Holding: A presumption of obviousness is not automatically created by a prior art reference that discloses a claimed feature in an amount that overlaps a claimed amount of that feature. A full obviousness inquiry may be necessary when considering additional features of the claim that go beyond the claimed amount.
Janssen sued Teva, alleging infringement of U.S. Patent No. 9,439,906 which is directed to dosing regimens for a long-acting injectable antipsychotic medication. In general, the dosing regimen claimed in the ‘906 Patent requires an initial dose of about 150 mg-eq. of paliperidone palmitate and a second dose of about 100 mg-eq. about a week later. These initial doses, known as loading doses, are followed by monthly maintenance doses of 25-150 mg-eq.
Teva primarily relied on three references for its obviousness challenge. The first reference was a written report of Janssen’s Phase III clinical trial testing a regimen of three equal-amount doses of paliperidone palmitate. The second reference was Janssen’s U.S. Patent No. 6,555,544 which discloses a pharmaceutical composition comprising a therapeutically effective amount of paliperidone palmitate. The last reference was Janssen’s International Publication No. WO 2006/114384 which discloses a process for preparing a crystalline paliperidone palmitate. The WO ‘384 Publication states that the formulation was filled into syringes in dose volumes corresponding to 25 to 150 mg-eq. of paliperidone. Based on these references, Teva argued that the challenged claims of the ‘906 Patent should be presumed to be obvious since they recite dose ranges that were disclosed in the prior art.
An overlapping range case involves a challenged claim that requires a feature in a numerical amount and a prior art reference that teaches that feature in a single figure or range that overlaps with the claimed amount. In these cases, the overlapping amount described in the prior art can be sufficient to create a presumption of obviousness. This presumption may apply even when the prior art range does not exactly overlap, but is close enough that a person skilled in the art would expect the numerical range to produce the same properties. The presumption also may apply in certain cases in which a plurality of prior art references together may be understood as teaching a range. Finally, the overlapping range presumption may also apply even when the claimed compound is only structurally similar and not identical to the prior art compounds. Whether the presumption applies is a factual question that depends on what properties a skilled artisan would expect from the similar prior art compounds.
However, the fact that a prior art reference discloses an overlapping range does not create an automatic presumption of obviousness. Instead, a presumption of obviousness is guided by the premises on which the presumption rests. The obviousness presumption due to disclosure of an overlapping range is guided by the fact that when the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges through routine experimentation. Additionally, motivation to determine the optimum range is provided by the normal desire of scientists to improve on what is already generally known. These are factual determinations that are generally similar to the factual inquiries for a full obviousness analysis.
The first reference presented by Teva disclosed loading doses of paliperidone palmitate and presented a second reference that disclosed a dosage range that included each of the claimed loading dosages. However, the first reference disclosed equal loading doses rather than a higher first loading dose followed by a second, lower loading dose. The relationship between the two claimed loading doses does not clearly fit within the premise of the presumption of obviousness created by the disclosure of an overlapping range. This presumption focuses simply on the selection of the dosage amount, but does not extend to the concept of using unequal loading doses. Therefore, a full obviousness analysis was required in this case.
In its full obviousness analysis, the Federal Circuit upheld the district court’s finding of nonobviousness. The main difference between the claims of the ‘906 Patent and the prior art was the unequal and decreasing loading doses. Neither the ‘544 Patent nor the WO ‘384 Publication disclosed loading doses, and it would not have been obvious to combine these references with other prior art references showing higher initial doses. Teva also argued that the district court erroneously considered factors not in the claims, such as safety and efficacy, during its analysis to show that a skilled artisan would not have had a reasonable expectation of success. However, it is not legal error to consider unclaimed factors if the skilled artisan would have considered those factors when trying to create a useful invention.
Federal Circuit Precedential 
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