INTELLECTUAL PROPERTY RIGHTS (IPRs)

GLOBAL RECOGNITION OF PATENT SYSTEM

PAKISTAN’S NATIONAL PHARMA INDUSTRY

UNDER THREAT

Opportunities & Threats for Pakistan’s

Pharmaceutical Sector under the
WTO Regime

December 14, 2006

Dr. Khawar Mehdi

 Background to TRIPS
 Pakistan became signatory to the TRIPS agreement in
1995.
 TRIPS grants 10-year transition period to developing
countries during which patents are filed in black box.
 Transition period for Least Developed Countries (LDCs)
extends to 2016.
 Pakistan is classified as developing country, not LDC.
 Prior to 1995, inventors filed patents in each country
individually.
 Prior to 1995, Pakistan granted process patents, not
product patents.
IPRs are sacred

 We, the national generic pharmaceutical industry

respect IPRs

 However, Pakistan’s MNCs are pushing TRIPS

and in the process seriously violating IPR
regimes as laid down by TRIPS
Looming Threat

 The unfair & inaccurate interpretation and

implementation of the spirit of TRIPS in Pakistan

 A disaster for:
a) People
b) Local Pharma
c) Government
d) All of the above
 A Pharmaceutical Patent is Different from
Other Types of Patents in many Respects

A New Pharmaceutical product Patent is supposed to:

 Improve quality of life

 Cure disease

 Save life

 Prevent illness from spreading

WHERE HUMAN HEALTH IS THE PRIMARY

BENEFICIARY
 In Pakistan our IPR law does not take
TRIPS articles 70(3) and 70(8) into account

 Article 70(3): Molecules that are available in the

public domain before 1995 are not required to be
covered under the product patent regime

 Article 70(8): All products (brands) that have been

launched prior to patent implementation (Jan 1,
2005) may continue to be marketed after
implementation of patent regime.

 Resultant litigation for products not covered under

TRIPS
 Process Patent
 “If the result of a new process is a new article
or a better article or a cheaper article than
that produced by an old method, that process
is patentable and is called the process
patent.”

 Patents filed prior to 1995 in Pakistan are

process patents
 Product Patent
 “A product patent means the grant of a
monopoly right to produce that product…
preventing any other person from producing
the same product…even by adopting a
different or new process.”

 Patents filed in Black box (post-1995) are

product patents
 Black Box Patent Rules in
Pakistan
 All international patents filed post-1995 are
called black box patents.
 Black box patents are applicable to all
countries that have signed TRIPS.
 In Pakistan, the black box was opened on
January 1, 2005.
 The products in black box will be processed
and granted patent protection.
 Black box patents are product patents
 Ever Green Patents
 There is a serious concern within the ranks of the
national pharmaceutical industry
 It is seriously felt that improper, ineffective, non-
comprehensive and ill-examination of Black Box
Applications will only result large number of product
patents thereby promoting the very concept of EVER
GREEN PATENTS as large number of Patent
Applications are believed to be mere repetition of old
and expired patents as has been done in the case of
Patent application for ROSIGLITAZONE and that of
MONTELUKAST.
 Basic Facts About Off Patent
Medicines:
 Are clinically equivalent versions of R&D medicines
 Are affordable
 Are quality medicines
 Carry a tradition of excellence
 Benefiting society
 Brining economic sense to pharmaceutical care
 Contributing to growth and employment
 Committed to the future
 Entire National Pharmaceutical Industry is based on
Off Patent Medicines
 Pharmaceutical patents are
distinct as they affect human life
 Pharmaceutical and Biotechnology products
claiming to improving the quality of Human
Health and Curing Disease can not be treated
at par with other products that humans use,
consume and depend on a daily basis
 Essentially and similarly a Drug Patent cannot
be treated at par with other patents with
reference to IPRs
 Drugs are Distinct & cannot be compared
with other forms of Intellectual Property
- a unique class of its own

 Aspirin  Ferrari V 12 Engine

 Penicillin  Motorola Razor
VS
 Tamoxifen  Boeing 767
 Rifampicin  iPOD
 In USA where some of the richest R&D
based Pharmaceuticals are based
Off Patent Drugs are thriving

