observation by the Special Master that "Myriad used the 'markedly different' language in finding a gene was not patentable, but used 'something new language'' in determining that another gene was patentable"(emphasis in opinion). In this regard, the Court understood the term "something new" to mean, "not found in nature and not patent ineligible natural phenomena" rather than being merely novel.
It is unclear whether these distinctions will in all cases help clarify the proper standards for finding patent eligibility. But it cannot be denied that focusing to any degree on novelty may help make the determination more objective, which could only help avoid the inherent subjectivity that has attended the application of the Supreme Court's subject matter eligibility standards both in the courts and the USPTO.
Order by District Judge Mark H. Cohen
