DCT
0:22-cv-61192
Scilex Pharma Inc v. Aveva Drug Delivery Systems Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Scilex Pharmaceuticals Inc. (Delaware), ITOCHU CHEMICAL FRONTIER Corporation (Japan), and Oishi Koseido Co., Ltd. (Japan)
- Defendant: Aveva Drug Delivery Systems, Inc. (Florida), Apotex Corp. (Delaware), and Apotex Inc. (Canada)
- Plaintiff’s Counsel: Carey Rodriguez Milian, LLP; Cooley LLP
- Case Identification: Scilex Pharmaceuticals Inc. et al. v. Aveva Drug Delivery Systems, Inc. et al., 0:22-cv-61192, S.D. Fla., 12/22/2022
- Venue Allegations: Venue is alleged to be proper as Defendant Aveva Drug Delivery Systems, Inc. is incorporated in Florida; Defendant Apotex Corp. has a principal place of business in the district; and Defendant Apotex Inc. is a foreign corporation that may be sued in any judicial district.
- Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' ZTLIDO® product constitutes an act of infringement of three patents related to non-aqueous lidocaine patch technology.
- Technical Context: The technology concerns transdermal drug delivery systems, specifically non-aqueous patches formulated to deliver the local anesthetic lidocaine through the skin for pain relief.
- Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendants' submission of ANDA No. 217221 and a corresponding "Notice Letter," dated May 10, 2022, asserting that Plaintiffs' patents are invalid, unenforceable, or not infringed. The complaint notes that the asserted patents are listed in the U.S. Food and Drug Administration's "Orange Book" for the ZTLIDO® drug product.
Case Timeline
| Date | Event |
|---|---|
| 2011-05-10 | Priority Date for ’174, ’264, and ’403 Patents |
| 2016-03-15 | U.S. Patent 9,283,174 Issued |
| 2018-03-27 | U.S. Patent 9,925,264 Issued |
| 2018-04-03 | U.S. Patent 9,931,403 Issued |
| 2022-05-10 | Date of Defendants' "Notice Letter" to Plaintiffs |
| 2022-12-22 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,283,174 - “Non-Aqueous Patch,” issued March 15, 2016
The Invention Explained
- Problem Addressed: The patent’s background section describes that conventional non-aqueous patches containing lidocaine exhibit poor skin permeability because the lidocaine is not dissolved and remains in a crystalline state. This necessitates high concentrations of lidocaine, which can have adverse effects, while patches with lower concentrations fail to release the drug stably over long periods (e.g., 12 hours or more) ('174 Patent, col. 1:44-61).
- The Patented Solution: The invention claims to solve this problem by using a specific "dissolving agent" composed of an organic acid and a polyalcohol within the patch's plaster. This agent is designed to completely dissolve a relatively low concentration of lidocaine, which allows the drug to be "percutaneously absorbed stably over a long period of time and permeate into the muscle" ('174 Patent, col. 2:5-8, col. 2:42-46).
- Technical Importance: This approach enabled the development of a low-dose, non-aqueous lidocaine patch with good adhesion and stable, long-term drug delivery, thereby offering efficacy while potentially reducing the side effects associated with higher-concentration formulations ('174 Patent, col. 4:47-56).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶62).
- Essential elements of claim 1 include:
- A non-aqueous patch comprising 0.5 to 7 mass % lidocaine and/or its reactant
- and a dissolving agent consisting of an organic acid and a polyalcohol
- which are contained in a plaster
- wherein the amount of lidocaine and/or its reactant is 0.1 to 1 mg/cm2 of the plaster
- and wherein the proportion of dissolving agent to lidocaine and/or its reactant is 0.5 to 5 mass % of dissolving agent relative to 1 mass % of lidocaine and/or its reactant.
- The complaint reserves the right to assert other claims of the patent (Compl. ¶63).
U.S. Patent No. 9,925,264 - “Non-Aqueous Patch,” issued March 27, 2018
The Invention Explained
- Problem Addressed: The '264 Patent addresses the same technical problem as its parent '174 Patent: the poor skin permeability and unstable release of lidocaine from conventional non-aqueous patches ('264 Patent, col. 1:50-65).
