Case Overview
The litigation between Endo Pharmaceuticals Inc. and Perrigo UK FINCO Limited Partnership, case number 1:19-CV-00437, is a patent infringement dispute that began in March 2019. Here is a detailed summary and analysis of the key points in this case.
Background
Endo Pharmaceuticals Inc. filed an intellectual property lawsuit against Perrigo UK FINCO Limited Partnership in the United States District Court for the District of Delaware on March 1, 2019. The lawsuit pertains to the infringement of several patents related to Endo's Nascobal Nasal Spray, a product containing cyanocobalamin[1][5].
Patents in Dispute
The litigation involves the infringement of multiple patents, including '636, '489, '349, '353, '714, and '007. These patents are listed in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations, also known as the "Orange Book," and are associated with Nascobal Nasal Spray[1].
Competitive Generic Therapy (CGT) Designation
Perrigo UK FINCO Limited Partnership had been granted a Competitive Generic Therapy (CGT) designation for its cyanocobalamin nasal spray. However, due to the presence of unexpired patents and exclusivities for the reference listed drug (RLD) Nascobal Nasal Spray, Perrigo's product was not eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act[1].
Litigation Proceedings
Endo Pharmaceuticals Inc. initiated litigation within the statutory 45-day period against Perrigo for patent infringement. The case was filed in the District of Delaware and involved motions for pro hac vice appearances by various attorneys for both parties[5].
Dismissal and Settlement
The case was subsequently dismissed. Endo Pharmaceuticals Inc. notified the FDA that the litigation had been dismissed, and Perrigo submitted a letter providing written consent to approval by the patent owner or exclusive patent licensee pursuant to 21 CFR 314.107(b)(3)(vi)[1].
Regulatory Implications
The FDA determined that Perrigo's cyanocobalamin nasal spray was bioequivalent and therapeutically equivalent to Endo's Nascobal Nasal Spray. However, any changes in the conditions described in the ANDA (Abbreviated New Drug Application) would require an approved supplemental application before implementation[1].
Analysis
The dismissal of the case suggests that the parties may have reached a settlement or agreement that resolved the patent infringement claims. This is common in ANDA litigation, where settlements can allow generic manufacturers to enter the market under specific terms, such as delayed entry or royalty payments.
Industry Impact
This case highlights the complexities and challenges involved in generic drug approvals, particularly when multiple patents are at stake. It underscores the importance of navigating the intellectual property landscape carefully to avoid litigation and ensure timely market entry for generic products.
Key Takeaways
- Patent Infringement Litigation: The case involved multiple patents related to Nascobal Nasal Spray.
- CGT Designation: Perrigo's product was not eligible for CGT exclusivity due to unexpired patents.
- Dismissal and Settlement: The litigation was dismissed, likely due to a settlement agreement.
- Regulatory Compliance: Any changes to the ANDA require FDA approval.
- Industry Implications: The case emphasizes the need for careful management of intellectual property in the pharmaceutical industry.
FAQs
Q: What was the basis of the litigation between Endo Pharmaceuticals Inc. and Perrigo UK FINCO Limited Partnership?
A: The litigation was based on patent infringement claims related to Endo's Nascobal Nasal Spray.
Q: Why was Perrigo's cyanocobalamin nasal spray not eligible for CGT exclusivity?
A: Perrigo's product was not eligible due to the presence of unexpired patents and exclusivities for the reference listed drug (RLD) Nascobal Nasal Spray.
Q: What was the outcome of the litigation?
A: The case was dismissed, indicating a likely settlement between the parties.
Q: What regulatory requirements must be met for changes to Perrigo's ANDA?
A: Any changes to the ANDA require an approved supplemental application before implementation.
Q: How does this case impact the pharmaceutical industry?
A: It highlights the importance of managing intellectual property carefully to avoid litigation and ensure timely market entry for generic products.
Cited Sources
- FDA Approval Letter: Cyanocobalamin Nasal Spray - accessdata.fda.gov
- PR Newswire: Endo Comments on Default Judgment on Liability in Tennessee State Court
- Robins Kaplan LLP: ANDA Litigation Settlements
- GovDelivery: Execution Version SETTLEMENT AGREEMENT
- UniCourt: Endo Pharmaceuticals Inc v Perrigo UK FINCO Limited Partnership
