Patent Docs: Patent-eligible subject matter in the district courts

Last month, in a decision by the Northern District of California in Ariosa Diagnostics v. Sequenom, the court granted summary judgment of invalidity for claims directed to non-invasive prenatal diagnosis of sex determination, blood typing, other genetic disorders and detection of pre-eclampsia, using a simple blood test that reduces or eliminates the need for amniocentesis and chorionic villus sampling (which incur risks to both mother and child). The court’s basis for its decision was, ultimately, recent Supreme Court cases proscribing the limits of patent eligibility for claims to diagnostic methods and isolated genetic material.

 

In setting forth its patent eligibility analysis, the court recognized that exceptions to patent eligibility under the statute are to be narrowly construed according to both the Federal Circuit and Supreme Court. But the court’s view of the “relevant” Supreme Court precedent (or at least that precedent from 1940 onward) resulted in a determination that these method claims were not patent-eligible. In addition to the Court’s recent decisions in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) and Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), the court also cited Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), Gottschalk v. Benson, 409 U.S. 63, 64 (1972), Diamond v. Diehr, 450 U.S. 175, 177 (1981) and particularly Parker v. Flook, 437 U.S. 584, 585 (1978) (anomalously, a case about an alarm limit on a mechanical device).

 

In doing so, the court adopted declaratory judgment plaintiff Ariosa’s argument that the claims did not recite patent-eligible subject matter “because paternally inherited DNA (cffDNA) as detected in the claimed methods is a natural phenomenon and the claims of the patent merely added well-understood, routine, conventional activity in the field to that natural phenomenon.” According to the court, the parties were in agreement that “neither cffDNA nor the discovery of cffDNA in maternal plasma or serum is patentable” as being a natural phenomenon, so that the court believed the relevant question was “whether the steps of the claimed methods in the ‘540 patent, applied to that natural phenomenon, are sufficient to render the claims patentable.” They were not, according to the court’s opinion, because the additional limitations in the claims (relating to steps directed to amplification and detection of cffDNA) “either apply well-understood, routine and conventional activity to the natural phenomenon or limit the natural phenomenon to specific types of the natural phenomenon, which are also unpatentable.” Said another way, the court held that the claims did not add “enough” to the natural phenomenon to be patent eligible.

 

Under the district court’s view, the only patent-eligible method claim would be one that could be practiced without infringing at the time the invention was made. It is hard to discern any advantage to patenting (as opposed to holding new methods as trade secrets) under this standard, because it would provide no benefit if the claims recited a specific method that one of ordinary skill in the art would understand could be circumvented using another known method. Under this standard, there would be little incentive to disclose, an outcome directly contrary to the constitutional mandate to “promote the progress . . . of the useful arts.”

 

This case illustrates the uncertainty that comes from enunciating a standard that raises a court’s subjective opinion on patent eligibility to be dispositive, as illustrated by the court’s finding of a substantial question before the Supreme Court’s Myriad decision came down.

 

Most of this anti-patent animus stems from two sources: first, an “inverted telescope” view of what the patentee gets from her “monopoly” versus what the public gets from disclosure, wherein an excessive focus on private benefits thwarts the benefits to the public; and second, the Goldilocks idea that a court’s role is to ensure the proper balance between too much and too little patenting. This case just demonstrates the consequences of deciding cases wherein judicial prejudices under the guise of law are used to decide what should and shouldn’t be patent eligible. But it is important to remember at times like this that “[o]ne swallow does not a summer make, nor one fine day . . .” and to take what lessons we can from this decision, which will be considered on appeal to the Federal Circuit sometime next year.

___________________________________

Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.