ETHIC Act

Summary#

The ETHIC Act changes patent rules for certain drug and biologic products. It adds a limit to 35 U.S.C. §271(e) so a patent owner may assert no more than one patent per "Patent Group" in an infringement action against certain drug or biologic applicants, holders, or makers. A "Patent Group" means two or more commonly owned patents or applications linked by disclaimers under section 253. The bill also bars bringing additional suits asserting other patents in the same Patent Group against the same party. The rule applies to applications submitted under 505(b)(2) or 505(j) of the Federal Food, Drug, and Cosmetic Act or 351(k) of the Public Health Service Act on or after the date the Act is enacted.

What it means for you#

• For generic drug or biosimilar applicants and makers: they may face fewer separate patent claims in court from the same patent owner for the same group of related patents.
• For patent owners: they may be limited to asserting only one patent from a commonly owned group of patents linked by section 253 disclaimers in an infringement action under 35 U.S.C. §271(e).
• For manufacturers, sellers, and importers of approved drugs or licensed biologics covered by those statutes: the bill changes which patent assertions can be brought against them in certain actions.

Expenses#

No publicly available information.

Proponents' View#

The bill title and text state the purpose is to address "patent thickets" and to increase competition by preventing multiple, closely related patent claims from being asserted against the same drug or biologic applicant or product.

Opponents' View#

No publicly available information.