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It must, in order to satisfy the patent laws that require that the patent specification teach those in the art how to “make and use the invention without undue experimentation.”

In Idenix v. Gilead, the patent was for a method of treating hepatitis C virus (“HCV”), a leading cause of chronic liver disease. The treatment used a compound having a specific chemical and stereochemical structure. Certain atomic groups in the compound could be substituted in particular up or down positions.

It was undisputed that there were “billions of potential” atomic groups that could be used in the compound. The issue was whether one skilled in the art “would know, without undue experimentation”, which atomic group “would be effective for treating HCV.”

The Federal Circuit explained that at least the following factors govern:

1.) the quantity of experimentation necessary

2.) whether the patent discloses specific working examples of the invention

3.) the amount of guidance presented in the patent

4.) the nature and predictability of the field

The Court found the patent lacked enablement. It pointed to the “many thousands” of atomic groups that “meet the structural limitations” of the patent but “not all of which are effective to treat HCV”, as well as the “unpredictability of the art”.

COMMENT: Patent claims are often drafted broader than the experimental examples disclosed. Doing so leaves open the possibility for patent invalidity based on lack of enablement.

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