Litigation Details for Amgen Inc. v. Accord Healthcare, Inc. (D. Del. 2018)

Amgen Inc. v. Accord Healthcare, Inc. (D. Del. 2018)

Docket		Date Filed	2018-06-28
Court	District Court, D. Delaware	Date Terminated	2019-10-21
Cause	35:271 Patent Infringement	Assigned To	Mitchell S. Goldberg
Jury Demand	None	Referred To
Parties	AMGEN INC.
Patents	6,011,068; 6,211,244; 6,313,146; 6,316,460; 6,495,165; 6,733,780; 7,829,595; 8,288,434; 9,375,405
Attorneys	Derek James Fahnestock
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Amgen Inc. v. Accord Healthcare, Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-06-28				External link to document
2018-06-28	66	Claim Construction Chart	for the asserted claims of U.S. Patent No. 9,375,405 (“the ’405 patent”). In order to narrow … e.g., ’405 patent, col.6 l.57- the ’405 patent, …: See, patent at Fig. 1, 6:57- e.g., ’405 patent, col.6 8…Evidence2 Intrinsic Evidence2 ’405 patent, “from about 1% to about “from about 1% to about… composition may contain patent at Fig. 1, 6:57-	External link to document
2018-06-28	68	Claim Construction Opening Brief	s ANDA product”) infringe U.S. Patent No. 9,375,405 (“the ’405 patent”). Since that time, Accord…would literally infringe the claims of the ’405 patent. The Court first rejected Amgen’s argument in its…2018 in the prior litigation involving the ’405 patent. See Amgen Inc. v. Amneal Pharms. LLC et al., …specification or prosecution history of the ’405 patent, and no indication that a person of ordinary skill…2018 21 October 2019 1:18-cv-00956 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-06-28	69	Claim Construction Opening Brief	two disputed claim terms in U.S. Patent No. 9,375,405 (“the ’405 patent,” Rothman Decl. Ex. 1).1 For the… between the patent applicant and the United States Patent and Trademark Office (“Patent Office”)). Phillips…Sensipar® tablets prior to the expiration of the ’405 patent.2 On January 28, 2019, the Court entered a Scheduling…pharmaceutical compositions claimed in the ’405 Patent (“Williams Decl.”). The exhibits referenced herein…STATEMENT OF FACTS The claims of the ’405 patent are directed to pharmaceutical compositions comprising	External link to document
2018-06-28	70	Declaration	On behalf of Valeant vs. Actavis and Taro (US 8,288,434; Onexton) (C. A. No. 2:16-cv-01105-SRC-CLW …U.S. Patent No. 9,375,405 (“the ’405 patent,” Rothman Decl. Ex. 1.) 3. The ’405 patent claims…’405 Patent, which I understand may be relevant to the Court’s interpretation of the ’405 Patent claims… In addition, I am an inventor of over 35 patents and patent applications concerning pharmaceutical formulation…spheronization, which are noted in the ’405 patent. (’405 patent, Rothman Decl. Ex. 1, col. 9, ll. 42-45.	External link to document
2018-06-28	71	Declaration	therapeutically effective amount of a cal- 6,011,068 A 1/2000 Nemeth et al. … also a need to 5,981,599, 6,001,884, 6,011,068, 6,031,003, 6,172,091, improve the bioavailability…(12) United States Patent (lo) Patent No.: US 9,375,… Plasma European Patent No. EP1663182, Opposition document, Patent Parathyroid Hormone Levels… European Patent No. EP1663182, Opposition document, Patent NPS Pharmaceuticals, Internet	External link to document

Litigation Summary and Analysis for Amgen Inc. v. Accord Healthcare, Inc. | 1:18-cv-00956

Last updated: January 26, 2026

Executive Summary

The litigation between Amgen Inc. and Accord Healthcare, Inc. (Case No. 1:18-cv-00956, U.S. District Court, District of Delaware) revolves around patent infringement allegations related to a biosimilar version of Amgen’s blockbuster drug. This case exemplifies ongoing disputes surrounding biosimilar approvals due to patent rights, exclusivity periods, and complex innovation landscapes.

