[Ip-health] Criticism of JAMA article on US HHS and Gilead - price of PrEP products

Baker, Brook b.baker at northeastern.edu
Wed Mar 4 07:20:17 PST 2020

There are at least two very questionable assertions in this article.

First, the article states that “categorical opposition of advocates to secondary use patents is unwise, particularly for case in which the patent holder has invested substantial resource in discovering, and validating, a novel use."  Patent decisions are supposed to be based on inventiveness (and novelty and industrial applicability) not on investment.  Moreover, as a practical matter, secondary use patents are granted in the U.S. both in cases of relatively small investment and of large investment.  If the new uses are discovered early in the primary patent life, drug companies will earn substantial rewards for larger volume sales at high prices to additional patients, and thus there is no need for a new 20-year patent on the new use.  Perversely, with the option of such new-use patents, patent holders have incentives to delay introduction of new uses and to product hop, both of which have been used by Gilead, which delayed the use of TDF/FTC for PrEP and thereafter delayed patenting and introduction of TAF and its co-formulations.

Second, the article mentions march-in rights under Bayh-Dole, but does address the U.S.'s repudiation of use of march-in to address high prices.  It wasn't "procedural challenges associated with march in [that] may have dampened interest," it was the U.S. categorical rejection of march-in.  Moreover, the article neglects to address addition government use options the government has to authorize generic production of PrEP medicines "by and for" the government in its multiple federal health programs under section 1498.

In sum, the article is disappointing, incomplete, and misleading is several key respects.


Professor Brook K. Baker
Northeastern U. School of Law
416 Huntington Ave., Boston MA 02115
Affiliate Center on Health Policy and Law
Affiliate and Resident Fellow Center on Law, Innovation, and Creativity
Affiliate Center for Public Interest Advocacy and Collaboration
Co-director, Program on Human Rights and the Global Economy

Senior Policy Analyst Health GAP (Global Access Project)

Office:  617-373-3217
Skype: brook_baker
b.baker at northeastern.edu<mailto:b.baker at northeastern.edu>


March 3, 2020
    Expanding Access and Reducing Prices for Drugs to Prevent HIV
    Should Government Enforce Its Patent Rights Against the Pharmaceutical Industry?

    Lawrence O. Gostin, JD1; Arti K. Rai, JD2

    1Georgetown University Law Center, Washington, DC
    2Duke University School of Law, Durham, North Carolina

    JAMA. 2020;323(9):821-822. doi:10.1001/jama.2019.22357

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