... The Hatch Waxman Act also created a new framework for innovator-generic drug patent litigation that promotes early resolution of patent issues and that fosters market certainty....
Introduction
The 1984 Hatch Waxman Act radically altered litigation over generic copies of brand drugs that are protected by patents. Generally speaking, the Hatch Waxman Act attempted to ameliorate certain patent-related difficulties faced by innovator and generic companies alike as a result of the time-consuming FDA approval process.
Although an innovator company might obtain a patent on a new chemical entity and its therapeutic uses, in practice, much of the patent term was consumed while seeking FDA approval to market the drug. Thus, while innovators in other industries often enjoyed the right to exclude competitors from the market for the patented innovations during the full term of the patent, drug innovators typically had only a few years of patent term remaining after substantial investments in creating an FDA-authorized market for their inventions. The Hatch Waxman Act addressed that problem by creating a mechanism to extend the term of drug patents to recapture some of the time lost to the regulatory approval process. See 35 U.S.C. § 156.
Generic drug companies faced other, patent-related problems of their own due to FDA approval. Ordinarily, a generic drug company must make some use of the patented drug, for example, to demonstrate its ability to manufacture the drug in a controlled manner. However, that work could not be conducted lawfully during the term of the innovator’s patents. Indeed, in Roche Products v. Bolar Pharmaceutical, 733 F.2d 858 (Fed. Cir. 1984), the Court of Appeals for the Federal Circuit held that such work conducted to gather information needed for the FDA application was an infringement and that no experimental use exception applied. The result of this situation is that a generic company’s development could begin only after the patents expired—effectively extending the term of those patents. The Hatch Waxman Act addressed that problem by creating a “safe harbor” that immunizes experimental uses of patented drugs for purposes of preparing an application for regulatory approval. See 35 U.S.C. § 271(e)(1).
The Hatch Waxman Act also created a new framework for innovator-generic drug patent litigation that promotes early resolution of patent issues and that fosters market certainty.
Following is a discussion of the procedural aspects preliminary to Orange Book listed drug patent litigation.
FDA Orange Book Listed Patents
As part of a new drug application (NDA), the applicant is required to submit certain patent information related to the proposed drug product. Specifically, the applicant is required to:
file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.
21 U.S.C. § 355(b)(1)(G).
If the patent issues after the NDA is filed but before the application is approved, then the applicant must submit the patent information by way of amending the application no later than 30 days after approval of the NDA. Id; 21 CFR § 314.53(c)(2)(ii). Similarly, if the patent issues after the NDA is approved, then the NDA holder must file the information with FDA within 30 days of the patent’s issuance. 21 U.S.C § 355(c)(2); 21 C.F.R. § 314.53(c)(2)(ii).
The submission of the patent information is mandatory. Failure to submit information about patents that issue before the NDA is approved is grounds for disapproval of the application. Id. at § 355(d)(6). Failure to file patent information within the 30-day deadline concerning patents that issue after NDA approval is grounds for withdrawing approval of the NDA. Id. at § 355(e)(4). Moreover, even if patent information is timely submitted, FDA will not list the patent if the form and substance of the submission do not comply with FDA’s regulations. 21 C.F.R. § 314.53(c)(2)(ii). FDA ordinarily notifies applicants when the submission is incomplete or does not comply with regulation. In such cases, the applicant must submit the corrected information within 15 days of receiving FDA’s notice of non-compliance. Id.
Upon approval of the NDA, FDA publishes the submitted patent information in its Orange Book: Approved Drugs with Therapeutic Equivalence Evaluations located online at:
In addition to the basic patent information submitted to FDA, the NDA holder is required to identify appropriate “use codes” applicable to drug product. The Orange Book use codes are intended to identify approved uses of the drug that may infringe an Orange Book listed patent if performed by a person without a license. In recent revisions to its regulations, FDA now requires the NDA holder to precisely identify only those use codes that are fairly within the scope of the method-of-use patent claims. 21 CFR 314.53(b)(1). The intent of this requirement is to insure the NDA holder will “identify with specificity the section(s) and subsection(s) of the approved labeling that describes the method(s) of use claimed by the patent submitted.” Id. at (b)(1) & (c)(2)(O).
