The US Patent Reform for Life Science Companies - C5

New speakers, 

new challenges, 

new Focus Day! 

C5’s 22 nd Forum on 

BIOTECH 

Business Information 

In A Global Context 

Key Speakers From: 

United States Patent and 

Trademark Office (US) 

Spanish Patents and 

Trademarks Offices (Spain) 

DMPA (German Patent and 

Trademark Office 

GlaxoSmithKline Biologicals 

(Belgium) 

Bayer Healthcare (Germany) 

Bavarian Nordic Group (US) 

Pfizer (France) 

QIAGEN GmbH (Germany) 

GE Healthcare (UK) 

Bracco Group (Italy) 

Ablynx (Belgium) 

MagForce (Germany) 

American Intellectual Property 

Law Association (US) 

Merck & Co (UK) 

UCB Pharma (Belgium) 

Associate Sponsor 

Session Sponsors 

PATENTING 

Protecting Your Global Biotech Patent Portfolio 

and Maximising Revenues 

14 – 15 March 2012 | Hotel Vier Jahreszeiten Kempinski 

Munich, Germany 

Gain valuable insight from experienced in-house counsel and their European 

and US expert legal advisors on the latest key developments and challenges in 

biotech patenting such as: 

• G2/10 decision: analysing its impact on the biotech disclaimer practice across Europe 

• Patentability of gene sequence patents: evaluate recent decisions and developments in 

Europe and the US 

- Outcome of Lilly v HGS in the UK Supreme Court and EPO 

- Update on Myriad, Prometheus and Classen cases 

• Latest decisions on patentability of stem cells: Examining the outcome of the recent 

CJEU decision in Brüstle 

• New patenting and marketing strategies to overcome the challenges of filing your SPC 

applications at an earlier stage 

• Cross-border litigation: developing successful strategies 

• US Patent Law reform: discussing the impact of the America Invests Act on European 

biotech companies 

• Case law developments in double patenting: from an European and US perspective 

PLUS maximise your time by attending the post-conference workshop 

on the 16th March: 

Strategies for Claiming Commercial Products in your Biotech Patent Applications 

Illustrating what the examiners are looking for by using examples of best practice approaches 

FOCUS DAY: 13 MARCH 2012 – MUNICH, GERMANY 

The US Patent Reform 

for Life Science Companies 

Analysing the impact of the America Invents Act on IP Owners in European 

pharma and biotech firms and what they need to consider when enforcing 

and protecting their rights in the USA 

Up to 

22.0 CPD 

Separately 

bookable 

event 

• Hear an in-depth examination of the legal and regulatory changes and challenges 

surrounding the patent reform from US and European industry experts and regulators 

• Evaluate the “first-inventor-to-file” system and its implications 

• Identify opportunities and risks of the post-grant review proceedings 

• Gain valuable insights from the USPTO on changes to their practice 

• Discuss emerging business opportunities and risks with experts from the life sciences industry 

To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/biotechpatenting

“ An excellent experience! A wide array of subject-matter essential for anyone working in the business 

of biotechnology” 

Stacey J Farmer, UK Solicitor/US Patent Attorney, Grund IP Group (past delegate to Biotech Patenting Munich) 

The Essential Update on Biotech Patenting Strategy 

The biotech patent landscape continues to evolve at a fast pace, with significant case law developments arising from new 

strategies being employed by generic companies. In order to stay competitive in this very lucrative industry it is important 

that patent attorneys stay abreast of recent court decisions and have up-to-date information on how to ensure they have the 

most successful strategies in place to protect and defend their patent portfolios and maximise revenues on inventions. 

The 2012 Biotech Patenting Munich forum will discuss the latest EU Court decisions on the Brüstle and Lilly v HGS cases 

case and analyse the impact of the recent G2/10 decision on the biotech disclaimer practice across Europe. US and European 

experts will clarify uncertainties and explain recent case law referring to gene sequence patents, double patenting, bolar 

provisions, bio-deposits and the “immediate product of the process”. 

You will hear directly from your industry peers on best practice approaches and their first-hand experiences with current 

industry challenges regarding the entire patenting process, throughout the patent cycle, from obtaining, extending to protecting. 

Walk away with fresh insights, tactics and tools to strategize your biotech patenting and remain 

competitive in today’s constantly changing patent environment. 

C5’s Biotech Patenting forum brings together key regulators, leading in-house representatives and their legal advisors from the 

US and different European jurisdictions. Do not miss the opportunity to hear a different perspective on the main challenges 

and opportunities for biotech patent attorneys from new speakers. The majority of this year’s eminent speaker panel has not 

spoken on a C5 patent conference before and will add fresh insights to our established forum. 

