Dispute Resolution in the Pharmaceuticals and Biotech ...

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1 Δεκ 2012 (πριν από 4 χρόνια και 6 μήνες)

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Dispute Resolution in the Pharmaceuticals and
Biotech Sectors
Nigel Jones
Co-Head, Healthcare Sector, Linklaters LLP
President, LES Britain and Ireland
29 January 2010
Key Messages
>Inevitable
>Commercial/Flexible
>Human
1
Structure
I.Types of IP-related disputes.
II.Mechanisms to resolve disputes.
III.
Main issues.
2
III.
Main issues.
Focus >Patents (not other IP or regulatory)
>Europe (not worldwide)
>Present (not future)
3
NewBio
MaxPharm Inc.
BioClone GmbH
Patent Licence
$$$
4
Structure
I.Types of IP-related disputes.
II.Mechanisms to resolve disputes.
III.
Main issues.
5
III.
Main issues.
I. Types of disputes 1.Intellectual property rights.
2.Contractual (e.g. Collaboration agreements, licences).
3.Competition/anti-trust.
6
I. Types of Dispute -Patents >Validity –opposition (at IP offices), revocation (at Court)
7
>Infringement (at Court) –injunctions, declarations, damages, interim
relief.
I. Types of Dispute -Patents in Europe >2 types: European Patents and national patents.EP Patents:>examined and granted centrally by EPO.
>
on grant, become a bundle of separate national patents that must be
enforced/challenged on a country
-
by
-
country basis.
8
>
on grant, become a bundle of separate national patents that must be
enforced/challenged on a country
-
by
-
country basis.
>after grant, there is 9 month window to file oppositions and challenge EP
patents centrally
Problems:
>backlog of oppositions.
>No cross-border injunctions ￿multiple infringement proceedings around
Europe for same EP Patent.
>Inconsistent decisions.
I. Types of Dispute -A Community Patent/Court?>Proposal to create a Community Patent that can be enforced and
challenged centrally through a single European Patents court.
>Not a knew idea, previous attempts have not succeeded.
>
New impetus?
9
>
New impetus?
>increasing costs of obtaining and enforcing EP patents.
>EPO backlogs.
>support of EU Commission and EU Council.
I. Types of Dispute -Contractual >More prevalent in troubled times?
>Licensees trying to terminate onerous contracts.
>Licensors looking to re-negotiate terms.
10
>“boiler plate” clauses will provide dispute resolution mechanism(s)
and governing law.
>rarely heavily negotiated –but should be
I. Types of Dispute -Competition/Anti-trust >Tension: competition vs monopoly
>EU competition law prohibits:
1.agreements that prevent, restrict or distort competition (Art 101)
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2.an abuse of a dominant market position (Art 102).
>Enforced by EU Commission and national competition authorities.
>Proceedings commenced on own initiative or in response to a
complaint.
>Broad powers: disclosure, inspection, fines, orders…
I. Types of Dispute -EU Commission (competition/anti-trust)
Pharmaceutical Sector Inquiry >launched January 2008
>concerns that competition distorted (generics slow to enter market)
12
>“toolbox” of strategies to keep generics off the market (patent
clusters, interventions before marketing authorisation companies
etc…)
>12 January 2010 –requests settlement agreements (reverse
payments)
>Impact on use of IPRs? (e.g. potentially discourages legitimate IP
litigation, settlements.)
II. Mechanisms to resolve disputes
1.Litigation
2.Arbitration
3.Mediation
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II. Mechanisms to resolve disputes -Litigation >Strict rules (may include document disclosure)
>Public
>Expensive (though tribunal is “free”)
14
>Fast/slow (depends on country)
>Adversarial (often 2 losers)
>Technical qualifications of tribunal vary
>Limited geographical enforceability of court orders (outside EU)
II. Mechanisms to resolve disputes -Arbitration >Flexible –parties can choose rules (if they agree!)
>Private
>Expensive (including cost of tribunal)
15
>Slow
>Adversarial
>Tribunal technically qualified
>Broad geographical enforceability
II. Mechanisms to resolve disputes -Mediation >Flexible
>Private
>Cheap
16
>Fast
>Conciliatory –aim is “win-win”
III. Issues >Importance of future relationship
>Budget
>Timescale
17
>Key countries (e.g. manufacturing site, local/biggest markets)
>Qualities and relevant tribunals
Case Study
18
NewBio
MaxPharm Inc.
BioClone GmbH
Patent Licence
$$$
Solutions?
Dispute 1: MaxPharm >refusing to pay for regulatory milestones.
20
Dispute 2: BioClone >infringement of NewBio’s patent.
>(in)validity of BioClone’s patent.
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Review >Inevitable
>Commercial/Flexible
>Human
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nigel.jones@linklaters.com
Questions?
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nigel.jones@linklaters.com