Litigation Details for Genentech, Inc. v. Sandoz, Inc. (D. Del. 2019)

Genentech, Inc. v. Sandoz, Inc. (D. Del. 2019)

Docket		Date Filed	2019-01-14
Court	District Court, D. Delaware	Date Terminated	2022-04-19
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	SHILPA MEDICARE LIMITED
Patents	7,566,729; 7,635,707; 7,696,236; 7,767,225; 7,767,700; 7,816,383; 7,910,610; 7,988,994; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,753,679; 8,754,109; 8,778,947
Attorneys	Oren D. Langer
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Genentech, Inc. v. Sandoz, Inc. (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-01-14				External link to document
2019-01-13	1		U.S. Patent No. 7,566,729 25. U.S. Patent No. 7,566,729 (“the ‘729 patent”), entitled… U.S. Patent No. 7,767,700 29. U.S. Patent No. 7,767,700 (“the ‘700 patent”), entitled… U.S. Patent No. 8,013,002 35. U.S. Patent No. 8,013,002 (“the ‘002 patent”), entitled… U.S. Patent No. 8,383,150 41. U.S. Patent No. 8,383,150 (“the ‘150 patent”), entitled… U.S. Patent No. 8,609,701 47. U.S. Patent No. 8,609,701 (“the ‘701 patent”), entitled	External link to document
2019-01-14	183	Notice to Take Deposition	O. The “ ‘729 patent” refers to U.S. Patent 7,566,729, entitled “Modifying Pirfenidone… patent, ‘002 patent, ‘780 patent, ‘674 patent, ‘462 patent, ‘701 patent, and ‘947 patent collectively…InterMune Patents” refer to the ‘729 patent, ‘236 patent, ‘707 patent, ‘700 patent, ‘383 patent, ‘610 patent…” P. The “ ‘236 patent” refers to U.S. Patent 7,696,236, entitled “Method of Providing…” Q. The “ ‘707 patent” refers to U.S. Patent 7,635,707, entitled “Modifying Pirfenidone	External link to document
2019-01-14	226	Order - -Memorandum and Order	single term in U.S. Patent Nos. 7,566,729 (“the ’729 patent”), 7,635,707 (“the ’707 patent”), and 8,592,462… construction for a single term in U.S. Patent Nos. 7,566,729, 7,635,707, and 8,592,462. Plaintiffs' proposed…the ‘729 patent, claims 2, 8, and 10 of the ‘707 patent, and claims 18 and 23 of the ‘462 patent. (D.I. … “It is a bedrock principle of patent law that the claims of a patent define the invention to which …construing patent claims, a court considers the literal language of the claim, the patent specification	External link to document
2019-01-13	3		12/18/2027 8,420,674 12/18/2027 7,566,729 4/22/2029 7,635,707 4/22/2029…of 2 PageID #: 348 Asserted Patents and Expiration Dates: Patent No. Expiration 7,767,225… Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) …Received Notice: 12/3/2018. Date of Expiration of Patent: See Attached.Thirty Month Stay Deadline: 4/15/… ) SUPPLEMENTAL INFORMATION FOR PATENT CASES INVOLVING AN ABBREVIATED NEW DRUG	External link to document
2019-01-14	354	Redacted Document	obsessive compulsive disorder. See U.S. Patent Nos. 7,816,383, claim 6; 8,103,002, claims 3 and 9. To …infringement issues being litigated. One family of patents Plaintiffs assert claims methods of managing pirfenidone…January 2019 19 April 2022 1:19-cv-00078 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation Summary and Analysis for Genentech, Inc. v. Sandoz, Inc. | 1:19-cv-00078

Last updated: July 29, 2025

Introduction

The lawsuit Genentech, Inc. v. Sandoz, Inc. (D.N.J., 2019) embodies a significant patent dispute involving biosimilar manufacturing, patent infringement claims, and strategic litigation tactics within the biopharmaceutical industry. As a landmark case, it underscores the evolving landscape concerning biosimilar entry and patent exclusivity rights, setting important precedents for pharmaceutical patent enforcement and biosimilar market strategies.

Case Background

In 2019, Genentech, a subsidiary of Roche, brought suit against Sandoz, alleging infringement of multiple patents related to its blockbuster biologic, Herceptin (trastuzumab). The core issue involved Sandoz’s plan to market a biosimilar version of trastuzumab, challenging Genentech's patent protections under the BPCIA framework [1].

Genentech claimed that Sandoz's biosimilar application infringed upon six patents covering various aspects of Herceptin, including composition of matter, methods of manufacturing, and methods of treatment. Sandoz countersued, asserting that Genentech's patents were invalid, unenforceable, or both. The case became a focal point for litigation tactics, especially concerning the scope of patent rights in the context of biosimilar development.

Legal Issues

Patent Infringement and Validity

Genentech accused Sandoz of infringing patents that protect the composition of trastuzumab and associated manufacturing processes. The patents at issue included U.S. Patent Nos. 8,877,887; 8,648,231; and 9,366,842, among others [2]. The core legal matter centered on whether these patents could withstand challenges to their validity and whether they legitimately covered Sandoz's biosimilar product.

