(a) (1) Except as provided in paragraph (3), an agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a pharmaceutical product, shall be presumed to have anticompetitive effects and shall be a violation of this section if both of the following apply: (A) A nonreference drug filer receives anything of value from another company asserting patent infringement, including, but not limited to, an exclusive license or a promise that the brand company will not launch an authorized generic version of its brand drug. (B) The nonreference drug filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the nonreference drug filerâs product for any period of time. (2) As used in subparagraph (A) of paragraph (1), âanything of valueâ does not include a settlement of a patent infringement claim in which the consideration granted by the brand or reference drug filer to the nonreference drug filer as part of the resolution or settlement consists of only one or more of the following: (A) The right to market the competing product in the United States before the expiration of either: (i) A patent that is the basis for the patent infringement claim. (ii) A patent right or other statutory exclusivity that would prevent the marketing of the drug. (B) A covenant not to sue on a claim that the nonreference drug product infringes a United States patent. (C) Compensation for saved reasonable future litigation expenses of the reference drug holder but only if both of the following are true: (i) The total compensation for saved litigation expenses is reflected in budgets that the reference drug holder documented and adopted at least six months before the settlement. (ii) The compensation does not exceed the lower of the following: (I) Seven million five hundred thousand dollars ($7,500,000). (II) Five percent of the revenue that the nonreference drug holder projected or forecasted it would receive in the first three years of sales of its version of the reference drug documented at least 12 months before the settlement. If no projections or forecasts are available, the compensation does not exceed two hundred fifty thousand dollars ($250,000). (D) An agreement resolving or settling a patent infringement claim that permits a nonreference drug filer to begin selling, offering for sale, or distributing the nonreference drug product if the reference drug holder seeks approval to launch, obtains approval to launch, or launches a different dosage, strength, or form of the reference drug having the same active ingredient before the date set by the agreement for entry of the nonreference drug filer. A different form of the reference drug does not include an authorized generic version of the reference drug. (E) An agreement by the reference drug holder not to interfere with the nonreference drug filerâs ability to secure and maintain regulatory approval to market the nonreference drug product or an agreement to facilitate the nonreference drug filerâs ability to secure and maintain regulatory approval to market the nonreference drug product. (F) An agreement resolving a patent infringement claim in which the reference drug holder forgives the potential damages accrued by a nonreference drug holder for an at-risk launch of the nonreference drug product that is the subject of that claim. (3) Parties to an agreement are not in violation of paragraph (1) if they can demonstrate by a preponderance of the evidence that either of the following are met: (A) The value received by the nonreference drug filer described in subparagraph (A) of paragraph (1) is a fair and reasonable compensation solely for other goods or services that the nonreference drug filer has promised to provide. (B) The agreement has directly generated procompetitive benefits and the procompetitive benefits of the agreement outweigh the anticompetitive effects of the agreement. (b) In determini
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