Court Opinion

ID: 9495953
Source: CourtListenerOpinion
Date Created: 2023-08-05 16:14:06.370756+00
Date Added: 2024-06-11T17:57:17.039258
License: Public Domain

SCHALL, Circuit Judge,
concurring in the judgment, with whom Circuit Judge CLEVENGER joins.
Because this case is controlled by Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 65 USPQ2d 1481 (Fed.Cir.2003), we must affirm the district court’s grant of summary judgment in favor of Alcon and B & L, and I therefore join in the judgment of the court in this case. However, I write separately to express my respectful disagreement with the decision of the court in Warner-Lambert.1 In my view, contrary to the conclusion reached in Warner-Lambert, a claim of induced infringement like the one asserted by Allergan against Alcon and B & L is cognizable under 35 U.S.C. § 271(e)(2). I say this for the following reasons:
A. §5 U.S.C. § 271(e)(2)
Statutory interpretation necessarily begins with the text of the statute. Hughes Aircraft Co. v. Jacobson, 525 U.S. 432, 438, 119 S.Ct. 755, 142 L.Ed.2d 881 (1999) (“As in any case of statutory construction, our analysis begins with the language of the *1335statute.”) (quotations omitted). Our task is to determine whether the statutory language “has a plain and unambiguous meaning with regard to the particular dispute in the case. Our inquiry must cease if the statutory language is unambiguous and ‘the statutory scheme is coherent and consistent.’ ” Robinson v. Shell Oil Co., 519 U.S. 337, 340, 117 S.Ct. 843, 136 L.Ed.2d 808 (1997) (quoting United States v. Ron Pair Enters., Inc., 489 U.S. 235, 240, 109 S.Ct. 1026, 103 L.Ed.2d 290 (1989)). I believe the language of 35 U.S.C. § 271(e)(2) is “plain and unambiguous.” The statute provides in relevant part as follows:
(2) It shall be an act of infringement to submit—
(A) an [ANDA] for a drug claimed in a patent or the use of which is claimed in a patent ...
if the purpose of such submission is to obtain approval under [the FDCA] 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 ubefore the expiration of such patent.
35 U.S.C. § 271(e)(2) (emphasis added).
In interpreting a statute, we presume that Congress intended to give words their ordinary meanings. Asgrow Seed Co. v. Winterboer, 513 U.S. 179, 187, 115 S.Ct. 788, 130 L.Ed.2d 682, 33 USPQ2d 1430, 1433 (1995). In section 271(e)(2), Congress chose to employ the clause “the use of which is claimed in a patent” in two places. In both places, the words “of which” refer to the word “drug.” Thus, Congress did not tie “the use” to the uses stated in the ANDA. Rather, Congress tied “the use” to the uses claimed in the patent. In short, the plain language of section 271(e)(2) compels the conclusion that an action for infringement may lie based upon the filing of an ANDA for a drug whose use is patented, even if approval for the patented use is not sought in the ANDA. 35 U.S.C. § 271(e)(2). Alcon’s and B & L’s conduct brings them squarely within the language of section 271(e)(2). That is because each has filed an ANDA seeking approval for the commercial sale of a drug (brimonidine) whose use is claimed in two patents that have not yet expired, the '415 patent and the '741 patent.
Alcon argues that an action for infringement of a method of use patent may only be brought under 35 U.S.C. § 271(e)(2) in the case of a “controlling use patent.”2 Congress was fully aware of the concept of controlling use. See H.R.Rep. No. 98-857, pt. 1, at 22, reprinted in 1984 U.S.C.C.A.N. 2647, 2655. Yet, Congress declined to employ that concept when it wrote section 271(e)(2). Chicago v. Envtl. Def. Fund, 511 U.S. 328, 337, 114 S.Ct. 1588, 128 L.Ed.2d 302 (1994) (“But it is the statute, and not the Committee Report, which is the authoritative expression of the law, and the statute prominently omits reference to generation.”) (emphasis in original).
