Pharmacia & Upjohn Company (“Upjohn”) appeals from the decision of the United States District Court for the Northern District of West Virginia granting summary judgment to Mylan Pharmaceuticals, Inc. The court held that Mylan did not infringe the claims of Upjohn’s U.S. Patent 4,916,163 under the doctrine of equivalents because of prosecution history estoppel, and alternatively, that Upjohn was collaterally estopped from asserting its infringement claim by a prior judgment of invalidity and unenforce-ability.
See Pharmacia & Upjohn Co. v. Mylan Pharm., Inc.,
BACKGROUND
A. The Invention
The patent at issue involves formulations of the anti-diabetic drug glyburide that contain two key components: micronized glyburide (finely divided glyburide) and lactose. Lactose exists in both hydrous (the monoh-ydrate) and anhydrous forms and acts as an excipient, i.e., an inactive ingredient, in pharmaceutical compositions. Hydrous lactose is difficult to use in manufacturing micronized glyburide formulations because of poor compressibility and poor hopper flow. To avoid those problems, “spray-dried lactose” (a particular form of hydrous lactose) or anhydrous lactose may be utilized. Both spray-dried and anhydrous lactose are readily compressible and have considerably larger particle size than hydrous lactose, qualities which facilitate tablet manufacture.
The ’163 patent is directed to micronized glyburide formulations containing spray-dried lactose as the principal excipient. Claim 1, the only independent claim, is writ *1375 ten in the Jepson format and reads as follows:
1. In an [sic] micronized anti-diabetic pharmaceutical composition as a unit dose, containing one or more pharma-ceutically acceptable excipients, the improvement which comprises: spray-dried lactose as the preponderant ex-cipient in said composition, being present therein at about not less that [sic] seventy percent (70%) by weight of the final composition.
’163 patent, col. 4, 11. 17-24. Claim 2 more particularly claims micronized glyburide of a specific surface area, see id. at 11. 25-27, while claims 3 and 4 more particularly claim combinations of excipients to be used with micronized glyburide, see id. at 11. 28-33.
Mylan, a generic drug manufacturer, devised several micronized glyburide compositions, all of which use anhydrous lactose as the principal excipient; they contain no spray-dried lactose. Mylan filed an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration seeking approval to sell 1.5 mg and 3.0 mg micron-ized glyburide tablets before the expiration of the ’163 patent. Mylan filed a supplement to the ANDA seeking approval for a 6.0 mg tablet as well. Pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), on August 30, 1996, Mylan sent Upjohn a “Notice of Paragraph IV Certification” notifying Upjohn of its submission of an ANDA for the 1.5 and 3.0 mg tablets and explaining why its tablets did not infringe the claims of the ’163 patent. On December 31, 1996, Mylan sent Upjohn a similar notification letter regarding its supplemental ANDA for the 6.0 mg tablets.
B. The District Court
Upjohn sued Mylan in the district court alleging that Mylan’s filing of the ANDA with respect to the 1.5, 3.0, and 6.0 mg compositions constituted infringement of claims 1 through 4 of the ’163 patent under 35 U.S.C. § 271(e)(2). Conceding a lack of literal infringement, Upjohn alleged that My-lan’s micronized glyburide compositions infringe under the doctrine of equivalents because “anhydrous lactose” is the equivalent of “spray-dried lactose.” Mylan moved for summary judgment, arguing that Mylan did not infringe because of prosecution history estoppel, and alternatively, that Upjohn was collaterally estopped by the judgment of invalidity and unenforceability in
Upjohn Co. v. Mova Pharmaceutical Corp.,
As to infringement under the doctrine of equivalents, the district court observed that throughout the prosecution of the ’163 patent, Upjohn emphasized the “criticality” of using spray-dried lactose as the principal excipient in its micronized glyburide formulations.
See Mylan,
As an alternative basis for summary judgment, the district court held that Upjohn was collaterally estopped by the judgment of invalidity and unenforceability in
Mova
under
Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundation,
DISCUSSION
A. Standards of Review
We review a district court’s grant of summary judgment
de novo. See Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.,
Whether prosecution history estoppel applies to limit the doctrine of equivalents is a question of law which we review de novo.
See Wang Lab., Inc. v. Mitsubishi Elecs. Am.,
B. Prosecution History Estoppel
Upjohn argues that the court improperly considered only selected portions of the prosecution history and incorrectly concluded that Upjohn relinquished micronized glyburide formulations containing
any
type of lactose other than spray-dried lactose.
