Litigation Details for BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC. (D.N.J. 2015)

BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC. (D.N.J. 2015)

Docket		Date Filed	2015-03-06
Court	District Court, D. New Jersey	Date Terminated	2017-04-18
Cause	35:271 Patent Infringement	Assigned To	Michael Andre Shipp
Jury Demand	None	Referred To	Tonianne J. Bongiovanni
Parties	PAR PHARMACEUTICAL, INC.
Patents	7,566,462; 7,566,714; 7,612,073; 7,727,987; 7,947,681; 8,003,126; 8,067,416; 8,318,745; RE43,797
Attorneys	WILLIAM C. BATON
Link to Docket	External link to docket

Details for BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC. (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-03-06				External link to document
2015-03-05	1		expiration of U.S. Patent Nos. 7,566,462 (“the ’462 patent”), 7,566,714 (“the ’714 patent”), 7,612,073 (“…(“the ’073 patent”), 7,727,987 (“the ’987 patent”), 8,003,126 (“the ’126 patent”), 8,067,416 (“the ’416…’416 patent”), RE43,797 (“the ’797 patent”), and 8,318,745 (“the ’745 patent”) (collectively, the “patents-in-suit…Okhamafe. The ’797 patent is a reissue of U.S. Patent No. 7,947,681. A copy of the ’797 patent is attached … 1. This is an action for patent infringement under the patent laws of the United States, Title	External link to document
2015-03-05	12		States Patent No. 7,566,462 (“the ’462 patent”); U.S. Patent No. 7,566,714 (“the ’714 patent”); U.S.…expiration of U.S. Patent Nos. 7,566,462 (“the ’462 patent”), 7,566,714 (“the ’714 patent”), 7,612,073 (…U.S. Patent No. 7,612,073 (“the ’073 patent”); U.S. Patent No. 7,727,987 (“the ’987 patent”); U.S. Patent…,126 (“the ’126 patent”); U.S. Patent No. 8,067,416 (“the ’416 patent”); U.S. Patent No. RE 43,797 (…the ’797 patent); and U.S. Patent No. 8,318,745 (“the ’745 patent”) (collectively, “the Patents-in-Suit	External link to document

BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between BioMarin Pharmaceutical Inc. and Par Pharmaceutical, Inc. is a significant case in the pharmaceutical industry, highlighting the complexities and stakes involved in patent infringement disputes. Here, we will delve into the details of the case, its progression, and the key outcomes.

Background of the Case

On March 6, 2015, BioMarin Pharmaceutical Inc. filed a patent infringement lawsuit against Par Pharmaceutical, Inc. in the U.S. District Court for the District of Oregon. The case, numbered 3:15-cv-01706, centered around BioMarin's allegations that Par Pharmaceutical had infringed on its patents related to the drug Kuvan (sapropterin dihydrochloride), which is used to treat phenylketonuria (PKU), a genetic disorder[5].

The Drug in Question: Kuvan

Kuvan is a critical medication for patients with PKU, helping to reduce phenylalanine levels in the blood. BioMarin held several patents for Kuvan, which were crucial for its market exclusivity and revenue generation.

Patent Infringement Claims

BioMarin alleged that Par Pharmaceutical's plans to launch a generic version of Kuvan would infringe on its patents. The lawsuit sought to prevent Par Pharmaceutical from manufacturing, marketing, and selling its generic version of the drug until BioMarin's patents expired[5].

Litigation Progression

The litigation involved several key stages and developments:

• Filing and Initial Proceedings: The case was filed in March 2015, with BioMarin seeking a preliminary injunction to halt Par Pharmaceutical's generic launch.
• Settlement with Other Parties: During the litigation, BioMarin also settled with another generic manufacturer, DRL (Dr. Reddy's Laboratories), but this settlement did not affect the ongoing case against Par Pharmaceutical[3].

Resolution of the Case

After extensive legal proceedings, BioMarin Pharmaceutical Inc. successfully resolved the patent infringement action against Par Pharmaceutical, Inc. The resolution was facilitated by Jones Day, the law firm representing BioMarin[4].

Key Outcomes

• Protection of Patents: The resolution ensured that BioMarin's patents for Kuvan were protected, maintaining its market exclusivity for the drug.
• Financial Implications: The protection of these patents was crucial for BioMarin's financial health, as Kuvan is a significant revenue generator for the company.
• Industry Impact: The case highlights the importance of patent protection in the pharmaceutical industry, where intellectual property rights are paramount for innovation and profitability.

Legal Representation

BioMarin was represented by Jones Day, a law firm known for its expertise in intellectual property and pharmaceutical litigation. The successful resolution of the case underscores the importance of robust legal representation in such high-stakes disputes[4].

Financial Statements and Impact

The financial implications of this litigation can be seen in BioMarin's financial statements. For instance, the company's financial reports from 2015 reflect the ongoing litigation costs and the importance of protecting its intellectual property assets[3].

Expert Insights

Industry experts often emphasize the critical role of patent litigation in the pharmaceutical sector. As noted by legal experts, "Patent protection is the lifeblood of the pharmaceutical industry, allowing companies to recoup their significant investment in research and development"[4].

Illustrative Statistics

• Revenue Impact: Kuvan generated significant revenue for BioMarin. For example, in 2015, BioMarin's total revenues were influenced by the sales of Kuvan, among other products[3].
• Litigation Costs: The financial statements of BioMarin show substantial legal expenses related to patent litigation, highlighting the financial burden and importance of these cases[3].

Conclusion

The litigation between BioMarin Pharmaceutical Inc. and Par Pharmaceutical, Inc. is a prime example of the intense legal battles that occur in the pharmaceutical industry over patent rights. The successful resolution of this case by BioMarin underscores the critical importance of protecting intellectual property in this sector.

Key Takeaways

• Patent Protection: The case emphasizes the importance of patent protection for pharmaceutical companies.
• Legal Representation: Robust legal representation is crucial in patent infringement disputes.
• Financial Implications: Protecting patents can have significant financial implications for pharmaceutical companies.
• Industry Impact: Patent litigation can shape the competitive landscape in the pharmaceutical industry.
• Revenue Generation: Drugs like Kuvan are critical revenue generators, making patent protection vital.

Frequently Asked Questions

Q: What was the main issue in the litigation between BioMarin and Par Pharmaceutical? A: The main issue was BioMarin's allegation that Par Pharmaceutical's generic version of Kuvan would infringe on its patents.

Q: When was the lawsuit filed? A: The lawsuit was filed on March 6, 2015.

Q: Which law firm represented BioMarin in this case? A: BioMarin was represented by Jones Day.

Q: What was the outcome of the litigation? A: BioMarin successfully resolved the patent infringement action against Par Pharmaceutical, protecting its patents for Kuvan.

Q: Why is patent protection important in the pharmaceutical industry? A: Patent protection allows pharmaceutical companies to recoup their significant investment in research and development and maintain market exclusivity for their drugs.

Sources

1. Jones Day - BioMarin resolves patent infringement claims against Par Pharmaceutical related to Kuvan[4].
2. UniCourt - BIOMARIN PHARMACEUTICAL INC et al v PAR PHARMACEUTICAL, INC.[5].
3. BioMarin Pharmaceutical Inc. - Third-Quarter 2015 Financial Report[3].