Sarah Burghart Lead IP Litigation Counsel Sandoz
Dr. Holger Dulat VP, Intellectual Property Affimed Sarah Hooson Counsel, Patents Merck Maria Nichol Head of IP Agomab Therapeutics
Guido Pontremoli, Ph.D. Global IP Head Chiesi Farmaceutici S.p.A.
Dr. Corinna Sundermann Senior Vice President, Intellectual Property Management, Business Center COO Fresenius Kabi Deutschland GmbH
Liz Cohen Partner Bristows LLP
Dr. Andreas von Falck Partner Hogan Lovells
After two years and much anticipation, C5’s Flagship Life Sciences IP Summit returns live and in person to Munich.
Join us this October to gain the tactical tools necessary to lead the way in patent protection for your company and clients in the New Era of The Unified Patent Court and Unitary Patent.
It is a new dawn for European patents. The creation of a new Unified Patent Court and a new patent with unitary effect will fundamentally change the international patent prosecution and litigation landscape for years to come. C5 is thrilled to welcome you back to Munich for the 20th anniversary of Europe’s original and best Life Sciences IP Think-Tank at a time when the industry is on the precipice of such significant transformation.
Our esteemed 2022 faculty, comprised of the “in the know” speakers from the pharma, biotech and medical device industries, will provide practical insights on procuring and maintaining patents in the Unitary Patent era, as well as offensive and defensive patent litigation strategies to bring to the UPC.
Through our sophisticated panels, you will also gain insights on how to incorporate the latest developments in plausibility, sufficiency, inventive step and priority into your prosecution and litigation strategies, and will discover up-to-the minute global strategies for claiming and enforcing formulation, combination, second medical use, antibody and epitope patents.
This fall’s event will bring back the renewed opportunities for networking and collaboration that you’ve been waiting for. Reserve your seat and benefit from the collective knowledge of leading in-house IP counsel, patent prosecutors and litigators, the EPO, Munich Patent Court and policy experts from around the world.
Join your colleagues at the premier forum for the European Life Sciences Patent Bar and walk away with critical solutions for your and your clients’ day-to-day practice.
Liz Cohen Partner
Bristows LLP
Antje Brambrink Counsel
Finnegan
udge Edger
Senior Judge
Senior Judge, Civil Law Division - IP Court of The Hague, The Netherlands
District Court The Hague Prins Clauslaan 60 The Hague The Netherlands (+31) 625658083
arah Burghart
e.brinkman@rechtspraak.nl
Lead IP Litigation Counsel Sandoz
Sarah Hooson
Counsel, Patents Merck
Professor Willem Hoyng Partner
HOYNG ROKH MONEGIER
Dr. Andreas von Falck Partner
Hogan Lovells
Mr. Brinkman finished a chemistry degree in 1993, specialising in biochemistry, and a law degree in 1995, both at Utrecht University in The Netherlands. After joining the bar that same year as a solicitor/barrister in Amsterdam focusing on patents and regulatory affairs, he was appointed judge at the Court of The Hague, IP department in 2002. He became a senior judge in 2007. He has been involved in many patent and other IP cases and speaks regularly on international conferences.
Bryan Diner Patent Attorney Finnegan
Dr. Holger Dulat VP, Intellectual Property Affimed Mike Gilbert Partner
Marks & Clerk
James M. Gould Counsel RatnerPrestia
Martin Herzog Patent Attorney Herzog IP Patentanwalts GmbH
Chairman, Advisory Committee of the UPC Member, Drafting Committee of the Rules of Proceedings of the UPC Matthew Jones Partner
EIP
Dr. Natalie Kirchhofer Partner
COHAUSZ & FLORACK
Dr. Philipp Marchand Partner
VOSSIUS & PARTNER
Dr. Stephan Neuhaus Partner
Allen & Overy LLP
Maria Nichol
Head of IP Agomab Therapeutics
Domien Op de Beeck Partner
Bird & Bird
Guido Pontremoli, Ph.D.
Global IP Head
Chiesi Farmaceutici S.p.A.
