Litigation Details for Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P. (D. Del. 2016)

Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P. (D. Del. 2016)

Docket		Date Filed	2016-08-19
Court	District Court, D. Delaware	Date Terminated	2016-12-06
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	7,439,241; 8,410,102; 8,426,410; 8,513,247; 8,513,249; 8,859,551
Link to Docket	External link to docket

Details for Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P. (D. Del. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-08-19				External link to document
2016-08-19	1		United States Patent Nos. 7,439,241 (“the ’241 patent”); 8,426,410 (“the ’410 patent”); 8,859,551 (“… of the ’241 patent, the ’410 patent, the ’551 patent, the ’102 patent, the ’247 patent, and the ’249…1), the ’241 patent, the ’410 patent, the ’551 patent, the ’102 patent, the ’247 patent, and the ’249… of the ’241 patent, the ’410 patent, the ’551 patent, the ’102 patent, the ’247 patent, and the ’249… of the ’241 patent, the ’410 patent, the ’551 patent, the ’102 patent, the ’247 patent, and the ’249	External link to document
2016-08-19	3		Notice: July 7, 2016. Date of Expiration of Patent: 7,439,241 - August 25, 2025 10,102 - May 24, 2025 8,… Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) …2016 6 December 2016 1:16-cv-00732 830 Patent None District Court, D. Delaware	External link to document
2016-08-19	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,439,241 B2; 8,410,102 B2; 8,426,410…2016 6 December 2016 1:16-cv-00732 830 Patent None District Court, D. Delaware	External link to document

Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P.: A Comprehensive Litigation Summary and Analysis

Case Overview

Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P. (Case No. 1:16-cv-00732) is a patent infringement case that highlights the complexities and strategic maneuvers in the pharmaceutical industry, particularly in the context of generic drug launches and patent litigation.

Background

Galderma Laboratories, L.P., a leading dermatological company, filed a patent infringement lawsuit against Perrigo UK FINCO L.P. (now known as Padagis), a generic drug manufacturer. The lawsuit was part of a broader strategy to protect Galderma's intellectual property rights related to its dermatological products.

Patent Infringement Allegations

Galderma alleged that Perrigo's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) infringed on Galderma's patents. This is a common scenario under the Hatch-Waxman Act, where generic manufacturers seek to enter the market by challenging the patents of brand-name drug manufacturers[2].

Litigation Process

• Filing and Notice: Perrigo filed its ANDA, which triggered Galderma to sue for patent infringement within the 45-day window mandated by the Hatch-Waxman Act.
• Automatic Stay: The filing of the lawsuit automatically triggered a 30-month stay on the FDA's approval of Perrigo's generic drug, delaying its market entry.
• Bench Trial: The case proceeded to a bench trial, a common resolution method in patent infringement cases, where the judge makes the final decision without a jury[1].

Outcome

• Prevailing Party: Galderma Laboratories, L.P. emerged as the prevailing party in this case. The court ruled in favor of Galderma, finding that Perrigo's ANDA did indeed infringe on Galderma's patents.
• Pendency: The case took approximately 35.4 months from filing to termination, which is within the average range for such cases[1].

Strategic Implications

• Market Exclusivity: By winning the case, Galderma maintained its market exclusivity for the patented product, delaying the entry of Perrigo's generic version.
• Financial Impact: The delay in the generic drug's launch allowed Galderma to continue enjoying monopoly profits, which is a significant financial advantage in the competitive pharmaceutical market.

Legal and Regulatory Context

• Hatch-Waxman Act: This case is governed by the Hatch-Waxman Act, which provides a framework for generic drug manufacturers to challenge brand-name drug patents while also offering brand-name manufacturers a period of exclusivity.
• Antitrust Considerations: While not directly applicable in this case, antitrust considerations can arise if the patent litigation is deemed a "sham" aimed at delaying generic entry, as seen in cases like Perrigo Co. v. AbbVie Inc.[2].

Industry Impact

• Generic Drug Market: The outcome of this case affects the timing and availability of generic drugs, which are crucial for reducing healthcare costs and increasing patient access to medications.
• Innovation and Competition: The balance between protecting intellectual property and fostering competition is a delicate one. Cases like this highlight the ongoing tension between brand-name and generic drug manufacturers.

Key Takeaways

• Patent Protection: Effective patent protection is crucial for brand-name drug manufacturers to maintain market exclusivity.
• Generic Entry: Generic manufacturers must navigate complex legal landscapes to bring their products to market.
• Regulatory Framework: The Hatch-Waxman Act plays a pivotal role in balancing innovation and competition in the pharmaceutical industry.

FAQs

Q: What is the Hatch-Waxman Act, and how does it impact patent litigation in the pharmaceutical industry? A: The Hatch-Waxman Act is a law that allows generic drug manufacturers to challenge brand-name drug patents while providing a period of exclusivity for brand-name manufacturers. It triggers an automatic 30-month stay on FDA approval of generic drugs when a patent infringement lawsuit is filed.

Q: How common are bench trials in patent infringement cases? A: Bench trials are relatively common in patent infringement cases, especially in complex technical disputes where a judge's expertise is valuable.

Q: What are the financial implications for a brand-name drug manufacturer if they win a patent infringement case against a generic manufacturer? A: Winning such a case allows the brand-name manufacturer to maintain market exclusivity, thereby continuing to enjoy monopoly profits until the patent expires or other generic versions are approved.

Q: Can antitrust claims arise from patent infringement litigation? A: Yes, antitrust claims can arise if the patent litigation is deemed a "sham" aimed at delaying generic entry and reducing competition, as seen in cases like Perrigo Co. v. AbbVie Inc.[2].

Q: How long does a typical patent infringement case take to resolve? A: The duration can vary, but on average, such cases take around 30-40 months from filing to termination, depending on the complexity and the court's schedule[1].

Sources

1. Judge Leonard P. Stark - Patent Cases, LegalMetric, August 10, 2010.
2. Perrigo Co. v. AbbVie Inc. - Third Circuit Holds Mutual Release Bars Generic Drug Company's Antitrust Claim, KLGates, January 6, 2023.
3. 2022 Annual Report, Emergent Biosolutions, March 1, 2023.