- The Patented Solution: This patent claims a method of treating pain in a human by applying a non-aqueous patch with a specific formulation. The core technology of the patch is the same, utilizing a dissolving agent "consisting essentially of an organic acid and a polyalcohol" to dissolve a low concentration of lidocaine in a plaster, which enables stable release and effective pain treatment ('264 Patent, Abstract; col. 2:25-31).
- Technical Importance: The patent claims a specific therapeutic application for the patch technology, providing a method for using a low-dose, stable, non-aqueous patch for pain relief, including for conditions such as post-herpetic neuralgia ('264 Patent, col. 9:30).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶74).
- Essential elements of claim 1 include:
- A method of treating pain in a human comprising applying a non-aqueous patch to the human
- the non-aqueous patch comprising 0.5 to 7 mass % lidocaine
- and a dissolving agent consisting essentially of an organic acid and a polyalcohol
- which are contained in a plaster
- wherein the amount of lidocaine is 0.1 to 1 mg/cm2 of the plaster
- and wherein the proportion of dissolving agent to lidocaine is 0.5 to 5 mass % of dissolving agent relative to 1 mass % of lidocaine.
- The complaint reserves the right to assert other claims of the patent (Compl. ¶75).
U.S. Patent No. 9,931,403 - “Non-Aqueous Patch,” issued April 3, 2018
- Technology Synopsis: Continuing the technology of the related patents, the ’403 Patent discloses a non-aqueous patch composition designed to overcome poor lidocaine permeability. The invention centers on a dissolving agent, consisting essentially of an organic acid and a polyalcohol, to fully dissolve a low concentration of lidocaine, thereby enabling stable, long-term transdermal drug delivery for relieving pain ('403 Patent, Abstract; col. 2:1-11).
- Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶88).
- Accused Features: The complaint alleges that the formulation of Defendants' ANDA product contains the components and ratios recited in the claims of the ’403 patent (Compl. ¶89-90).
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is the "Lidocaine Topical System, 1.8% product" that is the subject of Defendants' Abbreviated New Drug Application (ANDA) No. 217221 (Compl. ¶1).
- Functionality and Market Context: The product is a generic transdermal patch intended for the "relief of pain associated with post-herpetic neuralgia (PHN) in adults" (Compl. ¶1). The complaint alleges that Defendants' filing of the ANDA is a statutory act of infringement under 35 U.S.C. § 271(e)(2), undertaken for the purpose of obtaining FDA approval to market a generic version of Plaintiffs' ZTLIDO® product before the expiration of the asserted patents (Compl. ¶1, ¶67-68).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'174 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A non-aqueous patch comprising 0.5 to 7 mass % lidocaine and/or its reactant... | The complaint alleges, upon information and belief, that the formulation of Defendants' ANDA product is a non-aqueous patch containing lidocaine within the claimed mass percentage. | ¶62-64 | col. 2:28-34 |
| and a dissolving agent consisting of an organic acid and a polyalcohol, which are contained in a plaster... | The complaint alleges, upon information and belief, that the accused product's plaster contains a dissolving agent with components that perform the same function as the claimed agent. | ¶62, ¶64 | col. 2:14-16 |
| wherein the amount of lidocaine and/or its reactant is 0.1 to 1 mg/cm2 of the plaster... | The complaint alleges, upon information and belief, that the accused product meets the claimed concentration of lidocaine per unit area of the plaster. | ¶62-63 | col. 2:20-22 |
| and wherein the proportion of dissolving agent to lidocaine and/or its reactant is 0.5 to 5 mass % of dissolving agent relative to 1 mass % of lidocaine and/or its reactant. | The complaint alleges, upon information and belief, that the accused product's formulation meets the claimed ratio of dissolving agent to lidocaine. | ¶62-63 | col. 2:53-64 |
'264 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating pain in a human comprising applying a non-aqueous patch to the human... | The complaint alleges that Defendants' proposed product labeling will instruct users to apply the patch for the treatment of pain, thereby inducing infringement of the claimed method. | ¶74, ¶77 | col. 9:18-20 |
| the non-aqueous patch comprising 0.5 to 7 mass % lidocaine, and a dissolving agent consisting essentially of an organic acid and a polyalcohol... | The complaint alleges, upon information and belief, that the patch described in the ANDA contains lidocaine and a dissolving agent with the claimed characteristics. | ¶74-76 | col. 2:40-45 |
| wherein the amount of lidocaine is 0.1 to 1 mg/cm2 of the plaster... | The complaint alleges, upon information and belief, that the patch described in the ANDA meets this claimed concentration. | ¶74-75 | col. 2:31-32 |
| and wherein the proportion of dissolving agent to lidocaine is 0.5 to 5 mass % of dissolving agent relative to 1 mass % of lidocaine. | The complaint alleges, upon information and belief, that the patch described in the ANDA meets this claimed proportional limitation. | ¶74-75 | col. 3:1-12 |
- Identified Points of Contention:
- Technical Questions: A central factual question, the answer to which resides in the confidential portion of the ANDA, is whether the accused product's formulation literally meets every claimed compositional and proportional limitation. Specifically, does the accused product utilize a dissolving agent that is an organic acid and a polyalcohol, and are the mass percentages and drug load per cm² within the claimed ranges?
