MINNESOTA MINING AND MANUFACTURING COMPANY and Riker Laboratories, Inc., Plaintiffs-Appellants, and Alphapharm Pty. Ltd., Plaintiff-Appellant, v. BARR LABORATORIES, INC., Defendant-Appellee.
Nos. 01-1369, 01-1370.
United States Court of Appeals, Federal Circuit.
May 1, 2002.
289 F.3d 775
James K. Stronski, Frommer Lawrence & Haug LLP, of New York, NY, argued for plaintiff-appellant. With him on the brief was Edgar H. Haug. Of counsel on the brief was Bruce H. Little, Lindquist & Vennum, P.L.L.P., of Minneapolis, MN.
James F. Hurst, Winston & Strawn, of Chicago, IL, argued for defendant-appellee. With him on the brief were Christine J. Siwik and Christopher Shearer.
Before MICHEL, GAJARSA, and DYK, Circuit Judges.
DYK, Circuit Judge.
This case presents a question under the Hatch-Waxman Amendments to the Fed
I
The overall scheme of the Hatch-Waxman Amendments is described in detail in our decisions in Mylan and Andrx and need not be repeated here. The facts of this case are relatively simple considering the complexity of the statutory scheme.
3M is the assignee of U.S. Patent No. 4,642,384 (the “‘384 patent”). The ‘384 patent claims intermediate compounds that result from a process for producing a drug product containing the active ingredient flecainide acetate.1 As required by
Barr also sought to piggyback on the approval of 3M‘s NDA and filed an ANDA on May 22, 2000. Barr provided its paragraph IV certification that it did not infringe the ‘384 patent to 3M by letter dated July 12, 2000. As the second ANDA filer, Barr was not only potentially subject to the thirty-month stay under
If the [ANDA] application contains a [paragraph IV certification] and is for a drug for which a previous application has been submitted under this subsection continuing [sic] such a certification, the application shall be made effective not earlier than one hundred and eighty days after—
(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or
(II) the date of a decision of a court in an action described in [
21 U.S.C. § 355(j)(5)(B)(iii) ] holding the patent which is the subject of the certification to be invalid or not infringed, whichever is earlier.
(emphases added).
This provision is designed to provide an incentive, in the form of a 180-day period of marketing exclusivity, to an ANDA filer that is the first to challenge a patent listed in the Orange Book. The running of the 180-day period is triggered by “the Secretary[‘s] receiv[ing] notice from the [first ANDA applicant] of [its] first commercial marketing of the drug” or by “a decision of a court in an action described in [
Following Barr‘s initial notice to 3M of its paragraph IV certification, 3M sought additional information from Barr regarding its noninfringement position and on August 10, 2000, Barr elaborated, stating that “[a]s detailed in our letter dated July 12, 2000, Barr‘s proposed product does not
Unsatisfied by Barr‘s claim of noninfringement, 3M filed an infringement suit against Barr in the district of Minnesota on August 25, 2000. Alphapharm intervened because of its interest in delaying approval of Barr‘s ANDA application. Because 3M filed this suit within 45 days of receiving notice of Barr‘s paragraph IV certification, the thirty-month or litigation termination stay period under
In the course of discovery, information was disclosed by Barr that convinced 3M that Barr did not infringe the ‘384 patent. 3M sought to dismiss its suit without prejudice, because, it urged, a dismissal without prejudice would prevent the triggering of Alphapharm‘s 180-day period of exclusivity. In effect, 3M sought to prevent approval of Barr‘s ANDA until 180 days after Alphapharm began marketing its approved product. 3M urged that Barr had “hoodwinked” 3M into filing a suit by refusing to provide a more detailed statement as to why it did not infringe the ‘384 patent.
The district court declined to dismiss 3M‘s action without prejudice. The district court recognized that the decision whether to allow a party to voluntarily dismiss an action after filing, pursuant to Rule 41(a)(2), is generally within the discretion of the district court, and that under governing Eighth Circuit law factors to consider in exercising this discretion include: whether the party has presented a proper explanation for its desire to dismiss; whether a dismissal would result in a waste of judicial time and effort; whether a dismissal would prejudice the defendant; and whether the dismissal was designed to avoid an adverse judgment. Minn. Mining & Mfg. Co. v. Barr Labs., Inc., 139 F.Supp.2d 1109, 1115 (D.Minn.2001). The district court found no impropriety in Barr‘s declining to provide further information before 3M brought suit, finding specifically that “Barr‘s assurances [that it did not infringe the ‘384 patent], together with 3M‘s knowledge that other methods existed for producing flecainide acetate [that did not involve producing the claimed intermediate compounds], were sufficient to satisfy the notice requirements of the ANDA process.” Id. at 1115. The district court further found that 3M was merely attempting to avoid an adverse judgment in the district court proceeding and was therefore not entitled to a voluntary dismissal. Id. at 1116. Finally, the district court granted Barr‘s motion for summary judgment of noninfringement because 3M did not object to Barr‘s motion on the merits. Id. 3M and Alphapharm filed this timely appeal. We heard argument on March 7, 2002.
