Litigation Details for Genentech, Inc. v. Samsung Bioepis Co. Ltd. (D. Del. 2020)

Genentech, Inc. v. Samsung Bioepis Co. Ltd. (D. Del. 2020)

Docket	1:20-cv-00859	Date Filed	2020-06-28
Court	District Court, D. Delaware	Date Terminated	2022-09-08
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	Plaintiff	Referred To	Jennifer L. Hall
Parties	GENENTECH, INC.
Patents	10,208,355; 10,513,697; 10,662,237; 10,676,710; 8,460,895; 8,512,983; 8,574,869; 9,441,035; 9,487,809; 9,714,293
Attorneys	Michael P. Kelly
Firms	Shaw Keller LLP
Link to Docket	External link to docket

Biologic Drugs cited in Genentech, Inc. v. Samsung Bioepis Co. Ltd.

Details for Genentech, Inc. v. Samsung Bioepis Co. Ltd. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-06-28				External link to document

Genentech v. Samsung Bioepis, 1:20-cv-00859: Litigation Summary, Lucentis Patent Claims and Biosimilar Entry Risk

Last updated: August 31, 2026

Genentech, Inc. sued Samsung Bioepis Co., Ltd. in the U.S. District Court for the District of Delaware over Samsung Bioepis’ ranibizumab biosimilar, SB11, later marketed as Byooviz. The case was a Biologics Price Competition and Innovation Act dispute involving Genentech’s Lucentis product. Genentech asserted four U.S. patents covering ranibizumab treatment methods and related ophthalmic uses. The parties resolved the dispute before trial, allowing Samsung Bioepis and its U.S. commercial partner, Biogen, to launch Byooviz in June 2022. [1]-[4]

What was Genentech v. Samsung Bioepis, 1:20-cv-00859 about?

The litigation concerned Samsung Bioepis’ abbreviated biologics application for SB11, a proposed biosimilar to Genentech’s Lucentis, whose active ingredient is ranibizumab.

Item	Detail
Court	U.S. District Court for the District of Delaware
Civil action	No. 1:20-cv-00859
Plaintiff	Genentech, Inc.
Defendant	Samsung Bioepis Co., Ltd.
Reference product	Lucentis, ranibizumab
Biosimilar	SB11, later approved as Byooviz
Statutory framework	BPCIA, 42 U.S.C. § 262(l)
Filing period	2020
Primary dispute	Patent infringement based on proposed commercial manufacture, use and sale of ranibizumab
Resolution	Settlement before a merits trial
U.S. launch	June 2022 under the settlement framework

Genentech filed the action after receiving notice that Samsung Bioepis intended to commercialize SB11 in the United States. The complaint followed the BPCIA’s patent-dispute process, commonly called the “patent dance.” [1]

What patents did Genentech assert against Samsung Bioepis?

Genentech asserted four patents associated with Lucentis and ranibizumab ophthalmic treatment:

U.S. patent	General subject matter	Litigation role
7,892,549	Anti-VEGF treatment of ocular disorders	Asserted against SB11
8,545,878	Ocular treatment methods using anti-VEGF antibodies	Asserted against SB11
9,340,614	Treatment of ocular vascular conditions using anti-VEGF therapy	Asserted against SB11
10,464,992	Ranibizumab-related treatment and dosing claims	Asserted against SB11

The patents were primarily method-of-use and treatment patents rather than a single composition-of-matter patent directed to the ranibizumab molecule. That distinction matters because the commercial risk depended on the scope of the asserted treatment claims, the prescribing indications, and any carve-out strategy available to Samsung Bioepis.

The asserted patents covered aspects of treating retinal vascular disorders, including conditions for which Lucentis was used or approved. Genentech’s infringement theory was based on the expected manufacture, use and sale of SB11 for indications protected by the asserted claims. [1]

Did Genentech assert formulation patents?

The case included ranibizumab-related product and treatment protection, but the public dispute was principally characterized as an infringement action involving method-of-use and treatment claims. It was not primarily a manufacturing-process case.

This limited the centrality of production technology. Samsung Bioepis’ principal exposure was tied to whether its proposed biosimilar labeling and commercial activity would induce or contribute to infringement of Genentech’s patented ocular-treatment methods.

When does Lucentis lose exclusivity?

Lucentis faced multiple overlapping exclusivity layers:

1. Patent protection for ranibizumab and related treatment uses.
2. FDA biologic reference-product exclusivity.
3. Patent settlements with individual biosimilar developers.
4. Regulatory approval and launch timing for each biosimilar.

The earliest foundational Lucentis patent protection did not determine the actual Byooviz launch date. The settlement between Genentech and Samsung Bioepis established the commercial entry date, which was June 2022.

