Sec. 4. Excessive drug price license
390 words·~2 min read·
/bill/116/s/102/is/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
An entity accepting an open, non-exclusive license under section 3(a)(2) shall pay a reasonable royalty to the holder of a patent that claims the drug or that claims a use of the drug or to the holder of an application approved under subsection 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act for which any government-granted exclusivity with respect to the drug was terminated under section 5(a)(1). Such royalty rate shall be— a percentage of sales, where the percentage rate is no higher than the average royalty rate estimated from the data provided by the Internal Revenue Service for pharmaceutical manufacturer Federal income tax returns; or an amount as determined by the Secretary, taking into account— the value of the drug to patients; the size of the affected patient population; the risk adjusted value of the Federal Government subsidies and investments related to the drug; whether the drug provided a significant improvement in health outcomes, compared to other therapies available at the time of the approval; the extent to which the brand name drug manufacturer has recovered risk adjusted investments related to the drug, including the investments related to the invention, regulatory test data and any other relevant research and development costs; and any other information the Secretary determines appropriate.
A royalty rate under subsection
(a)shall be consistent with making drugs available to purchasers, including Federal, State, local, and nongovernmental purchasers and individuals, at prices that are affordable and reasonable. Under no condition shall a royalty be set at a rate that would cause a product for which an open, non-exclusive license was issued under section 3 to be sold at an excessive price, as determined under section 2. In the case that there is one or more holders or investors in the patented inventions related to the drug in addition to the brand name manufacturer, the royalty rate shall be divided among the holders or investors (including such manufacturer) in a manner agreed upon by the manufacturer and other holders or investors, or, in the absence of such an agreement, in a manner the Secretary determines to be appropriate. An entity accepting an open, non-exclusive license under section 3(a)(2) shall sell the drug at a price not higher than the excessive price determined for that drug under section 2(b).