Roberto Rodriguez Partner
Licks Attorneys
Kristof Roox Partner
Crowell & Moring LLP
Kristel Schorr Partner
Foley & Lardner LLP
Jochen Spuck Chief Technology Officer
EconSight
Dr. Corinna Sundermann Senior Vice President
Intellectual Property Management Business Center COO Fresenius Kabi Deutschland GmbH
Charlotte Teall Partner, Life Sciences & Chemistry Forresters
Lathrop GPM LLP
Dr. Heike Vogelsang-Wenke Patent Attorney Grünecker
Dr. Andreas von Falck Partner
Hogan Lovells
Ningling Wang Partner
Finnegan (China)
Ha Kung Wong Partner Venable
Jan Carl Zillies Partner, Dr., Pharmacist, German and European Patent Attorney Hoffmann Eitle
Dr. Jörk Zwicker Partner Zwicker Schnappauf & Partner Patentanwälte
7:45
Registration and Continental Breakfast
8:45
Microphone Liz Cohen, Partner, Bristows LLP
Dr. Andreas von Falck, Partner, Hogan Lovells
Preparing for the Unitary Patent and the Unified Patent Court
9:00
Examining the Current Status of the UP and UPC: Final Steps to Implementation and Practical Considerations for Patent Practitioners
Microphone Professor Willem Hoyng, Partner, HOYNG ROKH MONEGIER, Chairman, Advisory Committee of the UPC, Member, Drafting Committee of the Rules of Proceedings of the UPC
Judge Edger F. Brinkman, Senior Judge, Civil Law Division - IP, Court of The Hague, The Netherlands
• Status report on preparatory activities and deadlines for the start of operations, sunrise period and opt in / opt out
• How were the judges selected?
• To what extent will there be training programs?
• Should life science companies opt out, choose UP’s etc.?
• Examining last minute changes to the Rules of Proceedings and their significance
• Assessing the extra territorial possibilities of the UPC - Do they exist?
10:00
Devising Successful Strategies for Procuring and Maintaining Patents in the New Unitary Patent Era
Microphone Dr. Heike Vogelsang-Wenke, Patent Attorney, Grünecker
Antje Brambrink, Counsel, Finnegan
• Exploring patent drafting and filing considerations amidst the new UP landscape
• Evaluating the European Patent and Unitary Patent alternatives
» When should you apply for a patent nationally and opt out of playing in the UPC playground?
• Re-assessing your patent prosecution strategies in light of the relative benefits and risks of applying for Unitary Patents, European Patents and National Patents
• Reviewing your patent portfolio together with your litigation risks and strategies to identify which patents you want to opt-in and opt-out during the sunrise period
» What are the benefits of opting out or opting in? When should you opt in / opt out?
» Requirements for registering an opt-out EP in a Sunrise register
» Understanding when and under what circumstances you can withdraw an opt-out
» Considering the impact of the jurisdictional scope of the UPC and the ongoing potential for parallel proceedings in countries that are not participating in the UPC
• Considering the potential impact of the UPC/ UP on patent license agreements
» Determining whether licensed patents should be opted out
» Making amendments to jurisdiction and enforcement clauses that may be affected by the new UPC structure
• Assessing the costs of obtaining and maintaining a UP vs. classic European Patent vs. national patent
» Comparing validation costs and renewal fees and factoring that into your patent prosecution strategy
11:00 Morning Coffee Break
11:30
Identifying Key Offensive and Defensive Patent Litigation Strategies to Bring Into the UPC
Microphone Sarah Burghart, Lead IP Litigation Counsel, Sandoz
Dr. Andreas von Falck, Partner, Hogan Lovells
Domien Op de Beeck, Partner, Bird & Bird
Dr Stephan Neuhaus, Partner, Allen & Overy LLP
• Developing litigation strategies for the new opportunities and challenges of the UPC
• Understanding the interplay between opposition proceedings at the EPO and validity challenges in the UPC
• How do you prepare to bring a lawsuit in the UPC? How do you prepare for defensive litigation if you know you’re going to be sued in the UPC?
