A new bill introduced in Congress last week may limit the ability of branded pharmaceutical companies to extend the period of exclusivity products beyond the term of a single patent.
The bill, titled “Terminating the Extension of Rights Misappropriated Act of 2019” or “TERM Act of 2019,” places greater scrutiny on the practice of obtaining multiple patents with overlapping terms to cover a single drug product or biological product. The bipartisan legislation would create a presumption that a patentee has disclaimed the portion of any patent term that extends beyond the term of the earliest-expiring patent purported to cover a drug product or use of a drug. To rebut the presumption of disclaimer, a patentee must demonstrate by a preponderance of the evidence that the later-expiring patent(s) cover inventions that are “patentably distinct” from those claimed in the first patent. Additionally, the bill requires the PTO to conduct a review of its examination procedures for patents relating to the same drug or biological product and determine whether improvements can be made to reduce instances of double patenting.
The TERM Act is being co-sponsored by Representatives Doug Collins (R-GA), Hakeen Jeffries (D-NY), Debbie Mucarsel-Powell (D-FL), and Ben Cline (R-VA).
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