In order to prevail on a claim of infringement under section 271(e)(2), a patent holder must establish that “if the drug were approved based upon the ANDA, the manufacture, use, or sale of that drug would infringe the patent in the conventional sense.” Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569, 42 USPQ2d 1257, 1263 (Fed.Cir.1997). That is because section 271(e)(2) “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 patent.” Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130, 1135, 36 USPQ2d 1641, 1642-43 (Fed. Cir.1995). *1336Consequently, it has been said that when an ANDA filer makes a Paragraph IV certification under 21 U.S.C. § 355(j)(2)(A)(vii), the patent holder can establish infringement if it shows that the certification “is in error as to whether commercial manufacture, use, or sale of the new drug (none of which has actually occurred) violates 'the relevant patent.” Eli Lilly Co. v. Medtronic, Inc., 496 U.S. 661, 678, 110 S.Ct. 2683, 110 L.Ed.2d 605, 15 USPQ2d 1121, 1130 (1990). Thus, in order to prevail on a claim of induced infringement under section 271(e)(2), a patent holder must establish the traditional elements of a claim of induced infringement. In other words, the patentee must show that, if the ANDA is approved, the accused infringer will induce a third party to directly infringe the asserted patent and that the accused infringer knows or should know that his actions will induce infringement. See Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 553, 16 USPQ2d 1587, 1594 (Fed.Cir.1990).
Absent Warner-Lambert, I would hold that Allergan’s claims of induced infringement against Alcon and B & L are cognizable under 35 U.S.C. § 271(e)(2). In that regard, I note what I believe to be the difference between (1) an infringement action involving a method of use patent that claims a use that is the subject of an ANDA and (2) an infringement action involving a patent that claims a use that is not the subject of an ANDA. The only difference between the two types of actions is the degree of proof required. In each case, in order to establish infringement under section 271(e)(2), a patent holder must prove that, upon approval of the ANDA, the ANDA filer will actively induce a third party to directly infringe the asserted patent.3 Id. In the first case, the ANDA filer included a request to use the patented method of use in the ANDA itself. The request in the ANDA is highly probative evidence of likely induced infringement. The ANDA request, however, is just that, evidence. In the second case, a patent holder is not precluded from producing other evidence that also shows induced infringement. As we stated in Glaxo, “[t]he plain language of the statute does not ... mandate an infringement analysis limited to the scope of the approval sought.” Glaxo, 110 F.3d at 1567, 42 USPQ2d at 1262.
Under my reading of the statute, Aller-gan has stated a cause of action for induced infringement under section 271(e)(2) and would have been able to use evidence outside the ANDA itself to show infringement of its patents. It alleges that the '415 and '741 patents will be infringed by doctors who will prescribe Alcon’s and B & L’s generic brimonidine products for neu-roprotection. It also alleges that, with knowledge of the '415 and '741 patents, Alcon and B & L have taken steps to promote brimonidine for neuroprotection. In short, Allergan has asserted a viable claim of induced infringement under 35 U.S.C. § 271(b). The same cannot be said of Warner-Lambert’s claim. Even under my reading of the statute, Warner-Lambert’s case would have been dismissed and the FDA permitted to approve applicant Apotex’s ANDA. Warner-Lambert was not able to present evidence tending to show that Apotex had encouraged, or would encourage, doctors to infringe Warner-Lambert’s neurodegenerative method patent.4
*1337In my view, Allergan’s case is one in which section 271(e)(2) would benefit both the ANDA applicant and the patentee. The ANDA applicant would benefit by challenging the scope of a patentee’s rights before the patent expires and before the applicant has invested in production and manufacturing facilities in rebanee on its approved ANDA. The patentee, in turn, would profit by enforcing its patent rights before a generic drug manufacturer has moved into the market as a competitor. This balance is what Congress intended when it created the artificial act of infringement under section 271(e)(2).5 In the absence of the section 271(e)(2) mechanism, the owner of a method of use patent claiming an off-label use will bring a section 271(b) induced infringement action, after the ANDA has been approved by the FDA, to enjoin infringement of its patent.