In addition, if you are new to Biotech Patenting or would like a refresher on patent filing strategies don’t miss our practical 

and interactive post-conference workshop. 

WORKSHOP, FRIDAY THE 16TH MARCH 2012 

Strategies for Claiming Commercial Products in your Biotech Patent Applications 

This expert-led half-day workshop addresses the more complex areas of patent application strategies for commercial biotech 

products in this rapidly evolving industry. The emphasis throughout the session will be on worked examples and delegate 

participation. By the end of the seminar delegates will be able to: 

• Successfully file patent applications in this complex area 

• Understand what the examiners are looking for 

• Structuring your claim with attention to detail 

Following the main conference this workshop will take on board the knowledge gained in the previous 

two days and help attendees to apply it when filing patent applications back in their office. 

Workshop leader: Dr. Leo Polz, Partner, Hoffmann Eitle 

WHO SHOULD ATTEND 

C5’s 22nd Biotech Patenting forum and US Patent Reform 

Focus Day will provide valuable insights for: 

Media Partners 

From Pharma, Biotech and Chemical Companies: 

• In-house Counsel, Patent/IP Counsel, Legal Directors 

• Heads/ Directors of Patent/IP departments and Patent/IP Managers 

• Patent Specialists and Experts 

• Heads/ Directors of Licensing 

• Head of Business Development 

Private Practice Patent Attorneys specialising in: 

• Life Science/ Biotech/ Pharma 

• IP and Patents 

2 

To register call +44 (0) 20 7878 6888 OR fax +44 (0) 20 7878 6885

FOCUS DAY: 13 MARCH 2012 

The US Patent Reform for Life Science Companies 

Separately 

bookable 

event 

8.30 Registration & Coffee 

9.00 Chair’s Welcome & Opening Remarks 

Tony Rollins, Managing Counsel European Patents, 

Merck & Co (UK) 

9.10 Impact of the New Patent Law: An Overview of the 

America Invests Act (AIA) 

• Examining the specific provisions of the patent reform in 

The Leahy-Smith America Invents Act – what are the key 

developments 

• Discussing the statutory change for the Life Sciences IP market 

• Does the reform go far enough 

• What effect will the US patent reform have on overseas 

pharma companies 

9.40 Analysing the New “First-to-File” System and “Grace 

Period” and its Impact on the Life Science Industry 

Steven Lendaris, Special Counsel, Baker Botts (US) 

• What does “first-inventor-to-file” mean in the AIA 

• Examining how the U.S. “grace period” is being modified 

by the AIA 

• When will these changes come into effect and what can be 

done now in anticipation of this transition 

• Timing of your filings - are you better off filing under the 

current or the new rules 

- Identifying the pros & cons of filing ahead of the effective 

date and their implications for the biotech industry 

• Balancing compliance with the new rules and the existing 

written description & enablement requirements 

- How are the written description & enablement 

requirements being applied in life science cases 

- When should you file the case that will establish 

your earliest priority date 

- How can you maximize the benefit of the new grace 

period when addressing the written description & 

enablement requirements 

10.35 Refreshment Break 

11.05 Post-Grant Review Proceedings: Identifying 

Opportunities and Risks 

Anthony Tridico, Partner, Finnegan (Belgium) 

• An overview of the post-grant review proceedings 

• Examining the potential impact on life sciences companies 

• How will the enforcement landscape change What new risks 

and opportunities might arise 

12.00 Keynote Address 

Identifying Changes in USPTO Practice 

Jasemine Chambers, Ph.D. 

Deputy Administrator for Policy and External Affairs, 

United States Patent and Trademark Office (USPTO) 

• Examining the new fee and funding structure 

• Reviewing prioritized examination 

• Addressing submission of prior art and supplemental 

examination 

• Updates on USPTO-led studies 

12.45 Networking Lunch 

13.45 Identifying the Potential Impact of the AIA 

on Litigation of Patent Cases in US Courts 

Rouget F. (Ric) Henschel, Partner, Foley & Lardner LLP (US) 

• Will we see litigation costs drop after full implementation 

• Can we expect greater predictability in patent litigation 

outcomes 

• Which side stands to gain more, the patentee or 

the accused infringer 

• Advantages for defendants (accused infringers) and for 

plaintiffs (patentees) 

