## Facts

- Patent owners and exclusive licensee marketed Azasite®, an FDA-approved topical azithromycin solution for ocular infections.
- Four Orange Book–listed patents were asserted: U.S. Patent No. 6,861,411 and U.S. Patent Nos. 6,239,113; 6,569,443; 7,056,893.
- The ’411 patent claimed methods of treating ocular infections by topically administering azithromycin; azithromycin had been known mainly for oral administration.
- Sandoz filed an ANDA with a paragraph IV certification asserting invalidity or noninfringement, triggering suit under 35 U.S.C. § 271(e).
- After claim construction, Sandoz stipulated its ANDA product would infringe if the asserted claims were valid; the dispute proceeded on obviousness under 35 U.S.C. § 103(a).
- Shortly before trial and after the final pretrial conference, Sandoz sought to amend the pretrial order to add a European prosecution file as an exhibit, claiming it contained admissions relevant to obviousness; the district court denied the request as late and prejudicial.
- Following a bench trial, the district court held Sandoz failed to prove the asserted claims obvious by clear and convincing evidence.

## Issues

1. Whether the asserted claims were invalid as obvious under 35 U.S.C. § 103(a), including whether the district court improperly framed the problem addressed by the invention.
2. Whether the district court abused its discretion by refusing to amend the pretrial order to include a late-proffered European prosecution history exhibit.

## Decision

- The Federal Circuit affirmed the judgment that Sandoz failed to prove obviousness by clear and convincing evidence.
- The court upheld the district court’s framing of the obviousness inquiry as development of improved topical treatments for ocular infections, rejecting a narrower framing focused only on topical azithromycin for conjunctivitis.
- The court sustained findings that the prior art did not supply a reasonable expectation of success for topical ocular azithromycin and included teachings discouraging the claimed approach.
- The court upheld findings that Sandoz failed to show an adequate motivation to combine the cited references without relying on hindsight.
- The court agreed that objective indicia (including commercial success, industry praise, and failure of others) supported nonobviousness.
- The court held the district court did not abuse its discretion in excluding the late-added European prosecution file due to timing and prejudice.

## Legal Principles

- Obviousness must be assessed from the viewpoint of a person of ordinary skill in the art at the time of invention, with caution against hindsight reasoning.
- A party asserting obviousness must prove, by clear and convincing evidence, that the prior art taught or suggested the claimed invention with a sufficient motivation to combine and a reasonable expectation of success.
- Teachings in the prior art that discourage the claimed path may support a finding of nonobviousness.
- Objective indicia of nonobviousness (e.g., commercial success, industry praise, failure of others) are part of the Graham analysis and can corroborate nonobviousness.
- In bench trials, appellate review defers to district court factual findings unless clearly erroneous; ultimate obviousness is reviewed de novo.
- Trial courts have broad discretion to manage pretrial orders and may deny late amendments that would prejudice the opposing party or disrupt trial preparation.

## Conclusion

The Federal Circuit upheld a bench-trial determination that Sandoz did not meet its burden to invalidate the asserted ophthalmic azithromycin claims for obviousness and affirmed the exclusion of a late-disclosed foreign prosecution record, leaving Sandoz’s stipulated infringement to support judgment under § 271(e).


Insite Vision Inc. v. Sandoz, Inc., 783 F.3d 853 (Fed. Cir. 2015)