This bill addresses patent thickets, which occur when multiple related patents are used to block competitors from entering the market. Specifically, it limits pharmaceutical and biological product patent holders to asserting only one patent per patent group in infringement lawsuits against generic drug manufacturers and biosimilar competitors. A patent group is defined as two or more commonly owned patents that are linked through patent office disclaimers filed to avoid double patenting rejections. The restriction prevents patent holders from filing multiple lawsuits using different patents from the same family against the same generic or biosimilar competitor, which can increase litigation costs and delays for generic and biosimilar developers. The bill applies to drug and biological product applications submitted on or after the date the legislation is enacted, with no specific funding authorized.
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