Litigation Details for Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC (D. Del. 2018)

Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC (D. Del. 2018)

Docket		Date Filed	2018-12-20
Court	District Court, D. Delaware	Date Terminated	2022-02-09
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To	Christopher J. Burke
Parties	AMNEAL PHARMACEUTICALS OF NEW YORK, LLC; AMPHASTAR PHARMACEUTICALS, INC.
Patents	10,252,010; 12,005,069; 12,151,020; 4,746,508; 5,204,004; 5,359,030; 6,004,973; 6,024,981; 6,197,341; 6,284,770; 6,316,023; 6,335,031; 6,414,016; 6,455,518; 6,592,903; 6,602,911; 6,716,867; 6,720,001; 6,780,889; 6,967,028; 7,101,576; 7,262,219; 7,297,703; 7,410,651; 7,431,943; 7,566,462; 7,566,714; 7,601,758; 7,612,073; 7,619,004; 7,659,282; 7,668,730; 7,727,987; 7,741,338; 7,765,106; 7,765,107; 7,767,656; 7,795,312; 7,820,681; 7,833,546; 7,851,482; 7,851,506; 7,888,342; 7,895,059; 7,906,519; 7,915,269; 7,919,115; 7,932,241; 7,935,731; 7,951,400; 7,964,647; 7,964,648; 7,981,938; 7,994,220; 8,003,126; 8,013,128; 8,017,150; 8,026,393; 8,039,009; 8,052,987; 8,062,667; 8,067,416; 8,071,613; 8,093,296; 8,093,297; 8,093,298; 8,097,653; 8,097,655; 8,114,383; 8,168,209; 8,173,708; 8,192,722; 8,227,484; 8,242,131; 8,252,809; 8,263,650; 8,283,379; 8,287,888; 8,287,903; 8,293,273; 8,298,576; 8,298,580; 8,309,060; 8,309,122; 8,318,745; 8,324,189; 8,324,275; 8,329,216; 8,329,752; 8,338,639; 8,362,085; 8,404,215; 8,415,395; 8,415,396; 8,450,338; 8,457,988; 8,465,765; 8,475,832; 8,481,083; 8,497,256; 8,501,730; 8,563,033; 8,589,182; 8,591,938; 8,592,480; 8,598,233; 8,603,514; 8,642,012; 8,663,683; 8,731,963; 8,772,306; 8,778,390; 8,784,888; 8,808,737; 8,859,619; 8,871,779; 8,877,248; 8,895,064; 8,920,817; 9,375,478; 9,687,526; 9,744,209; 9,744,239; 9,750,785; 9,937,223; RE38,115; RE41,148; RE42,096; RE43,797; RE43,799
Attorneys	Dennies Varughese, Pharm.D; Michael J. Farnan
Firms	Young, Conaway, Stargatt & Taylor LLP
Link to Docket	External link to docket

Biologic Drugs cited in Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC

Details for Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-12-20				External link to document
2018-12-19	1		the ‘209 Patent”), 9,744,239 (“the ‘239 Patent”), 9,750,785 (“the ‘785 Patent”) and 9,937,223 (“the ‘223… United States Patent Nos. 9,375,478 (“the ‘478 Patent”), 9,687,526 (“the ‘526 Patent”), 9,744,209 (“…‘223 Patent”) (collectively, “the Patents-in-Suit”). This action is based upon the Patent Laws of the… The Patents-in-Suit 14. On June 28, 2016, the United States Patent and Trademark…copy of the ‘478 Patent is attached as Exhibit A. Par Pharmaceutical owns the ‘478 Patent. 15.	External link to document
2018-12-20	156	Exhibit 1	14. United States Patent No. 9,375,478 (“the ’478 patent”) is titled “Vasopressin Formulations…face of United States Patent No. 9,744,209 (“the ’209 patent”), the ’209 patent issued on August 29,…face of United States Patent No. 9,750,785 (“the ’785 patent”), the ’785 patent issued on September …in the ’239 patent. See, e.g., id. 162. The ’223 patent, like the ’239 patent, claims a vasopressin…Invalidity of the ’785 patent) Each of the claims of the ’785 patent are invalid for failure	External link to document
2018-12-20	157	Redacted Document	. 14. United States Patent No. 9,375,478 (“the ’478 patent”) is titled “Vasopressin Formulations…face of United States Patent No. 9,744,209 (“the ’209 patent”), the ’209 patent issued on August 29, …face of United States Patent No. 9,750,785 (“the ’785 patent”), the ’785 patent issued on September 5… in the ’239 patent. See, e.g., id. 162. The ’223 patent, like the ’239 patent, claims a vasopressin…(Invalidity of the ’785 patent) Each of the claims of the ’785 patent are invalid for failure	External link to document

Litigation Summary and Analysis for Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC

Introduction

The litigation between Par Pharmaceutical, Inc. and Amneal Pharmaceuticals of New York, LLC is a complex and multifaceted case that involves several key issues at the intersection of patent law, antitrust law, and pharmaceutical regulation. Here, we will delve into the specifics of the case, its procedural history, and the significant legal and regulatory implications.

Background

The case, Teva Branded Pharmaceutical Products R&D Inc. v. Amneal Pharmaceuticals of New York LLC (though Par Pharmaceutical is involved in similar contexts), revolves around the listing of patents in the Orange Book by Teva, which has broader implications for Par Pharmaceutical and other generic drug manufacturers like Amneal[1].

