Glaxo, Inc. and Glaxo Group Limited (collectively “Glaxo”) appeal from the judgment of the United States District Court for the Eastern District of North Carolina, dismissing Glaxo’s claims that Novopharm Ltd. and its wholly owned subsidiary, Granutec, Inc., (collectively “Novopharm”) (1) infringed U.S. Patent 4,521,431 under 35 U.S.C. § 271(e) by filing an abbreviated new drug application (ANDA), (2) would infringe U.S. Patent 4,672,133 under 35 U.S.C. § 271(g) by importing materials following the approval of the ANDA, and (3) violated state unfair competition law by violating a protective order.
Glaxo, Inc. v. Novopharm Ltd.,
BACKGROUND
This appeal involves the parties’ ongoing dispute over Novopharm’s efforts to market *1564 a generic version of Glaxo’s highly successful anti-ulcer medication, Zantac®. The active ingredient in Zantac® is ranitidine hydrochloride (RHC1), a salt that may occur in at least two distinct crystalline forms. Glaxo owns three patents that are relevant to this dispute: U.S. Patents 4,128,658; 4,521,431; and 4,672,133.
The ’658 patent discloses a method of making RHC1 and claims the compound per se, both specifically and generieally. This patent application was apparently filed before Glaxo scientists knew that RHC1 could exist in more than one crystalline form. It makes no reference to crystalline form, but the crystalline form of RHC1 first obtained by the procedures described in the ’658 patеnt has come to be known as Form 1 RHC1. The ’658 patent will expire on July 25, 1997.
After Glaxo scientists discovered that a different crystalline form of RHC1 could be made using the process described in the ’658 patent and that this new form had physical characteristics preferable to those of the first known crystalline form, they filed a patent application for the new form, which they named Form 2 RHC1. This crystalline form of RHC1 is currently the active ingredient in Zantac®. The ’431 and ’133 patents issued from this application, and they claim, respectively, Form 2 RHC1 and a process for making Form 2 RHC1. The claims in both of these patents characterize Form 2 RHC1 by means of a specific, 29-peak infra-red (IR) spectrum. Several dependent claims in these patents also define Form 2 RHC1 as characterized by a 32-intensity x-ray powder diffraction pattern. The ’431 patent will expire in 2002 and the ’133 patent will expire in 2004.
In 1991, Novopharm Ltd., a Canadian-based manufacturer, formulator, and seller of generic pharmaceuticals, filed an ANDA with the United States Food and Drug Administration (FDA) seeking permission to sell Form 2 RHC1.
See
21 U.S.C. § 355(j) (1994); 21 C.F.R. § 314 Subpart C (1996). In the course of an infringement suit brought by Glaxo under 35 U.S.C. § 271(e)(2), Novop-harm admitted infringement, but challenged the validity of the ’431 patent, alleging that the ’658 patent anticipated the ’431 patent’s claims to Form 2 RHC1. The district court found that none of the methods disclosed in the ’658 patent invariably yielded crystals of Form 2 RHC1, but could yield crystals of either crystalline form.
Glaxo, Inc. v. Novopharm Ltd.,
Not discouraged by its inability to use Form 2 to bring RHC1 to the market, Novop-harm filed another ANDA on April 25, 1994, this time seeking approval to market Form 1 RHC1. As part of this ANDA, Novopharm filed a so-called “paragraph IV certification,” indicating that its product would not infringe the ’431 patent and that it did not intend to market Form 1 RHC1 before the expiration of the ’658 patent. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (1994). The ANDA, as initially filed, specified that the marketed product be approximately 99% pure Form 1 RHC1 (with impurities that may include Form 2 RHC1) as determined by an IR spectroscopic analysis. Amended ANDAs filed by Novopharm would have permitted the marketed product to have a Form 1 RHC1 purity as low as 90%.
In response, on July 22, Glaxo sued No-vopharm, asserting infringement of the ’431 patent under § 271(e)(2) and seeking a declaratory judgment that Novopharm would infringe the ’133 patent under § 271(g) if and when it imported the product following FDA approval of the ANDA. Glaxo also asserted a state law unfair competition claim, based upon its allegation that Novopharm and its expert witness, Dr. Natalie Lazarowyeh, misappropriated Glaxo trade secrets regarding the production of Form 1 RHC1 in viоlation of a protective order issued by the Glaxo 1 court. Novopharm counter-claimed, assert *1565 ing that Glaxo violated federal antitrust and state unfair competition laws.
