Lead Opinion
Opinion for the court filed by Circuit Judge MOORE.
Dissenting opinion filed by Circuit Judge MAYER.
This case comes to us on remand from the Supreme Court, which vacated our earlier opinion reversing the district court’s judgment that certain claims-were not indefinite (Group I claims), and affirming the district court’s holdings that other claims (Group II claims) were valid and infringed.
BACKGROUND
The facts of this case were recited in this court’s previous opinion. In summary, Appellants submitted Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) seeking approval to market generic versions of Copaxone®. Teva, which markets Copaxone®, sued Appellants for patent infringement under 35 U.S.C. § 271(e)(2)(A). Claim 1 of the '808 patent recites a method of making a product called copolymer-1:
A method of manufacturing copolymer-1, comprising reacting protected copo-lymer-1 with hydro-bromic acid to form trifluoroacetyl. copolymer-1, treating said trifluoroacetyl copolymer-1 with aqueous piperidine solution to form co-polymer-1, and purifying said copolymer-1, to result in copolymer-1 having a molecular weight of about 5 to 9 Jcilodal-tons.
'808 patent claim 1 (emphases added).
Copolymer-1 consists of four different amino acids (alanine, glutamic acid, lysine, and tyrosine) combined in a certain ratio to make a polypeptide product. A sample of polymeric material like copolymer-1 typically consists of a mixture of individual polymer molecules that have varying molecular weights. There are three different measures of molecular weight relevant to this appeal: peak average molecular weight (M p), number average molecular weight (M n), and weight .average molecular weight (M w). Each measure is calculated in a different manner. The claim does not specify which measure to use and in a typical polymer sample, M p, M n, and M w have different values.
The district court rejected the Appellants’ argument that the term “molecular weight” was indefinite. Teva Pharm. USA, Inc. v. Sandoz, Inc. (Markman Order),
We reversed the district court’s judgment with respect to the Group I -claims, holding them indefinite. Teva,
The Supreme Court held that “it was proper to treat the ultimate question of the proper construction of the patent as a question of law in the way that we treat document construction as a question of law.” Teva,
if a district court resolves a dispute between experts and makes a factual finding that, in general, a certain term of art had a particular meaning to a person of ordinary skill in the art at the time of the invention, the district court must then conduct a legal analysis: whether a skilled artisan would ascribe that same meaning to that term in the context of the specific patent claim under review.
Id. Experts may explain terms of art and the state of the art at any given time, but they cannot be used to prove the legal construction of a writing. Id. If a district court resolves a subsidiary factual dispute, it will then interpret the patent claim in light of the facts as the court found them.
The Court vacated our decision, concluding that Teva identified at least one factual finding by the district court which we did not review for clear error. Appellants had argued that “molecular weight” could not mean M p because the molecular weight values in the Figure 1 legend did not match up with the peak values on the Figure 1 curves. The Supreme Court concluded that the district court’s finding “about how a skilled artisan would understand the way in which a curve created from chromatogram data reflects molecular weights” was a factual finding. Id. at 843. Distinguishing between the factual and legal components of the analysis, the Court explained that “[biased on that factual finding, the District Court reached the legal conclusion that figure 1 did not undermine Teva’s argument that molecular weight referred to the first method of calculation (peak average molecular weight).” Id. The Court vacated our decision instructing that the district court fact findings should be reviewed for clear error. Id. The Court acknowledged that Teva claimed there were two additional instances in which the Federal Circuit rejected fact findings without finding clear error. Expressing no opinion on those arguments, the Court left these matters for us to consider. Id.
While Teva was pending at the Supreme Court, the Court issued its opinion in Nautilus II. In Nautilus II, the Court evaluated our standards for indefiniteness under 35 U.S.C. § 112, ¶ 2 (2006),
We therefore reconsider the district court’s claim construction and indefiniteness determination in light of the Supreme Court’s guidance.
Disoussion
A patent’s specification must “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as [the] invention” 35 U.S.C. § 112, ¶ 2. A patent is indefinite “if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of
To determine whether the Group I claim at issue is indefinite, we look to the patent record — the claims, specification, and prosecution history — to ascertain if they convey to one of skill in the art with reasonable certainty the scope of the invention claimed. We conclude in this case that they do not convey with reasonable certainty the measure of molecular weight to be used. Claim 1 of the '808 patent recites “molecular weight” without specifying the meaning of that term. The parties agree that “molecular weight” could refer to M p, M w, or M n. And they agree that each of these measures is calculated in a different way and would typically yield a different result for a given polymer sample. But the claim on its face offers no guidance on which measure of “molecular weight” the claims cover.
