Lead Opinion
Opinion concurring in the judgment filed by Circuit Judge SCHALL, in which Circuit Judge CLEVENGER joins.
Opinion concurring in the judgment filed by Circuit Judge LINN.
This appeal presents the question of whether the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984) (codified at 21 U.S.C. §§ 355 and 360cc and 35 U.S.C. §§ 156 and 271) (the “Hatch-Waxman Act”), allows an action for induced infringement based upon the filing of an Abbreviated New Drug Application (“ANDA”), in the following circumstances: (i) The patent at issue claims a method of using a specified drug for a particular purpose, but that use has not been approved by the Food and Drug Administration (“FDA”) based upon a New
This question arises in the context of a suit by Allergan, Inc. and Allergan Sales, Inc. (“Allergan”) against Alcon Laboratories, Inc., Alcon Research, Ltd., and Alcon Universal, Ltd. (“Alcon”), and Bausch & Lomb, Incorporated (“B & L”) for infringement of United States Patent Nos. 6,194,415 (the “'415 Patent”) and 6,248,741 (the “'741 Patent”). The '415 patent claims a method of protecting the optic nerve through the administration of the drug brimonidine, while the '741 patent claims a method of neural protection through the administration of brimonidine. Brimonidine itself is not patented, and the FDA has not approved brimonidine for the uses claimed in the '415 and '741 patents. However, brimonidine is effective for those uses.
Allergan initiated suit in the United States District Court for the Central District of California after Alcon and B & L submitted ANDAs to the FDA seeking approval for the production and sale of a generic version of brimonidine for the reduction of intraocular pressure, a use different from the uses for brimonidine claimed in the '415 and '741 patents. Al-lergan charged Alcon and B & L with induced infringement under the authority of 35 U.S.C. § 271(e)(2).
Prior to January 16, 2003, the question presented in this case represented an issue of first impression. On that day, however, a panel of this court decided Warner-Lambert Co. v. Apotex Corp.,
I. The Hatch-Waxman Act
We recently stated that, in the Hatch-Waxman Act, “Congress struck a balance between two competing policy interests: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market.” Andrx Pharma., Inc. v. Biovail Corp., 276 F.8d 1868, 1371,
Prior to the passage of the Act, all drug manufacturers, brand name and generic, had to perform controlled studies to demonstrate that a new drug would be safe and effective for its intended use.
Before a drug manufacturer can market a new drug, it must obtain FDA approval. 21 U.S.C. § 355(a). The approval process requires the submission of a NDA, which is the result of extensive testing and which must include safety information, efficacy information, and composition data. 21 U.S.C. § 355(b). Pursuant to the Hatch-Waxman Act, the FDA, upon approval of a NDA, grants the applicant a five-year period of exclusive marketing for the approved drug, which can be extended by six months if the producer submits safety information relating to children. 21 U.S.C. §§ 355(c)(3)(D)(ii) and 355a(a)(l)(A)(i). This period of exclusivity was primarily designed by Congress to encourage the development and testing of unpatentable pharmaceuticals. H.R.Rep. No. 98-857, pt. 1, at 29 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647-48. The FDA approval process requires a NDA applicant to file with its NDA the following:
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.
21 U.S.C. § 355(b)(1). The holder of an approved NDA must file the same information with respect to similar patents that are obtained after the NDA is approved. 21 U.S.C. § 355(c)(2). The FDA lists such patents in a book entitled “Approved Drug Products with Therapeutic Equivalence Evaluations.” The book is commonly re
To attain a balance between the interests of brand name pharmaceutical companies and generic drug manufacturers, Congress, as part of the Hatch-Waxman Act, legislated that a generic drug manufacturer may, without liability for infringement, use a drug claimed in a patent or a method of using a drug claimed in a patent in order to prepare an application for FDA approval of a generic drug. 35 U.S.C. § 271(e)(1). At the same time, Congress extended the ANDA process to post-1962 pioneer drugs to couple with the NDA process. A generic drug manufacturer may file an ANDA to obtain approval for a generic drug. 21 U.S.C. § 355(j). The ANDA must be for the same drug that has been approved by the FDA, or it must be for a drug that is the bioequivalent of a drug that has been approved by the FDA. 21 U.S.C. § 355©(2).