The regulations require NDA holders to update the use codes with any information affecting the scope of the method-of-use patent claims. For example, NDA holders must amend “the description of the approved methods(s) of use claimed by the patent . . . within 30 days of a decision by the USPTO, or by a Federal district court, the Court of Appeals for the Federal Circuit, or the U.S. Supreme Court that is specific to the patent and alters the construction of a method-of-use claim(s) of the patent.” 21 C.F.R. §§ 314.50(i)(4)(i) & 314.94(a)(12)(vi)(A)(3). FDA has suggested, for example, that the NDA holder’s duty to update use code information includes notifying FDA of changes to patent claim scope resulting from a district court’s “Markman” claim construction ruling that alters the scope of the claims, even though the claim construction may be appealable to a higher court. See 81 Fed. Reg. 69602.
Recent amendments to FDA’s regulations require NDA holders to further update the patent information published in the Orange Book and “de-list” patents that no longer qualify for publication in the Orange. See 21 CFR § 314.53(f)(2)(i). Corrections to patent information are made on Form FDA 3542 or 3542a in an amendment or supplement to the NDA. Id. at (f)(2)(iii). If the term of the patent has been extended under 35 U.S.C. § 156(e), then the NDA holder must correct the published expiration date of the patent by submitting the new information on Form FDA 3542a within 30 days of receiving the certificate of extension under Section 156(e)(1). An NDA holder must request de-listing of a patent when a court rules that the patent is invalid, and the court’s ruling has not or cannot be appealed. Id.
Although NDA holders are required to report patents that no longer qualify for Orange Book publication, FDA will not remove patents from the Orange Book where “one or more first applicants are eligible for 180-day exclusivity based on a paragraph IV certification to that patent.” Id. at 314.50(i)(6)(ii). In such situations, the Orange Book will reflect the NDA holder’s request to de-list the patent but “the patent will remain listed until any 180-day exclusivity based on that patent has expired or has been extinguished.” Id. Retaining the Orange Book listing of such patents insures that an NDA holder’s request to de-list the patents will not deprive first-to-file ANDA applicants of their 180-day exclusivity.
FDA’s regulations allow third parties to contest patent and use code information published in the Orange Book through a “Patent Listing Dispute” by submitting a written narrative describing the disputed factual information. Id. at § 314.53(f)(1). The narrative description of the dispute is limited to no more than 250 words and should be non-confidential because FDA will send the narrative to the NDA holder. Id. Within 30 days of receiving the notice of patent listing dispute, the NDA holder must then either certify that the patent or use code information is correct as published in the Orange Book or withdraw the patent or amend the Orange Book information. Id. FDA will not adjudicate the dispute and will not issue its own determination of the correctness of the published Orange Book information. If the NDA holder certifies that the Orange Book information is correct, then FDA will not alter the Orange Book listing. Id. Although FDA does not adjudicate listing disputes, “FDA will promptly post information on its Web site regarding whether a patent listing dispute has been submitted . . . and whether the NDA holder has timely responded to the patent listing dispute.” Id.
The Orange Book thus presents up-to-date patent information together with basic information about the approved drug, its patented uses, and applicable regulatory exclusivities. The Orange Book further identifies approved drugs that are candidates as “listed drugs” for generic copying. In addition, the Orange Book provides generic manufacturers with information about when, based on applicable regulatory exclusivities, an ANDA or paper NDA may be submitted and what patents, if any, potentially stand in the way of final approval of the ANDA or paper NDA. In this way, the Orange Book serves an important notice function to the public and to generic drug manufacturers.
Paragraph IV Certification
In order to promote the orderly adjudication of drug patents, the FDCA imposes certain patent-related duties on paper NDA applicants and ANDA applicants. For each patent identified in the Orange Book as covering a listed drug or its use, the applicant is required to make one of four certifications to FDA that apprises FDA about patent-related timing issues affecting the final approval of the application. The four certifications that must be made “to the best of [the applicant’s] knowledge” include statements that:
(i) no relevant patent has been filed,
(ii) the patent has expired,
(iii) the generic copy of the drug will not be marketed before the patent expires, or
(iv) the patent is invalid or will not be infringed by the manufacture, use, or sale of the generic copy of the drug.
