Cal. HSC § 134000 — California Code / Code hsc / Division 114.01 / Section 134000
Section 134000
Status: in_force

For purposes of this division:

(a) “ANDA” means abbreviated new drug application.

(b) “ANDA filer” means a party that owns or controls an ANDA filed with the Food and Drug Administration or has the exclusive rights under that ANDA to distribute the ANDA product.

(c) “Agreement” means anything that would constitute an agreement under California state law or a “trust” under the Cartwright Act (Chapter 2 (commencing with Section 16700) of Division 7 of the Business and Professions Code).

(d) “Agreement resolving or settling a patent infringement claim” includes any agreement that is entered into within 30 days of the resolution or the settlement of the claim, or any other agreement that is contingent upon, provides a contingent condition for, or is otherwise related to the resolution or settlement of the claim. This shall include, but is not limited to, the following:

(1) Any agreement required to be provided to the Federal Trade Commission or the Antitrust Division of the United States Department of Justice under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173).

(2) Any agreement between a biosimilar or interchangeable product applicant and a reference product sponsor under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) (Public Law 111-148) that resolves patent claims between the applicant and sponsor.

(e) “Biosimilar biological product application filer” means a party that owns or controls a biosimilar biological product application filed with the Food and Drug Administration under Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) for licensure of a biological product as biosimilar to, or interchangeable with, a reference product, or that has the exclusive rights under the application to distribute the biosimilar biological product.

(f) “NDA” means new drug application.

(g) “Nonreference drug filer” means either:

(1) An ANDA filer.

(2) A biosimilar biological product application filer.

(h) “Nonreference drug product” means the product to be manufactured under an ANDA that is the subject of the patent infringement claim, a biosimilar biological product that is the product to be manufactured under the biosimilar biological product application that is the subject of the patent infringement claim, or both.

(i) “Patent infringement” means infringement of any patent or of any filed patent application, extension, reissue, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patents of addition, and extensions thereof.

(j) “Patent infringement claim” means any allegation made to a nonreference drug filer, whether or not included in a complaint filed with a court of law, that its nonreference drug product or application infringes any patent held by, or exclusively licensed to, the reference drug holder.

(k) “Reference drug holder” means either:

(1) A brand holder that is any of the following:

(A) The holder of an approved NDA for a drug product application filed under Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).

(B) A person owning or controlling enforcement of the patent listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the “FDA Orange Book”) in connection with the NDA.

(C) The predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with, any of the entities described in subparagraph (A) or (B), with control to be presumed by direct or indirect share ownership of 50 percent or greater, as well as the licensees, licensors, successors, and assigns of each of those entities.

(2) A biological product licenseholder, which means any of the following:

(A) The holder of an approved biological product license application for a biological drug product under Section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).

(B) A person owning or controlling enforcement of any patents that claim the biological product that is the subject of the approved biological patent license application.

(C) The predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with, any of the entities described in subparagraph (A) or (B), with control to be presumed by direct or indirect share ownership of 50 percent or greater, as well as the licensees, licensors, successors, and assigns of each of those entities.

(l) “Reference drug product” means the product to be manufactured by the reference drug holder and includes both branded drugs of the NDA holder and the biologic drug product of the biologic product license applicant.

(m) “Statutory exclusivity” means those prohibitions on the approval of drug applications under clauses (ii) through (iv), inclusive, of Section 505(c)(3)(E) (5-year and 3-year data exclusivity), Section 527 (orphan drug exclusivity), or Section 505A (pediatric exclusivity), of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E), 360cc, and 355a, respectively) or on the licensing of biological product applications under Section 262(k)(7) of Title 42 of the United States Code (12-year exclusivity) or Section 262(m)(2) or (3) of Title 42 of the United States Code (pediatric exclusivity).