The Innovative Medicines InitiativeIntellectual Property Policy

March 20th, 2006

Ulf PetrussonProfessor of Law

Director CIP

Boo EdgarDr Med Sci (Clin Pharm)

Director Gothenburg International

Bioscience Business School

IP Policy Task Force Members

• Melanie Frey Wick, Roche, chair • Magali Poinot, European Commission, DG Research, co-

chair• Axel Braun, Roche• Ruth Keir, Pfizer • Christine Lemke, Medigene• Volker Mahlbacher, Boehringer-Ingelheim• Alexandre Mencik, Amgen • Ulf Petrusson, Chalmers University of Technology, Göteborg• Ivo Roelants, University of Leuven/Thromb-X • David Rosenberg, GSK

Part 1

Background and Key Challenges

- to Balance Interests & Create a Platform

Issues to Consider

• Possible intellectual property protection• Ownership issues• Access issues• Utilization issues • Dissemination• Platform issues

Access to Knowledge Could Facilitate…

• …testing based on bio-samples to increase further knowledge

• …head-to-head comparisons with other compounds based on data in the database

• …a possibility to check the project data against other data in this area

• …

IP Principles to promote knowledge creation

IP Principles to promote the efficiency of the pharmaceutical R&D process

IP Principles to promote innovation systems in biomedicine

Institutes for special forefront therapies

Clinical Research Network

Biomedical Business School

Venture Fund(s)

Incubators

Science parks

Start-ups Business

Companies

Hospital

s

Health care

Health ca

re

Society Society

Society

Patient

systems

Acade

mi

a

Academi

a

Key Challenges

• IP principles that acknowledge the different agendas and interests of the Stakeholders - SME’s and University Spin-Outs vs. Established industry- Entrepreneurial Universities vs. Research Universities- European Interests vs. Global Industry

• IP principles that balance values, such as: making data widely available promote innovation and commercialization offer flexibility for stakeholders to find appropriate solutions generate ability to foresee

• IP principles that promote the creation of a Knowledge Management Platform

Discoveryresearch

Preclinicaldevelop.

Translationalmedicine

Clinicaldevelop.

IMI CollaborativeProject

Pharma/Research University position

SME/Entrepreneurial University position

IP guidelines should enable findings to be used in research royalty-free

IP guidelines should enable findings to be commercialised asresearch tools

Initial Positions

Part 2

An Illustrative Example

Efficacy and Safety are Often Disease SpecificFocus initially on four disease areas with high scientific challenges

Cancer

BrainDisorders

Diabetes

Predictive pharmacolo

gy

Predictive toxicolog

y

Identification and validation of biomarkers

Patient recruitmen

t

RegulatoryRisk assessment

InflammatoryDiseases

Infectious/ anti-bacterial

There is a Huge Medical Need …

Type 2 Diabetes – the Metabolic Syndrome

Glucose-induced insulin secretion

Tissue response to insulin

Hepatic glucose production

Glucose uptake

Impairedbeta cellfunction

Basal hyper- insulinemia

Post receptor defect

Glucosetransport

Insulin binding

Insulin deficiency

Insulin resistanceInsulin resistance

Hyperglycemia

GeneticAcquired Obesity Age

GeneticAcquired Glucotoxicity Lipotoxicity

Hepatic enzyme activators/inhibitors

DPPIV

Kinase/phosphatase modulator

Appetite regulators

Insulin mimeticsGlucose-sensitive insulin

Stem cells

Vaccination

A New Anti-diabetic Therapy Should

• Improve the level of HbA1c between 2 and 3 %• Reduce bodyweight • Result in no cases of hypoglycemia• Result in low incidence of nausea• Reduce the cardiovascular risk• Reduce incidence of MI with 15%

• Reduce mortality with 35%

Hypothesis: We Have Discovered an Enzyme

• It is reflecting HbA1c• It follows the changes in blood glucose• Patients with low concentration of the enzyme survive

longer, if they are females, i.e. lowered risk• Antidiabetic treatment reduces the enzyme level - hinting at

improved outcome• Patients with low levels of this enzyme may have high blood

glucose that needs treatment anyway• Note that it is only a part of the complicated picture• If we had a simple marker, a biomarker …