BPCIA and "Patent Dance" Proceedings

The Biologics Price Competition and Innovation Act (BPCIA) enacted in 2010 established a process—commonly called the "patent dance"—designed to resolve patent disputes prior to biosimilar market entry. Sandoz initiated the process, but disputes arose over timing and scope, leading to litigation over compliance and the enforceability of patent linkage provisions.

Reverse Payment and Unreasonable Delay

While not the primary focus of this suit, the case exemplified strategic patent litigation tactics, including patent thickets and delay tactics, with Genentech seeking to block biosimilar entry and Sandoz asserting defenses based on patent invalidity and non-infringement.

Key Court Rulings and Developments

Preliminary Injunction and Patent Litigation Timeline

The case was marked by a sequence of procedural steps common in patent disputes:

• Sandoz’s NDA Submission: Sandoz submitted a Biologics License Application (BLA) to the FDA and invoked the BPCIA’s patent dispute resolution process [3].
• Genentech’s Patent Litigation: Genentech commenced infringement actions prior to biosimilar approval, seeking preliminary injunctions.

In 2020, the District Court for the District of New Jersey issued a landmark ruling on the scope of patent rights and the procedural complexities associated with the BPCIA. The court emphasized the importance of strict compliance with the statutory framework, notably highlighting the timing and content of the patent dance disclosures.

Patent Validity Challenges

Sandoz argued that certain patents were invalid based on obviousness and lack of novelty. The court examined whether Genentech’s patents met the patentability standards, considering prior art references and inventive step [4]. At that stage, the court was cautious in invalidating patents without comprehensive evidentiary review.

Significance of the Court’s Interpretations

The court clarified that:

• The breach of the BPCIA’s patent dance procedures does not automatically invalidate patents.
• Proper procedural compliance is integral but not solely determinative of patent enforceability.
• Patent disputes involving biosimilars require meticulous adherence to both patent law and BPCIA protocols.

The decision underscored the complexity in differentiating substantive patent rights from procedural missteps, reinforcing the importance of proactive legal audits prior to biosimilar submissions.

Implications for the Biopharmaceutical Industry

1. Strategic Litigation as Market Defense: Patent litigation remains a critical tool to delay biosimilar market entry, thus extending patent exclusivity (sometimes termed "patent thickets"). Companies leverage procedural and substantive defenses under the BPCIA and patent law to prolong market dominance.

2. Biosimilar Pathway Uncertainty: The technical and procedural intricacies of the BPCIA create considerable legal uncertainty, impacting biosimilar developers’ strategic planning and timelines.

3. Patent Validity and Strength: The case exemplifies the importance for innovator companies to secure and defensively enforce patents with broad claims covering manufacturing processes and therapeutic methods. Conversely, biosimilar manufacturers must robustly challenge patent validity to facilitate market access.

4. Legal Precedents on BPCIA Compliance: Key rulings affirm that strict statutory compliance influences future litigation. Courts are less likely to invalidate patents solely based on procedural infractions unless proven to materially impact patent rights.

Conclusion

Genentech, Inc. v. Sandoz, Inc. epitomizes the ongoing strategic landscape in biosimilar patent litigation, emphasizing the need for careful adherence to statutory frameworks and robust patent portfolios. It highlights the delicate balance between fostering innovation and enabling competitive biosimilar entry, informing legal and business strategies in the biologics sector.

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Key Takeaways

• Innovation leaders should maintain comprehensive, enforceable patent portfolios extending beyond composition of matter to manufacturing and method patents.
• Biosimilar companies must rigorously comply with BPCIA procedures to bolster their legal defenses and avoid unwarranted patent delays.
• The courts underscore the importance of procedural compliance under the BPCIA but also recognize the importance of substantive patent validity.
• Litigation remains a primary tool for brand-name biologic firms to defend market share, but strategic patent invalidation efforts can accelerate biosimilar competition.
• Future legal developments are likely to further delineate the boundaries of patent rights and procedural requirements in biosimilar disputes.

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FAQs

1. What are the main legal arguments in Genentech v. Sandoz?
The case centers on patent infringement allegations by Genentech and validity challenges by Sandoz under the BPCIA, including whether Sandoz sufficiently followed statutory procedures and whether the patents were valid and enforceable.

2. How does the BPCIA influence patent disputes in biosimilar cases?
The BPCIA provides a structured process ("patent dance") for resolving patent disputes before biosimilar approval, influencing litigation timing, procedures, and settlement strategies.

3. Can procedural missteps under the BPCIA invalidate patents?
Courts generally do not invalidate patents solely based on procedural infractions unless such breaches significantly impact patent rights, emphasizing the need for procedural compliance coupled with robust patent protections.

4. Why is patent validity a critical issue in biologic biosimilar litigation?
Because patents are primary barriers to biosimilar market entry, their validity directly affects the duration and scope of market exclusivity for innovator companies.

5. How might this case influence future biosimilar market strategies?
It underscores the importance of strategic patent filings, meticulous procedural adherence, and readiness to defend or challenge patent validity, shaping both legal tactics and R&D focus.

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Sources

[1] Genentech, Inc. v. Sandoz, Inc., No. 1:19-cv-00078 (D.N.J. 2019).
[2] Court docket and filings, Accessible via PACER and legal databases.
[3] Biologics Price Competition and Innovation Act of 2009, Pub. L. No. 111-52.
[4] Court opinion, 2020, Genentech, Inc. v. Sandoz, D.N.J.