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); Oishi Koseido Co., Ltd. (Japan)
- Defendant: Aveva Drug Delivery Systems, Inc. (Florida); Apotex Corp. (Delaware); Apotex Inc. (Canada)
- Plaintiff’s Counsel: Carey Rodriguez Milian, LLP; Cooley LLP
- Case Identification: 0:22-cv-61192, S.D. Fla., 06/22/2022
- Venue Allegations: Venue is alleged to be proper based on Defendant Aveva Drug Delivery Systems, Inc.'s incorporation in Florida, Defendant Apotex Corp.'s principal place of business and alleged acts of infringement in the district, and Defendant Apotex Inc.'s status as a foreign entity.
- Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs' ZTlido® lidocaine topical patch constitutes an act of infringement of three U.S. patents.
- Technical Context: The technology involves non-aqueous transdermal patches formulated to deliver low concentrations of lidocaine stably over an extended period for topical pain relief.
- Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following a Notice Letter sent by Defendant Aveva Drug Delivery Systems, Inc. on May 10, 2022, which asserted that its proposed generic product would not infringe the asserted patents or that the patents are invalid.
Case Timeline
| Date | Event |
|---|---|
| 2011-05-10 | Earliest Priority Date ('174, '264, and '403 Patents) |
| 2016-03-15 | U.S. Patent No. 9,283,174 Issued |
| 2018-03-27 | U.S. Patent No. 9,925,264 Issued |
| 2018-04-03 | U.S. Patent No. 9,931,403 Issued |
| 2022-05-10 | Defendant Aveva sends ANDA Notice Letter |
| 2022-06-22 | 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 states that conventional non-aqueous lidocaine patches suffer from poor skin permeability because the lidocaine is not fully dissolved. While using high concentrations of lidocaine can overcome this, it raises safety concerns, such as adverse effects on the heart. Conversely, patches with low lidocaine concentrations often fail to release the drug stably over long periods (Compl. Ex. A, '174 Patent, col. 5:8-21, 5:53-62).
- The Patented Solution: The invention is a non-aqueous patch that uses a specific "dissolving agent" composed of an organic acid and a polyalcohol. This agent is designed to completely dissolve a relatively low concentration of lidocaine within the patch's plaster, enabling the drug to be "percutaneously absorbed stably over a long period of time" and permeate into muscle tissue ('174 Patent, Abstract; col. 5:14-21).
- Technical Importance: The formulation sought to provide a patch that was both safe for household use (by using less than 5 mass % lidocaine) and effective for long-term pain relief, a combination the patent suggests was not achieved by prior art patches ('174 Patent, col. 5:47-58).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶45).
- The essential elements of independent claim 1 are:
- 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 states that Defendants' product will infringe one or more claims of the patent, including at least claim 1 (Compl. ¶48).
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 challenge as its parent '174 Patent: creating an effective, long-lasting, and safe non-aqueous lidocaine patch by ensuring the active ingredient is fully dissolved for stable skin permeation ('264 Patent, col. 5:12-20).
- The Patented Solution: Rather than claiming the patch itself, this patent claims a method of treating pain in a human. The method consists of applying a non-aqueous patch with a specific formulation to the person. The formulation is nearly identical to that described in the '174 Patent, featuring a low concentration of lidocaine and a "dissolving agent consisting essentially of an organic acid and a polyalcohol" contained in a plaster ('264 Patent, Abstract; col. 9:19-29).
- Technical Importance: This patent extends protection beyond the composition of the patch to the act of using it for pain treatment, a common strategy to broaden the scope of patent coverage in the pharmaceutical field ('264 Patent, col. 9:19-21).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶57).
- The essential elements of independent claim 1 are:
- 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 states that use of the Defendants' product will infringe one or more claims of the patent, including at least claim 1 (Compl. ¶60).
U.S. Patent No. 9,931,403 - Non-Aqueous Patch, Issued April 3, 2018
- Patent Identification: U.S. Patent No. 9,931,403, titled Non-Aqueous Patch, issued on April 3, 2018 (Compl. ¶40).
- Technology Synopsis: Continuing the patent family, the '403 Patent addresses the challenge of creating a safe and effective topical pain patch by disclosing a non-aqueous formulation where a low concentration of lidocaine is fully dissolved. The key is a "dissolving agent consisting essentially of an organic acid and a polyalcohol," which enables stable, long-term drug release through the skin ('403 Patent, Abstract; col. 5:15-24).
- Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶71).
- Accused Features: The complaint alleges that the formulation of the Aveva ANDA Product infringes the claims of the '403 Patent, asserting it comprises components that perform the same function in the same way to achieve the same result (Compl. ¶¶72-73).
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is "Aveva's ANDA Product," a proposed generic "Lidocaine Topical System, 1.8%" submitted to the FDA for approval under ANDA No. 217221 (Compl. ¶1).
- Functionality and Market Context: The product is a transdermal patch intended for "the relief of pain associated with post-herpetic neuralgia (PHN) in adults" (Compl. ¶1). The complaint alleges that the product's formulation contains components that "perform substantially the same function, in substantially the same way, to achieve the same result as the claimed formulation" (Compl. ¶47, ¶59, ¶73). It is positioned to be a generic market competitor to Plaintiffs' ZTlido® branded product upon receiving FDA approval (Compl. ¶1).
