Download Overview of Data Exclusivity and Patent/Registration Linkage

Overview of Data
Protection, Data Exclusivity
and Patent/Registration
Linkage
Prof. Brook K. Baker, Health GAP
Northeastern U. School of Law, Program on
Human Rights and the Global Economy
UKZN IPR/A2M 2010
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Introduction to Data Exclusivity and
Patent/Registration Linkage Issues
Art. 39.3 – Data Protection.
TRIPS+ - Data Exclusivity and
Patent/Registration Linkage.
Successful resistance.
U.S. New Trade Policy on data
exclusivity and linkage.
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TRIPS Art. 39.3
SECTION 7: PROTECTION OF UNDISCLOSED
INFORMATION, Article 39.3:
Members, when requiring, as a condition of
approving the marketing of pharmaceutical or of
agricultural chemical products which utilize new
chemical entities, the submission of undisclosed test
or other data, the origination of which involves a
considerable effort, shall protect such data against
unfair commercial use. In addition, Members shall
protect such data against disclosure, except where
necessary to protect the public, or unless steps are
taken to ensure that the data are protected against
unfair commercial use.
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Art. 39.3 Has Limited Application
When is the data itself required?
What happens if the regulator relies on
the fact of registration elsewhere?
What are new chemical entities?
What is required if there is disclosed
data?
What does considerable effort mean?
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Art. 39.3 – What is “Unfair
Commercial Use”?
What do the words mean?
Where does the idea or legal doctrine come
from?
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Unfair Commercial Use
This provision has its origin in trade secret law.
Drug companies treat their clinical trial and other
data as confidential trade secrets.
U.S. law requires that information be treated
confidentially.
It is generally understood that trade secrets are
protected against commercial espionage.
Use or reference by a drug regulatory authority to
confirm the safety/efficacy of a follow-on product
does not entail unfair commercial use.
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Art. 39.3 Requires Protection
Against Disclosure
Countries must also protect such data against
disclosure, except where necessary to protect
the public.
When is disclosure required to protect the public?
Is mandatory, public reporting of clinical trial
results necessary to protect the public?
Does Article 39.3 say anything at all about
not registering generic equivalents or
checking the patent status of the first
registered medicine?
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What is Data Exclusivity?
Data exclusivity prevents a drug regulatory authority
from relying on clinical and other data provided by
the first registrant of a medicine, or
from relying on the fact of prior product registration
in that same country or elsewhere
in order to access the safety and efficacy of a
therapeutically equivalent follow-on generic medicines
so as to allow its registration and marketing.
The US seeks 5 years of data exclusivity for new
chemical entities plus 3 more years for new uses or
formulations.
Europe seeks 10 + 1 years.
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What is Registration/Patent
Linkage?
Patent/registration linkage prevents a drug
regulatory authority from registering a
generic equivalent of a previously registered
medicine if the patent holder of that
medicines makes any claim that the medicine
is patent protected.
Linkage, at a minimum, require notice to the
patent holder and a stay of registration
pending a court challenge.
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Why Do Drug Companies Want
Data Exclusivity and Linkage?
Drug companies spend significant $ on R&D for new
indications and formulations and think these
investments should be protected.
Drug companies often don’t file patent applications in
smaller and poor markets for unproven drug
candidates that have a .1% chance of being
marketed, and thus these drugs lack patent
protections.
Data exclusivity could be interpreted as offering such
complete protection that it prevents a product
produced according to a compulsory license from
being registered (EU standard).
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Add’l Reasons
Truly innovative medicines take a very long
time to come to the market thereby reducing
the period of patent protection (patent term
extensions help).
Evergreening strategies don’t always work
when patent standards are applied rigorously.
Biotech product are not always patentable
given exceptions from patenting life-forms.
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Why Do Drug Companies Want
Linkage?
Linkage rules could be interpreted to
interfere with the right to register a
generic equivalent during the entire 20year patent term even if the patent is
weak and even if a compulsory license
has been issued.
Linkage turns drug regulatory
authorities into patent enforcement
agencies.
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U.S. Practice – Data Exclusivity
Historically, U.S. had absolute data
exclusivity. Generics had to reproduce clinical
trials meaning that very few generics came to
the market
Hatch-Waxman Act gave first-registrant
patent extensions, limited but absolute data
exclusivity, and patent/registration linkage in
exchange for ending absolute data
exclusivity.
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U.S. Practice – Data Exclusivity
New chemical entities are entitled to five
years of data exclusivity.
Filing for registration during the five year
term is only allowed when claiming patent
invalidity or non-infringement and then only
after four years.
NDAs for new indications, new formulations,
and new combinations are ordinarily entitled
to three years of exclusivity if at least one
new clinical investigation is essential to
regulatory approval.
