ALLERGAN, INC. and Allergan Sales, Inc., Plaintiffs-Appellants, v. ALCON LABORATORIES, INC., Alcon Research, Ltd., and Alcon Universal, Ltd., Defendants-Appellees, and Bausch & Lomb, Incorporated, Defendant-Appellee.
No. 02-1449.
United States Court of Appeals, Federal Circuit.
March 28, 2003.
May 22, 2003.
For the reasons discussed, the district court‘s grant of summary judgment of non-infringement in favor of SSL is AFFIRMED.
COSTS
No costs.
Donald R. Dunner, Finnegan, Henderson, Farabow, Garrett & Dunner L.L.P., of Washington, DC, argued for plaintiffs-appellants. With him on the brief were Jonathan Singer, Fish & Rich-
Daniel J. Thomasch, Orrick, Herrington & Sutcliffe, LLP, of New York, New York, argued for defendants-appellees Alcon Laboratories, Inc., et al. With him on the brief was M. Veronica Mullally.
Edward W. Remus, McAndrews, Held & Malloy, Ltd., of Chicago, Illinois, argued for defendant-appellee Bausch & Lomb Incorporated. With him on the brief was Jonathan R. Sick.
Richard A. Samp, Washington Legal Foundation, of Washington, DC, for amicus curiae Washington Legal Foundation. With him on the brief was Daniel J. Popeo.
Before CLEVENGER, SCHALL, and LINN, Circuit Judges.
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.
PER CURIAM.
This appeal presents the question of whether the Drug Price Competition and Patent Term Restoration Act of 1984,
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.1
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. Allergan charged Alcon and B & L with induced infringement under the authority of
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., 316 F.3d 1348, 65 USPQ2d 1481 (Fed.Cir.2003). In Warner-Lambert, this court held that “it is not an act of infringement to submit an ANDA for approval to market a drug for a use when neither the drug nor the use is covered by an existing patent, and the patent at issue is for a use not approved under the NDA.” Warner-Lambert, 316 F.3d at 1354-55, 65 USPQ2d at 1484. Based upon Warner-Lambert, we affirm the district court‘s decision that the action for induced infringement brought by Allergan is not cognizable under
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 Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1371, 61 USPQ2d 1414, 1415 (Fed.Cir.2002). To accomplish the goals of the Act, Congress amended provisions of the patent statute and the Food, Drug, and Cosmetic Act (“FDCA“).
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.3 This requirement resulted in long delays between the time when a brand name drug manufacturer received a patent for a new drug and the drug reached the market. It also resulted in long delays between the time when the patent expired and generic drug manufacturers were able to market a generic version of the drug. The Hatch-Waxman Act sought to address this situation by providing brand name drug manufacturers with limited extensions of their patent terms in order to restore a portion of the market exclusivity lost through the lengthy process of drug development and FDA approval. At the same time, to counter this benefit to the brand name manufacturers, the Act provided generic drug manufacturers with a patent infringement exemption for experimentation in connection with an application for FDA approval of a generic drug. It also provided a shortened FDA approval process for generic drugs. H.R.Rep. No. 98-857, pt. 1, at 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647-48.
Before a drug manufacturer can market a new drug, it must obtain FDA approval.
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.
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.
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“).
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.4 The Hatch-Waxman Act provides that, in that situation, the filing of the ANDA is an act of infringement.
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.
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. Alphagan 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 Alphagan, 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 neurodegenerative disease of the optic nerve. Upon further investigation, Allergan‘s scientists discovered that brimonidine helps prevent neurodegeneration. 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 [brimonidine] to inhibit or prevent nerve cell injury or death ....” ‘415 patent, col. 17, ll. 35-39, col. 18, ll. 1-25. The first dependent claim defines the noxious action as “glaucomatous optic neuropathy.” ‘415 patent, col. 18, ll. 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 [brimonidine] to inhibit or prevent nerve cell injury or death ....” ‘741 patent, col. 17, ll. 27-39, col. 18, ll. 1-8. The first dependent claim defines the noxious action as being “a result of a crushed or compressed nerve.” ‘741 patent, col. 18, ll. 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 brimonidine 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 Allergan‘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
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.5 Allergan, 200 F.Supp.2d at 1225, 63 USPQ2d at 1431. The district court did not make a similar finding with respect to B & L. The district court, nevertheless, granted Alcon‘s and B & L‘s motions. Addressing Allergan‘s claim of induced infringement, the court held that the filing of an ANDA does not provide a predicate for a method of use patent holder to sue an ANDA applicant for induced infringement. Id. at 1232, 63 USPQ2d at 1437. The court viewed section 271(e)(2) as being symmetrical with section 271(e)(1), which, as noted above, allows a generic drug man-
Allergan now appeals the district court‘s grant of Alcon‘s and B & L‘s motions for summary judgment. We have jurisdiction pursuant to
DISCUSSION
I. Standard of Review
We review a grant of summary judgment by a district court de novo. Cortland Line Co. v. Orvis Co., 203 F.3d 1351, 1355-56, 53 USPQ2d 1734, 1736 (Fed.Cir.2000). Summary judgment is appropriate where the record shows “that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed. R. Civ. R. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). We review a district court‘s interpretation of statutory language, which is a question of law, without deference. Waymark Corp. v. Porta Sys. Corp., 245 F.3d 1364, 1366, 58 USPQ2d 1456, 1458 (Fed.Cir.2001). In this case, the issue before us is a question of law: whether the district court erred in holding that the Hatch-Waxman Act does not support Allergan‘s claim of induced infringement against Alcon and B & L.
