Why Are Biosimilars Not Living up to Their Promise in the US? No further action would be taken by the USPTO. (a) Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. A member of the State Bar of Wisconsin and the Virginia State Bar, she earned a JD from Marquette University Law School and an MA in bioethics from the Medical College of Wisconsin. 0000001659 00000 n https://www.uspto.gov/web/offices/pac/mpep/index.html. 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. If an invention can serve any conceivable beneficial purpose, the subject matter should be eligible for patent protection. This article considers what the term patented means, provides an overview of the US patent system, and discusses the scope of patentable subject matter under US patent law and the role of ethical, safety, and legal considerations in the patent examination process. %PDF-1.4 %âãÏÓ Scientists opposed to gene patents contend that numerous patents obstruct research because of the need to license or pay for patented technologies. As stated by the Federal Circuit Court of Appeals in 1999: The requirement of “utility” in patent law is not a directive to the Patent and Trademark Office or the courts to serve as arbiters of deceptive trade practices. Although it might not pass the scrutiny of other agencies, such as the US Food and Drug Administration, the USPTO would grant a patent on this technology as long as the application satisfies requirements for patentability as set forth in the statute. Mike Z. Zhai, Ameet Sarpatwari, JD, PhD, and Aaron S. Kesselheim, MD, JD, MPH. (k) The term “useful” means any invention or discovery that provides specific and practical utility in any field of technology through human intervention. United States Patent and Trademark Office, 42 USC §2181(a) (1961). (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. 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. During the first 2 weeks of June 2019, the US Senate Judiciary Subcommittee on Intellectual Property held hearings to discuss proposed legislative reform to redefine the scope of patent eligibility under Section 101 of Title 35 of the US Code pertaining to US patent law. To obtain a patent, an inventor must file a patent application that describes the invention with enough detail to allow a person skilled in the claimed technology to be able to reproduce the invention. Rebekah Davis Reed, PhD, JD and Erik L. Antonsen, PhD, MD, Ethics, Values, and Responsibility in Human Genome Editing, Sean C. McConnell, PhD and Alessandro Blasimme, PhD. “I have accepted the interim recommendations of WHO’s Expert Advisory Committee that regulatory authorities in all countries should not allow any further work in this area until its implications have been properly considered.”2. It is important to note that a patent does not provide an inventor with an affirmative right to make, use, sell, or offer to sell the claimed invention. Similarly, since ethical considerations are not relevant in determining patentability, it might be possible to obtain a patent on a new gene editing technique developed in violation of established ethical guidelines. AMA Policies and Code of Medical Ethics’ Opinions Related to Human Genome Editing. Contents and Term of Patent; Provisional Rights, 35 USC §154 (2016). 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.

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