Our Priority Areas in Patent Reform:
Pay-for-Delay Agreements
These anticompetitive practices involve brand-name drug companies paying generic manufacturers to delay bringing lower-cost alternatives to market. We support legislation that would make these agreements presumptively illegal and subject to antitrust scrutiny.
Sneha Dave speaking on a panel discussion on breaking down big pharma patent walls.
Patent Thickets
This anticompetitive practice involves brand-name drug companies filing for a large number of patents on the same high-priced medication, creating a dense web of patent protection. However, many of these patents aren’t innovative; they are just intended to block affordable generics from getting into the hands of patients. We support reforms that aim to limit the number of patents a drug maker can assert against competitors and expedite the arrival of affordable generic and biosimilar medication.
Product Hopping
This tactic involves pharmaceutical companies introducing slightly modified versions of their high-priced medications after generics have entered the market. Pharmaceutical companies will then utilize marketing tactics to deceive physicians and patients into believing their modified medication is better than the original; when in reality, it is the original medication. This tactic is intended to persuade physicians into prescribing this slightly modified high priced medication, rather than the cheaper generic now available. We recommend policies that would empower the Federal Trade Commission to challenge product hopping as an unfair method of competition.
USPTO-FDA Collaboration
We advocate for increased coordination between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to improve patent quality and prevent abuse. Specifically, we support policies that aim to prevent the granting of pharmaceutical patents that are abstract or lack uniqueness.
Increasing Public Engagement in the Patent System
We work to amplify young adult patients' voices in patent policy discussions. This includes engaging with agencies such as the United States Patent and Trademark Office, the National Institutes of Health, the Food and Drug Administration, and the Federal Trade Commission.
We also are working to ensure legislation that is harmful to young adult patients does not advance, such as:
PREVAIL (Protecting and Restoring Enduring Validity to Advance Innovation and Limit Excessive): The PREVAIL Act aims to limit the power of the Patent Trial and Appeal Board (PTAB) and make it harder for the public to challenge bad patents.
Patent Eligibility Restoration Act (PERA): PERA would expand patent-eligible subject matter to include abstract ideas, laws of nature, and natural phenomena, allowing companies to monopolize research building blocks and drive up testing costs and medication prices.
- Patent Reform Primer
- Letter in support of S. 2780, the Medication Affordability and Patent Integrity Act
- Generation Patient Comment to the U.S. Patent Trade Office: Terminal Disclaimer Practice To Obviate Nonstatutory Double Patenting Proposed Rule
- Generation Patient Comment on PTAB Rule
- Generation Patient Comment for the Record Submitted to Senate Committee Hearing
Our Goals for Patent Reform:
Ending the abuse of the patent system through policy reform and regulatory change
Increasing transparency in the patent system
Empowering young adult patients to be at the center of patent reform discussions
Young adults are disproportionately affected by these systemic issues and must be at the forefront of the conversation. We are working to ensure their lived experiences inform efforts to create a fairer and more patient-centered patent system.
- The Connection Between Patents and High Drug Prices - A Q&A in POLITICO featuring our executive director Sneha Dave along with other experts who shared their perspectives on the connection between pharmaceutical patents and high drug costs—and, more importantly, what can be done about it through patent reform.