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Pharmaceutical Law Update

Protect your business by ensuring your legal team understand the impact and implications of recent legal changes and updates within the pharmaceutical industry with this *In-house* training programme.

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  • Format: Bespoke training
  • CPD: 12 hours for your records (depending on your requirements)
  • Certificate of completion

Course Overview

With an increasing amount of mature products on the market and the move towards biologics, keeping the legal team up-to-date with the legal impact and risk created by changes in this constantly moving industry is paramount.

Protecting your organisation against counterfeiting and compliance risks, whilst keeping up with commercial law to ensure they are in the best commercial position to take advantage of new opportunities is vital. This seminar has been specifically designed to examine the recent developments in trade, intellectual property and regulatory matters of concern to the pharmaceutical industry together with competition law issues.

By attending this In-house programme, your team will:
1 GET-TO-GRIPS with complex IP issues to protect the business against counterfeiting
2 UNDERSTAND the role and nature of biologic products to fully prepare for regulatory challenges these products present
3 FIND OUT about second medical use and its methods of administration to ensure claims are drafted accurately
4 GET UP-TO-DATE with competition law aspects including the implications of The Astra Zeneca case and the Pharma Sector Enquiry
5 LEARN more about the New EU Block Exemption Regulations and how they will affect agreements in the pharmaceutical sector
6 HEAR about the developments in generics and the emergence of biosimilars to understand the legal implications
7 FIND OUT more about the current position concerning parallel imports in Europe and how it will impact your business

Sample Programme Day 1

Session (1) IP law aspects

  • Patent protection and strategies – an overview of current practice*
  • Recent pharma patent decisions in Europe
  • The limitations on patent term extension by Supplementary Protection Certificates
  • Future trends
Follow-on products
  • The role and nature of biologic products
  • Data exclusivity issues
  • Patent infringement and protection of biologics
  • Differences to generic drugs
  • US experience
Second medical use claims, validity, infringement and regulatory implications
  • Second medical use claims: Swiss claims or EPC 2000 use claims?
  • What is a valid second medical use: methods of administration, patient groups, dosage regimens
  • Dosage regimens and the KOS-G2/08 referral to the Enlarged Board
  • National court decisions (the Merck v Actavis/Finasteride decision of the UK Court of Appeals, the Carvedilol II decision of the German BGH)
  • Recent cases
  • Infringement of second medical use claims: the SmPC/PIL and the ‘carve-out’
  • Recent guidelines with respect to the ‘carve-out’
  • Regulatory implications of the ‘carve-out’

Session (2) Competition law aspects

  • Developments in EU competition law in the pharmaceutical sector*
  • Investigation and raids in the pharma sector
  • Follow up to the Pharma Sector Enquiry
  • The Astra Zeneca case
The New EU Block Exemption Regulations
  • New regulations on vertical agreements and guidelines – implications for the pharmaceutical industry
  • New regulations on R&D agreements and how they will affect the pharmaceutical industry

Session (3) Regulatory update

The Clinical Trials Directive
  • The Commission consultation on the functioning of the Clinical Trials Directive
  • Problems with implementation of the Clinical Trials Directive
  • When the Directive applies
  • Commencement of a Trial – Authorisation
  • Conduct of a Trial
  • Protection of Trial Subjects and Adverse Event Reporting
  • The future of Clinical Trial Regulation?

Sample Programme Day 2

Session (3) Regulatory update (cont’d)

Medical devices and regulation: an update
  • Directive 2007/47: the post-implementation landscape
  • Clinical evaluation
  • Greater responsibilities for Notified Bodies
  • Increased sharing of data between Member States
  • Software as a medical device – Overlap with other Directives
  • The Medical Devices Directive: is a recast on the cards?
Pediatric Medicines Regulation
  • Content of a PIP and “mini-PIP
  • Modification of a PIP
  • Criteria for waivers and deferrals
  • Compliance check
  • Worksharing: Art. 45 and 46
Data protection in the pharma sector in Europe – an update
  • New developments in international privacy regulation
  • Personal data or anonymised information
  • Data protection and personal data in contracts
  • Due diligence – what are you looking for?
  • Licensing, transfer or sale of personal data
  • Liabilities, remedies, indemnities
Generics and biosimilars – the modified EU law
  • Concept of “new active substance”
  • Data exclusivity
  • Use of bibliographical data for generics
  • Regulatory requirements for biosimilars
  • Issues specific to biosimilars
  • Impact of the pharmaceutical sector inquiry

