Affordable Prescriptions for Patients Act of 2019

Bill: 116-s-1416
Sponsor: Sen. Cornyn, John [R-TX]
Introduced: 2019-05-09 in the Senate
Policy area: Commerce
Subjects: Administrative remedies
Civil actions and liability
Competition and antitrust
Consumer affairs
Drug safety, medical device, and laboratory regulation
Federal Trade Commission (FTC)
Health care costs and insurance
Inflation and prices
Intellectual property
Judicial review and appeals
Manufacturing
Prescription drugs

Summary:
action_date: 2019-05-09
text: 

Affordable Prescriptions for Patients Act of 2019

 
 This bill prohibits patent thicketing and product hopping by drug manufacturers. In general, patent thicketing occurs when a drug manufacturer obtains new patents related to a previously-patented drug, biological product, or underlying chemical composition that extends the manufacturer&rsquo;s market exclusivity for that drug without demonstrating that the new patents serve a meaningful purpose other than limiting competition from generic drug manufacturers.
 
 Product hopping is presumed when a drug manufacturer obtains removal of a drug from the Food and Drug Administration&rsquo;s approved drug list, discontinues a drug, or markets a reformulation of an already-approved drug during a certain period after which the manufacturer has been notified that a competing drug manufacturer has applied for generic drug approval. These practices are not considered product hopping if the manufacturer demonstrates that the drug was removed from the approved-drug list for safety reasons. Or, in the case of a drug reformulation, the manufacturer shows that the modified product provides a significant health benefit, is the option least likely to reduce competition, and is based on substantial financial considerations unrelated to limiting competition.
 
 The Federal Trade Commission may penalize violating manufacturers and bring claims in federal court to prohibit the conduct and provide restitution.

action_date: 2019-06-28
text: 

Affordable Prescriptions for Patients Act of 2019

 
 This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a 
hard switch
 or a 
soft switch
. A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration&rsquo;s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A
 follow-on product 
is a changed, modified, or reformulated version of a manufacturer&rsquo;s already-approved drug or biological product that still treats the same medical condition.
 
 A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product.
 
 A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition.
 
 This bill also limits the number of patents that may be included in infringement claims brought by approved biological product license holders against applicants for a biosimilar product license.


Legislative actions:
action_date: 2019-06-28
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
action_date: 2019-06-28
text: Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.
action_date: 2019-06-28
text: Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.
action_date: 2019-06-27
text: Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2019-05-09
text: Read twice and referred to the Committee on the Judiciary.
action_date: 2019-05-09
text: Introduced in Senate