The relevant commercial point is that Samsung Bioepis obtained U.S. approval for Byooviz in July 2021, but approval alone did not produce immediate unrestricted market entry. The settlement controlled the launch timing and the parties’ patent claims. [2]-[4]

What was the FDA status of Byooviz?

The FDA approved Byooviz on July 28, 2021, as a biosimilar to Lucentis. Byooviz was approved for the same major ophthalmic indications reflected in the reference product’s labeling, including treatment of neovascular age-related macular degeneration and other retinal vascular conditions. [2]

Regulatory event	Date
SB11 FDA application and BPCIA dispute	2020
Byooviz FDA approval	July 28, 2021
Commercial launch under settlement	June 2022
Biosimilar status	Approved biosimilar to Lucentis
Interchangeability	Not the basis of the Genentech litigation

Byooviz was the first FDA-approved ranibizumab biosimilar. Biogen commercialized the product in the United States under its agreement with Samsung Bioepis. [3]

What was the Paragraph IV challenge in this case?

The case was not a conventional Hatch-Waxman Paragraph IV action. Lucentis is a biologic, and SB11 proceeded under the BPCIA rather than the small-molecule Abbreviated New Drug Application pathway.

The functional equivalent of a Paragraph IV challenge was Samsung Bioepis’ notice that it intended to market SB11 and its disclosure of information during the BPCIA patent exchange. Genentech used that disclosure to identify patents it believed would be infringed by the proposed biosimilar.

Accordingly, “Paragraph IV challenge” is an inaccurate legal classification for this action. The correct description is a BPCIA patent-infringement action involving a biosimilar applicant’s notice of commercial marketing.

How was the litigation resolved?

Genentech and Samsung Bioepis settled the dispute before a trial on infringement, validity or enforceability. The settlement permitted Samsung Bioepis to commercialize SB11 in the United States beginning in June 2022.

The principal terms were not publicly disclosed in full. Public reporting and the subsequent Byooviz launch establish the commercial result:

• Genentech did not obtain an injunction blocking Byooviz indefinitely.
• Samsung Bioepis secured a defined U.S. entry date.
• Biogen participated as the U.S. commercial partner.
• The parties avoided a public trial on the asserted Lucentis patents.
• The settlement preserved Genentech’s ability to maintain patent claims against other biosimilar entrants unless separately resolved.

The docket’s resolution did not create a judicial ruling validating or invalidating the asserted patents. It therefore provides limited precedent on the substantive strength of Genentech’s patent estate. [1], [4]

What was the litigation status and disposition?

The case ended by settlement and dismissal rather than by a merits judgment. The public docket does not establish that Samsung Bioepis admitted infringement or that any asserted patent was held valid and enforceable.

Issue	Outcome
Infringement trial	None
Validity ruling	None
Enforceability ruling	None
Preliminary injunction	No publicly reported permanent exclusion order
Settlement	Yes
Dismissal	Case resolved and dismissed following settlement
Commercial result	Byooviz launched in June 2022

The absence of a merits decision means the case should not be cited as authority that the four patents would have survived invalidity challenges. It is better understood as an entry-timing and risk-allocation settlement.

How strong was Genentech’s Lucentis patent estate?

Genentech’s estate had meaningful commercial value because it combined several patent families around a high-value ophthalmic biologic. Its practical strength was greater than the strength of any single patent viewed in isolation.

Strengths

Genentech had several overlapping patents directed to ocular treatment methods. That structure increased the cost of a biosimilar challenge and created multiple infringement theories.

The BPCIA process also gave Genentech early visibility into Samsung Bioepis’ product and manufacturing plans. This allowed Genentech to select patents for litigation before commercial launch.

Lucentis had substantial clinical and regulatory use in retinal diseases. A biosimilar applicant seeking broad labeling faced a greater risk of induced-infringement allegations than an applicant pursuing a narrow indication carve-out.

Limitations

The asserted claims were largely method-of-use claims. Such claims can be more vulnerable than a direct composition claim if:

• The biosimilar label omits the patented indication.
• Physicians prescribe the product for noninfringing uses.
• The applicant separates its commercial instructions from infringing treatment conduct.
• The patent claims face written-description, enablement or obviousness challenges.
• The reference product has multiple overlapping indications with different patent positions.

The settlement prevented judicial testing of these issues. No reported decision from the case establishes that Genentech’s asserted patents were definitively strong or weak.

Did the case involve biosimilar or generic competition?

The case involved biosimilar competition, not generic competition. SB11 was evaluated under the FDA’s biosimilar pathway, and Byooviz was approved under section 351(k) of the Public Health Service Act.

Competition type	Applicable product
Small-molecule generic	Not applicable
Biosimilar	Byooviz, ranibizumab-nuna
Reference biologic	Lucentis, ranibizumab
Approval pathway	Section 351(k) biosimilar application
Commercial partner	Biogen

Biosimilars do not automatically receive the same substitution treatment as generics. Pharmacy-level substitution depends on an interchangeability designation and state law. The Genentech-Samsung Bioepis settlement concerned patent-based market entry and did not determine automatic substitution rights.

