USPTO Extends Comment Period on FDA Collaboration Initiatives to Give Full Ear to Sparring Stakeholders
“[T]here simply is no relationship (linear or otherwise) between the number of patents and the amount of alleged delay; patents do not increase or decrease time-to-launch for biosimilars.” – Comment of BIO
On February 24, the U.S. Patent and Trademark Office (USPTO) issued a notice in the Federal Register indicating that the nation’s patent agency was reopening the comment period related to its request for comments (RFC) on collaboration initiatives with the U.S. Food & Drug Administration (FDA). Previously closed on February 6, the comment period on USPTO-FDA collaboration initiatives is now extended until March 10.
The reason stated in the Federal Register notice for reopening and extending this comment period is to “ensure that all stakeholders have a sufficient opportunity to submit comments on the questions presented” in the agency’s RFC on ways that the two agencies could cooperate to improve market entry of generic drugs and biosimilars, and to reduce the number of patent grants related to certain drugs.
The reopening of the comment period comes a few weeks after the USPTO also reopened and extended the deadline for responding to the agency’s RFC on ensuring robust and reliable patent rights. As reported at that time, while it’s understandable that the agency is interested in hearing from as many stakeholders as possible, some have said the extensions are creating uncertainty as to which stakeholders are being given more time to prepare their full comments for submission.
Below is a collection of some of the most recent comments on the USPTO-FDA collaboration initiatives, following up on our previous roundup .
Chief Judge Michel: Agency Collaboration Risks Confidential Information, Lacks Congressional Authority
The USPTO and the FDA lack Congressional authority to enter into many of the collaboration initiatives contemplated by the agency’s RFC, noted Retired Federal Circuit Chief Judge Paul R. Michel in his comment. “In short, the suggested USPTO-FDA coordination seemingly invites the FDA to participate in substantive legal decisions on patent law,” when the USPTO is the only Executive Branch agency authorized to make decisions based on patent law, Judge Michel wrote. Of particular concern are the conflicts of interest that could arise with FDA employees who are not subject to 35 U.S.C. § 4, which prevents USPTO employees from gaining an interest in any patent while employed by the agency.
Judge Michel raised several issues with the RFC’s proposal to increase agency collaboration with respect to America Invents Act (AIA) trials at the Patent Trial and Appeal Board (PTAB). Not only will FDA involvement in AIA trials further complicate trials at the expense of patent owners, but agency collaboration in this respect risks the disclosure of confidential clinical trial and manufacturing data that could have little relevance to an AIA trial. Judge Michel contended that it was incredibly likely that the proposed initiatives would spawn several lawsuits from parties concerned about those risks, and courts have entered injunctive relief against the USPTO when rulemaking has exceeded statutory authority as in Tafas v. Dudas (2007).
“This is not to say that agencies such as the USPTO and the FDA cannot share certain publicly accessible information in order to facilitate and encourage the best outcomes for advancing innovation,” Judge Michel wrote. He added that it was also possible that the agencies could develop mechanisms for sharing confidential information under congressional authority. However, Judge Michel argued that the RFC itself exhibited an inherent bias against patent owners and ignores their pro-innovative role while focusing on issues well outside the USPTO’s authority, such as the availability of generic medicines in the U.S. marketplace.
I-MAK: Abandoning 44 Patent Applications Speaks to Nefarious Hidden Legal Strategies
The Initiative for Medicines, Access & Knowledge (I-MAK) filed a comment in which the anti-patent advocacy group said that, according to its own data, “it is clear to see that companies are using the patent thicket strategy to get as close to or above 20 years of actual patent protected market exclusivity once a drug is approved.” I-MAK took the time to remind the USPTO that “the patent system provides 20 years of patent protection for an invention – not 20 years of patent protected market exclusivity.”
I-MAK spent the majority of its comment pushing back on market exclusivity data advanced elsewhere by both the Biotechnology Innovation Organization (BIO) and Novartis’ VP and Global Head of IP Affairs, Corey Salsberg. In a prior comment responding to the USPTO’s RFC, Salsberg contended that I-MAK’s inflated data on the patents covering the cancer treatment Gleevec by including a few dozen abandoned patents in its patent counts. I-MAK maintains that it hasn’t received any feedback from Salsberg and continued to assert that the abandoned Gleevec patent applications contribute to delayed market entry for generics:
“In the real world of the pharmaceutical business, these patents all form part of a hidden legal strategy, irrespective of whether they are enforced or actually result in longer protection. If they were not of relevance, then why were they filed? A similar question can be asked of Novartis and why they filed and abandoned 44 patent applications on their drug Gleevec? Despite Mr Salsberg’s comment that this makes Novartis, anti-patent, the truth lies elsewhere. Behind every patent application, pending, granted or abandoned is a strategy. Otherwise why re-apply 44 times?”
I-MAK was similarly vexed with Professor Adam Mossoff of George Mason University’s Antonin Scalia Law School, whose “limited analysis” of I-MAK’s patent data in a previous comment only relied on publicly available Orange Book patent data. “As any seasoned practicing attorney in this field would know,” the portfolio of patents that could be asserted against generic drugmakers include more than the patents listed in the FDA’s Orange Book, I-MAK noted in response to Mossoff’s claims of a vast discrepancy between Orange Book patent totals for drugs like the fibromyalgia treatment Lyrica and I-MAK’s patent totals for the same drug. In support of its case, I-MAK included a spreadsheet listing 118 patent applications related to Lyrica, 64 of which have resulted in issued patent grants.
BIO: There Is No Relationship Between Drug Patent Numbers and Market Delay
While the RFC on USPTO-FDA collaboration initiatives seems to suggest that additional communications between the two agencies could have a beneficial effect on drug pricing, a comment filed by the Biotechnology Innovation Organization(BIO) points out that neither agency has any authority for setting drug prices. Worse, the reasoning behind the RFC that additional agency collaboration would address industry issues is not supported by empirical evidence. Instead, such evidence points to the fact that drug industry entities are not obtaining disproportionate numbers of patents that differ in scope or quality from patents obtained in other industries, according to BIO.
Of the many popular misconceptions sought to be dispelled by BIO’s comment, the biotech industry association focused mainly on false claims that “patent thickets” are having a negative impact on the market entry of generic drugs. BIO’s data found no correlation between the number of patents asserted in litigation against generic drugmakers and the amount of market delay for generics or biosimilars. If anything, BIO contended that the data shows a weak negative relationship between the number of asserted patents and alleged delay, “[b]ut another way to interpret the data is that there simply is no relationship (linear or otherwise) between the number of patents and the amount of alleged delay; patents do not increase or decrease time-to-launch for biosimilars.”
BIO’s comment also dismissed the misleading narrative that patents covering methods of manufacturing drugs, which are often obtained well after the underlying biologic was patented, do not cover novel innovations. There are multiple valid reasons for obtaining such patents, BIO notes, and it is common for drug developers to continue to develop optimized manufacturing processes years after the reference biologic obtained market approval from the FDA.
In responding to specific questions in the RFC, BIO listed many reasons why increased collaboration between the USPTO and the FDA could create complications in agency operations without achieving the underlying purpose of the RFC. BIO also cited the example of Brazil, which in 2021 eliminated rules requiring that nation’s drug approval agency to review certain drug patent applications. This move was actually hailed as a positive development in Brazil’s intellectual property system by the U.S. Trade Representative’s 2022 Special 301 Report.
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