Litigation Details for SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC. (D.N.J. 2015)

SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC. (D.N.J. 2015)

Docket		Date Filed	2015-01-16
Court	District Court, D. New Jersey	Date Terminated	2015-10-16
Cause	35:271 Patent Infringement	Assigned To	Susan Davis Wigenton
Jury Demand	None	Referred To	Leda Dunn Wettre
Parties	PAR PHARMACEUTICAL COMPANIES, INC.; PAR PHARMACEUTICAL, INC.
Patents	6,248,363; 6,294,192; 6,503,884; 6,514,531; 7,763,635; 8,298,576; 8,298,580; 8,663,683; 8,877,248; 8,889,191; 8,992,989
Attorneys	CHARLES MICHAEL LIZZA; GERI L. ALBIN; WILLIAM C. BATON
Link to Docket	External link to docket

Biologic Drugs cited in SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.

Details for SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC. (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-01-16				External link to document
2015-01-15	1		Publication Data 6,248,363 B1 6/2001 Patel et al. … WO 02/03984 A2 112002 6,248,363 B1 6/2001 Patel eta!. …PageID: 2 ’576 patent”), 8,298,580 (“the ’580 patent”), 8,663,683 (“the ’683 patent”), and 8,877,248… This is a civil action for patent infringement arising under the patent laws of the United States, …title, and interest in the ’576 patent. 19. The ’580 patent, entitled “Sustained-Release Formulations	External link to document
2015-01-15	17		States Patent Nos. 8,298,576 (“the ’576 patent”), 8, 298,580 (“the ’580 patent”), 8,663,683…United States Patent Nos. 8,298,576 (the “’576 patent”), 8, 298,580 (the “’580 patent”), 8,663,683 (…seq., that U.S. Patent Nos. 8,298,576 (the “’576 patent”); 8,298,580 (the “’580 patent”); 8,663,683 (… (Declaratory Judgment Regarding U.S. Patent No. 8,298,576) 12. Counterclaim Plaintiffs…Defendants hereby certifies that United States Patent Nos. 8,298,576, 8, 298,580, 8,663,683, 8,877,248, and 8,889,191	External link to document
2015-01-15	67		for infringement of United States Patent Nos. 8298,576, 8,298,580, 8,663.683, 8.877,248, 8,889.191,…PERMANENT INJUNCTION This action for patent infringement having been brought by Plaintiff Supernus…and 8.992,989 (collectiveiy, the “Litigated Patents”); Par and Supernus have agreed…product, would infringe each of the Litigated Patents in the absence of a license; and Case 2:15-cv-00326… stated and limited herein, that the Litigated Patents, and all the claims contained therein, are	External link to document

Litigation Summary and Analysis for Supernus Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc.

Case Overview

The litigation in question involves Supernus Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc., and is part of the broader landscape of generic drug approvals and patent disputes under the Hatch-Waxman Act.

Background

Supernus Pharmaceuticals, Inc. is a pharmaceutical company that develops and markets various drugs, including those for central nervous system disorders. Par Pharmaceutical Companies, Inc. is a generic drug manufacturer. The case, filed in 2015, revolves around the generic version of one of Supernus's branded drugs.

Key Issues

Patent Disputes

The core of the litigation involves patent disputes related to Supernus's branded drug. When a generic manufacturer like Par Pharmaceutical Companies, Inc. seeks to enter the market with a generic version, it must navigate the patent landscape set by the brand-name drug's patents. This often involves filing an Abbreviated New Drug Application (ANDA) with the FDA, which may include a Paragraph IV certification challenging the validity or non-infringement of the brand-name drug's patents[3].

ANDA Litigation

In the context of this case, Par Pharmaceutical Companies, Inc. would have filed an ANDA with the FDA, likely including a Paragraph IV certification. This certification would have triggered a patent infringement lawsuit by Supernus Pharmaceuticals, Inc. under the Hatch-Waxman Act.

Litigation Process

Filing and Initial Proceedings

The lawsuit, Supernus Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc., was filed in the U.S. District Court for the District of New Jersey (Case No. 2:15-cv-00326). The initial proceedings would have involved Supernus asserting its patent rights and Par Pharmaceutical defending its right to market the generic version.

