Texas Border Business
WASHINGTON – U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) released the following statements after the Affordable Prescriptions for Patients Act passed out of the Senate Judiciary Committee unanimously:
“I’ve heard from countless Texans who are struggling to pay for their prescriptions and weighing financial decisions no family should have to make,” said Sen. Cornyn. “There is bipartisan agreement that something must be done to reel in skyrocketing costs and protect patients. I’m grateful to my colleagues on the Judiciary Committee for unanimously supporting this legislation so Texas families won’t have to choose between paying their mortgage and getting the medication they need.”
“Most Americans have never heard of product hopping or patent thicketting, but these abusive, anti-competitive tactics squeeze billions out of the pockets of American patients,” said Sen. Blumenthal. “Through commonsense reforms, our bill disarms and defangs these companies from misusing and abusing our patent system. It is a concrete step toward reining in Big Pharma’s greed, and enabling more robust competition to increase Americans’ access to cheaper generic drugs.”
Background on the Affordable Prescriptions for Patients Act:
To help prevent drug companies from deliberately abusing the patent system, the Affordable Prescriptions for Patients Act aims to curb the pharmaceutical drug industry’s anti-competitive behaviors of ‘product hopping’ and ‘patent thicketing’ that restrict access to generic and biosimilar drugs.
Product Hopping
Product Hopping takes advantage of our current FDA approval system to get around pharmacy-level generic substitution laws. When making a new version of a drug, like a minor reformulation, that new drug can’t be substituted for the generic, because the generic is tied to the old version. Sometimes the manufacturer will go so far as to remove the old version from the market completely. This leaves the generic with nowhere to go, as patients are forcibly switched to the new version.
The Affordable Prescriptions for Patients Act:
- Codifies definitions of product hopping within the FTC Act, empowering the FTC to challenge this behavior as anti-competitive.
- Enables the FTC to use its equitable remedy authority to keep companies from capitalizing on their abuse of the system.
Patent Thickets
Pharmaceutical drugs, especially the category known as biologics, are complex products that often have several patents to their name. Some manufacturers take advantage of the complex interplay of the different kinds of patents that belong to one drug and deploy these patents strategically in order to prevent competition. Would-be competitors, known as generic or biosimilar manufacturers, have to fight through these patents (the so-called ‘thicket’) before they can get their drug approved, or they risk losing their chance to sell their drug.
The Affordable Prescriptions for Patients Act:
- Disarms the patent thicket by implementing guardrails that provide greater certainty to generic manufacturers and transparency for brand drugmakers.
- Creates greater efficiency in the process by allowing resolution of patent differences between brand and generic drugmakers prior to litigation.
- Allows courts to stop drugmakers from using patent thickets to unjustly limit competitors from coming to market, ensuring more choice and affordable prices.
- Limits the number of late-filed, unutilized, and non-method of use patents branded drugmakers can use to lengthen litigation and keep more affordable alternatives off the market.
 and Richard Blumenthal (D-CT) released the following statements after the Affordable Prescriptions for Patients Act passed out of the Senate Judiciary Committee unanimously){kind=link}