Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio
Select a format
Select subscription type
Terms & conditions
Subscribers receive the product(s) listed on the Order Form and any Updates made available during the annual subscription period. Shipping and handling fees are not included in the annual price.
Subscribers are advised of the number of Updates that were made to the particular publication the prior year. The number of Updates may vary due to developments in the law and other publishing issues, but subscribers may use this as a rough estimate of future shipments. Subscribers may call Customer Support at 800-833-9844 for additional information.
Subscribers may cancel this subscription by: calling Customer Support at 800-833-9844; emailing email@example.com; or returning the invoice marked "CANCEL".
If subscribers cancel within 30 days after the product is ordered or received and return the product at their expense, then they will receive a full credit of the price for the annual subscription.
If subscribers cancel between 31 and 60 days after the invoice date and return the product at their expense, then they will receive a 5/6th credit of the price for the annual subscription. No credit will be given for cancellations more than 60 days after the invoice date. To receive any credit, subscriber must return all product(s) shipped during the year at their expense within the applicable cancellation period listed above.
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 strategy
- Preclinical and patent considerations
- Clinical trials and regulatory considerations
- Trademark (TM) and nonproprietary name considerations
- Acquiring and in-licensing pharmaceutical products
- Pre-litigation investigations and due diligence
- Market entry business considerations for generic companies
eBooks, CDs, downloadable content, and software purchases are noncancelable, nonrefundable and nonreturnable. Click here for more information about LexisNexis eBooks. The eBook versions of this title may feature links to Lexis+® for further legal research options. A valid subscription to Lexis+® is required to access this content.