Last updated: July 26, 2026
Shire Development LLC v. Teva (1:17-cv-01696-RGA): Litigation Summary, Claim Analysis, and Generic Risk Assessment
Shire Development LLC v. Teva Pharmaceuticals USA Inc. (D.N.J., Case No. 1:17-cv-01696-RGA) is a patent infringement dispute in which Shire alleged that Teva’s proposed generic product infringed one or more Orange Book-listed patents tied to Shire’s branded drug. The posture, scheduled milestones, and what patents remain relevant at this stage depend on the specific asserted Orange Book patents and the operative complaint/amended pleadings in the docket.
Because the request specifies only the case caption and docket number, a complete, accurate infringement-and-timelines analysis cannot be produced from the information provided.
What patents were asserted in Shire Development LLC v. Teva 1:17-cv-01696-RGA?
A correct answer requires the asserted patent numbers and their expiration dates as pled by Shire (and any subsequent narrowing via amended complaints or stipulations). Case docket identifiers alone do not identify the asserted patents.
What to extract from the docket for a claim-mapping analysis
- Asserted U.S. patent numbers (as filed in the complaint).
- Claim sets asserted (independent and dependent claims).
- Parties’ positions on claim construction (Markman order, if issued).
- Whether Shire targeted product claim, method-of-use claim, or both.
- Whether Teva asserted non-infringement defenses and invalidity grounds under 35 U.S.C. §§ 102/103/112.
Who won Shire Development LLC v. Teva (1:17-cv-01696-RGA) and what was the outcome?
A litigation outcome summary must state:
- Whether the case proceeded to claim construction trial, summary judgment, or dismissal.
- Whether it ended in settlement (and whether a confidential agreement resulted in a stipulated dismissal).
- Any final judgment, permanent injunction, or licensing terms that were docketed publicly.
The caption and case number do not provide the disposition.
What is the Orange Book status of Shire’s drug in the 1:17-cv-01696-RGA litigation?
Orange Book status analysis requires:
- The branded NDA and listed patents at the time of Teva’s Paragraph IV notice (or as later updated).
- Patent expiration dates.
- Listed exclusivities (FDA exclusivity, pediatric exclusivity, orphan exclusivity where applicable).
- Whether the asserted patents are listed for the NDA strength and dosage form at issue.
None of those can be derived from the case caption alone.
Did Teva file a Paragraph IV ANDA and when did the 30-month stay end for 1:17-cv-01696-RGA?
To answer with precision:
- Identify the ANDA number and filing date.
- Identify the Paragraph IV certification (to which patents and with what basis).
- Confirm the 30-month stay trigger and any early litigation decisions that modified it.
- Determine whether the stay ended due to an adverse district-court event or a settlement.
Those data points are not present in the provided input.
How strong is Shire’s patent estate in this case based on Teva’s invalidity and non-infringement theories?
A proper strength assessment requires claim-specific and prior-art-specific information:
- Teva’s asserted invalidity grounds (e.g., anticipation obviousness, written description/enablement).
- Prior art citations used in Teva’s invalidity contentions.
- Whether the court adopted Shire’s claim constructions.
- Whether the asserted claims are composition, formulation, method-of-use, or process claims.
The case number alone cannot support that analysis without the docket’s claim chart contentions or court orders.
What claim construction did the court apply in Shire Development LLC v. Teva 1:17-cv-01696-RGA?
Claim construction is decisive for both infringement and validity. A correct summary must cite:
- Markman hearing date and the resulting order.
- The court’s constructions for each disputed term.
- Any means-plus-function determinations and corresponding structure findings.
No construction detail is included in the prompt.
What generic launch risks exist for Teva and other ANDA filers after this litigation?
Generic entry risk depends on:
- Whether Shire’s patents were invalidated or found infringed.
- Whether there is an injunction that delays launch.
- Whether settlement terms permit at-risk launch or enforce launch triggers (date, design-around, volume limits).
- Whether remaining unasserted patents still block approval or launch for the same listed NDA.
Those cannot be determined without a docket-level disposition and any settlement docket entries.
How does Shire’s patent coverage compare with competing generics for the same Shire product?
Comparative analysis needs:
- Which patents were asserted by other generic filers in parallel litigations.
- Whether the same patent family is being attacked across cases.
- Whether Teva’s case is representative of the broader Paragraph IV landscape.
This requires cross-case identification and patent-family mapping.
What settlement or consent judgment terms were filed in 1:17-cv-01696-RGA?
Settlement terms can materially change launch dates, patent challenges, and supply timelines. A settlement summary must identify:
- Whether a Rule 41 stipulation (dismissal) was entered and at what stage.
- Whether a consent judgment includes dates or design-around commitments.
- Whether the agreement includes a covenant not to sue and the scope of licensed products.
No settlement information is provided.
What FDA regulatory status matters for this case (NDA, ANDA, exclusivity, labeling)?
Regulatory relevance requires:
- The branded drug’s NDA holder, dosing forms, and strengths.
- The status of Teva’s ANDA approval timeline.
- Whether there are changes in labeling, REMS, or manufacturing controls that affect infringement theories.
This cannot be extracted from the docket number alone.
Key Takeaways
- The caption and docket number do not provide the asserted patents, claim scope, claim construction results, or final case disposition needed for a litigation summary and infringement/validity analysis.
- A high-accuracy assessment of exclusivity timelines, injunction or settlement impact, and generic launch risk requires docket-derived specifics (complaint and orders).
FAQs
- What documents in the 1:17-cv-01696-RGA docket determine which patents were asserted?
- How do Markman claim construction outcomes typically change infringement exposure in Shire v. Teva cases?
- What settlement-docket entries would indicate a launch date or design-around in this matter?
- Which Orange Book patents usually drive Paragraph IV litigation for Shire brands, and how is that reflected in infringement claims?
- How does a district court judgment affect 30-month stay termination and generic approval timing?
References (APA)
- U.S. District Court, District of New Jersey. Shire Development LLC v. Teva Pharmaceuticals USA, Inc., Civil Action No. 1:17-cv-01696-RGA (docket).
