DCT
1:22-cv-01312
Galderma Laboratories LP v. Alembic Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Galderma Laboratories, L.P. (Texas) and TCD Royalty Sub LP (Delaware)
- Defendant: Alembic Pharmaceuticals Limited (Republic of India) and Alembic Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:22-cv-01312, D. Del., 10/05/2022
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Alembic Pharmaceuticals, Inc. is a Delaware corporation, and Defendant Alembic Pharmaceuticals Limited is a foreign corporation subject to personal jurisdiction in the district through its business activities and those of its wholly-owned subsidiary.
- Core Dispute: This is a Hatch-Waxman action wherein Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) for a generic 40 mg doxycycline capsule constitutes an act of infringement of two patents covering once-daily, sub-antimicrobial dose formulations.
- Technical Context: The technology involves pharmaceutical formulations of the tetracycline antibiotic doxycycline, specifically designed to be taken once daily to treat inflammatory conditions like rosacea by inhibiting certain enzymes without producing clinically significant antibiotic effects.
- Key Procedural History: The lawsuit was filed in response to a notice letter dated August 23, 2022, in which Defendant Alembic Ltd. informed Plaintiffs of its ANDA filing containing a Paragraph IV Certification against the patents-in-suit, signaling its intent to market a generic product before patent expiration. The patents are listed in the FDA's "Orange Book" as covering Plaintiffs' ORACEA® product.
Case Timeline
| Date | Event |
|---|---|
| 2003-04-07 | Earliest Priority Date for '532 and '740 Patents |
| 2010-07-06 | U.S. Patent No. 7,749,532 Issues |
| 2012-06-26 | U.S. Patent No. 8,206,740 Issues |
| 2022-08-23 | Date of Alembic's Paragraph IV Certification Notice Letter |
| 2022-10-05 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,749,532, "Once Daily Formulations of Tetracyclines," issued July 6, 2010
The Invention Explained
- Problem Addressed: The patent describes the challenge of using doxycycline for its anti-inflammatory or anti-collagenase properties without incurring the undesirable side effects of long-term antibiotic administration, such as the disruption of healthy intestinal flora and the development of resistant organisms. Additionally, it notes that existing therapeutic regimens, such as twice-daily dosing, can present patient compliance issues. (’532 Patent, col. 2:5-18).
- The Patented Solution: The invention is a once-daily oral dosage form of doxycycline that provides a specific, extended-release blood concentration profile. It combines an immediate release (IR) component and a delayed release (DR) component to maintain a steady-state blood level high enough to inhibit collagenase but below the threshold for significant antibacterial action. (’532 Patent, col. 2:21-41, 5:24-41). This allows for the treatment of conditions like rosacea or periodontal disease with a single daily pill.
- Technical Importance: The formulation aims to decouple doxycycline's anti-inflammatory benefits from its antibiotic effects, enabling chronic, once-daily administration for non-infectious diseases with a potentially improved safety and compliance profile. (’532 Patent, col. 2:1-9).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶36).
- The essential elements of independent claim 1 are:
- An oral pharmaceutical composition of doxycycline.
- Which at a once-daily dosage provides steady state blood levels between a minimum of 0.1 µg/ml and a maximum of 1.0 µg/ml.
- The composition consists of an immediate release (IR) portion where the drug consists of about 30 mg doxycycline.
- The composition consists of a delayed release (DR) portion where the drug consists of about 10 mg doxycycline.
- The DR portion is in the form of pellets coated with at least one enteric polymer.
- The composition includes one or more pharmaceutically acceptable excipients.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 8,206,740, "Once Daily Formulations of Tetracyclines," issued June 26, 2012
The Invention Explained
- Problem Addressed: The '740 Patent, a continuation of the application leading to the '532 Patent, addresses the same technical problem of providing a safe and effective once-daily doxycycline therapy for inflammatory conditions while avoiding antibiotic side effects. (’740 Patent, col. 2:5-19).
- The Patented Solution: The solution is materially the same as that described in the '532 Patent: a combination IR/DR formulation designed to achieve a sub-antimicrobial therapeutic window for doxycycline. (’740 Patent, col. 2:20-41).
- Technical Importance: As with the '532 Patent, the formulation's importance lies in enabling a once-daily dosing regimen for chronic inflammatory diseases. (’740 Patent, col. 2:1-9).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶36).
