Science&Industry News

Nº 11-12 | Volume 6 | 2007 | ISSN 1618-8276 | A 60711 | European Biotechnology Science&Industry News CENTRAL EUROPE Satraplatin misses endpoint; Germany to change stem cell rules

INSIGHT EUROPEAN UNION Council of Europe to harmonise framework for genetic testing

NORTHERN EUROPE Orexo expands; Pronova goes public for 73 million euros

WESTERN EUROPE Devgen buys Monsanto Asia; French President bans GMO crops

SOUTHERN EUROPE Cellerix to receive 250 million euros for Phase III stem cell product

EASTERN EUROPE Hungarian consortium gets funds for screening of selective MMP inhibitors

SCIENCE & TECHNOLOGY New MS approach: demyelination reversed; DNA dictates allergenicity 1st Berlin Conference on IP in Life Sciences Smart Clinical Trials

15 February 2008, 9:30 am, British Embassy Berlin, Germany

Key Note Lecture Prof. Dr. Reinhard Kurth, President, Robert Koch Institute First in Man – Preparation and Design of Clinical Trials Dr. Liz Allen, Director of Scientiﬁc Affairs, Quintiles Ltd. Patenting in the Pharmaceutical Field: Dr. Ute Kilger, Patent Attorney, Vossius & Partner First and Second Medical Use for Biologicals Covering Liability Issues in Clinical Trials Dr. Jan Dirk Heerma, Partner, SJ Berwin LLP Introducing the UK Clinical Research Network - Prof. Dr. Richard S. Kaplan, Associate Director, Clinical Trials with the UK National Health System UK Clinical Research Network Study Design and IP – Important Factors Dr. Peter Hug, Global Head of Pharma Partnering, for Successful Licensing F. Hoffmann-La Roche AG (enquired) Prolonging IP’s Life Span – Data Protection SPCs Dr. Christian Kilger, Patent Attorney, Vossius & Partner and the Law of Pedriatic Use Efﬁcient Clinical Trials – Lessons learned Dr. Wolfgang Söhngen, CEO, Paion AG (enquired) Closing Remarks Dr. Hans-Rainer Jaenichen, Partner, Vossius & Partner

Please register at www.biocom.de/events or mail to [email protected]. 20% Earlybird discount until Dec. 31st, 2007!

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IP since human embryonic stem cells were comprised by the patent. It would have been much simpler if, upon realisation of the mistake, the patent holder could have New patent law – had the option of repairing his deficient patent. However, not only were the patent holder’s hands tied - there was no way the Patent Office could correct the mistake ei- the EPC 2000 ther. The resulting spectacular opposition proceedings ended up being used by polit- ical groups to discuss the question of stem Dr. Christian Kilger & Dr. Ute Kilger, Patent Attorneys Vossius & Partner, Berlin cell research. In future, the patent holder would have the opportunity to limit proceedings by introducing the word “non- The European Patent Convention (EPC) 2000 will come into force on human”, thus limiting his own claim. 13 December, 2007. When the London Agreement also goes into force at the beginning of next year, many changes will take place in European Patentability Patent Law. What this means for patent applicants will be discussed in this article. The present “collection of laws/statutes”, the so-called European EPC 2000 also strengthens protection for Patent Convention (EPC) including Articles and Rules, supplemented by medical indications, namely by the intro- jurisdiction, was heavily revised at a diplomatic conference in November of duction of purpose-limited product pro- 2000. The revised EPC that is coming into force at the beginning of Decem- tection for medical indications. ber 2007 has so far been ratified by 24 member states. States which did Let us be clear: an absolute protection not ratify the new EPC – and as a result are no longer members of the EPC of products in medicinal use will, of – include France, Italy and Germany. There is no reason to assume that this course, continue to exist. In other words, will not change. The object of the revision was to increase the efficiency, if a completely new substance is found flexibility and user-friendliness of European patent systems, as well as to which, as a medicinal product, is suita- encourage deregulation and adjustment to existing treaties such as TRIPS ble against disease X, then said substance and PLT 2000. per se can be protected for any use, including non-medicinal use. Purpose-limited product protection for medicinal in- The EPC 2000 represents the introduc- alleged infringer has therefore been given dications will be available in addition to tion of a central limitation and revocation greater power. In Germany, the key phrase absolute product protection. An exam- procedure. The patent holder is given the is “state-of-the-art prejudicial to novelty”. ple: let’s assume that substance X was option to limit or withdraw his/her own In the case of infringement, the alleged in- known to be an effective medicinal prod- patent. What would be the point in that? fringer will file a request for suspension uct against disease X. Later, the producer Here an example: a patent holder wants to of proceedings with the Regional Court, discovers that this substance is also suit- sue a competitor for patent infringement. and in the nullity proceedings before the able as a medicinal product against dis- Recently, however, he searched the state- Federal Patent Court, he will attack the ease Y. Up until now, because therapeu- of-the-art in his field and discovered that patent’s novelty. Thus, ideally, the plain- tic methods were excluded from patent- his patent claim is not new over its entire tiff would like a patent “without deficien- ability, only the following claim could scope. In order to own a legally valid pat- cies”. With the EPC 2000, the patent owner be granted: “Use of substance X for the ent, he would have to limit his patent claim is able to “repair” his patent. Another ex- production of a medicinal product for the to subject matter that is new and not ob- ample is the “notorious” Edinburgh Pat- therapeutic use against disease Y”. When vious over the state-of-the-art. One might ent comprising the claim “animal trans- defending said claim against a third par- say now that in the nullity suit that could genic stem cells including embryonic stem ty in court who, despite a standing patent be expected from such a scenario, the pat- cells”. There was a heated discussion sur- on this medicinal product for the thera- ent may be limited as well. The problem in rounding the question of whether the Eng- py of disease Y, was selling same, pat- this case is that, if the patent holder sues lish term “animal stem cells” also includes ent holders have had serious problems the alleged infringer without limitation, human stem cells, and therefore also hu- in some European countries – includ- he is actually strengthening the position man embryonic stem cells and their mod- ing France. Now with the EPC 2000, the of the alleged infringer, as the reply is ification or use. The latter should not be patent holder is granted protection for usually in the form of a nullity suit to de- patentable. Let’s assume that by granting “substance X for the treatment of disease stroy the patent of the adverse party. The the patent, the examiner made a mistake, Y”. It is to be expected that clear prod- Nº 11-12 | Volume 6 | 2007 Euro|Biotech|News 43 PERSPECTIVES

