European Commission Pharmaceutical Sector Inquiry 3
Sarah Hanson, Partner, CMS Cameron McKenna LLP
On 8 July 2009, following an 18 month investigation, the European Commission published its final report in the pharmaceutical sector inquiry. The inquiry focused on why fewer pharmaceutical products were being brought to market by originator companies and the apparent difficulties faced by generic producers when launching a copy product following the originator’s loss of exclusivity. The inquiry also looked in broad terms at aspects of the regulatory framework, including legislation governing patents, marketing authorization and pricing and reimbursement.
Managing Growth by Minimising Risk 7
Stephen Appelbee, Chief Executive Officer, CMD Pharma Limited
When starting a new pharmaceutical company, two basic paths present themselves as potential business models (for the purposes of this exercise I shall ignore the possibility of failure):
- Research and Development Model – Raise a little finance, develop a range of products, raise some more finance, license the products out as late as possible (if necessary or possible doing an IPO) and sell out to big pharma
- Buy-and-Build Model - Raise a lot of finance, buy, build or rent a sales infrastructure, in license or co-promote some products and sell out to big pharma Both of these are noble strategies, but how about a hybrid?
Regulatory Data Exclusivity in the European Union 11
Grant H Castle, Partner Covington & Burling LLP
Regulatory data exclusivity is an important form of intellectual property protection that exists independently of patent protection in the European Economic Area (EEA). In essence, it offers a period of protection against the submission or approval of generic marketing authorisation applications that refer to data contained in the regulatory dossiers of innovative products.
This article:
- explains the justifications for offering data exclusivity protection to innovator companies;
- provides an overview of the data exclusivity rules under European Community (EC) law; and
- explains how the data exclusivity laws operate in practice.
Diversified or Dead? 14
Stuart Rose, Managing Director, Merz Pharma UK Ltd.
It is not that bad, really it’s not. In the same way that the Great Fire of London and the Ice Age had significant future benefits the current challenges that the pharmaceutical industry is facing will undoubtedly produce both casualties and, for the well positioned, significant opportunities that will deliver real upside over the next decade.
Negotiating with Governments 18
Andrew Gottschalk, Group AG
How much time do we spend negotiating directly with government or government agencies? How important is success in these negotiations? Do negotiations with government expose us to particular risks or rewards? Are negotiations with government characterised by different success factors compared to business-to-business negotiations? Will negotiations with government become easier or more difficult in the current economic environment? Were we to continue in this vein we could produce an exhaustive list of questions that might satisfy our intellectual curiosity but sadly not help us in concluding and implementing those agreements that meet the needs and interests of our stakeholders.
Evaluating Licensing Opportunities 25
Key Trends and Findings from a Global Survey of Pharmaceutical and Biotech Licensing Professionals
Fabian Schmidt, Director; Christian Schuler, Partner and Pooja Shaw, Consultant; Simon Kucher and Partners
The number of licensing transactions and deal values are soaring. In the light of this development, findings and conclusions from a global Simon-Kucher & Partners survey with 40 pharmaceutical and biotech licensing professionals explain shortcomings during the due diligence and valuation process of potential licensing candidates. Focusing on the assessment of a compound’s commercial potential, this article outlines the improvement opportunities that both Big Pharma and biotechs can leverage to ensure accurate valuation and astute selection of licensing candidates as a basis for successful licensing negotiations.
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