{"product_id":"pre-anda-litigation-kenneth-laurence-dorsney-9781639051144","title":"Pre-Anda Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition","description":"\u003cp\u003eAll 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, P\u003ci\u003ere-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition \u003c\/i\u003eis an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that pharmaceutical litigants could follow.\u003c\/p\u003e\u003cp\u003eFrom 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.\u003c\/p\u003e\u003cp\u003eANDA 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.\u003c\/p\u003e\u003cp\u003eTopics include: \u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eCoordinating new drug application (NDA) and patent portfolio strategy\u003c\/li\u003e\n\u003cli\u003ePreclinical and patent considerations\u003c\/li\u003e\n\u003cli\u003eClinical trials and regulatory considerations\u003c\/li\u003e\n\u003cli\u003eTrademark (TM) and nonproprietary name considerations\u003c\/li\u003e\n\u003cli\u003eAcquiring and in-licensing pharmaceutical products\u003c\/li\u003e\n\u003cli\u003ePre-litigation investigations and due diligence\u003c\/li\u003e\n\u003cli\u003eMarket entry business considerations for generic companies\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Kenneth Laurence Dorsney\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1639051147\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781639051144\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e American Bar Association\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 07\/15\/2022\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 1144\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 3.80lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.16h x 7.01w x 1.89d","brand":"Kenneth Laurence Dorsney","offers":[{"title":"Hardcover","offer_id":48459590533375,"sku":"9781639051144","price":349.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_3804e69c-f9c3-47a0-9cda-d192b7d2e0a6.jpg?v=1777410653","url":"https:\/\/www.whiterainbookhouse.com\/products\/pre-anda-litigation-kenneth-laurence-dorsney-9781639051144","provider":"WR Book House","version":"1.0","type":"link"}