Last updated: July 2, 2026
Executive summary: Corcept Therapeutics sued Teva in the Northern District of Illinois (case no. 1:18-cv-03632) over Abbreviated New Drug Application (ANDA) related patent rights for Corcept’s mifepristone-based products. The dispute centers on whether Teva’s proposed generic infringes and whether the asserted Corcept patents are invalid and/or unenforceable. The public docket for this case supports an IP-based challenge under the Hatch-Waxman framework, with outcomes and specific asserted patents determined by the district court record, including infringement contentions, claim construction, and any final merits or settlement entries.
What happened in Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc. (1:18-cv-03632)?
Answer: The case is a Hatch-Waxman patent infringement action filed by Corcept against Teva over Teva’s ANDA filing for a competing mifepristone product. The litigation track follows standard ANDA timing: complaint filing, service, responsive pleadings, infringement/validity disputes, claim construction, and dispositive or resolution events (final judgment or settlement).
Procedural posture and typical Hatch-Waxman sequence
While docket content is required to lock in exact milestones (and the specific date sequence), the case number indicates a federal patent dispute in the U.S. District Court for the Northern District of Illinois under Title 35 and the ANDA dispute framework. In such actions, the litigation normally proceeds through:
- Asserted patent identification in the complaint
- Teva’s answer with invalidity and non-infringement defenses
- Exchange of infringement contentions and invalidity contentions
- Claim construction (Markman)
- Summary judgment or trial on infringement/invalidity
- Post-judgment or settlement resolution and timing tied to FDA approval/launch
Which patents did Corcept assert against Teva in 1:18-cv-03632?
Answer: The specific asserted patent numbers are determined by the complaint and subsequent infringement contentions. Without the complaint’s asserted-patent list and any later narrowing/amendments, the patent estate cannot be stated accurately.
Why asserted patents matter for infringement analysis
In ANDA cases, the infringement analysis depends on:
- Independent claim elements tied to drug substance composition, formulation, or use
- Priority dates and claim scope determined in claim construction
- Obviousness/anticipation references tied to the asserted patent’s specification and effective filing date
What did Teva argue in defense in 1:18-cv-03632 (non-infringement, invalidity, unenforceability)?
Answer: Defenses in ANDA Paragraph IV cases typically include non-infringement of each asserted claim and invalidity (anticipation, obviousness) and sometimes unenforceability (prosecution history, inequitable conduct, or other doctrines), depending on the allegations and the specific patents asserted.
Common issue sets seen in these disputes
- Non-infringement based on proposed generic’s product and labeling
- Invalidity based on prior art disclosures matching claim elements
- Written description and enablement challenges tied to claim scope
- Inequitable conduct or failure-to-disclose allegations (if pleaded)
What is the legal framework behind CORCEPT v. TEVA ANDA patent litigation?
Answer: The case is a Hatch-Waxman patent infringement action triggered by Teva’s ANDA and Corcept’s listing and infringement allegations. The legal framework is:
- 35 U.S.C. § 271(e)(2) for infringement by submission of an ANDA
- 21 U.S.C. § 355(j) for ANDA approval and Paragraph IV certifications
- Claim-by-claim validity and infringement determinations under standard patent law
Hatch-Waxman timing impact (practical)
If Corcept’s asserted patents are found infringed and not invalid, Teva’s launch is blocked until expiration or a court-ordered allowance. If patents are found invalid or not infringed, Teva may have an FDA timing pathway to market.
How do courts in Hatch-Waxman cases handle claim construction and infringement of generic drug products?
Answer: Courts construe claims using ordinary patent construction principles and then assess whether Teva’s proposed product meets all elements of the asserted claims, as set forth in the claim construction order and the infringement contentions.
What drives infringement outcomes for generic drug claims
- Claim scope for composition, polymorph, crystalline form, particle size, coating, or formulation-specific parameters
- Whether Teva’s application includes comparable specifications or testing data
- Whether the claims require a specific method step or a specific use or dosing regimen
- Whether labeling-based method-of-use claims align with ANDA proposed labeling
When does exclusivity and patent expiration matter for this dispute?
Answer: Exclusivity and patent expiration define the commercial trigger for launch timing, but the case’s practical impact is realized only after the court resolves infringement and validity or after settlement.
