ETHIC Act
The Eliminating Thickets to Increase Competition Act (ETHIC Act) proposes a targeted reform to patent litigation tied to FDA drug approvals and biologics. It amends 35 U.S.C. § 271(e) by adding a new provision that limits how many patents can be asserted in an infringement action against a party with an FDA-related drug or biologic application. Specifically, in an infringement case brought under § 271(e), a plaintiff may assert no more than one patent per “Patent Group.” A Patent Group is defined as two or more commonly owned patents or applications that are linked to one another through disclaimers under 35 U.S.C. § 253. The bill also prohibits filing additional actions within the same Patent Group against the same party. The rule applies only to applications submitted after the enactment date (prospective effect) for certain drug approvals (under FD&C Act sections 505(b)(2) or (j)) and biosimilar licensure (section 351(k)). In short, the ETHIC Act aims to reduce “patent thickets”—dense webs of related patents that can block competition—by capping how many related patents can be asserted in a single infringement action against drug or biologic developers seeking regulatory approval.
Key Points
- 1Limit on patents per action: In an infringement suit under 35 U.S.C. § 271(e), a plaintiff may not assert more than one patent per Patent Group against the same party.
- 2Who is affected: The restriction targets actions involving drug approvals and biologic licensure, specifically parties submitting or holding applications under FD&C Act sections 505(b)(2) or (j) and 351(k).
- 3Definition of Patent Group: A Patent Group consists of two or more commonly owned patents or applications identified on one or more disclaimers under 35 U.S.C. § 253 to another commonly owned patent (i.e., linked by disclaimers to show common ownership).
- 4Scope within a group: A party asserting a patent in one Patent Group cannot bring additional actions in the same Patent Group against the same defendant.
- 5Effective date: The amendment applies to applications submitted on or after the date of enactment.