Proposed rule is in alignment with the Senators’ bipartisan bill to hold Big Pharma accountable for abusing the patent system
WASHINGTON, D.C. – Senators Peter Welch (D-Vt.), Mike Braun (R-Ind.),and Amy Klobuchar (D-Minn.) sent a letter to Kathi Videl, Director of the U.S. Patent and Trademark Office (USPTO), expressing strong support for a proposed rule released by USPTO that would help restore competition to the prescription drug market and lower prescription drug prices for patients. The Senators urged USPTO to quickly finalize the rule and called on Congress to pass their bipartisan, bicameral bill to streamline drug patent litigation and make it easier for generic and biosimilar companies to enter the market.
“Restoring competition to the prescription drug market would provide American patients with much needed and overdue relief on the cost of prescription drugs—and USPTO’s Notice of Proposed Rulemaking is an important step towards this goal. The rule would require patent applicants filing terminal disclaimers to agree that their patent will be unenforceable if any claim in another patent tied to the original patent by a terminal disclaimer has been held unpatentable or invalid by a federal court or the USPTO,” wrote the Senators. “Challenging patents is extremely costly, and this rule would reduce incentives for filing numerous duplicative patents that are tied to each other by terminal disclaimers, which would reduce gamesmanship by patent holders and allow for more innovation in the market. USPTO should finalize this rule without delay.”
“To further bolster USPTO’s efforts, Congress should also pass S. 3583, a bipartisan, bicameral bill that complements the proposed rule. S. 3583 would limit the number of patents with a common terminal disclaimer that a pharmaceutical company can assert in infringement litigation to one,” continued the Senators. “While our bill attempts to address patent thickets that have already been created, the proposed rule is equally as important, as it will prevent pharmaceutical companies from manipulating the use of terminal disclaimers to build future patent thickets. Together, by advancing our bill to address patent thickets and finalizing the proposed rule, we could provide tangible benefits to the patient community.”
The Senators concluded: “We strongly urge USPTO to finalize the proposed rule so that Americans can start to see the benefits of lower cost prescription drugs.”
In January, Senators Welch, Braun, and Klobuchar introduced bipartisan, bicameral legislation to streamline drug patent litigation, encourage fair market competition, and lower prescription drug prices by making it easier for generic and biosimilar companies to enter the market. The bill codifies the practice that many federal district courts across the country already apply to limit the number of patents or patent claims a company can assert in litigation. Rep. Jodey Arrington (R-TX-19) introduced companion legislation in the House. Read more about the bill.
Read the full letter.
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