Transcript The economic importance of industrial property

INTERNATIONAL CONFERENCE ON
INTELLECTUAL PROPERTY IN THE
PHARMACEUTICAL INDUSTRY
Warsaw, April 24, 2009
Patents for Pharmaceuticals
Products - Legal options and
flexibilities
WIPO Secretariat
Leading products in 2005 by global
pharmaceutical sales**
Rank
1
2
3
4
5
6
7
8
9
10
Audited World
Product Sales
%
Growth
(constant
$)
Lipitor
$12.9bn
+6.4%
Plavix
5.9
16.0
Nexium
5.7
16.7
Seretide/Advair
5.6
19.0
Zocor
5.3
-10.7
Norvasc
5.0
2.5
Zyprexa
4.7
-6.8
Risperdal
4.0
12.6
Ogastro/Prevacid
4.0
0.9
Effexor
3.8
20.1
Source: IMS MIDAS Quantum, MAT December 2005
**Note: excludes unaudited markets
2005
sales
($bn)
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
exclusive rights
patent issuance
(country by country)
20 years +
New delivery system
New method of use
* Generic Drugs, Compulsory Licensing, and other Intellectual Property Tools for Improving Access to Medicine,
Michael A. Gollin, 2001
drug
available
Patents to Pharmaceuticals in the
international context
 The Multilateral Context:
1. Paris Convention
2. Trips Agreement; and
 The Bilateral Context
The Paris Convention and the asymmetries
Some developing countries had excluded from
patentability pharmaceutical products, without any
challenge to the Paris Convention (Art. 4 bis, 4 ter, 5,
5 ter).
This situation that has been gradually changing due
multilateral commitments that were adopted in the
framework of the TRIPS Agreement or because
unilaterally some countries decided to do so.
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TRIPS AGREMMENT
 Patentable Subject Mater. Art. 27. 1), 2) y 3)
-
-
Ordre public or morality
Diagnostic, therapeutic and surgical methods (Art.27.3 (a))
Plants and animals (other than micro-organism) and
essentially biological processes for the production thereof
(other than non-biological and microbiological)
second uses of known substances; (Art. 27.1)
 Delay product protection (Art.65.4)(LDC Art.
66.1)
 Exceptions to rights Conferred (Art. 30)
 Other uses without authorization (Art. 31)
Doha Declaration on TRIPS and Public Health
 “We recognize that intellectual property protection is important
for the development of new medicines. We also recognize the
concerns about its effects on prices”
 “We agree that the TRIPS Agreement does not and should not
prevent Members from taking measures to protect public
health. Accordingly, while reiterating our commitment to the
TRIPS Agreement, we affirm that the Agreement can and
should be interpreted and implemented in a manner supportive
of WTO Members' right to protect public health and, in
particular, to promote access to medicines for all”.
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Doha and Public Health.
Decisions of the WTO Bodies
Decision of the Trips Council of 1 July 2002 for the
extension of the transition period (Art. 66.1) for Least
Develop Countries respect to pharmaceuticals
products (2016)
Decision of the Trips Council of 8 July 2002, which
waive for least Developed Countries the obligation
under paragraph 9 of article 70 (2016)
Decision of the General Council of 30 August 2003
for the implementation of the paragraph 6 of the Doha
Declaration
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Patents to Pharmaceuticals in the bilateral context
(USA bilateral Agreements)
Pending Congressional Approval
Colombia Panama Republic of Korea
In Force
Israel NAFTA Jordan Chile Singapore Australia
Morocco Bahrain
Pending Implementation
Peru Oman
Other FTA Negotiations
Malaysia Thailand SACU UAE
Patent provisions on recent U.S. FTAs
US-Chile
US-Australia
US-Singapore
Patent term
Extension given for delays caused by regulatory approval process (pharmaceuticals).
