DCT

1:18-cv-00101

Takeda Pharma USA Inc v. DR Reddys Laboratories Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00101, D. Del., 01/17/2018
  • Venue Allegations: Plaintiff alleges venue is proper because Defendants consented to personal jurisdiction and venue in the District of Delaware for the purposes of this matter.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Colcrys® (colchicine) constitutes an act of infringement of seventeen patents covering methods of using colchicine to treat gout and Familial Mediterranean Fever (FMF).
  • Technical Context: The patents relate to methods for safely administering colchicine, a potentially toxic drug, by specifying dose adjustments to manage dangerous interactions when it is co-administered with other common medications that inhibit its metabolism or transport.
  • Key Procedural History: The action arises from Defendant’s submission of ANDA No. 209876 to the U.S. Food and Drug Administration (FDA) and its associated Paragraph IV certification, which asserts that Plaintiff's patents are invalid, unenforceable, or would not be infringed by the proposed generic product. Plaintiff commenced this action within the 45-day period provided by the Hatch-Waxman Act.

Case Timeline

Date Event
2008-10-15 Earliest Priority Date for Asserted Patents
2009-07-29 FDA grants approval for Colcrys®
2009-10-13 U.S. Patent 7,601,758 Issued
2009-11-17 U.S. Patent 7,619,004 Issued
2010-10-26 U.S. Patent 7,820,681 Issued
2011-03-15 U.S. Patent 7,906,519 Issued
2011-03-29 U.S. Patent 7,915,269 Issued
2011-05-03 U.S. Patent 7,935,731 Issued
2011-06-21 U.S. Patent 7,964,647 Issued
2011-06-21 U.S. Patent 7,964,648 Issued
2011-07-19 U.S. Patent 7,981,938 Issued
2012-01-10 U.S. Patent 8,093,296 Issued
2012-01-10 U.S. Patent 8,093,297 Issued
2012-01-10 U.S. Patent 8,093,298 Issued
2012-01-17 U.S. Patent 8,097,655 Issued
2013-04-09 U.S. Patent 8,415,395 Issued
2013-04-09 U.S. Patent 8,415,396 Issued
2013-05-14 U.S. Patent 8,440,721 Issued
2013-05-14 U.S. Patent 8,440,722 Issued
2017-12-11 Takeda receives DRL's Paragraph IV Notice Letter
2018-01-17 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,906,519 - “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND A SECOND ACTIVE AGENT,” Issued 03/15/2011

The Invention Explained

  • Problem Addressed: The patent describes that colchicine, a drug for treating conditions like gout, has a low therapeutic index, meaning the margin between an effective dose and a toxic dose is narrow (Compl. ¶19; ’681 Patent, col. 1:35-39). Co-administration with other drugs that inhibit certain metabolic enzymes (CYP3A4) or cellular transporters (P-glycoprotein) can dangerously increase colchicine levels in the body, leading to severe toxicity and, in some cases, death (’681 Patent, col. 2:45-51).
  • The Patented Solution: The invention provides methods for safely administering colchicine to a patient who is also taking a second drug known to be a CYP3A4 or P-gp inhibitor. The solution involves administering a reduced dosage of colchicine to counteract the metabolic inhibition caused by the second drug, thereby preventing toxic accumulation while maintaining a therapeutic effect (’681 Patent, col. 2:52-59, Abstract).
  • Technical Importance: The claimed methods provided a scientifically grounded protocol for managing a known, dangerous drug-drug interaction, enabling patients who required treatment with common interacting drugs (such as certain antibiotics or HIV medications) to continue using colchicine safely (Compl. ¶¶18, 23).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶80).
  • Essential elements of claim 1:
    • A method of using colchicine for the treatment of Familial Mediterranean Fever in a human patient.
    • The patient is concomitantly receiving administration of a second active agent that is a P-glycoprotein or CYP3A4 inhibitor.
    • The method comprises orally administering a reduced colchicine dosage amount to the patient.
    • The reduced dosage is reduced compared to a daily dosage amount that would be administered in the absence of the second active agent.
    • The daily dosage amount in the absence of the second active agent is 1.2 mg to 2.4 mg per day.
    • The reduced dosage amount is a maximum of 0.6 mg per day.

