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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 – PowerPoint PPT presentation

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Title: Intellectual Property Rights and Pharmaceutical Industry


1
Intellectual Property Rights and Pharmaceutical
Industry
  • Drug Development Process and Importance of
    Intellectual Property Rights for RD Industry

2
Increasing Challenges in The Pharmaceutical
Industry
  • Increasing RD costs
  • High innovation pressure
  • Many more therapeutic targets to be explored and
    utilized as drug intervention sites

3
Costs of Drug RD
4
Number of New Approved Drugs as Compared to Total
RD Expenditure of the Pharmaceutical Industry
Inspite of increasing RD 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
Traditional drugs from plants
1900 1950 1970
1990
7
The Change of Paradigm in Pharmaceutical RD
  • Classical RD Approach
  • Known lead structure for symptomatic therapy
  • Optimization of active substance in animal model
  • Clinical trial. Safety and efficacy
  • Registration
  • New RD 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 RD
  • 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
Late Discovery
Early Discovery (exploratory)
Lead Optimization
Assay Development
Lead Identification
Target Identification
Disease
  • unmetmedicalneed
  • commercialopportunity
  • protein orgeneinvolvedin disease-relatedpatho
    logicalpathways
  • chemicalstarting point
  • optimizedcompound
  • primaryactivityscreens
  • functionalscreens
  • in vivo models

DevelopmentCandidate
11

The New Core Technologies Influence Each Step of
The Drug Development Process
Gene Technology/Genomics
Robotic Screening (HTS)
Combinatorial Chemistry
Rational Design
Information Technology
12
Why patent?
13
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 RD 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?
  • 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?
  • 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

The New Technologies of the RD Process are
Sources of Inventions
Gene Technology/Genomics
Robotic Screening (HTS)
Combinatorial Chemistry
Rational Design
Information Technology
19
Patentable Inventions Created During the RD
Process
  • Research Tools
  • target genes
  • screening assays
  • reagents
  • cDNAs, ESTs
  • animal models

20
Patentable Inventions Created During the RD
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
31.1.1992 foreign filings
Xmas 1990 Angiotensin receptor antagonist
Telmisartan synthesized
May 98 European patent for Telmisartan granted
February 1991 Priority patent application
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
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