II
While we review the district court‘s decision not to allow 3M to voluntarily dismiss its action for abuse of discretion, L.E.A. Dynatech, Inc. v. Allina, 49 F.3d 1527, 1530 (Fed.Cir.1995), the issue here is primarily a legal one—whether the district court was required to dismiss without prejudice or whether it grounded its dismissal on an erroneous proposition of law—namely Barr‘s compliance with the requirement of
III
A predicate to appellants’ arguments is that a dismissal with prejudice would trigger the running of the 180-day period. The District of Columbia Circuit has explicitly held that
IV
3M argues that the district court lacked subject matter jurisdiction and therefore should have dismissed the action without prejudice because, after filing the infringement action, 3M agreed that no infringement had occurred. The suggestion that the district court originally lacked subject matter jurisdiction is unfounded and incorrect. There was a clear controversy between 3M and Barr as to whether the ‘384 patent was infringed. The mere fact that 3M may have been operating under a misapprehension of the facts cannot affect the original subject matter jurisdiction of the district court.
However, if this case did not involve the Hatch-Waxman Amendments, appellants might well be correct that a case or controversy ceased to exist in the course of the litigation when 3M represented that it no longer claimed infringement by Barr. See Fina Research, S.A. v. Baroid Ltd., 141 F.3d 1479, 1483-84 (Fed.Cir.1998). But the case does involve the Hatch-Waxman Amendments, and the parties strenuously disagree about whether the action should be dismissed with or without prejudice. 3M urges that the form of dismissal could have significant consequences in the FDA proceedings. Whether or not 3M is correct that the form of dismissal will have consequences in the FDA proceedings, these differences are more than sufficient to create subject matter jurisdiction as the Supreme Court has made clear in ASARCO, Inc. v. Kadish, 490 U.S. 605 (1989). There the Court found that the original controversy between the parties in a state court action did not satisfy the requirements for federal jurisdiction (because the plaintiffs’ interest did not confer standing), but the ensuing controversy over the propriety of the relief awarded was sufficient for federal subject matter jurisdiction. Id. at 618. So here, the underlying patent controversy under Fina may not have been sufficient for continuing federal jurisdiction, but the controversy over the form of dismissal was itself sufficient under ASARCO. See also City of Erie v. Pap‘s A.M., 529 U.S. 277, 288 (2000) (a court‘s interest in preventing litigants from attempting to manipulate the court‘s jurisdiction to achieve a favorable decision counsels against a finding of mootness); Richard H.
V
Appellants urge that the district court was obligated to use its inherent power to sanction misconduct by Barr by dismissing the action without prejudice. Initially in their briefs to this court appellants complained that Barr had “hoodwinked” 3M into filing suit, and had violated a duty under the Federal Rules of Civil Procedure to disclose facts to 3M that would have resulted in a decision to forgo suit. Appellants argued, as well, that Barr could not properly cause the initiation of baseless litigation by 3M to secure an advantage under the Hatch-Waxman Amendments. We are aware of no such pre-filing disclosure obligation. Nor did Barr have any obligation to avoid triggering litigation that would advantage Barr by starting the 180-day exclusivity period.3 At oral argument 3M wisely receded from these arguments, urging only that Barr had violated its duty under the Hatch-Waxman Amendments to file a compliant notice of its noninfringement position that would enable 3M to make an informed judgment as to whether to bring suit. As noted above, the district court rejected this argument, holding that Barr‘s notice was compliant.
3M‘s claim concerning compliance with the paragraph IV certification requirement is not insubstantial. The statute requires that:
(i) An applicant who makes a certification described in subparagraph (A)(vii)(IV) shall include in the application a statement that the applicant will give the notice required by clause (ii) to—
(I) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and
(II) the holder of the approved application under subsection (b) of this section for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice.
