Teva v. Sandoz: Family Prosecution History affects Definiteness; Ratios turned into Percentages

By: Jesus Hernandez, Blog Editor/Contributor 
TitleTeva Pharma. USA, Inc. v. Sandoz, Inc., No. 2012-1567, -1568, 1569, -1570 (Fed. Cir. July 26, 2013).
Issue(s)[1 and 2: Definiteness] “Appellants argue that the term ‘molecular weight’ renders all of the asserted claims indefinite because it can refer to different measures, including Mp, Mw, and Mn. They contend that the scope of the claims varies significantly depending on the measure […] that Teva inconsistently defined “molecular weight” as Mw and Mp during prosecution of two of the familial patents […] that the specification does not resolve which molecular weight measure is intended […] [and] that their indefiniteness arguments apply equally to Group I and Group II claims.” Teva Pharma., at *6.
[3: Construction/Infringement] “The parties dispute whether the district court’s consideration of the percentages in conjunction with its consideration of the ‘approximately 6:2:5:1’ limitation constitutes a ‘derivative’ claim construction or a part of its infringement analysis. The former is a question of law; the latter is a question of fact.” Teva Pharma., at *16.
Holding(s)[1: Definiteness of Group I] “It is undisputed that Group I claims contain an ambiguity because their plain language does not indicate which average molecular weight measure is intended. Teva’s attempt to resolve this ambiguity hinges in part on the prosecution history. But two of its prosecution statements directly contradict each other and render the ambiguity insoluble.” Teva Pharma., at *8.
[2: Definiteness of Group II] “Instead of describing copolymer-1 in terms of a statistical measure, such as Mw, Group II claims recite the percentage of copolymer-1 molecules in a sample falling within an arbitrarily set molecular weight range. […] The scope of Group II claims is thus readily ascertainable. We hold that Group II claims are not invalid for indefiniteness.” Teva Pharma., at *10.
[3: Construction/Infringement] “We hold that whether the amino acid percentages in the accused products meet the ‘approximately 6:2:5:1’ limitation is a part of the district court’s infringement analysis.” Teva Pharma., at *16. 

Procedural History“The defendants in these consolidated patent in- fringement actions (collectively, Appellants) appeal from the district court’s judgment that various claims of the nine patents-in-suit asserted by the plaintiffs (collectively, Teva) are infringed, and from the court’s holdings regard- ing indefiniteness, nonenablement, and obviousness.” Teva Pharma., at *3.

Legal Reasoning (Rader, CJ, Moore, Benson)
Representative Claims
Group I Claims“Claim 1 of the ’589 patent [US Pat. 5,981,589] is representative of Group I claims, which use the first approach: Copolymer-1 having a molecular weight of about 5 to 9 kilodaltons, made by a process comprising the steps of: reacting protected copolymer-1 . . . ; and purifying said copolymer-1, to result in copolymer- 1 having a molecular weight of about 5 to 9 kilo-daltons.” Teva Pharma., at *5.
Group II Claims“Claim 1 of the ’430 [U.S. Pat. 6,054,430] patent is representative of Group II claims, which use the second approach: ‘Copolymer-1 having over 75% of its mole fraction within the molecular weight range from about 2 kDa to about 20 kDa....’ ’430 patent claim 1 (emphasis added).” Teva Pharma., at *5.
Defining the Groups"The six Group II claims are: claims 1 and 2 of the ’430 patent, claim 1 of the ’476 patent, claim 1 of the ’161 patent, and claims 1 and 8 of the ’098 patent. The remaining claims are collectively referred to as Group I claims." Teva Pharma., at n2.
Definiteness of Group I and Group II claims
Group I Indefinite
Family Prosecution History"During prosecution of the ’539 patent, the Examiner rejected pending claims as indefinite, stating that 'the term ‘average molecular weight’ . . . is indefinite since its method of measurement is not specified, i.e. [Mn], [Mw] . . . etc.' J.A. 3245. Teva stated in its response 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 shown in Figure 1,' i.e., Mp. J.A. 3258. The claims were allowed. During prosecution of the ’847 patent, the Examiner made an analogous rejection over the same claim term, stating that 'the term ‘average’ molecular weight . . . is meaningless as a limitation without specifying its basis, e.g., [Mw], [Mn], etc.' J.A. 3220. Teva overcame the rejection by responding that '[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight,' i.e., Mw. J.A. 3229. The only basis upon which the Examiner could have agreed that the ’539 patent claims were not indefinite was that 'molecular weight' means Mp. In contrast, the only basis for the Examiner’s withdrawal of the indefiniteness rejection of the ’847 patent claims was that the same term means Mw. Teva’s two definitions cannot be reconciled.” Teva Pharma., at *8.
Specification“The specification does not resolve the ambiguity. Teva’s expert, Dr. Gregory Grant, testified that after examining the curve depicted in Figure 1 and the accompanying legend, a skilled artisan would know that the claim terms “molecular weight” and “average molecular weight” denote Mp.“ Teva Pharma., at *8.
Group II DefinitePlain Meaning Clear“The numbers that set the boundaries of that range, such as ‘2 kDa’ and ‘20 kDa’ in the ’430 patent claim 1, refer to precise points on the ‘Molecular Weight’ axis, rather than to statistical properties of the polymer molecular weight curves. Like the numbers 10,000 (i.e., 10 kDa) and 20,000 (i.e., 20 kDa) in the figure above, ‘2 kDa’ and ‘20 kDa’ refer to exact values rather than statistical measures.” Teva Pharma., at *10.
Claim Construction / Infringement: Converting "approximately 6:2:5:1" to a Percentage
District Court Conversion and Rationale“The [district] court explained after trial that, in order to facilitate a comparison with the accused products, it converted the 6:2:5:1 ratio into percentages (42.9% alanine, 14.3% glutamic acid, 35.7% lysine, and 7.1% tyro- sine). […]. Based on various examples of copolymer-1 disclosed in the references cited in the specification, the court determined that an accused product meets the “approximately 6:2:5:1” limitation as long as its amino acid composition does not vary from the “ideal” percentages by an aggregate of more than 12%. Id. at 340. The court found that the Mylan accused product and the Sandoz accused product differ from the “ideal” percentages by an aggregate of 4.4% and 4.5% respectively, and thus infringe literally. […]” Teva Pharma., at *15-16.
Conversion for infringement Analysis Permissible“We see no basis for overturning the district court’s finding that the 6:2:5:1 ratio must be converted to percentages to ensure a comparison on the same scale with the amino acid percentages in the accused products. That comparison reveals that, in the aggregate, the four percentages in Mylan’s product (42.7%, 14.4%, 33.6%, and 9.2%) differ from the “ideal” percentages (42.9%, 14.3%, 35.7%, and 7.1%) by only 4.5%.4 Furthermore, no single amino acid differs from its corresponding ‘ideal’ percentage by more than about 2%. Id. at 338.” Teva Pharma., at *18.
“The district court did not clearly err in determining that these small differences from the ‘ideal’ percentages mean that the accused products literally infringe. The court’s conclusion is supported by its findings regarding prior art examples of copolymer-1. See id. at 339–40. These examples show that, even when one of the amino acids (lysine) differs from its “ideal” percentage by more than 5%, the material is still considered “copolymer-1.” Teva Pharma., at *18.
“Accordingly, we affirm the district court’s judgments of infringement and no invalidity with respect to Group II claims, reverse its judgment of no invalidity with respect to Group I claims, and remand.” Teva Pharma., at *20.


Editor's Note
This case also included short discussions on enablement and obviousness. A brief of said discussions is not provided above, but can be read here.



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