Alcon and B & L point to the fact that an ANDA may not seek approval from the FDA for an unapproved use of a drug.6 Based upon that fact, they argue that they are precluded by threat of civil and criminal penalties from applying to the FDA to market their generic versions of brimoni-dine for an unapproved use, such as neuro-protection. I am not persuaded by this argument. The fact that an ANDA may not seek approval from the FDA for an unapproved use of a drug does not mean that section 271(e)(2) fails to create an act of infringement with respect to a patent that claims that unapproved use. It merely suggests that a responsible drug manufacturer will be deterred from marketing a drug for an unapproved use in violation of the law. The threat of a patent infringement suit would further deter a generic drug manufacturer from marketing a generic drug for an off-label patented use and would provide a patentee an enforcement mechanism in the event a generic drug manufacturer violates the law. As I have explained, I believe that section 271(e)(2), by its terms, gives a method of use patent owner the right to bring an action for induced infringement based upon a generic drug manufacturer’s fihng of an ANDA even if the ANDA does not refer to the use claimed in the patent.
B. 21 U.S.C. § 355(b)(1), 21 U.S.C. § 355(j)(2)(A), and 35 U.S.C. § m(e)(4)
Alcon and B & L point to (i) 21 U.S.C. § 355(b)(1) (the “Patent Listing Provision”); (ii) 21 U.S.C. § 355(j)(2)(A) (the “Patent Certification Provision”); and (in) 35 U.S.C. § 271(e)(4) (the “Remedy Provision”). They argue that a correct reading of these statutes undermines the proposition that a method of use patent holder may bring an action under 35 U.S.C. § 271(e)(2) for induced infringement when the patent at issue claims a use for a drug not approved by the FDA and the claimed use is not the use of the drug for which the *1338ANDA filer seeks FDA approval. See Kokoszka v. Belford, 417 U.S. 642, 650, 94 S.Ct. 2431, 41 L.Ed.2d 374 (1974) (“When ‘interpreting a statute, the court will not look merely to a particular clause in which general words may be used, but will take in connection with it the whole statute ... and the objects and policy of the law ... and give to it such a construction as will carry into execution the will of the Legislature (quoting Brown v. Duchesne, 19 How. 183, 194, 15 L.Ed. 595 (1857)). I address these contentions in turn.
(i) The Patent Listing Provision, 21 U.S.C. § 355(b)(1)
The Patent Listing Provision provides in pertinent part as follows:
The applicant shall file with the [NDA] the patent number and 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.
21 U.S.C. § 355(b)(1) (emphasis added).7 Alcon and B & L assert that, as far as method of use patents are concerned, a NDA applicant may only file the patent number and expiration date (“patent information”) for patents that claim uses that are stated in the NDA. They also argue that a successful NDA applicant must seek to have removed from the Orange Book any patent that does not claim a use for which the NDA is approved.8 Accordingly, Alcon and B & L contend that Allergan, as the NDA holder for brimonidine, improperly obtained the fisting of its method of use patents in the Orange Book because the neuroprotective function of brimoni-dine is not an indication for brimonidine that has been approved by the FDA. Aller-gan responds that the Patent Listing Provision does not limit the method of use patents that should be fisted in the Orange Book to only those method of use patents that cover uses approved through the NDA process.
In my view, Allergan’s reading of the statute is true to its words. First, Congress chose to include the word “any” before “patent.” Congress thus required that “any patent ... which claims a method of using such drug ...” must be fisted. 21 U.S.C. § 355(b)(1) (emphasis added). Second, in the part of the statute that states “[t]he applicant shall file with the [NDA] the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application,” the word “drug” is followed by the words “for which the applicant submitted the application.” Id. However, the “or which claims a method of using” language of the statute, which immediately follows, contains no limitation that the method of using the drug be contained in the NDA. I believe the meaning of the statutory language is plain and unambiguous. A pharmaceutical manufacturer, such as Allergan, who holds an approved NDA for a drug is required to provide patent information for fisting in the Orange Book for any patent which claims a method of using the approved drug that is issued after the NDA is approved.
