Kenneth Laurence Dorsney – författare
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2 produkter
2 produkter
Inbunden, Engelska, 2022
4 421 kr
Skickas inom 3-6 vardagar
All pharmaceutical companies, whether they are an innovator or a generic, must navigate the same complex legal and regulatory framework to bring a product to market and fend off competition. Now completely updated, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that pharmaceutical litigants could follow.From the perspective of an innovator company, patents are vital to protect new drug products both to recoup the initial investment and for future investments. For the innovator and patent owner, the patentee must be aware of the risk to those intellectual property rights and be prepared for any patent challenge. Both entities can use Pre-ANDA Litigation as a resource to help formulate a strategy before patent litigation begins.ANDA Patent litigations and strategies are complex and require the patent professional to be able to explain complex technical and legal issues to lay persons, both within the organization and to judges and juries. This compendium provides lawyers with invaluable and in-depth tactics and advice so that any pharmaceutical litigant wanting to increase market share, whether as an innovator or a generic, can plan early and be ready to alter plans as new events occur.Topics include:Coordinating new drug application (NDA) and patent portfolio strategyPreclinical and patent considerationsClinical trials and regulatory considerationsTrademark (TM) and nonproprietary name considerationsAcquiring and in-licensing pharmaceutical productsPre-litigation investigations and due diligenceMarket entry business considerations for generic companies
Häftad, Engelska, 2024
1 479 kr
Tillfälligt slut
Biosimilars Litigation and Client Counseling is a guide to the field of biologic products and biosimilars, as well as the laws governing them - most notably the Biologics Price Competition and Innovation Act. This guide is instructive to patent attorneys practicing in this field, judges that are assigned cases involving these products and related patents, and managers of pharmaceutical companies that design biologic or biosimilar products or are considering entering this market. It describes the statutory and regulatory framework for applying for and receiving a biologic and biosimilar application, and it provides an in-depth analysis of the legal processes and challenges that come with it.Legal counsel will find practice strategies and tips from the country's top litigators that provide valuable insight into this developing area of law. This includes guidance on what the biosimilar application process looks like, how to navigate certain questions and pitfalls that are likely to arise during the litigation process, and how to best serve a client that is involved with biologics.Judges will appreciate this book as a quick reference to the Biologics Price Competition and Innovation Act which will likely be governing the lawsuit related to biologics that is before them. This includes a walkthrough of typical litigation and summary of the relevant statutes and regulations that will be involved. Judges will also have a guide to the common disputes that arise in these cases and an understanding of how they have been decided.Managers or other decision-making members of a pharmaceutical company will also enjoy this book as a reference when strategizing a patent portfolio or what to consider when designing a biosimilar product, as well as benefiting from the deeper understanding of the legal process that this book provides.