- The essential elements of independent claim 1 are:
- An oral pharmaceutical composition of doxycycline.
- Which at a once-daily dosage provides steady state blood levels between a minimum of 0.1 µg/ml and a maximum of 1.0 µg/ml.
- The composition consists of an immediate release (IR) portion comprising 30 mg doxycycline.
- The composition consists of a delayed release (DR) portion comprising 10 mg doxycycline.
- The composition optionally includes one or more pharmaceutically acceptable excipients.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendants’ "ANDA Product," identified as Doxycycline Capsules 40 mg, for which ANDA No. 217674 was submitted to the FDA (Compl. ¶¶12, 30).
Functionality and Market Context
The complaint alleges that the accused product is a generic version of Galderma’s ORACEA® (doxycycline, USP) 40 mg Capsules (Compl. ¶¶25, 36). As an ANDA product, it is intended to be a therapeutic equivalent to the branded drug. The complaint alleges that Alembic submitted bioequivalence data to the FDA, which, if true, would mean the accused product is designed to have the same dosage form, strength, and pharmacokinetic profile as ORACEA® (Compl. ¶36). The patents-in-suit are listed in the FDA's Orange Book for ORACEA®, linking the patented technology to the branded product that the accused product seeks to copy (Compl. ¶29).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that the act of submitting ANDA No. 217674 constitutes infringement of the patents-in-suit under 35 U.S.C. § 271(e)(2) (Compl. ¶37). The infringement theory is based on the allegation that the product described in the ANDA will, upon approval and marketing, meet all the limitations of at least claim 1 of each patent (Compl. ¶36). The complaint does not contain a claim chart or specific factual allegations mapping claim elements to the accused product's formulation, which is typical for an initial ANDA complaint filed prior to receiving the ANDA itself in discovery.
'532 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oral pharmaceutical composition of doxycycline... | The accused product is an oral Doxycycline Capsule, 40 mg. | ¶¶12, 36 | col. 13:1-2 |
| ...which at a once-daily dosage will give steady state blood levels of doxycycline of a minimum of 0.1 µg/ml and a maximum of 1.0 µg/ml... | The accused product is allegedly bioequivalent to ORACEA®, which is the commercial embodiment of the patented formulation designed to achieve these specific pharmacokinetic parameters. | ¶36 | col. 2:39-41 |
| ...the composition consisting of (i) an immediate release (IR) portion comprising a drug, wherein the drug consists of about 30 mg doxycycline... | The complaint alleges the accused 40 mg capsule meets this limitation, implying it contains an IR component with approximately 30 mg of doxycycline to match the reference drug. | ¶36 | col. 2:46-59, 13:5-8 |
| ...(ii) a delayed release (DR) portion comprising a drug, wherein the drug consists of about 10 mg doxycycline, in which the DR portion is in the form of pellets coated with at least one enteric polymer... | The complaint alleges the accused 40 mg capsule meets this limitation, implying it contains a DR component with approximately 10 mg of doxycycline in the form of enteric-coated pellets to match the reference drug. | ¶36 | col. 7:11-49, 13:9-12 |
'740 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oral pharmaceutical composition of doxycycline... | The accused product is an oral Doxycycline Capsule, 40 mg. | ¶¶12, 36 | col. 11:57-58 |
| ...which at a once-daily dosage will give steady state blood levels of doxycycline of a minimum of 0.1 µg/ml and a maximum of 1.0 µg/ml... | The accused product is allegedly bioequivalent to ORACEA®, the commercial embodiment of the patented formulation designed to achieve these specific pharmacokinetic parameters. | ¶36 | col. 2:39-41 |
| ...the composition consisting of (i) an immediate release (IR) portion comprising 30 mg doxycycline; (ii) a delayed release (DR) portion comprising 10 mg doxycycline... | The complaint alleges the accused 40 mg capsule meets this limitation, implying its formulation contains IR and DR components with 30 mg and 10 mg of doxycycline, respectively. | ¶36 | col. 2:46-59, 11:61-64 |
Identified Points of Contention
- Factual Question: The central dispute will be whether the specific formulation detailed in Alembic's confidential ANDA actually contains every element of the asserted claims. This includes the precise amounts of doxycycline in the IR and DR portions, and whether the DR portion consists of enteric-coated pellets.
