The Protection of Data
Submitted to Drug registration
Authorities
Workshop for the GCC on the Protection of
Invention in the Pharmaceutical Sector, Patents,
Undisclosed Information and Health Policies
Riyadh, Saudi Arabia
15-16 October
2012
Marco Aleman,
Deputy Director, Patent Law Division, and Head, Legislative and
Policy Advice Section, WIPO,
Giulia Ragonesi, Consultant, WIPO
Drug Discovery Process*
Drug
Discovery
Pre
Clinic
al
CLINICAL TRIALS
5 -3
compounds
5000-10000
compounds 250
NDA
One
approv
ed drug
Phase Phase Phase
1
2
3
VOLUNTEERS
20-100
3-6 years
* Pharma 2008
100-500
10005000
6-7 years
0,5-2
years
Postmarketin
g
surveillan
ce
LIFE CYCLE OF A DRUG*
literature
know-how
education
funding
Research
Basic
research
Applied Applied Pre-Clinical
research research research
equipment
Biological
model
time
biological
materials
bioinformatics
data
Development
Conception
publication
Reduction
to practice
(in vitro)
Patentee
Generic
Commercialization Commercialization
Clinical
trials
Generic
Testing
1st
2nd
Animal
Regulatory
clinical clinical
tests
approval
trial
trial
positive
(country by
positive positive
country)
patent
application
safety
efficiency
Generic
drug
available
(patent expires
or invalid)
sales
bioequivalent
3-10 years
patent
prosecution
New delivery system
exclusive rights
patent issuance
(country by country)
20 years +
New method of use
* Generic Drugs, Compulsory Licensing, and other Intellectual Property Tools for Improving Access to Medicine,
Michael A. Gollin, 2001
drug
available
Test data for pharmaceuticals
Undisclosed
Expensive to produce
Necessary to prove safety and efficacy for a drug
Need to consider the originator’s efforts in developing
this data (in terms of time, human resources and
financial investment)
Protection?
Which kind of protection?
Test data Protection: sui generis system
Article 39.3 TRIPS Agreement
“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”
Main aspects of data protection under
TRIPS Agreement
Open provision of law Negotiation history
Insertion in the part dedicated to undisclosed information and unfair
competition ( but not required evidence of fraud, deceit and
dishonesty)
Main aspect:
- test data obtained with a considerable effort
- data related to pharmaceutical and agro-chemical products only
- need of obtaining a marketing approval
- new chemical entity (NCE)
- protection against disclosure and unfair commercial use
- No mentioned explicitly exclusivity data protection
Patents
Trade
Secrets
Data protection
Data exclusivity
Protects
Products and
processes
Undisclosed
information
Data related to
pharmaceutical
or agrochemical
products NCE
Data related to
pharmaceutical or
agro-chemical
products NCE
Against
Not authorized
use by third
parties
- Disclosure
- Unfair
competition
- unfair
commercial use
- disclosure
grant of an
authorization to a
second applicant
based on the same,
previous data
Period
20 years
no limit
No limit
5 to 10 years
- Secret
- Measures
to keep it
secret
- Economic
value
- Undisclosed
- Considerable
efforts
- NCE
Authorization to
market
Requireme Novelty,
nts
inventive step,
industrial
applicability
Balance of two sets of interests
- Protection of efforts to
create data
- Keep it secret
- No! Need to reproduce data
already available
-disclosure to the public for
reasons of transparency
Protection against unfair commercial use (1)
“Unfair”: meaning more extend in comparison to “unfair”
competition embraces the notion of enrichment without
a cause (free-riding situations)
- free riding by competitors (not by everybody) - freeriding in the business world intrinsically dishonest
“Commercial”: usually refer to the “pertaining to
commerce or trade” and “looking toward financial profit”
 But: competitors are not in possession of this data,
only Governments  Which is the commercial use they
can make it?
Protection against unfair commercial use (2)
“Use”: The act of putting something to work, or
employing or applying a thing, for any (esp. a beneficial
or productive) purpose (Oxford English Dictionary) 
something different from exploitation (use direct to profit)
Consequences: a theory argues that “unfair commercial
use” possible under this provision might be constituted
by relying on the test data by the RRA  But: this hasn’t
been explicitly excluded by Article 39.3 TRIPS
Options to protect test data at legislative
level
Obligation of the Regulatory Review Authority to keep
secret the information. Other aspects to take into
consideration are the possibility by the RRA to rely on
the test data already in its possession in case of
application for a generic drug and remuneration to the
innovator in case of use by third parties.
Obligation to keep secret the information and determined
period of time during which the data cannot be used by
the RRA to grant authorization to a subsequent generic
drug for a certain period (data exclusivity regime)
Data protection: remuneration
No! Provided in Article 39.3 TRIPS  left to Member states which
decide to provide for it
Right of remuneration  intrinsic public nature of the interest
involved (argued that originators are not philosophically or ethically
endowed with the right to say no)
Argued in doctrine that it should take into account different values:
- cost to create the data
- opportunity costs
- economic and scientific value
- profit
Canadian Federal Court of Appeal, Bayer v.
