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Highlighting the various issues and uncertainties in the Supplementary Protection Certificates Regulations, this book provides a comprehensive, practical commentary on this legislation, enabling practitioners to make informed and strategic decisions in relation to these valuable rights.
Supplementary Protection Certificates Supplementary protection certificates (SPC) extend the effects of patents for medicinal products by a maximum of five and a half years, i.e. the certificate becomes effective at a time when the respective pharmaceutical is widely known on the market and thus generates the maximum revenue. This explains the enormous economic value of SPCs. They protect some of the most valuable products in the pharmaceutical industry. The legal basis for the SPC for medicinal products is a European Regulation. The obtaining provisions of that Regulation, the scope of protection etc. are highly disputed and have been the subject of numerous decisions of the CJEU. This handbook provides valuable insights into the world of SPCs and the most significant case law and legal sources at EU and national level of Germany, the UK, France, Italy, the Netherlands and Switzerland. The second completely revised edition specifically addresses recent developments of SPCs including manufacturing waivers and the implications of “Brexit”
The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
The supplementary protection certificate (SPC) prolongs the term of patents for pharmaceutical products for a maximum of five additional years. The SPC's legal bases are two European SPC Regulations and the SPC is based upon European or national patents. SPCs protect some of the most valuable products in the pharmaceutical industry where each day of additional protection may be worth millions of Euros. Despite the economic relevance SPCs have obtained in recent years, there exists only limited detailed literature on the subject. German jurisprudence on SPCs is of special importance, as this has often been the basis for decisions of the European Court of Justice (ECJ) and the German market is one of the leading markets for pharmaceuticals and thus for SPCs. This book is addressed to patent attorneys - in particular in-house and external - working for pharmaceutical companies, and attorneys-at-law specialising in patent law, especially in Europe but essentially worldwide.
A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. - No other 'how to' manual exists for this sector - Written by a range of expert professionals in each area, all in one book - Is the only 'bench to bedside' book covering the whole spectrum of development
A new patent right for Europe (the European Patent with Unitary Effect) and a new European enforcement and invalidation regime (the Unified Patent Court) are expected to come into operation soon, potentially as early as 2015. Existing patents granted by the European Patent Office (EPO), as well as those granted in the future, will automatically come under the jurisdiction of the new Court, unless opt-out rights are exercised. These measures represent one of the most complex and ambitious legal reforms in the field of European intellectual property since the creation of the EPO in 1977. For applicants and proprietors used to the current European system of national patents and national courts, the new system will present both opportunities and challenges in developing, maintaining and leveraging a cost-effective patent portfolio. For manufacturers, distributors and end-users, the new system will subject their activities to the jurisdiction of a new court, with unique and possibly unfamiliar powers and procedures. Decisions must therefore be made as to how best to take advantage of the possibilities afforded by the new system. Applicants and proprietors are already asking themselves questions such as: Should I start to register European patents as European Patents with Unitary Effect when they become available, or should I continue with national validation? For which European patents and applications should I make use of the opt-out to keep litigation in the national courts? Should I consider reverting to national filings instead of using the EPO? How will the new Unified Patent Court be structured, and how will it work? What choices will I have in future as to where to litigate – should I choose a national court or the UPC to enforce or invalidate a European patent? This Handbook provides both guidance for the strategic decisions which will have to be taken and a detailed reference manual to the law and practice of the new system.