*1339It is a concept of general patent law under 35 U.S.C. § 271(b) that the owner of a method of use patent may assert a claim of induced infringement if a third party, not licensed by the owner of the patent, engages in the patented use due to the active inducement of a product manufacturer. Chiuminatta Concrete Concepts, Inc. v. Cardinal Indus., 145 F.3d 1303, 1311, 46 USPQ2d 1752, 1759 (advertisements to customers encouraging infringing use were sufficient to support claim of induced infringement). This concept supports the general purpose of the Patent Listing Provision, which is to give notice to a potential infringer (direct or induced) of patents upon which the patentee could reasonably bring a suit. Moreover, in Eli Lilly, the Supreme Court described the Patent Listing Provision requirement as follows: “Pioneer drug applicants are required to file with the FDA the number and expiration date of any patent which claims ... a method of using such drug.” Eli Lilly, 496 U.S. at 677, 110 S.Ct. 2683, 15 USPQ2d at 1129 (emphasis added). The Court described the statute in terms that did not limit its application to only those patented methods of using the drug that are approved by the FDA. Id.
Alcon also points to the FDA regulation that implements the Patent Listing Provision, 21 C.F.R. § 314.53(b).9 Specifically, Alcon relies on the part of the regulation that states: “For patents that claim a method of use, the applicant shall submit information only on those patents that claim indications or other conditions of use of a pending or approved application.” 21 C.F.R. § 314.53(b) (emphasis added). Alcon argues that this means that only method of use patents claiming uses that have been approved by the FDA may be submitted for listing in the Orange Book. Allergan, on the other hand, reads section 314.53(b) as requiring the listing of patents, such as the '415 patent and the '741 patent, that claim “other conditions of use,” such as a neuroprotective use for brimonidine, for a drug that is the subject of a NDA or an approved NDA. In short, Allergan urges that section 314.53(b) does not limit the broad language of 21 U.S.C. § 355(b)(1). I agree.
I note at the outset that Alcon’s reading of the regulation is inconsistent with the clear language of 21 U.S.C. § 355(b)(1), which I have just examined. See Whitman v. Am. Trucking Ass’ns, Inc., 531 U.S. 457, 484, 121 S.Ct. 903, 149 L.Ed.2d 1 (2001) (rejecting an agency’s interpretation of a statutory requirement because the interpretation was at odds with the “structure and manifest purpose” of the statute). A court is properly reluctant to embrace a reading of a regulation that makes the regulation conflict with the statute that it is meant to implement. See Gomez v. Dept. of Air Force, 869 F.2d 852, 858 (5th Cir.1989) (“[W]e are compelled to interpret the regulation in accordance with Title VII because it is the governing statute.”).
As I read section 314.53(b), Allergan was required to provide information for the Orange Book for any method of use patents it held that claimed “indications or other conditions of use of a pending or approved application.” The '415 and '741 patents were covered by the language of the regulation because they claimed “other conditions of use” (the use of brimonidine for neuroprotection) of a “pending or approved application” (Allergan’s approved NDA application for brimonidine).10 In short, I see nothing in the Patent Listing *1340Provision that supports the argument that Allergan is barred from asserting its claim of induced infringement against Alcon and B & L.11
(ii) The Patent Certification Provision, 21 U.S.C. § 355(j)(2)(A)
The Patent Certification Provision provides in pertinent part as follows:
An [ANDA] shall contain—
(i) information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a drug listed under paragraph (7) (hereinafter in this subsection referred to as a “listed drug”);
(vii) a certification ... with respect to each patent which claims the listed drug ... or which claims a use for such listed drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b) or (c) of this section—
(I) that such patent information has not been filed,
(II) that such patent has expired,
(III) of the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and
