abcd boehringer ingelheim austria gmbh intellectual property rights and pharmaceutical industry drug...

ABCDBoehringer Ingelheim Austria GmbH

Intellectual Property Rights and Pharmaceutical Industry

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


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



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$



Number of New Approved Drugs as Compared to Total R&D Expenditure of the Pharmaceutical Industry

05

10152025

303540455055

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!


The Future of Drug Discovery

The future of drug discovery depends on understanding the genetic basis of the disease.



1900 1950 1970 1990

Traditional drugs from plants

Enzymes

Receptors

Recombinant Drugs

Genomics Gene Therapy

Technological Advancements in Pharma ResearchTechnological Advancements in Pharma Research



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



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



Known Molecular Processes Leading to Cancer



Steps in the NCE Discovery Process

primaryactivityscreens

functionalscreens

in vivo models

Early Discovery (exploratory) Late Discovery

Disease TargetIdentification

AssayDevelopment

LeadIdentification

LeadOptimization

unmetmedicalneed

commercialopportunity

protein orgeneinvolvedin disease-relatedpathologicalpathways

chemicalstarting point

optimizedcompound

DevelopmentCandidate



Gene Technology/Genomics

Robotic Screening (HTS)

Rational Design

Information Technology

Disease Target Assay LeadDevelopment Candidate

Combinatorial Chemistry

The New Core Technologies Influence Each Step of The Drug Development Process



Why patent?



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.



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.



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!



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



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



Gene Technology/Genomics

Robotic Screening (HTS)

Rational Design

Information Technology

Disease Target Assay LeadDevelopment Candidate

Combinatorial Chemistry

The New Technologies of the R&D Process are Sources of Inventions



Patentable Inventions Created During the R&D Process

Research Toolstarget genes

screening assays reagents

cDNAs, ESTsanimal models



Patentable Inventions Created During the R&D Process

Drug (NCE or NBE)per semethod of makingformulationcombinationnovel use (second indication)

drug delivery system gene therapy



Telmisartan - a Boehringer Ingelheim Success Story - Part I

Xmas 1990Angiotensin

receptor antagonist

Telmisartan synthesized

February 1991

Priority patent

application

31.1.1992foreign filings

May 98European patent for Telmisartan

granted*

*in additon, several manufacturing and processing patent applications filed



Telmisartan - a Boehringer Ingelheim Success Story - Part II

Xmas 1998Registration of

TelmisartanEuropean Market

Authorization

June 1999SPC filed

Xmas 2013SPC expiry

January 2012Expiry ofEuropean

Patent

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