There is no express definition of “molecular weight” in the '808 patent specification. Nowhere in the specification are the terms M p, M w, or M n used. Neither party argues to the contrary. Instead, in its supplemental briefing to this court, Teva argues that:
The factual findings establish that to a skilled artisan, ‘average molecular weight’ has a presumed meaning in this context, which means that the patent’s specification resolves any ambiguity; that the presumed meaning is consistent with Figure 1 of the specification; and that the only statement causing ambiguity in the prosecution history was an error.... And no intrinsic evidence defeats that definite meaning — not Figure 1, and not the prosecution history.
Appellees’ Supp. Br. 1; see also id. at 4-7 (Section 2. Heading: “The District Court Did Not Clearly Err in Finding That The Key Term Has A Presumed Meaning In The Art”). Teva’s recitation of what was found below is inaccurate. The district court did not find that the term molecular weight or average molecular weight had a presumed meaning in the art. And if there were such a finding, it would not have been supported by the record in this case. All parties agree that the term “molecular weight” or “average molecular weight” in the Group I claims could refer to any of the three weight measures M p, M n, or M w. Even Teva’s expert Dr. Grant repeatedly admitted that the term molecular weight has no default meaning to one of skill in the art. J.A. 3096-97. And while it is true that the district court used the word “presumed” once in its indefiniteness section, the use was in characterizing Teva’s argument, not in making a fact finding: “Thus, Teva (and Dr. Grant) conclude, M p can be read from the chromato-gram generated by SEC without any ‘further calculation’ and would be understood by a person of ordinary skill in the art to be the presumed meaning of [average molecular weight] in the context of the patents-in-suit.” Markman Order, at 588.
The district court’s determination about how a skilled artisan would understand the way in which SEC-generated chromato-gram data reflects molecular weight is a question of fact. And we see no clear error in that fact finding — that one of skill
To the extent that Teva argues that the meaning of “molecular weight” in the context of patents-in-suit is itself a question of fact, it is wrong. See Teva,
To determine whether one of skill in the art would be reasonably certain that the claim’s use of molecular weight is M p, we consider as well the prosecution history. Statements made during prosecu
In response to the indefiniteness rejection concerning the meaning of “molecular weight” during the prosecution of the '847 patent, the earlier of the two continuations, the applicants argued that the term “molecular weight” was not indefinite because “[o]ne of ordinary skill in the art could understand that kilodalton units implies a weight average molecular weight,” i.e., M w . J.A. 3229. To be clear, this was the only basis which the applicant argued in response to the indefiniteness rejection. And the applicant was successful. Defining “molecular weight” as M w, as the applicant did in response to the rejection, was what overcame the rejection. The district court heard testimony that the statement made during the prosecution of the '847 patent was scientifically erroneous because each type of “molecular weight” can be expressed in kilodaltons. Mark-man Order, at 592. The fact finding by the district'court — that one of skill in the art would understand that éaeh type of
The examiner required the applicants to provide a meaning for “molecular weight” and they provided one: M w. The fact that their explanation contained further elaboration which itself included a scientific error does not undermine the statement’s legal import. “The public notice function of a patent and its prosecution history requires that a patentee be held to what he declares during the prosecution of his patent.” Springs Window Fashions LP v. Novo Indus., L.P.,
During the prosecution of the '539 patent, the applicants responded to a nearly identical indefiniteness rejection to the term “molecular weight” by arguing that a person “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 distribution curve in Figure 1,” i.e., M p J.A. 3258. Here too the specification was identical to the '808 and '847 patents in all respects relevant to the molecular weight question, and the examiner found the specification did not provide the reasonable certainty required for definiteness. The patentee overcame that rejection by again defining which measure of molecular weight to use, in that case M p.
To summarize, it is undisputed that “molecular weight” or average molecular weight can be ascertained by any of three possible measures: M p, M and M w. The claims do not indicate which measure to use. The specification never defines molecular weight or even mentions M p, M w,
AFFIRMED-IN-PART, REVERSED-IN-PART
Costs
No costs.
