“The USPTO needs to be prudent in its requests, and the questions and comments it makes, or its implications, can destabilize the patent system and applicants’ willingness to use it.” -Dave・Kappos, C4IP
Yesterday, February 1st, was the deadline for submissions to the United States Patent and Trademark Office (USPTO) seeking answers to a number of questions aimed at making US patents more “robust and credible.” However, many commentators believe that the patent office, as a professional body on patents, could potentially make major adjustments to the U.S. patent system, even though it has not yet conducted its own data-driven investigations. question why we rely on data driven by advocacy groups to investigate Confirm the need for such changes.
The key data in question are those from the Initiative for Medicines, Access & Knowledge (I-MAK). I-MAK is an advocacy group that has become the “leading authoritative source” of data on the number of patents and patent applications covering pharmaceutical innovations. Several of the questions posed in the USPTO’s Request for Comments (RFC) appear to be based on many of the assumptions of the I-MAK data.
Congress and many others have come to rely on I-MAK data on pharmaceutical patents in policy debates. However, a January 2022 policy memo by Professor Adam Mozoff drew public attention to the fact that the I-MAK data were questionable in several respects, and that its sources were opaque, leading Tom Tillis to As Senators (Republican-North Carolina) will provide more information on the data to the USPTO, Food in late January 2022, the U.S. Drug Administration (FDA) and I-MAK twice last April and June, I have updated the request. The USPTO and FDA have not yet responded, but I-MAK said in March he responded to Tillis and defended the integrity of the data.
C4IP: Beware of destabilizing effects of ‘major overhaul’
Council for Promoting Innovation (C4IP) – Founded last September, headed by Frank Cullen, former Vice President for U.S. Policy at the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC), with a Board of Directors . Former USPTO Directors Andrei Iancu and David Kappos, former Court of Appeals for the Federal Circuit (CAFC) Judge Kathleen O’Malley, and former CAFC Chief Justice Paul Michelle, in their responses to the RFC, said the framework of questions raised: warned. The USPTO “questions the fundamental functioning of the patent system” and instructs the public to assume that major problems exist even if they do not. For example, the question of whether filing fees should be significantly increased or an ongoing practice should be terminated suggests that the system is not working as-is, leading to uncertainty and potential destabilizing effects. I guess.
In an interview with C4IP’s Kappos earlier this week, he told IPWatchdog, for example, that “decisions have been made at the congressional level for quite some time, which may set the filing fee at the actual cost of USPTO examination. The Board is concerned about questions that suggest that It takes 200 years to keep patent filing fees at very modest levels to encourage use of the system by companies of all makes, manners and sizes. If you ask a question that makes you think doubling it might be a good idea, you’ll be like, ‘Wow, that’s pretty radical.'”
Kappos and C4IP were annoyed by the initiative nature of the whole question, and Kappos reiterated that some of the potential changes proposed had already been attempted. Alluding to the lawsuits filed by GlaxoSmithKline and Triantafyllos Tafas, it would have “limited claims and continuing practices to raise the question of whether continuing practices should be abolished or substantially limited. Kappos himself rescinded these rules when he replaced Jon Dudas on the board.
“The PTO needs to be prudent in its requests, and the questions and comments it makes, or its implications, can destabilize the patent system and applicants’ willingness to use it,” Kappos said. added.
C4IP is also very concerned that the USPTO, as a professional agency responsible for patents, relies on the I-MAK for the data it should actually publish. “The USPTO is not out of the swimlane here,” said Kappos. “Relying on data that has been openly questioned by Congress and others, he said, on the I-MAK data, is in many ways plainly erroneous and part of advocacy, not part of policy making. department.” It calls into question the true purpose of the RFC, he said, Kappos.
He added: Get your own data and do your own analysis. Especially if you have the best ability to collect and analyze data from everyone in the world. “
GIPC: Changes are premature and aimed at industry
In its comments, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) reiterated its call for independent research to assess the need for changes suggested by the RFCs, including the most widely cited: called a study often relied upon by Congress. According to I-MAK’s research, it is “flawed, unreliable, and infected with mistakes.” GIPC identified three main concerns about RFCs. 1) Lack of independent objective factual support. 2) The potential for many of the proposals, if implemented, to overturn patent practices that “support innovation, economic growth, and patient choice.” 3) contradict international best practices;
The GIPC proposed instead that the USPTO withdraw the RFC and conduct an independent review of data in the life sciences sector to assess the need for change, and that Congress should pay $1.2 billion in previously collected USPTO fees. should be released so that the Agency can use them for improvement. Instead of raising the rates as suggested. Final action on many of the proposals, particularly those aimed at the life sciences industry, would be premature and not evidence-based, the GIPC said. He pointed out that it was inconsistent with his obligations.
Comments supporting the change
Many of the comments supporting some of the proposed changes in the RFC came from patient advocacy groups, alleging that patent overuse is responsible for prohibitively high drug prices in the United States.The Accessible Medicines Association (AAM) commended research by Rachel Goode and Bernard Chao, and the recent New York Times article Humira’s patent portfolio, by Rebecca Robbins, supports the assertion that, to name just one example, “composed of 80% duplicate patents.” The AAM has asked the AAM to increase examiner time and training and change the examiner counting system. The AAM says it now incentivizes rulings on “multiple overlapping patents.” .
Patients from Affordable Drugs Now, who participated in a recent USPTO listening session that addressed many of the issues raised in the RFC, have learned that the I-MAK data relied on in response to and Family USA.
As of February 2nd, 99 comments have been posted in response to the RFC.