Canada (Attorney General) (1)
NAFTA Article 1711: data exclusivity for at least 5 years
Federal Court:
Filing of an Abbreviated New Drug Submission (ANDS) by a generic
manufacturer  safety and effectiveness may be demonstrated by
showing that the product is the pharmaceutical and bioequivalent of
the innovator’s product  no! need to examine or rely upon the test
data of the innovator
If safety and effectiveness of the product can be established only by,
implicitly or explicitly, examining and relying upon the confidential
data  yes! Data exclusivity
Bioequivalence and bioavailability studies safety and
effectiveness are proved*
*Critical to this decision: in any case a comparison with the innovator’s data has to be carried out so
always data exclusivity protection
Undisclosed data
Test data: protectable as far as it is secret
Art. 39.2 TRIPS: undisclosed information (secret,
measures to keep it secret, commercial value)
Nothing to do with the novelty of the chemical entity
New Chemical Entity (NCE) (1)
No definition in the TRIPS But: different from the novelty
requirement for patentability
Possible interpretations:
- new application in the pharmaceutical sector of a product already
known in another field;
- « New »: first application in the world/in the country
“innovative drug” means a drug that contains a medicinal ingredient
not previously approved in a drug by the Minister and that is not a
variation of a previously approved medicinal ingredient such as a
salt, ester, enantiomer, solvate or polymorph. (Canada, Data
Protection Regulation (DPR), C.08.004.1)
« the designated therapeutic moiety, that has not been registered in
a region or Member State (also referred to as a new molecule entity
or new chemical entity). It may be a complex, simple ester, or salt of
a previously approved substance. (US Department of Health and
Human Services of the Food and Drug Administration, Federal
Register, vol. 62 No. 227 of 25711/1997)
New Chemical Entity (NCE) (2)
Products incorporating a NCE:
- a new pharmaceutical product is one that does not contain a chemical entity that
has been previously approved in the Party for use in a pharmaceutical product(…) –
Art. 14.9 .1 c) FTA USA-Baharain- a new pharmaceutical product is one that does not contain a chemical entity that
has been previously approved in the territory of the Party for use in a pharmaceutical
product – Oman, Article 15.9 of the USA-OMAN FTA
Old + new = old.
- “pharmaceuticals or chemical agricultural products which contain new chemical
substances” – Iraq, Coalition Provisional Authority Order Number 81- 
old + new = new
- «pharmaceutical or of agricultural chemical products that utilize new chemical
entities” – Jordan, Article (8) Unfair Competition Law - old + new = new
Considerable effort
No definition in the TRIPS Agreement
purpose: protect the investment made in producing test
data
Avoiding free-ride  no! Characteristics of IP rights
(protection of human ingenium through exclusive rights)
Unfair competition not only fraudulent behavior, but
also taking advantage of a given situation
Take into account both costs and intensity of the efforts
Decisions taken on a case by case basis by Member
States
Approval of the relevant chemical entity
Data protected as far as the authorization for marketing is
granted
Unapproved products no! Commercial interest
Astrazeneca A/S v. Laegemiddelstryrelsen, C- 223/01:
Danish Order No.165/95 on marketing authorizations for
medicinal product
“applicants do not need to submit toxological,
pharmaceutical and clinical documentation referred to point
9 of Paragraph 3 if they show that one of the following
conditions is satisfied: (…)
The medicinal product in respect of which has been
approved in the Community, under the legislation in force,
for at least six years, and marketed in Denmark
Products: has to be put into the market? But: still actual
market? If teh originator withdrew the marketing
authorization?
ECJ: it is necesary and sufficient that the marketing
authorization of the reference medicinal product be ni
force in the Member State concerned on the date of that
application.
Exceptions and limitations to rights
conferred (1)
Fair use of test data
- avoid the repetition of test data that cause suffering on humans
and animals
- compulsory licensing
- obtaining the data caused suffering on humans and animals
- cases of extreme urgency
-product not commercialized within a certian period of time
- originator found liable of anticompetitive practices
- test data necessary for the marketing approval of patented
product subject to compulsory license
Exceptions and limitations to rights
conferred (2)
Example: Regulations for the protection of Confidential Commercial
Information of May 5, 2005, Article 6 (Saudi Arabia)
The competent registration authority – during the protection term of
commercial secret – may permit third parties to use the undisclosed
data of secret tests submitted by another applicant in the following
cases:
(1) If the product first registered in the Kingdom has not been
subject to trading within a reasonable period of time determined by
the registration authority, after approving its marketing
(2) If this is required by a pressing necessity determined by the
competent authority to protect public.
Thank you!