P Farniok

ABCD
Boehringer Ingelheim
Austria GmbH
Intellectual Property Rights and Pharmaceutical Industry
Drug Development Process and Importance of Intellectual Property
Rights for R&D Industry
ABCD
Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 2
Increasing Challenges in The Pharmaceutical Industry

Increasing R&D costs
High innovation pressure
Many more therapeutic targets to be explored and utilized as drug intervention sites

ABCD
Austria GmbH
Costs of Drug R&D
Research 47 million US$
Preclinical phase 38 million US$
Clinical phase 1 9 million US$
Registration 19 million US$
Total 240 million US$
ABCD
Austria GmbH
Number of New Approved Drugs as Compared to Total R&D Expenditure of the
Pharmaceutical Industry
0
5
10
15
20
25
30
35
40
45
50
55
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998
Number of new approved drugs
R&D expenditures in US$ bn
Inspite of increasing R&D expenditure, the number of new approved drugs remains relatively constant !
ABCD
Austria GmbH
The Future of Drug Discovery
The future of drug discovery depends on understanding the genetic basis of the
disease.
ABCD
Austria GmbH
1900 1950 1970 1990
Traditional
drugs from
plants
Enzymes
Receptors
Recombinant
Drugs
Genomics
Gene Therapy
Technological Advancements in Pharma Research
ABCD
Austria GmbH
The Change of Paradigm in Pharmaceutical R&D

Classical R&D Approach

Known lead structure for symptomatic therapy
Optimization of active substance in animal model
Clinical trial. Safety and efficacy
Registration

New R&D Approach

Genetic cause of the disease (Genomics)
Rational selection of the active substance (molecular
genetics)
High Throughput Screen
Optimization of active substance with recombinant
human gene products and combinatorial chemistry
Clinical trial. Safety and efficacy
Registration
ABCD
Austria GmbH
Products of R&D

Classical

NCEs

Vaccines
bacterial extracts

Proteins
from animal tissue

New

NCEs (obtained by using genetic engineering
technology)

Non-infectious vaccines obtained by genetic
engineering

NBEs (recombinant human proteins, monoclonal
antibodies)
Gene Therapy

ABCD
Austria GmbH
Known Molecular Processes Leading to Cancer
ABCD
Austria GmbH
Steps in the NCE Discovery Process
primary
activity
screens
functional
screens
in vivo
models
Early Discovery (exploratory)
Late Discovery
Disease
Target
Identification
Assay
Development
Lead
Identification
Lead
Optimization
unmet
medical
need
commercial
opportunity
protein or
gene
involved
in disease-
related
pathological
pathways
chemical
starting point
optimized
compound
Development
Candidate
ABCD
Austria GmbH

Gene Technology/Genomics
Robotic Screening (HTS)
Rational Design
Information Technology
Disease Target Assay Lead
Development
Candidate
Combinatorial Chemistry
The New Core Technologies Influence Each Step of The Drug Development Process
ABCD
Austria GmbH
Why patent?
ABCD
Austria GmbH
Good Reasons for Patenting

Patents prevent others from commercially utilizing an invention.
For the research-based industry, periods of market exclusivity are crucial for the recoupment of R&D
expenditure.
Patents encourage financial risk and long-term research.
Patents guarantee the dissemination of information.

ABCD
Austria GmbH
What is a Patent?
Which Rights Does a Patent Confer?
A patent is a limited monopoly granted in respect of an invention.
A patent confers the right to exclude others from making, using or selling the invention.
This right is granted to the inventor (or his/her successor in title) by a national or regional authority.
This right is limited in terms of territory and duration.
The scope of this right is defined by the patent claims.

ABCD
Austria GmbH
Which Rights Does a Patent Not Confer?

A patent does not confer the "positive" right to use the invention!

The use of an invention, whether patented or not, is subject to other national laws and regulations!

ABCD
Austria GmbH
The Patent Right is Limited With Regard to Territory and Term

Territorial scope :
National patents - both granting procedure and
effect are national
European patents - the granting procedure is
European, the effect is national
International patent applications (PCT):
the application and examination procedure is international,
the granting procedure is European/national,
the effect is national
Term
20 years from filing
ABCD
Austria GmbH
Categories of Patent Claims

Product

Method

Use

Broadest protection. It covers all uses of the product,
even those not explicitly disclosed.

The protection for a method of manufacture also
covers the products obtained by that method.

Relatively narrow scope of protection - second
medical use
ABCD
Austria GmbH

Gene Technology/Genomics
Robotic Screening (HTS)
Rational Design
Information Technology
Disease Target Assay Lead
Development
Candidate
Combinatorial Chemistry
The New Technologies of the R&D Process are Sources of Inventions
ABCD
Austria GmbH
Patentable Inventions Created During the R&D Process

Research Tools
target genes
screening assays
reagents
cDNAs, ESTs
animal models
ABCD
Austria GmbH
Patentable Inventions Created During the R&D Process
Drug (NCE or NBE)
per se
method of making
formulation
combination
novel use (second indication)

drug delivery system
gene therapy

ABCD
Austria GmbH
Telmisartan - a Boehringer Ingelheim Success Story - Part I
Xmas 1990
Angiotensin receptor antagonist
Telmisartan
synthesized
February 1991
Priority patent
application

31.1.1992
foreign filings
May 98
European patent
for Telmisartan granted*
*in additon, several manufacturing and processing patent applications filed
ABCD
Austria GmbH
Telmisartan - a Boehringer Ingelheim Success Story - Part
II
Xmas 1998
Registration of
Telmisartan
European Market Authorization
June 1999
SPC filed
Xmas 2013
SPC expiry

January 2012
Expiry of
European Patent

P Farniok

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