Bird & Bird have been particularly active this autumn on the seminar front...
For our UK-based clients we'd like to extend an invitation to attend our Annual Life Sciences Update on Tuesday 4 October. The event will consist of three parallel sessions focussing on current key issues in the Life Sciences sector, with presentations on: Having your say at the EMA: opportunities for challenging European Medicines Agency opinions and decisions; An update on Supplementary Protection Certificates; and How to realise a successful sale in an M&A transaction: war stories from the front line. We also have joining us, special guest speaker, Ian Crosbie, Managing Director of Healthcare Investment Banking at Jefferies, one of the largest and most experienced healthcare investment banking teams in the world.
We recently hosted the first of a series of seminars based in Geneva, Switzerland. This particular seminar focused specifically on the legal and regulatory aspects involved in biotech drug development, with speakers from France, Belgium and the United Kingdom. The topics covered were: Biosimilars an update on developments in the US and in the EU: Prospects for global developments?; Medical applications and scientific research with human cells and tissues: Introduction to the EU regulatory framework; and Licensing issues in the pharma and biotech industry. Please let us know if you're interested in attending any of our future Geneva-based seminars by contacting Karla Fryer, karla.fryer@twobirds.com.
We'd be really interested to hear any particular topics that may be of interest to you for any future seminars or updates, please contact karla.fryer@twobirds.com to have your say.
This year we were delighted to receive, for the 4th consecutive year, the award for 'World's Leading Law Firm for Life Sciences' by Who's Who Legal, or perhaps we could just say at the end of our intro "Bird & Bird, the World's Leading Law Firm for Life Sciences", Who's Who Legal 2011, 2010, 2009, 2008.
Patents and SPCs
Court of Justice judgments in Synthon and Generics SPC references
Ewan Grist, London
On 28 July 2011, the Court of Justice of the European Union handed down its decision in Synthon v Merz (C-195/09) and Generics v Synaptech (C-427/09).
Germany: Prima facie evidence in PI proceedings - pramipexole
Beate Methner, Dusseldorf
Recently, the Higher Regional Court Dusseldorf decided on the standards for prima facie evidence in German preliminary injunction proceedings.
The plaintiff, an innovative pharmaceutical company, first obtained an ex parte preliminary injunction from the Regional Court Dusseldorf on the basis of a supplementary protection certificate (SPC) against a generic manufacturer on 9 December 2010. The defendant's objection to this decision was essentially rejected by the Regional Court in a judgment dated 24 February 2011. However, following an appeal filed by the defendant, the Higher Regional Court Dusseldorf revoked the decision and dismissed the plaintiff's motion for injunctive relief and disclosure on 4 August 2011.
Italy: Leo v Sandoz - Leo's patent covering the monohydrate calcipotriol invalid
Evelina Marchesoni, Milan
On 2 March 2011, the Court of Turin filed its decision in Leo Pharma v Sandoz revoking the Italian portion of Leo's European patent EP 0679154.
The patent EP '154 relates to a crystalline form of calcipotriol namely calcipotriol monohydrate used in the treatment of psoriasis (which was said to have superior stability and technical properties in the manufacture of crystal suspension formulation).
Regulatory
Data exclusivity and definition of a new active substance
Mary Smillie, London
We reported in the April 2010 edition of the International Life Sciences Update the case Sepracor Pharmaceuticals (Ireland) had brought against the Commission (Case T-275/09). On 4 July 2011 the General Court ordered that the action brought by Sepracor be dismissed as inadmissible.
European Court hands down judgment in GMO-contaminated honey case
Mary Smillie, London
The Court of Justice of the European Union has classed pollen which contains genetically modified material as a natural ingredient of honey, and therefore is subject to the European regime which requires authorisations for genetically modified organisms (GMO). This decision may lead to payment of compensation by the Bavarian State (on whose land the GMO-containing maize was grown) and Monsanto (who held the authorisation to grow the MON 810 maize) to the Bavarian bee-keeper who brought this action following contamination of his honey with the GMO.