14.30 Contrasting the US and the European Patent System: 

Are the Opposition Procedures Proposed in the 

America Invest Act Competitive 

Thomas Kowalski, Vedder Price (US) 

Petri van Someren, Partner, Arnold + Siedsma (Netherlands) 

• Overviews of European and US oppositions, and differences 

from a European perspective 

• How does the US “first-inventor-to-file” / “first-to-disclose” 

system differ from the European first-to-file system 

• Time limit of nine month to file an opposition in Europe vs 

time limit for post-grant oppositions but not for inter partes 

actions in the AIA - a new uncertainty 

• Different standards in US post-grant oppositions, inter partes 

actions and district court litigation - selecting the US forum 

• Dealing with all oppositions together in a single proceeding 

in Europe vs. a possible succession of individual US cases – 

coping with extra work and costs 

• Considerations of US Privilege and Work Product issues 

- avoiding very serious pitfalls of European practitioners 

advising on US oppositions, inter partes matters and litigation 

• Analysing advantages / disadvantages of the US system: 

- Opponents must demonstrate likelihood that patent claim 

is invalid 

- “estoppel” provisions for subsequent challenges 

15:30 Refreshment Break 

16.00 Discussing Potential Challenges and Opportunities 

for European Life Science Companies 

Andrew Bourgouin, Partner, 

Grosset-Fournier & Demachy (France) 

Dr. Jürgen Schneider, Vice President 

Global IP & IP Litigation, QIAGEN GmbH (Germany) 

Prof. Dr. Li Westerlund, Vice President Global IP, 


Dr. Jochen Pagenberg, Partner, 

Bardehle Pagenberg (Germany) 

• What technical and practical challenges will you have to expect 

as life science IP owner 

• Will the AIA law pave the way for more homogeneous 

international patent strategies 

• Will the AIA reduce patent prosecution delays 

- is there even a risk of a new USPTO log-jam of oppositions 

• What impact will the accelerated application process have on 

the industry 

• How are the US developments influencing the move to a 

common European patent court 

• Is a central European Court of Appeal possible in view of 

all the discrepancies in infringement doctrines in different 

European countries 

• Developing and maintaining a successful global patent strategy 

- Examining best practice strategies on how to protect 

and enforce your IP rights 

- Developing a more proactive filing strategy 

- How to use disputes to actively strenghten your patents in 

the USEuropean countries 

17.30 Chair’s Closing Remarks & End of Focus Day 

To register call +44 (0) 20 7878 6888 OR fax +44 (0) 20 7878 6885 

* Subject to final confirmation 

3

Updated Faculty: Benefit from fresh insights & meet new experts 

Focus Day: The US Patent Reform 

for Life Sciences 

Expert Faculty: 

Jasemine Chambers, Deputy Administrator for Policy 

and External Affairs, 

United States Patent and Trademark Office (USPTO) 

Dr. Jürgen Schneider, Vice President, Global IP & IP Litigation, 

QIAGEN GmbH (Germany) 



Andrew Bourgouin, Partner, 

Grosset-Fournier & Demachy (France) 

Steven Lendaris, Special Counsel, Baker Botts (US) 

Anthony Tridico, Partner, Finnegan (US) 

Thomas Kowalski, Vedder Price (US) 

Petri van Someren, Partner, Arnold + Siedsma (Netherlands) 

Rouget F. (Ric) Henschel, Partner, Foley & Lardner LLP (US) 

Dr. Jochen Pagenberg, Partner, Bardehle Pagenberg (Germany) 

Associate Sponsor 

Baker Botts is an international law 

firm with 725 lawyers and a network 

of 13 offices around the globe. 

Based on our broad experience 

and our in-depth knowledge of 

our clients’ industries, we are recognized as a leading firm in the energy, technology and 

life sciences sectors. 

Session Sponsor 

With more than 375 intellectual property 

lawyers, Finnegan is one of the largest IP law 

firms in the world. the firm practices all aspects of 

patent, trademark, copyright, and trade secret law, including counseling, prosecution, 

licensing, and litigation. 

Vedder Price is a business-oriented law firm with 

265 attorneys and offices in Chicago, New York, 

Washington, D.C. and London. Our IP group 

is composed of nearly 40 professionals with diverse technical backgrounds offering 

both domestic and international clients in the biotech, software, consumer products, 

chemical, electrical, mechanical, medical, and telecommunications industries a fullservice 

patent, trademark, copyright and technology law practice. www.vedderprice.com. 

