Litigation Details for Genentech, Inc. v. Amgen, Inc. (D. Del. 2017)

Genentech, Inc. v. Amgen, Inc. (D. Del. 2017)

Docket		Date Filed	2017-10-18
Court	District Court, D. Delaware	Date Terminated	2020-07-07
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	Plaintiff	Referred To
Patents	8,460,895; 8,512,983; 8,574,869; 9,441,035; 9,487,809
Link to Docket	External link to docket

Details for Genentech, Inc. v. Amgen, Inc. (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-10-18				External link to document

Genentech v. Amgen, 1:17-cv-01471: Avastin Biosimilar Patent Litigation Summary

Last updated: August 2, 2026

Genentech, Inc. v. Amgen Inc., No. 1:17-cv-01471-LPS, was a Delaware patent dispute concerning Amgen’s bevacizumab biosimilar candidate ABP 215, later marketed as Mvasi. Genentech alleged that Amgen’s product infringed patents covering bevacizumab and its use in cancer treatment. The case was resolved through a settlement that permitted U.S. commercialization before the asserted patent estate had fully expired. Mvasi received FDA approval in September 2017 and entered the U.S. market in July 2019.

The litigation is commercially important because it established the launch framework for the first U.S. biosimilar to Avastin and illustrates the value of BPCIA patent settlements even where the reference product’s primary patent protection is approaching expiration.

What drug and biosimilar were involved in Genentech v. Amgen?

The dispute concerned Genentech’s Avastin, the reference product for bevacizumab-awwb.

Item	Details
Reference product	Avastin
Active ingredient	Bevacizumab
Reference sponsor	Genentech, Inc., Roche group
Biosimilar	ABP 215, later branded Mvasi
Biosimilar sponsor	Amgen Inc.
FDA approval	September 14, 2017
FDA biosimilar designation	Bevacizumab-awwb
Court	U.S. District Court for the District of Delaware
Case number	1:17-cv-01471-LPS
Presiding judge	Leonard P. Stark
Statutory framework	Biologics Price Competition and Innovation Act

Amgen developed ABP 215 as a biosimilar to Avastin. The product was approved for the same principal oncology indications as Avastin, subject to the FDA’s biosimilarity determination and labeling.

The case should be distinguished from Genentech’s separate patent litigation concerning Amgen’s trastuzumab biosimilar ABP 980, marketed as Kanjinti. Case No. 1:17-cv-01471 relates to bevacizumab and Mvasi.

What patents did Genentech assert against Amgen?

Genentech asserted patent rights relating to bevacizumab and its therapeutic use. The dispute arose from Amgen’s BPCIA patent-notice and information-exchange process for ABP 215.

The asserted Avastin patent estate included patents directed to anti-VEGF antibodies, antibody production, and cancer-treatment methods. Key Genentech patents associated with the Avastin estate included the following:

Patent	General subject matter	Relevance
U.S. Patent No. 6,884,879	Anti-VEGF antibody technology	Core Avastin-related patent
U.S. Patent No. 7,060,268	Anti-VEGF antibody and related use claims	Avastin estate
U.S. Patent No. 7,169,400	VEGF-antibody technology	Avastin estate
U.S. Patent No. 7,807,799	Anti-VEGF antibody subject matter	Avastin estate
U.S. Patent No. 8,343,658	Therapeutic use and antibody-related claims	Avastin estate

The specific claims and patents at issue must be read from the complaint, amended pleadings, claim-construction filings, and settlement-related docket entries. Public biosimilar litigation summaries commonly group these patents within Genentech’s broader Avastin estate, but not every patent associated with Avastin was necessarily litigated to final judgment in this docket.

When did Genentech file the Avastin biosimilar lawsuit?

Genentech filed the Delaware action in 2017 after Amgen disclosed ABP 215 under the BPCIA process. The case followed the statutory exchange of information concerning Amgen’s biosimilar application and Genentech’s asserted patent rights.

