“If one patent is deemed worthless, the related duplicate patents should be deleted as well.” – Rep. Darrell Issa
A bipartisan group of lawmakers sent a letter late last week to U.S. Patent and Trademark Office (USPTO) Director Kathy Vidal to address the issue, outlined in the October 2022 Request for Comments on Robust and Credible Patents. I urged her to implement some of the suggestions I made. About drug prices.
The letter was written by Jodie Arrington (Republican-Texas), Lloyd Doggett (Democrat-Texas), Michael Burgess (Republican-Texas), Anne McClain Kuster (Democrat-New Hampshire) and Darrell Issa (Republican-California). sent by a member of the House of Representatives. They specifically expressed concern about the “patent chunky” practice, citing examples of his two separate patents granted to rheumatoid arthritis biologics by the same company, although the differences in the claims were seemingly minor. It was something. The letter cites for this reference a video titled “Patent Reform Case Study” featuring Fresenius Kabi’s Senior Vice President and Head of Legal and Intellectual Property Biosimilars.
The October RFC included questions about a number of initiatives the USPTO is considering or already working on. Notify other agencies and remind patent applicants of their disclosure obligations and the consequences of failing to disclose required information at the USPTO. 2) introducing more examination time into the examination system, providing more training and resources to the examiner, enhancing communication between the examiner and her PTAB, and “continuing applications for large families and/or Apply scrutiny through the use of declarative evidence to overcome rejections.” between the United States and other countries to investigate whether changes need to be made to minimize the effects of obviousness-type double patenting practices and to identify ways to strengthen the U.S. system. comparatively analyzes the prosecution and issuance of pharmaceutical patents and bio-patents. 3) Consider ways to improve the PTAB process, including conducting additional scrutiny when large families of continuation patents are involved when deciding whether to initiate AIA proceedings.
Members of Congress have urged Vidal to adopt a policy that would require “brand manufacturers seeking multiple patents for the same drug to recognize that the claims denied due to double patenting are patentably indistinguishable.” In particular, it encouraged consideration and allowed courts to consider an invalidation decision against a single patent as evidence. against others.
“Too often, the brilliant innovation of big pharma is to create new and manipulative ways to maintain monopoly power and charge monopoly prices,” Doggett said in a joint press release on the letter this week. “To avoid prices that are inaccessible to patients and to promote a healthy free market, the patent office needs to ensure that generic competitors are not forced to challenge these overlapping patents. If one patent is deemed worthless, the related duplicate patents will be removed as well.This modest reform will ensure timely entry of generics, reduce patient prices and reduce tax burden. It helps us realize significant savings for our customers.”
Issa added: However, the system must represent a commitment to fundamental fairness, and if that is threatened or thwarted, the USPTO will sanction all true patent owners and future inventors. , is obliged to course-correct with inspiration to advance our collective knowledge. Now is the time for reform.”
The USPTO has twice pushed back the October RFC submission deadline. The Office ultimately received a total of 294 comments and 227 were posted.
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