Life Sciences Update - Winter/Spring 2009


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Welcome to the Winter/Spring 2009 edition of Olswang's life sciences update.

A lot has happened in the months since our last report. The recession finally appeared. The stock markets crashed. Currency has been hit. The industry has been hit by job losses and redundancies. Acquisitions have continued to amaze and bewilder – not least the amounts being paid for companies and their pipelines. And finally, President Obama threatens to overhaul and revolutionise the pharmaceutical industry.

However, the industry has also seen some exciting changes and developments. The patent world has, for some, been kinder to the innovators. Lundbeck and Lilly (in the UK) have both been successful in resisting challenges to patents on their drugs. GSK and Pfizer have just recently announced an innovative collaboration and patent sharing scheme for the promotion and development of existing and new AIDS/HIV drugs and research. Despite press reports to the contrary, there has been investment in the sector. As testament to that Olswang has been involved in a series of fund raisings for pharmaceutical companies. The UK Government has reversed rules that previously excluded patients from NHS care where they paid privately for treatment using new innovative medicines.

However, perhaps one of the most significant events in recent months has been the European Commission's publication of its preliminary report. Many commentators have concluded that the European Commission has engaged with the industry in a public relations battle : the "evil" pharmaceutical companies using their wealth and power to restrict competition and keep prices high. However, the Commission's preliminary report has a substantial number of cracks beneath its thin gloss. The special report towards the end of this quarter's update provides our own summary and thoughts arising from the report.

In our last report, we mentioned the SPC Blog that was launched by members of Olswang's life sciences team (see http://thespcblog.blogspot.com/). The blog has had significant interest and now has a healthy number of email subscribers. Since the success of the SPC Blog, we have also launched a patent litigation focused blog (see http://patlit.blogspot.com). Creatively entitled PatLit I would encourage you to visit and sign up. Whilst it is not focused solely on life sciences, it is sure to deliver to your inbox the latest cases in the industry as they arise.

Stephen Reese
Olswang
+44 (0) 20 7067 3282
stephen.reese@olswang.com


No More Pens and Sticky Notes: The End of Gifts from Drug Firms? *

A working party led by the Royal College of Physicians has issued a report looking at ways to rebalance the relationship between medicine and industry. One of the significant recommendations in the report is that there should be an end to the supply of free gifts to health professionals.
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Proposals to Make More Drug Available on the NHS Published *

The Health Secretary, Alan Johnson, has announced that more drugs are to be made available to patients on the NHS, particularly for those facing a terminal illness and that the NHS should not withdraw treatment from the few patients who may still choose to pay privately for additional drugs from 4 November 2008.
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Developing the Quality and Outcomes Framework *

The UK's Chief Medical Officer, Sir Liam Donaldson has announced the formation of the implementation team for England and £1m of funding to support them.
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More Funding for Health Research and Development *

The Welsh Assembly Government has announced that it is to provide funding to support NHS research activities with almost £370,000 of investment.
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UK Companies Research and Development Grew by 10% Last Year *

The Department for Innovations, Universities and Skills has published a report compiling the latest data on investment in research and development (R&D) and financial performance of the 850 most active UK companies (including foreign-owned companies whose R&D is conducted and reported in the UK850). The report also includes data on the 1,400 most R&D active companies globally.
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DoH Consults on Creation of Professional Pharmacy Regulator *

The Department of Health has launched a consultation paper setting out proposals for the creation of regulator for pharmacy professionals and pharmacy premises in England, Wales and Scotland.
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Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and another

Hearing Date: 15 October 2008
Court: Chancery Division, Patents Court
Patent - Validity - Revocation - Common general knowledge - Supplementary protection certificate (SPC) - Defendants being proprietors of patent and SPC in respect of medicinal product - Claimant seeking declarations of invalidity - Whether declarations should be granted.
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Dr Reddy's Laboratoires (UK) Ltd v Eli Lilly and Co Ltd

Hearing Date: 13 October 2008
Court: Chancery Division
Patent - Petition for revocation - Particulars of prior use - Defendant company owning European patent concerning olanzapine drug used for treating schizophrenia - Claimant company seeking revocation of patent on basis of invalidity - Whether application should be granted.
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Les Laboratoires Servier and another v Apotex Inc and others

