Pharmaceutical Patent Term Extensions

Registration and Coffee

Opening Remarks from the Chair

Revisiting the scope of the SPC Regulations : How can patentees continue to be protected in the modern world?

• Is there really a legislative vacuum in the area of SPCs?
• Has the CJEU been unfairly pushed to interpret the regulations that are frequently not relevant to the legal issues in dispute?
• Is this resulting in problematic decisions?
• Which parts of the regulations require amendment?
• Does the duration of an SPC need to be re-considered?
• Do the newer products we are now seeing still fit into the framework of the SPC legislation and require drastic re-drafting?
  • Treatment of biologics
  • Cellular products
  • Medical devices
• How exactly could the legislation be widened sufficiently to accommodate:
  • “New” products that have emerged over the last twenty years
  • Future products not yet on the market?
• Are any trends arising or testing in other jurisdictions in trying to expand the scope?
  • Key cases or tests

Networking Refreshment Break

The long awaited Unitary Patent begins – How will SPC’s fit into the current and future picture?

Part 1 The operation of a “national right” under a unitary system

• How are people choosing their opt in/out strategy when managing their existing SPC portfolio under the UPC?
• Have companies been forced to switch their position in response to the ongoing uncertainty over commencement of the new regime?
• How is the UPC going to deal with SPC cases relating to:
  • infringement/validity of SPC involving several jurisdictions
• Is clarification still required of any aspect of the new regime in respect of SPC’s?

Part 2 How close is the reality of a Unitary SPC?

• Next steps concerning the development of a Unitary SPC
• Relevant issues surrounding a unitary SPC
  • What will it look like?
  • Who will have the granting authority?
  • What will be the position of the official bodies?

Networking Lunch

Implications of Brexit – Preparing and planning through the uncertainty knowing the options

• How are companies trying to plan strategy through such an uncertain legislative environment?
• What could be the difference between a “hard” and “soft” Brexit for the management of SPC portfolios?
• How could Brexit impact on other jurisdictions who work with the UK?
  • Cross border strategy planning
  • Challenges for in-house and advisors
• How is the “transition period” expected to work and be defined?
• What alternatives could form the ultimate end point we are moving towards?
  • Swiss or Liechtenstein model

SPC Case Law Round Up

Discussion surrounding key test cases regarding combination drugs and potential for SPC protection

Networking Refreshment Break

What are the benefits of an SPC Waiver for European Generics Manufacturing? How will this impact on the protection offered by SPC’s?

• What does the proposal entail?
• Current position on the likely timetable for introduction
• What are the possible consequences for the strength of an SPC in Europe?
• Rationale for the implementation of an SPC waiver for the generics manufacturing sector
• Will it achieve the objective to stimulate the pharma manufacturing market in the EU?
• What will be the impact on EU patentees?

Chair’s Closing Remarks – End of Day 1

Cocktail Reception

Registration and Coffee

Rectifying SPC duration: Resolution v Challenges

• Has Seattle Genetics resolved the issue or provided further challenges?
• What have been the practical challenges to obtaining an adjustment?
• Why does there not appear to be consistent approach by the different patent offices across Europe?
• How to work with different patent offices
• Is there a remedy if a patent office won’t respond to a legitimate request to adjust an SPC duration?

A focus on orphan drugs status: How effective are alternative ways to protect monopoly status?

• Why is the market now looking to use alternative regulatory forms of protecting products?
• What is driving particular companies to increasingly step up activity in this area?
• Consequences of increasing number of cases coming before the courts
  • Accord v Astellas
    • Date when a medicinal product IS authorised to be put onto the market
  • Teva v Novartis
    • CJEU’s rejection of Teva’s generic drug application for Glivec
• How successful is the process proving as a method of protection?
• What are the commercial repercussions for the market?
• What does the process involve?
• What are the regulatory challenges to using orphan drugs status
• Comparison between the US and Europe on their use

Extending patent terms in Russia and CIS countries

Networking Refreshment Break

SPC Squatting and Third Party Rights

• How big a problem is this becoming?
• Is an SPC a reward for innovation or a reward for bringing a product to the market?
• What is the nature of the SPC right?
  • regulatory protection based on the clinical trial
  • an IP right based on innovation?
• Why is there a lack of judicial guidance?
• Considerations of recent case law establishing the position of the CJEU

Networking Lunch

Patent Extensions in Japan

Patent Extensions in Israel

Networking Refreshment Break

Global Exchange – Roundtables

Speakers:   CANADA Howard Keith Withers European Patent Attorney Barrister & Solicitor (Ontario, Canada) DFMP (Panel Moderator)   US   CHINA Chengda Li Patent Attorney CCPIT Patent & Trademark Law Office     Some jurisdictions have experienced important changes in their patent extensions regime whilst others can be challenging due to their unique nature or distinction from the European system.

Chair’s Closing Remarks

End of Conference