By Kevin E. Noonan --
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 contours 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
Why was the "dehydrated" claim limitation not also significant for this rejected "in nature" type of proposed 101 rejection?
Posted by: Paul F. Morgan | August 17, 2017 at 09:37 AM
The claimed subject matter appears to fall into the "manufacture" category of Section 101.
Applying the criteria of Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615 (1887) as approved in Diamond v Chakrabarty 447 U.S. 303 (1980) in order to qualify the claim should be directed to a non-naturally occurring manufacture or composition of matter - a product of human ingenuity "having a distinctive name, character [and] use."
The claimed product indeed has a distinctive name, being a dehydrated, laminated tissue graft, and cannot be called either an amnion or a chorion. It has a distinctive character, being a cleaned and laminated structure and being dehydrated. It has a distinctive new use since the MiMedx® allografts of the patentees produced from the Company’s proprietary PURION® Process for amniotic membrane tissue can be stored at room temperature for five years without the need for refrigeration or freezing. The grafts can be utilized right out of the package without a complicated thawing process. These critical qualities of the MiMedx® allografts allow hospitals, clinics, and surgeons to immediately provide the appropriate treatment while effectively manage their inventory of allografts. It is gratifying to find that the language of new utility in the patent specification is closely reproduced in the website of the patentees and that it apparently represents medical and commercial reality.
It follows that the claimed subject matter falls as a matter of substance and not mere outward form within the eligible "process" category of Section 101. Any attempt by the Federal Circuit to deny patentability would raise "separation of powers" issues in clear and inescapable form. The need to consider positive eligibility before considering the judicial exceptions should be apparent to anyone who has completed legal education, but is strikingly and inappropriately ignored.
Posted by: Paul Cole | August 17, 2017 at 11:27 AM
Let's not get ahead of ourselves - this is denial of a motion to dismiss; there's a lot that needs to happen for this decision (or this post) to become more significant than that.
My reason for the post is that the Supreme Court has led the question of subject matter eligibility into the playground of fanciful lawyers representing people accused of infringement making arguments attacking patent validity. District courts in the first instance are considering these arguments, which can be much broader and categorical than they were prior to the Court's recent subject matter caselaw. There is an old saying that eating sausage may be discouraged by watching the process by which sausage is made. Our current situation is the opposite: it may be that only by looking at the sausage making that the Court has enabled and encouraged will courts at all levels be able to fully appreciate the folly of this approach.
Posted by: Kevin E Noonan | August 17, 2017 at 05:36 PM
Dr. Noonan,
For the result of your post to be reached, the Court has to be receptive to the fact that they have engaged in folly to begin with.
Do they have that capacity?
Well, I remain...
Posted by: skeptical | August 18, 2017 at 07:11 AM