Stakeholders

• The university group

• The diabetic clinic

• The SME

• The biopharmaceutical industry

• The general health care

•Discovered the enzyme, made the first animal studies

•Sampled blood in a biobank and attached that to survival data

•Discovered a way to analyse the enzyme correctly by a simple method

•Have developed compounds specific for the enzyme

•Have the organisation and patients to test this

Stakeholders

• The university group

• The diabetic clinic

• The SME

• The biopharmaceutical industry

• The general health care

• Patient

•New knowledge on diabetes, publication and possibilty to generate patent

•Improved therapy

•Patent biomarker(s) as research tools

•Validated drug targets and faster drug development, through sharing of knowledge

•Improved and cheaper way of treating diabetes

•Earlier access, improved safety and outcome

Part 3

The IP Principles in Practice

Issues to Consider

• Possible intellectual property protection• Ownership issues• Access issues• Utilization issues • Dissemination

Research Use shall mean the right to make and use of (but not sell or otherwise dispose of) products or processes which are protected by Foreground IP or Background IP for all purposes relating to research, development and approval of diagnostic or pharmaceutical products (4).

Foreground IP shall mean rights in data and information, inventions(whether or not patentable), patents and applications, know-how, copyrights,databases and designs which are generated by a Participant under the Project (2).

Background IP shall mean rights in data and information, inventions (whether or not patentable), patents and applications, know-how, copyrights, databases and designs owned by a Participant before the accession to the Grant Agreement and the Project Agreement, which is necessary for carrying out the Project or for using the Foreground IP or which are generated during the Project but which are incidental to the Project Objective as defined in the Grant Agreement (2).

A regulatory standard is any project or part of a project as defined in the Grant Agreement where the objective or part of the objective is to generate data that (i) may be used to progress, modify or create new regulations, regulatory guidance or processes related to the discovery, development or pharmacovigilance of medicinal products or (ii) may be required to be included in a regulatory submission for approval to conduct clinical trials or to market a medicinal product (4).

Definitions

Stakeholders

• The university group

• The diabetic clinic

• The SME

• The biopharmaceutical industry

• The general health care

•Discovered the enzyme, made the first animal studies - Background IP

•Sampled blood in a biobank and attached that to survival data

•Discovered a potential way to analyse the enzyme correctly by a simple method - Foreground IP•May develop compounds specific for the enzyme - Foreground IP

•Have the organisation and patients to test this

Ownership (2)

• Each Participant will remain the owner of its Background IP

• Ownership of the foreground IP belongs in the first instance to the Participant(s) who generated it

• Participants may agree on a different allocation of ownership in the project agreement

Stakeholders

• The university group

• The diabetic clinic

• The SME

• The biopharmaceutical industry

• The general health care

Researcher - Participant - Other Participants

•Discovered the enzyme, made the first animal studies - Background IP

•Sampled blood in a biobank and attached that to survival data

•Discovered a potential way to analyse the enzyme correctly by a simple method - Foreground IP•May develop compounds specific for the enzyme - Foreground IP

•Have the organisation and patients to test this

License under Background IP and Foreground IP to the Participants for purposes of completing the project (3)

• A royalty-free non-exclusive license

Licensing of IP for Research Use after Completion of Projects (4)Licensee Foreground IP Foreground IP generated

which is necessaryto progress or developregulatory standards

Background IPnecessary to use Foreground IP

ProjectParticipants

Freely available for research use

Freely available for research use

Made available forresearch use on a non-exclusive basis on fair and reasonable terms or royalty free

Third Parties Made available forresearch use on a non-exclusive basis on fair and reasonable terms

Freely available for research use

Made available for research use on a non-exclusive basis on fair and reasonable terms

Note: Project participants will be granted a royalty-free non-exclusive license under the Background and Foreground IP to the other Participants solely for the purpose and to the extent necessary for undertaking and completing the Project.

Project participants: freely available

Third parties: non-exclusive basis on fair and reasonable terms

When necessary to develop regulatory standard: freely available

Application on the earlier example

Foreground IP for Research Use

SME - Discovered a way to analyse the enzyme correctly by a simple method

Foreground IP - Biomarker - Research Tool

Project participants: non-exclusive basis on fair and reasonable terms

Third parties: non-exclusive basis on fair and reasonable terms

When necessary to develop regulatory standard: freely available

Modifying the earlier exampleBackground IP necessary to use Foreground IP

SME - Discovered a way to analyse the enzyme correctly by a simple method

Background IP - Biomarker - Research Tool

Commercialisation (5)

• No Other Restrictions

Dissemination (6)

• Dissemination of the Foreground IP as soon as possible but within one year after the termination or expiry of the Project, either through Project participant or through Executive Office, if Project Participant does not disseminate.