Dr' Khawar Mehdi

1
INTELLECTUAL PROPERTY RIGHTS (IPRs) GLOBAL
RECOGNITION OF PATENT SYSTEM PAKISTANS
NATIONAL PHARMA INDUSTRYUNDER THREAT
Opportunities Threats for Pakistans
Pharmaceutical Sector under the WTO
Regime December 14, 2006

• Dr. Khawar Mehdi

2
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.

3
IPRs are sacred

• We, the national generic pharmaceutical industry
  respect IPRs
• However, Pakistans MNCs are pushing TRIPS and in
  the process seriously violating IPR regimes as
  laid down by TRIPS

4
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

5
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

6
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

7
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

8
Product Patent

• A product patent means the grant of a monopoly
  right to produce that productpreventing any
  other person from producing the same producteven
  by adopting a different or new process.
• Patents filed in Black box (post-1995) are
  product patents

9
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

10
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.

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Basic Facts About Off Patent Medicines

• Are clinically equivalent versions of RD
  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

12
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

13
Drugs are Distinct cannot be compared with
other forms of Intellectual Property- a unique
class of its own

• Aspirin
• Penicillin
• Tamoxifen
• Rifampicin

• Ferrari V 12 Engine
• Motorola Razor
• Boeing 767
• iPOD

VS
14
In USA where some of the richest RD 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.

15
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

16
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

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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

18
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

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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

20
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

21
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

22
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

23
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,

24
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.

25
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

26
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

27
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

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Thank you