Conference Chairs: 

Allen Norris, Vice President, Head Group IP, 


Jennifer Gordon, Partner, Baker Botts (US) 

Expert Faculty: 

Dr. Hubertus M. Zink, Patent Examiner, 

DMPA (German Patent and Trademark Office) 



Bart van den Hazel, Director Patent Counsel, 

GlaxoSmithKline Biologicals (Belgium) 

Dr. Marc Markus, Head of Patents Biotherapeutics East, 


Ian Bryan, IP Counsel, GE Healthcare (UK) 

Dr. Frank Burkert, European Patent Attorney, 


Francesco Macchetta, Director IP, Bracco Group (Italy) 

Dr. Christoph Rehfuess, European Patent Attorney, 

Director Intellectual Property, MagForce (Germany) 

Harry Kraft, Senior Patent Attorney, Ablynx (Belgium) 

Javier Vera, Deputy Director of Patent Department, 

Spanish Patents and Trademarks Offices (Spain) 

Dr. Miranda van Heusden, Examiner in Biotechnology,, 

European Patent Office (Germany) 


Tim Powell, Partner, Powell Gilbert (UK) 

Dr. Thomas Friede, Partner, European Patent Attorney, 

Bardehle Pagenberg (Germany) 

Jens Victor Nørgaard, Partner, Hoiberg (Denmark) 

Dr. Thierry, Calame, Partner, Head of Intellectual Property, 

Lenz & Staehelin (Switzerland) 

Richard Ebbink, Partner, Brinkhof (Netherlands) 

Isabelle Romet, Partner, Vëron & Associës (France) 

Dr. Erik Scheuermann, Partner, 

Witte, Weller & Partner (Germany) 

Thomas Adocker, Partner, 

Schwarz Schönherr Rechtsanwälte (Austria) 

Marian Flattery, Of Counsel, Finnegan (US) 

Andrzej Kmiecik, Partner, Van Bael and Bellis (Belgium) 

Andreas Wildhack, Partner, Wildhack & Jellinek (Austria) 

Hari Subramaniam, Patent & Trademarks Attorney 

Subramaniam, Nataraj & Associates (India) 

GLOBAL SPONSORSHIP OPPORTUNITIES 

C5, Group, works closely with sponsors to create the perfect business development solution catered exclusively to the needs of any practice group, business line 

or corporation. With over 500 conferences held in Europe, Russia and the CIS, China, India, the US and Canada, C5, ACI and CI provide a diverse portfolio 

of first-class events tailored to the senior level executive. 

For more information about this program or our global portfolio, please contact: Jo Menzer on +44 (0)20 7878 6978 or email j.menzer@C5-Online.com 

4 


Main Conference Day One: 14 March 2012 

8.30 Coffee and Registration 

9.00 Chair’s Opening Remarks 


9.10 Keynote Address: Recent Case Law Developments 

and Trends for Biotech Patents in Germany 

Dr. Hubertus M. Zink 

Patent Examiner 

DMPA (German Patent and Trade Mark Office) 

9.40 Determining How the G2/10 Decision will Change 

Biotech Disclaimer Practice Across Europe 

Kristina Cornish, Partner, Kilburn and Strode (UK) 

• Brief review of the background to the referral from T1068/07, 

leading to G2/10 

• Analysing the outcome in G2/10: 

- under what conditions are “positive” disclaimers 

permissible in claims 

• How will G2/10 change the way you structure your patent 

application for Europe/the world 

• Using both “positive” and “negative” disclaimers (G2/10 or 

G1/03) in European applications/patents 

• What do the EPO Guidelines for Examination say about 

the use of disclaimers 

• Examples of positive disclaimers in European applications/ 

patents, using the new test, as set out in G2/10 

• Views of national offices and courts, within Europe, on G2/10 

10.20 Examining the Patentability of Stem Cell Derived 

Inventions in Europe 

Ian Bryan, IP Counsel, GE Healthcare (UK) 

The Patentability of inventions derived from human embryonic 

stem cells 

• Analysing the outcome of the CJEU Decision in Brüstle 

- what aspects of the Advocate General’s opinion has the 

Court followed 

- addressing the discrepancies between G2/06 and Brüstle 

- impact on derivatives and other medical products derived 

from human embryonic stem cells 

- validity of existing European patents 

• Assessing the current EPO approach to stem cell based 

inventions 

- the current stance on the destruction of embryos 

for the purposes of an invention 

- new standards for patentability: what will biotech companies 

need to include in their applications to the EPO 

• Patentability of human embryonic stem cell based inventions 

in other major jurisdictions 

The patentability of inventions derived from induced pluripotent 

stem cells 

• What is the position for induced pluripotent stem cell lines 

in Europe and other major jurisdictions 


11.30 Recent Developments on Biotech Products 

and Patent Considerations for Bio-Deposits 

Biotech Focus Session 

Jens Viktor Nørgaard, Partner, Hoiberg (Denmark) 