- Scope Questions: The complaint's alternative allegation of infringement under the doctrine of equivalents raises the question of whether any differences between the accused product and the claims are insubstantial (Compl. ¶64, ¶76). For the '264 Patent, a key issue may be the scope of the phrase "consisting essentially of," which could determine whether other unlisted ingredients in the accused product's dissolving agent avoid infringement by materially altering the patch's properties.
V. Key Claim Terms for Construction
- The Term: "dissolving agent consisting of an organic acid and a polyalcohol" (from '174 Patent) and "dissolving agent consisting essentially of an organic acid and a polyalcohol" (from '264 Patent)
- Context and Importance: This term defines the core of the patented technology. The dispute will likely center on whether the agent used in the accused product falls within this definition. Practitioners may focus on the different transition phrases—"consisting of" versus "consisting essentially of"—as the former is strictly limiting, while the latter permits the presence of unlisted components that do not materially affect the "basic and novel properties" of the invention, creating a critical distinction in infringement analysis between the product patents and the method patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party may argue that the specification's exemplary lists of organic acids (e.g., acetic acid, oleic acid, isostearic acid) and polyalcohols (e.g., 1,3-butylene glycol, propylene glycol, glycerin) support construing the term to encompass a wide range of chemicals within these general classes ('174 Patent, col. 2:47-51).
- Evidence for a Narrower Interpretation: A party may argue that the term should be limited by the specific embodiments and examples disclosed, such as the combination of oleic acid and 1,3-butylene glycol ('174 Patent, col. 4:18-23). The use of the highly restrictive phrase "consisting of" in the '174 and '403 patents provides strong evidence for a narrow interpretation that excludes any other components from the dissolving agent.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants will actively induce infringement of the '264 method patent. The alleged factual basis for inducement is that Defendants' proposed product labeling will instruct medical professionals and patients to apply the patch to treat pain, which is the patented method (Compl. ¶77, ¶83). The complaint also alleges contributory infringement, stating that the accused product is especially made or adapted for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶84).
- Willful Infringement: While the complaint does not use the term "willful infringement," it requests that the case be declared "exceptional" and seeks attorney fees (Compl. p. 20). The factual basis for this allegation is Defendants' alleged knowledge of the asserted patents, which stems from the patents being listed in the FDA's Orange Book for the ZTLIDO® product (Compl. ¶70, ¶82, ¶96).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of factual determination: does the specific chemical formulation detailed in the confidential sections of Defendants' ANDA literally meet the compositional and proportional limitations recited in the asserted claims, particularly regarding the identity and ratio of the "dissolving agent" components?
- A central legal issue will be one of claim scope: how will the court construe the transition phrases "consisting of" (in the '174 and '403 patents) and "consisting essentially of" (in the '264 patent)? The interpretation of these terms will be critical in determining whether the accused formulation, especially if it contains additional unlisted ingredients, infringes the patents.
- A key alternative question will be one of functional equivalence: should literal infringement fail, does the accused product's formulation, as alleged in the complaint, contain components that are insubstantially different from the claimed elements, thereby infringing under the doctrine of equivalents?