The litigation timeline was:

Date	Event
1990s-2000s	Genentech filed and prosecuted the foundational anti-VEGF patent portfolio
November 2004	Avastin received FDA approval
September 14, 2017	FDA approved Mvasi, the first U.S. bevacizumab biosimilar
October 2017	Genentech filed the Delaware patent action
2018-2019	The parties litigated patent and launch issues while settlement discussions proceeded
2019	Genentech and Amgen resolved the dispute
July 2019	Amgen launched Mvasi in the United States
2020 onward	Additional bevacizumab biosimilar competition entered the market

Mvasi’s FDA approval preceded its commercial launch. The delay reflected patent and market-entry arrangements rather than a regulatory deficiency.

Was this a Paragraph IV challenge?

No. Paragraph IV certifications apply to patents listed in the FDA Orange Book for small-molecule drugs under the Hatch-Waxman Act. Avastin is a biologic, so the dispute proceeded under the BPCIA rather than through a conventional Paragraph IV filing.

The relevant statutory mechanisms were:

• Disclosure of the biosimilar application.
• Exchange of manufacturing and patent information.
• Identification of patents that could be asserted.
• Notice of commercial marketing.
• Patent litigation under 42 U.S.C. § 262(l).

The legal effect was similar to Hatch-Waxman litigation in one commercial respect: Genentech sought to control the timing of competing-product entry. The procedural route and statutory remedies were different.

What was the outcome of Genentech v. Amgen?

The parties settled the dispute. The publicly known commercial consequence was an agreed pathway for Amgen to launch Mvasi in the United States before the full expiration of the relevant Avastin patent estate.

The settlement avoided a final merits judgment establishing whether Amgen’s commercial product infringed each asserted patent and whether each asserted claim was valid and enforceable. The case therefore did not produce a binding trial decision that could be used as a broad precedent on the validity of Genentech’s Avastin patents.

The settlement’s practical result was:

1. Amgen retained FDA approval for Mvasi.
2. Genentech preserved control over the launch timing through the negotiated resolution.
3. Amgen obtained a defined commercial entry date.
4. Genentech avoided the cost and uncertainty of a full trial and appeal.
5. Mvasi entered the market in July 2019.

Public reporting did not disclose the full economic terms of the settlement. No reliable public figure should be assigned to any royalty, milestone, or other payment unless drawn from a filed agreement or official company disclosure.

What is the patent expiration status of Avastin and Mvasi?

Avastin’s protection did not depend on a single uniform expiration date. The portfolio included patents with different priority dates, patent-term adjustments, statutory extensions, claim scopes, and possible use restrictions.

For business planning, the relevant distinction is between:

• Core composition and antibody patents.
• Manufacturing patents.
• Method-of-treatment patents.
• Indication-specific patents.
• Patent rights that can support an injunction.
• Patent rights that may generate damages without preventing launch.

By the time Mvasi launched, the principal commercial dispute was no longer whether Amgen could obtain FDA approval. The issue was when Amgen could sell the product without exposing itself to infringement liability.

The settlement effectively converted uncertain patent timing into a known launch date. That reduced litigation risk for Amgen and reduced the risk to Genentech of an immediate, unregulated commercial launch.

What was the FDA and Purple Book status of Mvasi?

Mvasi was FDA-approved as a biosimilar to Avastin under the abbreviated pathway created by the BPCIA.

Regulatory issue	Status
FDA pathway	BPCIA biosimilar pathway
Reference product	Avastin
Biosimilar product	Mvasi
Nonproprietary name	Bevacizumab-awwb
Interchangeability	Not initially designated interchangeable
Orange Book listing	Not applicable
Purple Book listing	Applicable
Approval date	September 14, 2017
Initial U.S. launch	July 2019

Biologics are not listed in the Orange Book. The Purple Book is the relevant FDA reference for biologic reference products, biosimilars, and interchangeability designations.