(viii) if with respect to the listed drug referred to in clause (i) information was filed under [the Patent Listing Provision] for a method of use patent which does not claim a use for which the appli*1341cant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use.
21 U.S.C. § 355(j)(2)(A) (emphasis added).
Alcon and B & L contend that the words “for which the applicant is seeking approval under this subsection” in clause (vii) refer to the term “use,” not “listed drug.” Therefore, they argue, an ANDA filer is not required to make a Paragraph IV certification with respect to a method of use patent that does not claim a use for which the ANDA filer is seeking FDA approval. Alcon and B & L reason that this demonstrates that section 271(e)(2) was not meant to support a claim of induced infringement such as the one advanced by Allergan. Allergan argues the contrary, stating that the phrase at issue modifies “listed drug,” not “use.”
As a matter of statutory interpretation, I believe Allergan is correct. There are two parallel “for which” clauses in the Patent Certification Provision: “for which the applicant is seeking approval under this subsection” and “for which information is required to be filed under subsection (b) or (c) of this section.” The references in the second clause to “subsections (b) and (c) of this section” are to 21 U.S.C. § 355(b) and 21 U.S.C. § 355(c), respectively. As already discussed, these subsections require the NDA filer or the holder of an approved NDA to submit for listing in the Orange Book specified information with respect to the drug, including “any patent which claims ... a method of using [the drug covered by the NDA] 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.” 21 U.S.C. §§ 355(b)(1) and 355(c)(2). The second clause, therefore, must modify “listed drug.” Since the first “for which” clause is parallel to the second, it must also modify “listed drug.” Moreover, the first clause is subject to the restriction “under this subsection.” 21 U.S.C. § 355(j)(2)(A)(vii). Subsection 355(j) deals with the filing of ANDAs for new drugs, stating that “[a]ny person may file with the Secretary an abbreviated application for the approval of a new drug.” 21 U.S.C. § 355(j)(l). In my view, this supports the parallel construction of the sentence and confirms that the phrase disputed by Allergan and Alcon modifies the term “listed drug,” as Allergan suggests. Therefore, I conclude that the Patent Certification Provision does not alter the plain meaning of 35 U.S.C. § 271(e)(2).
Alcon and B & L cite the legislative history of the Hatch-Waxman Act concerning the Patent Certification Provision for the proposition that an ANDA applicant need not make a Paragraph IV certification with respect to a patent that claims a method of using a drug for which the ANDA does not seek approval. The legislative history states in relevant part as follows:
... [A]n ANDA must include a certification by the applicant regarding the status of certain patents applicable to the listed drug if the patent information has been submitted under section 505(b) or (c). With respect to all product patents which claim the listed drug and all use patents which claim an indication for the drug for which the applicant is seeking approval (hereinafter described as a controlling use patent), the applicant must certify, in his opinion and to the best of his knowledge, as to one of four circumstances.
If appropriate, the applicant may certify that one or more of the product or controlling use patents provided have expired .... [A]n applicant may certify if applicable that one or more of the prod*1342uct or controlling use patents are invalid or will not be infringed.
The committee recognizes that in some instances an applicant will have to make multiple certifications with respect to product or controlling use patents. For example, if the product patent has expired and a valid controlling use patent will not expire for three years, then the applicant must certify that one patent has expired and the other will expire in three years. The committee intends that the applicant make the appropriate certification for each product and controlling use patent.
H.R.Rep. No. 98-857, pt. 1, at 22, reprinted in 1984 U.S.C.C.A.N. 2647, 2655 (emphasis added).
