Litigation Details for Pharmacyclics LLC v. Zydus Worldwide DMCC (D. Del. 2020)

Pharmacyclics LLC v. Zydus Worldwide DMCC (D. Del. 2020)

Docket		Date Filed	2020-04-24
Court	District Court, D. Delaware	Date Terminated	2021-03-31
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To
Parties	JANSSEN BIOTECH, INC.
Patents	10,010,507; 10,106,548; 10,125,140; 10,213,386; 10,478,439; 10,653,696; 10,828,259; 7,514,444; 8,008,309; 8,476,284; 8,497,277; 8,697,711; 8,735,403; 8,754,090; 8,754,091; 8,952,015; 8,957,079; 9,181,257; 9,296,753; 9,725,455
Attorneys	Hershy Stern
Firms	Wilson Sonsini Goodrich & Rosati
Link to Docket	External link to docket

Details for Pharmacyclics LLC v. Zydus Worldwide DMCC (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-04-24				External link to document
2020-04-24	1	Complaint	(“the ’455 Patent”); 10,010,507 (“the ’507 Patent”); 10,106,548 (“the ’548 Patent”); 10,125,140 … United States Patent Nos. 7,514,444 (“the ’444 Patent”); 8,008,309 (“the ’309 Patent”); 8,476,284 (“…(“the ’284 Patent”); 8,497,277 (“the ’277 Patent”); 8,697,711 (“the ’711 Patent”); 8,735,403 (“the ’403…’403 Patent”); 8,754,090 (“the ’090 Patent”); 8,754,091 (“the ’091 Patent”); 8,952,015 (“the ’015 Patent…,079 (“the ’079 Patent”); 9,181,257 (“the ’257 Patent”); 9,296,753 (“the ’753 Patent”); 9,725,455 Case	External link to document
2020-04-24	45	Complaint - Amended	“the ’455 Patent”); 10,010,507 (“the ’507 Patent”); 10,106,548 (“the ’548 Patent”); 10,125,140 (“the … United States Patent Nos. 7,514,444 (“the ’444 Patent”); 8,008,309 (“the ’309 Patent”); 8,476,284 (“…(“the ’284 Patent”); 8,497,277 (“the ’277 Patent”); 8,697,711 (“the ’711 Patent”); 8,735,403 (“the ’… ’403 Patent”); 8,754,090 (“the ’090 Patent”); 8,754,091 (“the ’091 Patent”); 8,952,015 (“the ’015 Patent…,079 (“the ’079 Patent”); 9,181,257 (“the ’257 Patent”); 9,296,753 (“the ’753 Patent”); 9,725,455 (“the	External link to document

Pharmacyclics LLC v. Zydus Worldwide DMCC: A Comprehensive Litigation Summary and Analysis

Introduction

The lawsuit Pharmacyclics LLC v. Zydus Worldwide DMCC (Case No. 1:20-cv-00560) is a significant patent infringement case filed in the District Court of Delaware. This case involves Pharmacyclics LLC and Janssen Biotech, Inc. as plaintiffs, and Zydus Worldwide DMCC and Cadila Healthcare Ltd. as defendants. Here is a detailed summary and analysis of the case.

Background

Pharmacyclics LLC, a wholly owned subsidiary of AbbVie Inc., and Janssen Biotech, Inc. are the owners and assignees of several patents related to the pharmaceutical product IMBRUVICA®, a Bruton's tyrosine kinase (BTK) inhibitor used primarily in the treatment of certain types of blood cancers[1][2][5].

Nature of the Action

The lawsuit was initiated in response to the defendants' submissions of Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA) seeking approval to market generic versions of IMBRUVICA®. The plaintiffs allege that these generic versions would infringe on their patents listed in the FDA's Orange Book, which includes patents such as '309, '444, '711, '403, '079, '257, '091, '277, '015, '284, '090, '999, '889, '881, '883, '721, '753, '455, '617, and '604[1].

Patents in Dispute

The patents at issue cover various aspects of IMBRUVICA®, including pharmaceutical formulations, crystalline forms, and the use of BTK inhibitors. Specific patents mentioned in the complaint include:

• U.S. Patent Nos. 10,010,507, 10,106,548, 10,125,140, 10,213,386, 10,478,439, 7,514,444, and 8,008,309[2].