(ii) The notice referred to in clause (i) shall state that an application, which contains data from bioavailability or bioequivalence studies, has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant‘s opinion that the patent is not valid or will not be infringed.
In Barr‘s initial July 12, 2000, notification to 3M, it stated that its proposed drug product would not infringe any claim of the ‘384 patent because “the active ingredient [in the proposed product] is . . . not the
The appellants argue that this notice was legally deficient under the statute because Barr‘s statement that its “proposed product does not contain any of the compounds claimed in the ‘384 patent” was at best ambiguous. Appellants urge that Barr, by referring to its statements in the July 12, 2000, letter, indicated that its noninfringement position had not changed, and that Barr still based its opinion of noninfringement on a comparison between the active ingredient in its proposed product and the claimed compounds, rather than on a comparison between any compounds in the proposed product and the compounds claimed in the ‘384 patent.
However, we hold that we need not, indeed cannot, decide this question of compliance with the paragraph IV certification requirements. Under the Hatch-Waxman Amendments we cannot enforce the requirements of paragraph IV certifications in an infringement suit.
In our decision in Mylan we confronted a claim that a particular patent listing in
On appeal, the appellee-ANDA applicant (the declaratory judgment plaintiff) urged that its action was proper because it arose under the patent laws (
We reaffirmed this holding in Andrx. In Andrx, in an infringement action between a patentee and an ANDA filer, the district court shortened the thirty-month stay period, citing
We conclude that this case is governed by Mylan and Andrx. Like Mylan, 3M here attempts to assert a private right of action under the FFDCA because of another party‘s alleged failure to comply with the statute. As we held in Mylan,
We see nothing in the Hatch-Waxman Amendments to alter the statement in section 337(a) of the FFDCA that “all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”
21 U.S.C § 337(a) (1994). “In a case in which neither the statute nor the legislative history reveals a congressional intent to create a private right of action for the benefit of the plaintiff,” the inquiry is at an end. Northwest Airlines, Inc. v. Transp. Workers, 451 U.S. 77, 94 n. 31 (1981).
Mylan at 1332. Accordingly, we hold that appellants cannot seek a judicial determination of whether a private party‘s paragraph IV certification complies with
VI
We also hold that the district court did not abuse its discretion in ordering a dismissal with prejudice. Under Federal Rule of Civil Procedure 41(a)(2), once an answer or a motion for summary judgment has been filed, an action may be dismissed at the plaintiff‘s request only upon order of the court and upon such terms and conditions as the court deems proper. Here, because the district court‘s dismissal with prejudice was not contrary to law, we review that decision for an abuse of discretion, applying the law of the Eighth Circuit. Hamm v. Rhone-Poulenc Rorer Pharms., Inc., 187 F.3d 941, 948 (8th Cir.1999). The district court here considered appellant‘s claimed entitlement to a dismissal without prejudice under Rule 41(a)(2), but found no legitimate justification for the appellants to dismiss the action without prejudice. The district court concluded that the appellants were seeking to avoid a judgment that would be adverse to their interest in delaying Barr‘s entrance in the market and that this was not a legitimate justification for their desire to dismiss without prejudice. Minn. Mining, 139 F.Supp.2d at 1116.
VII
Finally, in affirming the judgment of the district court, we think it appropriate to make clear what we are not deciding. First, we do not decide whether parties such as 3M and Alphapharm have standing to complain to the FDA, and to maintain a suit under the APA, concerning Barr‘s satisfaction of the paragraph IV certification requirement, nor do we decide when and whether the FDA must address such claims.5 Second, we do not decide whether, if the FDA had determined that Barr did not satisfy the paragraph IV notice requirement, this would have entitled 3M to a dismissal without prejudice in the infringement suit. Third, we do not decide whether a dismissal without prejudice would avoid triggering the running of the first ANDA filer‘s 180-day exclusivity period. Finally, we do not decide Barr‘s alternative claim that a dismissal without prejudice would not have mooted Barr‘s counterclaims, which Barr agreed to dismiss in this case because the district court granted Barr‘s motion for summary judgment of noninfringement. Resolution of these questions must await another day. We hold only in this case that the district court properly dismissed 3M‘s infringement action with prejudice and granted Barr‘s motion for summary judgment of noninfringement because we cannot decide whether Barr complied with the statutory and regulatory requirements for providing notice of a paragraph IV certification, and the district court did not otherwise abuse its discretion.
CONCLUSION
For the foregoing reasons, we affirm.
COSTS
No costs.
