ETHIC Act
The Eliminating Thickets to Increase Competition Act (ETHIC Act) would change how patent infringement lawsuits related to drug and biological product approvals can be brought under current U.S. patent law. Specifically, it would limit a plaintiff to asserting no more than one patent per “Patent Group” in any given infringement action against a party involved in FDA-approved drugs or biologics. A “Patent Group” is defined as two or more commonly owned patents (or applications) that are linked by a disclaimer used to avoid obviousness-type double patenting. The Welfare or party described (the defendant) is typically a sponsor or holder of a drug- or biologic-related approval or licensure. The rule would apply to actions filed after the law’s enactment. The bill aims to reduce patent thickets that can delay generic or biosimilar competition and accelerate access to lower-cost medicines.
Key Points
- 1Adds new 271(e)(7) to limit infringement actions to at most one patent per Patent Group, in actions brought against certain drug/biologic-related parties.
- 2Defines Patent Group as two or more commonly owned patents or applications that are identified on a disclaimer under section 253 to obviate obviousness-type double patenting, with group membership extending to all related patents/applications identified by that disclaimer.
- 3The restricted party (the defendant) includes entities that submit for FDA drug approval (under FFDCA §505(b)(2) or (j)) or licensure of a biological product (PHSA §351(k)), or their holders.
- 4If a party is sued for infringement within a Patent Group, the plaintiff may not pursue additional actions asserting other patents in the same Patent Group against that party.
- 5The amendment applies to applications submitted on or after enactment, meaning prospective effect from the date of enactment.