Life Science Patent Term Extensions Masterclass - WEB

EARN CLE CREDITS

PATENT TERM EXTENSIONS MASTERCLASS CALENDAR-ALT 19 October 2022 clock 7:45 a.m.–4:00 p.m.

The Westin Grand Munich | Munich The ONLY specialized forum focusing on SPCs and Patent Extension Developments in Europe and Around the World

M

aximizing your patent lifecycle is essential to maximizing your profit.

And in today’s highly competitive life science patent landscape – every day counts. Being equipped with the latest strategies for prosecuting SPCs, litigating Patent Term Extension rights and effectively utilizing available exclusivities is paramount to the success of your patent portfolio and company.

Attend this specialized masterclass on Global Life Science Patent Term Extensions and gain strategic solutions to tackle your greatest patent extension challenges, tools for navigating today’s drug exclusivity landscape, and insights on how to prepare for the potential sweeping changes that a Unitary SPC could bring to the industry.

AmericanConference.com/IPSummit • +44 20 4532 2313

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

SPEAKER FACULTY

PATENT TERM EXTENSIONS MASTERCLASS

CO-CHAIRS Muriel Morel-Pecheux Vice President, Synthetic Molecules Patents, Global Intellectual Property Department Sanofi

Oswin Ridderbusch Partner VOSSIUS & PARTNER

7:45

Rais Amils Arnal Partner Pérez-Llorca

Sebastian Moore Partner, Head of Intellectual Property Herbert Smith Freehill

Célia Benabou International Affairs Officer French Patent and Trademark Office (INPI)

Lena Pauschenwein Directorate-General GROW - Internal Market, Industry, Entrepreneurship and SMEs European Commission

Jochen Beyermann European Patent Attorney F. Hoffmann-La Roche

Muriel Morel-Pecheux Vice President, Synthetic Molecules Patents,Global Intellectual Property Department Sanofi

Xisca Borrás Partner Bristows

Co-Chairs’ Opening Remarks Microphone Muriel Morel-Pecheux, Vice President, Synthetic Molecules Patents, Global Intellectual Property Department, Sanofi Oswin Ridderbusch, Partner, VOSSIUS & PARTNER 9:00

Views from the European Patent Offices: Analyzing Recent Trends in SPC Case Law and How They Are Impacting SPC Approvals Microphone Dr. Imke Salmon, Patent Examiner, German Patent and Trade Mark Office

Dr. Martijn de Lange, Patent Examiner, Netherlands Patent Office

Michael Pears Partner, UK and European Patent Attorney Potter Clarkson

Garreth Duncan Partner D Young & Co LLP

Célia Benabou, International Affairs Officer, French Patent and Trademark Office (INPI) Dr. Patrick Purcell, Patent Examiner, UK Intellectual Property Office

Dr. Patrick Purcell Patent Examiner UK Intellectual Property Office

Dr. Johannes Freudenreich Judge German Federal Patent Court Dr. Martijn de Lange Patent Examiner Netherlands Patent Office Dr. Graham Lewis Partner, European and UK Patent Attorney JA Kemp (UK) José Manuel González European Patent Attorney MIA Patents

Romain Lorentz, Patent & SPC Examiner, French Patent Office (INPI) Moderator: José Manuel González, European Patent Attorney, MIA Patents

Oswin Ridderbusch Partner VOSSIUS & PARTNER Roberto Romandini Legal Member of the Boards of Appeal European Patent Office Jonathan Roses Shareholder Wolf Greenfield & Sacks Dr. Imke Salmon Patent Examiner German Patent and Trade Mark Office

Romain Lorentz Patent & SPC Examiner French Patent Office (INPI)

CREDITS

Registration and Continental Breakfast

8:30

SPEAKERS

EARN CLE

AGENDA

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

Learn how examiners from various different European patent offices are handling SPC cases. Gain insights on how different jurisdictions are interpreting recent case law on SPC and Article 3, as well as strategies for: • Managing the complexities of harmonizing these different interpretations and whether such harmony can be achieved by the ECJ and local jurisdictions • Understanding how recent SPC decision trends in each jurisdiction are impacting SPC approvals 10:15

Developing a Practical Checklist for Preparing and Prosecuting SPC and PTE Applications in Europe, the US and Beyond Microphone Michael Pears, Partner, UK and European Patent Attorney, Potter Clarkson

Jochen Beyermann, European Patent Attorney, F. Hoffmann-La Roche Moderator: Muriel Morel-Pecheux, Vice President, Synthetic Molecules Patents, Global Intellectual Property Department, Sanofi • Devising a pan-European SPC prosecution strategy which takes into consideration the diverging views of national patent offices

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

• Selecting the most appropriate patents on which to base an SPC filing

For more information on ACI’s CLE process visit: www.americanconference.com/accreditation/

• Tips for coordinating the filing and prosecution of SPCs/PTEs around the world

• Devising the optimal product definition for your SPC/PTE application

2 | #IPSummit twitter: @C5_Conferences linkedin: Life Science, Pharma & Biotech:

Legal, IP, Regulatory and Compliance Professionals in Europe

Develop Effective Strategies for Maximizing Patent Lifecycles and Increasing Profits.

