Tillis Renews Request to FDA and USPTO for Independent Assessment of I-MAK Patent Data

On Friday, April 1, Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to once again voice his concerns about several sources advancing data on the effects of pharmaceutical patents on drug pricing. Tillis is specifically troubled that the data seems to be based on opaque methodologies and to contain inaccurate or incomplete information that may mislead policymakers. In a previous letter to these organizations, he requested the agencies conduct an independent assessment of the accuracy and reliability of those sources.

In the present letter, Tillis again highlights his concern about work from the Initiative for Medicines, Access & Knowledge (I-MAK). He had previously written to Tahir Amin, Co-Founder and Co-Executive Director of I-MAK, requesting that I-MAK provide a detailed explanation of its methods to allow others to check the accuracy of I-MAK’s patent data and to assess the credibility of its other assertions. Tillis added that he shares I-MAK’s goal of lowering drug prices for all Americans but wants to ensure that the solutions are fact-driven. “Any solutions to this difficult and important issue must ensure that we do not undermine the robust intellectual property protections needed to enable the development of new medicines in the first place,” Tillis wrote.

Data Request Denied

I-MAK’s view is that the U.S. patent system creates patent monopolies that lead to the practice of “evergreening”, in which innovator pharmaceutical companies extend their rights beyond the original patent terms, preventing competition from generics, which in turn causes drug prices to remain high. As part of its mission, I-MAK has developed a database of patents covering key drugs. Its reports are often cited by academics, including in law journals, by policymakers and in congressional hearings. As a result, I-MAK has become one of the most authoritative sources for information on patents in this space.

However, in its response to Tillis’ previous letter, I-MAK declined to disclose its data, and instead largely repeated the same explanations it employs in its reports. In its letter, I-MAK addressed these requests by stating that “those familiar with patent searching techniques would be able to replicate” its methods to “arrive at the same or very similar dataset.” I-MAK also dismissed allegations that its data differs significantly from public sources like the FDA’s Orange Book and court filings. It argued that “relying on public sources and court filings is not an accurate methodology for identifying all patents on a drug” because the Orange Book does not require brand companies to list all patents on a product, particularly for patents covering the process or intermediate compound for making a drug or patents covering the substance resulting from the product of metabolism (metabolites).

Messy Metrics

Now, Tillis offers a question to the FDA and the USPTO that he hopes the organizations will address in their analysis: whether one can, by employing standard “patent searching techniques,” in fact credibly arrive at similar patent numbers and similar effective patent terms as those claimed in I-MAK’s reports. Tillis expresses skepticism on this point because, in its October 2017 report, I-MAK calculated a “total patents” figure, but included not only patents, but also pending patent applications and fully abandoned patent applications. According to Tillis, others employing “patent searching techniques” would not include pending and abandoned applications in their calculations.

In its previous letter to Tillis, I-MAK stated that “the number of years of patent protection for each drug studied is the drugmakers’ attempt or potential to extend its monopoly period that could block competition.” But now Tillis questions the accuracy of this claim against I-MAK’s own report in 2018. According to Tillis, I-MAK’s metrics were the “years blocking competition” and not the attempted or potential patent term. Tillis also points to I-MAK’s 2017 and 2018 reports that showed a number of drugs faced generic competitors today, years before its key metric of “years blocking competition.”

The Mossoff Memo Prompted Debate

A Policy Memo published by the Hudson Institute and authored by Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University prompted Tillis’ initial letter to I-MAK. The memo raised concerns regarding the reliability and accuracy of I-MAK’s data, including discrepancies concerning the total number of patents covering certain drugs and discrepancies between I-MAK’s reports and public sources concerning the period of exclusivity for these drugs.

The memo, titled “Unreliable Data Have Infected the Policy Debates Over Drug Patents,” also pointed to several examples of discrepancies in I-MAK’s data, including: the assertion in Overpatented, Overpriced that Pfizer’s treatment for nerve damage, Lyrica, is covered by 68 patents when the Food and Drug Administration’s (FDA’s) Orange Book lists only four (one of which is a reissue); that Bristol Myers Squibb’s popular drug to treat blood clots, Eliquis, is covered by 27 issued patents and 48 applications when the Orange Book lists only three; and that Janssen Pharmaceuticals’ blood clot treatment, Xarelto, is covered by 30 issued patents and 49 pending applications compared with the Orange Book’s six.

In response to the Mossoff Memo, I-MAK explained, “the system has deliberately been kept opaque by the pharmaceutical industry and its well-funded supporters over the years…. Current policy has failed to address this gaping hole in transparency from the pharmaceutical industry, so it has been left to researchers and public interest groups like ours concerned about drug prices to shed light on pharmaceutical patenting practices.” I-MAK has previously called for full transparency from the pharmaceutical industry and suggested solutions including, “request[ing] the companies to provide a list of all the patents held on a drug to the [USPTO] and FDA.”

I-MAK said that the characterization of its data as suspect due to its departure from Orange Book and other public sources is “an inaccurate narrative” that “fails to take into account the hidden real-world workings of the industry when it comes to patents.”

What’s Next?

 Tillis’s latest letter ultimately asks the FDA and USPTO to “ensure that policymaking in this critical area is based on accurate, reliable, and replicable facts and evidence” and reiterates his request for an independent assessment of these matters. The senator has asked that the agencies respond to him by May 1, 2022, to indicate they will conduct such an assessment, and to complete their review by December 31, 2022.

 

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