What was the geographic scope of the dispute?

The action was a U.S. federal patent case. Its direct legal effect was limited to U.S. patent rights and U.S. commercialization of SB11.

Samsung Bioepis and Genentech also had to manage patent and regulatory issues in other jurisdictions, but those rights were separate from the Delaware action. A U.S. settlement did not automatically resolve European, Asian or other national patent disputes.

For commercial planning, the relevant geographic conclusions are:

• The settlement controlled U.S. Byooviz entry.
• Foreign launch timing depended on local regulatory approvals and patent positions.
• U.S. dismissal did not eliminate global patent exposure.
• Manufacturing disclosures under the BPCIA could raise U.S. process-patent issues even where the primary claims were treatment-based.

What revenue exposure did the litigation create?

The dispute exposed Genentech to erosion of Lucentis revenue from a lower-priced biosimilar. Byooviz launch affected the U.S. market for ranibizumab, particularly in settings where payers favored biosimilar use.

Genentech’s exposure was moderated by several factors:

• Lucentis competed with other anti-VEGF products, especially Eylea and Avastin.
• Some retinal specialists used off-label bevacizumab as a lower-cost alternative.
• Biosimilar uptake depended on payer policy, reimbursement and contracting.
• Lucentis prescribing varied by indication and clinical preference.
• Genentech retained other ophthalmology products and broader oncology revenue.

For Samsung Bioepis and Biogen, the settlement converted patent uncertainty into a defined launch opportunity. The key business benefit was predictable U.S. market access rather than elimination of all competitive barriers.

How does Byooviz compare with other anti-VEGF competitors?

Product	Active ingredient	Sponsor or major marketer	Competitive position
Lucentis	Ranibizumab	Genentech/Novartis	Reference product for Byooviz
Byooviz	Ranibizumab-nuna	Samsung Bioepis/Biogen	First FDA-approved ranibizumab biosimilar
Eylea	Aflibercept	Regeneron/Bayer	Major branded retinal competitor
Avastin	Bevacizumab	Genentech	Widely used off label in ophthalmology
Vabysmo	Faricimab-svoa	Genentech	Newer retinal product with extended dosing claims

Byooviz entered a market where product substitution was influenced by administration frequency, physician practice, reimbursement and payer contracts, not only by patent expiration.

Key Takeaways

• Genentech v. Samsung Bioepis, No. 1:20-cv-00859, was a Delaware BPCIA case involving SB11, the ranibizumab biosimilar later marketed as Byooviz.
• Genentech asserted U.S. Patent Nos. 7,892,549, 8,545,878, 9,340,614 and 10,464,992.
• The asserted rights principally involved ranibizumab ocular-treatment methods and related use claims.
• The case settled before a trial or merits ruling.
• The settlement permitted U.S. Byooviz launch in June 2022.
• Byooviz received FDA approval on July 28, 2021.
• The case was governed by the BPCIA, not the Hatch-Waxman Paragraph IV process.
• No public judgment established that the asserted patents were valid, enforceable or infringed.
• The dispute reduced Samsung Bioepis’ U.S. launch uncertainty while exposing Lucentis to biosimilar price and volume pressure.
• The Delaware resolution did not automatically determine patent rights or launch timing outside the United States.

FAQs About Genentech v. Samsung Bioepis

Was Byooviz blocked by a permanent injunction?

No. The parties settled, and Byooviz launched in the United States in June 2022.

Did Samsung Bioepis win the patent case?

There was no merits judgment. The commercial resolution resulted from settlement rather than a court ruling that the asserted Genentech patents were invalid or not infringed.

Is Byooviz interchangeable with Lucentis?

FDA biosimilar approval and interchangeability are separate regulatory classifications. The Genentech litigation did not establish pharmacy-level interchangeability.

Who sells Byooviz in the United States?

Samsung Bioepis developed the product, and Biogen served as the U.S. commercial partner.

Does the case affect Eylea or Avastin patents?

No. The case directly concerned Lucentis and ranibizumab. Eylea and Avastin have separate products, patent estates, sponsors and litigation histories.

References

1. Genentech, Inc. v. Samsung Bioepis Co., Ltd., No. 1:20-cv-00859, U.S. District Court for the District of Delaware, docket filings and settlement disposition (2020-2021).

2. U.S. Food and Drug Administration. (2021, July 28). FDA approves first biosimilar to treat macular degeneration disease and other eye conditions. FDA.

3. U.S. Food and Drug Administration. (2021). Byooviz (ranibizumab-nuna) prescribing information. FDA.

4. Biogen Inc. (2022). Biogen announces U.S. launch of Byooviz, the first biosimilar to Lucentis. Corporate announcement.