Defendants and Their Actions

Zydus Worldwide DMCC and Cadila Healthcare Ltd. are accused of preparing and submitting ANDAs to the FDA, which the plaintiffs believe will lead to the distribution and sale of generic versions of IMBRUVICA® in the United States, including in the state of Delaware. This action is alleged to cause injury to the plaintiffs by displacing sales of their patented product[1].

Jurisdiction and Venue

The plaintiffs argue that the District Court of Delaware has personal jurisdiction over the defendants, who are foreign entities, due to their sufficient contacts within the United States. This includes participating in the preparation and submission of ANDAs to the FDA and manufacturing and selling pharmaceutical products distributed throughout the U.S., including in Delaware. Venue is also deemed proper under 28 U.S.C. §§ 1391 and 1400(b)[1].

Litigation Proceedings

The lawsuit was filed on April 16, 2020. The plaintiffs seek to prevent the defendants from marketing and selling their generic versions of IMBRUVICA® until the expiration of the relevant patents. The case involves complex patent law issues, including the validity and enforceability of the patents in question[2][5].

FDA Compliance and Litigation Timeline

Zydus Worldwide DMCC complied with the requirements of section 505(j)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by submitting their ANDA. The litigation was initiated within the statutory 45-day period following the ANDA submission, as required by law[5].

Industry Implications

This case highlights the ongoing battles between pharmaceutical companies and generic drug manufacturers over patent rights. The outcome of this litigation could have significant implications for the pharmaceutical industry, particularly in terms of patent protection and the timing of generic drug market entry.

Expert Insights

Industry experts often note that patent litigation in the pharmaceutical sector is a critical aspect of protecting intellectual property and ensuring that innovator companies can recoup their investment in research and development.

"The ability to protect patents is crucial for pharmaceutical companies to recover the significant investments made in developing new drugs," said a pharmaceutical industry analyst. "Cases like this underscore the importance of robust patent laws and enforcement mechanisms."

Statistics and Economic Impact

The economic stakes are high in such cases. For example, IMBRUVICA® generated significant revenue for AbbVie and Janssen Biotech, Inc. The entry of generic versions could substantially reduce these revenues, impacting the companies' financial performance and their ability to invest in future research and development.

Key Takeaways

• Patent Protection: The case emphasizes the importance of patent protection for pharmaceutical innovations.
• Generic Competition: The timing and legality of generic drug market entry are critical issues in this litigation.
• Jurisdiction and Venue: The court's jurisdiction over foreign defendants is a key aspect of the case.
• Industry Impact: The outcome could influence the broader pharmaceutical industry's approach to patent litigation and generic competition.

FAQs

Q: What is the main issue in the Pharmacyclics LLC v. Zydus Worldwide DMCC case? A: The main issue is the alleged infringement of patents related to the pharmaceutical product IMBRUVICA® by Zydus Worldwide DMCC and Cadila Healthcare Ltd. through their submission of ANDAs for generic versions.

Q: Which court is handling this case? A: The case is being handled by the District Court of Delaware.

Q: What are the patents in dispute? A: The patents include various U.S. Patent Nos. related to pharmaceutical formulations, crystalline forms, and the use of BTK inhibitors for IMBRUVICA®.

Q: Why is jurisdiction over the defendants important in this case? A: Jurisdiction is crucial because the defendants are foreign entities, and the court must establish that it has personal jurisdiction over them based on their contacts within the United States.

Q: What are the potential implications of this case for the pharmaceutical industry? A: The outcome could affect how pharmaceutical companies protect their patents and how generic drug manufacturers enter the market, impacting the industry's approach to innovation and competition.

Sources

1. Pharmacyclics LLC v. Zydus Worldwide DMCC, Complaint for Patent Infringement, Case 1:18-cv-00275-UNA, District Court of Delaware.
2. Life Sciences Court Report & COVID-19 Impact on District Court, JD Supra, May 18, 2020.
3. Patent Filings Roundup: 'Something in the Water' with Sharp Spike in District Court Filings, IP Watchdog, April 29, 2020.
4. Court Report - Patent Docs, Patent Docs, May 17, 2020.
5. US FOOD & DRUG - accessdata.fda.gov, FDA, December 8, 2020.