Litigation Details for Abraxis BioScience, LLC v. HBT Labs, Inc. (D. Del. 2018)

Abraxis BioScience, LLC v. HBT Labs, Inc. (D. Del. 2018)

Docket		Date Filed	2018-12-19
Court	District Court, D. Delaware	Date Terminated	2020-02-11
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	7,758,891; 7,820,788; 7,923,536; 8,034,375; 8,138,229; 8,268,348; 8,314,156; 8,853,260; 9,101,543; 9,101,545; 9,393,318; 9,511,046; 9,597,409
Link to Docket	External link to docket

Biologic Drugs cited in Abraxis BioScience, LLC v. HBT Labs, Inc.

Details for Abraxis BioScience, LLC v. HBT Labs, Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-12-19				External link to document
2018-12-19	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,758,891 B2 ;7,820,788 B2 ;7,923,536… 11 February 2020 1:18-cv-02019 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-12-19	17		1402 Patents-in-Suit in twelve separate counts, as follows: United States Patent Nos. 7,758,891 (891 …Tithe of Patent : _?) “Glanmed Use 0°: I fF 28-36: Ex A 7,758,891 | “Combinations and modes of | “A method…891 patent,” Count I; 7,820,788 (788 patent,” Count ID), 7,923,536 ¢°536 patent,” Count UD), 8,034,375 (… (°375 patent,” Count IV), 8,138,229 (229 patent,” Count V), 8,268,348 (348 patent,” Count V1), 8,314,…8,314,156 (° 156 patent,” Count VII), 8,853,260 (°°260 patent,” Count VII), 9,101,543 (543 patent,” Count IX	External link to document
2018-12-19	36	Order - -Memorandum and Order	The patents-in-suit include United States Patent Nos. 7,758,891 ("the '891 patent"),…in a patent or the use of which is claimed in a patent before the expiration of such patent. …infringement of twelve patents under 35 U.S.C. § 271(e). (D.I. 1). The patents-in-suit 1 relate to various… ("the '788 patent"), 7,923,536 (''the '536 patent"), 8,034,375 ("…"the '375 patent"), 8,138,229 ("the '229 patent"), 8,268,348 (''	External link to document

Abraxis BioScience, LLC v. HBT Labs, Inc.: A Comprehensive Litigation Summary and Analysis

Case Overview

The lawsuit Abraxis BioScience, LLC v. HBT Labs, Inc. (Case No. 1:18-cv-02019) is a patent infringement case that was filed in the United States District Court for the District of Delaware. Here is a detailed summary and analysis of the key aspects of this litigation.

Background

Abraxis BioScience, LLC, and Celgene Corporation (the plaintiffs) initiated this lawsuit against HBT Labs, Inc. (the defendant) on December 19, 2018. The plaintiffs alleged that HBT Labs infringed several patents related to Abraxane®, a drug formulation of paclitaxel protein-bound particles for injection[1][3][4].

Patents-in-Suit

The litigation involved multiple patents associated with the formulation and manufacturing of Abraxane®. These patents include:

• 7,758,891
• 7,820,788
• 7,923,536
• 8,034,375
• 8,138,229
• 8,268,348
• 8,314,156
• 8,853,260
• 9,101,543
• 9,393,318
• 9,511,046
• 9,597,409[1].

Allegations and Claims

The plaintiffs claimed that HBT Labs' submission of an Abbreviated New Drug Application (ANDA) to the FDA, which included a Paragraph IV (PIV) certification against the patents-in-suit, constituted a technical act of patent infringement. The PIV certification is a declaration that the patents are invalid, unenforceable, or will not be infringed by the generic drug[1].

Settlement Agreement

The case was resolved through a settlement agreement. Here are the key terms of the settlement:

• HBT Labs was enjoined from infringing the patents-in-suit until their expiration, unless specifically authorized by Abraxis.
• All claims, counterclaims, affirmative defenses, and demands were dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
• The settlement did not prohibit HBT Labs from maintaining a PIV certification against the patents-in-suit.
• The FDA was not restricted from approving HBT Labs' ANDA[1].

Legal Implications

The settlement highlights several important legal implications:

• Injunction: The injunction against HBT Labs until the patents' expiration ensures that Abraxis maintains its exclusive rights over the patented formulations.
• Dismissal of Claims: The dismissal of all claims and counterclaims with prejudice indicates a final resolution, preventing further litigation on these specific issues.
• PIV Certification: The allowance for HBT Labs to maintain a PIV certification suggests that while HBT Labs cannot market the product until the patents expire, they can still pursue regulatory approval for a generic version post-expiration[1].

Industry Impact

This case has significant implications for the pharmaceutical industry:

• Generic Drug Market: The settlement delays HBT Labs' entry into the market with a generic version of Abraxane®, allowing Abraxis to maintain market exclusivity for the patented period.
• Patent Enforcement: It underscores the importance of enforcing patent rights to protect intellectual property in the pharmaceutical sector.
• Regulatory Compliance: The case emphasizes the need for generic drug manufacturers to comply with patent laws and regulations when filing ANDAs[1].

Key Takeaways

• Patent Protection: The case highlights the importance of robust patent protection for innovative pharmaceutical products.
• Regulatory Compliance: Generic drug manufacturers must carefully navigate patent laws when seeking FDA approval.
• Settlement Strategies: Settlement agreements can be an effective way to resolve patent disputes, balancing the interests of both parties.

FAQs

Q: What was the main issue in the Abraxis BioScience, LLC v. HBT Labs, Inc. case? A: The main issue was the alleged patent infringement by HBT Labs through their submission of an ANDA with a PIV certification against Abraxis' patents related to Abraxane®.

Q: What were the key patents involved in the litigation? A: The patents included 7,758,891, 7,820,788, 7,923,536, and several others related to the formulation and manufacturing of Abraxane®.

Q: What were the terms of the settlement agreement? A: HBT Labs was enjoined from infringing the patents until their expiration, all claims were dismissed with prejudice, and HBT Labs could maintain a PIV certification.

Q: How does this case impact the pharmaceutical industry? A: It delays generic competition, emphasizes patent enforcement, and highlights the importance of regulatory compliance for generic drug manufacturers.

Q: What is the significance of a PIV certification in this context? A: A PIV certification is a declaration that the patents are invalid, unenforceable, or will not be infringed by the generic drug, which is a necessary step for generic drug approval but can lead to patent infringement litigation.

Cited Sources

1. Robins Kaplan, "ANDA Litigation Settlements Spring 2020 | Hatch-Waxman"
2. FedCIR Damages, "District court decisions on willfulness and enhancement post-Halo"
3. Patexia, "Abraxis BioScience, LLC v. HBT Labs, Inc. > Related Cases"
4. Casetext, "Abraxis BioScience, LLC v. HBT Labs, Inc."