Шаркабхарти ісі: Биотехнология саласындағы патенттік құқық шешімі

Diamond v. Chakrabarty, 447 U. S. 303 (1980), was a United States Supreme Court case dealing with whether living organisms can be patented. Writing for a five justice majority, Chief Justice Warren E. Burger held that human made bacteria could be patented under the patent laws of the United States because such an invention constituted a "manufacture" or "composition of matter". Justice William J. Brennan Jr., along with Justices Byron White, Thurgood Marshall, and Lewis F. Powell Jr., dissented from the Court's ruling, arguing that because Congress had not expressly authorized the patenting of biological organisms, the Court should not extend patent law to cover them. In the decades since the Court's ruling, the case has been recognized as a landmark case for U. S. patent law, with industry and legal commentators identifying it as a turning point for the biotechnology industry.

Genetic engineer Ananda Mohan Chakrabarty, working for General Electric, developed a bacterium (derived from the Pseudomonas genus and now known as Pseudomonas putida) capable of breaking down crude oil, which he proposed to use in treating oil spills. General Electric filed a patent application for the bacterium in the United States listing Chakrabarty as the inventor,

General Electric and Chakrabarty appealed the examiner's decision to the Board of Patent Appeals and Interferences. The Board however agreed with the examiner that the bacterium was not patentable under current law. General Electric and Chakrabarty thereafter appealed the Board's decision to the United States Court of Customs and Patent Appeals. This time, General Electric and Chakrabarty prevailed with the court overturning the examiner's decision and holding "the fact that micro organisms are alive is without legal significance for purposes of the patent law." The Patent Office, in the name of its Commissioner, Sidney A. Diamond, appealed this decision to the Supreme Court. The majority contrasted this outcome with the one reached nearly 50 years prior in Funk Bros. Seed Co. v. Kalo Inoculant Co., where the Court had rejected a patent application for the discovery of a naturally occurring bacterium that could be used to improve crops. Unlike the patentee in Funk Bros., the Supreme Court here held that Chakrabarty had not merely discovered the bacteria's existence, he had created it himself and adapted it to a particular purpose. Writing for IP Watchdog on the decision's 30th anniversary, Gene Quinn called the decision a "turning point for the biotech industry" and praised the Court's ruling as "emblematic of the need for an expansive view of what is patentable subject matter." Likewise, the Biotechnology Innovation Organization praised the decision as being "instrumental in spurring the creation of a dynamic and flourishing biotech industry." However, the Supreme Court's ruling has also attracted some criticism from scholars who believe the Court extended patent law in a way that Congress did not authorize. Writing in the Ohio State Law Journal, Frank Darr criticized the Court's decision as containing "serious interpretive problems" and "reflect[ing] a policy choice" by the majority rather than a neutral legal analysis.

George Mason University's Center for Intellectual Property and Innovation Policy has pointed out that, in the wake of Diamond v. Chakrabarty, the courts have continued to affirm the right of biotech industry developers to continue to claim ownership of altered biological life, while clarifying some limits in Mayo v. Prometheus and AMP v. Myriad. The Center has expressed concern over what may be interpreted as judicial activism, with this ambitious legal thrust in advance of Congressional ability to thoughtfully consider appropriate legislation. While cases subsequent to Chakrabarty have provided some safeguards, such as forbidding the patenting of "limited DNA sequences," concerns have arisen that these safeguards do not go far enough, and that "biopiracy" of the human genome could take place, especially in an era of global health crisis demanding a rapid pharmaceutical response. A legal collaboration at the University of Pittsburgh suggests that it "is a stretch" to label such presumptuous genomic editing as outright slavery. However, as such editing in its most contemporary form may include the insertion of what has been termed by the industry as an entire "operating platform," concerns may continue.