November 7 (Tue)
Latest Developments and Strategies /
欧米の知財最新動向と戦略
8:30 – 8:55 Registration / 受付
8:55 – 9:00 Welcome / ご挨拶
9:00 – 9:30
Update on significant decisions of the US Supreme Court, the CAFC, and PTAB / 米国最高裁とCAFC、PTABの重要判決
(Gerald Hrycyszyn / Scott McKeown)
Through the ever-evolving world of patent law, recent holdings from the Supreme Court, the Federal Circuit, and PTAB provide impactful shifts that are shaping the future of IP. The Supreme Court's decision on enablement will impact how patent practitioners prepare, prosecute, and strategically develop patent portfolios. Also before the Supreme Court is an impactful petition in CareDx v. Natera, related to whether a new and useful method for measuring a natural phenomenon is eligible for patent protection under 35 U.S.C. § 101. Other notable CAFC cases are Medtronic v. Teleflex, which addresses prior conception and reduction to practice required to antedate a prior art reference, and HIP v. Hormel, which addresses issues of joint inventorship. Of interest are also standing orders in the District of Delaware requiring parties in patent cases to disclose who is funding the litigation and who stands to benefit from it. Earlier this year, the CAFC denied as premature a petition for mandamus to halt these inquiries. Finally, a precedential PTAB decision, CommScope v. Dali, puts the emphasis back on the Fintiv analysis in institution decisions.
9:30 – 10:00
160 days since the start of the Unified Patent Court (UPC) – first lessons learned / 統一特許裁判所（UPC）開始から160日間で得た教訓
(Dr. Clemens Tobias Steins)
Although about half of all eligible patents have been excluded from the UPC's competence by opting out, the new court has had a good start since opening its doors on June 1, 2023. The first inter partes and ex parte injunctions have been granted, and the first preliminary objection decisions have been handed down. We will report on our first-hand impressions of the hearings and proceedings and draw conclusions for future proceedings. The first cases defy many expectations – they are much more diverse than expected. The court is not overly used to invalidating patents, but rather to enforcing them. The plaintiffs are both large and small companies, and they include Amgen, Astellas, Panasonic and Harvard. Technologies in suit range from biotechnology over mobile telecommunications to cappuccino milk foam.
10:00 – 10:55
Litigation strategies and forum shopping in Europe (involving national courts and the UPC) and in the US / 欧州（国内裁判所・UPC）および米国における訴訟戦略とフォーラムショッピング
(Dr. Dirk Schüssler-Langeheine / Dr. Mark A G Jones / Gerald Hrycyszyn)
In Europe, the litigation landscape has become more complex after the introduction of the UPC and the shared jurisdiction of the national courts and the UPC for all European patents which are not opted out. Creative litigation strategists exploit these options effectively, both for patent assertion and for defensive measures. We will discuss how to benefit from the new opportunities and avoid unpleasant surprises and disadvantages! --- With the advent of the UPC, all eyes are on Europe for the possibilities afforded by a new venue for patent litigation. However, across the Channel, the British Courts continue to develop possibilities for addressing disputes with significant elements outside the UK. This short briefing looks at how far the British courts have gone in expanding their jurisdictional reach, and considers how far, post-Brexit, they might continue to do so --- In the U.S., there are several ways in which forum shopping in patent cases has been addressed, but it has by no means eliminated the practice. For example, the Supreme Court’s 2017 ruling on a venue in T.C. Heartland dealt a substantial blow to forum shopping. Recent mandamus rulings from the CAFC further tamped down filings in forums like the Western District of Texas favored by plaintiffs and made it easier to transfer out of such districts. Local rules in the Western District of Texas likewise helped limit the patent filings in that district. But plaintiffs continue to look for ways to file cases in favored forums they believe offer some advantages.
