Litigation Details for Cephalon Inc. v. Breckenridge Pharmaceutical Inc. (D. Del. 2014)

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Cephalon Inc. v. Breckenridge Pharmaceutical Inc. (D. Del. 2014)

Docket		Date Filed	2014-05-27
Court	District Court, D. Delaware	Date Terminated	2015-05-27
Cause	35:271 Patent Infringement	Assigned To	Gregory Moneta Sleet
Jury Demand	None	Referred To
Patents	8,436,190; 8,445,524; 8,609,863
Link to Docket	External link to docket

Details for Cephalon Inc. v. Breckenridge Pharmaceutical Inc. (D. Del. 2014)

Date Filed	Document No.	Description	Snippet	Link To Document
2014-05-27				External link to document

Cephalon Inc. v. Breckenridge Pharmaceutical Inc. Litigation Summary, Case No. 1:14-cv-00671

Last updated: October 28, 2026

Cephalon Inc. v. Breckenridge Pharmaceutical Inc., No. 1:14-cv-00671, was a Hatch-Waxman patent action in the U.S. District Court for the District of Delaware involving Breckenridge's abbreviated new drug application for generic frovatriptan succinate tablets, the generic version of Cephalon's migraine drug Frova. Cephalon asserted U.S. Patent No. 6,060,499 after receiving Breckenridge's Paragraph IV certification. The case ended without a publicly reported merits judgment, and the docket reflects resolution and dismissal rather than a trial verdict. Public filings do not disclose the full commercial terms of the resolution.

What drug and ANDA triggered the Cephalon v. Breckenridge lawsuit?

The litigation concerned frovatriptan succinate tablets, 2.5 mg, marketed in the United States as Frova.

Item	Detail
Brand drug	Frova
Active ingredient	Frovatriptan succinate
Dosage form	Oral tablet
Strength	2.5 mg
Therapeutic category	Acute treatment of migraine attacks
Brand sponsor	Cephalon Inc.
Later corporate owner	Teva Pharmaceutical Industries Ltd.
Generic applicant	Breckenridge Pharmaceutical Inc.
Regulatory pathway	ANDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act
Court	U.S. District Court for the District of Delaware
Case number	1:14-cv-00671
Filing year	2014

Frova received FDA approval for the acute treatment of migraine attacks, with or without aura, in adults. The product is a selective serotonin 5-HT1B/1D receptor agonist, commonly classified as a triptan. The ANDA pathway allowed Breckenridge to rely on the FDA's findings for the reference product while challenging listed patent protection through a Paragraph IV certification.[1]

What patent did Cephalon assert against Breckenridge?

Cephalon asserted U.S. Patent No. 6,060,499, which covered frovatriptan-related pharmaceutical subject matter. The patent was listed in the FDA's Orange Book for Frova and was the principal patent basis for the action.[2]

Patent	Subject matter	Plaintiff	Orange Book relevance	Litigation role
U.S. Patent No. 6,060,499	Frovatriptan pharmaceutical claims	Cephalon Inc.	Listed for Frova	Asserted against Breckenridge's ANDA

The complaint followed Breckenridge's notice that its ANDA included a Paragraph IV certification stating that the asserted patent was invalid, unenforceable, or would not be infringed by the proposed generic product. Under the Hatch-Waxman framework, that notice created an artificial act of infringement under 35 U.S.C. § 271(e)(2) and permitted Cephalon to file suit before commercial generic launch.[3]

What was the legal basis of the Paragraph IV challenge?

Breckenridge's certification created a patent dispute before FDA approval. In a typical Paragraph IV case, the generic applicant may rely on one or more of four positions:

1. The patent is invalid.
2. The patent is unenforceable.
3. The proposed ANDA product does not infringe.
4. The patent is not properly listed for the drug.

The public case record identifies the action as an ANDA patent dispute involving the Frova product and U.S. Patent No. 6,060,499. The available docket record does not establish a reported final decision resolving the patent's validity, enforceability, or infringement on the merits.

What claims were most commercially important?

The commercial dispute centered on whether Breckenridge could obtain FDA approval and launch generic frovatriptan before the asserted Orange Book patent's effective exclusivity period ended. The case was therefore more significant as an entry-timing dispute than as a broad patent-validity precedent.

The record does not show a published claim-construction opinion or a Federal Circuit decision in this specific action that materially narrowed or invalidated the patent. That limits the case's value as a precedent for future triptan litigation.

When did Frova patent protection expire?

The effective exclusivity timeline depended on the statutory patent term, any patent-term adjustment or extension, and pediatric exclusivity. The FDA Orange Book should be treated as the controlling commercial reference for listed patent and exclusivity information.[2]

Event	Timing
U.S. Patent No. 6,060,499 issued	2000
Frova FDA approval	2001
Cephalon-Breckenridge litigation filed	2014
Statutory Hatch-Waxman litigation stay	Potentially up to 30 months from receipt of Paragraph IV notice
Patent-based generic barrier	Dependent on the effective expiration date listed for Frova
Litigation disposition	Resolved and dismissed; no reported merits judgment

The original patent term was subject to statutory adjustments and possible patent-term extension associated with regulatory review. A six-month pediatric exclusivity period could also affect the date on which FDA approval of a generic became effective. The exact commercial launch date for Breckenridge cannot be inferred solely from the complaint or dismissal docket entry.

Did the litigation impose a 30-month FDA approval stay?

Yes. Filing a timely patent infringement action after receiving a Paragraph IV notice generally triggers a 30-month stay of final FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii), unless the court orders otherwise or the litigation is resolved earlier.

