1. Intellectual Property Rights and Pharmaceutical Industry
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Intellectual Property Rights and Pharmaceutical Industry
Drug Development Process and Importance of Intellectual Property Rights for R&D Industry

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

3. Costs of Drug R&D

4. Number of New Approved Drugs as Compared to Total R&D Expenditure of the Pharmaceutical Industry
Inspite of increasing R&D expenditure, the number of new approved drugs remains relatively constant!

5. The Future of Drug Discovery
The future of drug discovery depends on understanding the genetic basis of the disease.

6. Technological Advancements in Pharma Research
Genomics Gene Therapy
Recombinant Drugs
Receptors
Enzymes
Traditional drugs from plants

7. The Change of Paradigm in Pharmaceutical R&D
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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

8. Products of R&D Classical New NCEs
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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

9. Known Molecular Processes Leading to Cancer

10. Steps in the NCE Discovery Process
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Steps in the NCE Discovery Process
Early Discovery (exploratory)
Late Discovery
Lead
Optimization
Target
Identification
Assay
Development
Lead
Identification
Disease
unmet medical need
commercial opportunity
protein or gene involved in disease- related pathological pathways
primary activity screens
functional screens
in vivo models
chemical starting point
optimized compound
Development Candidate 3

11. Robotic Screening (HTS) Information Technology
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The New Core Technologies Influence Each Step of The Drug Development Process
Disease
Target
Assay
Lead
Development Candidate
Gene Technology/Genomics
Robotic Screening (HTS)
Combinatorial Chemistry
Rational Design
Information Technology 4

12. Why patent?

13. Good Reasons for Patenting
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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.

14. What is a Patent? Which Rights Does a Patent Confer?
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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.

15. Which Rights Does a Patent Not Confer?
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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!

16. 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

17. 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

18. Robotic Screening (HTS) Information Technology
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The New Technologies of the R&D Process are Sources of Inventions
Disease
Target
Assay
Lead
Development Candidate
Gene Technology/Genomics
Robotic Screening (HTS)
Combinatorial Chemistry
Rational Design
Information Technology 4

19. Patentable Inventions Created During the R&D Process
Research Tools
target genes
screening assays
reagents
cDNAs, ESTs
animal models

20. 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

21. Telmisartan - a Boehringer Ingelheim Success Story - Part I
foreign filings
Xmas 1990
Angiotensin receptor antagonist Telmisartan
synthesized
February 1991
Priority patent
application
May 98
European patent
for Telmisartan granted*
*in additon, several manufacturing and processing patent applications filed

22. Telmisartan - a Boehringer Ingelheim Success Story - Part II
January 2012
Expiry of
European Patent
Xmas 1998
Registration of
Telmisartan
European Market Authorization
June 1999
SPC filed
Xmas 2013
SPC expiry