10:55 – 11:15 Coffee break / 休憩
11:15 – 12:00
Update on preliminary injunctions in Europe and equitable remedies in the US / 欧州における仮差止命令と米国における衡平法上の救済措置に関する最新情報
(Dr. Michael Pfeifer / Gerald Hrycyszyn )
Decisions on requests for preliminary injunctions are among the first handed down by the UPC - a particular challenge in view of considerable differences between the European jurisdictions. In parallel, the German courts are rebalancing their requirements for granting preliminary injunctions following the 2022 CJEU decision in Phoenix Contact (C-44/21). Plaintiffs and defendants alike need to be prepared to more than ever thoroughly discuss validity matters already in preliminary proceedings. --- In the U.S., in addition to monetary damages, there are various equitable remedies a patent owner can seek to prevent or halt harm arising from patent infringement: a temporary restraining order, a preliminary injunction, and a permanent injunction. There are different requirements a patent owner must satisfy for these different remedies.
12:00 – 12:45
Defense strategies: How to use IPRs in the US and what to do when you are sued before the UPC / 防衛戦略：米国でのIPRの活用法とUPCで提訴された場合の対処法
(Scott McKeown / Dr. Dirk Schüssler-Langeheine)
In the US, IPRs at the PTAB play an important role for an effective defense strategy. In that context, also ITC matters and timing have to be considered. We will also present the Apple v. Cal Tech case with regard to the scope of estoppel. --- As for Europe, many companies have opted out large parts of their portfolios from the Jurisdiction of the UPC. However, no company active on the European market is safe from being sued before the UPC. What is important to have in mind when you have to defend an action before the UPC is illustrated in this mini mock trial simulating an interim hearing.
12:45 - 14:00 Lunch break / 昼食 (Roppongi Hills Club)
14:00 – 14:45
A final look on plausibility by the EPO and its impact in Europe and enablement/written description requirements in the US / EPOによるPlausibilityの最終見解と欧州での影響、および米国における実施可能要件・記述要件に関する考察
(Dr. Daniel Grohs / Dr. Jeffrey D. Hsi)
The concept of plausibility has caused great controversy in European patent law in recent years. It was hoped that the decision of the Enlarged Board of Appeal (EBA) of the EPO in G 2/21 would bring clarity. Since the referral questions by Board 3.3.02 were very clear and seemed to present reasonable alternatives from which the Enlarged Board could have selected one, this hope appeared justified. However, following the Enlarged Board’s answer in G 2/21, many questions remain. In our presentation, we will shed light on the consequences arising from G 2/21. Similarly, appropriate support in filing of an application and the use of subsequent post-filing data to establish enablement under US requirements for patentability will be discussed. Additionally, we will discuss recent decisions by the US courts that have directed focus on the US requirement for a written description giving rise to questions on the appropriate standard to be applied.
14:45 – 15:15
Formal priority after the EPO´s Enlarged Board of Appeal decisions G1/22 and G2/22 / EPO拡大審判部決定G1/22およびG2/22後の形式的優先権
(Dr. Clemens Tobias Steins)
The decisions G1/22 and G2/22 of the Enlarged Board of Appeal will bring more clarity to the contentious issue of formal priority which can arise if the applicant(s) of the subsequent application differ(s) from the applicant(s) of the priority application.
15:15 – 15:30 Coffee break / 休憩
15:30 – 16:15
New rules and case law on patent exhaustion in Europe and the US / 欧州・米国における特許消尽に関する新しい規則と判例法
(Holger Stratmann / Gerald Hrycyszyn)
Recent decisions of the Japanese courts in Brother and Ricoh I and II give rise to the question whether issues of abuse of rights and antitrust law should be considered when deciding on patent exhaustion. Views from Europe and the US will be provided as a basis for a comparative discussion of how to solve the repair vs. manufacture or first sale doctrine in light of circumstances with a particular impact on the market.
16:15 – 17:00
Liability for infringement for acts (partly) carried out abroad – a comparative case study / (一部)外国で行われた特許侵害行為に対する責任－比較事例研究
(Dr. Michael Pfeifer / Dr. Andreas Stefferl / Dr. Jeffrey D. Hsi)
Liability for patent infringement in cases where certain steps of a patented process or method are realized abroad continues to be a hot topic throughout the jurisdictions. We will provide a comparative analysis on the Japanese Dwango vs. FC2 IP High Court decision and present a case study on liability for products directly obtained by a process performed abroad.