Bart van den Hazel, Director Patent Counsel, 

GlaxoSmithKline Biologicals (Belgium) 

• Addressing recent EPO practice: what biotech claims are 

permitted 

• Examining the latest Board of Appeal Case Law, including 

decisions on 

- the patentability of antibodies 

- the patentability of biological processes for the production 

of plants 

• Discuss the latest developments relating to disclosure 

of origin of genetic resources in patents 

• Developments and clarity on bio-deposits: how are 

bio-deposits dealt with in various countries 

• Examining patent considerations for bio-deposits 

- pros and cons of making deposits 

12.10 SPC Application Requirements in Europe: 

Update on Recent Case Law 

13.00 Lunch 

Erik Scheuermann, Witte, Weller & Partner (Germany) 

• Addressing the scope of the Bolar provisions - impact on 

market authorisation for generic companies 

• How do you produce evidence that a biosimilar is similar 

enough to be a biological product that you have patented 

• To what extent will third parties producing generic drugs 

be protected from patent infringement 

• Recent case law developments in Germany 

- how will the Court interpret the Bolar provisions in the 

German Patent Act 

• Patent litigation strategies to combat recent case law 

developments: method patents vs. product patents 

14.00 Tackling Diagnostic Methods and Personalised 

Medicines 

Harry Kraft, Senior Patent Attorney, Ablynx (Belgium) 

• Discovering new approaches to diagnostic methods 

• How do biotech companies successfully obtain patents 

for protein biomarkers 

• Exploring new areas: epigenetic methods 

• Assessing the challenges of research tool patents 

• Personalised medicine at the EPO level 

- exclusions of methods and medical treatments 

14.30 Process Patens and New Technologies: Protection 

of the Immediate Product of the Process 

Thomas Friede, Partner, Bardehle Pagenberg (Germany) 

• Defining the immediate product of the process 

• Manufacturing method v screening method 

- UK High Court (2011) MedImmune v Novartis 

• When is a product an immediate product of the process 

• Mixture or modification of the immediate product in the 

infringing embodiment 

- ECJ (2010) Monsanto v Cefetra 

• Considering time and location for carrying out the process 

- carrying out the process before the grant of the patent 

- carrying out the process abroad with subsequent 

importation 

- OLG Düsseldorf decision “Prepaid telephone cards” 


15.30 Strategies for successful Cross-Border Litigation 

Richard Ebbink, Partner, Brinkhof (Netherlands) 

• Addressing the legal basis for cross-border injunctions 

• Examining recent EUCJ case law 

- GAT v LuK 

- Solvay v Honeywell 

• Learning from recent provisional cross-border injunctions 

granted by the Dutch Courts: 

- Yellow v Yell 

- Apple v Samsung 

• What is the exposure for generic companies across Europe 

• Developing strategies for obtaining pan-European relief 

Fax order form to +44 (0) 20 7878 6885 or register online at www.C5-Online.com/biotechpatenting 

5

16.10 Thinking Ahead: How Will your Strategies Need to 

Change in Light of the New Initiatives and Reforms 

of EU and US Patent Laws 

6Panel Session 

Javier Vera, Deputy Director of Patent Department, 

Oficina Española de Patentes y Marcas (the Spanish Patents 

and Trademarks Office) 

Francesco Macchetta, Director IP, Bracco Group (Italy) 

Dr. Frank Burkert, European Patent Attorney, 


Prof. Dr. Li Westerlund, Vice President, Global IP, 


• Latest discussion on an “EU patent” and “unitary court system” 

• Evaluating the potential impact of an EU patent system on 

the internal practices of biotech companies 

• Distinguishing the two systems: European Patent Convention 

and EU Law 

• Update on the new US Patent Reform 

- Key developments of the America Invests Act: transition to 

“first-investor-to –file”, post-grant review proceedings and 

its impact on U.S. litigation 

- What impact will it have for the biotech industry How 

will the industry deal with increased work load and costs 

17.20 Chairman’s Closing Remarks and End of Day One 

Main Conference Day Two: 15 March 2012 

9.00 Chair’s Opening Remarks 

Allen Norris, Vice President, Head Group IP, 


9.05 Patentability of Gene Sequence Patents in Europe 

and the US 

Tim Powell, Partner, Powell Gilbert LLP (UK) 

