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NOVEMBER 12, 2013: GENERAL PROGRAM NOVEMBER 13, 2013: LIFE SCIENCE SPECIAL – TOWARDS A HARMONIZED IP WORLD? – AN UPDATE ON THE EVER FASTER CHANGING IP LAWS IN EUROPE AND THE US 知財制度の統一化にむけて 欧州および米国における知的財産法の最新情報 ACADEMY HILLS • アカデミーヒルズ ROPPONGI HILLS MORI TOWER 49F • 六本木ヒルズ森タワー49 www.cppc.jp

Towards a harmonized iP world? – an UPdaTe on The ever ...9:20 Navigating ePO Prosecution: A Case Law Update / Patent Prosecution Techniques in the U.S. 欧州特許庁における権利化に関する最近の判例

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Page 1: Towards a harmonized iP world? – an UPdaTe on The ever ...9:20 Navigating ePO Prosecution: A Case Law Update / Patent Prosecution Techniques in the U.S. 欧州特許庁における権利化に関する最近の判例

NOVeMBeR 12, 2013: GeNeRAL PROGRAMNOVeMBeR 13, 2013: LiFe SCieNCe SPeCiAL

– Towards a harmonized iP world? –an UPdaTe on The ever FasTer Changing

iP laws in eUroPe and The Us

– 知財制度の統一化にむけて –欧州および米国における知的財産法の最新情報

ACADEMY HILLS • アカデミーヒルズROPPONGI HILLS MORI TOWER 49F • 六本木ヒルズ森タワー49階

www.cppc.jp

Page 2: Towards a harmonized iP world? – an UPdaTe on The ever ...9:20 Navigating ePO Prosecution: A Case Law Update / Patent Prosecution Techniques in the U.S. 欧州特許庁における権利化に関する最近の判例

greetings ご挨拶

conference venue 会場ご案内

欧州では、EU全域における欧州単一特許と統一特許裁判所の導入にむけた最終段階に入っている一方で、現行制度の下の特許法のそれぞれの部分においても、近年著しい変化が見られています。本セミナーでは、現行制度下での特許の権利化と権利行使について、また、今後予想される変化やそれに対しどのように備えるべきかについてご紹介を致します。

米国では、米国改正特許法(AIA)の施行から丸一年が経過しようとする今もなお、知財の実務家は新しい法律への対応に追われています。また、合衆国最高裁判所や連邦巡回区控訴裁判所(CAFC)の重要な判決によって、これまで知財業界において常識とされていた理解の妥当性が新たに問われています。

このような最近の変化の中には、大西洋を隔てた両地域の制度の調和につながる流れとなるものもありますが、全てがそうではありません。このため、本セミナーでは、欧州および米国におけるこれらの傾向や相違点などについても、それぞれの視点から講演を行います。

実務面で特に関心を集める分野の一つであるライフサイエンスの業界では、変化をみせる法制度の下で大きな挑戦に直面しています。このため、セミナー初日には幅広く一般的なテーマを、そして第二日目にはライフサイエンス関連に焦点をあてたテーマをご紹介致します。セミナーへのお申込みは、ご関心のあるテーマに応じて一日もしくは両日のいずれかが可能となっております。

また、セミナーでは、欧米の比較的見地からのレクチャーに加え、日本の視点からの専門家のコメントも入ります。

なお、両日を通じて講演には日英の同時通訳をご用意しております。また、11月12日には、セミナー後にレセプションディナー(会場:51階六本木ヒルズクラブ)をご用意しております。

多くの皆さまのご参加をお待ちしております。

Subway 地下鉄 Roppongi Station – Hibiya Line Exit 1C (3 min) 日比谷線「六本木駅」1C出口徒歩3分(コンコースにて直結) Azabu-Juban Station – Nanboku Line Exit 4 (12 min) 南北線「麻布十番」4出口徒歩12分 Roppongi Station – O-Edo Line Exit 3 (6 min) 大江戸線「六本木駅」3出口徒歩6分 Azabu-Juban Station – O-Edo Line Exit 7 (9 min) 大江戸線「麻布十番」7出口徒歩9分

Academy Hills

Roppongi Hills Mori Tower 49F6-10-1 Roppongi, Minato-ku, TokyoTel: +81 (0)3-6406-6220