21 U.S.C. §§ 355(b)(2)(A)(i) – (iv) (paper NDA); 355(j)(2)(A)(vii)(I) – (IV) (ANDA).
The first two certifications inform FDA that no patent-related impediment stands in the way of finally approving the paper NDA or ANDA. Id. at §§ 355(c)(3)(A); 355(j)(5)(B)(i). In contrast, a “Paragraph III Certification” informs FDA of the applicant’s acquiescence in postponing final approval of the paper NDA or ANDA until after the patent has expired. Id. at §§ 355(c)(3)(B); 355(j)(5)(B)(ii). Because the applicant acquiesces in postponing final approval until after the patent expires, there is no basis for patent litigation. In fact, there is no obligation for the paper NDA applicant or ANDA applicant to notify the patent owner of the application’s submission. FDA may tentatively approve the application and specify that final approval will occur upon expiration of the patent.
A “Paragraph IV Certification” informs FDA of the applicant’s assessment that the Orange Book listed patent is either invalid or will not be infringed by the manufacture, use, or sale of the proposed drug product. The paper NDA or ANDA applicant thus informs FDA that the application may be finally approved before expiration of the patent term. FDA, however, does not adjudicate the applicant’s contentions of patent invalidity and non-infringement. Instead, FDA acts as a spectator to the courts’ adjudication of the patent issues. To that end, the FDCA and accompanying regulations provide a framework for (1) the patent owners and NDA holder to be notified of the applicant’s assertion of patent invalidity or non-infringement and (2) FDA’s monitoring of ensuing patent litigation, if any, to determine when a paper NDA or ANDA may be given final approval.
Notice of Paragraph IV Certification
The FDCA requires the paper NDA or ANDA applicant who makes a Paragraph IV Certification to give notice of the certification to the owner of the Orange Book listed patent and to the holder of the approved NDA for the reference listed drug forming the basis of the paper NDA or ANDA submission. See id. at §§ 355(b)(3) (paper NDA); 355(j)(2)(B) (ANDA).
The FDCA requires that the notice “shall”
(i) state that an application that contains data from bioavailability or bioequivalence studies has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and
(ii) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed.
Id. at §§ 355(b)(3)(D)(i) – (ii) (paper NDA); 355(j)(2)(B)(iv)(I) – (II) (ANDA).
FDA regulation clarifies and expands the required content of the notice, which must include:
(1) A statement that FDA has received an ANDA submitted by the applicant containing any required bioavailability or bioequivalence data or information.
(2) The ANDA number.
(3) A statement that the applicant has received the paragraph IV acknowledgment letter for the ANDA.
(4) The established name, if any, … of the proposed drug product.
(5) The active ingredient, strength, and dosage form of the proposed drug product.
(6) The patent number and expiration date, as submitted to the agency or as known to the applicant, of each patent alleged to be invalid, unenforceable, or not infringed.
(7) A detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid, unenforceable, or will not be infringed. The applicant shall include in the detailed statement:
(i) For each claim of a patent alleged not to be infringed, a full and detailed explanation of why the claim is not infringed.
(ii) For each claim of a patent alleged to be invalid or unenforceable, a full and detailed explanation of the grounds supporting the allegation.
(8) If the applicant alleges that the patent will not be infringed and the applicant seeks to preserve the option to later file a civil action for declaratory judgment . . . then the notice must be accompanied by an offer of confidential access to the ANDA for the sole and limited purpose of evaluating possible infringement of the patent....
(9) If the applicant does not reside or have a place of business in the United States, the name and address of an agent in the United States authorized to accept service of process for the applicant.
21 CFR § 314.95(c)(1) – (9).
The notice must be sent by registered or certified mail. Id. at § 314.95(a). Alternatively, the notice may be sent by “a designated delivery service.” Id. A designated delivery service is
any service provided by a trade or business that [FDA] determines:
(i) Is available to the general public throughout the United States;
(ii) Records electronically to its database, kept in the regular course of its business, or marks on the cover in which any item . . . is to be delivered, the date on which such item was given to such trade or business for delivery; and
(iii) Provides overnight or 2-day delivery service throughout the United States.
