Litigation Details for ABRAXIS BIOSCIENCE, LLC v. HBT LABS, INC. (D.N.J. 2018)

ABRAXIS BIOSCIENCE, LLC v. HBT LABS, INC. (D.N.J. 2018)

Docket		Date Filed	2018-12-17
Court	District Court, D. New Jersey	Date Terminated	2019-02-07
Cause	15:1126 Patent Infringement	Assigned To	John Michael Vazquez
Jury Demand	None	Referred To	Mark Falk
Parties	CELGENE CORPORATION
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; 9,393,318; 9,511,046; 9,597,409
Attorneys	DAVID LEIGH MOSES
Firms	Fox Rothschild LLP, Pc
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.N.J. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-12-17				External link to document
2018-12-16	1		States Patent Nos. 7,758,891 (“’891 patent”), 7,820,788 (“’788 patent”), 7,923,536 (“’536 patent”), 8,…(“’348 patent”), 8,314,156 (“’156 patent”), 8,853,260 (“’260 patent”), 9,101,543 (“’543 patent”), 9,393,318…,393,318 (“’318 patent”), 9,511,046 (“’046 patent”), and 9,597,409 (“’409 patent”), all owned by Abraxis… 1. This is an action for patent infringement under the patent laws of the United States, 35 U.S.C…8,034,375 (“’375 patent”), 8,138,229 (“’229 patent”), Case 2:18-cv-17304-JMV-MF Document 1 Filed 12/17	External link to document

ABRAXIS BIOSCIENCE, LLC v. HBT LABS, INC.: A Comprehensive Analysis of the Patent Infringement Case

In the complex world of pharmaceutical litigation, the case of ABRAXIS BIOSCIENCE, LLC v. HBT LABS, INC. stands out as a significant battle over patent rights. This high-stakes legal confrontation, filed in the District of Delaware, revolves around Abraxane®, a groundbreaking cancer treatment. Let's dive deep into the intricacies of this case and explore its implications for the pharmaceutical industry.

The Genesis of the Lawsuit

On December 19, 2018, Abraxis Bioscience, LLC and Celgene Corporation (collectively referred to as "Plaintiffs") filed a complaint against HBT Labs, Inc. (the "Defendant") alleging infringement of twelve patents[1]. The patents in question relate to various methods of use for the Plaintiffs' Abraxane® drug product, a revolutionary treatment for certain types of cancer.

The Catalyst: HBT's New Drug Application

The lawsuit was triggered when HBT Labs filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) seeking approval for a generic version of Abraxane®. This move by HBT Labs set the stage for a classic patent infringement battle under the Hatch-Waxman Act.

Plaintiffs initiated suit after receiving written notice of Defendant's Paragraph IV certification pursuant to 21 U.S.C. § 355(b)(2)(A)[1].

The Patents at the Heart of the Dispute

The lawsuit revolves around twelve patents owned by Abraxis Bioscience. These patents cover various aspects of Abraxane®, including its composition, manufacturing process, and methods of use. The patents-in-suit include:

1. United States Patent No. 7,758,891
2. United States Patent No. 7,820,788
3. United States Patent No. 7,923,536
4. United States Patent No. 8,034,375
5. United States Patent No. 8,138,229
6. United States Patent No. 8,268,348
7. United States Patent No. 8,314,156
8. United States Patent No. 8,853,260
9. United States Patent No. 9,101,543
10. United States Patent No. 9,393,318
11. United States Patent No. 9,511,046
12. United States Patent No. 9,597,409

The Significance of Abraxane®

Abraxane® is not just another drug in the pharmaceutical market. It represents a significant advancement in cancer treatment, particularly for breast cancer, non-small cell lung cancer, and pancreatic cancer. The drug's unique formulation allows for the delivery of paclitaxel, a potent chemotherapy agent, without the need for toxic solvents, potentially reducing side effects and improving efficacy.