六本木ヒルズ森タワー49階•アカデミーヒルズ〒106-6108東京都港区六本木6-10-1Tel: (03) 6406-6220

www.academyhills.com/aboutus/map.html

contact お問合せ先CPPC Office c/o German Chamber of Commerce and Industry in Japan (Ms. Inui)Sanbancho KS Bldg. 5F, 2-4 Sanbancho, Chiyoda-ku, Tokyo 102-0075, Japan

在日ドイツ商工会議所内 CPPC事務局(担当:乾)〒102-0075 東京都千代田区三番町2-4, 三番町KSビル5FTel: +81 (3) 5276-8826, Fax: +81 (3) 5276-8736 Email: [email protected]

While Europe is finally coming close to introducing both a European

patent with unitary effect throughout the European Union and a Uni-

fied Patent Court, there have been remarkable recent developments

under the present system in all areas of patent law. In this year’s CPPC

seminar, we will look at patent prosecution and litigation under the

present rules as well as the expected changes and how to prepare for

them.

In the U.S., it is approaching almost one full year since the America

Invents Act came into force, and IP practice is still in the course of

adapting to the new law. Moreover, several landmark decisions of the

Supreme Court and the CAFC have called into question what was

common understanding in the IP world for years.

Some, but not all, of the recent changes aim at or lead to harmoniza-

tion between the systems on both sides of the Atlantic, and we will

highlight the differences as well as the trends towards harmonization.

One area of particular interest is the life sciences industries which are

facing big challenges under the changing legal systems. We will there-

fore devote the second seminar day entirely to life science related is-

sues, while the first seminar day will deal with topics of a more gen-

eral nature that will be of interest to all industries. Depending on your

interest, you may register for just one or both seminar days.

In addition to comparative views of the situation in the U.S. and Eu-

rope, expert comments from a Japanese perspective will be provided.

Simultaneous interpretation into Japanese will be provided through-

out both seminars.

On the evening of November 12, all seminar participants are invited to

the CPPC Reception at the Roppongi Hills Club (51st floor).

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november 12 (tue): general program8:30 – 9:10 Registration / 受付

9:10 Welcome / 開会のご挨拶

9:20 Navigating ePO Prosecution: A Case Law Update / Patent Prosecution Techniques in the U.S. 欧州特許庁における権利化に関する最近の判例 / 米国におけ る権利化のテクニック

Prosecuting patents before the EPO can sometimes involve surprises.

Recently-identified substantive and procedural issues can sink even a

strong application. We guide you through the latest case law and give

you some simple tips to avoid the problems that many applicants face

in bringing their cases to a safe grant.

For the U.S., we present a review of useful U.S. prosecution tech-

niques including prioritized examination, accelerated design examina-

tion, Patent Prosecution Highway, and interviews.

10:00 Patentability of Software and Business Method Patents ソフトウェアの特許性とビジネスモデル特許

An update on software and business method patents in the U.S. after

the Federal Circuit’s split decision in CLS Bank v. Alice Corp. in May 2013.

We will review this important case, as well as cases leading up to it

and subsequent, to provide guidance on the current state of the law

on business method patents in the U.S.

In Europe, the Technical Boards of Appeal the EPO does allow patents

for software, games and business methods inventions if certain re-

quirements are fulfilled. We will guide you through some illustrative

cases and develop a “tool box” which you can use to easily make your

software etc. inventive and patentable.

10:45 – 11:15 Coffee Break / 休憩

11:15 Recent Case Law on “New Manufacture vs. Repair” 「新製品vsリサイクル品」に関する最近の判例

In many cases, the added value of inventions results from replacing

parts of patented apparatuses during their lifetime. Recent case law

in Europe has given guidance, as to when such replacements can be

covered by patent protection or are to be regarded as admissible re-

pair of a patented item.

As regards the U.S., we will review the definition and scope of the

patent exhaustion doctrine, as well as distinctions between repair and

reconstruction of a patented article

12:00 Product Protection by Process inventions 方法発明による製品保護

According to European patent law, the protection conferred by a pro-

cess claim extends to the product that is directly obtained by the pro-

cess. Recent decisions from the German and UK courts provide guid-

ance on the applicability of this provision for processes that do not

produce three-dimensional objects or chemicals, but generate signals

or information. For the U.S., we will discuss strategies and use of

product-by-process claims, the advantages and disadvantages of such

claims, and the current state of the law in the U.S.