GAJARSA, Circuit Judge, concurring in judgment.
I agree with the majority that the judgment of the district court should be affirmed; however, I disagree with their attempt to impose an administrative requirement by an expansive interpretation5
On the one hand, the majority affirms the lower court because it did not abuse its discretion in dismissing the action with prejudice after determining that the notice sent to 3M by Barr was in compliance with
The majority opinion fails to recognize the requirements of the specific policies expressed by the Congress when it enacted the Abbreviated New Drug Application (“ANDA”) statutory scheme,
I. The Definition of “Court Decision”
The relevant statutory provision
II. The Availability of a “Court Decision”
The Congressional policy with respect to generic drugs is clear: generic manufacturing of a drug should be allowed as soon as it is determined that it does not violate patent rights. Given this policy, the statute‘s provisions on the exclusivity period should not be read to reach nonsensical results. It should not be the case that a second ANDA filer whose method may infringe a patent can bring a suit that can trigger the exclusivity period, while a second ANDA filer whose method clearly does not infringe a patent cannot. In an effort to avoid this potential problem that has not yet been addressed by this court, Barr Labs, in this case, availed itself of the opportunities provided by the statutory scheme, by giving notice (albeit ambiguous) and inducing 3M to bring an action against them. The majority today, instead of addressing the correct interpretation of the statutory scheme and quelling the need for anyone to exploit the system, places another hurdle before the ANDA filers who clearly do not infringe: they must now survive administrative challenge to their paragraph IV certification notice before they can obtain a favorable judgment. There is no doubt that this process will increase the time period required to resolve these time-sensitive cases because district court infringement suits will need to be stayed pending administrative proceedings or may not be brought if the NDA patentee avails himself of the APA procedures proposed by the majority.
III. The Creation of an Unnecessary Administrative Quagmire
Today the majority extends the requirement of Mylan Pharmaceuticals, Inc. v. Thompson and Andrx Pharmaceuticals, Inc. v. Biovail Corp. beyond the necessary demands of the statute. Mylan, 268 F.3d 1323 (Fed.Cir.2001); Andrx, 276 F.3d 1368 (Fed.Cir.2002). In both of those cases the issue was whether or not the FDA had taken proper action in listing patents in the Orange Book. In Mylan, the ANDA applicant sued the FDA and the New Drug Application (“NDA”) holder alleging that the pertinent patent had been improperly listed in the Orange Book. Mylan, 268 F.3d at 1328. This court held that there was no private cause of action for de-listing a patent. Id. at 1332. In Andrx, the ANDA applicant had complained before the district court that the FDA and the NDA patentee had improperly listed a patent in the Orange Book in violation of the APA and that they improperly stayed approval of Andrx‘s ANDA based on the patentee‘s filing of a new patent, which the FDA said triggered a new 30-month stay period. Andrx, 276 F.3d at 1373-74.
Moreover, the proposed shift of the burden to the FDA is not required. The majority now metamorphosizes into an APA action the sufficiency of the statutory notice requirement, failing to perceive that under subparagraph 355(j)(2)(B)(i) an applicant who makes a paragraph IV certification “shall include in the application a statement that the applicant will give notice required by clause (ii) to—
(i) each owner of the patent . . . and
(ii) the holder of the approved [NDA] application....”
The statute does not require the notice to be filed with the FDA, the body now given the task of adjudicating its sufficiency. Moreover, the FDA regulations, which are in compliance with the statute, state that “[a] copy of the notice itself need not be submitted to the agency.”
Indeed the FDA has stated that the sufficiency of the notice is an issue to be resolved by the applicant and the patent owner without involvement of the FDA. The FDA published responses to comments about the proposed notice rules in the Federal Register. With respect to
18. FDA received three comments on proposed § 314.52(c) regarding the content of a notice of certification of invalidity or noninfringement of a patent.... In general, the statute requires a notice of certification of invalidity or noninfringement of a patent to state that an application has been submitted and to include “a detailed statement of the factual and legal basis of the applicant‘s opinion that the patent is not valid or will not be infringed.” (See section 505(b)(3)(B) and 355(j)(2)(B)(ii).) The proposed rule listed the type of information FDA considered necessary to enable patent owners to decide whether to sue for patent infringement. The list at proposed §§ 314.52(c) and 314.95(c) generated substantial debate, as reflected in the comments, as to the details to be
included in a notice. The agency is neither prepared nor required to become involved in issues concerning sufficiency of notice for purposes of enforcing patent law. Therefore, FDA has revised both §§ 314.52(c) and 314.95(c) so that the detailed statement of the factual and legal basis behind the applicant‘s opinion that the patent is invalid, unenforceable, or will not be infringed must include: (1) For each claim of the patent alleged not to be infringed, a full and detailed explanation why the claim is not infringed; and (2) for each claim of a patent alleged to be invalid or unenforceable, a full and detailed explanation of the grounds supporting the allegation. These provisions, as revised, paraphrase the statutory language. The sufficiency of the notice, for purposes of patent enforcement, is an issue to be resolved by the applicant and the patent owner or the holder of the approved application.