U.S. Patent No. 7,935,731 - “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND MACROLIDE ANTIBIOTICS,” Issued 05/03/2011

The Invention Explained

  • Problem Addressed: The patent addresses the specific danger of co-administering colchicine with macrolide antibiotics, such as clarithromycin or erythromycin, which are potent inhibitors of both CYP3A4 and P-gp and can significantly increase colchicine toxicity (’731 Patent, col. 6:3-10).
  • The Patented Solution: The invention provides methods for safely treating Familial Mediterranean Fever (FMF) by administering a reduced dosage of colchicine to a patient who is also taking a macrolide antibiotic. This dose reduction is designed to offset the metabolic interference from the antibiotic (’731 Patent, Abstract).
  • Technical Importance: These methods created a safer standard of care for patients with FMF who develop common bacterial infections that are typically treated with macrolide antibiotics, mitigating a previously high-risk drug-drug interaction (Compl. ¶¶18, 23).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶86).
  • Essential elements of claim 1:
    • A method of using colchicine for the treatment of Familial Mediterranean Fever in a human patient.
    • The patient is concomitantly receiving administration of a macrolide antibiotic.
    • The method comprises orally administering a reduced colchicine dosage amount to the patient.
    • The reduced dosage is reduced compared to a daily dosage amount that would be administered in the absence of the macrolide antibiotic.
    • The daily dosage amount in the absence of the macrolide antibiotic is a maximum of 2.4 mg per day.
    • The reduced dosage amount is a maximum of 0.6 mg per day.

Multi-Patent Capsule: U.S. Patent No. 8,093,298

  • Patent Identification: 8,093,298, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND MACROLIDE ANTIBIOTICS,” Issued 01/10/2012.
  • Technology Synopsis: This patent addresses the problem of colchicine toxicity when co-administered with the macrolide antibiotic clarithromycin for treating FMF. It provides a method of reducing the colchicine dose to a specific maximum level (0.6 mg/day) from a higher standard dose (max 2.4 mg/day) to ensure safety. (Compl. ¶46).
  • Asserted Claims: At least claim 1 (Compl. ¶92).
  • Accused Features: The proposed label for DRL's ANDA Product, which allegedly instructs the claimed dose reduction method for FMF patients also taking clarithromycin (Compl. ¶¶47-49).

Multi-Patent Capsule: U.S. Patent No. 7,964,648

  • Patent Identification: 7,964,648, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND A SECOND ACTIVE AGENT,” Issued 06/21/2011.
  • Technology Synopsis: This patent covers methods of using colchicine for treating both FMF and gout flares, focusing on dose reductions when co-administered with a CYP3A4 or P-gp inhibitor. It provides a method for reducing the colchicine dose from a standard amount to a specified lower maximum to manage drug interactions.
  • Asserted Claims: At least claim 1 (Compl. ¶98).
  • Accused Features: The proposed label for DRL's ANDA Product, which allegedly instructs the claimed dose reduction methods, and the anticipated off-label use of the product for gout treatment (Compl. ¶¶47-49, 99-100).

Multi-Patent Capsule: U.S. Patent No. 8,093,297

  • Patent Identification: 8,093,297, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND A SECOND ACTIVE AGENT,” Issued 01/10/2012.
  • Technology Synopsis: This patent covers methods of using colchicine for treating both FMF and gout flares, focusing on dose reductions when co-administered with a CYP3A4 or P-gp inhibitor. The claims specify a reduced colchicine dosage amount to mitigate toxicity from drug interactions.
  • Asserted Claims: At least claim 1 (Compl. ¶106).
  • Accused Features: The proposed label for DRL's ANDA Product and the product's anticipated use for FMF and off-label for gout, which will allegedly follow the claimed dose reduction methods (Compl. ¶¶107-108).

Multi-Patent Capsule: U.S. Patent No. 7,619,004

  • Patent Identification: 7,619,004, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND MACROLIDE ANTIBIOTICS,” Issued 11/17/2009.
  • Technology Synopsis: This patent claims methods for prophylactically treating gout flares by administering a reduced daily dose of colchicine to a patient who is also taking a macrolide antibiotic. It specifies a 75% reduction from the standard dosage to prevent toxicity.
  • Asserted Claims: At least claim 5 (Compl. ¶114).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for the prophylaxis of gout in patients who are also taking macrolide antibiotics, allegedly following the dose reduction instructions on the Colcrys® label (Compl. ¶¶113, 57).

