Life Science IP Seminar

Life Science IP Seminar
Program & Invitation
Monday, June 15 – Wednesday, June 17, 2015
We are very pleased to invite you to our biennial
Course V e n ue
Life Science IP Seminar, to be held on June 15–17,
2015 next to our new main office in Munich. The
seminar will be covering a number of hot topics
being debated in the IP world and will give a comprehensive overview of new developments, with a
special focus on how they impact inventions related
to the life sciences. Some examples of presentations in brief:
Sheraton München Arabellapark Hotel,
Room Cuvilliés
Arabellastraße 5
81925 Munich
Recent EPO and national European case law on inventive step, the plausibility of an invention, the burden of proof in establishing a technical effect, ambiguous claims (an issue of clarity or of sufficien-
cy?), and special claim types such as reach-through, second medical use and product-by-process claims.
▪ Supplementary protection certificates (SPC): recent CJEU decisions and new referrals.
▪ A closer look at biosimilars, bolar exemption, microorganisms in the prior art, and new pharma-
ceutical trends in the US and JP.
▪ How to safeguard your priority claims.
▪ Recent decisions on petitions for review under
Article 112(a) EPC.
L a n guage
June 15 – June 17, 2015
The costs include tuition fees, course notes, lunch,
reception and the dinner party.
EUR 995.00 Standard Rate
if booked and paid by May 8, 2015
EUR 850.00 Early Bird Rate
if booked and paid by April 8, 2015
▪ An outline on pharma patent litigation before the Unified Patent Court.
Second and further participants of the same firm
will receive a 20 % discount on the standard fee.
▪ Recent decisions on claim construction in DE and GB and the issue of enforcing use claims of pharma-
ceutical patents.
R egistratio n
▪ What happens in the case of the insolvency of a licensor?
▪ Traps and pitfalls in vexatious patent litigation and patent settlement.
For details, please see inside.
Last but not least, we are very happy to announce as
a guest speaker Mr. Christopher Rennie-Smith, former
Chairman of the EPO’s Technical Board of Appeal
3.3.8, who will be speaking on the neurokinase-α
decisions rendered by this board as well as by the
English national courts.
We hope and expect that all these topics will prompt
lively discussions and promote an exchange of ideas
so as to provide participants with a better grasp of
the new developments in life science IP.
Matthias Kindler | Joe Taormino
Seminar Chairmen
Places on the seminar will be allocated in the order
in which bookings are received.
Please submit your application as soon as possible
and no later than May 8, 2015.
Early booking is particularly appreciated to secure
adequate space in the Conference Hotel.
Co n tact f or boo k i n g
Hoffmann Eitle | Katharina Schwabe
Arabellastraße 30 | 81925 Munich
T +49. 89. 924 09. 1341
[email protected]
F +49. 89. 91 83 56
Life Science IP Seminar
Munich | Monday, June 15 – Wednesday, June 17, 2015
Monday, June 15
13:15 Welcome – Introduction | M. Kindler
The burden of proof at the EPO regarding technical effects | M. Garberg
▪ Comparison of Ex Parte and Inter Partes proceedings
▪ Reversing the burden of proof
▪ Relying on the ‘benefit of doubt’
Plausibility of an invention | N. Muncke
▪ Recent EPO case law
▪ How much data is required to pass the hurdle?
▪ Is there an element of ‘self-contradiction’ as part of the plausibility test? 14:30 New challenges to inventive step before
the German Federal Court of Justice | S. Disser, A. Stefferl
▪ Repaglinide (X ZR 128/09) – fatal blow to patents for enantiomers
of known racemates, relevance of regulatory requirements
▪ No more patents for sustained release formulations (X ZR 41/13)?
15:15 Coffee break
Ambiguity – a problem of clarity or sufficiency of disclosure? | M. Kindler, D. Mulhern
▪ The distinction between lack of clarity and lack of sufficiency and why it matters
▪ Examples from the life sciences
▪ Conclusions and advice for practice
‘Reach-Through Claims’ reloaded – renaissance of merely functionallydefined claims in Europe | L. Polz
▪ Claiming compositions according to function rather than structure
▪ EPO: Lack of sufficient disclosure
▪ German Federal Court of Justice: Allowing claims directed at functionallydefined compounds for pharmaceutical use
▪ Strategies for prosecuting reach-through claims
Second medical use claims | J. Taormino, M. Bachelin
▪ Which product is a ‘substance or composition’ – when does a claim fall within
the scope of Art. 54(5) EPC?
▪ Effect-based definition of medical indication – new clinical situation
versus explanation of a known therapy
▪ Selection of patient group – evolving criteria for assessment of novelty
18:00 Welcome reception – drinks and food
Tuesday, June 16
9:00 SPC: Recent CJEU judgments and new referrals | M. Kindler, K. Stratmann
▪ Georgetown (C-484/12), Actavis (C-443/12): The ‘core inventive advance’
▪ Eli Lilly v. HGS (C-493/12): UK High Court and the ‘what is the patent really about’ test
▪ GSK Biological (C-210/13), BCS (C-11/13): Are adjuvants and safeners active ingredients?