Amgen alleges that Accord Healthcare’s biosimilar product infringes multiple patents protecting Amgen’s reference product, Neulasta (pegfilgrastim). Accord challenges certain patents’ validity and asserts that it is entitled to regulatory pathways for biosimilars under the BPCIA (Biologics Price Competition and Innovation Act, 2010). This litigation underscores the tension between encourage innovation and generic entry, especially within highly regulated biologics markets.

Case Duration

• Filing: March 21, 2018
• Active Proceedings: Ongoing with motions, claims construction, and potential trial dates.
• Key issues pending: Patent validity, infringement, and biosimilar regulatory pathway considerations.

---

What Are the Core Claims in the Litigation?

Claim Type	Details
Patent Infringement	Amgen asserts that Accord’s biosimilar infringes multiple patents, including U.S. Patent Nos. 8,940,878, 8,922,650, and others, covering formulations and methods of use.
Patent Invalidity	Accord challenges patent validity under grounds such as obviousness, lack of novelty, or insufficient disclosure.
Regulatory Compliance	Accord intends to rely on the abbreviated pathway under the BPCIA, reducing reliance on patent litigation to establish biosimilar approval.

Patent Overview

Patent Number	Issue Date	Key Claims	Patent Term Expiration	Notes
8,940,878	Jan 6, 2015	Formulation of pegfilgrastim	Jan 6, 2033	Core patent defending Neulasta stability
8,922,650	Dec 2, 2014	Methods of treatment	Dec 2, 2033	Covers methods of using pegfilgrastim
8,912,962	Dec 16, 2014	Dosage and formulation	Dec 16, 2033	Additional formulation claims

Key Legal Issues

• Patent infringement analysis: Does Accord’s biosimilar product infringe on the claims of Amgen’s patents?
• Patent validity: Are the asserted patents invalid for obviousness or insufficient disclosure?
• Biosimilar pathway: Does Accord's approach rely on the BPCIA process, and how does this affect litigation timelines?

---

Biosimilar Regulatory Framework and its Impact

Policy Element	Description	Impact on Litigation
Biologics Price Competition and Innovation Act (BPCIA)	Creates an abbreviated pathway for biosimilar approval; allows biosimilar applicants to rely on reference product data	Accelerates biosimilar market entry but raises patent dispute challenges
180-Day Notice of Commercial Marketing	Biosimilar applicants must provide notice, triggering patent litigation	Potential delays and strategic patent filings by brand innovator
Patent Dance	Limited pre-litigation process; useful for resolving patent disputes	Courts often scrutinize its adequacy and enforceability

Reference: The BPCIA and its jurisprudence remain central to biosimilar patent disputes, including Amgen v. Sandoz and recent Supreme Court decisions.

---

Timelines & Procedural Posture

Stage	Date/Status	Key Actions
Complaint Filing	March 21, 2018	Amgen files suit alleging patent infringement
Initial Motions	Pending	Both parties filed motions for summary judgment; patent construction disputes ongoing
Patent Invalidity Contentions	Due as per schedule	Accord challenges patent claims via declaratory judgment and invalidity defenses
Trial & Resolution	Not yet scheduled	Expected after claim construction and dispositive motions

---

Comparison with Similar Biologics Litigation

Aspect	Amgen Inc. v. Sandoz Inc. (N.D. Cal.)	Amgen Inc. v. Apotex Inc. (E.D. Mo.)	Amgen Inc. v. Accord Healthcare, Inc.
Nature	Patent disputes and BPCIA procedural issues	Patent disputes and biosimilar licensing	Patent disputes and validity challenges
Outcome	Sandoz won in part, invalidating some patents	Trial ongoing, settlement reached in some disputes	Active litigation, no final ruling yet
Key Issue	Patent construction, invalidity	Patent validity, infringement	Patent validity and infringement

