Litigation Details for Teva Pharmaceuticals USA Inc. v. Synthon Pharmaceuticals, Inc. (D. Del. 2014)

Teva Pharmaceuticals USA Inc. v. Synthon Pharmaceuticals, Inc. (D. Del. 2014)

Docket		Date Filed	2014-11-18
Court	District Court, D. Delaware	Date Terminated	2017-01-31
Cause	35:271 Patent Infringement	Assigned To	Gregory Moneta Sleet
Jury Demand	None	Referred To
Patents	8,232,250; 8,399,413
Link to Docket	External link to docket

Details for Teva Pharmaceuticals USA Inc. v. Synthon Pharmaceuticals, Inc. (D. Del. 2014)

Date Filed	Document No.	Description	Snippet	Link To Document
2014-11-18				External link to document

Litigation summary and analysis for: Teva Pharmaceuticals USA Inc. v. Synthon Pharmaceuticals, Inc. (D. Del. 2014)

Last updated: July 29, 2026

Teva v. Synthon (1:14-cv-01419): litigation summary, claims asserted, procedural posture, and patent-expiration impact

Teva Pharmaceuticals USA Inc. v. Synthon Pharmaceuticals, Inc., docket 1:14-cv-01419 (E.D. Pennsylvania) is a branded-to-generic patent dispute tied to Teva’s branded pharmaceutical product and Synthon’s generic entry. The case is a Hatch-Waxman patent infringement action under the § 271(e)(2) framework, with the litigation centered on whether Synthon’s proposed product infringes specified Orange Book patents and whether any asserted patent claims are invalid and/or not infringed.

Key decision-point for exclusivity planning: the practical risk for Synthon (and for downstream ANDA generic launch timing) depends on (1) which patents were asserted, (2) the court’s claim construction and infringement findings, and (3) any settlement-driven launch dates. Without the operative complaint/claim list, stipulations, and final judgment record, the specific patents asserted and the final outcomes cannot be stated accurately from the docket number alone.

Actionable takeaway for IP and regulatory teams: treat 1:14-cv-01419 as a standard Hatch-Waxman infringement track where the next milestones that affect launch exposure are (a) the final non-appealable judgment (or dismissal with prejudice), (b) any settlement agreement that fixes a launch date or limits design-around scope, and (c) the Orange Book status of the asserted patents as of the litigation end state.

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What patent claims were asserted in Teva v. Synthon 1:14-cv-01419?

A Hatch-Waxman case filed by a branded NDA holder against an ANDA filer under 35 U.S.C. § 271(e)(2) typically asserts infringement of the patents listed for the drug in the FDA’s Orange Book. In these disputes, the branded plaintiff’s complaint usually identifies:

• the specific Orange Book patents asserted,
• the relevant claims for each patent (e.g., composition, formulation, method-of-use),
• how the accused ANDA product meets each claim limitation, and
• the basis for infringement allegations tied to the ANDA’s label and manufacturing description.

For 1:14-cv-01419, those details (patent numbers, claim numbers, and asserted theories such as composition vs method-of-use) are not contained in the docket identifier itself. A precise listing is required to provide a true litigation “claims asserted” summary.

Likely litigation claim categories in this posture

Even without the specific claim chart, these cases usually fall into one or more of the following buckets:

• Composition-of-matter / salt form / polymorph claims (active ingredient and/or solid state)
• Formulation claims (excipients, release profile, particle size distribution)
• Method-of-use claims (indication, dosing regimen, patient selection)
• Manufacturing process claims (process limitations, scale, temperature, drying)

Without the complaint and claim lists, assigning specific asserted categories to this docket would be speculative.

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What court outcomes mattered most in Teva v. Synthon 1:14-cv-01419?

From a decision-management standpoint, Hatch-Waxman litigations typically pivot on:

1. Claim construction
   The court interprets key claim terms. This often determines:

   • whether the accused ANDA product meets the construed limitation, and
   • whether invalidity arguments attack the narrowed or broad interpretation.

2. Infringement findings
   Courts rule based on the ANDA product description, sometimes supported by declarations, testing, and expert testimony.

3. Validity rulings
   Common defenses include anticipation/obviousness and written description/enablement. Outcomes determine whether the asserted patent claims survive.

4. Final judgment and injunction (or dismissal)
   A plaintiff win can support an injunction stopping launch. A settlement or dismissal can fix the timing of generic entry.

For 1:14-cv-01419, the docket number alone does not establish which of these events occurred, nor the final rulings. A complete litigation analysis requires the actual procedural disposition: claim construction order, summary judgment, bench trial outcome, or stipulation of dismissal.

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When does Teva’s exclusivity calendar get affected by Teva v. Synthon 1:14-cv-01419?

In Hatch-Waxman timing, the exclusivity and launch calendar depends on two layers:

• Statutory exclusivity (NCE, 3-year, 5-year exclusivity tied to NDA/label changes and exclusivity triggers)
• Patent term and FDA regulatory stays tied to an Orange Book-listed patent challenged via Paragraph IV

Litigation can affect timing through:

• 30-month stay triggered by a Paragraph IV filing,
• injunction period if the court enters a stay pending appeal or permanent injunction,
• settlement-based design-around limits that can delay launch beyond expiration.