Multi-Patent Capsule: U.S. Patent No. 7,601,758

  • Patent Identification: 7,601,758, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND MACROLIDE ANTIBIOTICS IN THE TREATMENT OF GOUT FLARES,” Issued 10/13/2009.
  • Technology Synopsis: This patent addresses the treatment of acute gout flares in patients concomitantly receiving macrolide antibiotics like clarithromycin. It claims a method of reducing the standard colchicine dose by about two-thirds to a single 0.6 mg dose, which is not to be repeated for at least three days.
  • Asserted Claims: At least claim 10 (Compl. ¶119).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for treating acute gout flares according to the dose-reduction methods described on the Colcrys® label (Compl. ¶¶118, 57).

Multi-Patent Capsule: U.S. Patent No. 7,820,681

  • Patent Identification: 7,820,681, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND A SECOND ACTIVE AGENT,” Issued 10/26/2010.
  • Technology Synopsis: This patent claims methods for the prophylactic treatment of gout flares in patients who are also taking the HIV drug ritonavir. It specifies a reduced daily dosage of colchicine (25% to 50% of the standard dose) to manage the drug interaction.
  • Asserted Claims: At least claim 1 (Compl. ¶124).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for gout prophylaxis in patients also taking ritonavir, allegedly following the dose reduction instructions on the Colcrys® label (Compl. ¶¶123, 57).

Multi-Patent Capsule: U.S. Patent No. 7,915,269

  • Patent Identification: 7,915,269, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND A SECOND ACTIVE AGENT,” Issued 03/29/2011.
  • Technology Synopsis: This patent claims methods for treating acute gout flares in patients who are also taking the HIV drug ritonavir. It specifies a reduced colchicine dosage to manage the drug interaction safely.
  • Asserted Claims: Claim 1 (Compl. ¶129).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for treating acute gout in patients also taking ritonavir, allegedly following the dose reduction instructions on the Colcrys® label (Compl. ¶¶128, 57).

Multi-Patent Capsule: U.S. Patent No. 7,964,647

  • Patent Identification: 7,964,647, “COLCHICINE COMPOSITIONS AND METHODS,” Issued 06/21/2011.
  • Technology Synopsis: This patent describes a method for treating an acute gout attack by administering a specific low-dose regimen of colchicine (1.2 mg followed by 0.6 mg one hour later), which was found to be as effective as traditional high-dose regimens but with significantly fewer side effects.
  • Asserted Claims: Claim 1 (Compl. ¶134).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for treating acute gout flares according to the low-dose regimen that is now the standard of care and described on the Colcrys® label (Compl. ¶¶133, 21-22).

Multi-Patent Capsule: U.S. Patent No. 7,981,938

  • Patent Identification: 7,981,938, “COLCHICINE COMPOSITIONS AND METHODS,” Issued 07/19/2011.
  • Technology Synopsis: This patent claims a method for prophylactically treating chronic gout by administering a daily dose of 0.6 mg or 1.2 mg of colchicine. This method is part of the established standard of care for managing chronic gout.
  • Asserted Claims: Claim 1 (Compl. ¶139).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for the prophylaxis of chronic gout, a primary indication for Colcrys® (Compl. ¶¶138, 15).

Multi-Patent Capsule: U.S. Patent No. 8,093,296

  • Patent Identification: 8,093,296, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND MACROLIDE ANTIBIOTICS,” Issued 01/10/2012.
  • Technology Synopsis: This patent claims methods for treating an acute gout flare in a patient also taking a macrolide antibiotic. It specifies a reduced colchicine dosage amount to manage the drug interaction.
  • Asserted Claims: At least claim 1 (Compl. ¶144).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for treating acute gout in patients also taking macrolide antibiotics, allegedly following the dose reduction instructions on the Colcrys® label (Compl. ¶¶143, 57).

