Litigation Details for Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited (D. Del. 2018)

Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited (D. Del. 2018)

Docket		Date Filed	2018-11-13
Court	District Court, D. Delaware	Date Terminated	2020-11-10
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To	Sherry R. Fallon
Patents	8,551,957; 9,949,997; 9,949,998
Link to Docket	External link to docket

Details for Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-11-13				External link to document
2018-11-12	4		Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,551,957 B2 ;9,949,997 B2 ;9,949,998… 10 November 2020 1:18-cv-01786 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Boehringer Ingelheim v. Annora Pharma (D. Del.) 1:18-cv-01786: Litigation Summary, Patent Scope, and Enforcement Impact

Last updated: July 4, 2026

Boehringer Ingelheim Pharmaceuticals Inc. brought suit against Annora Pharma Private Limited under the Hatch-Waxman framework in D. Delaware, case 1:18-cv-01786, tied to Annora’s proposed drug launch. The litigation’s business impact turns on (1) which patents were asserted, (2) claim construction and validity rulings, and (3) any settlement terms that controlled entry timing.

What does Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited (1:18-cv-01786) allege?

Short answer: The complaint asserts patent infringement under 35 U.S.C. § 271 in connection with a proposed generic or otherwise competing product submitted to FDA under Hatch-Waxman (typically an ANDA and related Orange Book listings).

What parties are involved and where is the case pending?

• Plaintiff: Boehringer Ingelheim Pharmaceuticals Inc.
• Defendant: Annora Pharma Private Limited
• Court: United States District Court for the District of Delaware
• Case number: 1:18-cv-01786

What type of infringement theory is typical in this posture?

In Hatch-Waxman cases like this one, the infringement theory generally maps to:

• FDA approval pathway and Orange Book patent listings
• § 271(e)(2) infringement based on the ANDA filing and the certification(s) to listed patents
• A set of asserted patents that may include one or more of:
  • composition-of-matter
  • formulation
  • method-of-use
  • manufacturing or process
  • device, if applicable (less common for ANDAs)

(This analysis depends on the complaint and claim charts. Those documents are not provided here.)

What patents were asserted in 1:18-cv-01786?

Short answer: The asserted patent list is the key driver of case value, but the specific patent numbers, families, priority dates, and claims asserted are not included in the information available in this prompt.

How the asserted patent set affects settlement value

Patent categories typically influence:

• Strength of infringement evidence (composition and formulation patents can be clearer to map)
• Invalidity leverage (method-of-use claims can be harder to knock out on written description or obviousness depending on the record)
• Design-around feasibility (formulations and methods can be easier to tweak than core composition claims)
• Regulatory timing (if patents block the Orange Book listing used for FDA approval, entry is delayed until resolution)

What happened procedurally in Boehringer Ingelheim v. Annora (1:18-cv-01786)?

Short answer: A litigation timeline requires concrete docket dates and order outcomes (Motions to dismiss, claim construction, summary judgment, trial outcomes, and any settlement dismissal). Those docket details are not included in the provided input.

Common procedural milestones that define leverage in Hatch-Waxman suits

In cases like this, business stakeholders typically track:

1. Initial pleadings and ANDA procedural posture
2. Motion to dismiss / venue and jurisdiction
3. Claim construction (Markman)
4. Summary judgment on infringement and/or invalidity
5. Trial or stipulations
6. Settlement and consent judgment
7. Dismissal with or without prejudice depending on the resolution structure

How did the court rule on infringement and validity?

Short answer: The litigation’s practical value depends on rulings. Patentability and noninfringement outcomes are not provided in the available information here.

What outcomes generally move the entry clock

• Validity upheld on asserted claims leads to strong enforcement.
• Noninfringement on key claims can narrow enforcement and enable design-around or future filings.
• Obviousness-type determinations on one family can reduce leverage and drive settlement concessions.
• Claim construction can determine whether the generic product lands in or out of the asserted claims.

Did the parties settle? What settlement terms control generic entry?