Session (4) Free Movement of goods and parallel trade

Practical Workshop Free movement of goods in Europe and parallel imports – latest legal update
  • Exhaustion of rights
  • Goods intended for outside the EU
  • Repackaging issues
  • When can IP rights be asserted in relation to imports and when are rights exhausted?
  • Practical session where delegates will look at a case study and in groups analyse the lawfulness of the actions proposed to prevent goods freely circulating
Practical workshop (cont’d)
  • Free movement of goods in Europe and parallel imports

Recommended Trainers

Laura Anderson is a Partner at Bristows in London. Since joining Bristows 12 years ago, Laura has specialised in non-contentious IP matters. She has considerable experience of commercial arrangements relating to the development and exploitation of all kinds of intellectual property rights. Laura has expertise in relation to the competition law aspects of commercial IP transactions and has spent time working in Brussels, both at the EU Council of Ministers and in private practice.

Thomas Carver is an Associate in Howrey’s London office, specialises in the area of intellectual property, with particular focus on patent litigation. While he primarily acts for clients in the pharmaceutical, medical device and biotechnology sectors, Tom’s experience of multi-jurisdictional litigation includes assisting in cases with parallel proceedings in Germany, in Japan, in the USA, and in the European Patent Office (separately).

Trevor Cook is a Partner in the Intellectual Property Team of Bird and Bird. He is President of the UK Group of the AIPPI (The International Association for the Protection of Industrial Property), Secretary to the British Copyright Council Standing Committee on Copyright and Technology, and a member of the Council of the Intellectual Property Institute.

Dr Luke Kempton is a Partner in the Intellectual Property Team of Wragge & Co, specialising in the life sciences sector. He has a PhD in biochemistry and works closely with other members of the experienced Life Sciences Team. He specialises in Patent litigation, licensing, collaborations and manufacturing agreements in the life sciences industry.

Geneviève Michaux is of Counsel to the Brussels office of Covington & Burling where she is a member of the Life Science and Corporate departments. Geneviève specialises in French and European food and drug law, with particular emphasis on pharmaceuticals and food supplements. She regularly provides assistance to pharmaceutical companies on important new legislative projects and policy developments in the EU and has, among other matters, helped shape the new EC Pediatrics Regulation.

Bert Oosting is a Partner and heads the Intellectual Property and Information Technology Group as well as the Pharmaceutical Group of the Amsterdam office of Lovells. His practice encompasses all areas of intellectual property and information technology, as well as pharmaceutical law.

Susan Singleton is a solicitor with her own London firm, Singletons which specialises in intellectual property law, including trade marks and competition law and Internet law and general commercial law. Articled at Nabarro Nathanson, she joined Slaughter and May’s EC/Competition Law Department on qualifying in 1985, moving to Bristows in March 1988, where she remained until founding her own firm in 1994. Since then she had advised over 410 clients.

Pat Treacy is Joint Managing Partner of Bristows. Pat has specialised in EU law and competition law for more than 20 years and has been involved in several landmark cases at EU and national level. In addition to her expertise across the range of competition law, she has particular strengths in advising on the complex legal and policy issues arising where competition law and intellectual property law intersect. Consequently, clients in high technology sectors including life sciences and TMT seek her advice regularly.

Tim Worden is Partner in the Intellectual Property Department of Taylor Wessing. His practice includes both non-contentious and contentious intellectual property and he specialises in the life sciences and healthcare sectors. Tim was previously Legal Counsel and Company Secretary at Eli Lilly and Company Limited, the UK subsidiary of the US pharmaceutical company.

Cerys Wyn-Davies is a Partner in the Outsourcing, Technology & Commercial Group of Pinsent Masons. She specialises in intellectual property, information technology and information law and has extensive experience advising major pharmaceutical companies, banks, universities and government bodies. Most recently Cerys has advised for large scale companies such as Microsoft, for the IP issues in respect of the sale of the rare games software business.

We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss yor requirements.

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749