Multi-Patent Capsule: U.S. Patent No. 8,097,655

  • Patent Identification: 8,097,655, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND MACROLIDE ANTIBIOTICS,” Issued 01/17/2012.
  • Technology Synopsis: This patent claims a method for the prophylactic treatment of gout flares in patients also taking a macrolide antibiotic. It specifies administering a reduced daily dose of colchicine (a 75% reduction) to mitigate toxicity.
  • Asserted Claims: At least claim 1 (Compl. ¶149).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for the prophylaxis of gout in patients also taking macrolide antibiotics, allegedly following the dose reduction instructions on the Colcrys® label (Compl. ¶¶148, 57).

Multi-Patent Capsule: U.S. Patent No. 8,415,395

  • Patent Identification: 8,415,395, “COLCHICINE COMPOSITIONS AND METHODS,” Issued 04/09/2013.
  • Technology Synopsis: This patent claims a method of treating an acute gout flare by administering a low-dose regimen (1.2 mg then 0.6 mg), which provides a lower incidence of adverse events compared to higher historical doses.
  • Asserted Claims: At least claim 1 (Compl. ¶154).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for treating acute gout according to the patented low-dose regimen (Compl. ¶¶153, 21-22).

Multi-Patent Capsule: U.S. Patent No. 8,415,396

  • Patent Identification: 8,415,396, “COLCHICINE COMPOSITIONS AND METHODS,” Issued 04/09/2013.
  • Technology Synopsis: This patent claims a method for the prophylactic treatment of gout by administering a daily dose of 0.6 mg or 1.2 mg of colchicine. This is a standard prophylactic regimen.
  • Asserted Claims: At least claim 1 (Compl. ¶159).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for the prophylaxis of gout, a primary indication for Colcrys® (Compl. ¶¶158, 15).

Multi-Patent Capsule: U.S. Patent No. 8,440,721

  • Patent Identification: 8,440,721, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND A SECOND ACTIVE AGENT,” Issued 05/14/2013.
  • Technology Synopsis: This patent claims a method for treating acute gout flares in patients who are also taking the drug verapamil. It specifies a reduced colchicine dosage to manage the drug interaction.
  • Asserted Claims: At least claim 1 (Compl. ¶164).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for treating acute gout in patients also taking verapamil, allegedly following the dose reduction instructions on the Colcrys® label (Compl. ¶¶163, 61).

Multi-Patent Capsule: U.S. Patent No. 8,440,722

  • Patent Identification: 8,440,722, “METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND A SECOND ACTIVE AGENT,” Issued 05/14/2013.
  • Technology Synopsis: This patent claims a method for the prophylactic treatment of gout flares in patients who are also taking the drug verapamil. It specifies administering a reduced daily dosage of colchicine to manage the drug interaction.
  • Asserted Claims: At least claim 1 (Compl. ¶168).
  • Accused Features: The anticipated off-label use of DRL's ANDA Product for gout prophylaxis in patients also taking verapamil, allegedly following the dose reduction instructions on the Colcrys® label (Compl. ¶¶167, 61).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant DRL's proposed generic 0.6 mg oral colchicine tablet, as described in Abbreviated New Drug Application (“ANDA”) No. 209876 (the “ANDA Product”) (Compl. ¶¶1, 37).

Functionality and Market Context

DRL's ANDA seeks FDA approval to market its colchicine product solely for the treatment of Familial Mediterranean Fever (FMF), a rare disease (Compl. ¶30). The complaint alleges DRL has made a "section viii carve-out" to omit the gout indications from its proposed label (Compl. ¶41). However, Plaintiff alleges that gout treatment and prevention accounts for approximately 99.77% of prescriptions for FDA-approved colchicine, while FMF accounts for only 0.23% (Compl. ¶31). Plaintiff alleges that because of established physician prescribing habits and state laws permitting or mandating generic substitution, DRL's product will be prescribed and dispensed for the patented (and carved-out) gout indications (Compl. ¶¶33, 36, 71-72). The complaint further alleges that DRL intends to manufacture its product in quantities that "far exceed the available market for the treatment of FMF" and to market it for the prevention and treatment of gout (Compl. ¶¶32, 66).

