[Ip-health] Rep Doggett amendment proposed the use of 28 USC 1498 in negotiations for affordable treatments to reverse opioid overdoses»Knowledge Ecology International
james.love at keionline.org
Fri May 18 06:28:31 PDT 2018
Rep Doggett amendment proposed the use of 28 USC 1498 in negotiations for
affordable treatments to reverse opioid overdoses»Knowledge Ecology
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
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. https://www.keionline.org/27541
August 30, 2017. US Federal rights in patents on Probuphine, to treat
opioid addiction. https://www.keionline.org/23432
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
James Love. Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
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