European Developments 

• Outcome of Lilly v HGS in the UK Supreme Court and EPO 

• Relationship between enablement, industrial applicability 

and obviousness 

• Examining underlying policy concerns 

• Addressing the enforceability of gene sequence patents 

- implications of the CJEU decision in Monsanto v Cefetra 

US Developments 

Jennifer Gordon, Ph.D., Partner, Baker Botts (US) 

The United States Court of Appeals for the Federal Circuit has recently 

rendered decisions in the Myriad, Prometheus and Classen cases that 

impact the patent eligibility of DNA sequences (and other biomarkers). 

These decisions further impact the patent eligibility of diagnostic and 

therapeutic methodologies that are based on a correlation between a 

biomarker and an important piece of medical information. This session 

will explore: 

• The standards set by the Federal Circuit and the U. S. Supreme 

Court under 35 USC 101 

- for patenting biological compositions of matter 

- for patenting processes or methods that involve a law 

of nature, a physical phenomenon or an abstract idea 

• Whether the U. S. Supreme Court will agree with the 

Federal Circuit’s analysis in Prometheus, which was based on 

the transformation prong of the “machine or transformation 

test” articulated in Bilski 

• Whether the U. S. Supreme Court will likely hear an appeal 

in the Myriad case and what the likely outcome may be 

• What the impact on the U. S. biotechnology and 

pharmaceutical industries may be, particularly with respect 

to the area of personalized medicine, if biomarkers and/or 

methods based thereon are deemed unpatentable by the U. S. 

Supreme Court 

• Whether the controversies in this area of law ultimately boil 

down to claim language and claim interpretation, and how 

best to draft claims that will pass the patent eligibility hurdle 

of 35 USC 101 and stand up in litigation 

10.10 Examining Case Law Developments in Double 

Patenting 

EU Perspective: 

Dr. Christoph Rehfuess, European Patent Attorney, 

Director Intellectual Property, MagForce (Germany) 

• Addressing double patenting at the EPO 

• Clarifying the legal framework for filing divisional applications 

• Analysing recent case law of the Enlarged Board of Appeals 

relating to double patenting (G 1/05 and G 1/06) 

• Implementation by the Technical Boards starting from 

T 307/03 and T 1423/07 

• Procedural consequences for the practice and open questions 

US Perspective: 

Marian Flattery, Of Counsel, Finnegan (US) 

• Clarifying double patenting and obviousness following 

the the refusal of grant certiorari in Eli Lilly & Co. v. Sun 

Pharmaceutical Industries Ltd. 

- utilizing obvious-type double patenting claims as a 

litigation tool 

- investigating the policy implications of patents whose 

terms are extended well-past twenty years and are 

vulnerable to invalidation by a double patenting finding 

- what are the issues that may influence an obviousness rejection 

• Discussing double patenting standards 

- understanding the implications of disclosures in the 

specification for double patenting 

- considering the public policy implications of double 

patenting following Amgen v. Roche 

- dissecting the dichotomy between strict statutory interpretation 

and policy considerations following Lilly v. Sun 


11.30 To Divide, or Not to Divide, That is the Question. 

Unity of Invention and Divisional Applications 

Dr. Miranda van Heusden, Examiner in Biotechnology, 

European Patent Office 

• Examining recent practice on the evaluation of unity of invention 

in biotechnology 

• Addressing implications for applications covering more than 

one invention 

• Filing of divisional applications: 

- recent rule changes and their practical implications for 

the practitioners 

- time frames for filing divisional applications 

- the issue of double patenting and the use of disclaimers 

12.10 Adopting New Patenting and Marketing Strategies 

to Overcome the Challenges of Filing your SPC 

Applications at an Earlier Stage 

Dr. Thierry, Calame, Partner, Head of Intellectual Property, 

Lenz & Staehelin (Switzerland) 

• Recent SPC cases referred to the CJEU and opinions by 

the Advocate General 

- Medeva BV 

- Georgetown University 

- Yeda Research and Development Company Ltd 

- Neurim Pharmaceuticals (1991) Ltd 

- Merck Sharp & Dohme Corp. 

