overig  

Beleidsnota Biotechnologie - reactie motie monopolisering in Nederlandse veredelingssector, Kamerstukken II 2012/13, 27 428, nr. 246.
In deze motie werd verzocht onderzoek te verrichten naar de mate, vormen en mogelijke maatschappelijke gevolgen van verdere monopolisering in de Nederlandse veredelingssector. Naar aanleiding van de motie Wiegman-Van Meppelen Scheppink en Dijkgraaf heeft mijn ambtsvoorganger SEO Economisch Onderzoek gevraagd monopolisering in de Nederlandse veredelingssector te onderzoeken. Het rapport «Concurrentie in de kiem» dat als bijlage bij deze brief is gevoegd, is het resultaat daarvan.

Uit het onderzoek blijkt tevens dat de concentratie in de veredelingssector twee typen oorzaken heeft, te weten:
a. economisch: de belangrijkste zijn schaal- en synergievoordelen in het innovatieproces, fusies en overnames en mondialisering.
b. institutioneel: intellectueel eigendomsbescherming, tot uiting komend in de doorlooptijd en kosten van octrooiaanvragen en vergunningen voor de ontwikkeling en het vermarkten van ggo’s.

Met de opkomst van de biotechnologie in de plantenveredeling en de introductie van genetische modificatie groeide ook de belangstelling voor het aanwenden van het octrooirecht als IE-beschermingssysteem. In Europa laat het octrooirecht sinds 1998, het jaar van de aanneming van de EU-Biotechnologierichtlijn3, octrooien toe voor planteigenschappen.

(...)

Actuele ontwikkeligen intellectueel eigendomsrecht

In het rapport stippen de onderzoekers de discussie aan die in uw Kamer gaande is om de balans tussen bescherming van en toegang tot biologisch materiaal te herstellen. Het herstellen van de balans tussen kwekersrecht en octrooirecht is mogelijk op basis van de oplossingsrichtingen aangedragen door het rapport van de heer Trojan, het voorstel tot wijziging van artikel 53b van de Rijksoctrooiwet 1995 in verband met de invoering van een beperkte veredelingsvrijstelling en door de invoering van een gedragscode voor licenties.

Wouter Pors, A legal innovation in patent law: a European intellectual property right and a single court to enforce it – a short note on key characteristics, IE-Forum.nl. en Kort verslag van het event 'Bird & Bird's Hague office holds first in a series of UPC seminars', 7 maart 2013.

Een bijdrage van Wouter Pors en Maurits Westerik, Bird & Bird LLP.

[red. artikel is ingekort, gehele short note]

What is the current situation?
Patents protect inventions and thus investments in innovation. Until now, patents in Europe have been national rights for all practical purpose. There is one system to apply for a patent for the whole of Europe, but after grant such a European Patent needs to be registered at national level, which also involves a recurring fee per country. It only provides protection in the countries where it is actually registered. In general, actions against infringers need to be brought in the national courts on a country-by-country basis.

The European Patent Convention has 38 member states. In practice an international patent dispute tends to be litigated in 3 – 6 countries. The European Court of Justice only allows national courts to decide for more than their own country in very limited situations.

What law will the court apply?
Primarily its own. The validity of European Patents and therefore also of Unitary Patents will be governed exclusively by the existing European Patent Convention. The basic criteria for infringement are in the UPC Agreement itself. The procedural law is also in the UPC Agreement and in the Rules of Procedure based on it. There already is a quite comprehensive draft of 382 detailed rules.

However, in addition there is a whole body of existing international law that will also apply and if that does not provide a solution, the court will apply national law as indicated by private international law.

When will it start?
With the signing of the UPC Agreement on 19 February all documents have been signed, but the UPC Agreement still needs to be ratified and the system needs to be set up. The European Commission is pushing very hard for the system to go live by April 2014, but it may take a number of additional months to be able to guarantee sufficient quality. Next to the UPC Agreement there is a declaration signed by the states that provides the framework for setting up the implementation which doesn’t require ratification. Preparatory work has already commenced and a kick-off meeting will probably be held before the end of March. Nevertheless, this is a massive job. A cross-border ICT-system needs to be built that will support case management and electronic filing of submissions, the central registry needs to be set up, judges need to be appointed and educated, facilities for court hearings need to be selected or even built.

Is the system mandatory?
The Unified Patent Court will be the only venue to litigate Unitary Patents, but for the first 7 years it will be optional for litigating traditional European Patents, with a possibility to extend that transition period for another 7 years.

Do you need expert counsel?
Every lawyer who is authorised to litigate in a national court can also litigate in the Unified Patent Court, as well as European Patent Attorneys who have obtained a special litigation certificate, so that provides a wide choice throughout Europe.

However, this system adds a new dimension to patent enforcement that requires developing elaborate strategies. There are new options for forum shopping among divisions of the Unified Patent Court and national courts. Procedural practices and substantive case law need to be developed. That calls for true in-depth knowledge and involvement in all relevant countries.

[red. bovenstaand artikel is ingekort, gehele short note]
Wouter Pors

Coming up Further seminars in the series will be happening as listed below:
• 21 March - Munich
• 18 April – London
• 31 May - Paris.
Please contact Katie Blampied if you would like to request an invitation to any of the seminars.