FDA approval did not eliminate patent risk. The FDA evaluates biosimilarity, manufacturing, safety, efficacy, and labeling. It does not decide whether commercialization infringes a private patent.

What generic-entry risks did the settlement create for Genentech?

The settlement reduced the duration of Avastin’s U.S. monopoly by authorizing Mvasi to enter before complete patent exhaustion. Genentech retained the benefit of a negotiated delay but accepted a defined competitor rather than pursuing an uncertain injunction.

The principal risks to Genentech were:

• Earlier price competition in oncology markets.
• Payer substitution toward lower-cost bevacizumab products.
• Loss of negotiating leverage with hospitals and group purchasing organizations.
• Erosion of Avastin volume before all patent disputes were exhausted.
• Expansion of biosimilar prescribing experience across oncology indications.
• A lower reference price for future bevacizumab competition.

The principal risks to Amgen were different:

• Potential damages for pre-settlement activity.
• An injunction that could delay launch.
• Patent invalidity and infringement findings affecting launch economics.
• Royalty or settlement payments.
• Manufacturing disclosure and BPCIA litigation costs.

The settlement was therefore commercially rational for both parties. Genentech controlled timing; Amgen obtained certainty.

How strong was Genentech’s Avastin patent estate?

Genentech’s estate was meaningful but declining in strategic strength by the time of the case.

Composition and antibody patents

The older anti-VEGF patents provided the strongest historical protection for Avastin. Their value depended on remaining patent term and the breadth of their claims against a biosimilar antibody.

Manufacturing patents

Manufacturing claims can create operational barriers if the biosimilar sponsor uses a process that falls within the asserted claims. Their value is lower when the accused manufacturer can redesign its process without changing product quality or regulatory comparability.

Method-of-use patents

Method patents can remain commercially relevant after composition claims expire, particularly where the reference product has multiple oncology indications. Their enforcement depends on claim language, physician conduct, labeling, induced infringement theories, and the availability of carve-outs.

Patent-term limitations

The estate’s principal weakness was timing. A biosimilar sponsor can accept litigation expense when the expected launch delay is shorter than the remaining commercial life of the reference product. Once a settlement establishes a launch date, the practical value of later-expiring claims may decline sharply.

Overall, Genentech had a credible patent position but not one that guaranteed long-term exclusion of Mvasi. The commercial result confirms that the portfolio supported delay and bargaining leverage more clearly than it supported permanent market exclusion.

Which companies compete with Avastin and Mvasi?

The U.S. bevacizumab market developed into a multi-supplier biologics market after Mvasi’s launch.

Company	Product	Biosimilar name
Amgen	Mvasi	Bevacizumab-awwb
Pfizer	Zirabev	Bevacizumab-bvzr
Biogen and Samsung Bioepis	Byooviz is ranibizumab, not bevacizumab	Not an Avastin biosimilar
Celltrion	Vegzelma	Bevacizumab-adcd
Fresenius Kabi	Avz세?	Market status depends on jurisdiction and approval timing

The principal U.S. competitors to Avastin have been Mvasi, Zirabev, and later FDA-approved bevacizumab biosimilars. Product-level competition depends on payer contracts, oncology practice purchasing, reimbursement, inventory, and site-of-care economics.

What was the revenue exposure from the litigation?

Avastin was a major Genentech oncology product before biosimilar entry. Its revenue exposure extended across colorectal cancer, non-small-cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian cancer, subject to the FDA-approved label and jurisdiction-specific use.

The case created exposure in four areas:

1. Direct Avastin sales erosion.
2. Discounting pressure from biosimilar contracting.
3. Reduced hospital purchasing leverage.
4. Lower future revenue from Avastin-related indications.

Amgen’s exposure was the cost of delayed commercialization. Because Mvasi had already secured FDA approval, every additional month of delay represented foregone biosimilar revenue, while every month of early launch increased potential patent damages or settlement cost.

