Are diagnostic claims now at risk?

On October 30, 2013 the United States District Court for the Northern District of California issued an Order holding that medical diagnostic method claims are not eligible for patent protection.  See Ariosa Diagnostics, Inc. v. Sequenom, Inc., Case No. C 11-06391 SI.  This District Court Order is significant because it was made upon remand and direction from the Federal Circuit to examine the subject matter eligibility of diagnostic patent claims in light of the Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc.,133 S. Ct. 2107 (2013).  However, the District Court decision is also potentially concerning because it raises the specter of whether lower courts will now feel compelled to issue rulings on important patent questions that are still evolving at the Supreme Court level.  Some might even argue that these patent questions deal with important public policy issues that should more appropriately be addressed by the legislative branch and the US Patent and Trademark Office.

At issue in the Sequenom litigation is US Patent No. 6,268,540, which is exclusively licensed to Sequenom, and which claims non-invasive prenatal diagnosis methods using maternal blood samples.  Such noninvasive methods employ cell-free fetal DNA from maternal blood and provide an alternative to techniques such as amniocentesis, which can pose a risk to both the mother and child.  The field of noninvasive prenatal testing is of significant commercial importance, because several companies are vying to commercialize such tests.

This recent District Court Order is the latest in ongoing litigation between Ariosa and Sequenom.  In December 2011, Ariosa had originally filed an action seeking a declaratory judgment that its noninvasive prenatal diagnostic test, the Harmony Test, does not infringe any claims of the ‘540 patent.  In March 2012, Sequenom filed an answer against Ariosa including a counterclaim for infringement and a motion for a preliminary injunction to enjoin Ariosa from marketing the Harmony Test.  In July, the District Court denied Sequenom’s requests, whereupon Sequenom appealed to the Federal Circuit.  In August, the Federal Circuit vacated the District Court order and remanded with instruction for the District Court to examine the patent eligibility of the asserted claims in view of the Myriad decision, which had just come down from the Supreme Court on June 13th.  On October 30th, the District Court issued its Order, holding that the ‘540 patent diagnostic claims are ineligible subject matter under 35 U.S.C. § 101 and that the patent is invalid.  Sequenom has since publicly stated its intent to appeal the Order to the Federal Circuit.

In issuing its Order, the District Court relied on Myriad and also several other high-profile Supreme Court cases going back to 1948.  The Court cited Funk Bros. for the proposition that “patents cannot issue for the discovery of the phenomena of nature.”  See Funk Bros. Seed Co. v. Kao inoculant Co., 333 U.S. 127, 130 (1948).  The Court then relied on Benson, Flook, Diehr, and Bilski for their holdings on the non-patentability of abstract ideas.  See Gottschalk v. Benson, 409 U.S. 63 (1972); Parker v. Flook, 437, U.S. 584 (1978); Diamond v. Diehr, 450 U.S. 175 (1981), and Bilski v. Kappos, 130 S. Ct 3218 (2010).  The Court next cited Mayo Collaborative Servs. v. Prometheus labs, Inc. 132 S. Ct. 1289 (2012).  At issue in Prometheus were claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and based on a known efficacy threshold for that drug, deciding whether to adjust the dosage of the drug.  The Supreme Court held that such claims were not patent eligible subject matter because they did not involve anything more than well-understood, routine, and conventional activity, and were essentially a drafting attempt to monopolize a law of nature.  Id. at 1294, 1297.  In analyzing the Prometheus decision, it is my view the District Court did not firmly get its hands around the central issues to apply them directly to the diagnostic claims in Sequenom.

The District Court, then proceeded to analyze Myriad, where the central issue was whether naturally occurring DNA was patentable.  The Myriad case was high-profile and emotionally charged.  Myriad was seeking to enforce several of its patents related to a diagnostic test for mutations of the BRCA1 and BRCA2 genes to determine an individual’s risk for developing breast and ovarian cancers.  Those opposing Myriad’s patents included, amongst others, patient groups, women’s advocacy organizations, university researchers, and the American Civil Liberties Union, who along with the Public Patent Foundation, represented the Association for Molecular Pathology.  Ultimately – after a loss by Myriad at the District Court and reversal at the Federal Circuit – the Supreme Court ruled that Myriad’s DNA claims were non-patentable.  The Supreme Court did go on to rule, however, that synthetically created complementary DNA (cDNA) is patentable.  It is important to note that none of Myriad’s diagnostic method claims and other claims in its patents were at issue before the Supreme Court.  Even more interesting is that the Supreme Court went out of its way to state that the case did not involve any method claims or patents on new applications of knowledge applying the BRCA1 and BRCA2 genes.  The result is that the decision had little practical effect on Myriad’s overall business.

The District Court Order in Sequenom comes across as strained and overly-detailed in its reasoning and analysis.  It seemed the Court went overboard to cite several major cases from 1948 to justify its holding, leading one to wonder whether the Court was more concerned with writing an historical overview of the case law rather than a well-reasoned opinion.  The Court seemed more hung up on the fact that Sequenom’s diagnostic methods involved cell-free fetal DNA, which in isolation would arguably be unpatentable according to Myriad, rather than carefully considering the overall scope and nature of the method claims, which would have more properly been analyzed in view of Prometheus.

In any event, this is not the end of the story.  The Sequenom case will be an important one to watch, as it again makes its way to the Federal Circuit, and possibly all the way to the Supreme Court.  Stay tuned for the next sequel to Sequenom.


–  Anthony D. Sabatelli, PhD, JD
Check out Anthony’s bio page


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