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

Outterson, Kevin mko at bu.edu
Wed Nov 26 16:43:50 PST 2014


Abandoning patent law (almost) entirely for exclusivity is a significant step, with many questions that should be raised. 

I prefer marketing exclusivity over data exclusivity because we need more data transparency, not less. 

Kevin

Sent from my iPhone 6

> On Nov 26, 2014, at 6:30 PM, Jamie Love <james.love at keionline.org> wrote:
> 
> 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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