12:45 – 14:00 Lunch / 昼食 (Roppongi Hills Club)

14:00 Update on Licenses and Covenants-Not-to-Sue ライセンスと不争条項に関する最新情報

Licenses and covenants-not-to-sue are often regarded as interchange-

able but they can have different legal implications. We provide an up-

date on the recent case-law in the US and Europe on licenses and

covenants-not-to-sue relating to (i) bankruptcy, (ii) assignments of

the patent, (iii) exhaustion, and (iv) validity challenges. Also, terminat-

ing a license may not free the licensor of all sub licensees; how to

ensure the comprehensive effect of a termination when drafting the

license.

14:45 Litigation Strategies: Recent Trends in europe and the U.S. 訴訟戦略: 欧州と米国における最近の傾向

Recent case law has changed the landscape for patent enforcement in

Europe: Cross-border injunctions have become frequently used in the

Netherlands. New strategies have to be developped for patent enfore-

ment in Germany when negative declaratory actions (so-called “torpe-

does”) have been filed in other countries. Moreover, enforcing stan-

dard-essential patents (SEPs) has become more complex after the RC

Duesseldorf ’s referral to the European Court of Justice.

We will present the U.S. perspective on litigating on multiple fronts.

Discussion of strategies involving review of patents by U.S. Patent Of-

fice through Inter Partes Review (IPR), Covered Business Method

(CBM) Patent Review, and Post Grant Review. Forum shopping and

different standards in U.S. among ITC, Federal Courts, and Patent Of-

fice. Strategies to defend against actions by non-practicing entities

(“patent trolls”).

15:30 – 16:00 Coffee Break / 休憩

16:00 America invents Act After One Year 米国改正特許法から一年

A review of the America Invents Act one year after implemenation.

A general discussion of new rules, procedures, and strategies as well

as feedback on trends after the first year.

16:20 The eU Patent Package 欧州単一特許

The Unified Patent Court Agreement has now been concluded and it

looks as if the Unitary Patent is going to come in Europe, sooner or

later. So it is good time to look at the various complex rules and regu-

lations in more detail.

16:45 Panel Discussion: Do’s and Don’ts in Patent Prosecution and Litigation / Q&A パネルディスカッション / Q&A

In this session we will address your questions and invite all speakers

to highlight what is most important in their view to be successful

before the various courts and patent offices. We will also present an

outlook to expected changes.

17:45 Closing Remark / 閉会のご挨拶

18:00 – 20:30 Reception Dinner / レセプション (Roppongi Hills Club)

在日ドイツ商工会議所内 CPPC事務局(担当:乾)〒102-0075 東京都千代田区三番町2-4, 三番町KSビル5FTel: +81 (3) 5276-8826, Fax: +81 (3) 5276-8736 Email: [email protected]

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november 13 (wed): life science special8:30 – 9:00 Registration / 受付

9:00 Welcome / 開会のご挨拶

9:05 Recent U.S. cases and ePO Appeal Board Practice in the Life Sciences ライフサイエンス分野における最近の米国の判例とePO審 判部の実務

Review of recent cases including Mayo v. Prometheus (method for de-

termining dosages) and Myriad Genetics (human genes) and how

these cases are affecting patent strategies for life sciences companies.

At the EPO, there are currently 27 Technical Boards of Appeal, 7 of

which handle life science cases. Upon reviewing 585 decisions of these

boards, the lecture tries to identify common trends and differences

between the boards.

9:45 Case Law Update on Supplementary Protection Certificates SPCに関する最近の判例

Over the last 2 years, very important decisions have come up which

have a strong influence on the practice for filing SPC applications and

for obtaining protection by SPCs. The consequences resulting from the

court decisions will be discussed in more detail together with open

questions still to be decided by case law.

10:10 Recent Developments in PTA Calculations PTAの算出に関する最近の展開

Patent Term Adjustment (PTA) is a hot topic in the U.S. and we will

review the AIA Technical Corrections Act and the Exelixis cases.

