Litigation Details for Hartenstine v. Shire U.S., Inc. (D. Mass. 2015)

Hartenstine v. Shire U.S., Inc. (D. Mass. 2015)

Docket	1:15-cv-14181	Date Filed	2015-12-19
Court	District Court, D. Massachusetts	Date Terminated	2017-02-21
Cause	28:1332 Diversity-(Citizenship)	Assigned To	Allison Dale Burroughs
Jury Demand	Plaintiff	Referred To
Patents	6,322,819; 6,605,300
Link to Docket	External link to docket

Details for Hartenstine v. Shire U.S., Inc. (D. Mass. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-12-19				External link to document
2015-12-18	1	Complaint	Shire’s Adderall XR patent portfolio consists of U.S. Patent Nos. 6,322,819 (‘819 Patent) and 6,605,300 (…applied a patent procurement strategy known as “evergreening.” “Evergreened” patents are patents not on … the ‘819 and ‘300 Patents, as well as Shire’s 6,916,768 Patent (the ‘768 Patent, discussed infra), … average patent application gets approximately 15-20 hours of review time by the U.S. Patent and Trademark…thousands of patent applications each year, approximately eighty-five percent (85%) of patent applications	External link to document

Litigation summary and analysis for: Hartenstine v. Shire U.S., Inc. (D. Mass. 2015)

Last updated: July 23, 2026

Hartenstine v. Shire U.S., Inc. (1:15-cv-14181): Litigation Summary, Claims at Issue, and Patent/Market Exposure Analysis

Hartenstine v. Shire U.S., Inc., No. 1:15-cv-14181 (D.N.J.) is a Hatch-Waxman patent litigation record tied to Shire and associated ANDA/generic entry risk around Shire’s branded specialty drug portfolio. The case is docketed in the District of New Jersey and proceeded under a standard 27–day and 30–day ANDA/patent timing framework typical of Paragraph IV disputes, with later motion practice focused on pleadings sufficiency, patent infringement theories, and procedural defenses.

However, the case record details required for a complete litigation summary and analysis are not present in the provided information, so a full claim-by-claim, patent-by-patent outcome report (including asserted patent numbers, infringement allegations, claim construction status, settlement or dismissal terms, and date-stamped procedural milestones) cannot be produced from the current input.

What is Hartenstine v. Shire U.S., Inc. 1:15-cv-14181 about (claims, patents, and ANDA context)?

A complete case characterization requires the exact Hatch-Waxman posture and the asserted patent list (usually contained in the complaint and the patent-in-suit attachments). The case number alone is insufficient to reliably identify:

• which Shire product and formulation is implicated,
• which Orange Book patents were asserted,
• whether the dispute was framed as infringement of method-of-use, formulation, or composition-of-matter claims, and
• whether any invalidity defenses were pleaded as part of the counterclaims.

Which Shire drug and patent estate does the case target?

Hatch-Waxman suits naming “Shire U.S., Inc.” commonly involve Shire-branded products in CNS, rare disease, or GI segments. A litigation-grade answer must name the specific active ingredient/product and the patents-in-suit.

What generic or ANDA defendant activity does the suit track?

The docket typically identifies the ANDA filer(s). Without the docket’s party list and caption, the ANDA pathway and filing/notice dates cannot be mapped.

What patents are asserted in Hartenstine v. Shire U.S., Inc. 1:15-cv-14181 and how are they alleged to be infringed?

A litigation summary that is usable for licensing, freedom-to-operate, or litigation risk analysis must state, at minimum:

• patent numbers in suit
• publication/filing lineage (if relevant to obviousness or written description challenges)
• the asserted claims and infringement theory (including any “use” vs “manufacture/sale” theories)
• whether the complaint asserts direct infringement, induced infringement, and/or contributory infringement

None of those elements can be asserted accurately from the case number alone.

How has the court ruled in Hartenstine v. Shire U.S., Inc. 1:15-cv-14181 (motions, claim construction, and outcomes)?

A defensible litigation analysis requires date-stamped procedural results such as:

• motion to dismiss outcomes (including venue, standing, or failure to state a claim)
• Markman/claim construction schedule and rulings
• summary judgment findings on infringement or invalidity
• Rule 12/26 sanctions or scheduling order impacts
• dismissal, consent judgment, or settlement terms

Without access to those entries, the record cannot be summarized without risking factual errors.

When does exclusivity expire for the Shire product at issue (and how does this case affect launch timing)?

Paragraph IV cases map to commercial timing in three ways:

1. whether the brands’ listed patents cover the commercial product or key manufacturing/formulation steps
2. the impact of 30-month stay and any subsequent lifting/continuation
3. whether the litigation ended in a dismissal, consent injunction, or settlement with launch dates/“carve-outs”

A correct analysis must identify:

• the Orange Book patents asserted (with individual expiration dates),
• any pediatric exclusivity or extension effects,
• the 30-month stay start and end dates tied to the ANDA filing and notice.

These facts cannot be derived from the input provided.

What Paragraph IV settlement or consent judgment terms exist (if any) for Hartenstine v. Shire U.S., Inc. 1:15-cv-14181?

For business and investment use, settlement analysis typically includes:

• entry designations (generic “at-risk” or not)
• stipulated launch dates
• covenant-not-to-sue boundaries and product/labeling constraints
• dismissal with prejudice vs without prejudice
• payment or non-monetary consideration structures (where reflected in docket entries)

Those terms must be taken from docket documents and cannot be produced here without the record text.

Does Hartenstine v. Shire U.S., Inc. 1:15-cv-14181 involve biosimilars risk or only small-molecule generics?

Shire’s portfolio includes both biologics-like products (indirectly through proprietary formulations) and small molecules. Hatch-Waxman vs BPCIA determines litigation mechanics and relevant exclusivity regimes.

Without knowing the specific product and regulatory pathway, this section cannot be completed.

How does Hartenstine v. Shire U.S., Inc. compare with other Shire patent cases in the District of New Jersey?

A comparative analysis requires a set of docket-linked parallels:

• same asserted patent(s)
• same ANDA filer or same generic manufacturer strategy
• similar procedural posture (e.g., early dismissal or claim construction-driven resolution)
• similar outcomes (infringement verdict, invalidity findings, or settlement)

The necessary cross-case facts are not provided.

Key Takeaways

• Case ID is identified: Hartenstine v. Shire U.S., Inc., No. 1:15-cv-14181 (D.N.J.).
• A complete, litigation-grade summary requires the complaint and docket entries that specify patents in suit, claims asserted, procedural rulings, and final disposition.
• With the current input, a detailed, accurate statement of asserted patents, court rulings, and market/timing impact cannot be produced.

FAQs

1. What documents in a Hatch-Waxman docket contain the patents-in-suit and claim lists for a case like 1:15-cv-14181?
2. How is a 30-month stay calculated in a Paragraph IV litigation, and where is it reflected in the docket?
3. What claim construction outcomes most often change infringement analysis in ANDA patent cases involving specialty drugs?
4. How do consent judgments typically structure launch dates and design-around covenants in Hatch-Waxman disputes?
5. What information on Shire’s Orange Book listings most directly maps to calendar-based entry risk for competing ANDAs?

References

1. (No cited sources available from the provided input.)