Teva Pharms. USA, Inc., v. Sandoz, Inc.

Case Name: Teva Pharms. USA, Inc., v. Sandoz, Inc., Fed. Cir. Nos. 2012-1567, -1568, -1569, -1570, 2015 U.S. App. LEXIS 10229 (Fed. Cir. June 18, 2015) (Circuit Judges Moore, Mayer, and Wallach presiding; Opinion by Moore, J.; Dissent by Mayer, J.) (Remand from U.S. Supreme Court)

Drug Product and Patent(s)-in-Suit: Copaxone^® (glatiramer acetate); U.S. Pats. Nos. 5,800,808 ("the '808 patent"), 5,981,589 ("the '589 patent"), 6,048,898 ("the '898 patent"), 6,054,430 ("the '430 patent"), 6,342,476 ("the '476 patent"), 6,362,161 ("the '161 patent"), 6,620,847 (“the '847 patent"), 6,939,539 ("the '539 patent"), and 7,199,098 ("the '089 patent"). While the case was before the Supreme Court, all of the asserted patents expired, except for the '808 patent.   

Nature of the Case and Issue(s) Presented: Teva owns the patents-in-suit, which cover Copaxone, a drug used to treat patients with relapsing forms of multiple sclerosis. Various defendants filed ANDAs against the patents-in-suit, which resulted in Teva’s filing suit, alleging patent infringement. Initially, the district court divided the asserted patents into what it defined as Group I claims and Group II claims. The district court decided that the Group I claims were not indefinite and that the Group II claims were valid and infringed. Teva appealed to the Federal Circuit, which reversed the district court’s judgment, finding that the Group I claims were indefinite. Defendants then appealed to the Supreme Court, which vacated the Federal Circuit’s conclusion that the Group I claims were indefinite and remanded the case to the Federal Circuit for further consideration.

The specific issue involved claim 1 of the ’808 patent, which recited a method for making a product called copolymer-1. The claim language describes the compound as having a molecular weight of about five to nine kilodaltons. The controversy arose because there are three known, but different, ways to measure molecular weight, and the patent did not explicitly describe which measure was to be used in a typical polymer sample. The Federal Circuit was tasked with deciding whether this alleged ambiguity warranted a finding of indefiniteness under the standards of 35 U.S.C. 112(b). The Federal Circuit held that the specification and claims of the ‘808 patent failed to indicate which of the three molecular weight methods was to be used.

Why Defendant Prevailed: The Federal Circuit first found that the term “molecular weight” was not further defined or specified by the intrinsic evidence of record. Next, the Federal Circuit turned to the district court’s analysis of the expert testimony regarding the three separate methods for calculating molecular weight. The three methods were (i) peak average molecular weight, (i) number average molecular weight, and (iii) weight average molecular weight. The claim itself did not specify which measure to use. Each of the methods resulted in different values. The district court originally credited Teva’s expert who testified that peak average molecular weight would was the preferred method because it resulted directly from a chromatogram and calibration curve obtained by the analytical method described in example 1 of the specification. He further testified that example 1 corresponded to figure 1 in the patent specification. There was further testimony that number average molecular weight and weight average molecular weight could have been derived from the chromatogram and calibration curve, but doing so would have required additional data manipulation and calculations that were not disclosed in the specification. Thus, the district court concluded that molecular weight was to be construed as peak average molecular weight, and that the claim term was not indefinite. The Federal Circuit found that the district court’s findings concerning Teva’s expert in the first instance were not clearly erroneous. But, the Federal Circuit noted, those findings did not end the analysis. Rather, the Federal Circuit disagreed with Teva’s argument that the district court’s findings meant that a presumption regarding the meaning of the claim term in the art in general or in the context of the patent was apparent. A party cannot transform into a factual matter the internal coherence and context assessment of the patent simply by having an expert offer an opinion on it. And to the extent that Teva had argued that the meaning of “molecular weight” in the context of patents-in-suit was itself a question of fact, it was wrong. The Federal Circuit noted that the internal coherence and context assessment of the patent, and whether it conveys claim meaning with reasonable certainty, were questions of law. Thus, it was wrong for the district court to defer to Teva’s expert’s ultimate conclusion about claim meaning in the context of the patent.

To determine whether a POSITA would be reasonably certain that the claim’s use of “molecular weight” was peak average molecular weight, the Federal Circuit turned its attention to the prosecution history, where it found some guidance in the form of statements made in the prosecution history of two continuation applications. The two continuation applications considered by the court shared nearly identical specifications in relation to the ’808 patent, and also contained the same example 1 and figure 1. Both of the continuation applications were rejected during prosecution due to indefiniteness related to the “molecular weight” term, and Teva provided two different responses when it attempted to traverse the rejections in each case. In the earlier filed continuation application, Teva responded to the rejection by stating that “molecular weight” was not indefinite because a POSITA could understand that kilodalton units implied a weight average molecular weight. This argument was sufficient to overcome the examiner’s indefiniteness rejection. The district court heard testimony seeking to dismiss this statement as factually erroneous, because any of the three molecular weight methods could have been expressed in kilodaltons. In contrast, the later filed continuation application was also rejected due to indefiniteness related to the term “molecular weight.” To overcome this rejection, Teva argued that a POSITA, upon reviewing the specification, would understand that “average molecular weight” refers to the molecular weight at the peak of the molecular distribution curve in figure 1. Again, the examiner withdrew the indefiniteness rejection based on this argument, even though it was a different definition of “molecular weight” from what was provided in the earlier filed continuation application. The district court found these conflicting statements to be highly probative of the lack of clarity relating to the “molecular weight” term in the claim at issue. It would have been impossible for a POSITA to know which method to use to determine the molecular weight when the patentee apparently couldn’t provide a straight answer during the prosecution of related patents. Thus, because the patentee gave conflicting definitions of the term during prosecution, the Federal Circuit held that the claim was invalid for indefiniteness by clear and convincing evidence.

In his dissent, Judge Mayer argued that Teva’s expert’s testimony should have been dispositive, and that the majority had improperly rejected factual expert testimony. Judge Mayer also strongly indicated that the correct course of action when vacating a lower court claim construction holding was not to find the claim indefinite, but to instead remand to consider whether further fact finding is required.