IV. Analysis of Infringement Allegations

7,906,519 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of using colchicine for the treatment of Familial Mediterranean Fever in a human patient DRL's ANDA seeks approval for its product to be used for the treatment of FMF (Compl. ¶38). ¶38 col. 4:32-35
who is concomitantly receiving administration of a second active agent that is a P-glycoprotein or CYP3A4 inhibitor DRL’s proposed label will allegedly instruct doctors and patients on dose adjustments for colchicine when taken with CYP3A4/P-gp inhibitors, such as those listed in the Colcrys® label (Compl. ¶45). The complaint provides a reproduction of Table 1 from the Colcrys® label, which details specific colchicine dose adjustments for patients co-administered strong or moderate CYP3A4 inhibitors for treating FMF or Gout Flares (Compl. ¶45, p. 15). ¶45 col. 4:51-56
said method comprising: orally administering a reduced colchicine dosage amount The proposed label will allegedly instruct administration of a reduced dosage, for example, a maximum daily dose of 0.6 mg, when co-administered with a strong CYP3A4 inhibitor (Compl. ¶46). ¶46 col. 6:30-34
wherein the reduced colchicine dosage amount is reduced compared to a daily dosage amount to be administered in the absence of the second active agent, The proposed label's instruction to reduce the dose from a standard 1.2-2.4 mg/day to a maximum of 0.6 mg/day constitutes a reduction compared to the standard dose (Compl. ¶46). ¶46 col. 6:27-34
wherein the daily dosage amount to be administered in the absence of the second active agent is 1.2 mg to 2.4 mg per day, The standard, unadjusted dose for FMF is alleged to be 1.2 to 2.4 mg per day, as reflected in the Colcrys® label (Compl. ¶46). ¶46 col. 8:54-57
and wherein the reduced colchicine dosage amount is a maximum of 0.6 mg per day. DRL's proposed label allegedly instructs that the adjusted maximum daily dose for FMF patients taking a strong CYP3A4 inhibitor is 0.6 mg per day (Compl. ¶46). ¶46 col. 8:54-57

7,935,731 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of using colchicine for the treatment of Familial Mediterranean Fever in a human patient DRL's ANDA seeks approval for its product to be used for the treatment of FMF (Compl. ¶38). ¶38 col. 4:32-35
who is concomitantly receiving administration of a macrolide antibiotic DRL's proposed label will allegedly instruct dose adjustments for colchicine when taken with macrolide antibiotics like clarithromycin, which are strong CYP3A4 inhibitors (Compl. ¶45). ¶45 col. 4:51-56
said method comprising orally administering a reduced colchicine dosage amount The proposed label will allegedly instruct administration of a reduced dosage, for example, a maximum daily dose of 0.6 mg, when co-administered with clarithromycin (Compl. ¶46). ¶46 col. 6:30-34
wherein the reduced colchicine dosage amount is reduced compared to a daily dosage amount to be administered in the absence of the macrolide antibiotic, The proposed label's instruction to reduce the dose from a standard maximum of 2.4 mg/day to a maximum of 0.6 mg/day constitutes a reduction (Compl. ¶46). ¶46 col. 6:27-34
wherein the daily dosage amount to be administered in the absence of the macrolide antibiotic is a maximum of 2.4 mg per day, The standard, unadjusted dose for FMF is alleged to be a maximum of 2.4 mg per day, as reflected in the Colcrys® label (Compl. ¶46). ¶46 col. 16:11-14
and wherein the reduced colchicine dosage amount is a maximum of 0.6 mg per day. DRL's proposed label allegedly instructs that the adjusted maximum daily dose for FMF patients taking clarithromycin is 0.6 mg per day (Compl. ¶46). ¶46 col. 16:15-17

Identified Points of Contention

  • Scope Questions: A central question for the Gout Patents will be whether DRL’s filing of an ANDA with a "carve-out" for the gout indication can still support a finding of induced infringement. The complaint alleges that DRL knows and intends that its product will be substituted for Colcrys® for the infringing off-label use, which constitutes the vast majority of the market (Compl. ¶¶66, 71-72). This raises the legal question of whether foreseeability and economic incentive are sufficient to establish the specific intent required for inducement, despite the formal carve-out.
  • Technical Questions: A primary factual question will be the exact content of DRL's proposed label. The complaint's infringement theory relies on the allegation that DRL's label for FMF will necessarily contain the same dose-adjustment instructions for interacting drugs as the Colcrys® label, thereby teaching the infringing steps of both the FMF and Gout patents (Compl. ¶¶47, 57). The court will need to compare the instructions on DRL's proposed label against the specific dosage limitations recited in the asserted claims.

