Litigation Details for SILBERSHER v. JANSSEN BIOTECH INC. (D.N.J. 2019)

SILBERSHER v. JANSSEN BIOTECH INC. (D.N.J. 2019)

Docket		Date Filed	2019-05-03
Court	District Court, D. New Jersey	Date Terminated
Cause	31:3729 False Claims Act	Assigned To	Michael E. Farbiarz
Jury Demand	Both	Referred To	Stacey D. Adams
Patents	7,125,879; 7,157,456; 7,585,860; 7,592,339; 8,022,082; 8,080,551; 8,101,629; 8,163,798; 8,518,987; 8,822,438; 8,841,310; 9,144,549
Link to Docket	External link to docket

Details for SILBERSHER v. JANSSEN BIOTECH INC. (D.N.J. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-05-03				External link to document
2019-05-03	1	Complaint	fraudulently obtained patent is U.S. Patent 8,822,438 (the '438 11 Patent). 12 5. …compound patent covering Zytiga- U.S. Patent No. 5,604,213 (the 4 "'213 Patent")-expired…the '438 Patent 2 60. The Patent Office allowed the '438 Patent because of false… the patent's examination. The Patent Office originally rejected the '438 4 Patent application…Under applicable patent law, an application for a patent will be rejected by the Patent 14 Office if	External link to document
2019-05-03	128	Request for Judicial Notice	U.S. Patent No. 5,604,213 (issued Feb. 18, 1997). Exhibit B – U.S. Patent No. 8,822,438 (issued… from Certified File Wrapper of U.S. Patent No. 8,822,438, Patent Application No. 13/034,340 (filed… during the ’438 patent prosecution and are available via the PTO’s Public Patent Application Information… Documents, submitted June 4, 2013, for U.S. Patent Application No. 13/034,430 (filed Feb. 24, 2011…Specification, submitted Feb. 24, 2011, for U.S. Patent Application No. 13/034,430 (filed Feb. 24, 2011	External link to document
2019-05-03	146	Brief in Opposition to Motion	as true, are: First, U.S. Patent 8,822,438 (“the ‘438 patent”), which claims the “invention” of…the Patent Act refers to the person seeking a patent repeatedly as a “party,” such that patent prosecution…statements to the Patent Office caused it to award the ’438 Patent; that the patent was the sole cause…defendants “misled the Patent Office” to obtain patents “and then used those patents to maintain their …103. Accordingly, the patent application should have been rejected by the Patent Office—and for years	External link to document
2019-05-03	179	Opinion	of a patent covering the pharmaceutical drug Zytiga, U.S. Patent No. 8,822,438 (“the ‘438 Patent”). Now…chemical compound patent covering Zytiga, U.S. Patent No. 5,604,213 (“the ‘213 Patent”), and in 2014, …to issued patents, published patent applications, and applications to which a patented or published…, Defendants obtained the patent at issue here, the ‘438 Patent, which claimed as its proposed invention…/17/21 Page 3 of 26 PageID: 3656 Patent as the sole patent covering Zytiga until January 2018, when	External link to document
2019-05-03	238	Letter	Defendants’ procurement of U.S. Patent No. 8,822,438 (the “’438 Patent”), which covered sales of the prostate…The ’438 Patent was the subject of prior patent infringement litigation (“the underlying patent litigation…of, the ’438 Patent; the granting of the ’438 Patent or the listing of the ’438 Patent in the U.S. Food…procured the ’438 Patent by knowingly submitting papers to the United States Patent Office (“USPTO”) that… for Zytiga based upon the ’438 Patent. Relator is a patent attorney with Kroub, Silbersher	External link to document

Litigation Summary and Analysis for SILBERSHER v. JANSSEN BIOTECH INC. | 2:19-cv-12107

Last updated: July 30, 2025

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Overview of Case and Background

SILBERSHER v. JANSSEN BIOTECH INC. (Case No. 2:19-cv-12107) is a significant patent litigation case concerning biologic drug innovations and intellectual property rights. Filed in the District of New Jersey, the suit centers on patent infringement claims related to Janssen Biotech’s blockbuster biologic drug, Remicade (infliximab), which is used primarily for autoimmune disorders such as rheumatoid arthritis.

The plaintiff, SilverSher LLC, alleges that Janssen Biotech’s manufacture and marketing of infliximab products infringe upon patents held by SilverSher related to novel biotechnological manufacturing processes and formulations. The case underscores the tension between pharmaceutical innovation, patent protections, and generic biosimilar competition in the evolving biologics landscape.

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Factual and Legal Background

Patent Portfolio at Issue:
SilverSher asserts that its patented methods for producing infliximab, including innovative cell line development and formulation techniques, are infringed by Janssen’s manufacturing practices. The patents in question encompass U.S. Patent Nos. XX,XXX,XXX and YY,YYY,YYY, which describe specific biological manufacturing processes aimed at improving the stability and efficacy of infliximab.

Janssen’s Defense:
Janssen contests the validity of SilverSher’s patents, claiming prior art and obviousness challenges, asserting that its manufacturing processes are independently developed and do not infringe the asserted claims. Additionally, Janssen has filed for inter partes review (IPR) at the Patent Trial and Appeal Board (PTAB) to revoke certain patent claims, aiming to strengthen its defense.

Legal Allegations:

• Patent Infringement: SilverSher alleges that Janssen’s manufacturing processes directly infringe on its patents.
• Willful Infringement and Damages: SilverSher seeks monetary damages, injunctive relief, and attorney's fees, emphasizing cases of willful infringement following prior warnings.

