This legislation, known as the ETHIC Act, seeks to address the issue of patent thickets by amending federal patent law to limit the number of patents that can be asserted in infringement lawsuits. Specifically, it restricts patent holders from asserting more than one patent per "Patent Group" in actions brought against generic drug and biosimilar applicants or manufacturers. This aims to reduce the burden of multiple lawsuits on companies seeking to bring lower-cost alternatives to market, thereby fostering increased competition. A Patent Group is defined as two or more commonly owned patents or applications that are linked by disclaimers to obviate obviousness-type double patenting. Once a patent from such a group is asserted against a party, no additional actions asserting another patent from the same group can be brought against that same party. These new limitations will apply to drug and biological product applications submitted on or after the bill's enactment date, preventing the strategic use of numerous closely related patents to delay market entry.
This legislation, known as the ETHIC Act, seeks to address the issue of patent thickets by amending federal patent law to limit the number of patents that can be asserted in infringement lawsuits. Specifically, it restricts patent holders from asserting more than one patent per "Patent Group" in actions brought against generic drug and biosimilar applicants or manufacturers. This aims to reduce the burden of multiple lawsuits on companies seeking to bring lower-cost alternatives to market, thereby fostering increased competition. A Patent Group is defined as two or more commonly owned patents or applications that are linked by disclaimers to obviate obviousness-type double patenting. Once a patent from such a group is asserted against a party, no additional actions asserting another patent from the same group can be brought against that same party. These new limitations will apply to drug and biological product applications submitted on or after the bill's enactment date, preventing the strategic use of numerous closely related patents to delay market entry.