Future European Patent Policy

1
Future European Patent Policy

• Lidia Mallo
• Legal and Government Affairs Manager
• EUPACO
• Brussels, 24 January 2007

2
Index

1. Introduction to the Generic Medicines Industry
2. Our patent concerns how to improve the European
   patent system
3. Our views on the European Patent Litigation
   Agreement (EPLA)

3
EGA - Who Are We ?

• EGA Established 1992. Secretariat in Brussels
• Membership is Pan-European. (represent 28
  European countries)
• Has over 80 direct members. Represents some 900
  companies.
• Employs over 100,000 persons.
• Brings savings of 18 Billion Euro per year

4
Contributions of Generic Medicines from a Public
Health perspective

• Increase access through affordable medicines
• Stimulate innovation through competition
• Provide budget headroom for financing genuine new
  innovations
• Develop for patients new formulations, methods of
  delivery etc.

5
Role of Generic Medicines

• Pricing studies have shown unequivocally that
  generic competition is the most effective way to
  ensure lasting price reductions
• WHO 55th Assembly
• May 2002

• The promotion of generics can have important
  impact in reducing costs and creates headroom to
  help pay for new innovative products
• EU Council of Ministers
• June 2000

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The Generic Reality 50

• In the new EU 27 the generic pharmaceutical
  industry is becoming the principal supplier of
  medicines for EU citizens
• 60-75 CEE / DK
• 40-60 UK/DE/NL
• 10-15 and expanding rapidly in PT/F/Belgium

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Growing Complexity Of Pharma Patents

• 1990s (18 properties)
• Primary uses
• Processes and intermediates
• Bulk forms
• Simple formulations
• Composition of matter
• Expansive numbers of uses
• Methods of treatment
• Mechanism of action
• Packaging
• Delivery profiles
• Dosing regimen
• Dosing range
• Dosing route
• Combinations
• Screening Methods
• Chemistry Methods
• Biological Target
• Field of use

• 1980s (5 properties)
• Primary uses
• Processes and intermediates
• Bulk forms
• Simple formulations
• Composition of matter

Source Evolution of IPR Pharmaceutical
discovery and Development, Eric Larson, Sr
Director, Groton Site Head, Pfizer Global
Research Development. Viewed on 9/11/2005 at
http//www7.nationalacademies.org/step/Larson_ppt.
ppt
8
Pharmaceutical Innovation

• IP protection in EU has increased dramatically
  since 1990 but the rate of innovation has
  declined.
• Only 22 of New medicines are truly innovative
  (Public Citizen July 2001)

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Getting the Right Environment For Generic
Competition

• Four Foundation Stones
• Efficient Regulatory System
• Single Market
• Intellectual Property Balance
• National Measures Promoting Generic Medicines

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• How to improve the patent system
• to favour generic competition

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1. Need to improve patent quality crucial role
of EPO

• Higher standards in examination and prior art
  search
• Revise level of inventive step should be higher
• No more weak patent granted by EPO
• Quality control system (external audit patent
  quality check?)
• Separation of powers to increase independence of
  examiners

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2. Patent system should not encourage strategies
against generic competition

• Patent linkage
• Frivolous abusive litigation
• Increased litigation based on dubious secondary
  patents
• Injunctions granted on low level of proof because
  of inexperience of judges

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• These strategies
• prevent generic competition
• restrict access and affordability
• discourage real innovation

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3. Need of harmonization of enforcement and
litigation procedures either through EPLA, COMPAT
or both.

• WHY?
• Litigation in parallel before several national
  courts is unaffordable
• Legal uncertainty because of diverging decision
  by multiple national courts

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• Disharmony of judicial system encourages Forum
  Shopping
• Different interpretation of patent law
• Different granting of damages
• Unpredictability
• Difficult to invest, plan and market.

16

• The European Patent Litigation Agreement
• (EPLA)

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3 different systems to deal with patents

• CURRENT SYSTEM National courts deal with
  National European patents
• PROPOSAL 1 A new European Patent Court (set
  up by the EPLA) would deal with European
  patents
• PROPOSAL 2 A new Community Patent Court
  would deal with a new EC Community Patent
  

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EPLA advantages

• Sets up a European Patent Court to deal with
  infringements/revocations of European Patents
• Central revocation of identical patents
• less revocation costs and less professional
  advice costs
• Centralization no more diverging decisions
• more legal certainty for generic producers

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EPLA advantages

• The Court will create a single ruling, so if
  patent is declared invalid, the generic company
  can market the product simultaneously in all
  countries where the patent has been revoked.
• Increase our EU market access

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• The real situation TODAY
• EPLA is not at good as it seems.
• Why?

21
EGA is against current draft of EPLA (I)

• Enormous increase of litigations costs for SMEs
• Cost base is unsuitable
• Need to generate revenue instead of sound
  decision making
• Risk of more litigation, instead of quality
  decisions
• Careful with EPO experience! Not again.

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EGA is against current draft of EPLA (II)

• Predominant role of the European Patent Office
  (EPO) independence of European Patent Judiciary
  not guaranteed
• Level of competence of judges is unclear
• Forum shopping will not disappear
• Some Regional EPLA courts will have more patent
  experience than others
• Patentee might choose to launch product in
  country where he likes the Regional EPLA Court.

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EGA is against current draft of EPLA (III)

• Danger of bottle necks, specially in 2d instance
• Detailed court procedures are inexistent
• Loss of flexibility
• If company brings badly prepared case and looses
  or poor decision is given EU 27 market
  simultaneously closed

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Recommendations to improve EPLA (I)

• EPLA should minimize court fees
• Need of detailed, transparent, easy to operate
  and fair Procedural Rules
• Need of experienced, independent and well trained
  patent judges to assure quality decisions
• Full case management from the EPLA with
  compulsory preliminary hearings to set a
  timetable with target dates for hearing and
  decision

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Recommendations (II)

• Transparency all EPLA cases should have simple
  Register of Proceedings open to public. All
  decisions should be published.
• National courts should not be phased out after 7
  years transitional period
• A review of EPOs role in granting patents is
  crucial

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Conclusion

• Draft EPLA shows clearly influence of EPO but has
  little details on how it will work for
  practitioners and users
• As currently drafted, EGA cannot support
• We believe in harmonization of patent procedural
  law of the different Member States, to facilitate
  harmonization of patent litigation.

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• Thank you!
• Our position paper on EPLA at
• www.egagenerics.com