Finding of inequitable conduct affirmed, Judge Rader expresses concern over resurgence of defenseMay 14, 2008

In a decision today, the Federal Circuit affirmed a district court's finding of inequitable conduct resulting from Rule 132 declarations that were used to overcome obviousness and anticipation rejections. The declarations used a difference in half-lives to distinguish the claimed composition over the prior art, however, it failed to indicate that the comparative half-lives were calculated using different initial dosages. The court determined that, despite having the underlying raw data before the examiner, the failure to explicitly indicate the difference was sufficient to support the finding of inequitable conduct.

Judge Rader filed a dissent focusing on a resurgence of the inequitable conduct defense and suggested the court revisit and reinvigorate the holding in Kingsdown which stemmed the earlier "plague" of inequitable conduct claims.

More detail of Aventis Pharma S.A. v. Amphastar Pharms., Inc. after the jump.

Aventis owns a patent for the drug Lovenox^®. Lovenox^® is used to help prevent thrombosis (blood clotting) during surgery while still minimizing the likelihood of hemorrhaging. Amphastar is a generic drug manufacturer planning to make a generic version of the drug. Aventis brought this suit to enforce its patent and prevent Amphastar from manufacturing the generic version of the drug. During the trial, Amphastar raised inequitable conduct as a defense and claimed that declarations signed by Dr. Uzan in support of patentability resulted in inequitable conduct.

The claim of inequitable conduct was based on two declarations submitted by Dr. Uzan that were used to overcome an anticipation and obviousness rejection. The rejections were over a similar compound patented in Europe which the examiner claimed inherently had the same composition as the claimed pharmaceutical. Dr. Uzan filed declarations stating that the drugs had different half-lives and claimed that this indicated that, because half-life is an inherent property of a composition, the compositions must be different. Additionally, Dr. Uzan claimed that the significant difference in half-lives was an unexpected result. The second declaration did not explicitly state the initial dosages used to calculate the half-lives, but it did contain a copy of the raw data used to make the calculations.

A previous appeal affirmed the district court's determination finding the omission to be material, but remanded the issue of deceptive intent to the district court for further proceedings. On remand, the district court conducted a bench trial on the issue. At this proceeding, Aventis claimed that the comparison was reasonable because the clinically relevant dosages were used, the half-life was dosage independent, and that any omission was inadvertent. The district court focused on the fact that the dosages were not indicated when the comparison was made and that the only dosage used was the only dosage yielding a statistically significant difference. Citing Dr. Uzan's credentials, the district court dismissed the claim of inadvertence. Based on this analysis, the district court found deceptive intent and held the patent invalid due to inequitable conduct. The Federal Circuit retraced the district court's reasoning and, not finding clear error, affirmed.

Judge Rader filed a dissent that compared the actions in the present case with the fact pattern in Kingsdown, the Federal Circuit's en banc decision regarding inequitable conduct. In Kingsdown the error resulted when the inventor's attorney filed a continuation application and inadvertently copied a previously rejected claim from the parent application. The patent issued with the previously rejected claim. Judge Rader noted that this was a mistake in the patent review process, that this mistake was material, but that there was no evidence of deceptive intent on the part of the attorney. Noting that inequitable conduct is intended to be a rarely occurring situation and the "atomic bomb" remedy of unenforceability that accompanies findings of inequitable conduct, Judge Rader turned to the facts of the present case.

Judge Rader reviewed Aventis's claims and found the explanations to be reasonable. Regarding the use of different dosages, Judge Rader noted that all contemporaneous clinical publications in the record compared clinically relevant dosages. Judge Rader also noted that all of the data was before the examiner. Finally, Judge Rader seriously doubted that Dr. Uzan, a highly accomplished researcher, would risk the damage to his reputation by through such an obvious move as intentionally omitting the initial dosages used to calculate half-lives when that information was included in the other sections of the affidavit that mentioned the half-lives. Noting the recent increase in inequitable conduct claims reaching the Federal Circuit and the effectiveness of Kingsdown in reducing the previous "plague" of such claims, Judge Rader stated that reversal was appropriate.

To read the full decision in Aventis Pharma S.A. v. Amphastar Pharms., Inc., click here.