“When one patent is deemed meritless, the associated duplicates should fall as well.” – Rep. Darrell Issa
A bipartisan group of congress members sent a letter to U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal late last week urging her to implement some of the proposals outlined in her October 2022 Request for Comments on Robust and Reliable Patents in order to address problems around drug pricing.
The letter was sent by Representatives Jodey Arrington (R-TX), Lloyd Doggett (D-TX), Michael Burgess (R-TX), Ann McLane Kuster (D-NH), and Darrell Issa (R-CA). They specifically expressed concerns about the practice of “patent thicketing” and gave the example of two separate patents granted for a rheumatoid arthritis biological drug by the same company, where the difference in the claims was seemingly minor. The letter cites to a video titled “The Case for Patent Reform,” featuring Senior Vice President and Head of Legal & Intellectual Property Biosimilars at Fresenius Kabi, for this reference.
The October RFC included questions on a number of initiatives the USPTO is considering or already acting on, including: 1) enhanced collaboration with agencies like the FDA, such as “initiatives to require patent applicants to provide relevant information to the USPTO that has been submitted to other agencies and to remind patent applicants of their disclosure obligations and the ramifications of failing to disclose required information at the USPTO”; 2) introducing more examination time into the examination system, providing examiners with more training and resources, enhancing communication between examiners and the PTAB, “applying greater scrutiny to continuation applications in large families and/or the use of declaratory evidence to overcome rejections,” exploring whether changes need to be made to minimize the effects of obviousness-type double patenting practices, and conducting a comparative analysis of examination and issuance of pharma and bio patents between the United States and other countries in order to identify ways to strengthen the U.S. system; and 3) considering ways to improve the PTAB process, such as additional scrutiny in cases involving continuation patents in large families when deciding whether to institute an America Invents Act (AIA) proceeding.
The congress members encouraged Vidal to especially consider policies that would require a “branded manufacturer seeking multiple patents on the same drug to admit that the claims rejected for double patenting are not patentably distinct,” thus allowing courts to consider invalidity rulings against one patent as evidence against the others.
“Too often, Big Pharma’s masterful innovation is in creating new, manipulative ways to maintain monopoly power and charge monopoly prices,” said Doggett in a joint press release about the letter this week. “To ensure patients are not priced out of access and to encourage a healthy free market, the Patent Office should ensure generic competitors are not forced to challenge these duplicate patents. When one patent is deemed meritless, the associated duplicates should fall as well. This modest reform would help ensure timely generic entry to drive down prices for patients and achieve huge savings for taxpayers.”
Issa added: “The greatness of America’s one-of-a-kind patent system is to be found in its protection of our greatest innovations and promotion of free minds and free markets. But that system must also represent a commitment to fundamental fairness, and when that is threatened or thwarted, the USPTO owes a course correction to every true patent holder and future inventor with an inspiration to advance our collective knowledge. It’s time for reform.”
The USPTO twice delayed the deadline for submissions on the October RFC. The Office ultimately received a total of 294 comments, with 227 posted.
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4 comments so far. Add my comment.
Pro SayApril 1, 2023 12:18 pm
“When one U.S. Representative is deemed incompetent, the associated Representatives should be found incompetent as well. This modest reform would help ensure the timely election of Representatives who know what the h.e.l.l. they’re doing when it comes to patents, intellectual property, and what’s best for Americans.”
Julie BurkeMarch 31, 2023 05:48 pm
Sherry & Mike: hear, hear!
mikeMarch 31, 2023 02:44 pm
These few Representatives in this letter are attempting to bypass the People of the United States by going directly to the Executive Branch. This is not the first time a small few members in Congress have tried such an unconstitutional persuasive tactic. As hero Sherry Knowles once said here on IPWatchdog:
Under the U.S. Constitution, only Congress has the power to create substantive patent laws, not the Executive Branch. The Senators may consider that by requesting the USPTO to do what is likely too difficult for them to do (pass statutes restricting the rights of innovators in the United States), they can create a fast bypass to their goal, but the structure of our government does not allow for that.
The same applies for you, Issa. If you can’t persuade a majority of members of Congress who represent the People of the United States, that’s your problem. Stop trying to cheat with your shortcuts that bypass the People and their voice and votes.
MoocowMarch 30, 2023 05:48 pm
So if I understand this correctly, they’re complaining that it’s impossible to overcome families of related, overlapping continuations. Like, if it costs 1 million to litigate one patent, then it costs 20 million to litigate 20 overlapping patents that claim basically the same thing. Does anyone here believe that to be true?