See Read Corp. v. Portec, Inc.,
We agree with Mylan that the district court properly concluded that Upjohn is barred from claiming that Mylan’s formulations containing micronized glyburide and anhydrous lactose are within the scope of the ’163 patent under the doctrine of equivalents. Prosecution history estoppel precludes a patentee from obtaining under the doctrine of equivalents coverage of subject matter that has been relinquished during the prosecution of its patent application.
See Mitsubishi
To determine what subject matter has been relinquished, an objective test is applied, inquiring “whether a competitor would reasonably believe that the applicant had surrendered the relevant subject matter.”
Cybor,
In reaching its conclusion, the district court focused on two key portions of the prosecution history: the response to the first office action, which contains statements made by the attorney prosecuting the application as well as by inventor Ni, and the opinion by the Board reversing the examiner’s rejection of the claims under 35 U.S.C. § 103. In the first office action, the examiner rejected the four claims of the patent as obvious over the disclosures of certain Weber patents and Rothe patents in view of patents to Sawada and Tokumori. See Paper No. 6 at 2. In response, Upjohn’s attorney made the following argument in attempting to gain allowance of the claims:
As indicated in the specification, the use of spray-dried lactose is a critical feature of the present invention. Using lactose which is not spray-dried does not yield a formulation which is easily and readily manufacturable.
Paper No. 7 at 1. Based on the plain meaning of this language, we agree with the district court that these statements would reasonably be interpreted as a “clear and unmistakable surrender” of micronized glyburide compositions that do not contain spray-dried lactose. Upjohn attempts to explain away these statements by contending that one must read them in the context of the subsequent paragraph, which reads:
In particular, the Examiner’s attention is invited to the Ni declaration, provided with this response. As indicated by Ni, in a side-by-side comparison of a spray-dried lactose formulation with a corresponding formulation made with conventional lactose, the resulting bulk pharmaceutical powder cannot be readily processed. As indicated by Ni, additional processing of the bulk powder is required in order to achieve manufacturability.
Id. (emphasis added). Upjohn argues that in making this reference to the Ni declaration it was merely comparing micronized glyburide *1378 formulations containing spray-dried lactose with those containing conventional, hydrous lactose. Thus, Upjohn continues, “lactose which is not spray-dried” in the preceding paragraph referred only to hydrous lactose, and it was only mieronized glyburide formulations containing hydrous lactose that were surrendered.
We find this argument unpersuasive. Rather, we agree with Mylan that the first paragraph is reasonably interpreted as a broad disclaimer of what the invention was not (mieronized glyburide formulations containing nonspray-dried lactose), followed by a specific example (hence the words “in particular”) of how Upjohn’s spray-dried lactose formulation was superior to a specific formulation with nonspray-dried lactose (here, hydrous lactose) in the second paragraph. Moreover, Upjohn’s argument fails to address the clear and unequivocal statement in the first paragraph that spray-dried lactose was deemed to be a “critical feature” of the claimed formulations.
Statements in inventor Ni’s declaration responding to the first office action closely mirror those made by Upjohn’s attorney:
8. The key feature of the present invention is the particular type of lactose employed in the composition. The claims in the specification clearly indicate the need for spray-dried lactose. If ordinary or nonspray-dried lactose is employed in place of the spray-dried lactose, then the advantages of the present invention are lost.
Paper No. 8 at 2 (emphasis added). Again, based on a plain reading of this language, especially the emphasized portion, we agree with the district court that mieronized glyburide compositions that do not contain spray-dried lactose have been surrendered. Upjohn argues that one must read Ni’s statements in the context of other paragraphs in both the first and second Ni declarations, as well as pages from Ni’s laboratory notebook. Upjohn asserts that these portions of the prosecution history indicate that Ni only compared mieronized glyburide formulations containing spray-dried lactose with those containing hydrous lactose. Moreover, Upjohn asserts that the language “ordinary or nonspray-dried lactose” in paragraph 8, id. (emphasis added), shows that the terms “nonspray-dried lactose” and “hydrous lactose” were in fact synonymous. Accordingly, Upjohn urges that “nonspray-dried lactose” was only meant to refer to hydrous lactose, and thus only mieronized glyburide formulations containing hydrous lactose were relinquished.
We find these arguments similarly unpersuasive. An Upjohn competitor would reasonably interpret Ni’s statements to mean that spray-dried lactose was an indispensable component of the claimed formulations. Upjohn’s arguments fail to address or to explain away the first two sentences of paragraph 8 in which Ni clearly and unequivocally emphasized how critical spray-dried lactose is to the claimed formulations. As to the third sentence, even assuming that the terms “non-spray-dried lactose” and “hydrous lactose” are synonymous, this sentence would reasonably be interpreted, in light of the two declarations and notebook excerpts, to be yet another assertion of how important spray-dried lactose is to the claimed formulations, and an example of how Upjohn’s mieronized glyburide formulations with spray-dried lactose are superior to formulations without spray-dried lactose.