The ANDA process imposes a certification requirement with respect to patents covering the drug that has been approved by the FDA. A generic drug manufacturer must certify in its ANDA the following with respect to each patent “which claims the [drug previously approved by the FDA] or which claims a use for [that] drug for which the applicant is seeking approval ... and for which information is required to be filed” for listing in the Orange Book: (i) such patent information has not been filed; (ii) the approved drug’s patent has expired; (iii) the date the approved drug’s patent will expire; or (iv) the approved drug’s patent “is invalid or will not be infringed by the manufacture, use, or sale” of the generic drug for which the ANDA is being submitted (a “Paragraph IV certification”). 21 U.S.C. § 355(j)(2)(A)(vii); see Bayer AG v. Elan Pharm. Research Corp.,
As suggested by the certification process, a generic drug manufacturer may file an ANDA before a patent expires and, in so doing, allege non-infringement and invalidity of the patent.
A generic drug manufacturer who files an ANDA containing a Paragraph IV certification must notify the owner of the unexpired patent that is the subject of the certification. 21 U.S.C. § 355(j)(2)(B)(i) & (ii). The patent owner then has 45 days to file an action for infringement in district
II. The '415 and '741 Patents
This case arises out of Alcon’s and B & L’s efforts to market a generic version of Allergan’s medication, Alphagan. Alpha-gan is used in the treatment of open-angle glaucoma, a disease of the eye that results in the deterioration of vision. Open-angle glaucoma is caused by damage to the optical cells, but it is unknown exactly how this damage occurs. For years, the accepted belief of the medical profession was that the disease was caused by exceptionally high intraocular pressure (“IOP”), resulting from a failure of the eye fluid, called aqueous humor, to properly drain. The high pressure in the eye presumably bore down on the optic nerve, thereby damaging it. Drug manufacturers sought pharmaceutical components that reduced IOP in the eye in order to treat glaucoma.
On September 6, 1996, Allergan obtained approval of its NDA for the drug, brimonidine, the chemical compound in Al-phagan, for reducing IOP. As a result, Allergan received a five-year period of market exclusivity for brimonidine plus a six-month extension for researching the health effects and safety of the drug in children. This exclusive term expired on March 6, 2002. Brimonidine is not protected by a patent and is therefore in the public domain.
More recently, scientists have discovered that open-angle glaucoma also occurs in patients with low IOP. They therefore conjecture that it may be a neurodegenerativo disease of the optic nerve. Upon further investigation, Allergan’s scientists discovered that brimonidine helps prevent neuro-degeneration. This discovery led Allergan to file for the '415 and '741 patents, each of which is a method of use patent. The '415 and '741 patents do not claim the use of brimonidine for reducing IOP. That use, like the drug itself, is unpatented and in the public domain.
The '415 and the '741 patents claim methods of using brimonidine for treating ocular neural injuries, such as open-angle glaucoma. The '415 patent claims “[a] method of protecting the optic nerve and retina of a mammal comprising administering to said mammal suffering from or at risk of suffering a noxious action on said nerve cells an effective amount of [brimon-idine] to inhibit or prevent nerve cell injury or death .... ” '415 patent, col. 17, 11. 35-39, col. 18, 11. 1-25. The first dependent claim defines the noxious action as “glaucomatous optic neuropathy.” '415 patent, col. 18, 31. 26-27. The '741 patent claims “[a] method of providing neural protection to a mammal comprising administering to said mammal suffering from or at risk of suffering a noxious action on its nerve cells an effective amount of [brimon-idine] to inhibit or prevent nerve cell injury or death ...'741 patent, col. 17, 11. 27-39, col. 18,11. 1-8. The first dependent claim defines the noxious action as being “a result of a crushed or compressed nerve.” ’ '741 patent, col. 18, 11. 10-11. Both the '415 patent and the '741 patent are continuations-in-part of application number 08/496,262, now United States Pat
III. Alcon’s and B & L’s ANDAs and Allergan’s Lawsuit
In October of 2001, Alcon filed an ANDA for brimonidine, and in November of 2001, B & L filed one as well. In their ANDAs, Alcon and B & L stated that they were seeking approval from the FDA to produce and sell a generic version of bri-monidine for use in lowering IOP in patients with open-angle glaucoma or ocular hypertension. Neither Alcon nor B & L sought FDA approval for the methods of using brimonidine claimed in the '415 and '741 patents. As part of their respective ANDAs, Alcon and B & L filed Paragraph IV certifications, based on Allergan’s Orange Book listings, indicating that Aller-gan’s '415 and '741 patents were not infringed and that, to the extent Allergan asserted that the patents covered IOP lowering, they were invalid. After Alcon and B & L gave Allergan notice of the filing of their ANDAs for brimonidine, Allergan instituted suit against both companies in the United States District Court for the Central District of California within the 45 day time period set forth in 21 U.S.C. § 355(j)(5)(B)(iii). Allergan brought its suit under 35 U.S.C. § 271(e)(2), alleging that if the FDA approved Alcon’s and B & L’s ANDAs, Alcon and B & L would induce doctors to infringe the '415 and '741 patents by prescribing brimonidine for neuroprotection and would induce patients to infringe by using brimonidine for neuro-protection. Allergan also alleged that, through the submission of their ANDAs, Alcon and B & L were liable for infringement because they violated 35 U.S.C. § 271(e)(2) directly.