II. Contentions of the Parties
On appeal, Allergan argues that the district court erred in construing
Alcon responds that the district court properly granted summary judgment against Allergan. Alcon argues that Allergan‘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
For the reasons that follow, we hold that Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 65 USPQ2d 1481 (Fed.Cir.2003), controls this case and that, under Warner-Lambert, Allergan may not sue Alcon and B & L under section 271(e)(2) for inducing infringement of the ‘415 and ‘741 patents. We therefore affirm the district court‘s grant of summary judgment in favor of Alcon and B & L.
III. Whether 35 U.S.C. § 271(e)(2) is a Jurisdictional Statute
The district court stated that “[s]ection 271(e)(2) ... provides no new substantive law, but much like the Declaratory Judgment Act,
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. 496 U.S. 661, 678, 110 S.Ct. 2683, 110 L.Ed.2d 605, 15 USPQ2d 1121, 1130 (1990). We explained in Glaxo that section 271(e)(2) “provide[s] patentees with a defined act of infringement sufficient to create case or controversy jurisdiction to enable a court to promptly resolve any dispute concerning infringement and validity.” Glaxo, 110 F.3d at 1569, 42 USPQ2d at 1263. Once Congress creates an act of infringement, jurisdiction in the district court is proper under
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
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, 200 F.Supp.2d at 1232, 63 USPQ2d at 1437.
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, 523 U.S. 83, 103-04, 118 S.Ct. 1003, 140 L.Ed.2d 210 (1998) (“This triad of injury in fact, causation, and redressability comprises the core of Article III‘s case-or-controversy requirement....“). A claim under
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, 316 F.3d at 1356, 65 USPQ2d at 1485. The district court found that Allergan presented a triable issue of fact with respect to induced infringement by Alcon sufficient to allow the parties to proceed to discovery. See supra note 5; Allergan, 200 F.Supp.2d at 1225, 63 USPQ2d at 1431. Allergan presented evidence that third-party doctors and patients will likely infringe its two method of use patents and that Alcon and B & L may knowingly induce this infringement through their actions. See Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 553, 16 USPQ2d 1587, 1594 (Fed.Cir.1990) (“The plaintiff has the burden of showing that the alleged infringer‘s actions induced infringing acts and that he knew or should have known his actions would induce actual infringements.“) (emphasis in original).
We must now determine whether Congress has prohibited the particular action for induced infringement brought by Allergan.
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, 200 F.Supp.2d at 1230, 63 USPQ2d at 1435. Allergan argues that the district court erred in its ruling. For their part, Alcon and B & L contend that the district court correctly held that only when the ANDA speaks to the use that is claimed in the patent at issue may the patent holder bring suit under section 271(e)(2).
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-Lambert, 316 F.3d at 1354-55, 65 USPQ2d at 1484. Warner-Lambert reasoned that “because an ANDA may not seek approval for an unapproved or off-label use of a drug under
In the Warner-Lambert case, Warner-Lambert obtained FDA approval through a NDA to market 1-aminomethyl-1-cyclohexane 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 neurodegenerative diseases with gabapentin.7 Warner-Lambert claimed gabapentin itself in United States Patent No. 4,024,175 (the “product patent“).
