DCT
1:23-cv-00711
Galderma Laboratories LP v. DR Reddy's Laboratories Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Galderma Laboratories, L.P. (Texas) and TCD Royalty Sub LP (Delaware)
- Defendant: Dr. Reddy’s Laboratories, Ltd. (India) and Dr. Reddy’s Laboratories, Inc. (New Jersey)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Cahill Gordon & Reindel LLP
- Case Identification: 1:23-cv-00711, D. Del., 06/30/2023
- Venue Allegations: Venue is alleged to be proper as Defendants have participated in acts of infringement in the district, including the preparation and filing of the Abbreviated New Drug Application (ANDA) that forms the basis of the suit.
- Core Dispute: Plaintiffs allege that Defendants' filing of an ANDA to market a generic 40 mg doxycycline capsule constitutes an act of infringement of two patents related to once-daily, dual-release oral formulations of the drug.
- Technical Context: The patents relate to pharmaceutical formulations for tetracycline-class antibiotics, specifically creating a once-daily dosage form that provides therapeutic anti-inflammatory effects while avoiding undesirable antibiotic side effects.
- Key Procedural History: This is a Hatch-Waxman action initiated under 35 U.S.C. § 271(e)(2) following Defendants' submission of ANDA No. 218034 with a Paragraph IV certification, seeking FDA approval to market a generic version of Plaintiffs' ORACEA® product. The patents-in-suit are listed in the FDA's "Orange Book" for ORACEA®. U.S. Patent No. 8,206,740 survived an inter partes review (IPR2013-00368), with a certificate issued in 2015 confirming the patentability of claims 1, 2, 5-15, and 19-22, which may strengthen its presumption of validity.
Case Timeline
| Date | Event |
|---|---|
| 2003-04-07 | Priority Date for ’532 and ’740 Patents |
| 2010-07-06 | Issue Date for U.S. Patent No. 7,749,532 |
| 2012-06-26 | Issue Date for U.S. Patent No. 8,206,740 |
| 2013-06-20 | Inter Partes Review (IPR2013-00368) filed against the ’740 Patent |
| 2015-05-13 | IPR Certificate issued, confirming patentability of asserted claims of the ’740 Patent |
| 2023-05-18 | Defendants send Paragraph IV Notice Letter to Plaintiffs |
| 2023-06-30 | Complaint Filed |
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 conventional doxycycline treatments as requiring twice-daily dosing, which can lead to poor patient compliance. Furthermore, standard antibiotic doses can cause undesirable side effects, such as disrupting healthy intestinal flora and fostering antibiotic resistance ('532 Patent, col. 2:1-17).
- The Patented Solution: The invention is a once-daily oral composition of doxycycline that achieves a specific therapeutic window. It combines an immediate release (IR) component with a delayed release (DR) component to maintain steady-state blood levels high enough for anti-inflammatory or anti-collagenase activity but low enough to avoid significant antibacterial effects ('532 Patent, col. 2:21-37). The goal is to keep blood levels between a minimum of approximately 0.1 µg/ml and a maximum of 1.0 µg/ml ('532 Patent, col. 2:38-41).
- Technical Importance: This formulation aimed to improve patient compliance for chronic conditions like rosacea and periodontal disease by enabling once-daily dosing, while minimizing the side effects associated with long-term antibiotic administration ('532 Patent, col. 1:5-17).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶26, ¶29).
- Essential elements of Claim 1:
- An oral pharmaceutical composition of doxycycline,
- that at a once-daily dosage provides steady state blood levels between 0.1 µg/ml and 1.0 µg/ml,
- the composition "consisting of":
- an immediate release (IR) portion of about 30 mg doxycycline,
- a delayed release (DR) portion of about 10 mg doxycycline, where the DR portion is in the form of pellets coated with an enteric polymer, and
- 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: As a continuation of the application leading to the ’532 patent, the ’740 patent addresses the same problems of patient non-compliance with twice-daily dosing and side effects from long-term antibiotic use (’740 Patent, col. 2:1-17).
- The Patented Solution: The invention is also a once-daily oral composition of doxycycline comprising both immediate and delayed release components to maintain blood concentrations within a sub-antimicrobial therapeutic range (’740 Patent, col. 2:21-37). It shares the same specification as the ’532 Patent.
- Technical Importance: The formulation provides the same clinical benefits of improved patient compliance and a more favorable side-effect profile for treating chronic inflammatory conditions (’740 Patent, col. 1:5-17).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶26, ¶29).
- Essential elements of Claim 1:
- An oral pharmaceutical composition of doxycycline,
- that at a once-daily dosage provides steady state blood levels between 0.1 µg/ml and 1.0 µg/ml,
- the composition "consisting of":
- an immediate release (IR) portion comprising 30 mg doxycycline,
- a delayed release (DR) portion comprising 10 mg doxycycline, and
- optionally, one or more pharmaceutically acceptable excipients.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
- Product Identification: Defendants’ proposed generic "Doxycycline Capsules, 40 mg," which is the subject of Abbreviated New Drug Application (ANDA) No. 218034 ("DRL's ANDA Product") (Compl. ¶7).
- Functionality and Market Context: The complaint alleges that DRL's ANDA Product is a generic version of Plaintiffs’ ORACEA® 40 mg doxycycline capsules (Compl. ¶26). It further alleges, upon information and belief, that Defendants have submitted data to the FDA demonstrating that their product is bioequivalent to ORACEA® (Compl. ¶26). The complaint states that Defendants have not provided Plaintiffs with a copy of the ANDA or detailed information about the product's formulation beyond what was in the notice letter (Compl. ¶24). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide specific details of the accused product's formulation, alleging infringement on the basis that the product is a generic version of ORACEA® and is bioequivalent, thereby meeting the claim limitations (Compl. ¶26).
