Case 1:22-cv-00252-MSG Document 59-2 Filed 03/02/23 Page 1 of 3 PageID #: 1023
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`Exhibit 2
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`Case 1:22-cv-00252-MSG Document 59-2 Filed 03/02/23 Page 2 of 3 PageID #: 1024
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`April 22, 2022
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`The Honorable Xavier Becerra
`Secretary
`U.S. Department of Health & Human Services
`200 Independence Avenue SW
`Washington, DC 20201
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`Dear Secretary Becerra:
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`I write to bring to your attention to a new letter, sent to me by over 25 legal and public
`health experts, describing “three powerful tools that the [Biden Administration] can use to lower
`drug prices by breaking patent barriers and accelerating competition.”1
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`According to the letter, which was led by experts from Yale Law School, Harvard
`Medical School, and Columbia Law School:
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`High prescription drug prices in the United States are a major problem today for
`both patients and the sustainability of our healthcare system. Importantly, these
`prices do not typically reflect material factors like supply shortages,
`manufacturing difficulties, or labor costs. Instead, drug prices are high primarily
`because brand-name drug companies use government-granted exclusivities, such
`as patents, to prevent competition and charge high prices.
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`Existing law gives the executive branch several tools to intervene when patients
`and public health are harmed by excessive drug prices. These tools can help the
`Administration break patent barriers, foster competition where currently there is
`none, and drive down prices. Critically, using them requires no additional
`congressional action.
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`This letter describes three of these tools: the “government patent use power”
`codified at 28 U.S.C. § 1498, and the Bayh-Dole Act’s “royalty-free license” and
`“march-in rights.” These tools are integral, longstanding, and legitimate parts
`of our patent system. Together, their directed use can help the government
`obtain fair prices for prescription drugs.
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`1 Letter from Legal and Public Health Experts to Senator Elizabeth Warren, April 20, 2022,
`https://www.warren.senate.gov/imo/media/doc/2022.4.20%20Letter%20to%20Warren%20on%20Drug%20Pricing
`%20Executive%20Authorities.pdf.
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`Case 1:22-cv-00252-MSG Document 59-2 Filed 03/02/23 Page 3 of 3 PageID #: 1025
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`I have repeatedly called upon the Administration to use its executive powers to lower
`drug prices,2 as explicitly contemplated by the Department of Health and Human Service’s
`Comprehensive Plan for Addressing High Drug Prices.3 The attached letter affirms in
`extraordinary detail that you have the legal authority to do so. Consistent with these experts’
`conclusions, I urge you to move swiftly to use your existing authorities to give sorely needed
`relief to the millions of Americans paying far too much for their prescription drugs.
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`Thank you for your attention to this important matter.
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`Sincerely,
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`_________________________________
`Elizabeth Warren
`United States Senator
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`Enclosure
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`2 See, e.g., Letter from Senator Elizabeth Warren, Senator Angus King, and Congressman Lloyd Doggett to HHS
`Secretary Xavier Becerra, February 17, 2022,
`https://www.warren.senate.gov/imo/media/doc/2022.02.17%20Letter%20to%20Sec.%20Becerra%20on%20Xtandi
`%20March-in%20Petition%20(2).pdf; Letter from Senator Elizabeth Warren, Senator Amy Klobuchar, and
`Congressman Lloyd Doggett to HHS Secretary Xavier Becerra, July 28, 2021,
`https://www.warren.senate.gov/imo/media/doc/2021.07.28%20Letter%20to%20Secretary%20Becerra%20re%20Dr
`ug%20Pricing%20Authorities.pdf.
`3 U.S. Department of Health & Human Services, Office of the Assistant Secretary for Planning and Evaluation,
`“Comprehensive Plan for Addressing High Drug Prices: A Report in Response to the Executive Order on
`Competition in the American Economy,” September 9, 2021, p. 22, https://aspe.hhs.gov/sites/default/files/2021-
`09/Competition%20EO%2045-Day%20Drug%20Pricing%20Report%209-8-2021.pdf.
`2
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