Further support for this conclusion comes from the Board itself. In its opinion reversing the examiner and allowing the claims, the Board characterized Upjohn’s argument as follows:
[Ajppellant argues that using spray-dried lactose instead of nonspray-dried lactose in this manner results in a product which is more easily manufactured due to the free flowing characteristics of the composition to be formed into a unit dose. Appellant relies upon his two declarations filed under 37 CFR § 1.132 in support of this assertion.
Paper No. 21 at 2. The Board, relying on Upjohn’s representations in reversing the examiner, apparently interpreted them as we do, and as the district court did, and premised its reversal of the examiner on that interpretation: that spray-dried lactose was crucial to the claimed mieronized glyburide formulations and that Upjohn had relin *1379 quished rights to micronized glyburide formulations with nonspray-dried laetose. 3 Accordingly, we conclude that the district court properly held that Upjohn cannot succeed in its claim that Mylan’s micronized glyburide formulations containing anhydrous lactose infringe the patent under the doctrine of equivalents.
C. Collateral Estoppel
Upjohn argues that the district court erred in two respects in holding that Upjohn was estopped from asserting its infringement claims against Mylan based on the judgment of invalidity and unenforceability in Mova. First, Upjohn asserts that the jury in Mova failed to grasp the technical subject matter and issues, and that under Blonder-Tongue, the Mova judgment should be accorded no collateral estoppel effect because Upjohn did not have a full and fair opportunity to litigate. Second, Upjohn asserts that the collateral estoppel effect of the Mova judgment is “uncertain” and should not have been applied against Upjohn. In its appeal brief, Upjohn contends that the district court should have stayed the proceedings pending the resolution in Mova of its JMOL/new trial motion and possible appeal. Following the denial of its JMOL/new trial motion, which occurred after Upjohn filed its appeal brief in the present case, Upjohn additionally urges us in its reply brief to consolidate this appeal with its appeal in Mova, which is currently pending. Mylan responds that Upjohn did indeed have a full and fair opportunity to litigate and merely disagrees with the result in Mova. Mylan argues that the jury did understand the technology at issue and that the Mova court’s “Opinion and Order” provides ample reasons to support the jury’s verdicts of invalidity and unenforceability. While not responding to Upjohn’s arguments that the application of collateral estoppel was premature based on the “uncertainty” of the Mova judgment, Mylan argues strenuously against consolidating this appeal with the Mova appeal. Mylan indicates that should we later reverse all or part of the Mova judgment, those portions of the judgment will no longer have collateral estoppel effect and the district court’s judgment here could be modified accordingly.
We find neither of Upjohn’s arguments persuasive and conclude that the district court did not err in applying collateral estoppel. Collateral estoppel, also known as issue preclusion, shields a defendant from having to litigate issues that have been fully and fairly tried in a previous action and decided adversely to a party.
See Comair Rotron, Inc. v. Nippon Densan Corp.,
The Court qualified its holding by stating that a judgment of invalidity will have no collateral estoppel effect if the patentee can show that it did not have a full and fair opportunity to litigate.
See Blonder-Tongue,
[I]f the issue is non-obviousness, appropriate inquiries would be whether the first validity determination purported to employ the standards announced in Graham v. John Deere Co. ...; whether the opinions filed by the District Court and the reviewing court, if any, indicate that the prior case was one of those relatively rare instances where the courts wholly failed to grasp the technical subject matter and issues in suit; and whether without fault of his own the patentee was deprived of crucial evidence or witnesses in the first litigation.
Id.
at 333,
We find Upjohn’s argument to be without merit. As an initial matter, our role is limited to reviewing the district court’s application of collateral estoppel, not the correctness of the jury verdicts in Mova. Under Blonder-Tongue, a district court’s inquiry into whether the plaintiff was afforded a full and fair opportunity to litigate is quite narrow and does not involve a judgment on the merits:
[I]t is clear from the case law that has developed since Blonder-Tongue that an inappropriate inquiry is whether the prior finding of invalidity was correct; instead, the court is only to decide whether the patentee had a full and fair opportunity to litigate the validity of his patent in the prior unsuccessful suit.
Stevenson,
In denying Upjohn’s JMOL/new trial motion, the
Mova
court rendered a careful, methodical analysis supporting the jury’s verdicts of invalidity and unenforceability.
See Mova,
Upjohn next argues that the district court should have stayed the proceedings pending the resolution of its motion in Mova for JMOL/new trial and its possible appeal. Further, now that Upjohn’s appeal in Mova is currently pending in this court, Upjohn contends that we should consolidate this appeal with the one in Mova. In these argu *1381 ments, Upjohn in effect disputes the finality of the Mova judgment, an essential component of its applicability for collateral estoppel purposes.
