ETHIC Act

The ETHIC Act limits the number of patents that can be asserted in a single infringement action against certain drug and biological product applicants or makers. Sec. 2, Addressing patent thickets: It amends patent law to allow a person suing for infringement against a generic drug applicant, a biosimilar applicant, or a maker of such approved drugs or biological products to assert no more than one patent per Patent Group in that action. It also bars that person from bringing any additional infringement actions asserting a patent in the same Patent Group against the same party. A Patent Group is defined as two or more commonly owned patents or applications that are linked by disclaimers filed to avoid obviousness-type double patenting. The new rule applies to applications for drug or biological product approval submitted on or after the date the Act becomes law.