While there is a presumption of obviousness that typically applies when claimed and prior-art ranges overlap, the U.S. Court of Appeals for the Federal Circuit recently held that the presumption did not apply to claims covering an integrated multi-dose regimen with a specific dose sequence. In particular, the court found that the presumption was inapplicable because the prior art did not teach the claimed combination of doses in sequence.
Background
Janssen Pharmaceuticals, Inc. owns U.S. Patent No. 9,439,906 related to dosing regimens for administering paliperidone palmitate to treat schizophrenia and related disorders. The asserted claims are directed to a dosing regimen with an initial loading dose of 150 mg-eq. followed by a second loading dose of 100 mg-eq. in a specified sequence with monthly maintenance injections.
Teva Pharmaceuticals USA, Inc. argued that the presumption of obviousness for overlapping ranges should apply because the prior art discloses the claimed numerical parameters within overlapping ranges. Teva pointed to prior art disclosing a clinical trial protocol involving administering at least three equal doses of 50, 100, or 150 mg-eq. of paliperidone palmitate at specified time intervals. Teva also relied on U.S. Patent No. 6,555,544, which discloses depot formulations of paliperidone palmitate, and International Publication No. WO 2006/114384, which discloses dose volumes corresponding to 25 to 150 mg-eq. of paliperidone.
Based on the prior art, Teva contended that the presumption of obviousness for overlapping ranges should be applied, which would shift the burden of production and require Janssen to present evidence of non-obviousness.
District Court Decision
The district court held that the presumption of obviousness did not apply because the claimed regimen differed from the prior art in more than one respect. The district court relied on a 20-year old appellate decision stating that a "prima facie case of obviousness may be made when the only difference from the prior art is a difference in the range or value of a particular variable." 2
Federal Circuit Rejects One Difference Approach
On appeal, the Federal Circuit agreed with the district court's ultimate conclusion but corrected part of its reasoning. The court explained that its prior decisions do not impose a categorical one difference limit on the overlapping-range presumption. It noted that, in Kumar, it did not declare a blanket rule that the presumption "only applies" when there is a single difference from the prior art, and it pointed out that no precedent establishes such a categorical limitation. However, the court noted that the number of differences and their relationship may be relevant in determining whether the presumption should be applied in a given context. This presumption of obviousness is based on factual premises "about relevant artisans' motivations to optimize and expectations from routine experimentation."
Because the district court made detailed findings that tended to negate at least some of the factual premises on which the presumption of obviousness is based, the Federal Circuit therefore conducted a full obviousness analysis, rather than the presumption. In particular the court emphasized that the claimed treatment regimen is a combination of dosages and times of injection with decreasing loading doses, and "the evidence reasonably characterizes the combination as an integrated unit of steps taken over time." The court noted that this choice for the combination did not clearly fit within the presumption's focus on routine optimization of ranges overlapping with prior-art ranges of multiple variables where each variable is properly considered separately.
With the presumption inapplicable, the Federal Circuit upheld the district court's findings that Teva had not shown sufficient evidence to motivate a skilled artisan to reduce the second loading dose. The Federal Circuit found no clear error in the district court's determination that a prior art reference relied on by Teva teaches increasing loading doses rather than decreasing loading doses, which would not have motivated a skilled artisan to adopt the claimed decreasing dosing regimen. The court also agreed that the complexities and unpredictability of multi-dose regimens, including drug accumulation and fluctuations in drug levels, would undermine a reasonable expectation of success.
Thus, while the Federal Circuit held that the overlapping-range presumption did not apply in this case, it nonetheless affirmed the district court's determination of non-obviousness.
Lessons learned
A presumption of obviousness of ranges applies when factually supported by the premises on which the presumption is based, including overlapping prior-art amounts or proportions. On the other hand, when an interrelationship between parameters is discovered and claimed, courts may determine that the overlapping-range presumption does not apply, and the challenger must prove obviousness without shifting the burden of production to the patentee, which can make invalidation more challenging. In prosecution, this decision likewise supports arguments that a prima facie case of obviousness based on an overlapping range is not present when the claimed invention is defined by a specific relationship among multiple parameters while the prior art merely discloses broad, independent ranges without teaching that relationship.
Footnotes
1. Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., 141 F.4th 1367 (Fed. Cir. 2025).
2. In re Kumar, 418 F.3d 1361, 1366 (Fed. Cir. 2005).
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