Spanish Government approves a number of measures to improve the management of pharmaceutical spending
Raquel Ballesteros and Enrique Rivas, Madrid
On 19 August 2011, the Spanish Government approved a new regulation: Royal Decree-Law 9/2011, regarding measures to improve the quality and cohesion of the National Health System, contributions to fiscal consolidation, and provisions to increase the maximum amount of state guarantees for 2011. This Royal Decree-Law brings changes to medicinal product pricing and reimbursement in order to reduce pharmaceutical spending. This is a highly controversial measure as it implies dramatic discounts to medicinal products in addition to those formerly imposed by the Spanish Government in 2010 (specially, the mandatory 7, 5% discount on the price of medicinal product which are not subject to reference prices).
Industry
European Commission publishes second report on monitoring patent settlements
Joseph Ward & Richard Eccles, London
On 6 July 2011, the European Commission published its second monitoring report of patent settlement agreements covering the period 1 January to 31 December 2010. The Commission concludes that the number of settlement agreements that are potentially problematic, from a competition law perspective, have decreased significantly, despite an overall increase in the number of patent settlements. The report compares the 2010 situation with that for the eight and a half years to 2008 covered in its Final Report on the pharmaceutical sector, and the position in 2009 covered in its first monitoring report, on which we reported in our September 2010 issue of this Bulletin.
The European Commission closes its investigation into alleged misuse of the patent system by Boehringer
Joseph Ward, London
On 6 July 2011, the European Commission announced that, in light of the settlement reached between the complainant and German pharmaceutical company Boehringer, it had closed its investigation in alleged misuse of the patent system by Boehringer.
OFT publishes the full text of its decision to fine Reckitt Benckiser £10.2 million for abuse of dominance
Joseph Ward & Richard Eccles, London
The OFT has now published its infringement decision which provides the detailed reasoning for its finding that Reckitt Benckiser ('RB') infringed Article 102 of the Treaty on the Functioning of the European Union ('TFEU') and the Chapter II prohibition of the Competition Act 1998, by strategically withdrawing and de-listing Gaviscon Original Liquid ('GL') from the NHS prescription channel in 2005 so as to favour its patent-protected Gaviscon Advance Liquid ('GA') and obstruct generic product entry. This case is interesting given that RB's conduct was lawful as a matter of regulatory process but was found to be illegal as a matter of competition law. This case is not dissimilar to the second abuse found in the Commission's decision against
Astrazeneca, whereby Astrazeneca deregistered marketing authorisations in order to delay the market entry of generic products.
Value Added Tax (VAT) and Life Science: Building bigger lips and treating wrinkles – taxable cosmetic treatment or exempt health care?
Ulrika Hansson and Jan Gedeborg, Stockholm
In Sweden there is an on-going discussion with the Tax Administration as well as in the courts with regard to the definition of exempt medical care under the Swedish VAT law (1994:200) and the EU VAT Directive, 2006/112/EC. The discussion which has arisen concerns services provided by centres for cosmetic surgery and cosmetic treatments. Their activities involve a number of different treatments for different purposes; laser treatments of the skin, Botox and Restylane injections for various purposes (wrinkle reduction for example), plastic surgery of different kinds, etc. The treatments are often carried out by licensed health personnel. The reason for such treatments may be purely medical, purely cosmetic or a combination of both. In many cases treatments are carried out in order to restore the body after disease or accidents.
Medicinal packaging and parallel imports. Joined cases of Orifarm and Paranova v Merck Sharp & Dohme, Cases C-400/09 and C-207/10
Tim Harris, London
This reference to the CJEU concerned the interpretation of Article 7(2) of the Trade Mark Directive. The ECJ has previously specified the conditions under which a parallel importer may market repackaged medicinal products bearing a trade mark, without the consent of the trade mark proprietor (the BMS Criteria).
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