After conducting a bench trial, the district court first determined that, in order to prevail under § 271(e)(2), Glaxo must prove by a preponderance of the evidence that the product sold by Novopharm pursuant to the approved ANDA “will at least more probably than not read on the [’431] patent.”
Glaxo, Inc. v. Novopharm, Ltd.,
DISCUSSION
Glaxo argues that the district court erred by dismissing its claim for infringement of the ’431 patent, its claim seeking a declaration that Novopharm’s post-approval importation of RHC1 would infringe the ’133 patent, and its state law unfair competition claim. We address the issues in that order.
A. Infringement of the %31 Patent
A determination of infringement requires а two step analysis. “First, the claim must be properly construed to determine its scope and meaning. Second, the claim as properly construed must be compared to the accused device or process.”
Carroll Touch, Inc. v. Electro Mechanical Sys., Inc.,
Glaxo argues that the district court erred by construing the ’431 (and the ’133) claims to cover only pure Form 2 RHC1 (and a method for making pure Form 2 RHC1). Glaxo argues that the claims are properly construed to encompass products containing any amount of Form 2 RHC1 and methods for making such products. Novopharm responds that the district court did not base its decision on a narrow (“pure Form 2 RHC1”) claim construction. Rather, Novopharm argues that, because the court accepted Glaxo’s broad claim construction for purposes of its infringement analysis, the narrow claim construction was dictum, not binding upon the parties. In fact, at oral argument Novop-harm disavowed the narrow claim construction by admitting that “there is nothing that comes from ... the lower court’s decision that gives Novopharm any entitlement to make a product that contains a mixture [containing Form 2].”
We
agree that the claims are not limited to pure Form 2 RHC1. In
Glaxo 2,
we explicitly affirmed the
Glaxo 1
court’s finding that Form 2 RHC1 was not reliably obtained by carrying out the procedures of Example 32 of the ’658 patent.
Glaxo 2,
Based on the evidence before it and on the proper claim construction, the district court found that Glaxo failed to prove infringement by a preponderance of the evidence. In fact, the court found that “the preponderance of the [infrared (IR) spectrаl] evidence indicates that Form 2 [RHC1] is not present in Novopharm’s product.”
Glaxo argues that the district court clearly erred in finding a lack of proof. Specifically, Glaxo argues that the only support for the district court’s finding is the following isolated statement of Glaxo’s expert witness, Dr. Byrn: “I would put a probability of 60/40 that [an IR spectrum of Glaxo’s Form 1 RHC1 product is] not Form 2.” Glaxo also argues that because Novopharm’s ANDA initially determined the content of Form 2 RHC1 in its Form 1 RHC1 product based upon a single IR рeak at 1045 cm-1, the district court must now engage in an infringement analysis based upon that single peak. Novopharm responds that the district court did not clearly err in finding that Glaxo had failed to prove infringement because the great weight of the evidence adduced at trial indicated that Novopharm will not sell a product containing any identifiable Form 2 RHC1. Specifically, Novopharm argues that the district court properly decided not to rely solely upon the IR peak at 1045 cm-1 because that peak was not necessarily indicative of Form 2 RHC1 and, more importantly, the claims at issue all identify Form 2 RHC1 by reference to a 29-peak IR spectrum. Accordingly, says Novopharm, proof of infringement rеquires proof that the drug alleged to infringe would exhibit all of those peaks, not a single, potentially meaningless peak.
We agree with Novopharm that the evidence supports the district court’s finding that the single peak analyzed was not sufficient to substitute for the claimed 29-peak spectrum. It is elementary patent law that all limitations are material. The single-peak analysis was thus insufficient because, as the district court correctly noted, in order to prove infringement Glaxo was required to establish the presence of each limitation of the asserted claims.
See Zenith Lab., Inc. v. Bristol-Myers Squibb Co.,
*1567 Moreover, the court’s finding that the single IR peak was “meaningless” to the identification of Form 2 RHC1 is supported by the testimony of Novopharm’s witness, Dr. Du-rig, as well as by Glaxo’s own witnesses, Drs. Klinkert and Snyder. Durig testified that a sample of Form 1 RHC1 (a sample that Glaxo stipulated to contain no Form 2 RHC1) exhibited a significant peak at 1045 em-1. Similarly, Glaxo’s own witnesses, Klinkert and Snydеr, agreed that, given the range of possible chemical impurities, the presence of the single IR peak was insufficient to differentiate Form 1 RHC1 from Form 2 RHC1. These statements, found credible by the district court, not merely the testimony of Byrn, provide ample support for the court’s factual finding that Glaxo failed to prove infringement under a single-peak analysis.
