Murray, Cornyn Re-Introduce Legislation to Crack Down On Sham Drug Patents
Updated legislation aims to increase scrutiny to prevent drug companies from using sham patents to block competition from cheaper generic drugs
Murray: “We need to be doing everything we can to help bring down prescription drug costs, and that means making it harder for drug companies to get away with using sham patents to keep cheaper generic drugs off the shelf.”
Cornyn: “Generic prescription drugs allow Texans to get the medicine they need at a reasonable price. This legislation will increase transparency and invite patent challenges where necessary to stop bad actors from blocking access to these cheaper drugs.”
Washington, D.C. – Yesterday, U.S. Senator Patty Murray (D-WA) and Senator John Cornyn (R-TX), re-introduced the Second Look at Drug Patents Act, legislation to improve the process for challenging sham drug patents which can block cheaper generic drugs from being available to patients and families.
“Families across the country were struggling with high prescription drug costs even before this pandemic threw millions of people into unexpected hardship. We need to be doing everything we can to help bring down prescription drug costs, and that means making it harder for drug companies to get away with using sham patents to keep cheaper generic drugs off the shelf,” said Senator Murray. “I’m going to be pressing to get this bill, and other meaningful steps to bring down drug costs, passed into law as soon as possible.”
“Generic prescription drugs allow Texans to get the medicine they need at a reasonable price,” said Senator Cornyn. “This legislation will increase transparency and invite patent challenges where necessary to stop bad actors from blocking access to these cheaper drugs.”
The Second Look at Drug Patents Act requires drug companies to submit all new patents to the U.S. Patent and Trademark Office (PTO) and that they be listed publicly on the PTO website and its official gazette, a move that will increase transparency, solicit additional information about the strength of those patents, and invite patent challenges.
The updated bill streamlines implementation based on feedback from the Food and Drug Administration (FDA) by simply requiring PTO submission and listing of patents—as proposed in the original legislation—without introducing potential uncertainty associated with creating a new “provisional” designation for such patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”).
Read a one-pager on the Second Look at Drug Patents Act of 2020 below, and see a PDF of the one pager HERE.
Read the bill text HERE.
The Second Look at Drug Patents Act of 2020
Senators Patty Murray (D-WA) and John Cornyn (R-TX)
The Second Look at Drug Patents Act improves the process for challenging sham drug patents, removing obstacles to lower-cost generic drugs’ entry to market.
The Second Look at Drug Patents Act requires that the U.S. Patent and Trademark Office initiate a process to facilitate reexamining the validity of patents before they are listed in the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”). Entry into the Orange Book is an important step for drug patents, because it has the legal effect of blocking generic entry.
The Act requires brand name drug manufacturers to submit all new patents to the U.S. Patent and Trademark Office within 30 days of approval. The Director of the U.S. Patent and Trademark Office is then required to post new patents on a new U.S. Patent and Trademark Office website and in the Official Gazette of the Patent and Trademark Office (“Official Gazette”). Listing patents in this website and the Official Gazette serves to solicit additional information about the strength of those patents and invite patent challenges.
These modifications to the patent process will ease the burden on patent challengers, including generic drug manufacturers, by flagging for the public patents eligible for lawful challenge. The Second Look at Drug Patents Act provides a new tool to help bring generic drugs to market in a timelier and more efficient manner, giving consumers needed access to lower-priced prescription drugs.
The Second Look at Drug Patents Act is supported by: the Campaign for Sustainable Rx Pricing (CSRxP).
###
