Allergan, Inc. v. Barr Lab., Inc.

Case Name: Allergan, Inc. v. Barr Lab., Inc., No. 2012-1040, 2013 U.S. App. LEXIS 2122 (Fed. Cir. Jan. 28, 2013) (Circuit Judges Rader, Bryson, and Wallach presiding; Opinion by Wallach) (Appeal from D. Del., Robinson, J.)

Drug Product and Patent(s)-in-Suit: Lumigan® (bimatoprost); U.S. Patent No. 5,688,819 (“the ’819 patent”)

Nature of the Case and Issue(s) Presented: Allergan asserted that the ’819 patent was infringed by defendants’ proposed generic product. Defendants asserted that under a proper claim construction, they did not infringe the ’819 patent. In particular, Defendants argued that a claim term providing for various substituents required the substituents to be the same. Allergan argued that the inventor acted as his own lexicographer and did not require the substituents to be the same.

Defendants also argued that the ’819 patent was invalid as obvious. Allergan argued that Defendants’ expert was completely discredited such that his testimony should be ignored, and that Defendants’ other obviousness combination was unsupported by expert testimony. Defendants argued that expert testimony was not required. The district court agreed with Allergan and found the ’819 patent valid. On appeal, the Federal Circuit affirmed the district court’s holdings.

Why Allergan Prevailed: As to the claim construction issue, the Federal Circuit found that the inventor acted as his own lexicographer because there were several examples where the substituents were not identical. Thus, the inventor deviated from plain and ordinary meaning, which would have required identical substituents, and used his own definition.

With respect to the lower court’s holding concerning the validity of the ’819 patent, the Federal Circuit first noted that the underlying factual determinations of obviousness are done by the fact finder, here the district court as it was a bench trial. The district court was free to ignore the testimony of an expert it had determined lack credibility. The Federal Circuit rejected Defendants’ argument that expert testimony on an obviousness combination was unnecessary because the district court was free to determine that this case was complex and the technology was not simple. Thus, expert opinion was necessary.

Finally, the Federal Circuit disagreed with the Defendants’ that Allergan’s expert had provided sufficient testimony to support obviousness. The record showed that Allergan’s expert provided testimony that contradicted one of the elements Defendants’ needed to prove obviousness. Thus, the Federal Circuit affirmed the district court’s finding of validity.