Glaxo also argues that the district court erred by applying a conventional infringement analysis, i.e., comparing the allegedly infringing composition to the claims, in an action brought under § 271(e)(2). More precisely, Glaxo argues that the district court erred by focusing on what Novopharm will sell under the ANDA if and when the ANDA is approved, instead of focusing solely on the fact that the scope of approval sought by Novopharm would allow it to manufacture compositions containing Form 2 RHC1. Under Glaxo’s reading of the statute, the ANDA itself, because of its broad scope, was sufficient evidence to prove infringement. Alternatively, Glaxo argues that the ANDA’s broad scope was sufficient to shift to Novop-harm the burden of proving that the ultimately marketed drug would not infringe. Novopharm responds that under § 271(e)(2), the scope of the ANDA is not the sole factor in an infringement analysis and that it does not alter a patentee’s normal burden of proving infringement by a preponderance of the evidence. Novopharm argues that the district court correctly required Glaxo tо prove that the product that Novopharm ultimately would put on the market would likely infringe the ’431 patent. We agree with No-vopharm’s view of the statute.
We review a district court’s interpretation of statutory language
de novo. Astra v. Lehman,
The relevant statute provides, in pertinent part:
It shall be an act of infringement to submit — (A) an application under [21 U.S.C. § 355(j)] or described in [21 U.S.C. § 355(b)(2) ] for a drug claimed in a patent or the use of which is claimed in a patent ... if the purpose of such a submission is to obtain approval under [Title 21 of the United States Code] to engage in the commercial manufacture, use, or sale of a drug ... claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.
35 U.S.C. § 271(e)(2) (1994). The plain language of the statute does not alter a paten-tee’s burden of proving infringement, nor does it mandate an infringement analysis limited to the scope of the approval sought. Likewise, Glaxo has not cited any legislative history to indicate that Congress intended to limit the infringement analysis to any particular aspect of the ANDA or to alter a paten-tee’s burden of proving infringement.
Glaxo argues that because an action brought under § 271(e)(2)(A) is based solely upon the filing of an ANDA, such an action requires a unique type of infringement analysis. In a case such as this, Glaxo argues, the alleged infringer must disprove infringement if the ANDA permits sale of a composition that may include an infringing product. Glaxo seems to be arguing that the act of infringement consisting of the filing of the ANDA presumptively settles the issue of infringement of the patent when the product is marketed and that anything possibly within the scope of the ANDA must be shown by the applicant not to infringe. Therefore, the question before us is whether the act of infringement created by § 271(e)(2)(A) directs the ultimate infringement inquiry to the ANDA or whether the inquiry should be *1568 focused on the product that is ultimately to be sold.
The statute refers to the question whether the purpose of the ANDA is to engage in the commеrcial manufacture, use, or sale of the patented drug. We conclude that, especially in a ease such as this, involving a compound capable of existing in various forms, the statute requires an infringement inquiry focused on what is likely to be sold following FDA approval. This inquiry must be based on all of the relevant evidence, including the ANDA. As is well-established for infringement actions brought under § 271,
see, e.g., Uniroyal, Inc. v. Rudkin-Wiley Corp.,
Subsection 271(e)(2)(A) was part of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. 98-417, 98 Stat. 1585 (hereinafter “the Hateh-Waxman Act” or “the Act”), legislation designed to benefit makers of generic drugs, research-based pharmaceutical companies, and not incidentally the public.
See
H.R.Rep. No. 98-857(1), at 14-15 (1984),
reprinted in
1984 U.S.C.C.A.N. 2647, 2647-48 (stating that the purposes of the legislation are “to make available more low cost generic drugs [and] to create a new incentive for increased expenditures for research and development of certain products which are subject to pre-market approval”);
Statement on Signing S. 1538 into Law,
20 Weekly Comp. Pres. Doc. 1359, 1360 (Sept. 24, 1984) (President’s statement that the Hatch-Waxman Act “will provide regulatory relief, increase competition, economy in government, and best of all, the American people will save money, and yet receive the best medicine that pharmaceutical science can provide”). The Hatch-Wax-man Act,
inter alia,
allows makers of generic drugs to market generic versions of patented drugs as soon as possible after expiration of the relevant patents, while providing patent holders with limited extensions of patent term in order to recover a portion of the market exclusivity lost during the lengthy process of development and FDA review.