▪ Sumitomo Chemical (C-210/12): No SPCs based on emergency authorizations
for plant products
▪ AstraZeneca (C-617/12): Swiss marketing authorizations and SPC terms within the EU
▪ Actavis v. Boehringer (C-577/13): SPC for combination products
▪ Seattle Genetics (C-471/14): How to determine the 6 month period for filing an SPC application
10:00 Update: Biosimilars, bolar exemptions | L. Werner-Jones, E. Pfaff
▪ Market perspective (biosimilars in Europe)
▪ Regulatory framework (EMA guidelines; marketing authorization)
▪ Patent perspective (1st and 2nd generation for medical indication protection)
▪ SPC protection: When do biological variants fall within the scope of an SPC?
▪ Latest developments regarding bolar exemptions in European case law
▪ The UK law reform /bolar and the unitary patent
10:30 Coffee break
11:00 The neutrokine- α cases at the EPO and before the English courts | C. Rennie-Smith
Microorganisms in the prior art | J. Renken
▪ Names, sequences, cell lines and samples
▪ Databases and deposition
▪ Public accessibility and reproducibility
Top priority: Getting your priority right and what to do if you didn’t | T. Steins, J. Ogle
▪ When and how to transfer a priority right
▪ The referral from T557/13 to the EPO Enlarged Board of Appeal on partial priority
▪ ‘Toxic’ divisionals and priority applications
14:45 Pharmatrends in the USA and in Japan | J. Taormino, M. Matsuzawa
▪ Patent eligibility issues raised by US Supreme Court decisions with regard to diagnostics, biotech inventions relating to natural products and second medical use inventions
▪ Perspectives from Japan
15:30 Coffee break
Petition for review – recent decisions | P. Klusmann, J. Zillies
▪ Overview and statistics
▪ Successful petitions
▪ Practical advice: Oral proceedings before the Board of Appeal;
analysis of the reasons for the decision under review; formulating the request
16:45 End of lectures for the day
17:45 Start time for conference dinner
Wednesday, June 17
EU patent package – Litigation before the Unified Patent Court
in pharma matters | T. Bausch, D. Schüßler-Langeheine, N. Hölder
▪ Mock trial scenarios demonstrating the pros and cons of national litigation vs. UPC litigation with regard to:
- NCE patents / SPCs
- formulation patents
- second medical use patents
- utility /design models
10:30 Coffee break
Product-by-process claims | D. Lethem, P. Klusmann
▪ The EPO‘s current position
▪ ‘obtainable by’ and ‘obtained by’: Any material difference?
▪ Recent decisions of the British and German courts
Enforcement of use claims in pharmaceutical patents | E. Pfaff
▪ What constitutes an infringing act for use claims?
▪ Overview of recent German case law – what has happened since Ribavirin and Buspiron
▪ The European perspective
13:30 Recent decisions in the UK and Germany on claim construction | T. Steins, M. Birkett
▪ Actavis v. Eli Lilly: DOE and should you learn from (prosecution) history?
▪ Styrolpolymerisatpartikel: Implicit limiting features due to the objective problem?
▪ Regenschirm and WC-Sitz: How has the case law on specific selections developed
since Okklusionsvorrichtung ?
▪ Drospirenon: Escaping DOE by doing the ‘opposite’?
Insolvency of licensor | N. Hölder
▪ German law: Discontinuation of licenses granted by the insolvent company
▪ Licensee in need of license – ‘misuse’ by the insolvency administrator
to achieve royalties above ‘market price’
▪ Recent German case law
▪ Options for partially solving or avoiding this problem
Vexatious patent litigation and patent settlements | H. Stratmann
▪ The EU’s request for balance between antitrust and intellectual property
▪ When may an IP owner be compelled to license its technology or refrain
from litigation to enforce its IP rights
▪ Impact of the European Commission investigations in the pharmaceutical industry
15:30 Closing Reception | J. Taormino
Hoffmann Eitle | Patent- und Rechtsanwälte PartmbB
Arabellastraße 30 | 81925 München
T +49. (0)89. 92 409. 0 | F +49. (0)89. 91 83 56 | [email protected]
Hoffmann Eitle | European Patent Attorneys
Harmsworth House | 13–15 Bouverie Street | London EC4Y 8DP
T +44. (0)20. 7427 0200 | F +44. (0)20. 7936 4510 | [email protected]
Hoffmann Eitle | Patent- und Rechtsanwälte PartmbB
Niederkasseler Lohweg 18 | 40547 Düsseldorf
T +49. (0)89. 92 409. 0 | F +49. (0)89. 91 83 56 | [email protected]
Hoffmann Eitle | Patent- und Rechtsanwälte PartmbB
Neuer Wall 80 | 20354 Hamburg
T +49. (0)89. 92 409. 0 | F +49. (0)89. 91 83 56 | [email protected]
Hoffmann Eitle S.r.l.
Via Torino 2 | 20123 Milano
T +39. 02. 725 46. 632 | F +39. 02. 725 46. 400 | [email protected]
Hoffmann Eitle S.L.U. | Agencia de la Propiedad Industrial
Paseo de la Habana 9–11 | 28036 Madrid
T +34. 91. 298 61 78 | F +34. 91. 563 97 10 | [email protected]