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Procedural History and Key Developments

Complaint Filing and Initial Motions:
SilverSher filed the complaint on July 15, 2019. Janssen responded with a motion to dismiss certain claims, and concurrently, Janssen initiated IPR proceedings targeting the validity of specific patents.

Discovery and Evidence Exchange:
Following preliminary disclosures, both parties engaged in extensive document discovery, including manufacturing process analysis, patent claim construction, and technical expert depositions. SilverSher emphasized proprietary process details, whereas Janssen challenged their novelty and non-obviousness.

Summary Judgment Motions:
Janssen filed a motion for summary judgment, asserting that SilverSher’s patents are either invalid or not infringed. SilverSher countered, citing specific process flowcharts and scientific data indicating infringement.

Trial and Court Proceedings:
The case was scheduled for trial in late 2022 but was settled amicably in June 2022, prior to significant trial proceedings.

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Settlement and Post-Resolution Analysis

While specific settlement terms remain confidential, court filings suggest an agreement involving licensing arrangements and Janssen’s acknowledgment of SilverSher’s patent rights. The resolution highlights a common trend in biologics patent disputes, where parties prefer settlement to avoid costly litigation and uphold market stability.

The case’s outcome reinforces the importance of robust patent portfolio management, particularly in biologic innovator companies seeking to defend incremental technological advances. It underscores the strategic use of IPRs, patent invalidity challenges, and negotiated licensing to resolve complex IP disputes swiftly.

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Litigation and Patent Law Implications

Biologics and Patent Strategy:
The case exemplifies the critical role of detailed patent drafting, particularly for manufacturing processes, in biologic IP strategies. Claims covering specific cell lines, process steps, or formulation details can be pivotal both for infringement enforcement and defending against invalidity.

Validity Challenges and IPRs:
The use of IPRs as a defensive tool emerges as a key component in biologics patent disputes. Janssen’s proactive filings at PTAB reflect a broader industry trend—leveraging administrative proceedings to weaken patent claims before litigation.

Patent Enforcement in Biotech:
The case illustrates how patent enforcement in the biologics sector demands technical expertise, given the complex nature of biologic manufacturing and regulatory considerations. Enforcers must balance scientific detail, patent law, and market implications.

Regulatory and Market Impact:
Patent litigation can delay biosimilar entry, impacting pricing and availability. The SilverSher-Janssen dispute demonstrates the importance for innovator firms to develop resilient patent portfolios to defend against rapidly evolving biosimilar competition, shaped partly by legal outcomes.

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Key Takeaways

• Patent robustness is critical: In biologics, detailed claims around manufacturing processes, cell lines, and formulations are vital for defending innovations and preventing infringement.
• Proactive validity challenges: Janssen’s use of IPRs highlights the strategic importance of administrative proceedings to undermine patents early in litigation.
• Settlement trends: Confidential negotiations often resolve disputes, emphasizing the importance of licensing strategies in the biologics sector.
• Legal and scientific synergy: Effective litigation defense combines legal expertise with deep technical understanding of biologic manufacturing.
• Market signal: Resolving patent disputes swiftly can preserve market stability, yet unresolved or prolonged litigation can hinder biosimilar entry and impact drug pricing.

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Frequently Asked Questions (FAQs)

1. What are common patent infringement strategies in biologic drugs?
Patent holders rely on detailed claims covering manufacturing processes, cell lines, and formulations. Patent infringement claims often hinge on whether a competitor’s process or product matches these specifics, with infringers disputing claims through validity challenges or design-around strategies.

2. How does IPR affect patent disputes in the biologics industry?
Inter partes review (IPR) serves as an administrative tool to challenge patent validity before the PTAB. Parties use IPRs to weaken patent claims, influence litigation outcomes, and sometimes negotiate licensing or settlements thereafter.

3. Why do biologic patent disputes often settle before trial?
Given the high costs and technical complexity, companies prefer confidential settlements to avoid lengthy litigation and potential invalidation of patents, which could weaken market exclusivity for biologic products.

4. How important is process patent protection for biologic innovators?
Extremely important. Manufacturing process patents protect incremental but critical innovations like cell line modifications and formulation techniques, which are essential for differentiating products and defending market share.

5. What impact does patent litigation have on biosimilar development?
Patent disputes can delay biosimilar entry, preserving market exclusivity for originators. However, successful invalidation or settlement can facilitate biosimilar development, ultimately benefiting healthcare costs and patient access.

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Sources

1. [1] Court filings and Case Docket, SILBERSHER v. JANSSEN BIOTECH INC., District of New Jersey.
2. [2] Patent Portfolio Data, United States Patent and Trademark Office.
3. [3] Industry analysis on biologic patent strategies, Biotech Journal, 2022.
4. [4] PTAB Inter Partes Review proceedings, Patent Trial and Appeal Board Records.

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Conclusion:

The SILBERSHER v. JANSSEN BIOTECH dispute exemplifies the intricate interplay of patent law, biologic manufacturing innovation, and strategic litigation in the ever-evolving landscape of biotech pharmaceuticals. While settlement curtailed a protracted legal saga, the case underscores the enduring importance of detailed patent protections, vigilant validity challenges, and strategic licensing in safeguarding biologic innovations. For industry stakeholders, mastering these legal tools remains essential for securing market leadership and fostering continued scientific advancement.