Alcon and B & L urge that the material quoted from the House Report demonstrates that a claim of infringement under 35 U.S.C. § 271(e)(2) may, in the case of a method of use patent, only be brought if the ANDA filer seeks approval for the use claimed in the patent. I do not agree. The legislative history states that “controlling use patents” include “all use patents which claim an indication for the drug for which the applicant is seeking approval,” while section 355(j)(2)(A) requires “a certification ... with respect to each patent ... which claims a use for such listed drug for which the applicant is seeking approval.” The language that must be interpreted in the statute is virtually the same as the language that appears in the House Report. Under these circumstances, one might say that the legislative history, in fact, is no narrower than section 355(j‘)(2)(A) and can be interpreted consistently.
In any event, Alcon’s and B & L’s reading of the phrase “controlling use patent” leads to an interpretation of the Patent Certification Provision that is inconsistent with what I have just concluded is the plain meaning of the statute. Given its near symmetry with the language of the statute, I do not believe the statement from the House Report upon which Alcon and B & L rely is sufficient to overcome this plain meaning, and therefore, alter the Patent Certification Provision requirement. Garcia v. United States, 469 U.S. 70, 75, 105 S.Ct. 479, 83 L.Ed.2d 472 (1984) (“[OJnly the most extraordinary showing of contrary intentions from [the legislative history] would justify a limitation on the “plain meaning” of the statutory language.”). I conclude that the legislative history relating to the Patent Certification Provision does not assist Alcon and B & L in their interpretation of section 271(e)(2).
Additionally, the Patent Listing Provision, discussed in section (B)(i) supra, requires a NDA holder to submit to the FDA for listing in the Orange Book all patents that claim a method of using the approved drug “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.” 21 U.S.C. § 355(b)(1). In my view, a distorted interpretation of the Patent Certification Provision results if one does not interpret 21 U.S.C. § 355(j)(2)(A) to require an ANDA filer to make a Paragraph IV certification for a method of use patent listed in the Orange Book with respect to which a claim of patent infringement could reasonably be asserted against the filer, even if the filer did not seek approval for the patented use in the ANDA. This is especially true because many patentees look to the Paragraph IV certification for error when establishing a claim of infringement under 35 U.S.C. § 271(e)(2). See Eli Lilly, 496 U.S. at 678, 110 S.Ct. 2683, 110 L.Ed.2d 605, 15 USPQ2d at 1130. Accordingly, I believe that an ANDA applicant must make a Paragraph IV certification for each listed patent that claims the drug included in the ANDA and for each listed method of use *1343patent related to that drug that could form the basis for a claim of infringement.12
I agree with Alcon and B & L that Congress intended a generic drug manufacturer to. be able to gain approval from the FDA to manufacture and market an unpatented drug for a use that is not covered by a patent. Both 21 U.S.C. § 355(j)(2)(A)(viii) and the example in House Report 98-857 suggest that this is the case. Section 355(j)(2)(A)(viii) requires an ANDA filer to state that it is not applying for the patented use. The example in the House Report illustrates this concept and states as follows: “For example, the listed drug may be approved for two indications. If the applicant is seeking approval only for indication No. 1, and not indication No. 2 because it is protected by a use patent, then the applicant must make the appropriate certification and a statement explaining that it is not seeking approval for indication No. 2.” H.R. Rep. No. 98-857, pt. 1, at 22-23 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647-48. However, I do not share the conclusion that Alcon and B & L draw from the language of section 355(j)(2)(A)(viii) and from the example in the House Report; namely that Congress intended a patent holder to be without recourse when a generic drug manufacturer will induce a third party to infringe a method of use patent upon approval of an ANDA. I believe the conclusion is at odds with the plain language of 35 U.S.C. § 271(e)(2). In addition, as the Supreme Court stated in Eli Lilly, “[the ANDA] scheme will not work, of course, if the holder of the patent pertaining to the pioneer drug is disabled from establishing in court that there has been an act of infringement.” Eli Lilly, 496 U.S. at 678, 110 S.Ct. 2683, 110 L.Ed.2d 605, 15 USPQ2d at 1130. (iii) The Remedy Provision, 35 U.S.C. § 271(e) (W
