On November 20, 2012, the Federal Circuit held that a method to assess the risk of fetal Down’s syndrome is not patent-eligible subject matter pursuant to 35 U.S.C. 101. In PerkinElmer Inc. v. Intema Ltd., a unanimous panel considered the issue of patentability under section 101 and concluded that Intema’s screening patent, U.S. Patent No. 6,573,103 (“the ’103 patent”), was not drawn to patent-eligible subject matter.
According to 35 U.S. C. 101, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . .” The U.S. Supreme Court has held that section 101, while broad in nature, is subject to certain limitations, and laws of nature, natural phenomena, and abstract ideas are not patentable. Mayo Collaborative Servs. v. Prometheus Labs, Inc., 132 S. Ct. 1289, 1293 (2012). For example, mental processes and products of nature are not patent-eligible subject matter. For a process claim to cover a patentable application of, for example, a natural law, it must contain other elements or a combination of elements sufficient to ensure that the patent in practice amounts to significantly more than a ptent upon the natural law itself.
The ’103 patent disclosed specific screening methods, which used markers from both the first and second trimesters of pregnancy, to estimate the risk of fetal Down’s syndrome. The Federal Circuit relied on two decisions to support its ruling that such methods do not cover patent-eligible subject matter. In Mayo Collaborative Services, the U.S. Supreme Court held that two patents on a diagnostic test used to treat autoimmune diseases were invalid because patents based on the use of a natural law must also contain an inventive concept. In Association for Molecular Pathology v. Myriad Genetics Inc., the Federal Circuit held that isolated human genes are patent-eligible but method claims for comparing or analyzing DNA sequences are not patent-eligible because the process claims were drawn to abstract mental processes. With respect to PerkinElmer, the Federal Circuit noted that the ’103 patent did not require any action besides comparing data with known statistical information. Also, the court concluded that the relationship between screening marker levels and the risk of fetal Down’s syndrome related to a law of nature claim. According to the Federal Circuit, because the asserted claims recite an ineligible mental step and natural law, and no aspect of the method converts these ineligible concepts into patent applications of those concepts, the claims cannot stand.