The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.)
By Andrew Williams --
On June 18, 2015, the Federal Circuit handed down its second opinion in the Teva Pharmaceuticals USA v. Sandoz Inc. case. And, much like with the first opinion in 2013, the Court reversed the District Court's holding with regard to claim 1 of U.S. Patent No. 5,800,808 ("the '808 patent") -- the only patent still pending. A split panel decided that, even though the District Court made factual determinations about how one skilled in the art would understand this claim, specifically the claim term "molecular weight," the claim was nevertheless indefinite. Of course, in the interim, for the same case, the Supreme Court reversed long standing Federal Circuit precedent regarding the level of deference to be afforded a District Court's factual determinations during claim construction. Or at least it thought it did. Judge Moore, writing the opinion for the Court, stated that it did not matter if they gave deference to the lower court in this case. In contrast, on June 23, 2015, the Federal Circuit determined in the Lighting Ballast Control LLC v. Philips Electronics North America remand that the deference to which the District Court's factual determinations were entitled dictated affirmance.
The background of the Teva case has been addressed in previous posts (see "Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Fed. Cir. 2013)") Basically, this case involves the drug Copaxone®, which was approved for the treatment of multiple sclerosis. The active ingredient is copolymer-1, or glatiramer acetate, which is a polypeptide product that consists of four different amino acids (alanine, glutamic acid, lysine, and tyrosine). Copolymer-1, however, is a mixture of individual polymer molecules with different constituent ratios, and different molecular weights. Therefore, it is often expressed as "average molecular weight." Statistically speaking, though, there are at least three ways to calculate average molecular weight: peak average molecular weight (Mp), number average molecular weight (Mn), and weight average molecular weight (Mw). Mp is the molecular weight of the most abundant molecule in the sample; Mn is the combined total mass of all of the molecules in the sample divided by the total number of molecules; and Mw is similar to number average molecular weight, except instead of dividing the sample by total number of molecules, you take into account the weight fraction of each molecule.
Teva's specification was silent as to which molecular weight measurement was used, or the appropriate way to measure it. The only mention was to the use of size exclusion chromatography (SEC), which can be used to obtain all three values. Moreover, the applicants made statements in related cases that compounded the problem. First, in the prosecution history of one of the patents, the applicants said that "[o]ne of ordinary skill in the art, upon reviewing the specification, would understand that 'average molecular weight' refers to the molecular weight at the peak of the molecular weight distribution curve," or Mp. However, in response to an identical rejection in an earlier related application, the patentees said that ""[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight," or Mw. Teva's expert explained that one skilled in the art would have understood that average molecular weight could only be Mp because the use of SEC without more would suggest it (because determining Mn and Mw would require additional calculations). The District Court found this testimony credible. Moreover, the District Court found that one skilled in the art would have recognized that the statement in the one application file history was false. In the first Teva v. Sandoz opinion, the Federal Circuit did not credit these findings and held the claims with this claim term to be indefinite.
On remand from the Supreme Court, the Federal Circuit clarified that the only relevant evidence was intrinsic. As such, even under the Supreme Court's analysis, whether the claims were indefinite was purely a legal question. In fact, this is not inconsistent with the original Federal Circuit holding: "On de novo review of the district court's indefiniteness holding, we conclude that Dr. Grant's testimony does not save Group I claims from indefiniteness." Just to be clear, the Court acknowledged that it found no error with the District Court's determination of how a skilled artisan would have understood the teaching of the specification ("And we see no clear error in that fact finding -- that one of skill in the art could read Mp from a chromatogram without further calculation and that Mw or Mn would both require further calculations."). This factual finding, however, did not change the fact that there are at least three different types of "average molecular weight" that are calculated three different ways and could give three different values. In fact, neither party disputed that there was "no express definition" for the claim term, and that the terms Mp, Mw, and Mn were not used in the specification.
The case, therefore, turned on the "internal coherence and context assessment" test articulated by the Federal Circuit. In fact, the Court stated that this test was itself a question of law that could not be converted to a factual question by the introduction of expert testimony. As such, the testimony of Teva's expert did nothing to resolve the ambiguity of which molecular weight measurement to use.