Hearing Date: 9 October 2008
Court: Chancery Division
Injunction - Interlocutory - Undertaking as to damages - Cross-undertaking as to damages - Patent action - Claimant obtaining interim injunction in patent infringement proceedings - Court subsequently revoking claimant's patent - Quantification of damage occasioned to defendant for purpose of enforcing cross-undertaking given by claimant.
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Actavis UK Ltd v Novartis AG *

Hearing Date: 20 January 2009
Court: Chancery Division, Patents Court
Patent - Petition for revocation - Obviousness - Insufficiency - Patent concerned with fluvastatin which had effect of reducing blood cholesterol - Defendant marketing fluvastatin - Claimant company seeking revocation of patent on grounds of obviousness and insufficiency - Whether patent obvious - Whether patent invalid for insufficiency.
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Corevalve Inc v Edwards Lifesciences AG and another *

Hearing Date: 9 January 2009
Court: Chancery Division, Patents Court
Patent - Petition for revocation - Obviousness - Insufficiency - Defendant companies owning patent concerned with artificial valves for implantation in human body - Claimant company applying for revocation of defendants' patent on basis of invalidity - Defendants counterclaiming for infringement of patent by claimant - Whether patent valid - Whether claimant infringing patent.
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Ratiopharm GmbH v Napp Pharmaceutical Holdings Ltd Sandoz Ltd v Napp Pharmaceutical Holdings Ltd *

Hearing Date: 16 December 2008
Court: Chancery Division, Patents Court
Patent - Petition for revocation - Obviousness - Claimant seeking revocation of defendant's European patents concerned with a known opiod pain killer 'oxycodone' - Defendant counterclaiming for infringement on basis that patents both valid and had been infringed - Whether patents invalid - Whether patents had been infringed.
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Generics (UK) Ltd and others v H Lundbeck A/S

Court: House of Lords
Patent - Biogen sufficiency - Claimant seeking revocation of defendant's European patent covering an isolated enantiomers from known racemate citalopram - Whether patents invalid.
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The Wellcome Foundation Ltd v Paranova Pharmazeuitka Handels GmbH (Case C-276/05) *

Hearing Date: 22 December 2008
Court: Court of Justice of the European Communities (Second Chamber)
European Community - Trade marks - Infringement - Pharmaceutical products - Repackaging - Parallel imports - Substantial change in appearance of packaging - Obligation of prior notice.
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Neurim Pharmaceuticals (1991) Ltd v Office for Harmonisation in the Internal Market (Trade Marks and Designs) (Case T-218/06) *

Hearing Date: 17 September 2008
Court: Court of First Instance of the European Communities (First Chamber)
European community - Trade marks - Community trade mark - Examiner refusing to register mark as Community trade mark - Applicant appealing to respondent - Applicant applying to have proceedings continued and “restitution in integrum” despite non-compliance with rules relating to filing of notice of appeal - Respondent appeal board declaring appeal 'inadmissible' - Board refusing to accede to additional applications - Whether board erring - Council Regulation (EC) 40/94, arts 59, 78, 78a - Commission Regulation (EC) 2868/95, rr 48, 49, 96.
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R (on the application of Synthon BV) v Licensing Authority of the Department of Health (Case C-452/06) *

Hearing Date: 16 October 2008
Court: Court of Justice of the European Communities (First Chamber)
European Community - Medicinal products - Marketing authorisation - Community code relating to medicinal products for human use - Essentially similar medicinal products - Abridged procedure - Procedure for mutual recognition - Liability of member state - Whether serious breach of Community law - European Parliament and Council Directive (EC) 2001/83, art 28.
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Sot. Lelos kai Sia EE and others v GlaxoSmithKline AEVE Farmakeftikon Proionton (Joined Cases C-468/06 to C-478/06) *

Hearing Date: 16 September 2008
Court: Court of Justice of the European Communities (Grand Chamber)
European Community - Rules on competition - Abuse of dominant position - Pharmaceuticals market - Reference to European Court - Request for preliminary ruling concerning interpretation of Community law - EC Treaty, art 82.
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R (on the application of Assura Pharmacy Ltd) v National Health Service Litigation Authority (Family Health Services Appeal Unit) *