• Overview of current requirements for SPC applications 

• Devising effective SPC filing strategies to overcome 

challenges based on recent case law 

12.50 Lunch 


13.40 Dosage Regimes: A Therapeutic Method 

Dr. Marc Markus, Head of Patents Biotherapeutics East, 


• Addressing the exception of patentability of therapeutic 

methods in Europe 

• Examining current EPO and EP national case law on dosage 

regimens 

• Comparing approaches to dosage regimes in the national Courts 

• To what degree have EU national courts achieved a common 

interpretation of the provisions in the EU Patent Convention 

on dosage regimes 

• Discussing dosage regimen claims in the context of personalized 

medicine & biomarkers 

14.20 Understanding the “Person Skilled in the Art” 

Concept when Litigating Patents 

Isabelle Romet, Partner, Vėron& Associės (France) 

• General criteria for determining the “person skilled in the art” 

- what are the deviations in approaches taken by the various 

EU national courts 

• Applying the judgment by Kitchen J in Astrazeneca 

(Esomeprazole) 

• How can you present the skilled person into evidence 

• Where you are permitted to have a “person skilled in the art” 

to give expert evidence, what are the requirements 

- requirements in UK proceedings 

- approach by other EU national Courts 

• How can you use the same expert in more than one jurisdiction 

15.00 Reviewing Recent Case Law Developments 

Regarding Reverse Payment Settlements 

Andrzej Kmiecik, Partner, Van Bael and Bellis (Belgium) 

• Review of the recent 2nd monitoring report by the European 

Commission 

• Update on the review of Servier by the European Commission 

• Recent US case law developments on reverse payment 

settlement agreements 

• Distinguishing the US approach with developments in Europe 


16.00 The Current Stance on Nanotechnology for Medical 

Devices in Europe 

Thomas Adocker, Partner, 

Schwarz Schönherr Rechtsanwälte (Austria) 

Andreas Wildhack, Partner, Wildhack & Jellinek (Austria) 

• Introduction to legal problems of nanotechnology and medical 

devices 

- protection 

- regulation 

- liability 

• Using nanotechnology for medical devices 

• What are the approaches to nanotechnology in the various 

EU national patent offices 

- review of the recent decisions 

• EPO approach to patent applications for nanotechnology 

16.50 Latest Biotech Patenting Regulatory Changes 

and Developments in India 

Hari Subramaniam, Patent & Trademarks Attorney, 

Subramaniam, Nataraj & Associates (India) 

• Recent case law developments and their potential impact 

on other jurisdictions 

• How to protect and enforce your patents in India 

- what aspects of the EU and US patentability criteria 

are followed 

• Sufficiency of disclosure 

• Novelty considerations 

• Defending patent infringements in India 

17.30 Chairman’s Closing Remarks and End of Conference 

“ Level of detail was just right. Very Useful.” 

M Rees, IP Manager, Podermed (past delegate to Biotech Patenting Munich) 

“I would highly recommend this conference to colleagues. The presentations and presentation material 

were very helpful.” 

Gabriel McCool, Edwards Angell Palmer & Dodge (past delegate to C5’s Biotech Patenting forum in Munich) 

POST-CONFERENCE WORKSHOP: 16 MARCH 2012 | 9.00am – 12.30pm 

Strategies for Claiming Commercial Products in your Biotech 

Patent Applications 

Workshop leaders: 

Dr. Leo Polz, Partner, Hoffmann Eitle (Germany) 

Based on the knowledge gained in the previous two days this practical 

workshop will address the more complex areas of patent application 

strategies for commercial biotech products. Areas to be examined will 

include, but are not limited to: 

• Determining what biotech products are already on the market 

• What are the examiners looking for 

• Identifying what prior art should be cited 

• Fall-back positions for possible later amendments 

• How much and what kind of experimental data is needed 

to support certain types of claims 

• Structuring your claims with attention to detail 

- When to file broad and when to file more narrow claims 

- How to ensure a broad scope of protection 

• Examples of best practice strategies from recent cases 

Benefit from interactive delegate participation: The emphasis throughout 

the workshop will be on practical examples, hands-on exercises and 

interactive discussions. 

