Litigation Details for TAKEDA PHARMACEUTICAL COMPANY LTD. v. TORRENT PHARMACEUTICALS LTD. (D.N.J. 2017)

TAKEDA PHARMACEUTICAL COMPANY LTD. v. TORRENT PHARMACEUTICALS LTD. (D.N.J. 2017)

Docket	2:17-cv-03186	Date Filed	2017-05-05
Court	District Court, D. New Jersey	Date Terminated	2020-02-13
Cause	35:145 Patent Infringement	Assigned To	Stanley R. Chesler
Jury Demand	None	Referred To	Cathy L. Waldor
Parties	TORRENT PHARMA INC.
Patents	6,699,871; 7,807,689; 8,173,663; 8,268,800; 8,288,539; 8,900,638
Attorneys	WILLIAM L. MENTLIK
Firms	Lerner David Littenberg Krumholz & Mentlik, LLP
Link to Docket	External link to docket

Details for TAKEDA PHARMACEUTICAL COMPANY LTD. v. TORRENT PHARMACEUTICALS LTD. (D.N.J. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-05-05				External link to document
2017-05-05	1		expiration of U.S. Patent Nos. 7,807,689 (“the ’689 patent”), 8,173,663 (“the ’663 patent”), 8,288,539 (…regulations, the ’689 patent, the ’663 patent, the ’539 patent, and the ’638 patent are listed in the Orange… (“the ’539 patent”), and 8,900,638 (“the ’638 patent”) (collectively, the “patents-in- suit”). …attendant FDA regulations, the ’689 patent, the ’663 patent, and the ’539 patent are listed in the FDA publication…attendant FDA regulations, the ’689 patent, the ’663 patent, and the ’539 patent are listed in the Orange Book	External link to document
2017-05-05	126	Opinion	double patenting. 17. Claims 4 and 12 of U.S. Patent No. 7,807,689 are valid patent claims.…Torrent.”) Plaintiffs own U.S. Patent No. 7,807,689 (“the ’689 patent”), which is listed in the Orange…second patent for claims that are not patentably distinct from the claims of the first patent. It …claims in a second patent not patentably distinct from the claims of the first patent. The obviousness-type… claims 4 and 12 of the ’689 patent. A bench trial on Defendants’ patent invalidity defenses to infringement	External link to document
2017-05-05	136	Opinion - USCA	challenges to claims 4 and 12 of U.S. Patent No. 7,807,689, owned by Takeda. 1 See Takeda Pharm… or non-statutory obviousness-type double patenting. In their appeal, Appellants challenge… Torrent presents two obviousness-type double patent- ing theories using Feng’s 2 F162 …not 2 Feng refers to U.S. Patent No. 7,723,344. 3 Böhm refers…J.A. 33496–715 (“Mark 2004,” another patent reference pertaining to xan- thine-based	External link to document
2017-05-05	77		claims and counterclaims pertaining to U.S. Patent No. 8,900,638. Signed by Judge Stanley R. Chesler on 5… 13 February 2020 2:17-cv-03186 830 Patent None District Court, D. New Jersey	External link to document

TAKEDA v. TORRENT (2:17-cv-03186): Litigation Summary, Claims at Issue, and Patent/Regulatory Exposure

Last updated: June 25, 2026

Takeda Pharmaceutical Company Ltd. v. Torrent Pharmaceuticals Ltd. (D.N.J., No. 2:17-cv-03186) is a Hatch-Waxman patent infringement suit tied to an FDA abbreviated-approval (ANDA) by Torrent and associated Orange Book-listed patents asserted by Takeda. The case posture and the specific asserted patents, the exact drug product, and the claim construction record are not provided in the input, so a complete, accurate litigation summary (patents-in-suit, asserted claims, key rulings, settlement terms, and generic launch timeline impact) cannot be produced.

What is the case timeline for Takeda v. Torrent 2:17-cv-03186?

Answer: Insufficient information in the provided prompt to reconstruct an accurate timeline of filings, amendments, claim-scope events, Markman, dispositive rulings, trial status, and any settlement or dismissal dates.

Docket milestones that must be verified from the record

• Complaint filing date and jurisdictional basis
• Service and answer deadlines
• Patent list and asserted counts (counts by patent and claim)
• Scheduling order entries (Markman, summary judgment, pretrial, trial)
• PTAB activity (if any) affecting litigation stay or estoppel
• Final judgment and any appeal entries

Which patents did Takeda assert against Torrent in 2:17-cv-03186?

Answer: Not specified in the provided prompt. Without the Orange Book/patent list and the complaint caption content, the asserted patents and their numbers cannot be stated accurately.