We disagree with Upjohn’s arguments. The vast weight of case law supports according the
Mova
judgment full collateral estoppel effect.
4
Although the Fourth Circuit has not directly spoken on the issue, a district court opinion from that circuit, affirmed without opinion, suggests that the Fourth Circuit follows “[t]he established rule in the federal courts ... that a final judgment retains all of its res judicata consequences pending decision of the appeal ... [.]”
Warwick Corp. v. Maryland Dep’t of Transp.,
[T]he law is well settled that the pendency of an appeal has no effect on the finality or binding effect of a trial court’s holding. Deposit Bank v. Board of Councilmen of City of Frankfort,191 U.S. 499 ,24 S.Ct. 154 ,48 L.Ed. 276 (1903). That rule is applicable to holdings of patent invalidity as well. Alamance Industries, Inc. v. Gold Medal Hosiery Co.,194 F.Supp. 538 , 540,129 USPQ 219 , 220 (S.D.N.Y.1961).
SSIH Equipment S.A. v. United States Int’l Trade Comm’n,
Moreover, the district court did not err in according the
Mova
judgment collateral es-toppel effect despite the pendency of Upjohn’s JMOL/new trial motion in
Mova.
While the Fourth Circuit has not addressed this issue, the authorities and modicum of case law that have done so are nearly uniform in concluding that the fact that post-trial motions are pending does not affect the finality of a judgment and thus does not prevent its preclusive effect.
See Hubbell v. United States,
As indicated by the district court, the
Mova
judgment was entered on December 2, 1997.
See Mylan,
We accordingly conclude that the district court did not err in applying collateral estop-pel based on the judgment of invalidity and unenforceability in Mova, despite the fact that the motion for JMOL/new trial had not yet been resolved by the Mova court, and despite the possibility of a subsequent appeal of the Mova judgment. We also decline Upjohn’s invitation to consolidate this appeal with the appeal in Mova. If another panel later concludes that one or more of the jury verdicts in Mova should be reversed, Upjohn may then move the district court to modify its judgment accordingly.
CONCLUSION
The district court properly granted summary judgment that Mylan does not infringe the T63 patent under the doctrine of equivalents based on prosecution history estoppel. The district court also properly granted summary judgment on the alternative ground of collateral estoppel based on the judgment of invalidity and unenforceability in Mova. We therefore
AFFIRM, 6
Notes
. The district court’s holding and corresponding order are somewhat inconsistent with the court’s reasoning in its Memorandum Opinion and Order. We clarify both the holding and the order at the conclusion of this opinion. See infra note 6.
. We have also stated that the prosecution history should be objectively viewed from the perspective of one skilled in the art.
See, e.g., Litton,
Ordinarily, the test for determining the meaning of a claim term is from the vantage point of one skilled in the art. This test would seem equally appropriate for determining what subject matter was relinquished in the context of prosecution history estoppel. Our precedent dealing with this specific question recites that the test is measured from the vantage point of a reasonable competitor. We do not see these formulations as necessarily inconsistent — the point is the knowledge of one reasonably skilled in the art who views the question from the perspective of a competitor in the marketplace.
Hoganas,
. Moreover, we observe that Upjohn unequivocally disclosed in the written description of the patent that spray-dried lactose is crucial to the success of the micronized glyburide formulations. See '163 patent, col. 2, 11. 26-29 ("Critical to the success of the present composition is the employment of spray-dried lactose as the preponderant component by weight of the resulting composition.”).
. Application of
Blonder-Tongue,
being an issue of patent law, is a matter within our exclusive jurisdiction and is hence subject to this court’s law. However, because the application of general collateral estoppel principles, such as finality of judgment, is not a matter within the exclusive jurisdiction of this court, we must apply the law of the circuit in which the district court here sits,
i.e.,
the Fourth Circuit.
See Hartley v. Mentor Corp.,
. We note that these cases are relatively rare, because, as Moore observes, post-trial motions are typically ruled upon shortly after judgment is entered. See Moore, § 131.30[3][a], at 131-100 ("Post-trial motions are usually made and disposed of in a comparatively narrow time frame, so the issue of what impact a possible or pending motion has on the preclusive effect of the judgment is seldom addressed.”) (footnote omitted). Here, the Mova court ruled on Upjohn’s JMOL/ new trial motion nearly nine months after judgment was entered.
. The language of the district court’s collateral estoppel holding was as follows: “As to the issue of invalidity, the Court concludes that the
Mova
verdict makes the ’163 patent unenforceable.”
Mylan,