Did the case produce a settlement agreement or final judgment?

The case was resolved by settlement rather than a publicly reported final merits judgment after trial. The settlement enabled Mvasi’s U.S. launch in July 2019.

The absence of a merits judgment limits the precedential value of the docket. It also means that the case should not be characterized as a definitive ruling that Genentech’s Avastin patents were valid, invalid, infringed, or not infringed. The operative business result was negotiated market entry.

What geographic coverage did the dispute have?

The docket was a U.S. federal action and addressed U.S. patent rights and U.S. commercialization of Mvasi. It did not determine the patent position in Europe, Canada, Japan, or other jurisdictions.

Amgen and Genentech pursued separate regulatory and patent strategies outside the United States. A U.S. settlement should not be treated as a worldwide license unless the settlement agreement expressly provides that scope.

For multinational launch planning, the relevant questions are:

• Whether the same antibody and manufacturing process are used globally.
• Whether local patents cover the product or its indications.
• Whether the biosimilar has been approved in each jurisdiction.
• Whether launch dates are governed by local settlement terms.
• Whether national reimbursement rules accelerate or delay substitution.

Key Takeaways

• Genentech v. Amgen, No. 1:17-cv-01471-LPS, concerned Avastin and Amgen’s bevacizumab biosimilar ABP 215, marketed as Mvasi.
• Mvasi received FDA approval on September 14, 2017.
• The dispute proceeded under the BPCIA, not the Orange Book or Paragraph IV framework.
• Genentech asserted Avastin-related patent rights covering anti-VEGF antibodies, manufacturing, and therapeutic use.
• The parties settled before a publicly reported final merits judgment.
• The settlement enabled Mvasi to launch in the United States in July 2019.
• The case’s commercial value was launch timing and risk allocation, not a definitive patent-validity precedent.
• Avastin is a biologic, so Purple Book status is relevant and Orange Book listing is not.
• The litigation reduced Genentech’s ability to preserve Avastin exclusivity after biosimilar approval.
• The case remains a useful model for analyzing BPCIA settlements involving approved biosimilars and late-life biologic patent estates.

FAQs About Genentech v. Amgen and Mvasi

Was Mvasi the first Avastin biosimilar in the United States?

Yes. Mvasi, or bevacizumab-awwb, was the first FDA-approved biosimilar to Avastin and entered the U.S. market in July 2019.

Did Genentech obtain an injunction blocking Mvasi?

No publicly reported final injunction permanently blocked Mvasi. The parties resolved the dispute through a settlement that established a commercial launch pathway.

Is Mvasi interchangeable with Avastin?

Mvasi was approved as a biosimilar, but it was not initially designated interchangeable by the FDA. Substitution rules depend on federal and state law, payer policy, and institutional practice.

Are Avastin patents listed in the Orange Book?

No. Avastin is a biologic. Its regulatory patent information is analyzed through the BPCIA framework and Purple Book system rather than the Orange Book.

Does the Genentech-Amgen settlement apply outside the United States?

The Delaware case addressed U.S. patent rights and U.S. commercialization. International effect depends on the settlement’s language and separate foreign proceedings.

References

1. Amgen Inc. (2017, September 14). FDA approves Amgen’s Mvasi, the first biosimilar to Avastin. https://www.amgen.com/newsroom/press-releases/2017/09/fda-approves-amgens-mvasi-the-first-biosimilar-to-avastin

2. Genentech, Inc. v. Amgen Inc., No. 1:17-cv-01471-LPS, U.S. District Court for the District of Delaware.

3. U.S. Food and Drug Administration. (2017, September 14). Mvasi (bevacizumab-awwb) approval letter. https://www.accessdata.fda.gov

4. U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov

5. U.S. Food and Drug Administration. (2024). Biosimilar and interchangeable biosimilar products. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars

6. U.S. Congress. (2010). Biologics Price Competition and Innovation Act of 2009, 42 U.S.C. § 262(l).