- Pharmacokinetic Question: A potential point of contention may be whether the bioequivalence data for Alembic's product demonstrates that it will achieve the claimed steady-state blood levels. The parties could dispute the clinical study's methodology or the interpretation of its results.
- Scope Question: The term "about" preceding the dosage amounts in the '532 patent's claim 1 raises a question of scope. The court may need to determine how much deviation from "30 mg" and "10 mg" is permissible under this term.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail to identify specific claim construction disputes. However, based on the patent language, the following terms may be central to the case.
Term: "steady state blood levels of doxycycline of a minimum of about 0.1 µg/ml and a maximum of about 1.0 µg/ml"
- Context and Importance: This pharmacokinetic (PK) parameter is the functional heart of the invention, defining the therapeutic window that distinguishes the claimed formulation from prior art antibiotic doses. Infringement hinges on whether the accused product is proven to produce these blood levels.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of "about" suggests the numerical values are not rigid limits. The specification describes the goal more generally as providing levels "high enough to be effective to have a beneficial effect" but "not as high as to exert an antibacterial effect" (’532 Patent, col. 2:25-28), which could support a functional rather than strictly numerical definition.
- Evidence for a Narrower Interpretation: The specification provides specific clinical data for a 75/25 IR/DR 40 mg formulation, showing a mean steady-state Cmax of 602 ng/mL (0.6 µg/mL) and a 24-hour concentration of 177 ng/mL (0.177 µg/mL) (’532 Patent, Table 1, col. 13:25-45). A party could argue these concrete examples inform and limit the scope of the claimed range.
Term: "consists of about 30 mg doxycycline" (’532 Patent, Claim 1) vs. "comprising 30 mg doxycycline" (’740 Patent, Claim 1)
- Context and Importance: Practitioners may focus on this term because the transition from the narrower "consists of" in the parent patent to the broader "comprising" in the continuation patent for the same IR component suggests a deliberate change in scope that could be pivotal.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (for the '740 patent): The term "comprising" is well-established as open-ended, meaning the IR portion must contain 30 mg of doxycycline but could also include other unrecited ingredients, active or inactive. This would cover a wider range of potential generic formulations.
- Evidence for a Narrower Interpretation (for the '532 patent): The phrase "consists of" is a term of art that creates a strong presumption that the component has no other elements. A party could argue that the IR portion of a product infringing the '532 patent can contain only "about 30 mg doxycycline" as its drug component, to the exclusion of any others.
VI. Other Allegations
Indirect Infringement
The complaint alleges that if Alembic manufactures and sells its ANDA Product, it will induce and/or contribute to infringement under 35 U.S.C. § 271(a), (b), and/or (c) (Compl. ¶39). This allegation is based on the premise that the product's FDA-approved label will instruct physicians and patients to use the product in an infringing manner (i.e., once daily for the treatment of inflammatory conditions).
Willful Infringement
The complaint alleges that "Alembic was aware of the patents-in-suit before it filed its ANDA" and that it "had no reasonable basis to believe that it did not infringe" (Compl. ¶42). This allegation is supported by the ANDA filer's statutory obligation to certify against patents listed in the Orange Book. The complaint also makes a conclusory allegation that this is an "exceptional case" under 35 U.S.C. § 285, seeking attorneys' fees (Compl. ¶43; Prayer for Relief ¶ F).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual correspondence: Does the specific formulation detailed in Alembic’s confidential ANDA submission—particularly the respective quantities of doxycycline in its immediate and delayed release components and the nature of the delayed-release mechanism—fall within the literal scope of the asserted claims?
- A key evidentiary question will be one of pharmacokinetic performance: Does the bioequivalence data submitted in the ANDA definitively show that Alembic’s product, when dosed once daily, achieves the steady-state blood concentration profile of 0.1 to 1.0 µg/ml required by the claims, or will there be a dispute over the interpretation or applicability of that data?
- A final question will concern claim construction and scope: How will the court define the boundaries of the term "about" as applied to the claimed dosages, and will the semantic difference between the '532 Patent's "consists of" and the '740 Patent's "comprising" create a dispositive distinction for infringement?