10:30 – 11:00 Coffee Break / 休憩

11:00 enablement and Written Description Requirement with respect to U.S. Life Sciences Applications 米国でのライフサイエンス特許出願における実施可能要件 と記述要件

A review of 35 U.S.C. 112 enablement and written description issues as

they affect bio-based inventions, including methods of treatment.

11:20 experimental data for new therapeutic indications – How much must be in the application? 新しい治療適応への実験データをどこまで出願に含めるべきか?

Applicants understandably want to file their applications as early as

possible. On the other hand, too speculative patent applications with

no data support run the risk of being rejected by the EPO. A new EPO

appeal board decision casts some hope for applicants facing this di-

lemma.

11:40 Therapeutic use versus non-therapeutic use 治療上の使用と非治療的使用

When an invention refers to a treatment of the human or animal

body, problems can come up when the therapeutic aspect and the

non- therapeutic aspect of this treatment can not be clearly limited

against each other. These problems will be discussed in more detail,

and also possibilities will be shown to overcome them and to result in

the grant of respective patents.

12:10 – 13:15 Lunch / 昼食 (Roppongi Hills Club)

13:15 Pharmaceutical Patents and Antitrust Law in Prosecution, enforcement and Settlement 医薬特許と権利化・権利行使・和解における独占禁止法上の 留意点

On both sides of the Atlantic antitrust authorities and courts have

shown a heightened interest in the enforcement of antitrust law in

the pharmaceutical field. (1) Pay-for-delay: In June 2013, the U.S. Su-

preme Court, in FTC v. Actavis found that pay-for-delay settlements

may violate antitrust laws. The European Commission fined Lundbeck

and several companies marketing generic medicines € 146 Million for

agreeing on a delayed market entry. Settlement options in view of

these cases will be discussed. (2) In AstraZeneca the European Court

of Justice confirmed that providing wrong information to a patent of-

fice may be a violation of antitrust law.

14:00 effective enforcement of pharma patents 医薬特許の効果的な行使

Cross-border injunctions in Europe are available and very useful

against infringers distributing pharmaceutical products throughout

Europe. However, in most cases patents still have to be enforced

country-by-country. Recent case law shows which countries are pat-

entee-friendly when time is of the essence and provisional measures

are required to enforce pharma patents effectively.

As regards the U.S., we will discuss friendly/nonfriendly and fast/slow

venues in the United States.

14:45 – 15:15 Coffee Break / 休憩

15:15 Binding advice on antibody inventions 抗体の発明に関するアドバイス

The criteria used for determining the patentability of inventions relat-

ing to antibodies is constantly changing due to the rapid develop-

ments in this technical field. An overview of possible structural as well

as functional features that can be used to define antibody inventions

and formulate antibody claims is provided.

16:00 Human embryonic stem cells ヒトeS細胞

This interesting and politically controversial technical field has seen

decisive case law in the last year. We will assess both EU and German

decisions and explore their impact on the patentability practice in this

area at the EPO. How does it affect already pending and future ap-

plications?

A discussion of the impact of the Myriad case on patentability of iso-

lated stem cells in the U.S. and a review of following cases such as the

recently filed complaint against Wisconsin Alumni Research Founda-

tion (WARF) by public interest groups.

16:45 Panel Discussion: Do’s and Don’ts in Life Science iP Prosecution and Litigation / Q&A パネルディスカッション / Q&A

Focussing on the topics addressed on the second day of the confer-

ence, we will address your questions and invite all speakers to high-

light what is most important in their view to be successful in prosecu-

tion and litigation of life science patents in Europe and the US.

17:15 end of Conference / 閉会

simultaneous translation 同時通訳: Yumiko Hayashi · 林由美子 / Keiko Mihara · 三原恵子 / Junji Tomoda · 友田淳治

