“[T]Here there is no relationship (linear or otherwise) between the number of patents and the amount of delay claimed. Patents do not increase or decrease the time to market for biosimilars. –BIO comments
On February 24, the U.S. Patent and Trademark Office (USPTO) issued a federal notice that the U.S. Patent Office has reopened its Request for Comments (RFC) on a joint initiative with the U.S. Food and Drug Administration. Published in official gazette. (FDA). Previously, he had closed on February 6, but his comment period on the joint USPTO-FDA initiative has been extended to March 10.
The reason stated in the Federal Register notice regarding the reopening and extension of this comment period is that the agency’s RFC “provides that all To ensure that we have sufficient opportunity to submit comments on the question.” Limit the use of generics and biosimilars and reduce the number of patent grants related to specific drugs.
The reopening of the comment period comes a few weeks after the USPTO also reopened and extended the agency’s deadline for responding to RFCs to ensure robust and credible patent rights. As was reported at the time, it is understandable that agencies are interested in hearing from as many stakeholders as possible, but the extension will not allow any stakeholders to prepare full comments for submission. Some say there is uncertainty about whether they are being given more time to
Below are some of the most recent comments on the joint USPTO and FDA initiative and follow on from our previous roundup.
Chief Justice Michelle: Agency Cooperation Risks Confidential Information, Lacks Congressional Authority
The USPTO and FDA do not have congressional authority to participate in many of the joint initiatives contemplated by the FDA’s RFCs, former Federal Circuit Chief Justice Paul R. Michel said in a comment. “In short, the proposed USPTO-FDA adjustment appears to involve the FDA in substantive legal decisions regarding patent law,” said the USPTO, the only official authorized to make decisions under patent law. is an executive branch of, Justice Michel writes. Of particular concern are potential conflicts of interest with her FDA employees who are not subject to 35 USC §4.
Judge Michel raised several questions about the RFC’s proposal to increase agency cooperation with the Patent Trial Board (PTAB) on trials of the American Invents Act (AIA). Not only does the FDA’s involvement in AIA trials further complicate trials at the expense of patent owners, agency cooperation in this regard also impairs confidential clinical trial and manufacturing data that has little to do with AIA trials. Risk disclosure. Justice Michel argued that the proposed initiative was very likely to provoke several lawsuits from parties concerned about these risks, and the court ruled that rulemaking went beyond statutory authority as follows: entered injunctive relief against the USPTO. Tafas v. Doubt (2007).
“This is not to say that agencies such as the USPTO and FDA cannot share certain publicly accessible information in order to promote and promote the best outcomes to foster innovation.” Judge Michelle writes. He added that it would also be possible for agencies to develop mechanisms for sharing classified information under congressional authority. , arguing that it ignored the innovation-promoting role of patent owners while focusing on issues well beyond the USPTO’s mandate, such as the availability of generic drugs in the U.S. market.
I-MAK: Abandonment of 44 patent applications reveals pernicious covert legal strategy
The Initiative for Medicines Access and Knowledge (I-MAK) has submitted comments, and anti-patent advocacy groups have said, according to their own data, that “companies are using patent thicket strategies to prevent drugs from getting approved. The actual patent-protected market exclusivity would be close to 20 years or more.” I-MAK took the time to tell the USPTO, “The patent system provides 20 years of patent protection for inventions. and not a 20-year patent-protected market exclusivity.”
I-MAK used the majority of its comments to refute market monopoly data advanced elsewhere by both the Biotechnology Innovation Organization (BIO) and Corey Salsberg, Vice President and Global Head of IP Practices for Novartis. spent on In previous USPTO comments to his RFC, Salsberg argued that by including dozens of abandoned patents in the I-MAK patent count, he was inflating data on patents covering the cancer treatment Gleevec. . I-MAK claims it has not received any feedback from Salsberg and continues to argue that his abandoned Gleevec patent application contributed to the slow market entry of generic drugs.
“In the real world of the pharmaceutical business, all of these patents form part of a hidden legal strategy, whether they are enforced or actually have long-term protection. If not relevant, why were they filed? You can ask Novartis a similar question, but why did they apply for and abandon 44 patents on their drug Gleevec? Despite Salsberg’s comments that this makes Novartis anti-patent, the truth lies elsewhere: Behind every patent application pending, granted, or abandoned is a strategy. Otherwise, why do I have to reapply 44 times?”
I-MAK was equally upset with Professor Adam Mossoff of the Antonin Scalia School of Law at George Mason University. His “limited analysis” of I-MAK’s patent data in his earlier comments relied solely on publicly available patent data from Orange’s book. “As any lawyer experienced in the field knows,” there are more patents in the portfolio of patents that can be asserted against generic drug makers than are listed in the FDA’s Orange Book. and I-MAK is the sum of Orange Book patents for drugs like the fibromyalgia drug Lyrica and the sum of I-MAK patents for the same drug. I-MAK has enclosed a spreadsheet listing 118 patent applications related to Lyrica, 64 of which have resulted in grants.
BIO: No relationship between drug patent number and market delay
An RFC on the USPTO-FDA cooperative initiative seems to suggest that additional communication between the two agencies could have a beneficial impact on drug pricing, but the Biotechnology Innovation Organization (BIO) A comment submitted by noted that neither agency has the authority to set drugs. price. Worse, the reasoning behind the RFC that cooperation with additional agencies would address industry issues is not supported by empirical evidence. Instead, according to BIO, such evidence points to the fact that entities in the pharmaceutical industry have not obtained a disproportionate number of patents that differ in scope or quality from patents obtained in other industries. .
Among the many common misconceptions that BIO’s comments sought to dispel, the Biotechnology Industry Association focused primarily on the false allegation that “patent thickets” are adversely affecting the market entry of generic drugs. I guessed. BIO’s data showed no correlation between the number of patents asserted in lawsuits against generic manufacturers and the amount of generic or biosimilar market delays. If anything, BIO argued that the data showed a weak negative relationship between the number of patents asserted and alleged delays.[b]Another way to interpret the data is that there is no relationship (linear or otherwise) between the number of patents and the amount of delay claimed. Patents do not increase or decrease the time to market for biosimilars. “
BIO’s comments also dismissed the misleading explanation that patents on methods of manufacturing pharmaceuticals are often obtained after the underlying biologic is patented and do not cover new innovations. bottom. There are multiple valid reasons for obtaining such a patent, and the BIO Note states that many years after a reference biologic has received market approval from the FDA, it is not possible for drug developers to pursue optimized manufacturing. It’s common to keep developing the process.
In response to the RFC’s specific questions, BIO cited a number of reasons why increased cooperation between the USPTO and FDA would complicate FDA’s work without achieving the RFC’s underlying purpose. BIO also cites Brazil as an example in 2021, repealing a rule requiring the country’s drug approval agency to examine certain drug patent applications. The move was, in fact, hailed by his 2022 Special 301 Report for the U.S. Trade Representative as a positive development in Brazil’s intellectual property system.
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