In a patent dispute over a method for detecting fetal Down syndrome, the United States District Court for the District of Massachusetts invalidated the patent owner's patent because it was anticipated and obvious. The patent at issue describes screening methods to determine Down syndrome in which physicians estimate the risk of Down syndrome using markers from both the first and second trimesters of a pregnancy. The patent teaches determining the risk for fetal Down syndrome by combining markers from both stages of pregnancy into a single assessment of risk.

According to the district court opinion, after the patent was filed tests that integrate first and second-trimester data into a single calculation of risk were considered to have a higher detection rate than any test that used the data from only one of the trimesters. The testing disclosed by the patent is widely adopted and is licensed to a number of entities with thousands of assessments conducted under theses licenses each year.

After declining to reconsider the prior claim construction ruling, the district court examined whether the patent met the conditions of patentability under 35 U.S.C. § 101. To make this determination, the district court examined whether the process disclosed in the patent amounted to an unpatentable algorithm for calculating the risk of Down syndrome. The district court concluded that it did not as the data gathering step of the method was not dictated by the algorithm: "the method of gathering data from the first and second trimesters is dictated not by the algorithm (which can just as easily render a result based on data from one trimester), but by the theory that data from two trimesters will yield a more accurate prediction of Down's syndrome. The data-gathering step is thus a focus of the claimed method, not a mere antecedent step."

The district court also analyzed whether the method satisfied the requirements of the Supreme Court's decision in Bilski v. Kappos, 130 S. Ct. 3218 (2010). Noting that the Bilski decision emphasized a broad construction of § 101 and caution against a rigid formula, the district court also found that the patent met the machine-or-transformation test. In reaching this conclusion, the district court relied heavily on the Federal Circuit's decision in Prometheus Labs., Inc. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010). "As in Prometheus, the [patent-at issue] also discloses a method for determining an optimal course of treatment. The method quantifies a likelihood that a fetus has Down syndrome. This, in turn, informs the choice of whether to undergo invasive and dangerous testing, and ultimately whether to terminate the pregnancy." Accordingly, the district court found that the patent met the standards for patentability under § 101.

Nonetheless, the district court determined that the patent was invalid as anticipated or obvious under 35 U.S.C. §§ 102 and 103 based on an article published prior to the filing date of the patent. The article derived from a clinical study of actual pregnancies and described using first and second-trimester marker levels to counsel clients as to Down syndrome risk. The district court also found that methods were obvious in light of the article and the knowledge of a person of ordinary skill in the art.

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The district court's decision finding the method patentable under § 101 continues the trend of allowing medical treatment claims after Bilski. Of note, however, is that the district court relied heavily on the Federal Circuit's decision in Prometheus--a decision that the Supreme Court has agreed to hear. As a result, until the Prometheus case is decided by the Supreme Court, the patentability of medical treatment claims under § 101 will remain in doubt.

Perkinelmer, Inc. and NTD Laboratories, Inc. v. Intema Limited, Case No. 09-10176-FDS (D. Mass. Aug. 12, 2011)