©C5, 2011 

Fax order form to +44 (0) 20 7878 6885 or register online at www.C5-Online.com/biotechpatenting 

7

C5’s 22 nd Forum on 

BIOTECH PATENTING 

Protecting Your Global Biotech Patent Portfolio and Maximising Revenues 

FOCUS DAY: The US Patent Reform for Life Sciences Companies 

Business Information 

In A Global Context 

FEE PER DELEGATE 

DELEGATE DETAILS 

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APPROVING MANAGER 

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BY CREDIT CARD 

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Register & Pay by 

9 December, 2011 

FOR MULTIPLE DELEGATE BOOKINGS PLEASE COPY THIS FORM 

BY CHEQUE 

I have enclosed a cheque for € ___________ made payable to C5 

BY BANK TRANSFER 

C5 Communications Limited 

Account Name: C5 Communications Limited 

Bank Name: HSBC BANK Plc 

Bank Address: 31 Chequer Street, St Albans Herts AL1 3YN, UK 

Bank Branch: St Albans Branch 

BIC ( Bank Identifier Code ): MIDLGB22 

IBAN: GB45 MIDL 4005 1569 7326 66 

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Account Currency: EURO 

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If you wish to pay in GBP£ or USD$ please contact Customer Service 

FAX 

Register & Pay by 

17 February, 2012 

Priority Service Code 

660L12.E 

Register & Pay after 

17 February, 2012 

ELITEPASS*: Conference, Focus Day 

€2597 €2697 €2797 

& Post Workshop 

Conference & Focus Day €2399 €2499 €2599 

Conference & Post Workshop €2099 €2199 €2299 

Conference Only €1599 €1699 €1799 

Focus Day €899 €999 €1099 

PLEASE ADD VAT TO ALL ORDERS 

*ELITEPASS is recommended for maximum learning and networking value. 

Event Code: 660L12-MUN 

5 EASY WAYS TO REGISTER 

 

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WEBSITE: www.C5-Online.com/ 

biotechpatenting 

REGISTRATIONS & ENQUIRIES 

+44 20 7878 6888 

EMAIL: registrations@C5-Online.com 

FAX: +44 20 7878 6885 

PLEASE RETURN TO 

C5, Customer Service 

6th Floor, Trans-World House, 100 City Road 

London EC1Y 2BP, UK 

CALL FOR GROUP DISCOUNTS 

Book 4+ places and save. Call +44 (0) 20 7878 6888. 

ADMINISTRATIVE DETAILS 

Date: 13 – 16 March 2012, Munich, Germany 

Time: 8.30 – 17.00 

Venue: Hotel Vier Jahreszeiten Kempinski Munich 

Address: Maximilianstrasse 17, 80539, Munich, Germany 

Telephone: +49 (0)89 2125 2799 

An allocation of bedrooms is being held for delegates at a negotiated rate until 

13 February 2012. To book your accommodation please call Venue Search on tel: 

+44 (0) 20 8541 5656 or e-mail beds@venuesearch.co.uk. Please note, lower 

rates may be available when booking via the internet or direct with the hotel, 

but different cancellation policies will apply. 

DOCUMENTATION IS PROVIDED BY CONFERENCE WORKBOOK 

If you are not able to attend, you can purchase a conference workbook or CD 

of the presentations provided to delegates on the day of the event. Please 

send us this completed booking form together with payment of €595 per 

copy requested. For further information please call +44 (0) 207 878 6888 or 

email enquiries@C5-Online.com. 

CONTINUING EDUCATION 

13 hours (conference only) plus 6 hours per master class towards Continuing 

Professional Developments hours (Solicitors Regulation Authority). Please contact 

C5 for further information on claiming your CPD points. 

PAYMENT POLICY 

Payment is due in full upon your registration. Full payment must be received 

prior to the event otherwise entry will be denied. All discounts will be applied to 

the Main Conference Only fee (excluding add-ons), cannot be combined with any 

other offer, and must be paid in full at time of order. Group discounts available to 

individuals employed by the same organisation. 

TERMS AND CONDITIONS 

You must notify us by email at least 48 hours in advance if you wish to send 

a substitute participant. Delegates may not “share” a pass between multiple 

attendees without prior authorization. If you are unable to find a substitute, 

please notify C5 in writing no later than 10 days prior to the conference date 

and a credit voucher will be issued to you for the full amount paid, redeemable 

against any other C5 conference. If you prefer, you may request a refund of 

fees paid less a 25% service charge. No credits or refunds will be given for 

cancellations received after 10 days prior to the conference date. C5 reserves 

the right to cancel any conference for any reason and will not be responsible for 

airfare, hotel or any other costs incurred by attendees. No liability is assumed by 

C5 for changes in programme date, content, speakers or venue. 

INCORRECT MAILING INFORMATION 

If you receive a duplicate mailing of this brochure or would like us to change 

any of your details, please email data@C5-Online.com or fax the label on 

this brochure to +44 (0) 20 7878 6887. To view our privacy policy go to 

www.C5-Online.com/privacy_policy_statement.

The US Patent Reform for Life Science Companies - C5

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