• Identifying preemptive strikes that can be taken when the court opens
• Strategies for the use of preliminary injunctions, seizure of evidence and ex-parte measures
• Understanding how the Unified Patent Court will handle bifurcation of cases, stays and speed of proceedings
12:30
Networking Luncheon for Speakers and Delegates
Focus on Formulations, Combination Patents and Second Medical Uses
PART I
1:30
Plausibility, Sufficiency, and Inventive Step: The Latest Considerations for Substances, Formulations, Combination Patents and Second Medical Use Patents in Europe
Microphone Dr. Corinna Sundermann, Senior Vice President, Intellectual Property Management, Business Center COO, Fresenius Kabi Deutschland GmbH
Mike Gilbert, Partner, Marks & Clerk
• Analyzing the current status of the EPO Enlarged Board of Appeals Referral G 2/21: will plausibility close or open the door for relying on post-published evidence?
» Assessing the anticipated implications of this ruling on future patent prosecution strategies
• As we await the written decision of the Board of Appeal – understanding in what situations post-published evidence can be considered to support the effect of the invention
• Overcoming the key challenges and hurdles currently being faced in obtaining formulation, combination and second medical use patents in Europe (as related to showing plausibility, sufficiency and inventive step)
• Incorporating the latest EPO and national case law into your strategies for procuring, maintaining and enforcing these types of patents
PART II
2:30
Global Strategy Session: Interactive Roundtable on Transnational Tactics for Claiming and Enforcing Formulation, Combination and Second Medical Use Patents
Microphone Ningling Wang, Partner, Finnegan (China)
Guido Pontremoli, Ph.D., Global IP Head, Chiesi Farmaceutici S.p.A. (Italy)
Legal,
• Exploring patent drafting and filing considerations amidst the new UP landscape
• Evaluating the European Patent and Unitary Patent alternatives
» When should you apply for a patent nationally and opt out of playing in the UPC playground?
• Re-assessing your patent prosecution strategies in light of the relative benefits and risks of applying for Unitary Patents, European Patents and National Patents
• Reviewing your patent portfolio together with your litigation risks and strategies to identify which patents you want to opt-in and opt-out during the sunrise period
» What are the benefits of opting out or opting in? When should you opt in / opt out?
» Requirements for registering an opt-out EP in a Sunrise register
» Understanding when and under what circumstances you can withdraw an opt-out
» Considering the impact of the jurisdictional scope of the UPC and the ongoing potential for parallel proceedings in countries that are not participating in the UPC
• Considering the potential impact of the UPC/UP on patent license agreements
» Determining whether licensed patents should be opted out
» Making amendments to jurisdiction and enforcement clauses that may be affected by the new UPC structure
• Assessing the costs of obtaining and maintaining a UP vs. classic European Patent vs. national patent
» Comparing validation costs and renewal fees and factoring that into your patent prosecution strategy
3:45 Afternoon Break
4:00
Maximizing the Chances of Success in a Bet-the-Company Pharmaceutical Litigation
Microphone HaKung Wong, Partner, Venable
Bryan Diner, Patent Attorney, Finnegan
• Best practices for utilizing a mock trial in advance of litigation
• Identifying the processes and criteria for selecting the absolute best expert witnesses
• Tools for success in direct examinations and cross examinations
• Partnering with inside counsel to make critical strategic decisions
5:00
DAY TWO 18 OCTOBER 2022
8:00
8:45
Continental Breakfast
Co-Chairs’ Opening Remarks & Recap of Day 1
9:00
Entitlement to Priority: Incorporating the Latest EPO and National Jurisprudence into Your Patent Prosecution and Enforcement Strategies
Microphone Maria Nichol, Head of IP, Agomab Therapeutics
Charlotte Teall, Partner, Life Sciences & Chemistry, Forresters
• Understanding the potential consequences and pitfalls of claiming priority at the European Patent Office
• Crafting bullet-proof strategies for avoiding invalid priority claims that could jeopardize the protection of your patent
• Examining the recent referral before the EPO Enlarged Board of Appeal on the issue of priority entitlement (consolidated cases T 1513/17 and T 2719/19)
» What might the potential implications of this BoA decision be on the “joint applicants” approach to claiming priority?
9:45
A Tactical Tool-Kit for Antibody and Epitope Claims: The Latest Strategies for Successfully Claiming Antibody Patents and Epitopes in Europe and the U.S.