Zustersites IE-Forum.nl en Reclameboek.nl hebben overzichten gepubliceerd met voor de praktijk relevante rechtspraak van het HvJ EU vanaf voorjaar 2010, inclusief conclusies en aanhangige prejudiciële vragen. Deze zullen dienst doen als living document: steeds als er arresten zijn gewezen, conclusies zijn genomen of verzoeken zijn neergelegd wordt dit overzicht bijgewerkt (in deze serie: auteursrecht, modellenrecht, merkenrecht, octrooirecht (incl. ABC) en reclamerecht).

Inhoudsopgave
A. HvJ EU
B. Gerecht EU
C. Conclusies AG HvJ EU
D. Aanhangige prejudiciële vragen
E. Hogere voorziening (verzoek)
F. Verder in de pijplijn (vragen nog niet definitief gesteld)
G. Aanhangig bij het Gerecht EU

Webinar (vereist: installatie Apple Quicktime) en PowerPoint Slides "monoclonal antibodies: Dawn of a New Era" van 7 juni 2012.

Een bijdrage van Wouter Pors, Bird & Bird.

MAbs: How to protect them using patents and SPCs, Michael Alt, Partner, Germany, 2-34
Infringement Issues Relating to MAbs, Trevor Cook, Partner, United Kingdom, p. 35-47
New US biosimilar guidelines: Compared to the EU, Liz Fuller, Partner, France p. 48-79
An update on the regulatory framework for MAbs and ATMPs, Marc Martens p. 80-114.
An industry perspective Frank Landolt, IP and Legal Counsel, Ablynx, p. 115-151

Uit't persbericht: Brussels, 01 March 2012. Medicines should enter the market faster. With this intention the European Commission has proposed today to streamline and reduce the duration of national decisions on pricing and reimbursement of medicines. In the future, such decisions should be taken within 120 days for innovative medicines, as a rule, and for generic medicinal products within only 30, instead of 180 days today. Commission also proposes strong enforcement measures in case the decisions do not comply with the time limits, as these are often exceeded by Member States. The new Directive represents an important simplification measure and shall repeal and replace the longstanding Directive from 19891, which no longer reflected the increased complexity of the pricing and reimbursement procedures in the Member States.

Presenting this proposal the European Commission Vice President Antonio Tajani, responsible for Industry and Entrepreneurship, underlined: "We need faster decisions leading to pricing and reimbursement to maintain a dynamic pharmaceutical market and to offer citizens better access to pharmaceuticals. Our proposal will lead to substantial savings for public health budgets, for example by allowing earlier market entry of generic products. It also creates a more predictable environment with greater transparency for pharmaceutical companies, thus improving their competitiveness."

https://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/pricing-reimbursement/transparency/index_en.htm

Background
After the quality, safety and efficacy of the medicinal products are established during the process of marketing authorisation,2 each Member State makes a further evaluation to decide whether the medicine is eligible for reimbursement, in compliance with the common procedural rules established under the Transparency Directive.

Complexity of national measures related to the pricing of medicinal products has increased since 1989, when the Transparency Directive for pharmaceutical products was adopted. By then, pricing and reimbursement procedures mainly involved the submission of an application followed by a decision-making process to determine the price of the medicine and/or its eligibility to reimbursement. However, the increasing diversity since 1989 led to complex pricing and reimbursement schemes (e.g. some of these schemes contain different categories of reimbursement). The Court of Justice ruled in its case-law that all national measures to control the prices of medicinal products or to restrict the range of medicinal products must comply with the Directive3. The proposal aims at reflecting the relevant case-law of the Court in the text of the Directive.

This revision is a follow up to the Commission report on the pharmaceutical sector in 2009 (Pharmaceutical Sector Inquiry)4 which revealed long and cumbersome pricing and reimbursement decisions. Studies have shown that delays in pricing and reimbursement decisions can go up to 700 days for innovative medicines5 and up to 250 days for generics .6

Today's proposal aims at introducing the following main changes:

• Guaranteeing shorter time limits for national, regional or local decisions on pricing and reimbursement of:
• all medicinal products in general (120 days instead of 180 days, except for more complex procedures) and
• generic medicinal products in particular (30 days instead of 180 days) when the price of the reference product has already been approved or it has already been included in the public health insurance system.
• Increasing the effectiveness of the directive by proposing strong enforcement measures, i.e. in case of non-compliance with the time limits, a Member State has to designate a body entrusted with the powers to take rapid measures such as:
• adopting interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned;
• awarding damages to the applicant;
• imposing a penalty payment, calculated by day of delay.
• Introducing the obligation fro Member States to regularly reporting on their decisions and the time involved.
• Notifying national pricing and reimbursement draft measures to the Commission to facilitate compliance from the beginning.
• Ensuring legal clarity and consistency with the Court of Justice case-law and clarifying the scope of transparency obligations.
• Addressing the uncertainties relating to innovative pricing and reimbursement procedures: e.g. exclusion of tendering (covered by public procurement law) and of managed entry agreements (covered by contractual/administrative law) from the scope of application of the Directive.