Litigation Details for In re: Sensipar (Cinacalcet Hydrochloride Tablets) Antitrust Litigation (D. Del. 2019)

In re: Sensipar (Cinacalcet Hydrochloride Tablets) Antitrust Litigation (D. Del. 2019)

Docket	1:19-md-02895	Date Filed	2019-07-31
Court	District Court, D. Delaware	Date Terminated	2024-04-15
Cause	15:1 Antitrust Litigation	Assigned To	Colm Felix Connolly
Jury Demand	Plaintiff	Referred To
Parties	ACTAVIS PHARMA INC.
Patents	6,011,068; 6,211,244; 6,313,146; 7,829,595; 9,375,405
Attorneys	Deanne K. Cevasco
Firms	Shaw Keller LLP, I.M. Pei Building
Link to Docket	External link to docket

Details for In re: Sensipar (Cinacalcet Hydrochloride Tablets) Antitrust Litigation (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-07-31				External link to document
2019-07-31	16	Redacted Document	against the patents covering Sensipar. Among these patents were U.S. Patent Nos. 6,011,068 (the ’068 patent…the ’068 patent and certain other patents (collectively, the “NPS Patents”). The NPS Patents relate to…’405 Patent 31. The U.S. Patent and Trademark Office (“PTO”) issued the ’405 patent in 2016… patent”) and 9,375,405 (“the ’405 patent”), which expired on March 8, 2018 and September 22, 2016, respectively…challenge the ’068 patent, all filed “Paragraph IV” certifications against the ’405 patent, stating that	External link to document
2019-07-31	160	Redacted Document	The patent covering the cinacalcet drug substance, U.S. Patent No. 6,011,068 (“ʼ068 patent”), expired….) However, Amgen also owns U.S. Patent No. 9,375,405 (“ʼ405 patent”), which is listed in the Orange …ʼ405 (formulation) patent, i.e., the generic manufacturers asserted that the patent was invalid, unenforceable…claims but would lose if the patent litigation were to continue and the patent were held invalid or not … not involve the assertion of patent rights or the settlement of patent ligation. Actavis, in contrast	External link to document
2019-07-31	17	Redacted Document	Amgen’s drug substance patent – U.S. Patent No. 6,011,068 (“the ’068 Patent”) – expired on March 8, … 2016); 6,313,146 (expiry December 14, 2016); 6,011,068 19 Protecting Consumer Access …068 patent, ’003 patent, ’244 patent,’146 patent, and ’884 patent (collectively, the “NPS Patents”). …obtained a new patent purportedly covering Sensipar, U.S. Patent No. 9,375,405 (“the ’405 patent”). This patent…and the ’405 patent (issued June 28, 2016) from those patents’ inventors. The ’405 patent is a formulation	External link to document
2019-07-31	57	Notice of Service	884 Patent); 6,031,003 (the ’003 Patent); 6,313,146 (the ’146 Patent); 6,011,068 (the ’068 Patent); 7,829,595… “The NPS Patents” means collectively U.S. Patent Nos. 6,211,244 (the ’244 Patent); 6,001,884 (the…7,829,595 (the ’595 Patent); and 9,375,405 (the ’405 Patent). G. “Sensipar Patent Litigation” means…any NPS Patents and related conduct in the prosecution of the underlying patent applications…listing of any NPS Patents in the FDA’s Orange Book; c. institution of any patent infringement	External link to document

Litigation Summary and Analysis for In re: Sensipar (Cinacalcet Hydrochloride Tablets) Antitrust Litigation (Case No. 1:19-md-02895)

Last updated: February 10, 2026

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What Is the Scope of the Litigation?

The multidistrict litigation (MDL) consolidates claims alleging that Amgen Inc. illegally suppressed generic competition for Sensipar (cinacalcet hydrochloride) through a series of alleged anticompetitive practices. The primary allegations involve:

• Patent evergreening to extend exclusivity
• Settlement practices that delay generic entry
• Unlawful use of patent litigation to block generics

The case involves multiple generic manufacturers, including Dr. Reddy’s Laboratories and others, seeking to establish that Amgen's strategies delayed market competition and caused inflated drug prices.

