Chamber Says USPTO Drug Patent Report Exposes ‘Activist’ Data as ‘Fake Facts’
“USPTO’s study shows that generic medicines are routinely approved and launched while patents associated with the branded medicine remain in force.” – Brad Watts
The U.S. Chamber of Commerce today responded to a recent U.S. Patent and Trademark Office (USPTO) report that the Chamber says proves much of the data that is often cited as proof of life sciences companies abusing the patent system is “more fiction than truth.”
According to the USPTO, the report, published on June 12, shows that “simply quantifying raw numbers of patents and exclusivities is an imprecise way to measure the intellectual property landscape of a drug product because not every patent or exclusivity has the same scope.”
Road to USPTO Report
The report was conducted in response to letters sent by Senator Thom Tillis (R-NC) in January and April of 2022 asking the Office to conduct an independent assessment of the source material being used to support the data. Most recently, Tillis wrote to both the USPTO and the Food and Drug Administration (FDA) again in May 2024 asking for an update, as the original deadline of December 31, 2022, had long since past.
“Numerous inquiries have been made by my staff in an attempt to determine when you would complete and provide the assessment and analysis to our offices,” Tillis wrote. “Unfortunately, neither agency has provided a firm commitment regarding a transmittal date.”
Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University first published a Policy Memo with the Hudson Institute in January 2022 charging that some of the key data relied upon in the heated debate over the effects of pharmaceutical patents on drug pricing and access may be faulty. Tillis subsequently wrote letters to the key organization responsible for the underlying data, the Initiative for Medicines, Access & Knowledge (I-MAK), as well as the FDA and the USPTO, expressing concern about the findings of Mossoff’s memo and requesting more information from I-MAK about its methodology.
Mossoff’s analysis revealed that there is a significant discrepancy between I-MAK’s and publicly available government data on patents covering blockbuster drugs that cannot be explained because I-MAK does not disclose or describe its underlying dataset, making its numbers “impossible to confirm.”
I-MAK responded to Tillis’ letter in March 2022 but declined to disclose its data, and instead largely repeated the same explanations it employs in its reports. I-MAK’s letter to Tillis said that “those familiar with patent searching techniques would be able to replicate” its methods to “arrive at the same or very similar dataset.”
Fake Facts
But in light of the USPTO’s June 12, 2024, report, Brad Watts, Vice President, Patents and Innovation Policy at the Chamber’s Global Innovation Policy Center (GIPC), wrote today that such datasets have now been revealed to be unreliable, resulting in “fake facts”. Watts explained:
“USPTO’s study covered a representative range of important medications and found no correlation between the numbers of patents on a product and generic entry. In fact, USPTO’s study shows that generic medicines are routinely approved and launched while patents associated with the branded medicine remain in force. The reason is simple—contrary to the activists’ claims, each patent associated with an innovative medicine covers a different invention, innovative aspect, or improvement of the medicine.”
The USPTO did not specifically analyze I-MAK’s or any other source’s data or methodologies. “Rather, the USPTO, with the assistance of the FDA, conducted an analysis of a representative sample of 25 New Drug Applications (NDAs) (representing 13 distinct active ingredients) listed in the FDA’s Orange Book1 between 2005-20182 that were also considered by these data sources using available public data points (e.g., patent numbers and exclusivities listed in the Orange Book, patent filing and issue dates, and drug application approval dates),” said the report. The samples were selected based on a number of factors, including “top grossing products by revenue in 2017, most prescribed branded products in 2017, and other factors….”
Among the report’s conclusions, the USPTO found that “a comprehensive analysis of all the patents and pending patent application claims that, if issued in a patent, could reasonably be asserted against an ANDA applicant could provide a more fulsome picture of the general competitive landscape for a drug product.” Furthermore, “[w]ith respect to multiple patents that cover a single product, multiple patents associated with a single marketed product are not unique to the pharmaceutical industry and are a common practice in many innovative industries, especially for complex products,” explained the report.
Watts’ blog post noted that the report debunks oft-cited data claiming that one popular drug in particular (possibly Bristol Myers Squibbs’ cancer drug, Revlimid) had decades worth of market exclusivity when in fact it only had 16 years.
“The patent system is too important to be evaluated based on anything but legitimate data,” concluded Watts. “If American leaders are going to propose changes to our patent system, they need to ensure those changes aren’t rooted in unreliable data from activists.”
Congress has long been debating the role of patents in drug pricing. In May of this year, Tillis expressed frustration about the lack of progress on drug pricing issues, which he blamed on the Committee’s narrow focus on patents, relying heavily on I-MAK’s data.
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Eileen McDermott
Eileen McDermott is the Editor-in-Chief of IPWatchdog.com. Eileen is a veteran IP and legal journalist, and no stranger to the intellectual property world, having held editorial and managerial positions at […see more]