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U.S. Practice – Linkage
Orange Book patent/registration linkage
system:
Owners of registered medicines file all applicable
patent claims in the FDA’s Orange Book.
Generic applicants must allege no relevant patent,
patent expiration, or invalidity/non-infringement.
In the later case, the patent holder is notified,
given 45 days to file an infringement action, which
results in a 30-month interdict.
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European Practice
Europe historically had a 6-10 years of data
exclusivity.
Revised Directive 2004/27/EC introduced an
8+2+1 formula that grants absolute data
exclusivity for 8 years, allows early working
and registration during a two-year window
(but no marketing), and grants an addition 1
year of exclusivity for new therapies offering
significant clinical benefits compared to
existing medicines.
Although Europe introduced early working, it
still does not mandate linkage.
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Drug Companies Control the Timing
of Registration Applications
Drug companies currently exercise
complete control over their decisions to
register their products.
They register quickly in rich and big
market countries, but slowly or not at
all in poorer and smaller countries.
Prevailing data exclusivity rules contain
no incentives for early registration.
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USTR 2003 Special 301 Report
Highlights Data Exclusivity
“One ... key implementation priority that we have
focused on in this review is the implementation of
Article 39.3, which requires WTO Members to protect
test data submitted by drug companies to health
authorities against disclosure of that data and against
‘unfair commercial use’ of that data.
[T]he original applicant should be entitled to a period
of exclusivity ... . During this period of exclusivity, the
data cannot be relied upon by regulatory officials to
approve similar products.”
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2002-07 Special 301 Reports
Highlight DE & Linkage
Special 301 Watchlist Listings re DE
& Linkage
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30
25
20
Listings re DE & Linkage
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10
5
0
2002 2003 2004 2005 2006 2007
Even after signing the
Doha Declaration,
which guarantee the
right of access to
medicine for all, the
U.S. complained about
a lack of data
exclusivity and/or
patent/registration
linkage in 2002-2007
Special 301 Watch
Lists 134 times.
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US Trade Agreements Routinely Seek
Data Exclusivity and Linkage
Since 2000, the US has concluded FTAs that include data exclusivity
and linkage provisions with Australia, Bahrain, Chile, Columbia,
Jordan, Korea, Oman, Morocco, Panama, Peru, Singapore, and the
six Central American parties to CAFTA (Costa Rica, Dominican
Republic, El Salvador, Guatemala, Honduras and Nicaragua).
The US been negotiating similar terms with other countries, but
those FTA negotiations are either ongoing or temporarily
suspended:
Thailand
US-SACU (Botswana, Lesotho, Namibia, South Africa and Swaziland).
Malaysia
United Arab Emirates
The most recent FTAs involving Peru, Columbia, and Panama are
being renegotiated pursuant to the New Trade Policy, including on
data exclusivity and linkage issues.
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USTR/PhRMA Are Seeking Even
Stronger forms of Data Exclusivity
In some of its recent agreements, the USTR is
seeking protection for disclosed as well as
undisclosed data.
Some agreement apply to new pharmaceutical
products – broader than new chemical entities.
Some agreements seeks 3-year exclusivity for new
uses/formulations.
Agreements seek protection from reliance on the fact
of foreign registration.
Agreements seek absence of time periods within
which the product must be submitted for registration.
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EU is seeking data exclusivity in
its EPAs
Data exclusivity referenced in
negotiations with Andean countries and
India.
Length is not always clear, but
presumably 10 + 1 years.
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Activists fought against DE, linkage and
other TRIPS-plus provisions in Thailand
“Following a week-long
negotiation that fell
short of U.S. goals and
was marred by Thai
protests, the U.S. chief
negotiator said today
(Jan. 13) that the Bush
Administration needs to
reevaluate efforts to
negotiate a free-trade
agreement with
Thailand.” WSJ 1/12/06
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New Trade Policy for America (2007)
The New Trade Policy for America (May 11,
2007) included improved data exclusivity and
linkages provisions:
No mandatory patent-registration linkage
Tightened standards and limited concurrency for
data exclusivity and
An explicit exception to data exclusivity when a
compulsory license is issued or when access to
medicines is needed in a no-patent situation.
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Other Proposals for Taming Data
Exclusivity
Liability rule – royalties for data use/reliance
based on economic value, usually waived
where a compulsory license with royalties has
already been filed.
Express compulsory license and public health
exceptions, even in no patent situations.
Concurrency and sunset rules – use-it or loseit.
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It’s Better to Avoid Data
Exclusivity and Linkage Altogether
US and Big Pharma will continue to try to
seek data exclusivity and linkage through 301
Special Watch List, GSP
preferences/withdrawals, technical
assistance, commercial lobbying/
threats, and trade negotiations.
Fighting data exclusivity and linkage is
important for access to medicines and should
be a priority for A2M activists.
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