Litigation Details for Journey Medical Corporation v. Perrigo Pharma International DAC (D. Del. 2020)

Journey Medical Corporation v. Perrigo Pharma International DAC (D. Del. 2020)

Docket		Date Filed	2020-10-21
Court	District Court, D. Delaware	Date Terminated	2022-05-19
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To	Jennifer L. Hall
Patents	10,004,717; 10,052,267; 10,543,192; 10,548,875; 8,618,160; 8,859,610; 9,259,414; 9,744,105
Attorneys	Deepa Kannappan
Link to Docket	External link to docket

Details for Journey Medical Corporation v. Perrigo Pharma International DAC (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-10-21				External link to document
2020-10-21	1	Complaint	the ’267 patent”); 8,859,610 (“the ’610 patent”); 9,259,414 (“the ’414 patent”); 10,004,717 (“the ’717…expiration of U.S. Patent Nos. 8,618,160 (“the ’160 patent”); 9,744,105 (“the ’105 patent”); 10,052,267 (…717 patent”); 10,543,192 (“the ’192 patent”); and 10,548,875 (“the ’875 patent”) (collectively “the … 1. This is an action for patent infringement under the patent laws of the United States, Title…Asserted Patents. Upon information and belief, Perrigo deliberately challenged Plaintiffs’ patent rights	External link to document
2020-10-21	93	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 10,543,192 B2; 10,548,875 B2;… 2020 19 May 2022 1:20-cv-01413 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation Summary and Analysis for Journey Medical Corporation v. Perrigo Pharma International DAC

Case Overview

The litigation between Journey Medical Corporation and Perrigo Pharma International DAC, filed as Journey Medical Corporation v. Perrigo Pharma International DAC (Case No. 1:20-cv-01413), revolves around patent infringement claims related to the drug Qbrexza®. Here is a detailed summary and analysis of the case.

Background

Journey Medical Corporation, formerly known as Dermira, Inc., acquired the rights to Qbrexza®, a topical treatment for excessive sweating, as part of its asset purchase from Dermira. Perrigo Pharma International DAC, a subsidiary of Perrigo Company PLC, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Qbrexza® before the expiration of the Qbrexza® patents[5].

Initiation of Litigation

Following Perrigo's ANDA submission, Journey Medical Corporation initiated patent litigation against Perrigo in the U.S. District Court of Delaware on October 21, 2020. The lawsuit alleges that Perrigo's proposed generic version of Qbrexza® infringes on certain patents covering Qbrexza®, which are part of the proprietary rights acquired by Journey Medical Corporation[5].

Hatch-Waxman Act Implications

The litigation is governed by the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. Under this act, the filing of the ANDA by Perrigo triggered an automatic 30-month stay, preventing Perrigo from selling its generic version of Qbrexza® until the stay expires or the litigation is resolved[5].

Key Issues in Dispute

• Patent Validity and Infringement: The primary issue is whether Perrigo's proposed generic version of Qbrexza® infringes on the Qbrexza® patents held by Journey Medical Corporation. Perrigo's ANDA also challenges the validity of these patents.
• 30-Month Stay: The automatic 30-month stay imposed by the Hatch-Waxman Act is a critical aspect, as it delays Perrigo's ability to market its generic version until the stay expires or the court resolves the litigation[5].

Current Status and Future Proceedings

As of the latest updates, the 30-month stay is set to expire on March 9, 2023. The trial in the patent litigation was scheduled for September 19, 2022. However, the outcome of the trial and any subsequent appeals are yet to be determined[5].

Financial and Strategic Implications

The outcome of this litigation has significant financial and strategic implications for both parties. For Journey Medical Corporation, protecting the Qbrexza® patents is crucial to maintaining its market exclusivity and revenue stream. For Perrigo, successfully challenging these patents could allow it to enter the market with a generic version, potentially reducing prices and increasing competition.

Analysis of Legal Arguments

• Journey Medical Corporation's Argument: The company argues that Perrigo's ANDA product infringes on the valid and enforceable Qbrexza® patents. Journey Medical Corporation seeks to protect its intellectual property rights and maintain its exclusive market position.
• Perrigo's Argument: Perrigo challenges the validity of the Qbrexza® patents and argues that its generic version does not infringe on these patents. Perrigo aims to enter the market with a generic version, which could significantly impact the pricing and availability of Qbrexza®.

Court's Role and Potential Outcomes

The court will need to determine the validity of the Qbrexza® patents and whether Perrigo's ANDA product infringes on these patents. If the court upholds the patents and finds infringement, Perrigo will be barred from marketing its generic version until the patents expire. Conversely, if the court invalidates the patents or finds no infringement, Perrigo can proceed with marketing its generic version, subject to FDA approval.

Key Takeaways

• The litigation involves complex patent infringement claims under the Hatch-Waxman Act.
• The outcome will significantly impact the market exclusivity and revenue streams of both Journey Medical Corporation and Perrigo.
• The automatic 30-month stay delays Perrigo's market entry, giving Journey Medical Corporation temporary protection.
• The trial and any subsequent appeals will determine the final outcome, affecting the competitive landscape for Qbrexza®.

FAQs

Q: What is the primary issue in the Journey Medical Corporation v. Perrigo Pharma International DAC litigation? A: The primary issue is whether Perrigo's proposed generic version of Qbrexza® infringes on the Qbrexza® patents held by Journey Medical Corporation.

Q: What is the role of the Hatch-Waxman Act in this litigation? A: The Hatch-Waxman Act governs the procedures for ANDA submissions and imposes an automatic 30-month stay, preventing Perrigo from selling its generic version until the stay expires or the litigation is resolved.

Q: What are the financial implications of this litigation for both parties? A: For Journey Medical Corporation, protecting the Qbrexza® patents is crucial for maintaining market exclusivity and revenue. For Perrigo, successfully challenging these patents could allow it to enter the market with a generic version, reducing prices and increasing competition.

Q: What is the current status of the litigation? A: The trial was scheduled for September 19, 2022, and the 30-month stay is set to expire on March 9, 2023. The outcome is yet to be determined.

Q: How does the outcome of this litigation affect the market for Qbrexza®? A: If Journey Medical Corporation prevails, it maintains market exclusivity. If Perrigo prevails, it can enter the market with a generic version, potentially reducing prices and increasing competition.

Cited Sources

1. Journey Medical Corporation - [PDF] Journey Medical Corporation, Financials, Quarterly Reports[5].
2. KLGates - Perrigo Co. v. AbbVie Inc. - Third Circuit Holds Mutual Release Bars Generic Drug Company's Antitrust Claim[1].
3. PomLaw - Pomerantz Obtains $97 Million Settlement in Perrigo Shareholder Suit[2].
4. Battea Class Action Services - Perrigo Company PLC Settlement[4].