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speakers 講師

Dr. Matthias KindlerDr. マティアス・キンドラー

Partner & Co-head of Chemical Department, Hoffmann ·

Eitle, Munich

Dr. rer. nat. (Chemistry), European and German Patent

Attorney

Specialized in chemical and pharmaceutical patents, in particular

prosecution, opposition and appeal proceedings before the EPO,

invalidation actions and infringement litigations

Numerous cases in SPC matters before the German Federal Patent

Court, the German Supreme Court and the European Court of Justice

Dr. Mark A G JonesDr. マーク・ジョーンズ

Associate, Mechanical Engineering Department,

Hoffmann · Eitle, London

DPhil (Physics) (Oxford University), European and

Chartered British Patent Attorney

Particular interests in applied physics, high-tech manufacturing

and medical technology

Legal opinions and advisory services with regard to both European

and British law and practice

Contentious and non-contentious matters before the European

and British Patent Offices

Steven G. Davis, Ph.D.スティーブン・デイビス

Partner, IP/IT Group, McCarter & English LLP

(Boston, MA)

J.D., Case Western University School of Law; Ph.D., John

Hopkins University, Chemistry; M.S., John Hopkins

University; B.A., Swarthmore College

Specializes in chemical and pharmaceutical patents

Advises clients on general portfolio strategy, freedom to operate

issues, due diligence investigations and licensing issues

Dr. Thorsten BauschDr. トーステン・バウシュ

Partner & Co-head of Chemical Dept.,

Hoffmann · Eitle, Munich

Dr. rer. nat. (Chemistry), Dipl.-Chem., European

and German Patent Attorney

Specialized in chemical, pharmaceutical and biotech patents, in

particular litigation, both cross-border and national

Frequently involved in cases before the EPO, the German Federal

Patent Court, the German Supreme Court and the European Court

of Justice

Michael R. Frisciaマイケル・フリシャ

Partner, IP/IT Group, McCarter & English LLP

(Newark, NJ)

Bachelor of Engineering, Stevens Institute of Technology;

J.D. New York Law School

Specializes in patent prosecution in mechanical and

electrical arts

Extensive IP litigation experience; Inter Partes

Reexamination / Review; Mediation

Adjunct Professor, Seton Hall Law School 1999 – 2006

Dr. Thomas KochDr. トーマス・コッホ

Partner, Electrical & IT Department, Hoffmann · Eitle,

Munich

PhD of University College London, UK; European

and German Patent Attorney

Work experience at Siemens Research Labs Munich,

Germany & University College London, UK / assistant professor at King’s

College London in Optical communications & Microwave Technology

Specialized in prosecution, opposition and litigation, in particular in

telecommunications, computer software, semiconductors, digital

communications (e.g. MP3) & business patents

Mark D. Giarratanaマーク・ジラターナ

Partner, IP/IT Group, McCarter & English LLP

(Hartford, CT)

Admitted in New York, Connecticut, and to U.S.

Patent and Trademark Office

J.D., University of Connecticut School of Law, with

honors; B.S.M.E., Catholic University

Extensive experience in litigating patent and other IP cases

in federal courts

Advises clients on IP issues related to all aspects of patent,

trademark and copyright procurement, litigation, licensing, and

the negotiation of IP transactions

Thomas O. Hooverトーマス・フーバー

Partner, IP/IT Group, McCarter & English, LLP

(Boston, MA)

J.D., South Texas College of Law; A.B., Worcester

Polytechnic Institute and College of the Holy Cross

His practice includes the prosecution of patents before USPTO,

patent appeals, reissue, re-examination and opposition proceedings

in foreign jurisdictions

Has served as lead counsel in contested interference proceedings and

conducted trade secret and patent infringement litigation

Gerald Levyジェラルド・レヴィー

Partner, IP/IT Group, McCarter & English, LLP

(New York, NY)

J.D. Brooklyn Law School; B.S.M.E Columbia University

Admitted in New York and U.S. Patent & Trademark

Office

Patent professional experienced in patent prosecution, licensing,

strategic planning and litigation

Extensive experience in handling various patent office matters including

complex re-examinations and interferences

Christopher Furlongクリストファー・フォーロング

Partner, Mechanical Department, Hoffmann · Eitle,

Munich

B.E., Mech. Eng, Univ. Coll. Dublin

European Patent Attorney (1994), Cert. In IP Law,

Univ. of London (1995), Chartered British Patent

Attorney (2002)

Frequent speaker on issues of European IP law

Specialised in European prosecution and inter partes validy

and infringement proceedings

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speakers 講師

Dr. Nadja G. MunckeDr. ナディア・ムンケ

Associate, Biotech Department, Hoffmann · Eitle,

Munich

Dr. rer. nat. (Biology), European and Chartered British

patent attorney

Examination, opposition and appeal proceedings

before the EPO

Legal Opinions and strategy advice

Particular expertise in the area of cancer/diabetes/Alzheimer’s disease,

antibodies, vaccines, cell culture, etc.

