## Facts

- Altana Pharma AG and Wyeth owned/licensed U.S. Patent No. 4,758,579 covering pantoprazole, the active ingredient in the antiulcer drug Protonix®, a proton pump inhibitor (PPI).
- Teva and Sun filed ANDAs seeking FDA approval to market generic pantoprazole before the patent’s expiration (as extended under 35 U.S.C. § 156).
- Altana sued for infringement and moved for a preliminary injunction to block generic launch during litigation.
- The district court denied the motion, concluding (1) defendants raised a substantial question that the asserted claims were obvious and (2) Altana did not show irreparable harm.
- Defendants’ obviousness theory relied on a prior Altana patent disclosing structurally related compounds, including “compound 12,” which defendants argued would have been selected as a lead compound and modified, in view of other prior art, to reach pantoprazole.
- Altana argued the prior art did not support lead-compound selection or the proposed modifications and relied on anticipated harms such as price erosion and loss of market share.

## Issues

1. Whether the district court abused its discretion in finding defendants raised a substantial question of obviousness sufficient to defeat Altana’s likelihood of success on the merits for a preliminary injunction.
2. Whether the district court clearly erred in finding Altana failed to establish irreparable harm absent a preliminary injunction.

## Decision

- The Federal Circuit affirmed the denial of a preliminary injunction.
- The court held the district court did not abuse its discretion in finding a substantial question of validity based on obviousness, given the prior art and competing expert testimony supporting selection of “compound 12” as a lead compound and motivation to modify it toward pantoprazole.
- The court held the district court did not clearly err in finding Altana’s claimed injuries were largely compensable by money damages and supported by evidence permitting quantification.
- A concurring judge agreed with affirmance in light of the preliminary-injunction posture and deferential review.

## Legal Principles

- A preliminary injunction in a patent case requires the movant to show, among other factors, a likelihood of success on the merits and irreparable harm.
- A defendant can defeat the movant’s likelihood-of-success showing at the preliminary-injunction stage by raising a “substantial question” concerning validity (including obviousness) or infringement.
- At the preliminary-injunction stage, the court does not finally decide validity; it reviews whether the district court’s assessment of the evidence reflects an abuse of discretion.
- Irreparable harm is not presumed in patent cases; economic harms may be deemed reparable where they are quantifiable and money damages are an adequate remedy.

## Conclusion

The Federal Circuit upheld denial of a preliminary injunction because the generic challengers presented a substantial obviousness question under a lead-compound theory, and the patentee did not carry its burden to show irreparable harm beyond compensable economic injury.


Altana Pharma AG v. Teva Pharms. USA, Inc., 566 F.3d 999 (Fed. Cir. 2009)