In addition, extension given when a delay in the granting of the patent exceeds four years from the filing of the application (five years
for US- Chile) or two years after a request for examination ( three years for US-Chile). In the case of Singapore when decision is taken
on the basis of the examination conducted in another Country, if in the later extension is granted, them it could be also extended up
to five years
Second-use
patents
No specific provision
Obligation to provide patens for new uses of
known products
No specific provision
Patenting of life Best efforts to pass legislation
forms
on the protection through patents to
plants
Exclusions only allowed for ordre public or
morality and diagnostic, therapeutic and
surgical methods.
Each party may exclude only as defined in Art 27.2
and 27.3.(b)
Compulsory
Licenses
Compulsory licenses limited to cases in which is a remedy to anti-competitive practice or
national emergencies or other circumstances of extreme emergency and for public
non-commercial use (conditions see Art. 17.9.7.(b)). In particular (iii).
No specific provision
Parallel imports No specific provisions
of
patented products
Patent holders may limit parallel imports
through contracts or other means
Cause of action to prevent or redress the
procurement of patented pharma Product by a
person that knows that the product is distributed
in a breach of contract (in the territory or outside)
Regulatory
si
review exception
Si, if consistent with paragraph 3
(exceptions)
si
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Democrat's wish to incorporate key priorities on
IP in FTAs (letter March 12 to USTR) The
proposal
Data protection. The inclusion of caps in the periods
available; measures to facilitate the approval of generics to
stimulate competition.
Patent extension. To limit the total duration permitted.
Linkage. To mitigate the burden on the regulatory authorities,
like the obligation to withhold the approval if a patent could
be violated.
Compulsory licensing. Recalled each country freedom to
determine the grounds upon which such licenses are granted.
Avoid the use of side letters which are “non binding to the
parties”.
Consumer safeguards. Bolar provision; the applicant
indications of the best mode to reproduce the invention and
measures to avoid evergreening patents.
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The Agreement (just for pharmaceutical
products).
DATA EXCLUSIVITY. Five years of data
exclusivity for NCEs, considering the nature of the
data and efforts and expenditure. If the parties
grants the approval within six months when relying
in FDA approval, the terms will count from them
(concurrent period).
PATENT EXTENSIONS. The obligation “shall”
would be changed to “May”. Cooperation and
assistance to avoid “unreasonable delays” is
envisaged.
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The Agreement (just for pharmaceutical
products). Cont…
 THE LINKAGE. There is no obligation to establish a linkage
between drug regulatory agencies and patent issues, particularly,
no requirement that the agency withhold approval of the generic
until it can certify that no patent would be violated.
 NEW KING OF LINKAGE. The party would be required:
1. to provide procedures and remedies (judicial or administrative)
and preliminary injunctions (equivalent) do dealt with patent
infringement and validity disputes; and
2. A transparent system to give patent holders sufficient time and
opportunity to enforce their rights (notifications, website info, etc).
 LINKAGE OPTION. A party can be free to chose to fulfill this
obligations (procedures and remedies) through a linkage system, if
at the same time: adopt an expeditious system to challenge the
validity or the infringement of a patent and a system to reward to
those who successfully challenge a patent.
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IP DECISION TREE FOR ACCESS TO
ESSENTIAL DRUGS*
Subject to Regulatory Drug
Approval
N
Y
Make it
Non-infringing version available?
N
Comply with Approval Regulations
Y
Patent Invalid?
AND
N
Make it
Y
Patented in country X?
N
Y
Negotiate
1) Negotiate; 2) Litigate-challenge in Country X
License
Patentee offer
Available to purchase
Patent Term
at low price?
Short? Long?
N
High?
Slow?
Y
Get ready to Jump in!
Compulsory
License Available?
- Law is in effect and
Y
is applicable?
N
Government
License
Support Generic Manufacturing
Buy License
Y
Take compulsory license
Buy and Distribute Once Approved as a Drug
*Generic Drugs, Compulsory Licensing, and other Intellectual Property Tools for Improving Access to Medecine, Michael A. Gollin, 2001
Thank you!
Marco M. Aleman
Deputy Director, Division for
Public Policy and Development
[email protected]
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