17:00 – 17:30 Q&A / 質疑応答
17:30 End of Conference Day 1
18:00 Reception dinner / レセプション・ディナー (Roppongi Hills Club)
基調講演
日立製作所 グローバル知的財産統括本部 知財イノベーション本部 担当本部長 比嘉正人 氏
「変化し続ける知財マネジメント －事業貢献のために－」
本基調講演では、日立製作所の知財部門が社会・事業の変化にどのように対応し、今後、どのようなアプローチで事業に貢献しようとしているかをご紹介します。
Keynote speech
Hitachi, Ltd., Mr. Masato Higa, General Manager, IP Strategy, Creation and Protection, IP Innovation Division, Global Intellectual Property Group
(Patent Attorney (JP))
Title: "Keep changing IP management - For contribution to the company's business"
Summary: In the keynote, we will learn how Hitachi’s IP department survived through environmental and business changes and how Hitachi’s IP department will try to contribute to Hitachi’s business in the future.
November 8 (Wed)
Morning Session: Focus Life Sciences / ライフサイエンス
8:30 – 8:55 Registration / 受付
8:55 – 9:00 Welcome / ご挨拶
9:00 – 9:40
US Supreme Court Amgen vs. Sanofi and its impact on enablement / Amgen 対 Sanofi 事件に関する米国最高裁判決と実施可能性への影響
(Dr. John Van Amsterdam / Dr. Andreas Stefferl)
The US Supreme Court issued a decision this year that impacts how the enablement requirement is implemented for all types of inventions in the US. Although focused on a particular antibody invention, the Amgen v. Sanofi decision is applicable to any technological field, and requires more comprehensive teaching of how to make and use an invention to obtain broad claims. The US discussion on the "patent bargain" finds its European counterpart in the form of "plausibility". We will thus discuss what G 2/21 means for broad antibody claims under the EPC. We will also look at how the litigation on PCSK9 inhibitors has developed in Europe and Japan.
9:40 – 10:15
Teva v. GSK (CAFC) and the current state of "skinny labeling" by generic drug manufacturers in the US and in Europe / Teva 対GSK（CAFC）事件と、米国・欧州でのジェネリック医薬品メーカーによる「スキニー・ラベル」の現状
(Dr. Jeffrey D. Hsi / Dr. Michael Pfeifer)
An update on the US Supreme Court petition for certiorari in Teva v. GSK and the resulting state of "skinny labeling" in US pharmaceutical patent infringement will be discussed. For Europe, we will give an update on the recent case law on skinny labelling and infringement of patent and regulatory law.
10:15 – 10:45
Obvious-type double-patenting after the CAFC’s decision In re Cellect / CAFCのIn re Cellect事件判決とObvious-type double-patenting
(Scott McKeown)
10:45 – 11:00 Coffee break / 休憩
11:00 – 11:40
Clinical trials as prior art – Practical advice following from the most recent EPO case law and update on the US / 先行技術としての臨床試験－最新のEPO判例に基づく実践的アドバイスと米国最新情報
(Dr. Jan Carl Zillies / Dr. Jeffrey D. Hsi)
T 670/20 - Clinical trial medication as prior art? Clinical trials were carried out in accordance with the EMEA Guidelines for Good Clinical Practice requiring adherence to the prescribed protocol and assurance of drug accountability. Patients who decided to participate in the trials agreed, following their informed consent, to use the provided medication according to instruction or to return the unused medication. Accordingly, participating patients who were provided with the tablets under investigation entered into a special relationship with the investigators of the trials and were – with regard to the provided tablets – not members of the public that could freely dispose over these tablets. We will also discuss the implications in the US of the initiation of and published information on clinical studies for the discussion of novelty and inventive step of patent applications relating to further results and observations.
11:40 – 12:20
Case study: Doctrine of Equivalence for biological products defined by sequence information / 事例研究：配列情報によって定義される生物製剤の均等論
(Dr. Andreas Stefferl / Dr. John Van Amsterdam)
A number of decisions appeared to narrow the practical applicability of the doctrine of equivalence in Germany. This case study reports that a claim directed to specific, structurally limited proteins can provide protection outside its literal scope, even when there are significant structural differences in the infringing embodiment. It confirms the potential practical use of the doctrine of equivalence in the field of biotechnological inventions. The US counterpart will be discussed in the context of recent cases that focus on the doctrine of equivalence as applied to biological products.
