Terminating the Extension of Rights Misappropriated Act of 2019

To amend title 35, United States Code, to prevent double patenting, and for other purposes. 1. Short title This Act may be cited as the Terminating the Extension of Rights Misappropriated Act of 2019 Term Act of 2019 2. Prevention of double patenting (a) In general Section 253 of title 35, United States Code, is amended by adding at the end the following: (c) Disclaimers of drug patent term (1) In general Except as provided in paragraph (2), in a proceeding challenging the validity of patents under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) 42 U.S.C. 262(l) (2) Demonstration of distinct inventions If a patentee demonstrates by a preponderance of the evidence that certain patents described in paragraph (1) cover patentably distinct inventions from the invention claimed in the first such patent to expire, no part of the term of any such patent shall be presumed to have been disclaimed, and all patent term extensions granted by the United States Patent and Trademark Office shall be respected, unless and to the extent the patentee expressly disclaims, in writing, the patent term for each such patent. . (b) USPTO review (1) Definitions In this subsection— (A) the term Office (B) the term Director (2) Review The Director shall conduct a comprehensive review of the patent examination procedures of the Office to determine whether the Office— (A) is using best examination practices, guidance, and procedures to avoid the issuance of patents relating to the same drug, or biological product, that are not patentably distinct from one another, and not subject to an appropriate disclaimer of patent term; and (B) should develop and implement new practices, guidance, or procedures to— (i) improve examination of patent applications relating to the same drug or biological product; and (ii) reduce the improper issuance of patents that improperly extend the term of exclusivity afforded a new drug or biological product. (3) Report Not later than 1 year after the date of enactment of this Act, the Director shall submit to the Committee on the Judiciary of the House of Representatives a report that contains— (A) the findings from the review conducted under paragraph (2); and (B) any recommendations of the Director with respect to the review conducted under paragraph (2).

Summary: Terminating the Extension of Rights Misappropriated Act of 2019 or the Term Act of 2019 This bill addresses double patenting with respect to drug-related patents. Specifically, the bill requires an owner of drug-related patents, if the owner lists more than one patent as covering a particular drug, to prove in certain proceedings that each patent covers a distinct invention. If the patent owner fails to do so, then the owner shall have disclaimed patent protection from all the listed patents after the first patent expires. This requirement shall apply to various proceedings challenging the validity of drug-related patents, as well as to infringement lawsuits filed by the patent owner against companies seeking Food and Drug Administration approval for generic or biosimilar versions of patented drugs. The bill also directs the U.S. Patent and Trademark Office (USPTO) to review its examination procedures to prevent granting multiple patents for the same drug or biological product, unless the patents cover distinct inventions. The USPTO shall report to Congress its findings and recommendations from the review.