Here is some material from the National Health Council, whence this proposed legislation comes --
It includes a lot of features, but I sense that the patent protection is the most pertinent for ALS today.
Here are the descriptions of the patent aspects --
TITLE II — CAPTURING LOST OPPORTUNITIES FOR PATIENTSSome examples would really help me understand.
Sec. 201 – DESIGNATION OF DORMANT THERAPIES
This section creates a new class of drugs, named “dormant therapies.” A dormant therapy is a new drug or biological product that has insufficient patent protection and meets the FDA definition of “unmet medical need.” The Secretary is required to establish a methodology and criteria for this designation. In its request for designation as a dormant therapy, the manufacturer must provide a list of all patents and applications for patents to which the manufacturer has rights, and must agree to waive those rights in order to receive the designation.
Sec. 202 – PROMOTING THE DEVELOPMENT OF DORMANT THERAPIES
This section provides for a 15-year period of data exclusivity after FDA approval to encourage the development of dormant therapies. The Secretary is required to make its determinations available to the public. This bill will establish a predictable pathway for introducing low-cost generic equivalents to dormant therapies.
1. What if there is a drug that is within a year of losing its patent and the manufacturer holding the patent decides to pursue testing of that drug for ALS? It will take years to test the drug for ALS. What happens? What does it mean to waive the old patent rights? What does the 15-year period of "data exclusivity" mean?
2. What if there is a drug that is within a year of losing its patent and another manufacturer is interested in pursuing it for ALS? How would that work?
3. What if there is an old drug whose patent protection has long since passed. Can it get new patent protection with this?
Thanks to anyone with insights.