Legal Maneuvers: HBT's Motion to Dismiss

Following the filing of the lawsuit, HBT Labs didn't sit idle. The company filed a motion seeking to:

1. Dismiss Plaintiff Celgene Corporation for lack of standing
2. Transfer the case to the Central District of California
3. Dismiss Counts I, IV, VI, VII, and IX-XII of the Complaint for failure to state a claim

The Court's Ruling on Standing

In an interesting turn of events, Celgene Corporation did not oppose HBT's motion to dismiss it from the case. As a result, the court dismissed Celgene as a Plaintiff, leaving Abraxis Bioscience as the sole plaintiff in the case[1].

The Battle Over Venue

HBT Labs pushed for a transfer of the case to the Central District of California under 28 U.S.C. § 1404(a). This move was likely strategic, possibly aiming to gain a home-court advantage or to inconvenience the plaintiff. However, the court denied this motion, keeping the case in Delaware[1].

The Attempt to Dismiss Specific Counts

HBT Labs also sought to dismiss several counts of the complaint, arguing that these counts asserted patents that solely encompassed indications for which HBT had not sought FDA approval. This argument, however, did not sway the court.

Plaintiff have adequately pled a claim for infringement under § 271(e)(2) in Counts I, IV, VI, VII, and IX-XII. Thus, I deny Defendant's motion to dismiss those counts[1].

The Crux of the Legal Argument

At the heart of this case lies the interpretation of the Hatch-Waxman Act and its provisions regarding patent infringement in the context of generic drug applications. The Act specifies that filing an NDA containing a Paragraph IV certification constitutes an act of infringement.

The Significance of Paragraph IV Certification

HBT Labs notified Abraxis that it had submitted Paragraph IV certifications for all of the patents-in-suit. This certification is a statement by the generic drug company that the brand-name company's patents are either invalid or will not be infringed by the generic product.

The Court's Interpretation

The court's decision to deny HBT's motion to dismiss certain counts hinged on its interpretation of the Hatch-Waxman Act and the sufficiency of Abraxis's pleadings. The court found that Abraxis had adequately pleaded a claim for infringement under § 271(e)(2) for all the challenged counts.

The Implications for the Pharmaceutical Industry

This case highlights the ongoing tension between brand-name pharmaceutical companies seeking to protect their patents and generic drug manufacturers aiming to bring lower-cost alternatives to market. It underscores the complexity of pharmaceutical patent litigation and the high stakes involved.

The Balance Between Innovation and Accessibility

Cases like this one bring to the forefront the delicate balance between incentivizing pharmaceutical innovation through patent protection and ensuring access to affordable medications through generic competition. The outcome of such cases can have far-reaching implications for both the industry and patients.

The Role of the Hatch-Waxman Act

The Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act, plays a crucial role in these disputes. It provides a framework for generic drug approvals while also offering certain protections for brand-name drug patents. The interpretation and application of this Act are often at the center of pharmaceutical patent litigation.

The Settlement: A Turning Point

On February 11, 2020, the case took an unexpected turn. The parties reached a settlement agreement, bringing the litigation to a close[7]. The terms of the settlement provide valuable insights into how such high-stakes pharmaceutical patent disputes are often resolved.

Key Terms of the Settlement

The settlement agreement included several key provisions:

1. HBT Labs is enjoined from infringing the patents-in-suit until their expiration, unless specifically authorized by Abraxis.
2. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys' fees to any party.
3. HBT Labs is not prohibited from maintaining a Paragraph IV certification against the patents-in-suit.
4. The FDA is not restricted from approving HBT's NDA[4].

The Implications of the Settlement

This settlement represents a compromise between the parties. While Abraxis maintains the integrity of its patents, HBT Labs retains the possibility of future market entry. The agreement also leaves the door open for potential future challenges to the patents.

The Broader Context: Abraxis's Litigation Strategy

The case against HBT Labs is not an isolated incident. Abraxis has been involved in numerous patent infringement lawsuits related to Abraxane®. This pattern suggests a robust strategy to protect its intellectual property and market position.

