[Ip-health] A bill giving 15 years of data exclusivity for a "dormant therapy"

Jamie Love james.love at keionline.org
Wed Nov 26 15:26:25 PST 2014


I think there may be an effort to move this bill (HR 3116) next year, in
the new Congress.  It currently has 80 co-sponsors in the House.


"Establishes a dormant therapy designation for medicine that addresses
unmet medical needs. Gives such medicine 15 years of data exclusivity under
which no drug can be approved by relying on the approval or licensure of
the dormant therapy."


https://www.congress.gov/bill/113th-congress/house-bill/3116



SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Modernizing Our Drug & Diagnostics
Evaluation and Regulatory Network Cures Act of 2013'' or the ``MODDERN
Cures Act of 2013''.


TITLE I--ADVANCING DIAGNOSTICS FOR PATIENTS

Sec. 101. Developing a common lexicon to facilitate progress on
                            diagnostics.
Sec. 102. Creating incentives for innovative diagnostics.
Sec. 103. Promoting the development of innovative diagnostics.
          TITLE II--CAPTURING LOST OPPORTUNITIES FOR PATIENTS

Section 3, Findings

(5) Advanced and innovative diagnostic tests have the potential to
dramatically increase the efficacy and safety of drugs by better
predicting how patients will respond to a given therapy.

(6) Despite their promise, many drugs and diagnostics may go
undeveloped due to uncertain regulatory and reimbursement processes,
among other reasons.

(7) In addition, there is reason to believe that potential treatments
with tremendous value to patients are never developed or are
discontinued during research and development due to insufficiencies in
the intellectual property system.

(8) It is in the public interest to address the hurdles that may be
precluding new treatments from reaching patients and to remove the
disincentives for the development of therapies for these unmet needs.



-- 

James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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