See Eli Lilly & Co. v. Medtronic, Inc.,
Under the portions of the Act relevant to this appeal, a generic drug manufacturer may seek expedited approval to market a generic version of an already-approved drug by submitting an ANDA.
See
21 U.S.C. § 355® (1994); 21 C.F.R. § 314.94 (1996). While performing development work and seeking such approval, a generic drug manufacturer is free from liability for patent infringement based solely upon acts necessary to prepare the ANDA
See
35 U.S.C. § 271(e)(1) (1994) (“It shall not be an act of infringement to make use, offer for sale, or sell ... a patented invention ... solely for uses reasonably related to the development and submission of information under the Federal law which regulates the manufacture, use, or sale of drugs____”) (overruling
Roche Prod., Inc. v. Bolar Pharm. Co.,
The Act also benefits the patentee (aside from patent term extension). If a patent relevant to the ANDA has not expired, the generic drug manufacturer must certify either that the generic drug will not enter the market before the patent’s expiration date or that the patent is “invalid or will not be infringed by the manufacture, use, or sale of the drug for which the [ANDA] is submitted.” 21 U.S.C. § 355®(2)(A)(vii)(III)-(rV) (1994). If the ANDA contains the latter certification, the generic drug manufacturer must notify the patentee, who, if it disagrees with the certification, will then have forty-five days to sue the ANDA applicant for infringement under 35 U.S.C. § 271(e)(2). *1569 See 21 U.S.C. § 355(j)(4)(B)(iii) (1994). Such a suit suspends FDA approval until the earliest of the expiration of the patent, judicial resоlution of the correctness of the ANDA applicant’s certification, or thirty months from the receipt of notice. Id.
Thus, § 271(e)(2) provided patentees with a defined act of infringement sufficient to create case or controversy jurisdiction to enable a court to promptly resolve any dispute concerning infringement and validity. Pat-entees were given a jurisdictional basis for bringing suit in federal district court under 35 U.S.C. § 271(e)(2) when, in light of § 271(e)(1), the ANDA applicant was not making, using, or selling the patented product, the traditional statutorily-defined acts of infringement. By bringing such a suit, a patentee could also suspend FDA approval of the ANDA pending judicial determination of the correctness of the applicant’s certification filed under 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
See
21 U.S.C. § 355(j)(4)(B) (1994);
Bristol-Myers Squibb Co. v. Royce Lab., Inc.,
Notwithstanding this defined act of infringement, a district court’s inquiry in a suit brought under § 271(e)(2) is the same as it is in any other infringement suit, viz., whether the patent in question is “invalid or will not be infringed by the manufacture, use, or sale of the drug for which the [ANDA] is submitted.” 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (emphasis added). The only difference in actions brought under § 271(e)(2) is that the allegedly infringing drug has not yet been marketed and therefore the question of infringement must focus on what the ANDA applicant will likely market if its application is approved, an act that has not yet occurred. The occurrence of the defined “act of infringement” does not determine the ultimate question whether what will be sold will infringe any relevant patent. Since the compound for which approval is sought is that which is expected to be marketed, the purposе of the submission of the ANDA is to sell that well-defined compound and the ultimate question of infringement is usually straightforward. However, in this case, where the subject matter is a compound capable of existing in multiple crystalline forms, or mixtures thereof, the ultimate question of infringement is not so simple. The FDA’s interest in fixing the exact nature of such a product to be sold, in discharging its own responsibility to ensure the purity, efficacy, and safety of the product, may cause the nature of the product originally applied for to differ somewhat from that ultimately approved.
The act of infringement that gives rise to a case or controversy under section 271(e)(2) has been stated to be “artificial,”
Eli Lilly & Co.,
[S]ection 271(e)(2)(A) makes it possible for a patent owner to have the court determine whether, if a particular drug were put on the market, it would infringe the relevant pаtent. If the court determines that the patent is not invalid and that infringement would occur, and that therefore the ANDA applicant’s paragraph IV certification is incorrect, the patent owner is entitled to an order that FDA approval of the ANDA containing the paragraph IV certification not be effective until the patent expires. See 21 U.S.C. § 355(j)(4)(B)(iii)(II); 35 U.S.C. § 271(e)(4)(A).
