07/06/2015 | Lucas & Mercanti, LLP
There are a number of lessons to take away from the Ariosa decision. To begin, it is not clear that the Ariosa analysis will remain confined to the life sciences and to methods of diagnosing illness, treatment monitoring and the like. We may possibly see an analogous analysis applied to claims directed to methods of detecting or monitoring other types of processes that could be argued to be naturally occurring. The common element would be that a claim could be argued to represent the correlation of a naturally occurring phenomenon with a condition, result or activity of interest. Consequently, legal advisors to patent applicants should consider the potential impacts of the Ariosa decision on their patent drafting, patent prosecution and litigation strategies.
The Federal Circuit’s decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., Nos. 2014-1139, 2014-1144, slip op. (“Ariosa Diagnostics,” Fed. Cir. June 12, 2015) held that the diagnostic type claims before the Court did not represent patentable subject matter. We believe that this case illustrates the directions that the Court will likely take in future litigation and the USPTO will take with regard to examination of analogous method or process claims.
In a series of decisions during the past several years, the U.S. Supreme Court has upended U.S. patent practice by more closely defining what constitutes patentable subject matter under U.S. law, across a number of art areas. On the subject of diagnostic and process claims, in Mayo Collaborative Services v. Prometheus Labs., Inc. No. 10-1150; 132 S. Ct. 1289, (“Mayo,” Supreme Court, March 20, 2012), the Court held that the mere correlation, “between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove… ineffective or cause harm” did not represent patentable subject matter (Mayo Id at 1291). This decision has impacted U.S. law and practice with regard to claims directed to diagnosis and monitoring of diseases, and now the Ariosa Diagnostics decision provides a Federal Circuit decision directly interpreting and applying the Mayo decision in this context.
The patent in contention was US 6,258,540, with claims directed to methods for detecting paternally inherited nucleic acid of fetal origin. Claim 1 is illustrative, and is one of three independent claims, and is copied below for convenient reference.
1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
We have reviewed the decision relative to the most recent interim examination guidelines issued by the USPTO in December of 2014. The guidelines emphasize that the “claim as a whole” must be analyzed. In Ariosa Diagnostics, the Court cited the Supreme Court holding in Mayo for the proposition that it is required to look at both the claim elements and then at the claim as a whole (Ariosa, page 8, slip opinion) “to determine whether additional elements ‘transform the nature of the claim’ into a patent-eligible application.” We believe that this holding could potentially change the way the USPTO analyzes these types of claims during examination, by making it easier to pick apart claims and find natural products or processes in specific claim elements.
The Court also rejected the patent holder’s argument that their claimed process is new and useful and represented the “significantly more than a patent upon the natural law itself,” required by the Mayo analysis (Ariosa Diagnostics, Id., slip opinion page 8, citing to Mayo 132 S. Ct. at 1297). The Court reached the conclusion that “[t]he only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum” (Ariosa Diagnostics, slip opinion, page 11). The Court also quoted another Supreme Court holding for the conclusion that a, “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” citing to Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___, 133 S.Ct. 2107, 2117 (2013).
In addition, the Court rejected the argument that the litigated claims did not preempt the entire field of the natural phenomenon. As stated by the Court, “while preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.” Ariosa Diagnostics, page 14 of slip opinion.
Factors to Consider After Ariosa Diagnostics
With Ariosa Diagnostics as a guide, U.S. patent claims directed to a method of diagnosing, determining or monitoring a disease, disorder or other condition, by correlating levels of some naturally occurring target moiety or effect, should be carefully analyzed. This caution applies even if the target moiety or effect is newly discovered or newly identified in the disease or disorder. The same caution also applies to method claims in any other art areas, where the claims is directed to correlating any natural phenomenon with a result of interest.
When drafting a patent application that will include claims of this type, where possible, for U.S. purposes, the application and claims should include an express teaching of the “something more” required by the Mayo decision and suggested by Ariosa Diagnostics. Preferably, the something more can be a novel apparatus or novel non-naturally occurring reagent for conducting the process. Routine processes, such as nucleic acid amplification, taken alone, clearly will not fill this purpose.
We offer some suggestions for pending U.S. patent applications with claims that may fall into the Ariosa and Mayo category. In those cases where prosecution has just begun and a Restriction Requirement has been made, consideration should be given to electing and pursuing any claims that would not be subject to a patentable subject matter inquiry. For example, if there are groups of claims directed to a novel apparatus or non-naturally occurring reagent, those claims might be more productively prosecuted before claims directed to methods of diagnosis or monitoring. A divisional application with claims falling into the Ariosa and Mayo category can be filed later when the law and USPTO examination guidelines may be more favorable for patentees. Where this is not an option, claims directed to diagnosis or monitoring conditions need to include the “significantly more” required by Mayo (Mayo Id 132 S. Ct. at 1297) and the “something more” required by the December 16th USPTO guidelines (Federal Register 79 (241): 74618-74633 at e.g., 74626). Later-filed continuation applications may also be an option to preserve the potential to obtain broader claims in the event of a change in the law.
We recommend that any existing U.S. patents with claims that may fall into the Ariosa and Mayo category be carefully evaluated, as above, before taking any enforcement action.
The Ariosa Diagnostics decision has already drawn criticism from patent commentators. Given the type of criticism, we believe that an appeal by the patent owner to the U.S. Supreme Court is likely. Should that take place, we will keep you advised of further significant changes to the law in this area.
Dr. Manber represents clients in the biotechnology, chemical, and pharmaceutical fields. Reach him at firstname.lastname@example.org or at 212-661-8000. You may also e-mail the firm at email@example.com
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