Gene editing technologies offer enormous potential for scientific advancement in fields such as medicine and agriculture, but their use also raises serious ethical and public policy concerns. hŞb```b``^ÇÀÂÀÀÆÀÏ€ ü¬@ÈÂÀ± Âïr“a(ÈxÀ}xWÇ*f7©[‘ú Æ]ŒKX-Yìy¬hNªH“$—˜åŠŠ6§¶m‹¥^x™W©)NX¸5£»#E#Ğëfo�—cW`Ëı��Ü(/—w@Y‡6§Ö³©«]ìIrI‡uì ê l]íâäŠ ÕÅ\S±€f³400¤e %%%c‹ CPH4€``6î€�XJ@ÂØ& The short answer is no, but to fully understand why, one needs to understand patentability requirements in the United States. Although governments can also theoretically discourage innovations potentially harmful to society by excluding detrimental areas of technology from patent protection, in practice, this is rarely done. Gene editing technologies offer enormous potential for scientific advancement in fields such as medicine and agriculture, but their use also raises serious ethical and public policy concerns. 0000004293 00000 n (b) Eligibility under this section shall be determined only while considering the claimed invention as a whole, without discounting or disregarding any claim limitation.19. Although the courts encourage and direct both reforms and limitations of Section 101 of Title 35 of the US Code to be pursued through legislation, only 2 such statutes currently exist. Other agencies, such as the Federal Trade Commission and the Food and Drug Administration, are assigned the task of protecting consumers from fraud and deception in the sale of food products. The USPTO is now joined in its review of new technologies by agencies such as the US Department of Agriculture and the FDA that were created to address these issues in their review processes. 0000001002 00000 n Although this omission might seem contrary to public policy, the USPTO is no longer an appropriate forum in which to address these concerns. This article will provide an overview of the US patent system and discuss the scope of patentable subject matter under US patent law and the role of ethical, safety, and legal considerations in the patent examination process with reference to gene editing. Although advisory groups like the World Health Organization question whether certain forms of gene editing should be permitted, the US Patent Office routinely issues patents protecting this technology. Public Affairs, UC Berkeley. 0000001659 00000 n Chakrabarty in 1980, and the first patent on an animal was on an oyster in 1987 in the USA. Fuller v Berger, 120 F2d 274 (7th Cir, 1903), cert denied, 193 US 668 (1904). What Is Prudent Governance of Human Genome Editing? trailer <<24E58633B4194BE8AEEAB72ED32571F4>]/Prev 155369/XRefStm 1002>> startxref 0 %%EOF 238 0 obj <>stream America Invents Act (AIA), 35 USC §33(a) (2011). Any patent granted for any such invention or discovery is hereby revoked, and just compensation shall be made therefor.”17 The second limitation was enacted in 2012 as part of the America Invents Act, which provides a ban on patenting human beings. For example, a patent application directed to a new method of human germline genome editing might violate the WHO’s new recommendation.2 If it did, the invention would not be disqualified as patentable subject matter under Section 101 of Title 35 of the US Code. The author(s) had no conflicts of interest to disclose. Lowell v Lewis, F Cas 1018 (CCD Mass 1817). Published March 2014. The US patent system currently recognizes 3 types of patents: utility patents,8 design patents,9 and plant patents.10 Utility patents are the oldest and most common type of patent. United States Patent and Trademark Office, 42 USC §2181(a) (1961). How Should Gene Editing Be Managed by Risk Managers? To qualify for protection as a utility patent, the subject matter of an invention must be a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof,” as defined under Section 101 of Title 35 of the US Code.8 This section of the US Code serves as a gatekeeper for the patent office. Cf. It is unclear what will happen with the current proposed bill. Both were the result of social and ethical concerns raised about the related technology patented. Should NASA Collect Astronauts’ Genetic Information for Occupational Surveillance and Research?

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