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Court of Appeals Gets Specific with Enablement

July 11, 2017

In Storer v. Clark, the Court of Appeals explored whether a provisional application had sufficiently enabled interference subject matter.  In order to prove enablement it must be shown that “one skilled in the art, having read the specification, could practice the invention without ‘undue experimentation.’” ALZA Corp. v. Andrx Pharm., LLC, 603 F.3d 935, 940 (Fed. Cir. 2010). Undue experimentation is determined by weighing many factual considerations.Id. Those factual considerations “include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”In re Wands, 858 F.2d 731,737 (Fed. Cir. 1988).

In this case, Storer was the senior party based on a June 28, 2002 filing date of a provisional application. His application generically described the method for treating hepatitis C by synthesizing a heterocyclic compound having a fluorine substituent in the 2’ position. However, the description in Storer’s application stopped two steps short of the full synthesis. Storer argued on appeal that the next step was disclosed in prior art and the final step was one which was well-known in the art.

The Court ultimately agreed with the Patent Trial and Appeal Board’s application of the Wands factors and found, after reading Storer’s specifications, it would still require undue experimentation and therefore the application did not enable the targeted compound.

View the full opinion here.

For more information or if you have questions, please contact one of our MVS IP attorneys or call us at (515) 288-3667.


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