 During 2003 -2005, off patent drugs growth reached

24% - compared with growth of ‘Brands' of just 8%
 Off patent drugs are typically a third to half the price
of new brand-name drugs and are underutilized.
 Off patent drugs make up about 45% of all
prescriptions.
 Each 1% increase in generic use that replaces
brands saves from $2.1 billion to $2.8 billion a year.
 US $ 55-65bn worth of drugs
would go off patent by 2007
 2001: Prozac, Buspar,
 2002: Glucophage, Prinivil, Augmentin
 2003: Prilosec, Topamax, Claritin, Ciprofloxacin,
 2004: Neurontin, Wellbutrin, Allegra,
 2005: Plavix, Biaxin, Pravachol, Zithromax, Zyprexa

 2006: Zocor, Premarin, Zofran, Norvasc

 2007: Zoloft, Lipitor, Zyrtec, Fosamax
 A Popular National Culture is
sensitive to the needs of the populace
and nation both
 Reflective of indigenous ground reality
 Have elements of growth and grooming
 Evolutionary
 Promoting merit
 Engaging the national mainstream
 Liberating us of any exploiting influences and
discourage Neo-colonial masters
 Enabling national agenda
Let us make sure that IPR laws will not end
up becoming a tool of EXPLOITATION by
vested interests

 It is extremely important that a fair and

leveled understanding is created by the state
to the advantage of all stakeholders, till the
system achieves equilibrium and is
competent and reflective of the indigenous
ground reality
 A Tacit Acknowledgement
 ---how national IPR rights could best be designed to
benefit developing countries. Inherent in that remit
was the acknowledgement that IPRs could be a tool
which could help or hinder more fragile economies.

Clare Short, the Secretary of State for International

Development in UK, who established the
Commission on Intellectual Property Rights in May
2001
 The fact of the matter is
 Insofar as their benefits outweigh their disadvantages,
the developed world has the wealth and infrastructure
to take advantage of the opportunities provided. It is
likely that neither of these holds true for developing
and least developed countries.

 Poor and developing countries may find them useful

provided they are accommodated to suit local palates.

Sir Hugh Laddie UK High Court Patents Judge

 IPRs are here to stay
 We respect IPRs, but it seems to us that they are neither the
problem nor the solution they are often portrayed to be. They are
themselves only tools
 How these tools are used is what matters:
 To use in humanitarian efforts to give developing countries better
access to the new life saving technologies and scientific
pharmaceutical developments
 Or to deprive them of these very life saving technologies and
steal them of their basic right to health
 The key is to match the proper IPRs with
 specific socioeconomic,
 technical,
 commercial,
 and administrative conditions with specific developing countries,
and manage them well
 Current Situation
 IPR LAWS IN PAKISTAN ARE TRIPS +++
 New ordinance is totally in favor of MNCs & is
being exploited by MNCs by filing DUAL
APPLICATIONS – 1 under regular system
and 1 under Black Box
 The Black Box examinations are not being
conducted according to the law
 Current Situation

The newly created IPO organization is a step in

the right direction. Equally important is the fact
that major reforms and structural changes
need to be taken at lower levels of the
organization and its reporting bureaucracy
Concerns Of National Pharma
Industry

The National Pharmaceutical Industry humbly

pleads, before it gets too late, that every effort
should be made to evade such eventualities. In this
regard few suggestion or recommendation are
submitted for a fair interpretation/clarification of
procedure of examination under the Patent
Ordinance 2000,
Concerns Of National Pharma
Industry
 We, therefore, cannot rule out the vital concern
expressed by many that after the acceptance of BLACK
BOX APPLICATION and/or product patent rights, drugs
which are being produced by national companies, would
go off the market, as provided under Section 22 of the
Patent Ordinance 2000. This would lead to a quantum
leap in drug prices as MNCs will use their patent
monopoly to hike up the prices for these drugs.
 Recommendations
 Review of IPR laws with specific relevance to the
development of Off Patent Pharma Industry
 Support the development of Governmental policies
which seek to ensure access to medicinal care for
all consumers
 Promote balanced and off patent/generic-friendly
intellectual property rights in the pharmaceutical
sector which ensure that timely access to Pakistani
market is guaranteed for off patent/generic
pharmaceutical products
 Recommendations
 Encourage the scientific development, professional
awareness and general knowledge of generic
medicines
 Promote the harmonization of departmental
regulations relating to generic products
 Provide guidance to national organizations and
Pakistan government in improving the regulatory
and legal expertise relating to the registration and
marketing of generic medicines
 Recommendations
 Review, fair interpretation & accurate implementation of
IPR laws in order to promote balanced and generic
friendly IPR environment for the pharmaceutical industry
in Pakistan
 IPO office is a positive development and its priority
should be to save the national pharmaceutical industry
from being take advantage of by the MNCs, without
negating the spirit of TRIPS