Litigation Details for Pharmacyclics LLC v. Alvogen Pine Brook LLC (D. Del. 2019)

Pharmacyclics LLC v. Alvogen Pine Brook LLC (D. Del. 2019)

Docket		Date Filed	2019-03-01
Court	District Court, D. Delaware	Date Terminated	2021-08-30
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To	Christopher J. Burke
Parties	PHARMACYCLICS LLC
Patents	10,004,746; 10,010,507; 10,016,435; 10,106,548; 10,125,140; 10,213,386; 10,294,231; 10,294,232; 11,058,667; 11,135,192; 6,346,532; 7,342,117; 7,514,444; 7,879,828; 7,982,049; 8,008,309; 8,022,106; 8,101,659; 8,476,284; 8,497,277; 8,501,751; 8,563,563; 8,697,711; 8,703,780; 8,735,403; 8,754,090; 8,754,091; 8,796,331; 8,877,938; 8,952,015; 8,957,079; 8,999,999; 9,125,889; 9,181,257; 9,296,753; 9,388,134; 9,517,226; 9,540,382; 9,655,857; 9,713,617; 9,725,455; 9,795,604; 9,801,881; 9,801,883; 9,814,721; 9,937,143
Attorneys	Irena Royzman
Firms	Young, Conaway, Stargatt & Taylor LLP
Link to Docket	External link to docket

Biologic Drugs cited in Pharmacyclics LLC v. Alvogen Pine Brook LLC

Details for Pharmacyclics LLC v. Alvogen Pine Brook LLC (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-03-01				External link to document
2019-03-01	1	Complaint	PageID #: 2 Patent”); 9,655,857 (“the ’857 Patent”); 9,725,455 (“the ’455 Patent”); 10,010,507 (“the ’507… 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…507 Patent”); 10,106,548 (“the ’548 Patent”); and 10,125,140 (“the ’140 Patent”).	External link to document
2019-03-01	1120		FINAL JUDGMENT Regarding U.S. Patent No. 8,101,659 (see Judgment for further details). Signed by…2019 30 August 2021 1:19-cv-00434 835 Patent - Abbreviated New Drug Application(ANDA) Defendant	External link to document

Pharmacyclics LLC v. Alvogen Pine Brook LLC: A Comprehensive Litigation Summary and Analysis

Case Overview

The case of Pharmacyclics LLC v. Alvogen Pine Brook LLC is a significant patent infringement lawsuit that involves the drug Imbruvica (ibrutinib), a crucial treatment for various types of lymphoma. Here is a detailed summary and analysis of the case.

Parties Involved

• Plaintiff: Pharmacyclics LLC
• Defendants: Alvogen Pine Brook LLC and Natco Pharma Ltd.
• Counter Defendant: Janssen Biotech, Inc.[2][4].

Nature of the Suit

This lawsuit falls under the category of patent infringement related to an Abbreviated New Drug Application (ANDA) and is governed by 35 U.S.C. § 271. The case was filed in the U.S. District Court for the District of Delaware on March 1, 2019[2].

Patents-in-Suit

The litigation revolves around several patents related to ibrutinib:

• U.S. Patent No. 8,008,309 (the ’309 patent): Directed to the ibrutinib molecule itself.
• U.S. Patent No. 8,754,090 (the ’090 patent): Claims methods of treating small cell lymphoma.
• U.S. Patent No. 9,655,857 (the ’857 patent): Directed to formulations of tablets containing ibrutinib.
• U.S. Patent No. 9,725,455 (the ’455 patent): Claims a crystalline form of ibrutinib[1][3].

Alvogen's Arguments and Court Findings

Alvogen argued that the asserted claims of the patents-in-suit were invalid on several grounds:

Invalidity of the ’309 Patent

Alvogen claimed that the ’309 patent was invalid as anticipated, arguing that it was not entitled to its claim of priority, which would make the Pan reference prior art. However, the court found that the provisional applications disclosed ibrutinib’s structure, and a skilled artisan could have synthesized ibrutinib based on this disclosure. Therefore, the ’309 patent was entitled to its claim of priority, and Pan was not considered prior art[1][4].

Invalidity of the ’090 Patent

Alvogen argued that the ’090 patent lacked written description, was not enabled, was obvious, and was invalid for obviousness-type double patenting (OTDP). The court rejected these arguments:

• Written Description and Enablement: The court found that Example 13 of the patent provided a protocol to evaluate the efficacy of treating mantle cell lymphoma with ibrutinib, thus satisfying the written description and enablement requirements.
• Obviousness: Alvogen failed to demonstrate that one of skill would have been motivated to combine prior art to achieve the claimed method of treating mantle cell lymphoma with 560 mg of ibrutinib.
• OTDP: The court determined that the prior art reference did not disclose a numerical dosage amount or range, making the claims patentably distinct[1][4].

Infringement Findings

The district court held a bench trial and determined that all the asserted claims were infringed by Alvogen. Specifically, the court found that Alvogen infringed the asserted claims of the ’857 patent[4].

Appeal and Affirmation

Alvogen appealed the district court's decision to the United States Court of Appeals for the Federal Circuit. However, the appeals court affirmed the district court's findings, upholding that all the asserted claims were infringed and not invalid[4].

Key Takeaways

• Patent Validity: The court upheld the validity of all the asserted claims against various invalidity arguments.
• Infringement: Alvogen was found to have infringed the patents related to ibrutinib.
• Legal Precedent: This case sets a precedent for the robust protection of pharmaceutical patents, particularly those related to innovative treatments like ibrutinib.

FAQs

Q: What is the main drug involved in the Pharmacyclics LLC v. Alvogen Pine Brook LLC case?

A: The main drug involved is Imbruvica (ibrutinib), used for treating various types of lymphoma.

Q: Which patents were at the center of the litigation?

A: The patents included U.S. Patent Nos. 8,008,309, 8,754,090, 9,655,857, and 9,725,455.

Q: What were the primary arguments made by Alvogen regarding the patents?

A: Alvogen argued that the patents were invalid due to anticipation, lack of written description, lack of enablement, obviousness, and obviousness-type double patenting.

Q: How did the court rule on Alvogen's arguments?

A: The court rejected all of Alvogen's invalidity arguments and found that the patents were valid and infringed by Alvogen.

Q: Was the district court's decision appealed, and what was the outcome?

A: Yes, the decision was appealed to the Federal Circuit, which affirmed the district court's findings.

Cited Sources:

1. Pharmacyclics LLC v. Alvogen Pine Brook LLC | Robins Kaplan LLP
2. Pharmacyclics LLC et al v. Alvogen Pine Brook LLC ... - Justia Dockets
3. Analyses of Pharmacyclics LLC v. Alvogen Pine Brook ... - Casetext
4. PHARMACYCLICS LLC v. ALVOGEN, INC. - United States Court of Appeals for the Federal Circuit