Patent Validity and Infringement

The litigation would have focused on the validity and enforceability of Supernus's patents, as well as whether Par Pharmaceutical's generic product infringes these patents. This phase often involves extensive expert testimony and technical analysis.

Settlements and Outcomes

Settlement Agreements

Many ANDA litigations are resolved through settlement agreements. These agreements can involve various terms, such as:

• Exclusivity Periods: The generic manufacturer may agree not to enter the market until a certain date or after a specific period of exclusivity for the brand-name drug.
• License Agreements: The brand-name drug manufacturer may grant a license to the generic manufacturer to produce and sell the generic version under certain conditions.
• Dismissal of Claims: The parties may agree to dismiss all claims, counterclaims, and affirmative defenses without prejudice or with prejudice, depending on the terms of the settlement[3].

Specific Outcome

While the specific details of the settlement in this case are not provided in the sources, it is common for such litigations to end in a settlement that balances the interests of both parties. For example, the generic manufacturer might be allowed to enter the market after a certain period, or the brand-name manufacturer might receive some form of compensation or agreement to limit competition.

Impact on Market Competition

Delayed Entry of Generics

Litigations like this can significantly delay the entry of generic drugs into the market, which can impact competition and drug prices. Brand-name drug manufacturers often use various strategies, including filing citizen petitions and imposing distribution restrictions, to delay generic entry and protect their market share[1].

Consumer and Healthcare Implications

The delay in generic drug entry can have significant implications for consumers and the healthcare system. Generic drugs are generally cheaper than their brand-name counterparts, so delays can keep prices higher and limit access to affordable medications.

Legal and Regulatory Context

Hatch-Waxman Act

The Hatch-Waxman Act provides a framework for the approval of generic drugs and the resolution of patent disputes. It allows generic manufacturers to challenge brand-name drug patents through Paragraph IV certifications, which can lead to litigation but also facilitates the eventual entry of generic drugs into the market[3].

FDA Role

The FDA plays a crucial role in this process by reviewing ANDAs and ensuring that generic drugs meet the necessary standards for safety and efficacy. The FDA's decisions can influence the outcome of these litigations, especially if they involve issues related to the approval process or the compatibility of generic products with brand-name delivery systems[1].

Key Takeaways

• Patent Disputes: The core issue in such litigations is often the validity and enforceability of patents related to the brand-name drug.
• Settlement Agreements: Most cases are resolved through settlements that balance the interests of both parties.
• Market Impact: These litigations can delay the entry of generic drugs, affecting market competition and drug prices.
• Regulatory Framework: The Hatch-Waxman Act and FDA regulations provide the legal and regulatory context for these disputes.

FAQs

What is the Hatch-Waxman Act, and how does it relate to generic drug approvals?

The Hatch-Waxman Act is a federal law that provides a framework for the approval of generic drugs. It allows generic manufacturers to file Abbreviated New Drug Applications (ANDAs) and challenge brand-name drug patents through Paragraph IV certifications, facilitating the entry of generic drugs into the market.

How do patent disputes affect the entry of generic drugs into the market?

Patent disputes can significantly delay the entry of generic drugs. Brand-name drug manufacturers may file lawsuits to protect their patents, which can keep generic drugs off the market until the disputes are resolved.

What role does the FDA play in ANDA litigations?

The FDA reviews ANDAs to ensure that generic drugs meet safety and efficacy standards. Their decisions can influence the outcome of litigations, especially if they involve issues related to the approval process or the compatibility of generic products with brand-name delivery systems.

What are common terms in settlement agreements between brand-name and generic drug manufacturers?

Common terms include exclusivity periods, license agreements, and the dismissal of claims. These terms can allow the generic manufacturer to enter the market after a certain period or under specific conditions.

How do these litigations impact consumers and the healthcare system?

These litigations can keep generic drugs off the market, resulting in higher drug prices and limited access to affordable medications. This can have significant implications for consumers and the overall healthcare system.

Cited Sources:

1. United States District Court - District of Delaware, "In the United States District Court - District of Delaware" [PDF].
2. Supernus Pharmaceuticals, Inc., "UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q".
3. Robins Kaplan, "ANDA Litigation Settlements of Q3 - Fall 2023 | Hatch-Waxman".