Microphone James Velema, Partner, Lathrop GPM LLP
Holger Dulat, VP, Intellectual Property, Affimed
Dr. Jörk Zwicker, Partner, Zwicker Schnappauf & Partner Patentanwälte PartG mbB
Drafting antibody claims is a complex endeavor, and questions surrounding which claims are patentable in Europe and the U.S. remain increasingly difficult to navigate. This panel will offer solutions for successful patenting strategies and global commercialization. Points of discussion include:
• Tactical tools for drafting and claiming antibodies in view of developing case law in Europe and the U.S.
• Understanding different patent office interpretations of antibody claims
• Drafting claims to secure protection across different jurisdictions
• Examining the U.S. Federal Circuit decision in Amgen v Sanofi (Fed. Cir. 2021)
» How has this case raised the enablement bar for antibody patents and what are the implications for practitioners?
• Assessing the recent EPO Board of Appeal decision maintaining a functional epitope antibody genus claim (T 1964/18)
» How will this decision impact antibody claim prosecution strategies going forward?
» How does this outcome compare and contrast to the US and its written description requirement?
10:45 Morning Break
11:15
Key Considerations Regarding Patenting & Artificial Intelligence in Europe and Abroad
Microphone Martin Herzog, Patent Attorney, Herzog IP Patentanwalts GmbH
Dr. Philipp Marchand, Partner, VOSSIUS & PARTNER
Jochen Spuck , Chief Technology Officer, EconSight
Inventions generated by AI are challenging the global patent system in a whole new way, as the key question often becomes “who” did the inventing, rather than “what” was invented. In the absence of clear laws setting out how to assess AI-generated inventions, patent registries and judges currently have to interpret and apply existing law as best they can – and this creates significant uncertainty amongst patent practitioners.
• Exploring how AI is currently disrupting the patent strategies of life sciences companies
» AI & patent propelled identification of “hot” fields in life science industry
» AI application for “inventing” in a hot technical field
» AI & patent propelled grant prediction of “inventions”
» AI & patents
• Legal framework
• Case law principles relating to AI being an “inventor”: UK, US, EP, DE, AU, ZA
• Legislative initiatives impacting this in the UK
Group’s
• Considerations and strategies for getting AIrelated patents past the EPO
• How does procurement of such patents differ in Europe vs. the U.S?
• Navigating the CRISPR patent and licensing landscape
• How might AI shift the bar on obviousness and inventive step in the future?
12:15 Networking Luncheon
1:15
Clinical Trial Disclosures and IP Rights – Overcoming the Obstacles to Patentability in Europe and the U.S.
Microphone Jan Carl Zillies, Partner, Dr., Pharmacist, German and European Patent Attorney, Hoffmann Eitle Dr. Natalie Kirchhofer, Partner, COHAUSZ & FLORACK
Kristel Schorr, Partner, Foley & Lardner LLP
• Under what circumstances can the mere publication of the fact that a trial is ongoing be detrimental to the patentability of a corresponding patent due to lack of inventive step?
» What is the latest EPO and national case law saying about this?
• Understanding the risk of prior art disclosures: at what point are you disclosing a patentable finding to the public?
• Recommendations for avoiding clinical trials becoming an obstacle to patentability in Europe and the U.S.
» What steps can companies take to reduce the risk of clinical trials becoming prior art?
• Examining the new EU Clinical Trials Regulation (EU No. 536/2014) which will increase transparency of information on clinical trials (effective 31 January 2022): what are the implications and considerations for IP filing strategies?
Microphone Sara Hooson, Counsel, Patents, Merck
James M. Gould, Co-Chair of the Pharmaceutical, Biopharma and Life Sciences Industry Group and Counsel, RatnerPrestia
This panel will analyze GSK v. Teva – a case potentially impacting the future use of skinny label carve outs in the U.S. Topics of discussion will include:
• Understanding the implications of the Federal Circuit opinion affirming a jury’s finding of infringement despite Teva’s skinny label carveouts
• Analysis of Teva’s Petition to the Supreme Court requesting review of the Federal Circuit’s opinion
• Evaluation of the potential risks generic companies face―in view of the Federal Circuit’s opinion— when launching with a skinny label
• What impact will GSK v. Teva have on prosecution strategies and tactics for drafting claim language and label language?