21 CFR § 314.95(g)(1)(i) - (iii).
There is one exception to an ANDA applicant’s obligation to provide notice of the ANDA to the Orange Book listed patent owner and NDA holder. An ANDA applicant is not required to provide notice regarding “a method-of-use patent that does not claim a use for which the applicant is seeking approval.” 21 CFR § 314.95(a)(3); see also 21 U.S.C. § 355(j)(2)(A)(viii). An ANDA applicant who has “carved out” all patented uses from its product label and seeks approval of only non-patented uses, is thus not required to provide notice. If no other Orange Book listed patent is applicable to the ANDA, then presumably FDA may approve the ANDA without notice to the NDA holder or method-of-use patent owner.
The timing of the notice is governed by the FDCA. If the Paragraph IV Certification is included in the original submission of the paper NDA or ANDA, then the applicant must wait until FDA gives the applicant notice that the submitted application has been accepted for filing. FDA’s notice of acceptance will include a “paragraph IV acknowledgment.” See 21 CFR § 314.95(b)(1). The applicant must then give notice of the Paragraph IV Certification to the patent and NDA stakeholders within 20 days of FDA’s acceptance of the paper NDA or ANDA’s filing. See 21 U.S.C. §§ 355(b)(3)(B)(i) (paper NDA); 355(j)(2)(B)(ii)(I) (ANDA). “The 20-day clock . . . begins on the day after the date of the postmark on the paragraph IV acknowledgment letter.” 21 CFR § 314.95(b)(1). However, “[w]hen the 20th day falls on Saturday, Sunday, or a Federal holiday, the 20th day will be the next day that is not a Saturday, Sunday, or Federal holiday.” Id.
If, however, the Paragraph IV Certification is made through an amendment to a filed paper NDA or ANDA, then the notice of the Paragraph IV Certification must be made at the same time as the amendment. Id. at §§ 355(b)(3)(B)(ii) (paper NDA); 355(j)(2)(B)(ii)(II) (ANDA).
In either situation, the paper NDA applicant or ANDA applicant must document receipt of the notice of the Paragraph IV Certification in the following manner:
The applicant must amend its ANDA to provide documentation of the date of receipt of the notice … by each person provided the notice. The amendment must be submitted to FDA within 30 days after the last date on which notice was received by [the patent owner or NDA holder]. The applicant’s amendment also must include documentation that its notice was sent on a date that complies [with regulatory requirements]. . . . FDA will accept, as adequate documentation of the date the notice was sent, a copy of the registered mail receipt, certified mail receipt, or receipt from a designated delivery service. . . . FDA will accept as adequate documentation of the date of receipt a return receipt, signature proof of delivery by a designated delivery service, or a letter acknowledging receipt by the person provided the notice. . . . A copy of the notice itself need not be submitted to [FDA].
21 CFR § 314.95(e).
45-Day Deadline & 30-Month Stay of Final Approval
The notice of the Paragraph IV Certification sent by the paper NDA applicant or ANDA applicant starts the clock on a very significant 45-day period. More specifically, the counting of the 45-day period begins on “the day following the date of receipt of the notice by the patent owner or its representative and by the approved application holder as the first day of the 45-day period….” 21 CFR § 314.95(f); see also 21 U.S.C. §§ 355(c)(3)(C) & 355(j)(5)(B)(iii).
The 45-day period gives the patent owner and NDA holder an opportunity to seize certain benefits by filing a patent infringement lawsuit against the paper NDA applicant or ANDA applicant before the 45-day deadline expires. If the stakeholders do not file suit within the 45-day period, then FDA may finally approve the paper NDA or ANDA at any time. See 21 U.S.C. §§ 355(c)(3)(C) & 355(j)(5)(B)(iii).
An ANDA or paper NDA applicant “must notify FDA in writing within 14 days of the filing of any legal action filed within 45 days of receipt of the notice of paragraph IV certification by any recipient.” 21 CFR § 314.107(f)(2)(i). The notice must include, among other things, “[a] statement that an action for patent infringement, identified by court, case number, and the patent number(s) of the patent(s) at issue in the action, has been filed in an appropriate court on a specified date.” Id.