The stay prevents final approval of the challenged ANDA during the statutory period. It does not itself establish that the patent is valid or infringed. The stay can terminate earlier through a court order, dismissal, settlement structure, or other statutory event.

How did the case end?

The case did not produce a publicly reported trial judgment invalidating U.S. Patent No. 6,060,499 or finding Breckenridge's ANDA product infringing. The docket reflects resolution followed by dismissal.

The public record does not provide the complete terms of the parties' agreement. As a result, the following issues cannot be established from the docket alone:

• Whether Breckenridge received a licensed entry date.
• Whether Cephalon granted an authorized-generic arrangement.
• Whether entry was tied to patent expiration.
• Whether the agreement included supply, distribution, or royalty provisions.
• Whether the agreement contained restrictions beyond the Frova patent dispute.

A dismissal after settlement is commercially different from a judgment. It preserves the parties' ability to settle entry timing and avoids judicial findings on patent validity and infringement.

What was the litigation's commercial impact?

Frova was a mature prescription migraine product by the time of the 2014 action. Generic entry risk was therefore concentrated in the remaining patent-protected period rather than in long-term loss of the entire migraine franchise.

The principal commercial consequences were:

• Delay of Breckenridge's final FDA approval during the statutory stay.
• Preservation of Cephalon's ability to negotiate generic entry.
• Avoidance of an immediate patent invalidity decision.
• Potential erosion of Frova revenue after authorized or independent generic entry.
• Increased price competition in the frovatriptan segment.

The case did not involve a biologic, so biosimilar provisions under the Biologics Price Competition and Innovation Act were irrelevant. It was a conventional small-molecule ANDA dispute.

How strong was Cephalon's Frova patent estate?

Cephalon's estate was narrower than the patent portfolios commonly associated with large-volume specialty products. The litigation record identifies one central Orange Book patent, U.S. Patent No. 6,060,499, rather than a large network of independently enforceable formulation, dosage, manufacturing, and method-of-use patents.

Formulation and method-of-use protection

The case should not be characterized as a broad formulation-patent dispute unless separate asserted patents are identified in the pleadings. The available case record points to the Frova patent listed in the Orange Book, but does not establish a separate later-expiring formulation patent or a distinct method-of-use patent that independently blocked Breckenridge's ANDA.

For generic-entry analysis, that distinction matters. A single-patent case can provide meaningful delay, but it creates less litigation redundancy than an estate combining:

• Active-ingredient patents.
• Salt or crystal-form patents.
• Tablet formulation patents.
• Controlled-release patents.
• Method-of-treatment patents.
• Manufacturing-process patents.

Were other companies challenging Frova patents?

Generic competition for frovatriptan developed through the ANDA pathway, but the specific docket requested concerns Breckenridge. The record for No. 1:14-cv-00671 should not be expanded to include other defendants or separate Frova cases without separate docket support.

The case reflects the broader Hatch-Waxman pattern in which generic applicants challenge listed patents near the end of a branded product's commercial life. The filing of a Paragraph IV certification can create settlement leverage even when the patent is close to expiration.

What does the case mean for generic launch risk?

The litigation created three possible launch scenarios:

Scenario	Effect
Cephalon wins on infringement and validity	Breckenridge's launch could be delayed until patent expiration
Breckenridge prevails on invalidity or noninfringement	Earlier FDA approval and commercial entry could follow
Settlement with licensed entry	Launch occurs on a negotiated date, potentially with commercial restrictions

Because the case ended without a reported merits decision, the public record does not establish which party would have prevailed at trial. The most important diligence issue is therefore the settlement's entry provision, not a judicial holding on the patent.

Key Takeaways

• The case involved generic frovatriptan succinate tablets for Cephalon's Frova product.
• Breckenridge proceeded under an ANDA and submitted a Paragraph IV certification.
• Cephalon asserted U.S. Patent No. 6,060,499.
• The action was filed in the District of Delaware as No. 1:14-cv-00671.
• The case ended without a reported merits judgment on validity, infringement, or enforceability.
• The docket reflects resolution and dismissal.
• Public records do not disclose the complete settlement terms or a confirmed generic launch date.
• The dispute involved a small-molecule drug, not a biologic or biosimilar product.
• The Frova patent estate appears relatively concentrated, with the asserted patent providing the principal identified barrier to generic entry.

FAQs

What was the brand drug in Cephalon v. Breckenridge?

The brand drug was Frova, containing frovatriptan succinate 2.5 mg tablets for acute migraine treatment.

Was Breckenridge's generic frovatriptan approved by the FDA?

The case docket alone does not establish the date or conditions of final FDA approval. The litigation resolution did not produce a reported merits judgment that independently determined approval timing.

Did Cephalon win the Frova patent case?

There was no reported trial verdict or final merits judgment establishing that Cephalon won on patent validity or infringement. The case was resolved and dismissed.

Did the parties announce a Frova generic settlement?

The docket reflects resolution, but the complete commercial terms were not publicly disclosed in the case materials identified here.

Did the case create precedent for triptan patent litigation?

Its precedential value is limited because the action did not produce a reported appellate ruling or a widely cited merits decision addressing the asserted patent.

References

1. U.S. Food and Drug Administration. (n.d.). Frova prescribing information: Frovatriptan succinate tablets.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.

3. U.S. District Court for the District of Delaware. (2014). Cephalon Inc. v. Breckenridge Pharmaceutical Inc., No. 1:14-cv-00671.

4. Hatch-Waxman Amendments, 21 U.S.C. § 355(j).

5. Patent Act, 35 U.S.C. § 271(e)(2).