very high costs. In March 2007, Malta be- came the 32nd member state of the Euro- pean Patent Convention. If protection were sought for all thirty-two European countries, the patent would have to be translated into all of these national languages. With average costs amounting to a3,000 for a patent application of average size, 20 countries would mean translation costs of a60,000. The London Agreement, a convention based on the free consent of the member states, eases the translation re- quirements considerably. The countries signing the Agreement will no longer de- mand a translation of the complete Euro- pean patent. Only claims will have to be translated into the national languages, while translation of the description will European Patent Office in Munich no longer be necessary. This will reduce translation costs considerably. Despite the uct claims like these are defended more It will also be possible, one year after the London Agreement having been decid- easily and will be accepted in all Euro- filing of the initial application, for exam- ed upon in 1999 and amended in 2000, it pean countries. ple, in Germany or in Europe, to file a is not yet in force. To date, the following patent application effective throughout states have signed the Agreement: Germa- Further processing the entire world while claiming the ear- ny, Great Britain, The Netherlands, Swit- lier initial priority date. Up to now, this zerland, Iceland, Latvia, the Principality If time limits are exceeded, an applica- was no longer possible if you had missed of Liechtenstein, Monaco and Slovenia. tion may be “lost“. In principal, reviv- the time limit the first time around. Pri- The parliaments of Sweden and Denmark al is possible by means of two methods: ority date was the most fatal of all time have also already ratified the Agreement. further processing and re-establishment. limits. Now, according to the new Eu- Thus, the London Agreement will proba- Further processing of a patent is rela- ropean Patent Convention 2000, at least bly come into effect before long in twelve tively uncomplicated; the omitted act is re-establishment (cf. above) is possible of the thirty-two countries of the Europe- completed, a small fee is paid, and a let- within a term of two months. One must an Patent Organisation. France has been ter is written requesting further process- bear in mind, however, that even under hesitant to sign the Agreement for years, ing. Unfortunately, up to now, further the EPC, a missed priority date should be but in November 2007, the French parlia- processing was only admissible in con- avoided at all costs. Re-establishment is ment voted to sign. If the ratification of the nection with few time limits. Now the not easily obtained. London Agreement were to follow at the possibility for further processing has beginning of next year in France, it would been extended to a large number of time European patent at low cost come into effect three months later. Let’s limits, facilitating the revival of an appli- hope that further countries will also en- cation for the applicant. “Re-establish- A European patent application is exam- ter into the agreement. ment”, however, is difficult to obtain. It ined in a central grant procedure by the requires the submission of statutory dec- European Patent Office, and the patent is Conclusion larations by patent attorneys’ assistants granted if all patentability criteria are met. stating that they omitted time limits, not- Once the patent has been granted, any per- The patent procedure will hopefully be- withstanding many years of experience son can file an opposition with the EPO come more effective, less expensive and and excellent training, and despite the within nine months after the patent has more flexible through the changes de- patent attorney’s control. Even if pur- been granted. After the patent is grant- scribed, as well as through further changes sued, these measures are not always suc- ed the patent “falls apart into” individu- the new European Patent Convention will cessful. One should bear in mind that a al national patents – into a German part, bring about. This is particularly important strict observance of all time limits de- a French part, a British part and so on. At for medium and small-scale enterprise ap- spite the possibility of further processing present, for every country in which the Eu- plicants, which will then no longer refrain is always a preferable scenario, since fur- ropean patent enters the national phase a from filing a European patent application ther processing can be expensive. translation has to be filed. This involves simply because the costs are too high. 