Dr. Joachim RenkenDr. ヨアヒム・レンケン

Partner, Biotech Department, Hoffmann · Eitle, Munich

Dr. rer. nat. (Biophysical Chemistry), European and

German Patent Attorney

Specialized in biotech, chemical, and pharmaceutical

patents, in particular examination, opposition and

appeal proceedings before the EPO, invalidation actions, and

infringement actions

Frequent lecturer on issues of European patent law

Dr. Clemens Tobias SteinsDr. クレメンス トビアス・シュタインス

Dr. jur., Legal Department, Hoffmann Eitle, Munich

Attorney at law since 1999

Specialized in IP contracts and transactional work,

patent litigation

Several years work experience at a law firm in Tokyo

and counseling Japanese entities on European law

Keith J. McWhaキース・マクワ

Partner, IP/IT Group, McCarter & English, LLP

(Newark, NJ & New York, NY)

J.D., Seton Hall University School of Law; M.S.,

University of Massachusetts; B.S., University of

Massachusetts summa cum laude

Extensive experience in IP prosecution, opinions, transaction matters,

due diligence and client counseling

Holger Stratmann ホルガー・シュトラトマン

Partner & Co-head of Legal Department,

Hoffmann · Eitle, Munich

Postgraduate Diploma in EU Competition Law from

King‘s College London (1996)

Specialised in national and cross-border patent and unfair

competition litigation, licensing and contract law, anti-counterfeiting

and product piracy, coordination of EU-wide border seizure proceedings

Publications and lectures on patent law, domain grabbing

and product piracy

Prof. Katsuya Tamai 玉井克哉 教授 東京大学先端科学技術研究センター教授(知的財産法)マックス・プランク国際知的財産法研究所客員研究員(1989 – 92)

ジョージ・ワシントン大学ロー・スクール及び連邦巡回区担当合衆国控訴裁判所客員研究員(1999 – 2000)

慶應義塾大学特別招聘教授政策研究大学院大学客員教授

Dr. Joe Taormino Dr. ジョー・タオルミノ

Partner & Co-head of the Biotech Department,

Hoffmann · Eitle, Munich

Ph. D. (The John Hopkins University), molecular

biologist, Doctoral thesis in the field of biochemistry,

cellular and molecular biology and genetics.

European Patent Attorney since 1998

Specialized in biotech patents, litigation and all aspects of prosecution

procedures before the EPO

Various lectures and publications on Biotech and Intellectual Property

Dr. Henrik Vocke Dr. ヘンリック・フォッケ

Partner, Mechanical Department, Hoffmann · Eitle,

Munich

Dr.-Ing. (Civ. Eng.) of University of Stuttgart, European

and German Patent Attorney

Working experience in Japan (Kajima Technical Research

Institute, Tokyo)

Specialized in prosecution and litigation, in particular in developing and

enforcing combined patent and utility model strategies

Frequent speaker on issues of European and German IP law

Maria Laccotripe Zacharakis, Ph.D. マリア・ラコトライプ・ザカラキス

Partner, IP/IT Group, McCarter & English, LLP

(Boston, MA)

J.D., Suffolk University Law School, High Technology Law

Concentration with Distinction; Ph.D., Boston University

of Medicine, Biochemistry; B.A./M.A., Boston University, Biology/

Biotechnology, magna cum laude

Extensive experience in patent preparation and prosecution, due

diligence evaluations of patent portfolios, freedom-to-operate

assessments, patent validity opinions and competitive landscape

analyses

Specializes in the area of life sciences/biotechnology

Dr. Dirk Schüssler-Langeheine Dr. ディルク・シュスラー=ランゲハイネ

Dr. jur., Partner & Co-head of Legal Department,

Hoffmann · Eitle, Munich

Attorney-at-Law (since 2000)

Specialised in national and multi-jurisdictional patent

litigation, licensing, competition law, contract law and arbitration

Fluent in Japanese, Doctoral thesis on Japanese law on damages (2004)

Publications and lectures on German, European and Japanese IP Law