Notes
. The asserted patents were: U.S. Patent Nos. 5,800,808; 5,981,589; 6,048,898; 6,054,430; 6,342,476; 6,362,161; 6,620,847; 6,939,539; and 7,199,098. The Supreme Court decision does not affect our prior holding with respect to the Group II claims. For the reasons articulated in our earlier opinion, we adopt those holdings.
. While the case was pending at the Supreme Court, all of the patents-in-suit expired, with the exception of U.S. Patent No. 5,800,808. Thus, claim 1 of the '808 patent is the sole unexpired Group I claim. Our analysis will therefore focus on that claim, but to the extent that issues relating to the expired Group I claims remain unresolved, this analysis should be understood to apply equally to the other Group I claims.
. Paragraph 2 of 35 U.S.C. § 112 was replaced with newly designated § 112(b) when §'4(c) of the Leahy-Smith America Invents Act ("AIA”), Pub.L. No. 112-29, took effect on September 16, 2012. Because this case was filed before that date, we will refer to the pre-AIA version of § 112.
. Prior to the expiration of the other patents-in-suit, Teva did not dispute the relevance of the prosecution history of related patents to the construction of the term "molecular weight." See Markman Order, at 592; J.A. 1018. Now Teva argues that “the prosecution history of later patents ... cannot override the specification or invalidate the patent.” Appellees’ Supp. Br. 1; see also id. at 12. But we have said before, and reaffirm today, that past and future prosecution of related patents may be relevant to the construction of a given claim term.
Dissenting Opinion
dissenting.
“[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.” Teva Pharm. USA, Inc. v. Sandoz, Inc.,. — U.S.-,
I.
In some cases, a trial court can decide an indefiniteness dispute based solely on the intrinsic evidence. When a district court’s review is confined to the intrinsic record, its conclusion on indefiniteness will be a legal determination which we can appropriately review de novo. See Teva,
The court here is once again led astray by its failure to afford sufficient deference to the trial court’s findings of fact. See Teva,
We must be “mindful that we are a court of review, not of first view,” Cutter v. Wilkinson,
As this court has repeatedly made clear, obviously erroneous statements in the prosecution file carry little weight in determining claim meaning. See, e.g., Rambus Inc. v. Infineon Techs. AG,
According to the court, although Teva’s statement that the use of kilodalton units “implie[d] a weight average molecular weight” was scientifically incorrect, a skilled artisan would nonetheless have understood that the applicants defined the term “molecular weight” as weight average molecular weight to gain allowance of the claims. Ante at 1344. This argument is unconvincing. Read as a whole, Teva’s statement that the use of kilodalton units “implie[d] a weight average molecular weight” is nonsensical, and a skilled artisan would not rely upon any part of it. This is particularly true given that Teva confirmed, when subsequently prosecuting the '539 patent, that — consistent with the use of the SEC method disclosed in the specification — the term “molecular weight” meant peak average molecular weight. See Elbex Video, Ltd. v. Sensormatic Elecs. Corp.,
The court’s approach here contravenes binding precedent. In Enzo Biochem Inc. v. Applera Corp., we held that under Teva a trial court’s conclusion, based on expert testimony, as to whether an example in the specification disclosed, “direct detection” was a “factual finding” which was subject to clear error review.
Although the ultimate conclusion of indefiniteness. under 35 U.S.C. § 112 is a legal question, see Eidos Display, LLC v. AU Optronics Corp.,
II.
In Nautilus, Inc. v. Biosig Instruments, Inc., the Supreme Court rejected this
The '808 patent will expire in September 2015. This looming expiration date does not, however, permit us to overstep our appellate role or feign first-hand experience with the testimony or the technology. We are neither equipped nor authorized to make the predicate factual determinations necessary to assess whether the '808 patent withstands definiteness scrutiny under the Nautilus standard. See Anderson v. Bessemer City,
Teva Pharmaceuticals USA, Inc. and related parties (collectively "Teva”) own the '808 patent, which is the sole patent at issue in this appeal. The '808 patent is related to both the '539 patent and U.S. Patent No. 6,620,847 (the "'847 patent”), and the three patents share substantially identical specifications.
