Patent Case before the Supreme Court may affect medical research.
The Supreme Court justices will decide in Bilski v. Doll whether certain business methods regarding medical research are patentable. The case arose after the CEO of an energy company sued the USPTO after the office denied a patent on trading techniques of certain commodities. The two issues to be addressed are as follows:
(1) Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (“machine-or-transformation” test), to be eligible for patenting under 35 U.S.C. § 101, despite [the Supreme Court's] precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”
(2) Whether the Federal Circuit’s “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. § 273.
Generally, federal law bars the patentability of laws of nature, natural phenomena and abstract ideas. The 2008 CAFC decision that led to this Supreme Court case involved narrowing the standards for patenting a common principle being transformed into a novel development. Many medical and biotechnology groups are concerned that a conservative decision by the Supreme Court may limit medical innovations. Biotechnology Industry Organization General Counsel Tom DiLenge stated that the limitations “could jeopardize already-issued biotechnology claims and will create uncertainty surrounding future grants” of patents on biologic, diagnostic and genetic testing methods. Thus, the organizations are asking the Supreme Court to overturn the CAFC in favor of allowing the more flexible patentability standard that was enforced previously.
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