Friday, April 1, 2016

Patent Obviousness Case Review: Prometheus Labs versus Roxane Labs



In the patent case between Prometheus Laboratories and a combination of Roxane Laboratories and Cipa Ltd., the U.S. Court of Appeals for the Federal Circuit upheld the finding from the U.S. District Court for the District of New Jersey of patent invalidity on the basis of obviousness but did not reach the issue of invalidity due to double patenting.

The patent at issue, U.S. Patent No. 6,284,770, relates to Prometheus’ medication used to treat irritable bowel syndrome (IBS), Lotronex. Prometheus filed suit against Roxane alleging infringement of select claims of the ‘770 patent. Roxane challenged the validity of the ‘770 patent under theories of obviousness and obviousness-type double patenting in view of another patent owned by Prometheus and the state of the prior art of treating IBS. The parties agreed on the level of one of skill in the art of the ‘770 patent), a gastroenterologist with three years of experience).

Finding this case to another case between AbbVie Inc. versus Mathilda and Terrence Kennedy Institute of Technology, the court held that 1) the ‘770 patent was obvious; 2) secondary considerations did not support a conclusion that the patent was not obvious; and 3) the district court did not improperly shift the burden of proof to Prometheus to demonstrate a connection between its secondary consideration evidence and the ‘770 patent claims to show non-obviousness.

In essence, the court did not find significant differences between the prior art and the limitations mentioned in claim five of the ‘770 patent. Additionally, the court found that Prometheus had not provided sufficient evidence of commercial success following its re-launch of the drug with prescribing information mirroring the ‘770 patent claims. The court concluded the incremental increase in Lotronex revenue was due to marketing activity and increases in sales price.

In conclusion, I believe that the courts ruled correctly against Prometheus Laboratories. Their development, while scientifically beneficial, does not improve enough on prior art and does not extend far enough from prior art.

2 comments:

  1. Hi Jay,

    I found your conclusion particularly interesting when you admit that Prometheus Laboratories may provide scientific benefits--but still remains an obvious progression of research to treat IBS. I found your analysis very easy to follow and informative. Thanks for a great read!

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  2. Great post! I think that as obviousness becomes an increasingly more relevant IP issue, demonstrating what distinguishes obvious from non-obvious methods and products will ensure that companies have the capacity to conserve, protect, and enforce their IP that gives them a competitive advantage.

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