Hearing Date: 5 December 2008
Court: Court of Appeal, Civil Division
National Health Service - Pharmaceutical services - Application for admission to pharmaceutical list - Proper approach to application - Guidance - Reasonable choice - National Health Service Act 1977 - National Health Service (Pharmaceutical Services) Regulations 2005, SI 2005/641, reg 12.
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Hyaltech Ltd, petitioners *

Hearing Date: 5 December 2008
Court: Extra Division, Inner House, Court of Session
Judicial review - Licensing of medicines and healthcare products - Whether product should be classified as medicinal product or medical device - Council Directive (EEC) 93/42, arts 1.2, 1.4 - Medical Devices Regulations 2002, SI 2002/618, reg 2(1).
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Claimants registered in the Group Litigation Order v Sanofi Sythelabo Ltd *

Hearing Date: 23 January 2009
Court: Queen's Bench Division
Evidence - Expert evidence - Application to adduce expert evidence - Claimants bringing proceedings in respect of damage sustained as a result of mothers’ use of drug - Claimants seeking to adduce expert evidence as to sales and profitability of drug - Whether proposed evidence reasonably required.
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Farraj and others v King's Healthcare NHS Trust and another *

Hearing Date: 17 October 2008
Court: Queen's Bench Division
Hospital - Liability for negligence of members of staff - Medical practitioner - First defendant NHS Trust undertaking genetic testing of sample provided by first claimant - Second defendant culturing sample - Report providing sample foetus would not suffer from Beta Thalassaemia Major (BTM) - Claimant's son suffering from BTM - Whether defendants negligent.
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The Likely Impact of the Commission's Preliminary Report on the Pharmaceutical Sector Inquiry

On 28 November 2008 the European Commission published its preliminary report in its inquiry into competition in the European pharmaceutical sector. In summary, its initial findings were that the pharmaceutical market is not working as well as it should and that originator companies have engaged in commercial practices with the objective of delaying or blocking market entry of competing medicines. As might be expected, the Commission's preliminary report has been the subject of a great deal of commentary since it was published. Below we consider the broader issues it raises and the potential impact it may have on the pharmaceutical sector.
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Health Care and Associated Professions (Miscellaneous Amendments) Order 2008 (Commencement No.1) Order of Council 2008 *

This statutory instrument brought into force, on 3 November 2008, the provisions of the Health Care and Associated Professions (Miscellaneous Amendments) Order 2008 that relate to changes to the system for the approval of providers of primary United Kingdom medical qualifications. These changes include the establishment of a new list of approved providers, which is to be kept by the General Medical Council (“GMC”).
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Two Basic Freedoms of Pharmaceutical Companies Regarding the Sale of Medicines in Spain: Freedom to Set Prices and Freedom to Contract *

Attempts to support, on the basis of acknowledged principles of law (including EU law), the lawfulness of commercial policies based on the partial and reasonable exercise of the freedom to set prices and select wholesalers.
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Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008 *

This statutory instrument controls the maximum price of prescription-only branded medicines supplied to the National Health Service and requires manufacturers and suppliers of branded pharmaceutical companies to provide the Department of Health with information on sales income and discounts.
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Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2008 *

This statutory instrument amends the Medicines for Human Use (Marketing Authorisation) Regulations 2004 in order to introduce measures in the UK to enforce the obligations set out in Council Reg 1901/2006/EC for Paediatric Use.
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Medicines (Pharmacies) (Applications for Registration and Fees) Amendment Regulations 2008 *

This statutory instrument further amends the Medicines (Pharmacies) (Applications for Registration and Fees) Regulations 1973 as follows:
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Medical Devices (Amendment) Regulations 2008 *

This statutory instrument amends the Medical Devices Regulations 2002. The main objective of the amendments to the Directives are to better specify the obligations of manufacturers, notified bodies and authorities with particular respect to the key issues of conformity assessment, clinical evaluation and post market surveillance, this is in order to continue to ensure the highest level of safety, to ensure access to the market and to allow for a smooth functioning of the legal framework.
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* This material first published by the LexisNexis Butterworths. All rights reserved.