Patents and Medicines:How the system has

discouraged innovation and reduced patient access to

benefits of knowledgeGREG PERRY

Director General, EGAWorld Science Forum

Budapest 10-12 November 2005

Medicines Applying Scientific Knowledge for Mankind

1. Medicines are an important example of where the development of knowledge and application of science can bring major benefits to humankind

2. Two principal sectors

Originator to develop and bring to market innovative patented products based on new investigation and knowledge

Generic to increase access to medicines, stimulate innovation through competition, and provide financial headroom for purchasing new medicines. Off–patent based on well-established use and public right to use prior knowledge.

Global Healthcare Challenges Needs a Responsible Solution

1. Ageing populations – requires measures to ensure sustainable healthcare

2. Population increases and growth of diseases e.g. Aids – Depression – Coronary Diseases - requires greater access to medicines worldwide

3. Increasing resistance to established therapies - TB anti-bacterial resistance - requires the development of new medicines

4. Lack of purchasing power in developing countries for critical patented medicines - requires new structures for access to medicines

EU’s Ageing Population and Sustainable Healthcare

50

75

100

125

150

175

200

225

250

2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050

Elderly

Working age

Employment

Expenditure on Healthcare in Relation to Age

Source: Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations

Belgium

Denmark

Germany

Spain

Spain

France

France

Italy

Netherlands

Austria

Austria

Finland

Sweden

United Kingdom

United Kingdom

0

5

10

15

20

0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94 95+

Age groups

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P p

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IP Knowledge, Ethics and Responsibility - a Balance

Healthcare challenges create critical role for both originator and generic producers of medicines

Consequently, it also requires a careful balance of the IP rights of medicines based on public interest and healthcare requirements

Increasing Access

Increasing Innovation

IP – Must Stimulate Real Advances in Knowledge and Patients Access

Whilst patents are important for encouraging innovation, excessive, frivolous and/or easily - granted patent rights will

a) Restrict access - by preventing generic competition

b) Discourage innovation - by allowing development of products of insignificant value to patients, and it delays research into real innovation

Pharma Properties Eligible For Patenting

1980s (5 properties)

1. Primary uses2. Processes and

intermediates3. Bulk forms4. Simple formulations5. Composition of matter

1990s (18 properties)

1. Primary uses2. Processes and

intermediates3. Bulk forms4. Simple formulations5. Composition of matter6. Expansive numbers of

uses7. Methods of treatment8. Mechanism of action9. Packaging 10. Delivery profiles11. Dosing regimen 12. Dosing range13. Dosing route 14. Combinations15. Screening Methods16. Chemistry Methods17. Biological Target18. Field of use

Source: “Evolution of IPR & Pharmaceutical discovery and Development”, Eric Larson, Sr Director, Groton Site Head, Pfizer Global Research & Development.

Viewed on 9/112005 at: http://www7.nationalacademies.org/step/Larson_ppt.ppt

Patents For Protection Not For Innovation

By changing the salt or ester in the chemical make-up of an active agent immediately prior to the market release, the originator company can present old products as “new” and create a new market to effectively prevent generic competition with no benefit to patients

Patenting various – and often insignificant – new

versions for older medications is used to

create a complex array of IP protection to block

registration of generic versions

Increasing IP Protection: Example Europe

1992 SPC regulation granting up to 25 year patent life. 1992-94 introduction of Product Patents for pharmaceuticals in CEE and South Europe.Mid 1990s increasing secondary patents1994 introduction of TRIPS.2004 data exclusivity increased to 8-11 yrs. By 2005 over 7500 Patent extensions granted through SPC Regulation2006 Paediatric extensionsDespite increased IP the rate of “innovation is declining”

Innovation & Added Value

NO Important Therapeutic Advance - 78%

Important Therapeutic Advance - 22%

Source: US National Institutes of Health (NIH)

Administrative Report - February 2000

Innovation & Added Value

“Two-thirds of the drugs approved from 1989 to 2000 were modified versions of existing drugs or even identical to those already on the market, rather than truly new medicines, according to a new study. The report also said that most of the increased spending on new prescription drugs was on products that the FDA had determined did not provide significant benefits over those already on the market.”

Source: "New Medicines Seldom Contain Anything New”New York Times – 29 May 2002 - Reporting on a study by the

National Institute for Health Care Management Foundation (NIHCM)

Vol 331 BMJ 8-10-05

Ethics of Paying For Pseudo Innovation

Ethics of Granting Pseudo Patents

In 2000 27 NCEs granted by FDA but 6,730 patents granted in the main patent class for new drug compositions (source IPA 28/06/2004)

Many patents are subsequently challenged and “invalidated” – generic companies win 70% of cases. Why waste resources in this way?

Public is the Major Source of Pharma Research Funding

85% of Pharmaceutical R&D is paid for by taxpayers &

academic institutions.

Only 15% is paid for by Patent Holder and Industry Studies.

Recommendations (1)

A global re-assessment of the use of IP laws relating to medicines, particularly when granting patent extensions, secondary patents and data exclusivity

Stronger enforcement of the criteria for granting patents by patent offices –

Recommendations (2)

Greater encouragement of the development of genuine innovative medicines and discouraging the development and protection of "me-too" products Allocation of public funding to research into priority medicines Ensuring quick access to the post-patent market for generic equivalents