Transcript Patents and Medicines: How the system has

Patents and Medicines:
How the system has discouraged
innovation and reduced patient
access to benefits of knowledge
GREG PERRY
Director General, EGA
World 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
250
225
Working age
200
175
Employment
150
125
Elderly
100
75
50
2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
Expenditure on Healthcare
in Relation to Age
Source: Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations
France
Germany
um
lgi
Be
ia
str
Au
15
Finland
Spain
Sweden
Netherlands
Italy
United Kingdom
10
Denmark
Spain
5
France
ria
st
Au
Average expenditure per head expressed as a share of GDP per capita
(%)
United Kingdom
20
0
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
Age groups
95+
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.
2.
3.
4.
5.
Primary uses
Processes and intermediates
Bulk forms
Simple formulations
Composition of matter
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
1990s (18 properties)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Primary uses
Processes and intermediates
Bulk forms
Simple formulations
Composition of matter
Expansive numbers of uses
Methods of treatment
Mechanism of action
Packaging
Delivery profiles
Dosing regimen
Dosing range
Dosing route
Combinations
Screening Methods
Chemistry Methods
Biological Target
Field of use
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 patents
1994 introduction of TRIPS.
2004 data exclusivity increased to 8-11 yrs.
By 2005 over 7500 Patent extensions
granted through SPC Regulation
2006 Paediatric extensions
Despite 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)
Ethics of Paying For Pseudo
Innovation
Vol 331 BMJ 8-10-05
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 "metoo" products
Allocation of public funding to research
into priority medicines
Ensuring quick access to the postpatent market for generic equivalents