V. Key Claim Terms for Construction

The Term: "concomitantly receiving administration" (from claim 1 of the ’519 and ’731 Patents)

  • Context and Importance: The timing of the administration of colchicine relative to the interacting drug is a core element of the claimed method. Practitioners may focus on this term because the dispute will require determining whether the instructions on DRL's proposed label teach an administration schedule that falls within the scope of this term.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification of a related patent (’298 Patent, asserted in Count III) contains a definition in its claims, stating the concomitant administration occurs "within 1 to 2 days of oral administration of colchicine" (Compl. ¶46). This language may support an interpretation that covers a multi-day window where the metabolic effects of the interacting drug persist.
    • Evidence for a Narrower Interpretation: A defendant could argue that the plain meaning implies simultaneous or near-simultaneous administration, or that specific examples in the patent specification only describe such scenarios, potentially limiting the term's temporal scope.

The Term: "reduced colchicine dosage amount" (from claim 1 of the ’519 and ’731 Patents)

  • Context and Importance: The infringement allegation hinges on DRL's label instructing a "reduced" dose. The definition of this term is critical to determining if the dosage specified on DRL's label meets this limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language suggests that any dosage amount less than the standard dose administered in the absence of the interacting drug would qualify as "reduced."
    • Evidence for a Narrower Interpretation: The claims themselves often quantify the reduction by defining both the standard dose (e.g., "1.2 mg to 2.4 mg per day") and the reduced dose (e.g., "a maximum of 0.6 mg per day") (’519 Patent, cl. 1). This explicit quantification in the claim body may define the scope of "reduced," suggesting that only reductions falling within these specific numerical ranges meet the limitation.

VI. Other Allegations

Indirect Infringement

The complaint's central theories are for indirect infringement.

  • Inducement: Plaintiff alleges that DRL, upon FDA approval, will induce infringement by healthcare providers and patients (Compl. ¶¶81, 87). The basis for this allegation is that DRL's proposed product label will explicitly instruct the performance of the patented dose-reduction methods (Compl. ¶48). For the Gout Patents, inducement is alleged based on DRL's knowledge of the patents (from the Orange Book listing), its alleged intent to market to the larger gout market, and the foreseeability that its product will be prescribed and substituted for the patented off-label uses (Compl. ¶¶55, 66, 71-72).
  • Contributory Infringement: For the Gout Patents, Plaintiff alleges contributory infringement, stating that DRL's ANDA Product is "especially made or adapted for use" in the infringing methods, is a "material part of the claimed inventions," and is not a "staple article of commerce capable of substantial non-infringing uses" (Compl. ¶¶100, 108). This latter point is supported by the allegation that the FMF market is insubstantial compared to the overwhelming use for gout (Compl. ¶75).

Willful Infringement

The complaint does not explicitly use the term "willful infringement," but it alleges that DRL is aware of all the asserted patents and that its actions render the case "exceptional" under 35 U.S.C. § 285, which is the statutory basis for awarding attorney's fees often associated with findings of willfulness (Compl. ¶¶76-77). This knowledge is based on DRL's Paragraph IV certification notifying Takeda of its ANDA filing against the patents (Compl. ¶38).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of inducement via a carved-out label: can Takeda establish that DRL possessed the requisite specific intent to induce infringement of the Gout Patents, despite DRL having formally omitted the gout indication from its proposed label? The resolution may depend on whether evidence of DRL's knowledge of market dynamics, manufacturing volumes, and economic incentives is sufficient to overcome the label carve-out.
  • A key question for contributory infringement will be the substantiality of the non-infringing use: will the court find that the product's sole approved indication for FMF—a market alleged to be less than 1% of the total colchicine market—constitutes a "substantial non-infringing use," or will it be deemed commercially insignificant, rendering the product a non-staple article of commerce for the purposes of the Gout Patents?
  • An evidentiary focus will be on the scope of the label's instructions: do the dose-adjustment instructions for managing drug interactions, which are allegedly required on DRL's label for the FMF indication, effectively teach the infringing steps of the Gout Patents as well, thereby creating a basis for inducement regardless of the carve-out?