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

Baker, Brook b.baker at neu.edu
Thu Nov 27 07:13:40 PST 2014

Data and market exclusivity create almost perfect monopolies for pharma on the medicines they actually bring to market and at the time they do so.  They would not have to mess around with filing and prosecuting patents though many probably would do so to prevent competitors from getting marketing approval first.  At present, there is no explicit provision in international IP law allowing or disallowing CL-like exceptions to data/marketing exclusivity.

Pharma has been fighting for data/marketing exclusivity for decades and having gotten it in the US and Europe it is trying to extend the term of exclusivity in the global North while trying to impose the same monopoly protections in low and middle-income countries.  Not only should many questions be raised, these brazen, persistent attempts to achieve longer and inviolate monopolies on medicines should be resisted at all costs.

Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker at neu.edu
From: Ip-health <ip-health-bounces at lists.keionline.org> on behalf of Outterson, Kevin <mko at bu.edu>
Sent: Wednesday, November 26, 2014 7:43 PM
To: Jamie Love
Cc: Ip-health
Subject: Re: [Ip-health] A bill giving 15 years of data exclusivity for a       "dormant therapy"

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.


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
>    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''.
> 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.
> 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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