Short answer: Settlement terms (which drive the real exclusivity and launch window impact) are not included in the provided prompt.

Settlement terms that usually matter in Hatch-Waxman agreements

When present, stakeholders focus on:

• Effective entry date for the defendant’s product
• Carve-outs (for non-infringing launch, revised formulations, or supply-only arrangements)
• Dismissal structure (dismissal with prejudice vs. without prejudice)
• License scope and ongoing royalties (if any)
• Stipulated judgment terms
• Covenants not to sue covering specific products and patents

What generic entry risks does 1:18-cv-01786 create for other ANDA filers?

Short answer: Litigation against one filer can signal:

• how courts interpret key claim features
• whether the patent family has enforceable scope
• whether other filers face similar claim-mapping risks

But the specific risk cannot be quantified without:

• the asserted patents and claim themes
• court outcomes or settlement terms

How to translate one defendant’s outcome into broader market risk

A strong court ruling or settlement tied to a specific patent set typically increases:

• the expected probability of injunction for other ANDA filers certifying similarly
• the likelihood of other defendants offering similar entry-limiting settlements
• the importance of design-around workstreams for reformulation, process changes, or alternative indications

What is the Orange Book status of the relevant Boehringer patents in this case?

Short answer: Orange Book listing identification requires the FDA record for the exact drug and the asserted patents. The prompt does not include the drug name, NDA/ANDA number, or patent identifiers, so the Orange Book status cannot be stated accurately here.

What to look for in the Orange Book (business controls)

• Patent numbers and expiration dates
• Patent types (drug substance, drug product, method of use)
• Expiration and remaining exclusivity windows
• Certification labels (Paragraph I, II, III, IV; and carve-outs)

How does this litigation compare with other Boehringer Ingelheim patent estates?

Short answer: Comparison requires the specific Boehringer product and patent estate at issue. The prompt does not specify the drug.

Comparison dimensions investors and litigators use

• breadth of asserted family (single patent vs. portfolio)
• typical claim construction outcomes for Boehringer’s chemistry
• frequency and results of ANDA challenges in this family
• history of settlements controlling entry dates

What is the revenue and exclusivity exposure tied to this case?

Short answer: Revenue exposure depends on:

• the drug’s annual sales
• the competitive set (other generics/biosimilars)
• the remaining patent and exclusivity life
• the settlement entry date

Those facts are not provided, and the drug is not identified in the prompt.

How to model impact once the settlement and patent status are known

A standard model uses:

• patent expiry and regulatory exclusivity end dates
• probability of injunction vs. continued litigation vs. settlement
• expected at-risk launch date and erosion curves

What manufacturing/IP barriers are implicated by the litigation?

Short answer: IP barriers depend on whether asserted patents cover:

• composition (harder to design around)
• formulation (often tweakable but regulated)
• method of use (requires label and indication alignment)
• process (requires process similarity and evidence of use)

The specific asserted claims are not present in the provided input.

Key Takeaways

• Case identity: Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited, 1:18-cv-01786 (D. Delaware).
• Business driver: outcomes hinge on the asserted patent set and any settlement or consent terms controlling launch timing.
• Missing actionable inputs in this prompt: the drug/NDA-ANDA linkage, asserted patent numbers, docket rulings, and settlement terms are required to produce a complete litigation summary and enforceability analysis.

FAQs

1) What product is tied to Boehringer Ingelheim v. Annora (1:18-cv-01786)?
Not determinable from the provided input.

2) Which Orange Book patents were certified in the ANDA underlying 1:18-cv-01786?
Not determinable from the provided input.

3) Did the court issue a Markman claim construction order in 1:18-cv-01786?
Not determinable from the provided input.

4) Was there a consent judgment or stipulated dismissal in 1:18-cv-01786 that controlled entry?
Not determinable from the provided input.

5) How does this case affect other ANDA challenges to the same Boehringer Ingelheim product?
Not determinable from the provided input.

References (APA)

1. United States District Court for the District of Delaware. (2018). Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited, Civil Action No. 1:18-cv-01786.