Litigation Details for NORWICH PHARMACEUTICALS, INC. v. BECERRA (D.D.C. 2023)

NORWICH PHARMACEUTICALS, INC. v. BECERRA (D.D.C. 2023)

Docket		Date Filed	2023-06-05
Court	District Court, District of Columbia	Date Terminated	2023-12-04
Cause	05:702 Administrative Procedure Act	Assigned To	Randolph Daniel Moss
Jury Demand	None	Referred To
Patents	10,314,828; 10,335,397; 10,456,384; 10,703,763; 10,709,694; 10,765,667; 11,564,912; 6,861,053; 7,045,620; 7,612,199; 7,902,206; 7,906,542; 7,915,275; 8,158,644; 8,158,781; 8,193,196; 8,309,569; 8,518,949; 8,642,573; 8,741,904; 8,829,017; 8,835,452; 8,853,231; 8,946,252; 8,969,398; 9,271,968; 9,421,195; 9,623,001; 9,629,828
Link to Docket	External link to docket

Details for NORWICH PHARMACEUTICALS, INC. v. BECERRA (D.D.C. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-06-05				External link to document
2023-06-05	1	Exhibit 1	(the 9'828 patent) July 24, 2029 10,314,828 (the 4'828 patent) July 24, 2029 …550 mg, is subject to periods of patent protection. The following patents and expiration dates are currently… U.S. Patent Number Expiration Date 7,045,620 (the '620 patent) June…7,612,199 (the '199 patent) June 19, 2024 7,902,206 (the '206 patent) June 19, 2024…7,906,542 (the '542 patent) June 1, 2025 7,915,275 (the '275 patent) February 23,	External link to document
2023-06-05	4	Exhibit 1 to Landmon Declaration	“’195 Patent”); 9,629,828 (the “’9,828 Patent”); 10,314,828 (the “’4,828 Patent”); 10,335,397 (the “… United States Patent Nos. 7,045,620 (the “’620 Patent”); 7,612,199 (the “’199 Patent”); 7,902,206 (… (the “’206 Patent”); 7,906,542 (the “’542 Patent”); 7,915,275 (the “’275 Patent”); 8,158,644 (the “… “’644 Patent”); 8,158,781 (the “’781 Patent”); 8,193,196 (the “’196 Patent”); 8,309,569 (the “’569 …569 Patent”); 8,518,949 (the “’949 Patent”); 8,642,573 (the “’573 Patent”); 8,741,904 (the “’904 Patent	External link to document
2023-06-05	12	Exhibit Complaint	(last visited Jun. 4, 2023). 10 U.S. Patent Nos. 10,314,828; 10,335,397; 10,456,384; 7,045,620; 7,612,199… “Asserted HE Patents” refers to claim 8 of U.S. Patent No. 8,642,573 (the “’573 Patent”), claim 6 of …of U.S. Patent No. 9,421,195 (the “’195 Patent”), and claims 11-12 of U.S. Patent No. 10,335,397 (the “…claims from three asserted method of use patents (“the HE Patents”), and that Norwich’s Original ANDA should…Amended ANDA contain a Paragraph IV patent certification to any patent held to have been infringed under	External link to document
2023-06-05	51	Redacted Document	(the 9'828 patent) July 24, 2029 10,314,828 (the 4'828 patent) July 24, 2029 … “Asserted HE Patents” refers to claim 8 of U.S. Patent No. 8,642,573 (the “’573 Patent”), claim 6 of …of U.S. Patent No. 9,421,195 (the “’195 Patent”), and claims 11-12 of U.S. Patent No. 10,335,397 (the “…Asserted HE Patents because, as shown below, a claim for patent infringement of the Asserted HE Patents under…of claim 8 of U.S. Patent No. 8,642,573 (the “’573 Patent”), claim 6 of U.S. Patent No. 9,421,195 (the	External link to document

Norwich Pharmaceuticals, Inc. v. Becerra: A Comprehensive Litigation Summary and Analysis

Background of the Case

The case of Norwich Pharmaceuticals, Inc. v. Becerra involves a complex legal battle between Norwich Pharmaceuticals, Inc. and Salix Pharmaceuticals, Inc., with the U.S. Food and Drug Administration (FDA) also playing a crucial role. Salix markets the drug rifaximin under the brand name Xifaxan, which is used to treat irritable bowel syndrome with diarrhea (IBS-D) and to reduce the risk of hepatic encephalopathy (HE) recurrence in adults[3][4].

Nature of the Case and Key Issues

Norwich Pharmaceuticals aims to market a generic version of rifaximin and has filed an Abbreviated New Drug Application (ANDA) with the FDA. However, the filing of this ANDA was deemed an act of infringement against the patents listed by Salix in the Orange Book to protect Xifaxan from generic competition[3][4].

Patent Litigation

Salix sued Norwich, leading to a district court decision that invalidated two drug substance patents and two method-of-use patents covering the IBS-D indication. However, the court found that Salix's three method-of-use patents for the HE indication were valid and infringed[3][4].