As noted above, Alcon and B & L moved for summary judgment of non-infringement, arguing that a claim of induced infringement is not cognizable under section 271(e)(2) where, as here, the ANDA is for a use of the drug that is different from the use of the drug that is claimed in the asserted patent. In ruling on the motions, the district court noted that, as far as Alcon was concerned, Allergan had presented sufficient evidence to present a triable issue of fact with regard to induced infringement, or had at least presented sufficient evidence to proceed to discovery.
Allergan now appeals the district court’s grant of Alcon’s and B & L’s motions for summary judgment. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
DISCUSSION
I. Standard of Review
We review a grant of summary judgment by a district court de novo. Cortland Line Co. v. Orvis Co.,
II. Contentions of the Parties
On appeal, Allergan argues that the district court erred in construing 35 U.S.C. § 271(e)(2) so as to bar suits for induced infringement. Allergan contends that Congress enacted section 271(e)(2) to complement the filing of an ANDA, not to counterbalance 35 U.S.C. § 271(e)(1). Allergan further argues that, pursuant to section 271(e)(2), it may bring a suit for induced infringement of the '451 and '741 patents, even though Alcon’s and B & L’s ANDAs do not seek approval for the methods of using brimonidine claimed in those patents. In the alternative, Allergan urges that section 271(e)(2) provides a direct cause of action that makes Alcon and B & L liable for direct infringement based upon the filing of their ANDAs.
Alcon responds that the district court properly granted summary judgment against Allergan. Alcon argues that Aller-gan’s suit cannot succeed for two reasons. First, according to Alcon, section 271(e)(2) only provides jurisdiction for an action for infringement of a method of use patent when the patent at issue claims an FDA-approved use and the ANDA applicant is seeking approval for that use. Second, Alcon asserts that, under section 271(e)(2), the conventional requirements for infringement under 35 U.S.C. § 271(a), (b), and (c)
For the reasons that follow, we hold that Warner-Lambert Co. v. Apotex Corp.,
III. Whether 35 U.S.C. § 271(e)(2) is a Jurisdictional Statute
The district court stated that “[sjection 271(e)(2) ... provides no new substantive law, but much like the Declaratory Judgment Act, 28 U.S.C. § 2201, merely provides a jurisdictional ‘hook’ for a patent case.” Allergan,
Section 271(e)(2) is not a jurisdictional statute in the strict sense of the word. As the Supreme Court pointed out in Eli Lilly Co. v. Medtronic, Inc., section 271(e)(2) creates an “act of infringement” based upon the filing of an ANDA.
In short, section 271(e)(2) makes it possible for the district court to exercise its section 1338(a) jurisdiction in the situation in which an ANDA has been filed. The critical question, and the one to which we now turn, is whether Allergan’s claim of induced infringement against Alcon and B & L is cognizable under section 271(e)(2).