Other Notable Cases

Some of the other significant cases involving Abraxis include:

1. Abraxis Bioscience, LLC v. Actavis LLC (2:16-cv-01925)
2. Abraxis Bioscience, LLC v. Cipla Ltd. (2:16-cv-09074)
3. Abraxis Bioscience, LLC v. Sun Pharma Advanced Research Company, Ltd. (2:19-cv-16495)[6]

These cases demonstrate Abraxis's commitment to defending its patents against various generic challengers.

The Role of Inter Partes Review

In addition to district court litigation, Abraxis has also faced challenges to its patents through Inter Partes Review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB). Companies like Actavis LLC, Apotex Inc., and Cipla Ltd. have filed IPR petitions challenging the validity of Abraxis's patents[6].

The Impact of IPR Proceedings

IPR proceedings provide an additional avenue for challenging patent validity and can significantly impact the outcome of related district court litigation. The interplay between IPR proceedings and district court litigation adds another layer of complexity to pharmaceutical patent disputes.

The Future of Abraxane® and Generic Competition

While the settlement with HBT Labs provides some clarity, the future of Abraxane® and potential generic competition remains uncertain. The outcome of ongoing and future litigation, as well as the expiration dates of the various patents, will play crucial roles in determining when generic versions of Abraxane® may enter the market.

The Importance of Patent Expiration Dates

The expiration dates of the patents-in-suit are critical in determining the timeline for potential generic entry. As these dates approach, we can expect increased activity from generic manufacturers seeking to enter the market.

The Potential Impact on Patient Access

The eventual entry of generic versions of Abraxane® could significantly impact patient access to this important cancer treatment. Generic competition typically leads to lower prices, potentially making the treatment more accessible to a broader range of patients.

Key Takeaways

1. The ABRAXIS BIOSCIENCE, LLC v. HBT LABS, INC. case highlights the complex interplay between patent protection and generic drug development in the pharmaceutical industry.

2. The case centered around twelve patents related to Abraxane®, a significant cancer treatment.

3. HBT Labs' attempt to transfer the case to California and dismiss certain counts was unsuccessful.

4. The parties reached a settlement in February 2020, with HBT Labs agreeing not to infringe the patents-in-suit until their expiration.

5. This case is part of a broader litigation strategy by Abraxis to protect its Abraxane® patents.

6. The outcome of such cases can have significant implications for both the pharmaceutical industry and patient access to treatments.

7. The interplay between district court litigation and IPR proceedings adds complexity to pharmaceutical patent disputes.

8. The future of generic competition for Abraxane® will depend on the outcomes of ongoing litigation and patent expiration dates.

FAQs

1. Q: What is Abraxane® used for? A: Abraxane® is used to treat certain types of cancer, including breast cancer, non-small cell lung cancer, and pancreatic cancer.

2. Q: What is a Paragraph IV certification? A: A Paragraph IV certification is a statement by a generic drug manufacturer that the brand-name company's patents are either invalid or will not be infringed by the generic product.

3. Q: What is the significance of the Hatch-Waxman Act in this case? A: The Hatch-Waxman Act provides the legal framework for generic drug approvals and patent infringement cases in the pharmaceutical industry.

4. Q: What is Inter Partes Review (IPR)? A: IPR is a procedure for challenging the validity of a patent before the Patent Trial and Appeal Board, an alternative to traditional court proceedings.

5. Q: How might the outcome of this case affect patients? A: The outcome of cases like this can impact when generic versions of drugs become available, potentially affecting drug prices and patient access to treatments.

Sources cited: [1] https://www.ded.uscourts.gov/sites/ded/files/opinions/18-2019.pdf [4] https://www.robinskaplan.com/newsroom/insights/resources-legal-updates-generically-speaking-hatch-waxman-bulletin-2020-generically-speaking-spring-2020-anda-litigation-settlements2 [6] https://services.patexia.com/lawsuits/Abraxis-BioScience-LLC--v-HBT-Labs-Inc-id-134585/cases [7] https://casetext.com/case/abraxis-bioscience-llc-v-hbt-labs-inc/analysis?citingPage=1&sort=relevance