Bristol-Myers Squibb Co.,
*1570 Thus, contrary to Glaxo’s arguments, the patentee’s burden of proving ultimate infringement is not met by the filing of the ANDA. The relevant inquiry is whether the patentee has proven by a preponderance of the evidence that the alleged infringer will likely market an infringing product. What is likely to be sold, or, preferably, what will be sold, will ultimately determine whether infringement exists. The district court correctly chose to determine whether Novop-harm would likely sell an infringing composition pursuant to an approved ANDA. In conducting this infringement analysis, the district court properly considered the ANDA itself, the materials submitted by Novop-harm to the FDA, and other pertinent evidence provided by the parties. Thus, the court did not clearly err in finding that Glaxo did not prove infringement of the claims to Form 2 RHC1 by a preponderance of the evidence and in dismissing Glaxo’s claim for infringement of the ’431 patent.
B. Infringement Of The’133 Patent
Glaxo also sought a declaration that No-vopharm, after receiving FDA approval of its ANDA, would violate 35 U.S.C. § 271(g) (1994) by importing RHC1 after producing it via the process claimed in the T33 patent. Glaxo alleged that Novopharm, by communicating to Glaxo that it intended to market RHC1 before the expiration of the ’133 patent pursuant to FDA approval, had created a reasonable apprehension of imminent and irreparable harm. The district court dismissed Glaxo’s declaratory judgment action on the merits, based upon the same analysis it applied to the § 271(e)(2) infringement claim.
While the § 271(e)(2) provides the federal courts with jurisdiction to hear infringement eases regarding claims directed to drugs or to methods of using drugs, it does not provide jurisdiction to hear infringement cases regarding claims directed to methods for making drugs. 35 U.S.C. § 271(e)(2) (1994) (pertaining only to “a drug claimed in a patent or the use of which is claimed in a patent”). Therefore, Glaxo’s claim that No-vopharm would infringe the ’133 patent, which claims a method of making Form 2 RHC1, was necessarily based upon the Declaratory Judgment Act, 28 U.S.C. § 2201 (1994).
A patentee may seek a declaration that a person will infringe a patent in the future.
See Lang v. Pacific Marine & Supply Co.,
Notwithstanding this deferential standard of review, if there is no actual controversy the district court is without jurisdiction to hear a claim for declaratory relief.
See Skelly Oil Co. v. Phillips Petroleum Co.,
The requirement that there be an actual controversy “is met by a sufficient allegation of immediacy and reality.”
Lang,
(1) the defendant must be engaged in an activity directed toward ... an infringement charge ... or be making meaningful preparation for such activity; and (2) acts of the defendant must indicate a refusal to change the course of its actions in the face of acts by the patentеe sufficient to create a reasonable apprehension that a suit will be forthcoming.
Id.
Under this standard, the district court properly exercised its jurisdiction to consider Glaxo’s declaratory judgment claim. Glaxo’s complaint was based in part on a letter dated June 8, 1994, in which Novop-harm asserted that it intended to market its Form 1 RHC1 product
after
December 5, 1995 (the then expiration date of the ’658 patent) but
before
the expiration of the ’431 patent. Novopharm also indicated that it had submitted an ANDA accompanied by data sufficient to make FDA approval imminent. Thus, unlike
T'electronics,
in which we affirmed the dismissal of a declaratory judgment for lack of jurisdiction, the threat of Novopharm entering the U.S. market was not “years away” nor was there doubt that Novopharm wished to sell some form of RHC1.
See
Some of Novopharm’s acts that form the basis of the declaratory judgment action are of course protected from liability for infringement under § 271(e)(1) (“It shall not be an act of infringement to ... import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”). Nevertheless, the protected status of Novopharm’s activities leading to its submissions to the FDA does not by itself prevent the district court from considering Glaxo’s request for declaratory relief because such relief is directed to the time after the ANDA is approved, when § 271(e)(1) no longer provides a shelter against infringement liability. Accordingly, declaratory relief is available to the patentee asserting a “method of making” claim if, as here, sufficient facts are alleged to create an actual case or controversy. Such allegations may include, as here, imminent FDA approval and actual threats of future infringement. Therefore, the district court properly exercised its discretion to hear Glaxo’s declaratory judgment action, even though that action was premised in part on actions protected under § 271(e)(1).
On the merits, as discussed earlier, the court did not clearly err in finding that Glaxo failed to prove that Novopharm’s product would contain Form 2 RHC1. If its product does not contain Form 2 RHC1, then Novop-harm cannot be using a process that provides Form 2 RHC1. Thus, Glaxo also failed to prove that Novopharm was using a process claimed in the ’133 patent. Accordingly, the district court did not abuse its discretion in dismissing Glaxo’s declaratory judgment action.
