Litigation Details for Anacor Pharmaceuticals, Inc. v. Lupin Limited (D. Del. 2018)

Anacor Pharmaceuticals, Inc. v. Lupin Limited (D. Del. 2018)

Docket	1:18-cv-01606	Date Filed	2018-10-17
Court	District Court, D. Delaware	Date Terminated	2020-09-11
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	LUPIN PHARMACEUTICALS, INC.
Patents	7,582,621; 9,549,938; 9,566,289; 9,566,290; 9,572,823
Attorneys	Aryeh N. Feinstein
Firms	Shaw Keller LLP
Link to Docket	External link to docket

Details for Anacor Pharmaceuticals, Inc. v. Lupin Limited (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-10-17				External link to document
2018-10-17	1		of U.S. Patent No. 9,459,938 (“the ’938 patent”); U.S. Patent No. 9,566,289 (“the ’289 patent”); U.S. …. Patent No. 9,566,290 (“the ’290 patent”); and U.S. Patent No. 9,572,823 (“the ’823 patent”). These…the ’938 patent, the ’290 patent, the ’823 patent, or claims 1–5 or 7–15 of the ’289 patent. …the ’938 patent, the ’290 patent, the ’823 patent, or claims 1–5 or 7–15 of the ’289 patent. …the ’289 patent; claims 2, 5–6, 8, and 11–12 of the ’290 patent; and claim 2 of the ’823 patent.	External link to document
2018-10-17	108	Report and Recommendations	An ancestor to the patents-in-suit, U.S. Patent No. 7,582,621 (“the ’621 patent”), also claimed methods…of U.S. Patent Nos. 9,549,938, 9,566,289, 9,566,290, and 9,572,823 (collectively, the “patents-in- suit… While the IPR of the ʼ621 patent was pending, the patents-in-suit were being prosecuted before… the four patents-in-suit in early 2017 (before the PTAB’s IPR decision on the ʼ621 patent). Anacor listed…review of the patents-in-suit. The PTAB instituted review of all claims of all four patents-in-suit in	External link to document
2018-10-17	4		Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,459,938 B2; 9,566,289 B2; 9,566,290… 11 September 2020 1:18-cv-01606 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-10-17	97	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,459,938 B2; 9,566,289 B2; 9,566,290… 11 September 2020 1:18-cv-01606 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation Summary and Analysis: Anacor Pharmaceuticals, Inc. v. Lupin Limited | 1:18-cv-01606

Last updated: February 24, 2026

What Are the Key Details of the Case?

The case involves patent infringement claims brought by Anacor Pharmaceuticals, Inc. against Lupin Limited. The dispute centers on Lupin’s alleged unauthorized production and sale of a drug that infringes on Anacor's patent rights.

Case Overview

• Court: United States District Court for the District of Delaware
• Docket Number: 1:18-cv-01606
• Filing Date: August 30, 2018
• Parties:
  • Plaintiff: Anacor Pharmaceuticals, Inc.
  • Defendant: Lupin Limited

Core Patent and Drug

• Patent in Question: U.S. Patent No. 9,705,364 (granted December 12, 2017)
• Patent Title: "Topical compositions for skin disorders"
• Patent Rights: Claim covers a topical formulation including crisaborole, a phosphodiesterase-4 (PDE4) inhibitor.
• Accused Product: Generic crisaborole formulations marketed by Lupin, intended for treatment of atopic dermatitis.

Timeline

• Patent Filing: Application filed in 2012, granted in December 2017.
• Lupin’s Product Launch: Came after the patent’s issuance, leading to patent infringement allegations.
• Litigation Filed: August 2018.

What Are the Allegations?

Anacor claims Lupin unlawfully infringed on the '364 patent by manufacturing, offering for sale, and selling generic crisaborole products before patent expiration.

Claims:

• Patent infringement under 35 U.S.C. § 271.
• Wilful infringement with potential damages including enhanced damages and attorney’s fees.

Lupin argues that the patent is invalid and/or that their product does not infringe.

What Are the Defense and Counterclaims?

Lupin contends that:

• The patent is invalid due to obviousness, prior art disclosures, or failure to meet patentability requirements.
• No infringement occurred as their formulations differ technically or functionally.
• They have rights to a compulsory license or invalidity defenses under Hatch-Waxman provisions.

How Has the Court Proceeded?

• Summary Judgments: The parties have filed motions for summary judgment on patent validity and infringement status.

• Claim Construction: Key claim terms from the '364 patent have been construed by the court, influencing infringement and validity arguments.

• Expert Testimony: Both parties have presented expert opinions regarding patent scope and prior art references.

What Are the Potential Outcomes?

• Infringement Finding: The court may find Lupin’s product infringes, leading to injunctions and damages.

• Invalidity Ruling: Alternatively, the court may declare the patent invalid, allowing Lupin to market generics freely.

• Settlement: The parties may settle, especially if the court leans toward infringement or invalidity.

• Impact on Market: A ruling favoring Anacor would strengthen patent rights, potentially delaying market entry for Lupin’s generic.

Implications for Stakeholders

• Patent Holders: Reinforces the importance of robust patent prosecution and claim drafting.

• Generic Manufacturers: Highlights the risks of patent challenges, emphasizing the need for thorough patent invalidity strategies.

• Investors: Outcomes could influence stock prices, licensing negotiations, and market share for both entities.

Related Legal Trends

The case reflects broader industry trends:

• Increased litigation over biotech and topical drug patents.
• Tensions between patent rights and ARE (Abbreviated New Drug Application) approvals.
• Patent validity challenges based on obviousness and prior art.

Final Remarks

This case exemplifies typical patent enforcement in the pharmaceutical industry, emphasizing careful patent drafting and clear infringement boundaries. Court decisions will influence on-patent market exclusivity and generic competition trajectories.

Key Takeaways

• The case concerns patent infringement relating to a topical PDE4 inhibitor drug.
• Both parties are litigating validity and infringement, with key procedural rulings pending.
• Outcomes will shape prosecution strategies for similar biotech patents.
• The case underscores the importance of precise claim construction.
• Industry watchers should monitor court rulings for implications on generic patent pathways.

FAQs

1. What is the main legal issue in the case?
The primary issue is whether Lupin’s product infringes Anacor’s patent or if the patent is invalid.

2. What is the potential impact of a ruling in favor of Anacor?
A positive ruling could delay Lupin’s entry into the market with a generic version, maintaining patent-based exclusivity.

3. How might Lupin defend against the infringement claim?
Lupin can challenge the patent's validity or argue non-infringement based on formulation differences.

4. What are the key patent claims at stake?
Claims related to the composition including crisaborole and its formulation specifics.

5. When might a resolution occur?
The case’s procedural schedule indicates a potential resolution within 12-24 months, subject to appeals and settlement negotiations.

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References

1. U.S. Patent and Trademark Office. (2017). Patent No. 9,705,364.
2. District of Delaware. (2018). Complaint filed in Anacor Pharmaceuticals, Inc. v. Lupin Limited. Docket No. 1:18-cv-01606.