An Act Concerning The Availability Of Generic Pharmaceuticals.
Impact
The enactment of SB00251 would significantly modify the landscape of pharmaceutical agreements by imposing stricter regulations on how patent disputes are handled. This law seeks to protect the interests of consumers by ensuring that generic drug products can enter the market without undue delays caused by settlements between brand name and generic drug manufacturers. This legislative change is also expected to create a more robust competitive environment by limiting practices that can keep prices for generic drugs artificially high.
Summary
SB00251, titled 'An Act Concerning The Availability Of Generic Pharmaceuticals', aims to enhance consumer access to affordable generic drugs by preventing agreements that unnecessarily stifle competition within the pharmaceutical market. The proposed legislation includes provisions that declare certain agreements surrounding patent infringement claims as having anticompetitive effects. It stipulates that any agreement where a nonreference drug filer receives value and subsequently agrees to limit or suspend its own research or marketing activities will be presumed illegal under this legislation.
Contention
Notable points of contention surrounding SB00251 include concerns from pharmaceutical companies about the sufficiency of operating within a more regulated environment that may impact their profit margins. Industry representatives have suggested that the bill could deter investment in new drug development due to the increased risks associated with patent litigations. Conversely, consumer advocacy groups support the bill, arguing that the availability of generics is essential for lowering healthcare costs and improving patient access to necessary medications.
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Relates to preserving access to affordable drugs; provides that 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 if a nonreference drug filer receives anything of value from another company asserting patent infringement and if the nonreference drug filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the nonreference drug filer's product for any period of time.
Provides that an agreement resolving a patent infringement claim, in connection with the sale of a pharmaceutical product, is to be presumed to have anticompetitive effects if a nonreference drug filer receives anything of value.