To map Teva v. Synthon 1:14-cv-01419 into an exclusivity timeline, the asserted Orange Book patents and their expiration dates must be identified. The case number is insufficient to determine those dates.

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Did Synthon file a Paragraph IV ANDA, and what does that imply for 30-month stay in 1:14-cv-01419?

In any branded-versus-ANDA infringement case under § 271(e)(2), the ANDA filer typically files a Paragraph IV certification against one or more Orange Book patents. The legal implication is:

• a 30-month stay of FDA approval can be triggered if the suit is timely filed, and
• a court judgment that invalidates or finds noninfringement can allow approval sooner, subject to any remaining patents or settlement terms.

However, whether Synthon’s certification was Paragraph IV (and which patents were challenged) is not derivable from the docket number.

A correct answer for 1:14-cv-01419 requires the patent list tied to the ANDA and the complaint’s identified Orange Book patents.

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What is the Orange Book status of the patents at issue in Teva v. Synthon 1:14-cv-01419?

Orange Book status determines:

• which patents were “listed” at the time of ANDA submission,
• the patent term expiration or adjusted expiration dates,
• whether a patent is a method-of-use or formulation/composition patent, and
• whether any listed patents are tied to market exclusivity periods rather than enforceable patent terms.

For a litigation-linked Orange Book status analysis, the asserted patent numbers must be stated and cross-referenced to Orange Book.

Because the asserted Orange Book patents cannot be extracted from the case number, no accurate Orange Book table can be produced for this docket.

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How strong was Teva’s patent estate vs Synthon’s invalidity defenses in 1:14-cv-01419?

Litigation strength assessment is usually built from:

• breadth of asserted claims,
• prior art citation landscape,
• litigation outcomes (claim construction, summary judgment, final judgment),
• whether invalidity defenses were sustained for specific claims.

A credible strength analysis requires knowing:

• which patents and claims were asserted,
• which invalidity grounds were argued (anticipation, obviousness, lack of written description, indefiniteness),
• and which claims survived.

Without the docket’s order history and claim list, this cannot be stated precisely.

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What generic entry risks existed for Synthon after Teva v. Synthon 1:14-cv-01419?

Generic entry risk post-litigation is driven by:

• whether the final judgment enjoined launch for the asserted patents,
• whether a settlement enabled an at-risk launch date,
• whether other Orange Book patents not asserted in the case still block approval,
• whether design-around is feasible without infringing additional patents.

A precise entry-risk matrix is not possible without:

• the case outcome disposition (win/lose/dismissal/settlement),
• the remaining unasserted patents on the Orange Book, and
• any fixed settlement launch date.

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How does Teva v. Synthon 1:14-cv-01419 compare with other Teva vs generic ANDA litigations?

Without the asserted product/patents and outcome, a comparison cannot be executed on factual grounds.

What can be said generally for similarly structured cases:

• early claim construction often predicts outcomes,
• settlements are common when both sides face nontrivial risk on validity and infringement,
• and the product’s remaining unasserted patents often determine final market entry.

A case-specific comparison requires the asserted patent list and final result.

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Key Takeaways

• 1:14-cv-01419 is a Hatch-Waxman patent infringement docket structure where litigation typically targets Orange Book-listed patents tied to Teva’s branded product and Synthon’s ANDA entry.
• A business-relevant exclusivity and launch timeline depends on (a) which patents were asserted, (b) the court’s infringement/validity outcomes, and (c) any settlement terms that set launch dates or design-around limits.
• The case number alone is not sufficient to provide an accurate patent-by-patent litigation summary, including claim list, validity grounds, court findings, or settlement impacts.

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FAQs

1. What happens to FDA approval timing if a Hatch-Waxman case like 1:14-cv-01419 ends in dismissal with prejudice?
   Outcome depends on whether patents are dismissed as invalid/noninfringed, whether FDA remains blocked by other listed patents, and whether a settlement creates contractual launch timing.

2. Do method-of-use patents in an Orange Book listing generally create different launch risk than composition patents?
   Yes, because infringement can hinge on the label and prescribing behavior, not just the composition and manufacturing.

3. If claim construction narrows the asserted limitations, can that shift both infringement and invalidity outcomes?
   Yes; narrowing can make noninfringement easier to prove and can change the relevance of prior art.

4. How do settlement agreements in Hatch-Waxman cases typically affect design-around strategies?
   They can restrict launch timing and sometimes restrict specific formulation or labeling changes that would otherwise be available.

5. What is the fastest way to assess whether a given ANDA is still blocked after a Teva v. generic litigation?
   Compare Orange Book listings at the time of ANDA approval decision against the patents actually resolved in the case.

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References

1. 35 U.S.C. § 271(e)(2) (Hatch-Waxman).
2. FDA, “Orange Book” (Approved Drug Products with Therapeutic Equivalence Evaluations).