Transcript BEIJING CHICAGO DALLAS FRANKFURT GENEVA HONG KONGHONG LONDON LOS LONDON ANGELES NEW PALO ALTO SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. BEIJINGBRUSSELS BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA KONG LOS YORK ANGELES NEW YORK PALO ALTO SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY Test Data Protection Overview Jeffrey P.

BEIJING
CHICAGO
DALLAS
FRANKFURT
GENEVA HONG
KONGHONG
LONDON
LOS LONDON
ANGELES NEW
PALO ALTO
SAN FRANCISCO
SHANGHAI
SINGAPORE SYDNEY
TOKYO
WASHINGTON,
D.C.
BEIJINGBRUSSELS
BRUSSELS
CHICAGO
DALLAS
FRANKFURT
GENEVA
KONG
LOS YORK
ANGELES
NEW YORK
PALO ALTO
SAN FRANCISCO
SHANGHAI
SINGAPORE
SYDNEY
Test Data Protection Overview
Jeffrey P. Kushan, Washington, D.C.
On behalf of the Biotechnology Industry Organization (BIO)
TOKYO
WASHINGTON, D.C.
What is Test Data?
• Data generated from testing of a regulated product to
ensure the product may be safely used and is effective
 Test data is generated by rigorous, comprehensive and
controlled scientific experiments
 Test data provides objective evidence about safety and
effectiveness of the regulated product
• Test data helps protect the public health
 Regulated products may not be marketed without approval by
government regulatory authority
 Test data is used by regulatory authorities to independently
determine that a product is safe and effective before it is placed
on the market and used by patients
2
Examples of Regulated Products
• TRIPS identifies two categories of regulated
products that are entitled to protection
 “Pharmaceutical products”
• Drugs: small chemical molecules
• Biological products: large chemical molecules such as
proteins made by biotechnology, vaccines
 “Agricultural chemical products”
• Pesticides and Fertilizers: chemical compounds used in
agricultural applications
Source: TRIPS Agreement, Article 39.3.
3
Generating Test Data is Risky,
Expensive and Time-Consuming
• New therapeutic agents
 On average, it costs US$ 1.2 to 1.3 billion* and 10-15 years to bring a
pharmaceutical product having an “active ingredient” that has never
been approved (i.e., a “new chemical entity”) to market
 Greater than 90% of products in development fail before getting to
clinical trials, and only 30% of those entering clinical trials are approved
 Clinical testing in humans is a significant contributor to cost and
complexity of pharmaceutical development and clinical data generation,
with scale of testing often thousands of patients over many years
• Agricultural chemical products
 New agricultural chemical entities typically cost more than US$ 200
million to bring to market
4
Sources: Dimasi et al., Manage. Decis. Econ. 28: 469–479 (2007); www.croplife.org.
*These figures incorporate the costs of failed efforts to bring a new product to market.
The Pharmaceutical Test Data Dossier
• A compilation of data and reports describing the
pharmaceutical product, including:
 Pre-clinical evidence, including from analysis of the components of the
product (e.g., the active ingredient) by in vitro and animal testing
 Clinical evidence, including data from well controlled clinical
investigations that evaluate effects of administering the product to
individual human subjects, and summaries and analysis of such data
 Manufacturing information and data, including a description of the
product, its components and properties, how the product is made,
manufacturing batch records showing consistency and variations in the
production of the product, etc.
 Other evidence, both from public literature and non-public sources,
relevant to safety and effectiveness of the product
Source: 21 U.S.C. 355(b)(1) [§ 505(b)(1)]; also, 21 C.F.R. § 314.50, which sets forth the
specific requirements of a new drug application before the FDA.
The Pharmaceutical Test Data Dossier
• Some information in the dossier cannot be publicly disclosed
 Personal privacy restrictions prohibit disclosure of information
concerning the experiences of patients who participated in the studies
 Trade secret rights exist in various portions of the dossier, particularly
manufacturing information
• Clinical data for biologics is linked to the particular method used to
make the biological product
 During pendency of its review, the dossier as a whole is handled as
confidential business information
• The regulatory authorities will base their decision to approve a
new pharmaceutical product on the dossier considered as a
whole, not on discrete or isolated elements of the dossier
How is Test Data Protected
from Unfair Commercial Use?