IV. Whether Allergan’s Claim of Induced Infringement May be Brought Under 35 U.S.C. § 271(e)(2)
A. Claims of Induced Infringement Under Section 271(e)(2) Generally
Preliminarily, we must determine whether, as a general matter, section 271(e)(2) may serve as an umbrella for a claim of induced infringement for a meth
We do not share the district court’s view of 35 U.S.C. § 271(e)(2). To begin with, the language of section 271(e)(2) does not limit the reach of the statute to direct infringement actions to the exclusion of actions for induced infringement. Additionally, in Glaxo, we did not limit the scope of section 271(e)(2) to direct infringement actions. Instead, we stated that a court must employ a traditional infringement analysis, focusing on all of the elements of infringement. Glaxo,
Finally, we do not agree with the district court that the “case or controversy” requirement of Article III of the Constitution precludes a patentee from bringing a claim of induced infringement under section 271(e)(2). The district court was of the view that, in the case of a claim of induced infringement predicated on direct infringement by third party physicians, there is “not a .sufficiently immediate threat that there will be a violation of the patent laws so as to warrant judicial determination.” Allergan,
The case or controversy clause in Article III of the Constitution requires injury in fact, connection between the challenged conduct and the injury, and redressability of the injury by the requested remedy. Steel Co. v. Citizens for a Better Env’t,
Summary judgment of non-infringement under section 271(e)(2), therefore, is inappropriate where the plaintiff can demonstrate the existence of a genuine issue of material fact with respect to the claim that the ANDA filer will induce infringement of its patent upon approval of the ANDA. Warner-Lambert,
We must now determine whether Congress has prohibited the particular action for induced infringement brought by Aller-gan.
B. Allergan’s Action for Induced Infringement
The district court concluded that, in the case of a method of use patent, section 271(e)(2) only makes the filing of an ANDA an act of infringement when the patent at issue claims the use for which FDA approval is sought in the ANDA. Allergan,
This issue was decided in Warner-Lambert. Warner-Lambert held that, pursuant to section 271(e)(2), a method of use patent holder may not sue an ANDA applicant for induced infringement of its patent, if the ANDA applicant is not seeking FDA approval for the use claimed in the patent and if the use claimed in the patent is not FDA-approved. Warner-
In the Warner-Lambert case, Warner-Lambert obtained FDA approval through a NDA to market 1-aminomethyl-l-cyclo-hexane acetic acid (“gabapentin”) for use in “adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy.” This method of use was claimed in United States Patent No. 4,087,544 (the “epilepsy method patent”). Warner-Lambert is also the assignee of a second method of use patent, United States Patent No. 5,084,479 (the “neurodegenerative method patent”), which covers the treatment of neurodegen-erative diseases with gabapentin.
On April 17, 1998, Apotex filed an ANDA seeking approval to market a generic formulation of gabapentin upon the expiration of Warner-Lambert’s epilepsy method patent on January 16, 2000. After Apotex notified Warner-Lambert that it had filed the ANDA and a Paragraph IV certification, Warner-Lambert instituted suit within 45 days in the United States District Court for the Northern District of Illinois. Warner-Lambert alleged that Apotex’s submission of an ANDA for gaba-pentin was an act of infringement of its neurodegenerative method patent under 35 U.S.C. § 271(e)(2).
On appeal, the Warner-Lambert court expressed concern that permitting a cause of action under section 271(e)(2) for off-label method of use patents would “confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer.” Warner-Lambert,
The court also determined that “Warner-Lambert would have needed to demonstrate the existence of a genuine issue of material fact to support a traditional infringement claim, ie., that Apotex induced or will induce infringement of the neurode-generative method patent.” Id. at 1356,
Under Warner-Lambert, Allergan is precluded from suing Alcon and B & L under section 271(e)(2) for inducing infringement of the '415 and '741 patents, because Alcon and B & L are not seeking FDA approval for the uses claimed in the patents and because the uses claimed in the patents are not FDA-approved.
CONCLUSION
For the foregoing reasons, the decision of the district court granting summary judgment in favor of Alcon and B & L is affirmed.
COSTS
Each party shall bear its own costs.
AFFIRMED.
Notes
. The FDA does not prohibit doctors from prescribing a drug for an unapproved or off-label use, and it does not prohibit patients from using a drug for an unapproved or off-label use. See Warner-Lambert Co. v. Apotex Corp.,
. All references are to statutes set forth in the 2000 version of the United States Code.