Abbreviated New Drug Application Regulations; Patent Exclusivity Provisions, 59 Fed.Reg. 50338, 50342 (October 3, 1994) (emphasis added).
With respect to § 314.95, which relates to ANDAs, the FDA stated:
54. One comment recommended that FDA revise the regulation by adding a mechanism whereby FDA or the United States Patent and Trademark Office would review notices of certification of invalidity or noninfringement. The comment would have FDA suspend the 45-day period provided by section 505(j)(4)(B)(iii) of the act until FDA or the United States Patent and Trademark Office determined that the notice was sufficient.
FDA declines to adopt the comment. As stated elsewhere in this preamble, FDA lacks expertise in patent law. Moreover, neither FDA nor the United States Patent and Trademark Office currently has access to the additional resources that would be necessary to review these notices, and a patent certification review system would subject the agency‘s decisions to questioning that would require further resource expenditures and create delays in the statutory patent certification and challenge process.
The agency does note, however, that in cases where the notice was deemed inadequate by the patent owner or exclusive patent licensee and where the ANDA applicant subsequently amends the notice, the agency may, if the applicant amends its ANDA with a written statement that the date of receipt of the amended notification should be considered the date of receipt of notice, use the date of the amended notification to begin the 45-day statutory period for institution of an action for patent infringement (see 54 FR 28872 at 28888; see also § 314.95(f)).
60. FDA received five comments regarding the exact contents of a notice of certification of invalidity or noninfringement of a patent....
As noted above in comment 18, the agency did not anticipate that the list in proposed § 314.95(c) would generate the debate reflected in the comments and, again, reiterates that the agency does not have the expertise or the desire to become involved in issues concerning patent law and sufficiency of notice. Therefore, FDA has revised § 314.95 to require that the detailed statement of the factual and legal basis behind the applicant‘s opinion that the patent is invalid, unenforceable, or will not be infringed include the following: (1) For each claim of a patent alleged not to be infringed, a full and detailed explanation why the claim is not infringed; and (2)
for each claim of a patent alleged to be invalid or unenforceable, a full and detailed explanation of the grounds supporting the allegation (see §§ 314.52(c)(6)(i) and (c)(6)(ii) and 314.95(c)(6)(i) and (c)(6)(ii)). Disputes involving the sufficiency of the notice must be resolved by the applicant, patent owner, and holder of the approved application rather than by action on the part of FDA. 61. FDA also received five comments opposing the use of a referee or designated intermediary under proposed § 314.95(c)(6)(iii). The proposal would have required an ANDA applicant to describe a mechanism for disclosing the formulation or composition of the proposed drug product to the patent owner or to a “designated intermediary who will act as a referee” on the subject of patent invalidity or noninfringement. The comments said that the concept was legally unauthorized and interfered with the traditional judicial process for resolving patent disputes.
FDA agrees that traditional processes for resolving patent disputes, which do not involve the agency‘s regulations, are appropriate under these circumstances. Therefore, the agency has deleted the provision in its entirety.
Id. at 50349-50 (emphasis added).
Thus, there is no doubt that FDA has no intention of entering into disputes over the sufficiency of the notice, and indeed is unqualified to do so. The statute is silent on the question of who determines the sufficiency of notice. Given such a statutory ambiguity, this court must defer to the agency‘s reasonable interpretation of the statute. Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 843-44 (1984). The FDA has reasonably interpreted the statute to mean that the FDA should not review the sufficiency of the notice. This court must defer to that interpretation.
IV. The Declaratory Judgment as the “Court Decision”
The majority‘s addition of new administrative obstacles certainly deters Barr-like behavior, but it does so by creating a disincentive to challenging drug patents. Yet the problem with Barr‘s type of “hoodwinking” is not that we do not want companies to challenge drug patents. The problem is that there is no sense in making second ANDA filers go through this labyrinth to trigger the exclusivity period that they have every right to trigger. Congress wanted second ANDA filers to be able to manufacture their drugs quickly if they could prove noninfringement. In a case where proving noninfringement is effortless, it should be a simple process.
