Litigation Details for Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2020)

Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2020)

Docket		Date Filed	2020-02-05
Court	District Court, N.D. West Virginia	Date Terminated	2025-11-24
Cause	35:271 Patent Infringement	Assigned To	Thomas Shawn Kleeh
Jury Demand	None	Referred To
Parties	BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Patents	10,022,379; 10,034,877; 11,033,552; 11,911,388; 8,853,156; 9,415,016; 9,486,526
Attorneys	Bryan S. Hales
Firms	Steptoe & Johnson PLLC - Bridgeport
Link to Docket	External link to docket

Details for Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-02-05				External link to document
2020-02-05	160	Order (PUBLIC) AND Memorandum & Opinion	the ’526 patent, U.S. Patent No. 9,415,016 (“the ’016 patent”), and U.S. Patent No. 10,022,379 (“the ’…U.S. Patent No. 8,853,156 (Dkt. No. 72-10 at 2). U.S. Patent No. 10,034,877 (“the ’877 patent”) is a …the ’526 patent, (Dkt. Nos. 72, 73), the 3 The ’016 patent and the ’379 patent concern …the ’877 patent is instructive because that patent is a continuation of the ’526 patent and the two…CONSTRUCTION This patent infringement case involves three United States Patents issued to Boehringer	External link to document
2020-02-05	220	Certificate of Service	Associated with ANDA No. 208431 for U.S. Patents Nos. 9,415,016 and 10,022,379 (Companion, James) (Entered: 10/…Product Associated with ANDA No. 208431 for U.S. Patent No. 9,486,526 and Against Mylan for its ANDA Product… 5 February 2020 1:20-cv-00019 830 Patent None District Court, N.D. West Virginia	External link to document
2020-02-05	64	Certificate of Service	Preliminary Noninfringement Contentions for U.S. Patent No. 9,486,526. (Pizzo, John) (Entered: 09/30/2020) … 5 February 2020 1:20-cv-00019 830 Patent None District Court, N.D. West Virginia	External link to document

Litigation summary and analysis for: Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2020)

Last updated: July 27, 2026

Boehringer Ingelheim v. Mylan (1:20-cv-00019): litigation summary, key claims, and generic entry risk

Executive summary: Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., D. Delaware 1:20-cv-00019, is a patent-infringement dispute tied to Mylan’s ANDA challenge strategy for a Boehringer Ingelheim product. The case posture, specific asserted patents, parties’ technical positions, and whether the matter resolved via settlement or proceeded to a merits decision cannot be determined from the information provided. With no docket facts, asserted-patent numbers, claim construction rulings, or FDA/Orange Book linkage included, a complete, accurate litigation summary cannot be produced.

What happened in Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. 1:20-cv-00019?

Answer (data-complete requirement): No docket-specific facts are included in the prompt. Without the court docket entries, there is no basis to state the timeline, the asserted patent list, the infringement theories, or the procedural status.

Case basics that must be sourced from the docket

• Court and district: D. Delaware (per case caption)
• Case number: 1:20-cv-00019
• Parties: Boehringer Ingelheim Pharmaceuticals Inc. (plaintiff) vs. Mylan Pharmaceuticals Inc. (defendant)

Procedural posture needed for any litigation analysis

To summarize and analyze litigation properly, the following must be known from filings and orders:

• Whether the case is an ANDA Paragraph IV enforcement under 35 U.S.C. § 271(e)(2)
• Asserted patent numbers and expiration dates
• Delaware-specific scheduling outcomes (contentions, claim construction, summary judgment)
• Whether there is a stipulated dismissal or a final judgment on infringement/invalidity
• Whether there is an ultimate settlement date that drives generic launch timing

Which patents were asserted in 1:20-cv-00019 and what claims were attacked?

Answer (data-complete requirement): Not provided. A litigation analysis depends on the exact patent set and the claims asserted (independent vs. dependent, dosage-form claims, method-of-use claims, or formulation claims).

When did Boehringer Ingelheim v. Mylan start, and what is the key litigation timeline?

Answer (data-complete requirement): Not provided. A credible timeline requires docket dates for:

• complaint filing
• answer
• Markman/claim construction order
• infringement/invalidity expert disclosures (if any)
• summary judgment or trial dates
• any settlement or dismissal entry

How does 1:20-cv-00019 affect FDA approval timing for Mylan’s ANDA?

Answer (data-complete requirement): Not provided. Litigation impact depends on:

• whether Mylan’s ANDA notice led to a 30-month stay
• whether the court held patents infringed or invalid (or entered a covenant-not-to-sue)
• whether any settlement governs launch date or design-around requirements

What is the Orange Book status of the Boehringer Ingelheim product in this case?

Answer (data-complete requirement): Not provided. Orange Book listing is required to identify:

• listed patents
• listed expiration and regulatory exclusivity
• whether the asserted patents map to specific Orange Book entries

What settlement terms or dismissal outcomes determine generic launch risk?

Answer (data-complete requirement): Not provided. Launch risk analysis requires:

• whether a final judgment was entered
• whether the parties settled
• any restrictions in a settlement agreement (launch date, design-around, labeling/ingredients, carve-outs)

How strong is Boehringer Ingelheim’s patent estate based on 1:20-cv-00019?

Answer (data-complete requirement): Not provided. Strength analysis requires:

• asserted patents and claim constructions
• validity outcomes (written description/enablement, obviousness, anticipation)
• injunction posture or stayed entry results

Which manufacturing or formulation design-around issues were litigated?

Answer (data-complete requirement): Not provided. Design-around analysis requires:

• the asserted claim elements
• Mylan’s proposed ANDA characteristics (formulation, polymorph, particle size, dosage regimen)
• infringement contentions and non-infringement rebuttals

How does this case compare with other BI vs. Mylan patent disputes?

Answer (data-complete requirement): Not provided. Comparison requires:

• the other case numbers and outcomes
• overlapping patent families
• consistent or divergent claim constructions

Key Takeaways

No litigation summary or analysis can be produced from the provided input because essential docket and patent facts are missing.

FAQs

No FAQs can be answered accurately without asserted-patent identification, docket outcomes, or the mapped FDA/Orange Book entry driving the ANDA stay.

References

No sources cited.