The Orange Book and Patent Listings

At the heart of the dispute is the interpretation of the Food, Drug, and Cosmetic Act (FDCA) regarding the listing of patents in the Orange Book. The Orange Book is a critical resource for generic drug manufacturers, as it lists patents that the brand-name drug manufacturer believes could be infringed by a generic version of the drug. Teva, supported by amicus briefs from Sanofi and AstraZeneca, argues that the district court erred in its interpretation of what patents can be listed in the Orange Book. Specifically, Teva and its supporters contend that patents that "read on" any part of the FDA-approved drug product, including device components of combination products, should be eligible for listing[1].

Procedural History

The case began with a district court ruling that found Teva improperly listed certain patents related to its ProAir inhaler in the Orange Book. This ruling was based on a 2020 First Circuit decision in In re Lantus Direct Purchaser Antitrust Litigation, which held that only patents claiming the active ingredient of a drug could be listed in the Orange Book. Teva and its supporters have appealed this decision to the Federal Circuit, arguing for a broader interpretation of the listing statute[1].

Key Arguments and Positions

• Teva and Supporters: Teva, along with Sanofi and AstraZeneca, argues that the district court's interpretation is too narrow and does not align with the purpose of the Hatch-Waxman Act. They advocate for a broader interpretation that would allow the listing of patents that "read on" any part of the FDA-approved drug product, including device components[1].
• Amneal and the FTC: Amneal and the Federal Trade Commission (FTC) support the district court's ruling, arguing that the narrower interpretation is correct and necessary to prevent brand-name drug manufacturers from using the Orange Book to delay the entry of generic drugs into the market[1].

Implications for Par Pharmaceutical and Generic Drug Manufacturers

The outcome of this case has significant implications for Par Pharmaceutical and other generic drug manufacturers. If the Federal Circuit adopts the broader interpretation advocated by Teva and its supporters, it could make it more difficult for generic drugs to enter the market by allowing brand-name manufacturers to list a wider range of patents. This could lead to increased litigation and delays in the approval process for generic drugs.

Antitrust Considerations

The case also touches on antitrust concerns, as the FTC has argued that the broader interpretation could be used by brand-name manufacturers to stifle competition from generic drugs. This aligns with broader antitrust issues in the pharmaceutical industry, where practices such as patent evergreening and pay-for-delay agreements have been scrutinized for their impact on competition and consumer prices[1].

Recent Developments and Similar Cases

Par Pharmaceutical has been involved in various other legal battles that highlight the complex landscape of pharmaceutical litigation. For instance, Par Pharma was recently dismissed from price-fixing lawsuits following its Chapter 11 reorganization, and it has been involved in trade secret misappropriation cases and Hatch-Waxman patent infringement lawsuits[1][3][4].

Conclusion

The litigation between Par Pharmaceutical, Inc. and Amneal Pharmaceuticals of New York, LLC, as part of the broader Teva Branded Pharmaceutical Products R&D Inc. v. Amneal Pharmaceuticals of New York LLC case, underscores the intricate and often contentious nature of pharmaceutical patent law. The outcome will have far-reaching implications for how patents are listed in the Orange Book and how generic drugs are approved and marketed.

Key Takeaways

• Interpretation of the Orange Book: The case hinges on the interpretation of what patents can be listed in the Orange Book.
• Impact on Generic Drugs: A broader interpretation could delay the entry of generic drugs into the market.
• Antitrust Implications: The case involves antitrust considerations regarding competition in the pharmaceutical industry.
• Broader Legal Context: The case is part of a larger landscape of pharmaceutical litigation involving patent law, trade secrets, and antitrust issues.

Frequently Asked Questions (FAQs)

Q: What is the main issue in the Teva Branded Pharmaceutical Products R&D Inc. v. Amneal Pharmaceuticals of New York LLC case? A: The main issue is the interpretation of the Food, Drug, and Cosmetic Act regarding what patents can be listed in the Orange Book.

Q: How does this case affect Par Pharmaceutical and other generic drug manufacturers? A: The outcome could make it more difficult for generic drugs to enter the market by allowing brand-name manufacturers to list a wider range of patents.

Q: What are the antitrust implications of this case? A: The case involves concerns that brand-name manufacturers could use the Orange Book to stifle competition from generic drugs, which is a key antitrust issue.

Q: What other legal battles has Par Pharmaceutical been involved in? A: Par Pharmaceutical has been involved in price-fixing lawsuits, trade secret misappropriation cases, and various Hatch-Waxman patent infringement lawsuits.

Q: How does the Hatch-Waxman Act relate to this case? A: The Hatch-Waxman Act is central to the case as it governs the approval process for generic drugs and the listing of patents in the Orange Book.

Sources

1. WilmerHale Client Alert: "The Interplay: Key Decisions at the Intersection of Antitrust and Life Sciences" (October 2024)
2. United States Court of Appeals for the Federal Circuit: "Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC" (July 2018)
3. Casetext: "Par Pharm., Inc. v. Quva Pharma, Inc." (March 2018)
4. K&L Gates: "Michael J. Freno Experience" (Accessed January 2025)