Appellants argue that it would be frivolous for someone in Barr‘s position to seek a declaratory judgment of noninfringement. Therefore, appellants assert, Barr would have no standing to bring a declaratory judgment action.2 This misses the logic of the statute. Because Congress has mandated a court decision in order to trigger the exclusivity period, it is incumbent upon second ANDA filers who clearly do not infringe to obtain a court decision. This is in accordance with the congressional purpose. They can do this in one of two ways: by being sued for infringement or by seeking a declaratory judgment.
Congress contemplated the availability of a declaratory judgment action in this context. Subsection (j)(5)(B)(iii) states:
(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that—
(I) if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision,
(II) if before the expiration of such period the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under
section 271(e)(4)(A) of Title 35 , or(III) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision.
In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under
section 2201 of Title 28 , for a declaratory judgment with respect to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.
This court has repeatedly articulated the requirements for a declaratory judgment action in patent suits.
In declaratory judgment patent suits, there are two prerequisites for establishing the existence of a case or actual controversy between the parties: first, the defendant must have engaged in conduct giving rise to a reasonable apprehension on the plaintiff‘s part that it will face an infringement suit or the threat of one if it commences or continues the activity in question; second, the plaintiff must have actually produced the accused device or have actually prepared to produce it. Cordis Corp. v. Medtronic, Inc., 835 F.2d 859, 862 (Fed.Cir.1987) (citing, inter alia, Jervis B. Webb Co. v. Southern Sys., Inc., 742 F.2d 1388, 1398-99 (Fed.Cir.1984)); see also Sandt Tech., Ltd. v. Resco Metal and Plastics Corp., 264 F.3d 1344, 1356 n. 4 (Fed.Cir.2001). The second prong of the test has been characterized as requiring “present activity which could constitute infringement or concrete steps taken with the intent to conduct such activity.” BP Chems. Ltd. v. Union Carbide Corp., 4 F.3d 975, 978 (Fed.Cir.1993).
The applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.
Prong two is also met by statutory terms under
Therefore, the logical conclusion, which also solves the dilemma in this case, is to make it clear that a declaratory judgment suit is available for ANDA filers who are not sued by the NDA patentee within the 45-day period. The two acts of (1) a patentee listing a patent in the Orange Book through the filing of a NDA, and (2) a generic manufacturer filing an ANDA, together meet the case or controversy requirement so as to allow a declaratory judgment action of noninfringement.
It is noteworthy that the District of Columbia Circuit, which also handles a large number of ANDA cases, has suggested an alternative method of explaining the availability of declaratory judgment actions in this context. In Mova Pharmaceutical Corp. v. Shalala, the court stated,
[T]he Federal Circuit has had no occasion to decide whether there is “a controversy of sufficient immediacy and reality” to support a declaratory judgment action, . . . when the plaintiff requires a judgment under section 355(j)(5)(B) in order to bring its product to market. It is possible that such a statutorily-created bottleneck, coupled with the statute‘s express reference to declaratory judgment actions as a means of relieving that bottleneck, might suffice to allow a plaintiff to show the existence of a “case or controversy” without demonstrating an immediate risk of being sued.
140 F.3d 1060, 1073 n. 18 (D.C.Cir.1998) (citations omitted). Therefore, the inability to market a product without a court decision may create sufficient case or controversy for purposes of a declaratory judgment action. Certainly, in cases such as this, there is a controversy over whether a triggering decision is permissible, and the parties have much at stake in that determination.
Whether the basis for a case or controversy for declaratory judgment purposes is
V. The Majority‘s Loose Ends
In addition, Part VII of the majority opinion continues its illogical pursuit by positing numerous issues that it does not decide, including the standing of parties to bring an APA administrative proceeding before the FDA. If we do not decide them, then all of these observations and conclusions are advisory and dicta. It is unnecessary to delineate them in order to decide this appeal.
Because I find the majority‘s holding to be inconsistent with the goals established by Congress and inconsistent with the internal logic of the statute, I concur in judgment only.
Notes
(iv) If the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this subsection continuing such a certification, the application shall be made effective not earlier than one hundred and eighty days after—
(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or
(II) the date of a decision of a court in an action described in clause (iii) holding the patent which is the subject of the certification to be invalid or not infringed, whichever is earlier.