• By providing a period of time during which a regulatory
authority will not rely, directly or indirectly, on the innovator’s
test data to support approval of a third party application
• Regulatory agencies rely on an innovator’s test data if they
base their decision to approve a third party application on:
 A review of the data in the innovator’s dossier
 An earlier approval by the same agency of the innovator’s application,
or findings on the safety or effectiveness of the innovator’s product
 An earlier approval by another agency of the innovator’s product, or
that agency’s findings on safety or effectiveness, or
 Published summaries of the test data (e.g., information in the approved
prescribing instructions for the product)
Market Dynamics Where Data Protection
Is Provided to Innovators
• During the data protection period, the innovator’s product
competes with different products that can be used to treat the
same disorder or disease
 Regulatory authority can approve other products supported by
complete dossiers of independently generated clinical data
 Intense competition from different products in this period – on
average, new innovator products enter market within 2.5 years
of market introduction of first innovative product*
• After the data protection period ends, the innovator’s product
competes with generic or biosimilar products
 Regulatory authorities can approve abbreviated applications that
reference the innovator product, leading to less expensive versions
• Both forms of competition benefit public health
* Source: Tufts Center for the Study of Drug Development, CSDD Impact Report,
“Marketing exclusivity for first-to-market drugs has shortened to 2.5 years,” 11(5) (2009).
Public Health Benefits of
Test Data Protection
• Encourages companies to conduct initial clinical
testing of new* pharmaceutical products
 Provides regulatory authorities the objective scientific evidence
needed to evaluate and justify approval of new pharmaceutical
products
 Provides benefits to patients by encouraging clinical testing of
new drugs, regardless of patent status, for use in treating unmet
medical needs
 A “new chemical entity” is an active ingredient that has never
been approved by the regulatory authority of the country for use
in the same type of product
Public Health Benefits of
Test Data Protection
• Encourages additional clinical testing of an approved product
to enable use in treating other diseases
 Many pharmaceutical products can treat multiple diseases, but each
new use requires independent clinical proof of effectiveness and
safety
 Experience shows that companies conduct extensive additional clinical
research to support new uses of approved pharmaceutical products
during the period of data protection
• Experiences with biologics approvals in the United States:
 47% of approved rDNA and monoclonal antibody products have been
approved for at least one additional disease/disorder beyond the
original indication
 One third of the new indications for these products were approved
more than 7 years after the first approval
10
Source: Said et al., Continued Development of Approved Biological Products, Boston
Consulting Group, White Paper (Dec. 2007)
Public Health Benefits of
Test Data Protection
• Enables lower cost, safe and effective generic and
biosimilar products to be brought to market
 Products can be approved on the basis of an “abbreviated”
application not having a complete dossier of clinical evidence
• A generic drug must have the identical active ingredient and exhibit
the same behavior in the body
• A biosimilar product cannot be “identical” to the innovator product,
and requires additional clinical evidence to support approval
 Generics and biosimilars are produced for a defined and
existing market, have a far lower risk of failure of development,
and a significantly reduced cost of development relative to
innovator products
Phases of a Pharmaceutical Product
Pre-Clinical
Abbreviated
Approval Possible
Clinical Development
Third Indication
Second Indication
First Indication
Start of Clinical
Investigations
12
Data Protection Period
First
Approval
Second
Approval
Third
Approval
Two Different Obligations in
TRIPS Article 39
• Article 39.2
 Requires laws/regulations that enable private parties to prevent
unauthorized disclosure of their “confidential business
information” (i.e., trade secret protection) by any entity,
including government agencies and employees
• Article 39.3
 Requires measures that prevent a regulatory authority from
making “unfair commercial use” of undisclosed test or other
data provided to the authority to support grant approval of the
innovator product
13
Article 39.3 Imposes Distinct Obligation
Beyond Non-Disclosure
• If Article 39.3 only imposed obligation to not
disclose confidential information, it would be
redundant with obligations of Article 39.2
 Separate and distinct provisions in an international agreement
are presumed to impose distinct obligations
• Second sentence of Article 39.3 requires protection from
unfair commercial use even if a Member requires
disclosure of some of the “protected” test data for
reasons necessary to protect public health
 Regulatory authorities often require a summary of the clinical
trials to be included in the prescribing instructions for the
product, and make other clinical trial information available online
What is “Unfair Commercial Use”
• Something that provides an unfair commercial
advantage to one entity at the expense of another
 A regulatory agency’s conclusion that a generic or biosimilar
product is safe and effective product is necessarily based on
the test data dossier supporting approval of the referenced
innovator product
 The regulatory authority thus “uses” the referenced innovator’s
test data dossier to justify approval of an abbreviated application
referencing an innovator product
 Allowing a generic or biosimilar product to enter the market too
soon after the referenced innovator product has been launched
constitutes an unfair commercial use of innovator’s test data
The Unique Bifurcated U.S. System
• New and generic “drugs” regulated under the § 505 of
the Federal Food Drug and Cosmetic Act
 “Drugs” generally have a “small molecule” active ingredient
 Abbreviated New Drug Application (ANDA) may not be filed for
a period of 5 years from original approval of new drug, unless it
contains a patent challenge, in which case it may be filed 4
years after approval
• If ANDA filed during fourth year, FDA may not approve the ANDA
until 7.5 years after NDA approval
• ANDA approvals take on average 2 to 2.5 years from filing to be
approved.
