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

Reshma Ramachandran reshmagar at gmail.com
Mon Dec 15 08:21:47 PST 2014


There's now a Senate version of MODDERN Cures introduced by Senators Bennet
(D-CO) and Hatch (D-UT) called the Dormant Therapies Act:

http://www.hatch.senate.gov/public/_cache/files/634caf10-ff8f-448e-8f8a-3e34ea38707d/Dormant%20Therapies%20Act.pdf

Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs
Posted 12 December 2014
<http://www.raps.org/Regulatory-Focus/News/2014/12/12/20974/Senators-Call-for-15-Years-of-Marketing-Exclusivity-for-Some-New-Drugs/#>

[image: placeholder+image]

Two US senators have proposed new legislation that would grant an
unprecedented 15 years of marketing exclusivity to certain types of
pharmaceutical and biopharmaceutical products.
Background

The bill, known as the *Dormant Therapies Act*
<http://www.hatch.senate.gov/public/_cache/files/634caf10-ff8f-448e-8f8a-3e34ea38707d/Dormant%20Therapies%20Act.pdf>of
2014, is the second piece of legislation introduced in as many days by
Sens. Orrin Hatch and Michael Bennet (D-CO). The duo introduced the *Promise
for Antibiotics and Therapeutics for Health (PATH) Act*
<http://www.raps.org/Regulatory-Focus/News/2014/12/11/20966/Bill-Seeks-Creation-of-New-Pathway-for-Antibiotic-Drug-Approvals/>on
10 December 2014.

*Read up on other bills slated to potentially affect FDA in our FDA
Legislation Tracker*
<http://www.raps.org/Regulatory-Focus/FDA-Legislation-Tracker/>*.*

Unlike the *PATH Act*, which is primarily intended to incentivize the
development of new antibiotics, the *Dormant Therapies Act *is aimed at
providing an attractive incentive to invest in diseases for which there are
"one or more unmet medical needs."

The bill would create a new designation—Dormant Therapy Designation—modeled
off of FDA's other existing designation programs, including breakthrough
therapy designation, orphan product designation and fast-track designation.
Those programs are intended to offer designees special incentives, such as
added periods of marketing exclusivity (orphan product designation) and
additional support during the review process (fast-track and breakthrough
therapy designations).

As with the other programs, the legislation requires a sponsor to
specifically request the designation from FDA. As the legislation makes
clear, the designation will only be given to new drugs (either a different
active moiety, or a biological product that is "not highly similar to" an
approved biologic).
Heavy Focus on Patents

Sponsors hoping to obtain the designation—and its 15 years of market
exclusivity—will also need to waive all patent rights to the drug,
including all patents "that may be reasonably construed to provide
protection for the medicine,” after the 15 years of exclusivity ends. The
unusual language seems intended to avoid lengthy patent battles between
patent holders and prospective generic entrants. At present, patent
litigation can sometimes add months or years of marketing exclusivity to a
drug's lifetime.

However, it's unclear how the patent waiver would—or if it would—apply to
patents applied for and granted *after *the approval of a medicine. Many of
these patents cover the manufacture of medicines using new methods, which
can be used to delay or prevent generic competition. The legislation is
also unusual in that it would allow patents to be extended throughout the
entire 15-year period of dormant product exclusivity "if the patent would
otherwise expire before the end of the protection period."
How Much Exclusivity is too Much?

The legislation is closely modeled off of the *Modernizing Our Drug &
Diagnostics Evaluation and Regulatory Network Cures (MODDERN Cures) Act* of
2013, a piece of legislation heavily advocated for by the pharmaceutical
manufacturer Eli Lilly
<https://lillypad.lilly.com/page.php?name=moddern-cures>.

In particular, Hatch and Bennet's legislation is essentially Title II of
the *MODDERN Cures Act*—"Capturing Lost Opportunities for Patients," which
also establishes the Dormant Therapies designation.

Sponsors, including Lilly, have said the bill would help drive development
of new drugs for treatments that lack adequate treatment options. "The *MODDERN
Cures Act* would align the patent term and data protection period at the
FDA approval date for these dormant therapies," Lilly explains on its
website. "This will help provide companies with the incentive to pursue the
best medicines, not just the medicines with the best patents."

That legislation, however, has come under fire by some critics
<http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/06/will-more-marketing-exclusivity-be-the-21st-century-cure-hearing-witnesses-debate-incentives.html>
as
being overly generous. In particular, critics have targeted the
legislation's proposed 15 years of marketing exclusivity, which would be
provided to any product intending to treat a disease for which there is
"one or more unmet need." That, as it turns out, is quite a large number of
diseases. In fact, many of the drugs FDA already approves each year as new
drug products would be eligible for the "dormant" exclusivity, which is
considerably longer than the current periods of exclusivity afforded to new
drugs (e.g. 5 years for new drugs, 3 years for new uses for old drugs, 7
years for orphan drugs, and 12 years for biologics.)

That has some advocates worried that the added exclusivity could be used to
maintain high drug prices for years, all without the threat of generic
competition. Provisions of the bill also provide added protections to
drugmakers' patents, potentially making them even more difficult to
challenge.

Despite its critics, the *MODDERN Cures *bill has proven popular in
Congress. The bill now has 91 co-sponsors from both sides of the political
aisle, though it has thus far not been voted on.



*Dormant Therapies Act*
<http://www.hatch.senate.gov/public/_cache/files/634caf10-ff8f-448e-8f8a-3e34ea38707d/Dormant%20Therapies%20Act.pdf>*
(S.3004
<https://www.congress.gov/bill/113th-congress/senate-bill/3004/text>)*

Hatch, Bennet Introduce Dormant Therapies Act
<http://www.hatch.senate.gov/public/index.cfm/releases?ID=a8f7bd9c-291b-4e88-98c3-8a9cf4eefd21>

MODDERN Cures Act of 2013
<https://www.congress.gov/bill/113th-congress/house-bill/3116/cosponsors>
- See more at:
http://www.raps.org/Regulatory-Focus/News/2014/12/12/20974/Senators-Call-for-15-Years-of-Marketing-Exclusivity-for-Some-New-Drugs/#sthash.sjmOQTIS.dpuf

On Wed, Nov 26, 2014 at 6:26 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
> _______________________________________________
> Ip-health mailing list
> Ip-health at lists.keionline.org
> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>



-- 
Reshma Ramachandran
Harvard Kennedy School of Government '15
Warren Alpert School of Medicine at Brown University '15
National Physicians Alliance FDA Task Force Co-Chair
m: 786-271-1531



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