12:20 – 12:30 Q&A / 質疑応答
12:30 - 13:30 Lunch break / 昼食 (Roppongi Hills Club)
Afternoon Session: Focus Digital Technologies / デジタルテクノロジー
13:30 – 14:15
Challenges of IP protection for AI generated content in drug development and other context / 医薬品等の開発におけるAI生成コンテンツの知財保護の課題
(Edmund Walsh / Dr. Andreas Stefferl / Dr. Axel T. Esser)
Generative AI has the potential to dramatically change countless ways in which we do business. In 2023, following a new release of ChatGPT, businesses have noticed the startling possibilities. We’ll discuss the opportunities and challenges of IP protection for AI-generated text, software, images, drug structures, and other content that underlies businesses built on AI-generated content. Digital innovations in AI, machine learning, quantum computing and others are becoming ubiquitous for the health industry. Yet, protecting such digital innovations is a challenge in Europe and may become even more challenging in view of recent decisions and developments at the EPO.
14:15 – 15:00
Risks of functional claiming and the importance of experimental data for sufficiency of disclosure and inventive step / 機能的クレームのリスク、開示の十分性と進歩性のための実験データの重要性
(Edmund Walsh / Michele Baccelli)
Functional claims are attractive to patent practitioners because they can broadly capture myriad ways to implement an inventive concept. The trend in U.S. courts, however, is against this practice. The Supreme Court’s decision in Alice v. CLS Bank International, for example, has led to many functional claims for software-implemented inventions being invalidated for being too abstract. American Axle v. Neapco Holdings surprised many with the prospect that a similar reasoning might apply even to mechanical inventions. A potential new challenge has emerged with Amgen v. Sanofi, which potentially impacts claims that generically recite elements of an invention. While Amgen related to biotechnology, we’ll discuss the prospects and consequences of an analogous reasoning being applied to electronic and mechanical inventions. --- From a European perspective it is important that inventions in the digital realm often rely on abstract elements including models, simulators, neuronal networks and artificial intelligence engines. While the EPO is ready to accept inventions at that level of abstractness, the requirements on sufficient disclosure and presenting plausible working examples has recently become more important. We will provide an overview of the applicable issues and practical guidance for drafting successful EP patent applications.
15:00 – 15:45 Coffee break / 休憩
15:15 – 15:45
Assessing and avoiding the risks of building a business around AI-generated content / 生成AIによるコンテンツに関するビジネスを構築する場合のリスク評価と回避策
(Edmund Walsh)
The surprisingly human outputs of generative AI systems have captured the imagination of businesses, which are embracing the prospects of endless content, whether text or software or drug designs, supplied by computers. However, that content is not created solely by the computer. Rather, it comes from a computer leveraging prior work of people, who may object to its use in a generative AI system. We'll explore the IP risks that come with leveraging prior content and consider ways to reduce that risk.
15:45 – 16:15
Case studies on the patent offices' approach to new technologies in different industries / 事例研究：様々な産業における新技術に対する特許庁のアプローチ
(Dr. Dominik Scheible)
The specifics of the invention, its purpose, and applications influence aspects such as technical effect and inventive step. We will consider decisions in various technical fields including finance, gaming, autonomous driving and medical monitoring to highlight specific nuances and challenges that may arise in these fields.
16:15 – 16:50
New legislation in hightech and case law on SEP enforcement and how to calculate FRAND royalties / 標準必須特許(SEP)の権利行使とFRANDロイヤルティの計算方法に関するハイテク分野の新しい法律と判例法
(Holger Stratmann / Edmund Walsh)
The power struggle between licensors and licensees of standard essential patents continued in 2023, with neither side prevailing. What royalty would be reasonable, and who should pay it, continues to be debated. Neither side scored a decisive victory, but each side can point to incremental wins in legislative proposals and court cases. For Europe we will be looking into the EU Commission Proposal for changing the playing field, which triggered strong reactions from the industry and stakeholders, and give an update on the most recent case law established by the various national courts.