Events and offers to readers
Bird & Bird Upcoming Event
Brussels Seminar: EU Regulatory Law Update for the Biotech industry with guest speaker from industry
7 June 2012 - For an invitation please contact Karla Fryer: firstname.lastname@example.org
Discounts for Readers
EU Pharmaceutical Law Forum - 25% discount
Join Bird & Bird Life Sciences Head, Trevor Cook, and a host of experts from in-house counsel and industry at Europe's leading pharmaceutical law conference taking place in Brussels on the 22-23 May 2012. To book please visit www.informaglobalevents.com/event/pharmalaw12 and enter CQ5171BRD.
A User's Guide to Patents, 3rd edition, Trevor Cook - 20% discount until 20 April 2012
Fully updated to include the latest developments, this new third edition will be of great use to in-house lawyers, solicitors and barristers, as well as professionals interested in patents, including patent agents, and top level management executives. To receive the discount please email email@example.com and quote UGPBB20.
Bird & Bird Special Heathcare Report - Authors from the UK, Italy and the Netherlands*
Click here to read the pdf of our country chapters.
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Patents & SPC Decisions
Initial attempts to apply the recent CJEU case law on SPCs
Trevor Cook, London
In the December 2011 issue of our Life Sciences Update we commented on the immediate aftermath of the decisions of the Court of Justice of the EU (CJEU) of 24 November 2011 concerning Supplementary Protection Certificates (SPCs) for combination products in Cases C-32/10 Medeva (C 322/10) and C-422/10 Georgetown University. We discussed its consequential reasoned orders in Case C-630/10 Queensland and Case C-518/10 Yeda but at the time of writing the reasoned order of the CJEU in Case C-6/11 Daiichi Sankyo was not available. In the event however, and despite the third question in Daiichi providing greater scope than the others for the CJEU to clarify whether for example, a genus type claim, "specifies" or "identifies" such active, so that a patent with such a claim could properly constitute a basic patent for such an active, the reasoned order in Daiichi goes no further than its other judgments and reasoned orders.
EU: CJEU orders that SPC for single active are infringed by combination products containing that active
Ewan Grist, London
On 9 February 2012, the Court of Justice handed down a reasoned order following a reference from the English High Court in Novartis v Actavis.
Spanish Patents Office allows the introduction of product claims in lapsed patents affected by the EPC reservation
Teresa Mercadal Menchaca, Madrid
At the time of its accession to the European Patent Convention (EPC), Spain made a reservation to the Convention under Article 167.2a, which excluded chemical and pharmaceutical products from being patentable in Spain until 7 October 1992. Prior to this date, applicants of European Patents (EP patents) for chemical and pharmaceutical products with product claims had to file a special set of process claims for the Spanish validation of these EP patents. Similarly, applicants of Spanish patents could only apply for patents with process or use claims until 7 October 1992.
Spain: The direct affect of TRIP's is also applied to SPCs
Manuel Lobato, Madrid
In a recent decision (dated 21 February 2012), the Commercial Court No. 7 of Barcelona has granted an inter partes
Preliminary Injunction in favour of Pfizer against 16 generic companies regarding sildenafil.
EU: More discretion for the Paediatric Committee when deciding on a Paediatric Investigation Plan (PIP) the 'Nycomed decision'
Hanneke Later-Nijland, The Hague
According to Regulation (EC) 1901/2006, also known as the 'Paediatric Regulation', a pharmaceutical company is obliged to submit a Paediatric Investigation Plan (PIP) for a new medicinal product when applying for a marketing authorization. A PIP ensures that the necessary data is obtained through studies performed in children in order to support an authorisation of the medicinal product for children. Many of the medicinal products currently used to treat children have not been studied or authorised for such use. The aim of the Paediatric Regulation is therefore to facilitate the development and accessibility of medicinal products for use by children.
EU: Proposals on new legislation on "Information to Patients" and "Pharmacovigilance" adopted by the Commission
Mary Smillie, LondonOn 10 February 2012 the Commission adopted proposals to amend Regulation (EC) No. 726/2004 and Directive 2001/83/EC in relation to Information to Patients and Pharmacovigilance.
Hungary – Changes in Pharmaceutical Regulatory Law
Balint Halasz, Budapest
As a part of the Hungarian government's efforts to make drug prescription and reimbursement schemes more cost efficient, the Hungarian parliament and governmental bodies passed several amendments concerning pharmaceutical regulatory law. In this briefing we provide an insight into some of these new provisions, in particular the Pharmacy Generic Programme, the obligation on pharmacies to provide detailed information to patients on substitutable medicines and the yearly auctions for determining the group of preferred biological medicines.
Spain: Problems with late payment of public administration in the pharmaceutical sector in Spain - mechanisms for claiming
Jose Manuel Ramos, Madrid
The economic crisis in which Europe is currently immersed is significantly affecting the pharmaceutical sector in Spain, which is having to face up to long delays in collecting invoices for medicines supplied to public hospitals.
Poland: New rules on refunding of medicinal products and ban on advertising of pharmacies
Joanna Szumilas and Piotr Dynowski LL.M., Warsaw
The new Polish Act on refunding medicinal products ("Act on Refunding") came into force in January 2012 and has caused significant confusion, in particular amongst doctors and pharmacists. It has profoundly changed the existing refunding system of medicinal products in Poland.
The "advertising" of prescription based medicinal products to journalists is prohibited in Sweden
David Nilsson and Richard Lewinson, Stockholm
In a somewhat controversial decision, the Swedish Medical Products Agency (the "Agency") prohibited Boehringer Ingelheim AB ("Boehringer") in September 2011 from advertising the prescription-based product Pradaxa to the public. Interestingly, the advertising at issue consisted of a press release that was published on the Internet, and the 'public' in this case comprised journalists, as the press release was explicitly targeted at journalists.
*Reproduced with permission from Law Business Research Ltd. This article was first published in Getting the Deal Through – Life Sciences 2012, (published in February, 2012; contributing editors: Alexander Ehlers and Cord Willhöft, Ehlers, Ehlers & Partner). For further information please visit www.GettingTheDealThrough.com