Bill 119 s 43, also known as the "Safe Harbor for Method of Use Patents Act," aims to amend title 35 of the United States Code in order to establish a safe harbor provision for infringement of method of use patents related to drugs or biological products.
The bill seeks to provide protection for healthcare providers, pharmacists, and other entities who use patented drugs or biological products in accordance with FDA-approved labeling. This safe harbor would prevent these entities from being held liable for patent infringement when using a drug or biological product for an approved purpose, even if the use falls outside the scope of the patent.
The purpose of this legislation is to encourage the use of innovative drugs and biological products by ensuring that healthcare providers can use them without fear of infringing on method of use patents. This, in turn, is intended to promote access to new and potentially life-saving treatments for patients.
Overall, Bill 119 s 43 aims to strike a balance between protecting the rights of patent holders and promoting access to innovative drugs and biological products for the benefit of public health.