Patents challenges

The data do not establish, however, whether even more appropriate patent challenges might have been brought if the period of generic market exclusivity was longer than 180 days. 

Patent Challenges and the Strategic Use of the Hatch-Waxman Act by Brand Firms... 

Patent Challenges and Strategic Uses of the 1984 Act by Generic Firms... 

Documentation of Observation. It is very important to document all relevant observations during the experimental procedure. Observations are the most important information that can be used if an investigation is needed. Furthermore, observations that are documented provide evidence in the event of patent challenge and other court cases. 

Burton,T. M., Lilly, in Coup, Settles for Only 4 Million Portion of Patent Challenge to Prozac. ... 

Patent lawsuits based on the Act are rare because generally challenges to patents on prescription medicines are rare. FDA reports that of 8,259 generic applications filed between 1984 and 2001, only 6% raised a patent issue, the necessary condition for patent litigation. According to the Federal Trade Commission, more than one-quarter of patent challenges studied did not result in a lawsuit by the innovator company. Since enactment of the law, generic company share of prescription medicine use has increased from 19% of prescription units in 1984 to 50% today. 

This poses an interesting situation. When competitors come onto the scene, will they duplicate the exact structure, or will they alter it in some way to get around further patent challenges If they develop a product with the identical structures and actions this may pose a barrier to entry, especially if they cannot prove very similar results through the entire process. On the other hand, if competitors develop an equivalent product with similar end-points, then this may be a safer way to go in anticipation of market approval. It is anticipated that the regulators will be keeping a keen eye on this situation, and may or may not issue guidance in the not so distant future. 

Depending on the size of the project, at least 6-12 months are required to prepare the complete documents. Unexpected events such as objections from ousiders (private persons, environmental organizations, patent challenges) can greatly increase this period of time. 

Bionanotechnology Patenting Challenges and Opportunities Raj Bawa, S.R. Bawa, Stephen B. Maebius, Chid Iyer. 

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