Prelude Summit | Pharma & Biotech Patent Litigation in Europe

Prelude Summit

Day One | Day Two


12:10	Opening Remarks from the Co-Chairs Dominic Adair Partner Bristows LLP (U.K) Ruud van der Velden Partner Hogan Lovells

12:15	UPC Think Tank: Ratification, Implementation, and Protocols Domien Op de Beeck Partner Bird & Bird Jochen Herr Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP The Unitary Patent and the Unified Patent Court have been designed to bring forth a simpler, cost-effective means of protecting and enforcing patents in Europe. In 2022, the UP and UPC will supplement and strengthen the existing centralised European patent granting system. They will offer users of the patent system a cost-effective option for patent protection and dispute settlement across Europe. Topics of discussion will include: Considering the costs and benefits of the system for patent applications Understanding the territorial scope of protection Predicting the impact to litigation and legal certainty Detailing the non-exclusive jurisdiction for all national validations of European patents

1:00	Patent Enforcement Roundtable: Best Practices for Protecting Patent Rights and the Procedures to Enforce Them António Andrade Partner Abreu Advogados Laëtitia Bénard Partner Allen & Overy LLP Dr Penny Gilbert Partner Powell Gilbert LLP The European patent system is experiencing a major reformation centered on the idea of unifying the European patent system. For decades, patent enforcement decisions across jurisdictions within Europe have produced contradictory enforcement decisions across jurisdictions within Europe. There are important differences in the legal systems across the jurisdictions, and the strategies for practicing, protecting and enforcing must take these differences into account. Topics of discussion will include: Comparing the timelines of proceedings across jurisdictions Reconciling the proportionality of defenses Predicting cross-border injunctions in the region

2:15	1:1 Networking Break

3:00	The ABCs of SPCs: Scope, Duration and Requirements Steven Baldwin Partner Kirkland & Ellis LLP Sture Rygaard Partner Pleasner SPCs and Brexit SPCs and the UPC Update on recent case law The CJEU Teva and Royalty Pharma The MSD referral The CJEU Santen-decision SPC squatting

3:45	Second Medical Use: Reconciling Infringement and Enforcement Sara Burghart Lead IP Litigation Counsel Global Litigation & Launch – Global IP Sandoz International GmbH (DEU) Miquel Montañá Partner Clifford Chance S.l. Jonas Westerberg Partner Westerberg & Partners Advokatbyrå AB Patents that cover new uses for previously known medicines are called “second medical use patents”. This form of patent protection has drawn much attention in recent years as courts around the world continue to adjudicate the complex questions that underlie them. Topics of discussion will include: Understanding second medical use patents & carve Out Strategies Clarifying the patentability of further medical use inventions Assessing the implications of second use patents for: Regulatory Market Access Legal Outlining the implications What form can second medical use claims take? What must be established for a second medical use patent to be infringed? How do you enforce a second medical use patent? Can you prevent off-label use?

4:30	Conference Adjourns to Day Two

Day Two


12:10	Opening Remarks and Recap from the Co-Chairs Dominic Adair Partner Bristows LLP (U.K) Ruud van der Velden Partner Hogan Lovells

12:15	Compulsory Licensing: Access to Medicines, The TRIPS Agreement and Vaccines Daan de Lange Partner Brinkhof Advocaten Peter Ling Partner Lenz & Staehelin Anticipating the potential impact of COVID-19 on IP legal matters, including patent protection for new uses and diagnostics How will IP protection work? Can the distribution of a vaccine await licensing and agreement on pricing? What is the impact to IP licensing and enforcement? Compulsory licenses in Europe Assessing COVID-19 related antibody litigation Developing strategies for evolving to succeed in a post-COVID marketplace

1:00	The Latest Developments Impacting Preliminary Injunctions in Europe Dominic Adair Partner Bristows LLP (U.K) Selma Ünlü Senior Partner NSN Law Firm Dr. Kai Rüting Partner Vossius & Partner In a recent referral to the CJEU, the Munich Regional Court opposed what it considered to be an overly restrictive practice of in proceedings for preliminary injunctions in patent matters. According to current practice, the patent must have survived nullity or opposition proceedings and hence a “second examination” of the patent (in addition to the granting procedure) as one of the conditions for a preliminary injunction (PI). This referral is astonishing (sensational?) as the Munich I Regional Court de facto lets the CJEU review a practice which originated from the Düsseldorf Court of Appeal. There is no decision of the CJEU yet but there is the chance that PIs may be obtained much easier in the future. There has, since long, been an exception to this rule of “second examination” in Generics-Originator proceedings, but this exception may be extended to further proceedings (originator-originator or Gx-Gx).

1:45	1:1 Networking Break

2:00	Patent Enforcement Liability Towards Third Parties: Liability and Unjust Enrichment on Retrospectively Invalid Patents Eran Bareket Partner, Head of Legal Practice Gilat, Bareket & Co., Attorneys at Law Jean-Hyacinthe de Mitry Partner Gide Loyrette Nouel A.A.R.P.I Ruud van der Velden Partner Hogan Lovells On October 14, 2020 the decision in Menzis/AstraZeneca was issued by the District Court of The Hague. The District Court considered AstraZeneca liable for damages vis-à-vis health insurer Menzis because of AstraZeneca’s enforcement of a patent against a generic manufacturer. AstaZeneca was initially awarded an injunction which AstraZeneca enforced, but the patent was later revoked. The District Court held that AstraZeneca had been unjustifiably enriched at the expense of health insurer Menzis by enforcing the preliminary injunction based on the patent against the generic manufacturer. The District Court considered that the enforcement precluded Menzis from designating a generic quetiapine product as ‘preferred product’ under its preference policy, so that Menzis had to reimburse the price of the originator product instead of a cheaper generic product.

2:45	Mediation and Arbitration in European Pharma & Biotech Patent Law Professor Dr. Maximilian Haedicke Professor of Intellectual Property Law Freiburg University (Former Judge at Higher Regional Court of Duesseldorf) André Pohlmann Member of the 5th Board of Appeal European Union Intellectual Property Office Understanding how BoA and the EUIPO helps with ADR ADRs in the EUIPO Boards of Appeal Assisted Negotiation and Expert Determination Effective Dispute Resolution (EDR) Co-mediation mechanisms ADR Cooperation Initiatives Detailing why parties should consider using EUIPO ADR mechanisms Combining parallel disputes at national and international levels into one resolution Avoiding complex litigation proceedings Achieving quicker, more efficient outcomes in a cost-effective way

3:30	Conference Concludes

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