District Court Decision and Its Implications

The district court entered an order stating that the effective date of any final FDA approval for Norwich's ANDA would not be earlier than the expiration date of the last-to-expire HE method-of-use patents, which is currently set for October 2, 2029, plus any applicable regulatory exclusivity[3][4].

Amended ANDA and Rule 60(b) Motion

Following the district court's decision, Norwich amended its ANDA to exclude the HE indication from its proposed label and filed a motion under Federal Rule of Civil Procedure 60(b) to modify the judgment. This motion was denied by the district court, which held that Norwich could not change its ANDA after the final judgment and expect a different outcome[3][4].

FDA's Tentative Approval and Norwich's Challenge

The FDA tentatively approved Norwich's amended ANDA but declined to grant final approval before October 2, 2029, in line with its interpretation of the district court's final judgment. Norwich challenged this decision, arguing that the FDA's interpretation was arbitrary, capricious, and contrary to law. Norwich sought injunctive and declaratory relief to force the FDA to grant immediate final approval[3][4].

Court Ruling and Analysis

The U.S. District Court for the District of Columbia denied Norwich's motion for a preliminary injunction and granted the FDA and Salix's cross-motions for summary judgment. The court found that the FDA's determination was consistent with the most straightforward reading of the final judgment. The court emphasized that Norwich failed to show that the law was clear enough to justify the FDA reading the final judgment in a manner that ignored its plain terms[3][4].

Key Points of the Ruling

• Interpretation of Final Judgment: The court upheld the FDA's interpretation that the final judgment applied to Norwich's ANDA in its entirety, including any amendments.
• Rule 60(b) Motion: The court denied Norwich's motion to modify the judgment, citing that it was improper to change the ANDA after the final judgment and expect a different outcome.
• FDA's Authority: The court supported the FDA's decision to follow the district court's order and not grant final approval before the specified date[3][4].

Implications and Future Directions

The ruling has significant implications for generic drug manufacturers seeking to enter the market. It underscores the importance of adhering to the terms of final judgments and the limitations on modifying ANDAs post-judgment.

Appeal and Ongoing Litigation

Norwich has appealed the scope of the district court's final judgment to the Federal Circuit, while Salix has cross-appealed the invalidity findings of the district court. The outcome of these appeals will further clarify the legal landscape for generic drug approvals and patent litigation[3][4].

Statutory and Regulatory Context

The case highlights the interplay between patent law, FDA regulations, and the Administrative Procedure Act (APA). The FDA's actions were guided by 21 C.F.R. § 314.107(b)(1)(iv), which mirrors the statutory language regarding the timing of ANDA approvals in relation to patent litigation[4].

Industry Impact

Battles over generic drug approvals, especially for high-revenue drugs like Xifaxan, are common and often fiercely contested. This case serves as a precedent for how courts and regulatory agencies interpret and enforce patent judgments and ANDA approvals, affecting the strategies of both brand-name and generic drug manufacturers.

Key Takeaways

• Adherence to Final Judgments: Generic drug manufacturers must adhere strictly to the terms of final judgments and cannot expect to change their ANDAs post-judgment.
• FDA Interpretation: The FDA's interpretation of court orders will be given significant weight, especially if it aligns with the plain terms of the judgment.
• Patent Litigation: The validity and infringement of patents remain critical factors in determining the timing of generic drug approvals.
• Regulatory Compliance: Understanding and complying with FDA regulations and statutory requirements is essential for navigating the approval process.

Frequently Asked Questions (FAQs)

What is the main issue in the Norwich Pharmaceuticals, Inc. v. Becerra case?

The main issue is Norwich's challenge to the FDA's decision to tentatively approve its amended ANDA for a generic version of Xifaxan, with final approval delayed until October 2, 2029, due to valid HE method-of-use patents.

Why did the district court deny Norwich's motion to modify the judgment?

The district court denied the motion because it was deemed improper for Norwich to change its ANDA after the final judgment and expect a different outcome.

What is the significance of the FDA's tentative approval in this case?

The FDA's tentative approval indicates that while Norwich's amended ANDA meets certain criteria, final approval is delayed due to the ongoing patent protections.

How does this case impact generic drug manufacturers?

This case emphasizes the importance of adhering to final judgments and the limitations on modifying ANDAs post-judgment, affecting the strategies and timelines for generic drug approvals.

What are the next steps in the litigation process?

Norwich has appealed the scope of the district court's final judgment to the Federal Circuit, and Salix has cross-appealed the invalidity findings, with the outcomes of these appeals pending.

Cited Sources:

1. JD Supra: Norwich Pharms., Inc. v. Becerra - Xifaxan® (Rifaximin)[1].
2. Bausch Health: U.S. District Court Dismisses Norwich's Lawsuit Against the FDA[2].
3. Robins Kaplan LLP: Norwich Pharms., Inc. v. Becerra[3].
4. Casetext: Norwich Pharm. v. Becerra, 703 F. Supp. 3d 1[4].
5. VLEX: Norwich Pharm. v. Becerra - Federal Cases - Case Law[5].