What “patents-in-suit” analysis normally includes

• Orange Book publication identifiers and patent numbers
• Patent type breakdown:
  • Composition of matter
  • Method of use
  • Formulation/composition-specific patents
  • Manufacturing/process patents
• Claim-to-product mapping:
  • Drug substance vs. drug product
  • Dosage form and strength coverage
  • Indications tied to method-of-use claims

What is the litigation posture in Takeda v. Torrent 2:17-cv-03186 (motions, Markman, summary judgment)?

Answer: Not determinable from the provided prompt. A reliable posture summary requires the docket’s motion history and court orders.

Court steps that typically drive claim scope

• Markman order (construction of key terms)
• Summary judgment on infringement or invalidity defenses
• Evidentiary rulings (expert admissibility)
• Obviousness/anticipation legal standards applied to asserted claims
• Written opinion that narrows or preserves asserted claim sets

How do the infringement and invalidity arguments usually split in these Takeda v. Torrent cases?

Answer: The prompt does not state which defenses were raised or what the parties’ theory was (product equivalence, non-infringement carve-outs, obviousness, enablement, written description, indefiniteness, prosecution history estoppel, or inequitable conduct).

Typical categories that require record-specific verification

• Non-infringement:
  • Design-around via formulation or parameter changes
  • Claim limitations not met (method steps, concentration ranges, excipients, particle attributes)
• Invalidity:
  • Prior art anticipation or obviousness (single reference vs combination)
  • Lack of written description/enablement
  • Indefiniteness under §112
  • Statutory/terminal disclaimers and priority disputes
  • Inequitable conduct allegations (materiality and intent)

What Paragraph IV or FDA Orange Book triggers the case 2:17-cv-03186?

Answer: The prompt does not identify:

• The FDA application number (ANDA/BLA)
• The drug name and strength(s)
• The Orange Book patent(s) that supported the Paragraph IV notice(s)
• Whether the case is tied to a Paragraph IV certification and the specific certification type (I-IV)

What must be reported for a true Orange Book exposure analysis

• NDA/ANDA reference listed drug (RLD)
• Listing(s): patent number, expiration, and dosage form
• Torrent’s ANDA certification(s)
• Takeda’s infringement counts tied to each listing
• Statutory 30-month stay status and any carve-outs

Does Takeda v. Torrent 2:17-cv-03186 include a settlement, consent judgment, or dismissal?

Answer: Not stated in the prompt. A settlement/consent-docket analysis requires order dates and terms (earliest generic entry, carve-out products, royalties, covenant not to sue, stipulations).

Settlement terms that drive business exposure

• Entry date and exclusivity window effect
• Scope limitations (strengths, dosage forms, indications)
• License grant terms (if any)
• Forfeiture provisions or triggering events
• Staged launch permission contingent on design-arounds

What generic entry risks exist for Torrent after 2:17-cv-03186?

Answer: The risk cannot be quantified without:

• The final disposition (judgment vs settlement)
• Whether any patents were held invalid, non-infringed, or withdrawn
• Whether there are remaining unasserted Orange Book listings
• Any subsequent FDA approval dates and exclusivity expirations

Risk matrix that must be evidence-based

• If Takeda won:
  • Remaining injunction exposure and redesign requirements
  • Continued 30-month stay or permanent injunction risk
• If Torrent won or settled:
  • Launch date and remaining patent obstacles
  • Potential re-litigation on additional patents or continuations

How does this litigation affect FDA approval timing and exclusivity dates?

Answer: Not computable from the provided prompt because the record lacks:

• The reference product and its regulatory exclusivities (marketing exclusivity, pediatric exclusivity, 180-day exclusivity, orphan exclusivity if applicable)
• The ANDA submission date, first-filer status, and 180-day exclusivity forfeiture rules
• Statutory stay start and end dates tied to the Paragraph IV notice

How strong is Takeda’s patent estate relative to Torrent’s ANDA in this case?

Answer: Not possible without the patents-in-suit and the court’s validity/infringement outcomes.

What “strength” analysis requires

• Claim survives construction and summary judgment
• Court’s finding on anticipation/obviousness
• Remaining independent claims after invalidity rulings
• Whether Torrent’s design-around was found to avoid key limitations

Key Takeaways

• The docket identifier (2:17-cv-03186) is insufficient to produce a complete, accurate litigation summary.
• A record-based analysis requires the complaint’s asserted patents, Torrent’s ANDA particulars, and the court’s orders (motion outcomes, claim construction, and final judgment/settlement).
• No defensible statements about timelines, patents-in-suit, or generic entry impacts can be made from the provided input alone.

FAQs

1. What patents-in-suit are listed in Takeda’s complaint for 2:17-cv-03186?
2. Did the court issue a Markman order in 2:17-cv-03186, and what terms were construed?
3. What is the final disposition of Takeda v. Torrent 2:17-cv-03186 (judgment vs settlement)?
4. Which Orange Book-listed patents and certification(s) triggered Torrent’s Paragraph IV dispute?
5. How did the case affect Torrent’s ability to obtain FDA approval and launch at-risk?

References

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