How to Avoid Patent Infringement in Developing APIs and Generics

In developing generic pharmaceuticals for today’s market there are many pitfalls, the most significant of which is infringement of patents.  Based on the significant costs involved with litigation or the lost revenues from being forced to withdraw a product from the market, patent infringement is a potential threat not only to individual products, but also to any organisation without significant financial resources.

Drug originators are increasingly using intellectual property in an attempt to prolong the life of their branded products in the face of increasing acceptance, and even promotion of generics by government health authorities and a corresponding increase in the number of generics companies.  As if this didn’t make development of generics difficult enough, generics manufacturers are no longer content sharing the post patent-expiry market with other generics and are themselves using patents to block any development holes that the innovator has left open, in order to secure larger market share and cross-licensing revenues.

Where does this leave the small to medium-sized generics manufacturers, or those focused on the most cost-effective way of getting a bioequivalent, essentially similar generic onto the market?  The answer is that they are in the middle of a patent minefield, where the location, size and type of each mine is constantly changing.  This paper outlines some recommendations to overcome the threat that this situation poses to these generics manufacturers.

This paper discusses:

• Understanding the importance of patent information
• Obtaining reliable, accurate patent information    
• Knowing when to obtain patent information
• Understanding the patent position

To download the complete article please click here….  http://www.genericsweb.com/How%20to%20Avoid%20Patent%20Infringement%20in%20Developing%20APIs%20and%20Generics.pdf

Leighton Howard: l.howard@genericsweb.com
Managing Director, GenericsWeb
www.genericsweb.com