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