In Response to Questions Signaling Major Changes to Patent System, Commenters Ask USPTO: ‘Where’s Your Data?’
“The USPTO needs to be judicious in its request and the questions and comments it makes or the effect could be destabilizing on the patent system and on the willingness of applicants to use it.” -Dave Kappos, C4IP
Yesterday, February 1, was the deadline for submissions to the U.S. Patent and Trademark Office (USPTO) on its call for responses to a number of questions purportedly aimed at making U.S. patents more “robust and reliable.” But many commenters have weighed in to question why the Office is relying on data driven by advocacy groups to explore potentially major adjustments to the U.S. patent system when, as the expert agency on patents, it has not yet undertaken a data-driven study itself to confirm the need for such changes.
The key data being questioned is that of the Initiative for Medicines, Access & Knowledge (I-MAK), an advocacy organization that has become a “principal, go-to source” for data on the number of patents and patent applications covering pharmaceutical innovations. Some of the questions raised in the USPTO’s Request for Comments (RFC) seem to be based on many of the premises of the I-MAK data.
Congress and many others have come to rely on I-MAK’s data about pharmaceutical patents in policy debates. However, a January 2022 Policy Memo by Professor Adam Mossoff brought public attention to the fact that I-MAK’s data is questionable in some respects, and its sourcing opaque, which caused Senator Thom Tillis (R-NC) to ask the USPTO, the Food and Drug Administration (FDA) and I-MAK to provide more information about the data in late January 2022—a request he renewed two more times, in April and June of last year. The USPTO and FDA have yet to respond, but I-MAK replied to Tillis in March, defending the integrity of the data.
C4IP: Beware the Destabilizing Effects of an ‘Extensive Overhaul’
The Council for Innovation Promotion (C4IP)—an organization formed in September of last year that is headed by former vice president of U.S. policy at the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC), Frank Cullen, and features a Board of Directors composed of former USPTO Directors Andrei Iancu and David Kappos, Retired U.S. Court of Appeals for the Federal Circuit (CAFC) Judge Kathleen O’Malley and Retired CAFC Chief Judge Paul Michel—warned in its response to the RFC that the framing of the questions posed by the USPTO “directs the public to question fundamental functions of the patent system” and to assume that major problems exist when they do not. Questions about whether filing fees should be significantly raised or continuations practice ended, for example, presume the system isn’t working as is and introduces uncertainty, leading to a potential destabilizing effect.
In an interview with C4IP’s Kappos earlier this week, he told IPWatchdog that the Council is concerned about questions that suggest potentially setting filing fees at the actual cost of USPTO examination, for example, because “decisions have been made at the congressional level for well over 200 years to keep the patent filing fees at a very modest level to encourage use of the system by entities of all makes, manners and sizes,” Kappos explained. “To put out a question in a way that leads one to believe, ‘maybe we think it’s a good idea to double, triple or quadruple filing fees,’ you find yourself saying, ‘woah, that’s pretty radical.’”
Kappos and C4IP were troubled by the leading nature of the questions overall, and Kappos reiterated that some of the potential changes posed have already been attempted. “To put out a question about whether we should do away with or significantly limit continuation practice, well that was tried before,” Kappos said, alluding to the lawsuit brought by GlaxoSmithKline and Triantafyllos Tafas in 2007 against the Office for publishing a rules package that would have limited claims and continuation practice. Kappos himself rescinded those rules when he succeeded Jon Dudas as Director.
“The PTO needs to be judicious in its request and the questions and comments it makes or the effect could be destabilizing on the patent system and on the willingness of applicants to use it,” Kappos added.
C4IP is also very concerned about the USPTO’s reliance on I-MAK for data that, as the expert agency in charge of patents, it should really be publishing itself. “It’s not like the USPTO is outside of its swim lane here,” Kappos said. “To be relying on data that’s been openly questioned by congress and others—and by that I mean the I-MAK data—that’s so demonstrably false in so many ways and so much a piece of advocacy and not a piece of policymaking,” calls into question the real goal of the RFC, Kappos said.
He added: “You’re talking about data that you’ve got, and that’s in your expert zone; get your own data, do your own analysis. Particularly when you’ve got the best ability to collect and analyze the data of anyone in the world – so go do that.”
GIPC: Any Changes Would Be Premature and Industry-Targeted
The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) in its comments reiterated the call for an independent study to assess the need for the changes implied by the RFC, and called the studies often relied upon by congress, including the most widely-cited I-MAK study, “flawed, unreliable and infected with mistakes.” The GIPC noted three main concerns with the RFC: 1) a lack of support by independent and objective facts; 2) the potential for many of the suggestions, if implemented, to upend patenting practices that “support innovation, economic growth and patient choice”; and 3) conflict with international best practices.
The GIPC proposed that the USPTO instead withdraw the RFC and undertake an independent study of its data in the life sciences area to assess the need for changes and Congress should release the $1.2 billion in previously collected USPTO fees so the Office can use them to make improvements instead of raising fees as proposed. Any final action on many of the proposals, specifically those aimed at the life sciences industry, would be premature and not evidence-based, said the GIPC. The submission also called out the RFC as being inconsistent with the “technology neutral” mandate of the patent system since “it is clear that any contemplated agency action is targeted solely toward life science technologies and patent applications.”
Comments in Support of Change
Many of the comments supporting some of the changes proposed in the RFC were submitted by patient advocacy groups that contend over-patenting is the source of exorbitantly high drug prices in the United States. The Association for Accessible Medicines (AAM) cited to a study by Rachel Goode & Bernard Chao, as well as a recent New York Times article by Rebecca Robbins, to support its contention that the Humira patent estate, to take one example, “is comprised of 80% duplicative patents.” AAM urged the Office to increase examiner time and training, to modify its count system for examiners, which AAM says presently incentivizes the award of “numerous, overlapping patents,” to consider terminal disclaimers evidence of “obviousness type double patenting,” among other suggestions.
Patients for Affordable Drugs Now, which participated in the recent USPTO Listening Session that addressed many of the issues raised in the RFC, relied on I-MAK’s data in its response, as did the Interfaith Center on Corporate Responsibility, the Campaign for Sustainable Rx Pricing and Families USA.
There were 99 comments posted in response to the RFC as of February 2.
