Last updated: February 19, 2026
I. Executive Summary
Journey Medical Corporation (JMC) filed patent infringement litigation against Teva Pharmaceuticals, Inc. in the U.S. District Court for the District of Delaware on March 7, 2022. The lawsuit, Case No. 1:22-cv-00288, alleges that Teva's proposed Abbreviated New Drug Application (ANDA) for a generic version of JMC's Dapsone Gel, 5% infringes upon U.S. Patent No. 9,895,444 (the '444 patent). JMC seeks to prevent Teva from launching its generic product before the expiration of the '444 patent. This litigation centers on a single patent and involves allegations of infringement of claims related to the formulation of Dapsone Gel.
II. Background of the Dispute
What is the subject of the litigation?
The core of the litigation is Teva Pharmaceuticals' intent to market a generic version of Journey Medical Corporation's Dapsone Gel, 5%. JMC holds U.S. Patent No. 9,895,444, which covers specific aspects of its Dapsone Gel formulation. JMC asserts that Teva's proposed generic product will infringe upon this patent, thereby seeking to block its market entry.
What is Dapsone Gel, 5%?
Dapsone Gel, 5% is a topical prescription medication approved for the treatment of acne vulgaris. It is a sulfonamide derivative that possesses anti-inflammatory properties. JMC markets the branded product as Aczone®.
What is the '444 patent and what does it claim?
U.S. Patent No. 9,895,444, titled "DAPSONE GEL FORMULATIONS AND USES," was issued on February 20, 2018. The patent claims methods of making and using dapsone gel formulations. The asserted claims in the litigation focus on the composition of the gel, specifically mentioning components that contribute to the stability and efficacy of the topical dapsone. For example, claim 1 of the '444 patent recites a topical pharmaceutical composition comprising:
- Dapsone
- At least one suspending agent
- At least one thickening agent
- At least one humectant
- At least one solvent
- Water
The claims also define specific ranges and types of these ingredients, which JMC alleges are critical to the performance of its product and are replicated in Teva's proposed generic formulation.
Who are the parties involved?
- Plaintiff: Journey Medical Corporation
- Defendant: Teva Pharmaceuticals, Inc.
III. Litigation Status and Key Events
When was the lawsuit filed?
The complaint was filed on March 7, 2022.
What is Teva's regulatory filing?
Teva has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of JMC's Dapsone Gel, 5%.
What is the legal basis for JMC's claim?
JMC's claim is based on patent infringement. Specifically, JMC alleges that Teva's proposed generic product falls within the scope of one or more claims of U.S. Patent No. 9,895,444. This type of lawsuit is commonly referred to as a "Paragraph IV" challenge under the Hatch-Waxman Act, where a generic company notifies the brand manufacturer of its intent to market a drug that may infringe on existing patents.
Has Teva filed a response?
As of the latest available public records, Teva has filed an Answer to the Complaint and has contested the infringement allegations. Teva's defense likely includes arguments that its generic formulation does not infringe the '444 patent or that the patent is invalid.
What is the current procedural stage?
The litigation is in its discovery phase. This involves the exchange of information and evidence between the parties, including the depositions of witnesses, interrogatories, and requests for production of documents. Both parties are gathering evidence to support their respective positions on infringement and validity.
Are there any other related proceedings?
While the primary litigation is in the District Court, patent validity can also be challenged at the Patent Trial and Appeal Board (PTAB). It is possible that Teva could file an inter partes review (IPR) challenging the validity of the '444 patent at the PTAB, though this has not been publicly confirmed as of the latest update.
IV. Analysis of Infringement and Validity
What are the primary infringement arguments?
JMC's primary infringement argument is that Teva's proposed generic Dapsone Gel, 5% contains the same or substantially similar active ingredient (dapsone) and a substantially similar inactive ingredient formulation that falls within the scope of the asserted claims of the '444 patent. JMC must demonstrate that each element of at least one asserted claim is present in Teva's product. This often involves detailed chemical analysis and comparison of ingredient lists and manufacturing processes.
What are Teva's potential defenses?
Teva's defenses are likely to include:
- Non-Infringement: Teva may argue that its generic formulation does not contain all the elements recited in the asserted claims of the '444 patent. This could involve demonstrating differences in specific excipients, their concentrations, or the overall composition that places it outside the patent's claims.
- Invalidity: Teva may challenge the validity of the '444 patent. Common grounds for invalidity include:
- Anticipation: Prior art that existed before the filing date of the patent and discloses all the elements of the claimed invention.
- Obviousness: Prior art that, when combined, would have made the claimed invention obvious to a person of ordinary skill in the art at the time of invention.
- Lack of Enablement or Written Description: The patent does not adequately describe the invention or enable someone skilled in the art to make and use it.
- Experimental Use or Prior Public Disclosure: If elements of the patented invention were known or used publicly before the critical dates.
What is the importance of claim construction?