Although the ANDA or paper NDA applicant must notify FDA of lawsuits filed within the 45-day period, FDA regulations permit the patent owner or NDA holder that initiates the lawsuit to “also notify FDA of the filing of any legal action for patent infringement.” Id. at (f)(2)(ii). Most plaintiff patent owners and NDA holders take advantage of this option to notify FDA of the filed lawsuit to insure FDA is aware that a lawsuit was filed within the 45-day deadline and that FDA approval of the ANDA or paper NDA will be postponed.
When the patent owner, NDA holder, or both together file a lawsuit within the 45-day period, then FDA’s final approval of the paper NDA or ANDA is automatically stayed or postponed for a period of 30 months, “beginning on the date of the receipt of the [Paragraph IV Certification] notice” by the patent owner and NDA holder. Id. The 30-month stay of final approval is intended to give the parties and the court time to orderly adjudicate the merits of the patent validity and infringement issues. Congress’s expectation is that parties and the court will use the 30-month period efficiently and act expeditiously in litigating the patent issues.
Although the stay is initially set for a duration of 30 months, in practice, the stay of FDA’s final approval of the ANDA or paper NDA is subject to adjustment. For example, the stay may be shortened or extended “as the court may order because either party to the action failed to reasonably cooperate in expediting the action.” See 21 U.S.C. §§ 355(c)(3)(C) & 355(j)(5)(B)(iii). Other possible modifications to the duration of the 30-month stay of final FDA approval include:
(i) if before the expiration of such period the district court decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity), the approval shall be made effective on
(I) the date on which the court enters judgment reflecting the decision; or
(II) the date of a settlement order or consent decree signed and entered by the court stating that the patent that is the subject of the certification is invalid or not infringed;
(ii) if before the expiration of such period the district court decides that the patent has been infringed
(I) if the judgment of the district court is appealed, the approval shall be made effective on
(aa) the date on which the court of appeals decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity); or
(bb) the date of a settlement order or consent decree signed and entered by the court of appeals stating that the patent that is the subject of the certification is invalid or not infringed; or
(II) if the judgment of the district court is not appealed or is affirmed, the approval shall be made effective on the date specified by the district court in a court order under section 271(e)(4)(A) of title 35;
(iii) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective as provided in clause (i); or
(iv) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent has been infringed, the approval shall be made effective as provided in clause (ii).
See 21 U.S.C. §§ 355(c)(3)(C)(i) – (iv) (paper NDA) & 355(j)(5)(B)(I) – (IV) (ANDA).
Declaratory Judgment Action by Paper NDA/ANDA Applicant
Another significant aspect of the 45-day period following notice of a Paragraph IV Certification is that failure by the patent owner or NDA holder to file suit within the 45-day period permits the paper NDA applicant or ANDA applicant to file a declaratory judgment action against the patent owner and NDA holder. A declaratory judgment action is a lawsuit in which the generic drug manufacturer asks the court to declare that the patent is invalid or not infringed. A generic drug manufacturer might wish to file such a suit in order to obtain certainty that further investment in developing its drug will not be wasted due to the intervention of third-party patent rights.
The FDCA restrains the generic drug manufacturer’s ability file such a declaratory judgment action—giving a 45-day preference to the patent owner and NDA holder to file suit first. That preference is given in an effort to facilitate the orderly adjudication of patent issues. Recognizing that multiple generic drug manufacturers may seek approval for the same reference listed drug, it was thought that the brand company should not be forced to litigate in multiple courts chosen by the generic drug manufacturers but instead, to the extent possible, should be permitted to bring suit in a single court against all applicants.
Thus, the FDCA provides that
No [declaratory judgment] action may be brought … by an applicant … for a declaratory judgment with respect to a patent which is the subject of [a Paragraph IV Certification] … unless
(aa) the 45-day period referred to in such subparagraph has expired;
(bb) neither the owner of such patent nor the holder of the approved application under subsection (b) of this section for the drug that is claimed by the patent or a use of which is claimed by the patent brought a civil action against the applicant for infringement of the patent before the expiration of such period….; and
(cc) in any case in which the [Paragraph IV Certification] relates to noninfringement, the notice was accompanied by [an offer of confidential access to information].