Finally, Alcon and B & L argue that the exclusive remedies of 35 U.S.C. § 271(e)(4) are particularly severe in a case where an ANDA filer is seeking approval for the production of an unpatented drug for an unpatented use. From that point, they contend that Congress could only have meant those remedies to apply in the case of a method of use patent that claims an approved use of a drug for which the ANDA filer seeks approval, and that, therefore, the reach of section 271(e)(2) must be limited to such patents. The Remedy Provision of section 271(e)(4) states in relevant part as follows:
(4) For an act of infringement described in paragraph (2)—
(A) the court shall order the effective date of any approval of the drug ... involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed,
(B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug ..., and
(C) damages or other monetary relief may be awarded against an infringer only if there has been commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug....
The remedies prescribed by subpara-graphs (A), (B), and (C) are the only remedies which may be granted by a *1344court for an act of infringement described in paragraph (2)....
35 U.S.C. § 271(e)(4). I do not think that Alcon’s and B & L’s argument that the remedies provided in section 271(e)(4) are extreme in the situation where there is a determination of induced infringement under 35 U.S.C. § 271(e)(2) is sufficient to override the plain language of the statute. It is within the purview of Congress to fashion remedies in the manner it deems appropriate. The Remedy Provision does not require that section 271(e)(2) be limited to method of use patents that claim an approved use of a drug for which the ANDA filer seeks approval.
I do note, however, that Alcon’s and B & L’s arguments concerning the Remedy Provision bring into focus the fact that, to a large extent, their contentions in this case are grounded in policy considerations. It is the view of Alcon and B & L and the holding of Warner-Lambert that a method of use patent holder, such as Allergan, should not be able to bring an action for induced infringement under 35 U.S.C. § 271(e)(2) against a generic drug manufacturer who submits an ANDA seeking approval to market a drug for an approved, non-patented use that is different from the unapproved use for the same drug that is claimed in the method of use patent. I conclude, however, that the language of section 271(e)(2) and the overall statutory scheme of the Hatch-Waxman Act do not bar such an action.
If Congress determines that the owner of a method of use patent should not have an action for induced infringement against an ANDA filer in the circumstances that exist in this case, or that a more lenient injunctive remedy should be available for infringers of such method of use patents, it can amend section 271(e)(2) or section 271(e)(4) so as to compel a result different from the one I would reach. See Reid v. Dep’t of Commerce, 793 F.2d 277, 284 (Fed.Cir.1986) (“ ‘The remedy for any dissatisfaction with the results in particular cases lies with Congress’ and not with this court. ‘Congress may amend the statute; we may not.’ ”) (quoting Griffin v. Oceanic Contractors, Inc., 458 U.S. 564, 576, 102 S.Ct. 3245, 73 L.Ed.2d 973 (1982)). However, until Congress takes such action, I believe we must apply the statute as written.
For the foregoing reasons, I respectfully disagree with the decision of the court in Warner-Lambert. I would hold that 35 U.S.C. § 271(e)(2) may serve as the basis for an infringement action with respect to a method of use patent for an off-label use, when the patentee can prove that an ANDA applicant applying for the right to manufacture, use, or sell a drug actively encourages doctors and/or patients to use the generic version of the drug for the patented off-label use once the ANDA is approved. As a result, were I free to do so, I would reverse the decision of the district court and would remand the case in order to allow Allergan’s suit for induced infringement under section 271(e)(2) to proceed.13

