Bill 118 s 5573, 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 method of use.
The purpose of this legislation is to encourage the use of innovative drugs and biological products by ensuring that healthcare providers can prescribe and administer these products without fear of facing costly patent infringement lawsuits. By providing this safe harbor, the bill aims to promote access to new and potentially life-saving medications for patients.
Overall, Bill 118 s 5573 seeks to strike a balance between protecting the intellectual property rights of patent holders and ensuring that healthcare providers can effectively and safely use patented drugs and biological products for their intended purposes.