1. International IP Issues Federal Lab Consortium Meeting International IP Issues Dr Roisin McNally - European Patent Attorney 20 September 2006

2. International IP Issues IP Strategy Major markets - US and Europe Practical Advice Costs

3. International Patent Protection Granted European Patent Granted National Patents 12 Months File Individual Overseas Applications File Individual Overseas Application File European Application File International PCT Application File European Application File US Application

4. International Patent Protection International (PCT) Application Individual Overseas Applications Regional Applications Different claims/ different scope Enforceability International (PCT) Application Individual Overseas Applications Regional Applications Different claims/ different scope Enforceability

5. National/ Regional Procedures National / Regional Applications 12/30 months EP Search Examination Grant US Exam Poss.C.I.Ps Issue CA/JP - Exam Issue AU/NZ Exam Issue -

6. US / EP Procedural Differences First to invent Grace periods (prior art, deposits) Must disclose best mode Can with-hold publication Duty of Disclosure Continuation-in-part practice EP US First to file No grace period Enabling disclosure Application publishes at 18 months No duty of disclosure No information can be added

7. Patentable Subject Matter? US/EP Methods of Medical Treatment Methods of Diagnosis Computer Programs/Computer related IP Plants/Plant varieties Animals/Animal varieties Contrary to “ordre public” Presentation of Information Technical Character Algorithms

8. Continuation-In-Part (“CIP”) Common subject matter – original priority Added subject matter – priority as of CIP filing Useful to: cover improvements add new experimental data Dis-incentive – patent term calculated from earliest U.S. filing date No CIP practice in Europe or other international territories – all material must be derivable from application as filed. Common subject matter – original priority Added subject matter – priority as of CIP filing Useful to: cover improvements add new experimental data Dis-incentive – patent term calculated from earliest U.S. filing date No CIP practice in Europe or other international territories – all material must be derivable from application as filed.

9. Best Mode Statutory requirement in US – not elsewhere Must set forth best mode of carrying out invention known to inventor at time of filing Failure to disclose best mode invalidates patent; e.g. no preferred embodiment described aspects which materially affect claimed invention left out Not an issue outside US – application must be enabled Statutory requirement in US – not elsewhere Must set forth best mode of carrying out invention known to inventor at time of filing Failure to disclose best mode invalidates patent; e.g. no preferred embodiment described aspects which materially affect claimed invention left out Not an issue outside US – application must be enabled

10. First to invent system Rights to invention based on earliest date of invention Proved by corroborated evidence of conception and reduction to practice Written records that are signed, dated and witnessed notebooks invention disclosure forms Priority contest is an “interference” Rest of world – first to file Rights to invention based on earliest date of invention Proved by corroborated evidence of conception and reduction to practice Written records that are signed, dated and witnessed notebooks invention disclosure forms Priority contest is an “interference” Rest of world – first to file

11. Grace periods/ Biological deposits Prior art 12 month grace period for own disclosure after 12 months, absolute bar to patentability Biological deposits (cells, bacteria, plasmids, etc.) can deposit any time during pendency of application No grace period in Europe, might change soon but not yet. Deposits required to be identified within 12 months – details within 16 months Prior art 12 month grace period for own disclosure after 12 months, absolute bar to patentability Biological deposits (cells, bacteria, plasmids, etc.) can deposit any time during pendency of application No grace period in Europe, might change soon but not yet. Deposits required to be identified within 12 months – details within 16 months

12. Duty of Disclosure Must disclose to USPTO all known information material to patentability All persons involved with application under duty inventors attorneys Failure to disclose invalidates patent No duty of disclosure in Europe – often recommended to disclose to ensure valid enforceable patent – but not necessary – can be used as defensive mechanism. Must disclose to USPTO all known information material to patentability All persons involved with application under duty inventors attorneys Failure to disclose invalidates patent No duty of disclosure in Europe – often recommended to disclose to ensure valid enforceable patent – but not necessary – can be used as defensive mechanism.

13. U.S. Non-Publication Must be requested at time of filing Foreign filing abrogates request Otherwise, application publishes 18 months from priority date In Europe and rest of the world application must be withdrawn to avoid publication at 18 months. Must be requested at time of filing Foreign filing abrogates request Otherwise, application publishes 18 months from priority date In Europe and rest of the world application must be withdrawn to avoid publication at 18 months.

14. Practical Tips and Costs Consider overseas protection from the beginning Remember first to file and not first to invent For important inventions consider defensive patenting Consider using different text for outside USA Minimise translation costs where possible Minimise claim numbers and categories Review US text early for international issues Consider subject matter and national requirements Consider markets, competitors and enforceability – separately and together. Consider overseas protection from the beginning Remember first to file and not first to invent For important inventions consider defensive patenting Consider using different text for outside USA Minimise translation costs where possible Minimise claim numbers and categories Review US text early for international issues Consider subject matter and national requirements Consider markets, competitors and enforceability – separately and together.

15. International IP Issues Thank you for your attention. roisin.mcnally@murgitroyd.com www.murgitroyd.com Belfast, Dublin, Glasgow, Aberdeen, London, Nice Munich 011443078400 or 011442890320441