On Wed, May 16, 2018, the House Ways & Means Committee held a markup on HR. 5773, a bill dealing with the opioid crisis, which would require Medicare prescription drug plans to establish drug management programs for at-risk beneficiaries.
Representative Lloyd Doggett (D-TX) offered an amendment to the bill that would require require the negotiation of lower covered Part D drug prices for opioid overdose reversal drugs. The amendment provided that “in case the Secretary is unable to negotiate a price. .. . the Secretary shall . . establish such price . . at the amount negotiated by the Secretary of Veterans Affairs” or use “the remedies specified in section 1498 of title 28, United States Code, use or manufacture such drug and set a price for such drug as determined appropriate by the Secretary.” A copy of the amendment offered is attached here:
The video of Representative Doggett offering the amendment is here:
The amendment was ruled out of order, but only after but every democrat member of the committee voted to permit the amendment to be considered.
What is significant is that the Congress is beginning to see the use of compulsory licensing of drug patents as instrumental in ensuring that negotiations over prices do not result in an impasse that harms access.
Another aspect of the amendment that deserves notice was the suggestion that in using 1498, the Secretary of HHS would “set a price for such drug as determined appropriate by the Secretary,” which is somewhat different than how 1498 is now used, but may set some boundaries on the royalties a court would set for patent holders.
KEI has earlier made a proposal as regards the use of 1498, as well as the Bayh-Dole royalty free or march-in rights, to address the opioid crisis.
- April 2, 2018. KEI requests that federal government use compulsory licenses on Kaléo held patents for devices used to administer opioid overdose reversal drug.
- August 30, 2017. US Federal rights in patents on Probuphine, to treat opioid addiction.
KEI also has a list of more than 1,000 federal court cases that cite 28 USC 1498, here: http://drugdatabase.info/databases/, and has more about 28 USC 1498 here: https://www.keionline.org/cl/28usc1498