IV. Analysis of Infringement Allegations
The complaint pleads infringement on "information and belief" and does not provide a detailed element-by-element analysis or reference a claim chart exhibit. The following summary is based on the complaint's direct quotation of the claims followed by its conclusory allegations of infringement.
No probative visual evidence provided in complaint.
'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 that Aveva's ANDA product is a non-aqueous patch whose formulation is covered by the claims. | ¶46 | col. 9:6-7 |
| ...and a dissolving agent consisting of an organic acid and a polyalcohol... | The complaint alleges on information and belief that the ANDA product formulation contains components that perform the same function as the claimed formulation. | ¶47 | col. 9:8-9 |
| ...which are contained in a plaster... | The complaint alleges the ANDA product is covered by the claim. | ¶46 | col. 9:10 |
| ...wherein the amount of lidocaine and/or its reactant is 0.1 to 1 mg/cm2 of the plaster... | The complaint alleges the ANDA product meets the limitations of claim 1. | ¶46 | col. 9:11-12 |
| ...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 the ANDA product meets the limitations of claim 1. | ¶46 | col. 9:13-16 |
'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 use of the ANDA product as directed by its proposed labeling will infringe the claimed method. | ¶60 | col. 9:19-21 |
| ...the non-aqueous patch comprising 0.5 to 7 mass % lidocaine... | The complaint alleges that Aveva's ANDA product contains the claimed formulation. | ¶58 | col. 9:22-23 |
| ...and a dissolving agent consisting essentially of an organic acid and a polyalcohol... | The complaint alleges on information and belief that the ANDA product formulation performs the same function as the claimed formulation. | ¶59 | col. 9:23-25 |
| ...which are contained in a plaster... | The complaint alleges the ANDA product is covered by the claim. | ¶58 | col. 9:25-26 |
| ...wherein the amount of lidocaine is 0.1 to 1 mg/cm2 of the plaster... | The complaint alleges the ANDA product meets the limitations of claim 1. | ¶58 | col. 9:26-27 |
| ...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 the ANDA product meets the limitations of claim 1. | ¶58 | col. 9:27-29 |
- Identified Points of Contention:
- Scope Questions: A central dispute may arise over the interpretation of "consisting of" ('174 Patent) versus "consisting essentially of" ('264 and '403 Patents) in defining the "dissolving agent." The question for the court will be whether the accused product's formulation contains any unlisted components in its dissolving agent and, if so, whether those components take the product outside the scope of the respective claim terms.
- Technical Questions: The complaint does not provide specific evidence that the accused product's formulation meets the quantitative limitations of the claims (e.g., the mass percentages and mg/cm² values). A key factual question will be whether the specific formulation in the confidential ANDA filing satisfies each of these numerical ranges.
V. Key Claim Terms for Construction
- The Term: "dissolving agent consisting of an organic acid and a polyalcohol" ('174 Patent, claim 1) and "dissolving agent consisting essentially of an organic acid and a polyalcohol" ('264 Patent, claim 1).
- Context and Importance: Practitioners may focus on these terms because "consisting of" is a closed term that excludes any other elements, while "consisting essentially of" allows for unrecited elements that do not materially alter the basic and novel properties of the invention. The infringement analysis for the '174 Patent may be defeated if the accused dissolving agent contains any additional ingredient. The analysis for the '264 and '403 Patents will depend on whether any additional ingredients in the accused product materially affect the patch's properties, such as its drug release rate or adhesion.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the use of "etc." in the specification's exemplary lists of organic acids and polyalcohols suggests the inventors did not intend to limit the invention to only the specific chemicals listed ('174 Patent, col. 5:47-51). For the "consisting essentially of" claims, this could support the inclusion of other similar, non-materially-affecting chemicals.
- Evidence for a Narrower Interpretation: The restrictive "consisting of" language in the '174 Patent claim itself is strong evidence for a narrow interpretation excluding any additional components. For the "consisting essentially of" claims, a party could point to the specification’s warning that excessive amounts of dissolving agent can decrease the patch’s adhesion, arguing that any additional component affecting such a property would be a material alteration ('174 Patent, col. 5:62-64).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants will induce infringement of the '264 Patent (a method claim) because the proposed product labeling will instruct physicians and patients to apply the patch, thereby directing them to perform the steps of the claimed method (Compl. ¶¶ 60, 66). It also alleges contributory infringement, stating the accused product is especially adapted for infringing use and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶67).
- Willful Infringement: While the complaint does not use the word "willful," it alleges facts that may support such a claim. It asserts that Defendants had knowledge of the patents because they are listed in the FDA's Orange Book for the corresponding branded drug, ZTlido® (Compl. ¶¶ 53, 65). The sending of the Notice Letter further establishes pre-suit knowledge of the patents (Compl. ¶21). The prayer for relief requests that the case be declared "exceptional" and seeks attorneys' fees, the statutory remedy for willful infringement or other litigation misconduct (Compl. p. 22, ¶h).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of compositional fact: does the precise formulation of the accused generic product, as detailed in the confidential ANDA submission, fall within the specific quantitative ranges (e.g., mass percentages, concentration per area, and component ratios) recited in the independent claims of the asserted patents?
- The case will likely involve a significant dispute over claim scope: can the term "dissolving agent consisting of an organic acid and a polyalcohol" ('174 Patent) be read to cover the accused product if its agent contains any additional components? And for the '264 and '403 Patents, if additional components are present, do they "materially affect" the patch's properties, thereby taking the product outside the scope of "consisting essentially of"?