’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 identified as Doxycycline Capsules, 40 mg. | ¶26 | col. 11:64-65 |
| 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 complaint alleges the accused product is bioequivalent to ORACEA®, which is asserted to meet this pharmacokinetic profile. | ¶26 | col. 11:66-col. 12:1 |
| 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 40 mg accused product meets all limitations of Claim 1, which implies it contains a 30 mg IR portion. | ¶26 | col. 12:2-4 |
| (ii) a delayed release (DR) portion comprising a drug, wherein the drug consists of about 10 mg doxycycline... | The complaint alleges the 40 mg accused product meets all limitations of Claim 1, which implies it contains a 10 mg DR portion. | ¶26 | col. 12:4-6 |
| in which the DR portion is in the form of pellets coated with at least one enteric polymer | The complaint alleges infringement of Claim 1, which requires this specific formulation for the DR portion. The factual basis for this allegation is not detailed. | ¶26 | col. 12:6-8 |
’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 identified as Doxycycline Capsules, 40 mg. | ¶26 | col. 11:57 |
| 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 complaint alleges the accused product is bioequivalent to ORACEA®, which is asserted to meet this pharmacokinetic profile. | ¶26 | col. 11:58-61 |
| the composition consisting of (i) an immediate release (IR) portion comprising 30 mg doxycycline; | The complaint alleges the 40 mg accused product meets all limitations of Claim 1, which implies it contains a 30 mg IR portion. | ¶26 | col. 11:62-63 |
| (ii) a delayed release (DR) portion comprising 10 mg doxycycline; | The complaint alleges the 40 mg accused product meets all limitations of Claim 1, which implies it contains a 10 mg DR portion. | ¶26 | col. 11:63-64 |
Identified Points of Contention
- Factual Questions: The central dispute will likely be factual, pending discovery of the ANDA's contents. Key questions include: Does the accused product's formulation contain distinct IR and DR portions? Do these portions contain 30 mg and 10 mg of doxycycline, respectively? Specifically for the ’532 patent, is the DR portion formulated as "pellets coated with at least one enteric polymer"?
- Scope Questions: The claims use the transition phrase "consisting of," which is highly restrictive and generally excludes any unrecited elements. A potential issue is whether the accused product contains any additional components that could place it outside the literal scope of the claims.
- Functional Limitation Questions: Infringement of the "steady state blood levels" limitation is a functional requirement. A dispute may arise over whether the bioequivalence data submitted to the FDA is sufficient to prove this limitation is met, or if different testing methodologies would yield a result outside the claimed 0.1-1.0 µg/ml range.
V. Key Claim Terms for Construction
The Term: "consisting of" (in the preamble of the composition list in Claim 1 of both patents)
- Context and Importance: This is a term of art in patent law that creates a strong presumption that the claim is "closed" and does not read on compositions containing unrecited ingredients. Its construction is critical because if Defendants' formulation includes other active agents or formulation components that materially alter the product, they may argue for non-infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term is generally understood to be closed, but courts have allowed for impurities or components that do not materially affect the "basic and novel" properties of the invention. Plaintiffs might argue any additional excipients in the accused product fall into this category.
- Evidence for a Narrower Interpretation: The term's plain meaning in patent law is strictly limiting. Defendants may argue that any unrecited element, regardless of its effect, removes the product from the claim's scope. The specification does not appear to provide language that would broaden this standard interpretation.
The Term: "delayed release (DR) portion" (Claim 1 of both patents)
- Context and Importance: The invention's core is the specific combination of an IR portion and a DR portion. The definition of what qualifies as a "delayed release" portion is fundamental. This is especially true for the ’740 patent, whose claim does not specify the structure of the DR portion (unlike the ’532 patent).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is functional. Plaintiffs may argue that any component that releases doxycycline on a delayed timeline after administration meets the limitation, regardless of the specific mechanism.
- Evidence for a Narrower Interpretation: The specification provides specific examples of DR technology, primarily "a coating of enteric materials" that are "substantially insoluble in the acidic environment of the stomach" and dissolve at a higher pH (’532 Patent, col. 7:12-18). Defendants may argue the term should be limited to such pH-dependent enteric-coated systems as described in the specification.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon approval and commercialization, Defendants will induce and contribute to infringement by marketing the ANDA product with instructions for once-daily use, which would cause patients and doctors to infringe the method claims of treating conditions like rosacea (Compl. ¶29).
- Willful Infringement: The complaint alleges that Defendants were aware of the patents-in-suit before filing the ANDA, yet proceeded with an infringing product (Compl. ¶32). This is supported by the fact that the patents are listed in the FDA's Orange Book and Defendants filed a Paragraph IV certification, which constitutes notice.
VII. Analyst’s Conclusion: Key Questions for the Case
A primary issue will be one of evidentiary proof: As Plaintiffs have not yet seen the contents of the ANDA, the case will turn on whether discovery reveals that Defendants' 40 mg doxycycline capsule is formulated with a 30 mg immediate-release portion and a 10 mg delayed-release portion, as required by the claims. For the ’532 patent specifically, does the delayed-release portion use enterically coated pellets?
A second issue will be one of claim scope: How will the court interpret the restrictive "consisting of" language in the claims? If Defendants' formulation is found to contain additional, unrecited components, the case may center on whether those components are mere impurities or materially alter the composition so as to avoid infringement.
A final key question will be functional performance: Will the bioequivalence data submitted to the FDA be deemed sufficient to prove that the accused product achieves the "steady state blood levels" recited in the claims, or will the parties need to conduct new clinical studies, creating a battle of expert evidence on pharmacokinetics?