In addition, when the Federal Circuit first decided the case, it found that the contradictory statements in the prosecution history of related applications rendered the ambiguity of the claim term insoluble. Of course, in the interim, the Supreme Court rejected the "insolubly ambiguous" standard, and articulated the "reasonable certainty" standard in the Nautilus, Inc. v. Biosig Instruments, Inc. case. As the Federal Circuit noted, somewhat snarkily, when it decided that case on remand "[t]he Court has accordingly modified the standard by which lower courts examine allegedly ambiguous claims; we may now steer by the bright star of 'reasonable certainty,' rather than the unreliable compass of 'insoluble ambiguity.'" Therefore, even assuming that a skilled artisan would recognize the scientifically erroneous claim made by the patentees, the specification would still not have informed a person of ordinary skill in the art of the scope of the invention with reasonable certainty.
Interestingly, the only Judge on the current panel that was on the panel in 2013 was Judge Moore, who wrote the opinion for the Court in both instances. In the 2013 Teva v. Sandoz case, then-Chief Judge Rader and District Judge Benson of the District of Utah sitting by designation completed the panel. On remand, these two judges were replaced by Judges Mayer and Wallach. You probably could not find a member of the Federal Circuit that has been more outspoken against the de novo standard of claim construction review as Judge Mayer. It seemed almost fitting that he had an opportunity to dissent from this case.
In dissent, Judge Mayer cited the Supreme Court in Teva: "'[I]n some instances, a factual finding may be close to dispositive of the ultimate legal question of the proper meaning of [a claim] term in the context of [a] patent." It stood to reason, therefore, that this was "such a case." Not surprisingly, Judge Mayer criticized the majority for not giving the District Court's "extensive fact-finding" any deference. In cases with complex technology, he pointed out, it is often necessary to look outside the patent and its prosecution history. Perhaps in an attempt to trigger another bite at the Supreme Court apple, a disproportionate number of Judge Mayer's citations were to Supreme Court precedent -- some dating back to the 1800s. Judge Mayer was also critical of the citation to the prosecution history -- because even though statements made in the prosecution of related applications may be used to interpret claims, the same is not true to find a claim indefinite. This is even truer when the erroneous or conflicting statements came years after the patent at issue issued. However, the majority would likely agree with this sentiment -- the issue for them was not that the erroneous statements damned the claims, but that a skilled artisan's recognition of this erroneous statement would not have saved the claims.
The Federal Circuit came to almost the opposite outcome in the remand from Lighting Ballast Control LLC v. Philips Electonics North America. That case had an even more complicated history. The District Court had first determined (in part) that the claim term "voltage source means" was governed by 35 U.S.C. § 112, ¶ 6, and was therefore indefinite because the specification did not disclose sufficient structure. Then it reversed itself when deciding a motion for reconsideration because it did not give sufficient weight to the expert testimony about how those skilled in the art would understand the specification. The Federal Circuit disagreed and reversed. This set the stage for the Lighting Ballast en banc decision, in which the Court reaffirmed the de novo standard of review for all claim construction issues. Of course, this decision was short lived in view of the Supreme Court's Teva decision.
Lighting Ballast returned to the Federal Circuit after its prior en banc decision was vacated and remanded. This time, because it could not say that the District Court's factual determinations were clearly erroneous, it affirmed the lower court's determination that the specification provided the requisite structure and that the claims were therefore not indefinite. Even though the outcome was different than the Teva remand, these cases were distinct enough to support such outcomes. In this case, the expert testimony was used to explain what the specification meant. In contrast, the expert testimony in the Teva case was cast as supplementing missing information from the specification -- mainly which molecular weight measurement to use. It therefore didn't matter how a skilled artisan would have interpreted a particular figure or a statement in the prosecution history -- the claim term could have been one of three different possibilities and nothing in the intrinsic record resolved that issue. It will nevertheless be interesting to see how subsequent cases are decided, and whether this decision will stave off the feared use of expert testimony in every claim construction proceeding (see "Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. (2015)"). Somehow, this scenario seems unlikely.