21 U.S.C. §§ 355(c)(3)(D)(i)(I)(aa) – (cc) (paper NDA); 355(j)(5)(C)(i)(I)(aa) – (cc) (ANDA).
If those three conditions are met, then the paper NDA applicant or ANDA applicant may file a declaratory judgment action in the judicial district in which it has a principal place of business or a regular established place of business. See 21 U.S.C. §§ 355(c)(3)(D)(i)(II) (paper NDA); 355(j)(5)(C)(i)(II) (ANDA).
Offer of Confidential Access to Information
As discussed above, the paper NDA applicant or ANDA applicant may certify under paragraph IV that the proposed drug product will not infringe a valid Orange Book listed patent. The defense of non-infringement ordinarily turns on some aspect of the proposed drug product being different from or outside of the scope of the patent claims.
However, merely informing the patent and reference listed drug stakeholders that, in the opinion of the paper NDA applicant or ANDA applicant, the proposed product does not infringe reveals nothing about the merits of that contention. Without access to information about the proposed drug product, the patent owner and NDA holder cannot assess the ANDA applicant’s non-infringement contention and then make an informed decision about whether to file suit. Thus, in order to fairly assess and understand the applicant’s contention that the proposed drug product does not infringe the patent, the patent owner and NDA holder must be informed about the properties of the proposed drug product.
Accordingly, in order to obtain the right to file an action for a declaratory judgment of non-infringement in the event that the stakeholders do not file their own lawsuit within the 45-day period, a paper NDA applicant and ANDA applicant must include an “offer of confidential access to application” in their notice of Paragraph IV Certification that asserts a defense of non-infringement. See 21 U.S.C. §§ 355(c)(3)(D)(i)(I)(cc) (paper NDA); 355(j)(5)(C)(i)(I)(cc) (ANDA).
The FDCA imposes the following requirements on an offer of confidential access:
[An offer of confidential access to application] is a document providing an offer of confidential access to the application that is in the custody of the [paper NDA applicant or ANDA applicant] for the purpose of determining whether an action [within the 45-day period] should be brought. The document providing the offer of confidential access shall contain such restrictions as to persons entitled to access, and on the use and disposition of any information accessed, as would apply had a protective order been entered for the purpose of protecting trade secrets and other confidential business information. A request for access to an application under an offer of confidential access shall be considered acceptance of the offer of confidential access with the restrictions as to persons entitled to access, and on the use and disposition of any information accessed, contained in the offer of confidential access, and those restrictions and other terms of the offer of confidential access shall be considered terms of an enforceable contract. Any person provided an offer of confidential access shall review the application for the sole and limited purpose of evaluating possible infringement of the patent that is the subject of the [Paragraph IV Certification] and for no other purpose, and may not disclose information of no relevance to any issue of patent infringement to any person other than a person provided an offer of confidential access. Further, the application may be redacted by the applicant to remove any information of no relevance to any issue of patent infringement.
21 U.S.C. §§ 355(c)(3)(D)(i)(III) (paper NDA); 355(j)(5)(C)(i)(III) (ANDA).
The Orange Book listed patent owner and NDA holder ordinarily accept the offer of confidential access in order to determine if they have a good-faith basis for filing a lawsuit asserting infringement of the listed patent. If such grounds for a lawsuit are present, the stakeholders typically file suit within the 45-day deadline, triggering the 30-month stay of FDA approval of the ANDA or paper NDA. However, if the stakeholders do not file suit within the 45-day deadline, then FDA can approve the ANDA or paper NDA at any time. However, the ANDA applicant or paper NDA applicant are faced with uncertainty about whether the stakeholders will file suit at some future time and disrupt the launch and sell of their generic drug.
To eliminate that uncertainty, the ANDA applicant or paper NDA applicant may file a lawsuit seeking the court’s declaration that the Orange Book listed patent is invalid, unenforceable, or not infringed. A declaratory judgment lawsuit brought by an ANDA applicant or paper NDA applicant is different from litigation brought by an Orange Book patent owner or NDA holder under the Hatch-Waxman Act. There is no 30-month stay of FDA approval of the generic drug application, and the litigation proceeds without concern for other regulations affecting the timing of FDA’s approval of the application.