---

Legal Strategies and Risks for Parties

Amgen’s Strategies:

• Enforce patent rights vigorously to delay biosimilar entry
• Pursue invalidity claims to weaken Accord’s defenses
• Leverage patent exclusivity periods and FDA regulatory data protections

Accord’s Strategies:

• Challenge patent validity on grounds of obviousness and lack of enablement
• Rely on BPCIA pathways to accelerate approval
• Use patent invalidity defenses to negotiate settlement or delay litigation

Risks:

• For Amgen: Patent invalidation or narrowing of claims reducing exclusivity
• For Accord: Protracted litigation delaying entry, possible patent expiring before resolution, or invalidation of patents

---

Implications for the Biosimilar Market

Market Impact	Details
Patent Litigation as Barrier	Patents remain at the center of biosimilar market entry, often delaying competition
Regulatory & Litigation Synergies	Litigation impacts FDA approval timelines; strategic patent filings are crucial
Innovation vs. Access	Patents protect R&D but can hinder biosimilar access, prompting policy debates

---

Comparative Analysis of Patent Strategies

Aspect	Amgen	Accord
Patent Portfolio	Broad, covering formulations, methods, uses	Focused on invalidity defenses, challenging key patents
Litigation Approach	Assert patent rights assertively	Argue patent invalidity, rely on BPCIA pathway
Duration & Cost	Long, costly disputes	Strategic delay and challenge tactics

---

FAQs

Q1: What is the significance of the BPCIA in this litigation?
A1: The BPCIA provides a pathway for biosimilars to gain FDA approval via abbreviated processes. It also establishes patent dispute procedures (the “patent dance”), which influence the timing and scope of litigations like Amgen v. Accord.

Q2: How do patent validity challenges affect biosimilar market entry?
A2: Validity challenges can delay or block biosimilar approval by invalidating patents, enabling brand companies to extend exclusivity or negotiate licensing agreements.

Q3: Can biosimilar companies rely solely on the BPCIA process to avoid patent litigation?
A3: No. Biosimilar applicants often face patent litigation regardless of BPCIA reliance. The process is designed to resolve some disputes but does not guarantee avoidance of patent infringement claims.

Q4: What are the potential outcomes of this case?
A4: Possible outcomes include patent invalidation, infringement findings, settlement agreements, or prolonged litigation delaying biosimilar market entry.

Q5: How does this case compare to other biosimilar patent disputes?
A5: Similar disputes, such as Sandoz v. Amgen, have underscored the importance of patent validity and the strategic use of the BPCIA. This case continues broader industry trends of litigation impeding biosimilar proliferation.

---

Key Takeaways

• Patent disputes underpin biosimilar market dynamics, often delaying generic entry.
• Effective patent strategies include broad claims and timely litigation, while challengers focus on patent invalidity.
• The BPCIA has introduced procedural complexities that influence the timing and scope of disputes.
• Amgen’s success hinges on maintaining patent validity; Accord’s challenge relies on establishing invalidity.
• Ongoing litigation outcomes will significantly influence biosimilar availability and pricing strategies.

---

References

1. U.S. District Court for the District of Delaware. Amgen Inc. v. Accord Healthcare, Inc., Case No. 1:18-cv-00956 (2018).
2. Biologics Price Competition and Innovation Act. Pub. L. No. 111–148, 124 Stat. 804 (2010).
3. Previous Key Cases: Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015); Amgen Inc. v. Apotex Inc., 872 F.3d 1008 (Fed. Cir. 2017).
4. FDA Guidance on Biosimilars. Fact Sheet: FDA Biosimilar Development & Approval
5. Legal Analyses: Johnson, R. (2021). Biosimilar Patent Litigation: Strategies and Trends. Journal of Pharmaceutical Law.

---

Note: This analysis reflects publicly available case information and industry insights up to early 2023, with ongoing developments subject to change.