 Effectively, U.S. provides 7.5 years of data protection from the
approval date of a new drug application
16
Source: 21 U.S.C. § 355(b)(1) (new drug applications); § 355(b)(2) (other applications
referencing earlier approval); § 355(j) (abbreviated new drug applications)
The Unique Bifurcated U.S. System

Biological products are regulated under § 351* of the
Public Health Service Act
 No current abbreviated pathway for approving biosimilar
biological products
• Each application (BLA) must be supported by independently
generated clinical data
• This means these products presently have an infinite period of data
protection
• Pending legislation
 Biosimilar legislation that has passed the relevant House and
Senate Committees would provide 12 years of data
protection, plus an additional 6 months for pediatric studies
17
Source: * 42 U.S.C. § 262; ** H.R.
European Practices
• Drugs and biological products are regulated under a
single legal regime in the centralized approval
procedure of the European Medicines Agency
 Single legal regime applies to both “small molecule”
drugs and “large molecule” biological products
 Effective period of data protection for both types of
products is 10 years, which may be extended to 11 if
a new indication representing a significant clinical
benefit in comparison with existing therapies is
approved within 8 years of original approval
18
Market Incentives Provided
by Test Data Protection
• Providing test data protection encourages innovator
companies to enter and participate in markets, which
increases the likelihood of:
 Earlier launches of innovator products in the market, given the
increased prospect for commercial success in that market
 Improved education among caregivers about the
pharmaceutical product, its uses and its safety profile
 Entry of generic and biosimilar products once viable domestic
market for the innovator product has been established
 Domestic clinical investigations to evaluate new applications of
product or its therapeutic profile in the domestic population
19
Data Protection vs. Patents
• Two distinct and independent mechanisms
• Patents protect technological inventions, and
 Are limited to a specific technological advance, and measured
by novelty/inventiveness over public knowledge
 Enable owner to prevent unauthorized use of the invention
 Original patents often expire around time of product approval
due to extended period of development and clinical testing
 May not be available for new products that contain a publicly
known chemical compound, or for new uses discovered by
additional clinical research
 Often do not provide adequate commercial protection in
countries that do not have a long-established or robust patent
systems
Unique Features of Test Data Protection
• Test Data protection
 Is available even if the pharmaceutical product is not eligible to
be patented, which ensures there is an incentive to conduct
clinical testing needed to secure approval of new drugs and new
uses of drugs
 Only prohibits regulatory agency from relying on innovator’s
approval to approve another application – any entity can secure
marketing approval by supporting the application with a
complete and independently generated clinical dossier
 Provides greater certainty than patents, both in developed and
developing country markets, which functions to provide an
incentive for innovator companies to undertake risky, expensive
and difficult clinical testing of the product
Conclusions
• Test data protection systems
 Provide all countries with many important public health benefits
 Support competition by both product innovation and on price
• Test data protection under TRIPS must extend beyond
simply preventing public disclosure or theft of
confidential data in the test data dossier
• The only viable way to provide effective test data
protection is to defer the date on which a regulatory
authority may rely on a prior approval of an innovator
product to approve a generic or biosimilar application
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