. Both Warner-Lambert and this case were argued and submitted for decision the week of October 7, 2002. When Warner-Lambert and this case were argued, the issues they presented were ones of first impression.

. As explained below, a "controlling use patent” is a patent that claims an indication for a drug for which an ANDA applicant is seeking FDA approval.

. A patentee could only allege direct infringement of a method of use patent if the ANDA applicant experimented with or otherwise employed the method of use claimed in the patent and was not protected from infringement by the experimental use exemption granted by the Hatch-Waxman Act. See 35 U.S.C. § 271(e)(1).

. The Warner-Lambert court stated that “[i]n the absence of any evidence that Apotex has or will promote or encourage doctors to in*1337fringe the neurodegenerative method patent, there has been raised no genuine issue of material fact” under section 271(b). Warner-Lambert, 316 F.3d at 1364, 65 USPQ2d at 1491.

. These cases do not present a significant threat of abuse by a patent holder attempting to extend its patent exclusion through extensive litigation, because Congress gave district courts the ability to end a party’s attempts to delay litigation by controlling the timing of the suit. See 21 U.S.C. § 355(j)(5)(B)(iii) (granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action”).

. See 21 U.S.C. § 355(j)(2)(A)(i) (An ANDA must contain information "to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a drug listed under paragraph (7) ...”); 21 U.S.C. § 331(d) (prohibited conduct); 21 U.S.C. § 332(a) (injunctions); 21 U.S.C. § 333(a) (criminal penalties); 21 U.S.C. § 334(a)(1) (seizure of the drug).

. The holder of an approved NDA is required to provide the patent number and expiration date of similar method of use patents that are issued after the date the NDA is approved. See 21 U.S.C. § 355(c)(2).

. This court has held that “a generic drug manufacturer cannot bring a declaratory judgment action or an injunctive action against a NDA holder under either the [FDCA] or the patent laws requiring it to take steps to ‘delist’ a patent from the Orange Book.” Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1373-74, 61 USPQ2d 1414, 1417 (Fed.Cir.2002).

. All references are to regulations as set forth in the 2002 version of the Code of Federal Regulations.

. The regulation that governs the content and format of NDAs is set forth at 21 C.F.R. § 314.50. The regulation indicates that the FDA distinguishes between a drug product's proposed indications of use and other uses of *1340the drug product. Compare 21 C.F.R. § 314.50(a)(1) (requiring submission of the drug product's "proposed indications for use”) with 21 C.F.R. § 314.50(d)(5)(iv) (requiring submission of "relevant” clinical data concerning "uses of the drug other than those proposed in the application”).

. On October 24, 2002, the FDA issue a proposed rule that would, among other things, amend 21 C.F.R. § 314.53(b). See Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not be Infringed, 67 Fed.Reg. 65,448 (proposed October 24, 2002). Under the proposed rule, the part of section 314.53(b) that speaks to method of use patents would be amended to read as follows:
For patents that claim a method of use, the [NDA] applicant shall submit information only on those patents that claim indications or other conditions of use that are the subject of a pending or approved application.
67 Fed.Reg. at 65,451 (emphasis added).
Alcon and B & L argue that the FDA’s proposed rule supports their contention that so-called "off-label” use patents — patents such as the '415 and '741 patents that claim unapproved uses of a drug — "were not intended to serve as the basis for an action under 35 U.S.C. § 271(e)(2).” Allergan responds that the "perceived need of FDA to change its current regulation indicates that the current regulation permits the listing of all method of use patents concerning an approved drug whether or not the use is approved.”
I am reluctant to look to a notice of proposed rule making as a tool of statutory construction. See Commodity Futures Trading Comm'n v. Schor, 478 U.S. 833, 845, 106 S.Ct. 3245, 92 L.Ed.2d 675 (1986) ("It goes without saying that a proposed regulation does not represent an agency’s considered interpretation of its statute and that an agency is entitled to consider alternative interpretations before settling on the view it considers most sound.”). In any event, having concluded that under the plain language of 21 U.S.C. § 355(b)(1), Allergan was required to provide patent information for the '415 patent and '741 patent when the patents issued, I would not construe the language of the proposed amended version of section 314.53(b). See Whitman, 531 U.S. at 484, 121 S.Ct. 903; Gomez, 869 F.2d at 858.

. If a patent is not listed in the Orange Book, a Paragraph I certification may be appropriate.

. As noted in the per curiam opinion, the district court found that, as far as Allergan’s claim of induced infringement against Alcon was concerned, the record before the court was sufficient to present a triable issue of fact or, at the least, was sufficient to permit Aller-gan to conduct discovery under Fed.R.Civ.P. 56(f). In its motion for summary judgment, B & L argued that Allergan could raise no triable issue of fact regarding whether, if its ANDA were approved, B & L would induce infringement of the '415 and '741 patents. In granting Alcon's and B & L’s motions for summary judgment, the district court did not address B & L's contention that Allergan could not establish a genuine issue of material fact with respect to B & L's alleged inducing of infringement. On remand, the district court would have the opportunity to consider this issue.