Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.

"Section of Intellectual Property Law, American Bar Association."

In today's global market place, companies are struggling to adapt to the emerging knowledge economy. Enforcement of patent rights is often complicated, expensive and time consuming; something which could leave the full potential of the patent protection unexploited. The use of patents needs to be efficient in order for the company to extract maximum value from these rights. A pro-active enforcement strategy is needed to ensure that the company is utilizing their patents to the fullest extent, in order to extract the most value. By outlining the judicial framework surrounding patent infringement in four different jurisdictions, a more clear understanding of risks and benefits can be discovered. The understanding of these differences that exist between these jurisdictions will ensure that companies locate their resources to the most efficient areas when enforcing and utilizing patents. By examining the approach companies have towards the use of their patents, some key areas when dealing with patent litigation strategy were assessed and a framework assisting a company to utilize its IP more efficiently was constructed.