“Exclusivity timeline” inputs typically used
- Patent expiration dates for each asserted patent
- Any pediatric exclusivity extensions or other statutory adjustments
- Any exclusivity tied to regulatory approvals
- Triggering effect of a Paragraph IV notice on FDA approval timing
What is the Orange Book status of Corcept’s mifepristone product(s) relevant to this case?
Answer: Orange Book status depends on the drug listing(s) in question and the patents tied to those listings. The case docket and FDA Orange Book entries must be mapped patent-by-patent to identify the exact listing(s) implicated by the Paragraph IV certification.
How Orange Book listings connect to litigation risk
Orange Book listing alignment determines:
- Which patents are legally implicated in a §271(e)(2) claim
- The scope of what Teva certified to (e.g., “not infringed,” “invalid,” or “expired”)
- The time-to-launch barrier if patents remain enforceable
What generic entry risks exist for Teva if the court invalidates or narrows Corcept’s patents?
Answer: If asserted patents are found invalid or not infringed, Teva can typically proceed toward FDA approval and launch, subject to any remaining patents listed for the relevant drug/strength/form. Risk is reduced claim-by-claim as courts narrow scope or strike dependent claims.
Launch sequencing in Hatch-Waxman
- If all asserted patents are eliminated, the FDA approval can convert into market authorization at the appropriate statutory time.
- If some claims survive, launch can be delayed or require non-infringing design-around.
- Settlement often exchanges patent certainty for a fixed launch date or agreed workaround.
What patent litigation affects settlement probability and licensing leverage in this matter?
Answer: Settlement leverage is driven by:
- Strength of the asserted claims after claim construction
- Prior art landscape and obviousness/anticipation record
- Speed of procedural milestones and the likelihood of summary judgment
- Commercial value of the NDA product and potential damages exposure
Settlement and licensing mechanisms typically seen
- Consent judgments
- Licensing agreements with fixed royalty structures
- Stipulated dismissals tied to FDA and launch dates
- Carve-outs for additional formulations, strengths, or indications
Which companies are involved beyond Corcept and Teva in the enforcement ecosystem?
Answer: The caption shows Corcept Therapeutics, Inc. as plaintiff and Teva Pharmaceuticals USA, Inc. as defendant. Related entities (such as parent/affiliate manufacturers or ANDA marketing authorization holders) can be involved depending on the ANDA chain of title and distribution.
How does this case compare with other Corcept mifepristone generic challenges?
Answer: Without the specific asserted patent list and resolution terms in this case, direct comparison cannot be made in a way that preserves accuracy. Corcept’s broader mifepristone litigation history often includes multiple defendants, but each case turns on different patents and different ANDA specifics.
Outcome analysis for 1:18-cv-03632: what did the court decide?
Answer: A litigation outcome requires docket-specific facts such as: dismissal, summary judgment, claim construction rulings, jury verdict (if any), final judgment date, and whether it ended via settlement. Those details are not present in the prompt and cannot be stated.
Key data table: what this analysis depends on
| Field |
What must be sourced from docket/pleadings |
Status in prompt |
| Court |
Northern District of Illinois |
Provided by case number context only |
| Parties |
Corcept vs. Teva |
Provided |
| Asserted patents |
Complaint and infringement contentions |
Not provided |
| ANDA and drug/strength/form |
Complaint and FDA filings |
Not provided |
| Claim construction date and holdings |
Markman order |
Not provided |
| Resolution |
Final judgment or settlement entry |
Not provided |
| Launch date impact |
Consent judgment terms or settlement |
Not provided |
Key Takeaways
- The case is an ANDA-triggered Hatch-Waxman patent infringement dispute between Corcept and Teva under 35 U.S.C. §271(e)(2).
- The outcome and commercial impact turn on the asserted patent list, claim construction, and the court’s infringement/validity determinations or settlement terms.
- Accurate analysis of “who won,” “which patents fell,” and “when generic launch becomes permitted” requires docket-specific rulings and settlement/judgment entries.
FAQs
- What is a Paragraph IV ANDA certification in Corcept v. Teva mifepristone litigation?
- How does claim construction usually determine infringement in ANDA patent cases?
- What happens to remaining Orange Book patents if some asserted patents are invalidated in court?
- Do settlements in Hatch-Waxman cases typically include agreed launch dates or licensing terms?
- How are damages and remedies handled under 35 U.S.C. § 271(e)(2) when an ANDA is “offered” but not yet launched?
References
(No sources were provided in the prompt for citation.)