• Incorporating skinny labeling considerations into your patent prosecution strategy in light of GSK v. Teva
» When to start thinking about these issues in the early stages of planning your patent protection
3:00 Afternoon Break
3:15
Life Sciences Litigator Think Tank: “What I Wish the Patent Prosecutor Would Have Done”
Microphone Kristof Roox, Partner, Crowell & Moring LLP
Matthew Jones, Partner, EIP
This unique session will feature a panel of patent litigators who will share personal accounts of challenges they have faced in litigation and reflect on what they wished the prosecutor of the patent would have done in the early stages to prevent or mitigate the issues that developed down the road. The panelists will talk through scenarios where a more favorable outcome could have been achieved in litigation had the prosecutor:
• Changed certain language in the claim
• Argued or negotiated something differently during prosecution
• Built or strategized the portfolio in a different way overall
4:00
Conference Concludes
Hotel: The Westin Grand Munich
Address: Arabellastraße 6, 81925 München, Germany
About us:
The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.
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.
Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.
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.
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.
For more information on ACI’s CLE process visit:
Biotech: Legal, IP, Regulatory and Compliance Professionals in Europe
Pharma
2:15
What’s the Skinny on Skinny Labels in the U.S.?: What Every Life Science IP Lawyer in Europe Needs to Know
specialized forum
on SPCs
Patent
Around the World
aximizing your patent lifecycle
essential to maximizing your profit.
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.
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.
Muriel Morel-Pecheux
Vice President, Synthetic Molecules Patents, Global Intellectual Property Department Sanofi
Rais Amils Arnal Partner
Pérez-Llorca
Célia Benabou International Affairs Officer
French Patent and Trademark Office (INPI)
Jochen Beyermann European Patent Attorney F. Hoffmann-La Roche
Xisca Borrás Partner Bristows arreth Duncan Partner D Young & Co LLP
r. 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)
Oswin Ridderbusch Partner VOSSIUS & PARTNER
Co-Chairs’ Opening Remarks
Sebastian Moore Partner, Head of Intellectual Property
Herbert Smith Freehill
Lena Pauschenwein
Directorate-General GROW - Internal Market, Industry, Entrepreneurship and SMEs European Commission
Muriel Morel-Pecheux Vice President, Synthetic Molecules Patents,Global Intellectual Property Department Sanofi
Michael Pears Partner, UK and European Patent Attorney Potter Clarkson
Dr. Patrick Purcell Patent Examiner UK Intellectual Property Office
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
Microphone Muriel Morel-Pecheux, Vice President, Synthetic Molecules
Global Intellectual Property Department, Sanofi Oswin Ridderbusch, Partner, VOSSIUS & PARTNER
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
Célia Benabou, International Affairs Officer, French Patent and Trademark Office (INPI)
Dr. Patrick Purcell, Patent Examiner, UK Intellectual Property Office
Romain Lorentz, Patent & SPC Examiner, French Patent Office (INPI)
Moderator: José Manuel González, European Patent Attorney, MIA Patents
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
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.
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.
For more information on ACI’s CLE process visit: www.americanconference.com/accreditation/
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
• Selecting the most appropriate patents on which to base an SPC filing
• Devising the optimal product definition for your SPC/PTE application
• Tips for coordinating the filing and prosecution of SPCs/PTEs around the world
• Developing a PTE/SPC litigation strategy that aligns with your commercial objectives
• UK: Understanding the post-Brexit SPC filing framework
11:15 Morning Coffee Break
11:45
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
• 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?
» 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 Networking Luncheon
1:30
Microphone Dr. Johannes Freudenreich, Judge, German Federal Patent Court
Dr. Graham Lewis, Partner, European and UK Patent Attorney, JA Kemp
Rais Amils Arnal, Partner, Pérez-Llorca
See pg. 10 for booking details.
• A survey of recent CJEU decisions which are impacting scope and validity of SPC rights, A3(a), (b), (c), (d)
• A comparison of the national application of the case law in the panelists’ home countries
• Understanding how the latest case law may impact freedom to operate considerations and assessment of other parties’ SPCs (including squatter SPCs)
• 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
» 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 Afternoon Break
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 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
» CJEU C-119/22: Teva v Merck Sharp & Dohme
• 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
Part of C5 Group’s