See pg. 4 for booking details.

• Developing a PTE/SPC litigation strategy that aligns with your commercial objectives

• A survey of recent CJEU decisions which are impacting scope and validity of SPC rights, A3(a), (b), (c), (d)

• UK: Understanding the post-Brexit SPC filing framework

• A comparison of the national application of the case law in the panelists’ home countries

11:15

• Understanding how the latest case law may impact freedom to operate considerations and assessment of other parties’ SPCs (including squatter SPCs)

Morning Coffee Break

11:45

Unitary SPCs: Addressing Key Questions as to How, Where and When They Would Work Microphone Oswin Ridderbusch, Partner, VOSSIUS & PARTNER Lena Pauschenwein, Directorate-General GROW - Internal Market, Industry, Entrepreneurship and SMEs, European Commission Roberto Romandini, Legal Member of the Boards of Appeal, European Patent Office • Examining how existing SPCs will operate under the Unified Patent Court, and how the new Unitary Patent will affect SPC filing strategies

• Assessing how SPC prosecution strategy may influence a litigation strategy 2:15

Examining the Current Drug Exclusivity Landscape in Europe: Implementing the Latest Strategies for Effective Patent Lifecycle Management Microphone Xisca Borrás , Partner, Bristows Jonathan Roses, Shareholder, Wolf Greenfield & Sacks • Assessing the latest developments in loss of exclusivity and incorporating those developments into your patent lifecycle management strategy

• Exploring the current status of reforms and the plans of the European Commission regarding the introduction of a Unitary SPC • Addressing key practical questions surrounding the implementation of a Unitary SPC: » Which institution is best equipped to examine and grant them? » What potential problems could arise with using the European Patent Office (EPO) or the European Union Intellectual Property Office (EUIPO) as the granting authority for Unitary SPCs? » Understanding how an appeal system would work for a Unitary SPC » How would individual country marketing authorizations play out in the face of a Unitary SPC? • Exploring the possible creation of a single unified examination and grant procedure for national SPCs – as an alternative or as a complementary measure to the introduction of a Unitary SPC » Could the same institution be entrusted with granting Unitary SPCs and national SPCs?

» Strategies for managing data exclusivity, market protection, orphan drug exclusivity, pediatric extensions/pediatric rewards • Understanding how to effectively achieve market exclusivity and protection of clinical trial data to best safeguard your (or your client’s) investment • Examining the recent trend of withdrawing orphan drug status to obtain a pediatric extension » Exploring the latest case law on the validity of this practice and understanding the implications 3:00 3:15

Interpreting Findings from Recent Case Law on Drug Combination SPCs Microphone Garreth Duncan, Partner, D Young & Co LLP Sebastian Moore, Partner, Head of Intellectual Property, Herbert Smith Freehill

» Understanding how appeals against the rejection of national SPCs by a centralized granting authority could be handled » Practical challenges including language-related issues • What could be the potential drawbacks of a Unitary SPC and/or a single unified grant procedure for national SPCs 12:30

Afternoon Break

• Understanding the latest case law on SPC eligibility of patents for combination products • Examining how the latest SPC referral cases are interpretating Article 3(a) and 3(c) of the SPC Regulation » CJEU C-149/22: Merck Sharp & Dohme v. Clonmel Healthcare

Networking Luncheon

» CJEU C-119/22: Teva v Merck Sharp & Dohme 1:30

A Discussion of Recent Case Law With Implications For the Litigation of SPC Rights in Europe Microphone Dr. Johannes Freudenreich, Judge, German Federal Patent Court

• Analyzing the persisting differences in the national practice and case law regarding SPCs for combination products • Incorporating the latest case law into your SPC prosecution strategy 4:00

Conference Ends

Dr. Graham Lewis, Partner, European and UK Patent Attorney, JA Kemp Rais Amils Arnal, Partner, Pérez-Llorca

AmericanConference.com/IPSummit • +44 20 4532 2313

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

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Accreditation will be sought in those

EARN CLE jurisdictions requested by the registrants

"

CREDITS

which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

For over 30 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

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For more information on ACI’s CLE process visit: www.americanconference.com/accreditation/

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