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.
Summary
Bill S03203 aims to amend the public health law in New York to preserve access to affordable drugs by addressing patent infringement agreements between pharmaceutical companies. Specifically, it establishes that any agreement resolving a patent infringement claim will be presumed to have anticompetitive effects if a nonreference drug filer receives anything of value from a reference drug holder and agrees to limit or forego certain business activities. This presumption is intended to deter practices that may delay the entry of generic or biosimilar drugs into the market, thereby maintaining competitive pricing for consumers.
Impact
If enacted, this bill will significantly alter the landscape of pharmaceutical patent agreements in New York. It will impose stricter scrutiny on agreements that may limit competition, potentially leading to increased availability of affordable drugs. The bill reinforces existing antitrust laws and provides for civil penalties for violations, which could deter companies from engaging in practices that hinder market competition. It is expected to benefit consumers by promoting access to lower-cost medications.
Sentiment
The sentiment surrounding Bill S03203 appears to be largely supportive among proponents who argue that it is necessary to combat high drug prices and ensure fair competition in the pharmaceutical market. However, there are concerns from some industry stakeholders regarding the implications for innovation and the potential for unintended consequences that could arise from the presumption of anticompetitive effects.
Contention
Notable points of contention include concerns from pharmaceutical companies about the bill's potential to stifle innovation and the ability to negotiate settlements in patent disputes. Critics argue that the presumption of anticompetitive effects may discourage legitimate agreements that could benefit consumers. Proponents counter that the bill is essential for preventing anti-competitive practices that currently delay the availability of affordable drugs.
Same As
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.
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.
Amends the types of products which pharmacists may prescribe as substitute drugs or products to include "devices and supplies" and "therapeutically equivalent drugs and pharmaceuticals".
Amends the types of products which pharmacists may prescribe as substitute drugs or products to include "devices and supplies" and "therapeutically equivalent drugs and pharmaceuticals."
Prescription drugs; creating the Insulin Access and Affordability Program; requiring certain financial support and agreement. Effective date. Emergency.
Prohibits bad faith assertions of patent infringement where the person making the assertion is not engaging, has not engaged or attempted to engage, or does not intend to engage in the bona fide use of the patent in the production, development, licensing or commercialization of goods or services.