Signed by Governor Gavin Newsom

Vote Smart's Synopsis:

Vote to pass with amendment a bill that prohibits pharmaceutical companies from using tactics that slow generic drug manufacturers from releasing lower cost medications.

Highlights:

• Defines “ANDA” as abbreviated new drug application (Sec. 1).

• Defines “ANDA filer” as 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 (Sec. 1).

• Defines “non-reference drug product” as either an ANDA filer or a biosimilar biological product application filer (Sec. 1).

• Defines “patent infringement claim” as any allegation made to a nonreference drug filer that its non-reference drug product or application infringes any patent held by, or exclusively licensed to, the reference drug holder (Sec. 1).

• Establishes that an agreement which resolves or settles a patent infringement claim for a pharmaceutical product, is considered anticompetitive and a violation of this act if (Sec. 1):

• A non-reference drug filer gets something of value from another company claiming patent infringement; and

• The non-reference drug filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the non-reference drug filer’s product for a period of time. 

• Establishes that parties to an agreement do not violate the preceding highlight if they have evidence to prove that (Sec. 1):

• The value that the non-reference drug filer receives is a fair and reasonable compensation specifically for other goods or services promised by the non-reference drug filer; or

• The agreement promotes procompetitive benefits and the benefits of this competition outweigh the anticompetitive effects of the agreement.

• Establishes that every individual that violates or assists in the violation of this act will forfeit and pay a civil penalty to the State of California (Sec. 1).

• Specifies that the civil penalty will accrue only to the State of California and will be recovered in a civil action brought by the Attorney General in its own name against any party to an agreement in violation of this act (Sec. 1).

• Requires any action taken to enforce a cause of action for a violation to be commenced within 4 years after the cause of action accrued (Sec. 1).

Full Bill Text

Vote Smart's Synopsis:

Vote to pass a bill that prohibits pharmaceutical companies from using tactics that slow generic drug manufacturers from releasing lower cost medications.

Highlights:

• Defines “ANDA” as abbreviated new drug application (Sec. 1).

• Defines “ANDA filer” as 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 (Sec. 1).

• Defines “non-reference drug product” as either an ANDA filer or a biosimilar biological product application filer (Sec. 1).

• Defines “patent infringement claim” as any allegation made to a non-reference drug filer that its non-reference drug product or application infringes any patent held by, exclusively licensed to, the reference drug holder (Sec. 1).

• Establishes that an agreement which resolves or settles a patent infringement claim for a pharmaceutical product, is considered anticompetitive and a violation of this act if (Sec. 1):

• A non-reference drug filer gets something of value from another company claiming patent infringement; and

• The non-reference drug filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the non-reference drug filer’s product for a period of time. 

• Establishes that parties to an agreement do not violate the preceding highlight if they have evidence to prove that (Sec. 1):

• The value that the non-reference drug filer receives is a fair and reasonable compensation specifically for other goods or services promised by the non-reference drug filer; or

• The agreement promotes competition that would not otherwise occur through less restrictive means, and that the benefits of this competition outweigh the anticompetitive effects of the agreement.

• Establishes that every individual that violates or assists in the violation of this act will forfeit and pay a civil penalty to the State of California for detering violations of this act (Sec. 1).

• Specifies that the civil penalty will accrue only to the State of California and will be recovered in a civil action brought by the Attorney General in its own name against any party to an agreement in violation of this act (Sec. 1).

Full Bill Text