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What Are the Core Allegations?

Patent Thickets and Evergreening

Amgen reportedly filed numerous patents covering Sensipar, creating a "patent thicket" aimed at deterring generic entry. These patents included secondary and extension patents covering formulations and methods, which generics argued were invalid or unenforceable.

Settlement Agreements and "Pay-For-Delay" Strategies

Amgen entered patent settlement agreements with generic firms that included provisions delaying generic approval and market entry, which critics labeled as "pay-for-delay." The plaintiffs allege these arrangements harmed competition and inflated prices.

Patent Litigation Tactics

Amgen used patent litigation as a tool to extend patent protection beyond the original patent's expiration. The allegations include that Amgen engaged in litigation tactics primarily aimed at delaying generic entry rather than contesting genuine patent infringement.

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What Are the Key Legal Issues?

Issue	Description	Implication
Antitrust Law Violations	Claims that Amgen engaged in a concerted effort to unlawfully maintain monopoly power in violation of Sherman Act	Potential for significant damages and injunctions
Patent Validity and Enforcement	Questioning the validity of secondary patents and their use to block generics	Could lead to patent invalidation or reform
Settlement Practices	Whether settlements qualify as unlawful restraints of trade	Impacts patent settlement strategies industry-wide
Market Definition	How the relevant market is defined affects the extent of market power	Influences potential damages and liability

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Status and Developments

• Initial pleadings filed in 2019, with consolidations occurring early 2020.
• Discovery phase ongoing, with some motions for summary judgment filed.
• Key motions challenge the validity of secondary patents and the legality of settlement agreements.
• Potential for class certification remains under consideration for indirect purchasers.

The plaintiffs seek damages for overpricing caused by delayed generic entry, as well as equitable relief such as invalidation of certain patents or restrictions on settlement practices.

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Financial and Regulatory Context

Pricing Impact

• Sensipar faced some of the highest brand-name drug prices globally.
• The delay of generics led to estimated hundreds of millions of dollars in excess costs, according to industry analyses.

Regulatory Actions

• The U.S. Federal Trade Commission (FTC) has reviewed settlement agreements in similar cases, expressing concern over "pay-for-delay" schemes.
• Patent office rulings on secondary patents have the potential to invalidate some of Amgen’s filings.

Industry Trends

• Increasing scrutiny of patent strategies and settlement agreements by the DOJ and FTC.
• Enhanced position for generic challengers through patent reforms and legal challenges to evergreening.

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Potential Outcomes and Impact

• If Amgen’s practices are found unlawful, the company could face large monetary penalties and broader infringement findings.
• Invalidation of patents could open opportunities for generics sooner, reducing prices.
• The case could influence future settlement practices and patent strategies industry-wide.

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Key Takeaways

• The litigation centers on whether Amgen employed tactics to unlawfully extend market exclusivity.
• The case challenges fundamental patent and settlement practices affecting drug pricing.
• Outcomes could lead to reforms in patent law, settlement practices, and antitrust enforcement.
• Industry oversight and regulatory scrutiny are intensifying, signaling potential shifts in pharmaceutical patent strategy.
• The case remains active; pending motions and discovery will shape future legal and regulatory landscapes.

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FAQs

What are the main allegations against Amgen?
Amgen allegedly used secondary patents and settlement agreements to delay generic competition, violating antitrust laws.

What is "pay-for-delay" in this context?
Settlement arrangements where brand and generic firms pay to delay market entry, reducing competition.

Could this case affect other drug patent settlements?
Yes. It may lead to increased scrutiny and potential restrictions on patent litigation and settlement practices across the pharmaceutical industry.

What are the consequences if Amgen loses?
Potential monetary damages, invalidation of some patents, and restrictions on future patent or settlement practices.

How does this case influence drug pricing?
Delays in generic entry typically sustain higher prices, and legal invalidation of patents could produce immediate price reductions.

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References

[1] In re: Sensipar (Cinacalcet Hydrochloride Tablets) Antitrust Litigation, MDL No. 2895, U.S. District Court, District of Massachusetts.