Claim construction, also known as Markman proceedings, is a critical phase in patent litigation. The court interprets the meaning and scope of the patent claims. The court's construction of the claims directly impacts the infringement analysis, as it defines what the patent holder is actually claiming. A narrow construction may make it harder for JMC to prove infringement, while a broader construction would strengthen its case.
What is the potential impact of a PTAB challenge?
If Teva initiates an IPR at the PTAB, it creates a parallel proceeding. The PTAB has a different standard of review for patent validity than a district court. If the PTAB finds the '444 patent invalid, it can significantly weaken or terminate the district court infringement case. Conversely, if the PTAB upholds the patent, it strengthens JMC's position.
V. Market and Business Implications
What is the market size for Dapsone Gel, 5%?
The market for acne treatments is substantial, with topical treatments like Dapsone Gel, 5% holding a significant share. While specific revenue figures for JMC's Aczone® are proprietary, the market for prescription acne medications globally is valued in the billions of dollars annually. The introduction of a generic competitor typically leads to a significant price reduction and an increase in overall market volume due to increased patient access and prescribing.
What is the potential impact of generic entry on JMC?
The entry of a generic competitor into the market can lead to a substantial decline in revenue for the brand-name product. JMC's revenue streams would be directly impacted by reduced pricing power and market share erosion. The duration of patent protection is critical for recouping R&D costs and maximizing profitability.
What are the potential outcomes of the litigation?
- Injunction: If JMC prevails on infringement and validity, and the patent has remaining term, the court can issue an injunction preventing Teva from launching its generic product until the patent expires.
- Monetary Damages: If infringement is found, the court can award damages to JMC, typically based on lost profits or a reasonable royalty. However, in ANDA litigation, the primary goal is usually to prevent generic entry before patent expiration.
- Settlement: The parties may reach a settlement agreement, which could involve licensing terms for Teva to launch its generic product on a certain date, or other financial arrangements.
- Dismissal: If Teva successfully defends against infringement or proves the patent invalid, the lawsuit would be dismissed, allowing Teva to launch its generic product.
What is the remaining term of the '444 patent?
U.S. Patent No. 9,895,444 was issued on February 20, 2018. Barring any extensions (such as patent term adjustment or supplementary protection certificates, which are less common for formulations), the patent is expected to expire on February 20, 2038. This leaves a significant period during which JMC would seek to maintain market exclusivity.
VI. Key Takeaways
- Journey Medical Corporation (JMC) is defending its market exclusivity for Dapsone Gel, 5% (Aczone®) against Teva Pharmaceuticals' generic entry, based on alleged infringement of U.S. Patent No. 9,895,444.
- The litigation hinges on whether Teva's proposed generic formulation infringes the specific claims of the '444 patent, which pertains to the composition of the topical gel.
- Teva's defense will likely focus on non-infringement and/or patent invalidity, potentially leveraging prior art or challenging the patent's scope.
- The outcome of claim construction proceedings and any potential PTAB challenges will be critical determinants of the litigation's success for both parties.
- A successful defense by JMC would preserve its market exclusivity until patent expiration in 2038, while a loss could result in significant revenue decline due to generic competition.
VII. FAQs
- What is the specific formulation detail in the '444 patent that JMC alleges Teva infringes?
The '444 patent claims dapsone gel formulations containing dapsone, a suspending agent, a thickening agent, a humectant, a solvent, and water, with specific ranges and types of these components potentially defining the scope of infringement.
- Has Teva filed an Abbreviated New Drug Application (ANDA) for a different strength of Dapsone Gel?
The current litigation concerns Teva's ANDA for Dapsone Gel, 5%. Information regarding other strengths is not directly relevant to this specific case.
- What is the typical timeline for a patent infringement lawsuit in the U.S. District Court?
Patent litigation can be lengthy, often taking 1.5 to 3 years from filing to trial, though complex cases can extend beyond that. Discovery and claim construction proceedings are significant time drivers.
- Can Teva launch its generic product while the patent litigation is ongoing?
Teva cannot launch its generic product if it infringes a valid and unexpired patent without risking substantial damages and an injunction. However, if Teva prevails in invalidating the patent or proving non-infringement, or if a settlement allows for it, launch can occur.
- What happens if the '444 patent is found invalid by the PTAB?
If the PTAB finds the '444 patent invalid through an inter partes review, it significantly undermines JMC's infringement case in the district court, potentially allowing Teva to launch its generic product without further patent-related obstruction.
VIII. Cited Sources
[1] Complaint for Patent Infringement, Journey Medical Corporation v. Teva Pharmaceuticals, Inc., No. 1:22-cv-00288 (D. Del. Mar. 7, 2022).
[2] U.S. Patent No. 9,895,444 (filed May 26, 2016) (issued Feb. 20, 2018).
[3] Court Docket for Case No. 1:22-cv-00288 (D. Del.), various filings.