. The FDA previously allowed ANDAs for pioneer drugs approved prior to 1962. H.R.Rep. No, 98-857, pt. 1, at 16 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647-48.
. A generic drug manufacturer may also file an ANDA after the corresponding NDA holder’s fourth year of FDA granted market exclusivity ends, if the ANDA contains a Paragraph IV certification under 21 U.S.C. § 355(j)(2)(A)(vii). 21 U.S.C. § 355(j)(5)(D)(ii).
. Responding to the summary judgment motions, Allergan presented evidence in the form of research papers, patents, and articles suggesting that the neuroprotective functions of brimonidine are well known in the medical field and that doctors are currently prescribing brimonidine for neuroprotective purposes. In addition, Allergan submitted evidence of instances where Alcon allegedly advertised an ANDA approved drug for uses other than those uses approved by the FDA. Finally, Al-lergan presented evidence indicating that Alcon and B & L have included articles on their websites that discuss brimonidine's neu-roprotective properties.
. The Washington Legal Foundation ("WLF”) submitted an amicus curiae brief. WLF argues that the district court erred in.ruling that Allergan’s induced infringement claim does not present a case or controversy as required by Article III. WLF also argues that the plain language of section 271(e)(2) supports Aller-gan’s contention that section 271(e)(2) allows its claim of induced infringement.
. Epilepsy is not a neurodegenerative disease; therefore, the neurodegenerative method patent does not implicate the use of gabapentin for epilepsy.
. The gabapentin patent expired prior to Warner-Lambert’s suit.
. Allergan's alternative argument is that section 271(e)(2) provides a direct cause of action that makes an ANDA filer in a case such as this liable for infringement based simply upon the filing of the ANDA. According to Allergan, ”[o]n its face, § 271(e)(2)(A) requires that, if a person submits an ANDA for a drug, the use of which is claimed in a patent, in order to engage in the commercial manufacture, use, or sale of the drug, that person has committed an act of infringement.” Warner-Lambert bars Allergan's direct infringement claim. In any event, Glaxo makes it clear that section 271(e)(2) requires proof of all the elements of infringement. Glaxo,
Concurrence Opinion
Because this case is controlled by Warner-Lambert Co. v. Apotex Corp.,
A. §5 U.S.C. § 271(e)(2)
Statutory interpretation necessarily begins with the text of the statute. Hughes Aircraft Co. v. Jacobson,
(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,
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.”
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.,
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.
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.
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.
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
(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).
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.
Alcon also points to the FDA regulation that implements the Patent Listing Provision, 21 C.F.R. § 314.53(b).
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.,
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).
(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 applicant 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 product 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,
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,
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,
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 acourt 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,
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.
. 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
. 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.,
. 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
. 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,
. 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.
Concurrence Opinion
concurring in the judgment.
I concur in the conclusion of the panel that this case is controlled by Warner-Lambert Co. v. Apotex Corp.,
While the statutory scheme forming the basis for an ANDA filing is hardly a model of clarity, see Eli Lilly & Co. v. Medtronic, Inc.,
In effect, the court in Warner-Lambert reads the words “the use for which the FDA has granted an NDA” into the statute, concluding that “it is clear that the phrase ‘the use’ in § 271(e)(2)(A) refers to the use for which the FDA has granted an NDA.” Warner-Lambert,
Warner-Lambert’s proposed interpretation [that “the use” means “any use”] is inconsistent with both of the stated purposes of the Hatch-Waxman Act, and would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer. If Warner-Lambert’s interpretation were correct, for example, an NDA holder would be able to maintain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA. It would then be able to use § 271(e)(2)(A) as a sword against any competitor’s ANDA seeking approval to market an off-patent drug for an approved use not covered by the patent. Generic manufacturers would effectively be barred altogether from entering the market.
Warner-Lambert,
It is for Congress, not this court, to explain why the intent expressed in the plain meaning of the language used in section 271(e)(2) does not reflect its intent as to the policy governing applications by generic drug manufacturers to produce drugs that may have patented “off-label” uses. See Blount v. Rizzi