In Short
The Situation: U.S. Sen. Thom Tillis (R-N.C.) sent a letter to the U.S. Food and Drug Administration ("FDA") and the United States Patent and Trademark Office ("USPTO") raising concerns regarding potentially inaccurate data and false narratives used by certain groups to allege that pharmaceutical companies misuse patent laws to delay generic competition and drive up drug prices. Tillis asked the agencies to complete an independent study on the sources and data that are being used by those advocating for patent-based solutions to drug pricing.
The Issue: The letter raises doubts about the credibility of certain organizations, such as Initiative for Medicines, Access & Knowledge ("I-MAK"), and their claims that drug makers use patent laws to extend their monopolies in ways not contemplated by U.S. patent laws. These reports are increasingly being cited during policy debates calling for changes to the patent system to lower drug prices.
Looking Ahead: New independent studies from the FDA and USPTO, along with additional explanation by I-MAK of its methodology, will shed light on the reliability of the data cited by drug critics and will ensure that policymakers are relying on accurate and objective data in making decisions regarding patent protection in the pharmaceutical industry.
On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew Hirschfield, Commissioner for Patents of the USPTO, raising concerns regarding potentially inaccurate data and false narratives being advanced by some that pharmaceutical companies use patent laws to improperly extend patent protection on their drugs and, as a result, drive up drug prices. Tillis specifically identified the Initiative for Medicines, Access & Knowledge ("I-MAK") and the Evergreen Drug Patent Search project from University of California Hastings Law School as two groups advancing these false narratives. I-MAK and the Evergreen Drug Patent Search project produce reports that allege that drug makers use strategies such as evergreening or patent thickets to artificially extend patent protection and maintain exclusivity. These reports are frequently cited in the current policy debate over patents and drug prices.
In his letter, however, Tillis cited a recent policy memo published last month by Adam Mossoff, a professor at George Mason University's Antonin Scalia Law School, that finds that a subsequent analysis of I-MAK's data has raised concerns about the inaccuracy in the underlying data, inadequate transparency, and flawed methodology. Mossoff's policy memo identifies various concerning discrepancies between claims in I-MAK's reports and public documents, such as the FDA Orange Book. For example, Mossoff found that I-MAK asserts that 68 patents cover Pfizer's Lyrica, yet the Orange Book only identifies 3 patents covering Lyrica, none of which cover the capsule formulation of Lyrica. Additionally, I-MAK claims Pfizer will retain exclusive rights over Lyrica until 2038. But the patent covering Lyrica's main ingredient expired in December 2018, the FDA approved nine generic versions of Lyrica in 2019, and the three Orange Book patents (that relate to the extended-release formulation only) all expire in 2027. Mossoff noted that I-MAK does not provide its underlying methodology or explain how I-MAK reaches its conclusions. The article concludes that, without empirical evidence, the data in I-MAK's reports should not be relied on by policymakers or scholars in the current debate regarding patent laws and drug prices.
Tillis separately questioned the Evergreen Drug Patent Search database, identifying concerns about inaccuracy in the underlying data, inadequate transparency, and flawed methodology. As one example, Tillis highlighted that the database indicates that aspirin is still enjoying exclusivity under an evergreening strategy, despite being available as a generic for over 100 years.
Based on these concerns, Tillis asked the FDA and USPTO to complete an independent study on the sources and data that are being used by those advocating for patent-based solutions to drug pricing, with the hope that the study be completed by December 31, 2022. The studies will ensure that policymakers are relying on objective and accurate data. Since President Biden's July 9, 2021, Executive Order on Promoting Competition in the American Economy, the FDA and USPTO have faced increased scrutiny with respect to the role that pharmaceutical patents play in high U.S. drug prices. In considering this issue, participants in a FDA-USPTO roundtable discussion, held January 21, 2022, questioned the reliability of data underlying arguments about evergreening, patent thickets, and other alleged patent abuses, and both agencies seem primed to investigate this issue.
On January 31, Sen. Tillis also wrote a letter to Tahir Amin, the co-founder and co-executive director of I-MAK, requesting a detailed explanation of I-MAK's methodology and an explanation for why the numbers are so dramatically different from public sources to further support independent review of these issues.
Three Key Takeaways
- The FDA and USPTO continue to face criticism for the role that the pharmaceutical patent system plays in drug pricing in the United States, and such criticism has only increased under the Biden administration.
- The methodology underlying analysis by drug critic groups such as I-MAK is opaque, and discrepancies between their reports and other sources of information call into question reliance on these analyses when considering new patent or regulatory policies.
- Senator Tillis' letter to the FDA and USPTO highlights important concerns in the debate over pharmaceutical patent protection and high drug prices and the need to ensure that any policy changes are made using reliable and accurate data.