C. Unfair Competition Claim For Violation Of The Protective Order
Finally, Glaxo argues that the district court erred by finding that the Glaxo 1 court’s Protective Order was not violated. Specifically, Glаxo argues that Dr. Lazarow-ych, after gaining access to relevant, sensitive information as an expert witness in Glaxo 1, violated the Protective Order and *1572 its related affidavit by working with Novop-harm and by participating in the development of its process for making Form 1 RHC1. Glaxo argues that both Novopharm and Lazarowych should be found hable even if the information they used was publicly available because Lazarowych swore, without qualification, that she would “never use the information [in any document marked CONFIDENTIAL UNDER PROTECTIVE ORDER], directly or indirectly, in competition with [Glaxo].” Novopharm responds that neither it nor Lazarowych acted in contempt of the Protective Order or the related affidavit. Novopharm argues that the fact that the information was publicly available means that the use of that information is not an act of unfair competition. We agree with No-vopharm that neither it nor Lazarowych was in violation of the Protective Order or the related affidavit.
In reviewing the court’s dismissal of Glaxo’s unfair competition claim, which raises issues not within our exclusive jurisdiction, we are guided by the law of the regional circuit.
See Baldwin Hardware Corp. v. Franksu Enter. Corp.,
The court did not clearly err in determining that neither Novopharm nor Laza-rowych violated the Protective Order. At paragraph 14(a), the Protective Order clearly states that it does not restrict the dissemination of information in “documents that are used as exhibits in Court (unless such exhibits were filed under seal).” Glaxo does not contest the district court’s findings that “all of the purported ‘secrets’ are to be found in documents submitted as exhibits without seal,”
' Likewise, dissemination of the information did not contradict Lazarowych’s obligation under the affidavit. As Novopharm accurately points out, the affidavit merely summarized the obligations under the Protective Order without adding additional obligations. It served to notify each affiant of his or her obligations under the Protective Order and to memorialize those obligations. Thus, La-zarowych’s affidavit must be interpreted consistently with the Protective Order. Accordingly, neither the Protective Order nor the related affidavit encompasses the information allegedly usеd by Lazarowych; her alleged use of this information cannot form a valid basis for Glaxo’s unfair competition claim.
'The district court did not clearly err in finding that Novopharm did not violate the Protective Order or that Lazarowych did not violate any specific obligation under the Protective Order or the related affidavit. Because the unfair competition claim was based solely on Novopharm’s alleged violation of the Protective Order, the district court did not err in dismissing Glaxo’s unfair competition claim.
CONCLUSION
The district court correctly required Glaxo to prove by a preponderance of the evidence the likelihood that Novopharm would infringe the ’431 patent, i.e., that it would manufacture, use, оr sell an infringing composition when the ANDA is approved. The district court did not clearly err in finding that Glaxo failed to prove that Novopharm would infringe the ’431 patent by selling RHC1 pursuant to its ANDA. Based upon the same factual finding, the court did not abuse its discretion in dismissing Glaxo’s declaratory judgment action asserting infringement of the ’133 patent under § 271(g). Finally, the district court did not clearly err in finding *1573 that neither Novopharm nor its employees violated the Protective Order. Accordingly, the judgment of the district court is
AFFIRMED.
Notes
. The district court did not decide whether small amounts of Form 2 RHC1 in a mixture with Form 1 RHC1 would infringe the '431 patent. For that reason and also in view of our disposition of the infringement issue infra, whether small amounts of Form 2 RHC1 would infringe and, if so, what amount of Form 2 RHC1 would be required are not before us on this appeal.
. As Novopharm points out, access to actual samples and the extensive technical data required by the FDA generally removes much of the uncertainty from a court’s otherwise hypothetical inquiry. For example, pursuant to 21 *1570 U.S.C. § 355(j)(2)(vi) (1994) (incorporating the requirements of § 355(b)(l)(B)-(F)), the FDA may require an applicant for an ANDA to submit actual samples of the drug. Also, pursuant to 21 C.F.R. § 314.94 (1996), the ANDA must include information that shows the drug product is bioe-quivalent to an already-approved drug, see § 314.94(a)(7), and must describe in detail the composition, manufacture, and specification of the drug substance and drug product. See § 314.94(9)(i). In this case, Novopharm provided Glaxo with actual samples of its Form 1 RHC1 composition. Glaxo could have further informed the court’s infringement analysis by offering analyses of these samples at trial, but it chose not to do so.