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 gabapentin was an act of infringement of its neurodegenerative method patent under
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, 316 F.3d at 1359, 65 USPQ2d at 1487. The court also expressed concern about the threat of abuse by a patent holder attempting to extend its patent exclusion. Id. Accordingly, the court held
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, i.e., that Apotex induced or will induce infringement of the neurodegenerative method patent.” Id. at 1356, 65 USPQ2d at 1485. Upon considering Warner-Lambert‘s cause of action under section 271(b), the court concluded that “[i]n the absence of any evidence that Apotex has or will promote or encourage doctors to infringe the neurodegenerative method patent, there has been raised no genuine issue of material fact.” Id. at 1364, 65 USPQ2d at 1491. The court, therefore, affirmed the district court‘s dismissal of Warner-Lambert‘s suit.
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.9
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.
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
A. 35 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
(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 before the expiration of such patent.
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.
Alcon argues that an action for infringement of a method of use patent may only be brought under
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).
Absent Warner-Lambert, I would hold that Allergan‘s claims of induced infringement against Alcon and B & L are cognizable under
Under my reading of the statute, Allergan 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 neuroprotection. 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
In 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 reliance 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 brimonidine for an unapproved use, such as neuroprotection. 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 filing 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. § 271(e)(4)
Alcon and B & L point to (i)
(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.
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 listed.
Alcon also points to the FDA regulation that implements the Patent Listing Provision,
I note at the outset that Alcon‘s reading of the regulation is inconsistent with the clear language of
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
(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“);
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(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-
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
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.
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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-
uct 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
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) (“[O]nly 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.”
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
(iii) The Remedy Provision, 35 U.S.C. § 271(e)(4)
Finally, Alcon and B & L argue that the exclusive remedies of
(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 subparagraphs (A), (B), and (C) are the only remedies which may be granted by a
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
If Congress determines that the owner of a method of use patent should not have
For the foregoing reasons, I respectfully disagree with the decision of the court in Warner-Lambert. I would hold that
LINN, Circuit Judge, concurring in the judgment.
I concur in the conclusion of the panel that this case is controlled by Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed.Cir.2003). I also agree that it is reasonable, as a matter of patent policy, to conclude, as the Warner-Lambert panel did, that it should not be “an act of infringement to submit an ANDA for approval to market a drug for a use when neither the drug nor that use is covered by an existing patent, and the patent at issue is for a use not approved under the NDA.” Id. at 1354-55. I write separately to express my disagreement not with the logical conclusions reached by the court in Warner-Lambert but with the court‘s looking beyond the congressional intent expressed in the plain meaning of the statute to reach those conclusions. In my opinion, the court in Warner-Lambert has ventured beyond our interpretive role and, in interpreting the complex statutory scheme before it, has allowed its policy choices and its evaluation of the legislative history—reasonable as they may be—to override the terms of the statute chosen by Congress.
While the statutory scheme forming the basis for an ANDA filing is hardly a model of clarity, see Eli Lilly Co. v. Medtronic, Inc., 496 U.S. 661, 679, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990),
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, 316 F.3d at 1356. Moreover, the opinion discusses the purposes of the Hatch-Waxman Act and concludes that a broader interpretation of section 271(e)(2) would lead to undesirable consequences:
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 ANDA holder would be able to main-
tain 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, 316 F.3d at 1359. However compelling such arguments may be, it is the function of Congress, not the courts, to shape legislation in accordance with policy goals. “Under our constitutional framework, federal courts do not sit as councils of revision, empowered to rewrite legislation in accord with their own conceptions of prudent public policy.” United States v. Rutherford, 442 U.S. 544, 555, 99 S.Ct. 2470, 61 L.Ed.2d 68 (1979). See also Artuz v. Bennett, 531 U.S. 4, 10, 121 S.Ct. 361, 148 L.Ed.2d 213 (2000) (“Whatever merits these and other policy arguments may have, it is not the province of this Court to rewrite the statute to accommodate them.“); Badaracco v. Comm‘r of Internal Revenue, 464 U.S. 386, 398, 104 S.Ct. 756, 78 L.Ed.2d 549 (1984) (“Courts are not authorized to rewrite a statute because they might deem its effects susceptible of improvement.“); Bankamerica Corp. v. United States, 462 U.S. 122, 140, 103 S.Ct. 2266, 76 L.Ed.2d 456 (1983) (“[W]e are not to rewrite the statute based on our notions of appropriate policy.“).
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, 400 U.S. 410, 419, 91 S.Ct. 423, 27 L.Ed.2d 498 (1971) (“[I]t is for Congress, not this Court, to rewrite the statute.“). The importance of this issue suggests that Congress consider revisiting the terms of the Hatch-Waxman Act to clarify or confirm its intent. In the absence of any congressional action to that end, I would interpret the statute as set forth in Judge Schall‘s concurring opinion if I were not bound to follow the precedent of our Warner-Lambert decision.