Litigation Details for Gilead Sciences, Inc. v. Lupin Ltd. (D. Del. 2022)

Gilead Sciences, Inc. v. Lupin Ltd. (D. Del. 2022)

Docket		Date Filed	2022-05-09
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	None	Referred To
Parties	LAURUS LABS LIMITED
Patents	10,385,067; 10,548,846; 11,744,802; 9,708,342
Attorneys	J. Scott McBride
Firms	Phillips, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for Gilead Sciences, Inc. v. Lupin Ltd. (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-05-09				External link to document
2022-05-09	1	Complaint	expiration of U.S. Patent Nos. 9,708,342, 10,385,067, and 10,548,846 (collectively, “the Patents-In-Suit”). … the ’342 patent and holds title to the ’342 patent. 41. The ’342 patent claims, among…of the ’067 patent and holds title to the ’067 patent. 44. The ’067 patent claims, among…of the ’846 patent and holds title to the ’846 patent. 47. The ’846 patent claims, among…Defendant has infringed the ’342 patent, the ’067 patent, and/or the ’846 patent under 35 U.S.C. § 271(e)(2	External link to document
2022-05-09	3	ANDA Form	Expiration of Patent: U.S. Patent No. 9,708,342: June 19, 2035. U.S. Patent No. 10,385,067: June 19, 2035… Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) …2035. U.S. Patent No. 10,548,846: November 8, 2036.Thirty Month Stay Deadline: 8/7/2025. (srs) (Entered… 9 May 2022 1:22-cv-00615 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2022-05-09	4	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,708,342 B2 ;10,385,067 B2 ;10,548,… 9 May 2022 1:22-cv-00615 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2022-05-09	58	Notice of Service	Invalidity Contentions Regarding U.S. Patent Nos. 10,548,846, 10,385,067 and 9,708,342 filed by Lupin Ltd.… 9 May 2022 1:22-cv-00615 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2022-05-09	167	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,708,342 B2; 10,385,067 B2; 10,548,… 9 May 2022 1:22-cv-00615 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2022-05-09	171	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,708,342 B2; 10,385,067 B2; 10,548,… 9 May 2022 1:22-cv-00615 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Gilead Sciences, Inc. v. Lupin Ltd. et al: A Comprehensive Litigation Summary and Analysis

Case Overview

Gilead Sciences, Inc. has initiated a significant patent infringement lawsuit against Lupin Ltd., Laurus Labs Limited, and Cipla Limited in the U.S. District Court for the District of Delaware. The case, filed on May 9, 2022, and designated as 1:22-cv-00615, revolves around Gilead's efforts to protect its intellectual property rights related to the HIV treatment drug Biktarvy.

Nature of the Suit

The lawsuit is categorized under patent infringement, specifically targeting the defendants' submissions of Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA). Gilead alleges that these generic versions of Biktarvy infringe on its patents, including U.S. Patent No. 11,744,802[2][5].

Parties Involved

• Plaintiff: Gilead Sciences, Inc.
• Defendants: Lupin Ltd., Laurus Labs Limited, and Cipla Limited.

Jurisdiction and Venue

The U.S. District Court for the District of Delaware has jurisdiction over the case, as the defendants have systematic and continuous contacts with the jurisdiction. Specifically, Lupin Ltd. and its affiliates have been shown to conduct significant business in Delaware, including the intention to market, sell, and distribute their generic products in the state[2][3].

Patent Infringement Claims

Gilead's complaint alleges that the defendants' ANDAs for generic versions of Biktarvy, which contains the combination of bictegravir, emtricitabine, and tenofovir alafenamide, infringe on Gilead's patents. The lawsuit highlights that the defendants had actual and constructive notice of Gilead's patents prior to filing their ANDAs[2].

ANDA Filings and FDA Approval

The defendants submitted their ANDAs under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FFDCA), seeking FDA approval to manufacture, import, market, and sell their generic versions of Biktarvy. Gilead's lawsuit was filed within the 45-day period after receiving the defendants' notice letters, which triggers a stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii)[2].

Personal Jurisdiction

The court has personal jurisdiction over the defendants due to their extensive contacts with the state of Delaware. This includes Lupin Ltd.'s intention to market and sell its products in Delaware, its continuous business activities in the state, and its incorporation of subsidiaries in Delaware[2][3].

Venue

Venue is proper in the U.S. District Court for the District of Delaware, as the defendants are subject to the court's personal jurisdiction and have sufficient contacts with the U.S. as a whole. For Lupin Pharmaceuticals, Inc., venue is proper because it is incorporated in this district[3].

Legal Basis

The lawsuit is grounded in the patent laws of the United States, specifically 35 U.S.C. § 271(a)-(c), (e), and 281. Gilead seeks declaratory relief and an injunction to prevent the defendants from infringing on its patents[2][5].

Impact on the Pharmaceutical Industry

This litigation has significant implications for the pharmaceutical industry, particularly in the context of generic drug approvals and patent protection. It highlights the ongoing battles between branded drug manufacturers and generic drug producers over intellectual property rights.

Key Takeaways

• Patent Protection: The case underscores the importance of patent protection for pharmaceutical companies and the legal measures they take to safeguard their intellectual property.
• Generic Drug Approvals: The lawsuit illustrates the complexities surrounding ANDA filings and the potential for litigation when generic drug manufacturers seek to enter the market.
• Jurisdiction and Venue: The court's jurisdiction and venue decisions are crucial in such cases, often hinging on the defendants' business activities and contacts within the jurisdiction.

FAQs

Q: What is the main issue in the Gilead Sciences, Inc. v. Lupin Ltd. et al lawsuit? A: The main issue is Gilead Sciences, Inc.'s allegation that Lupin Ltd., Laurus Labs Limited, and Cipla Limited are infringing on its patents by filing ANDAs for generic versions of the HIV treatment drug Biktarvy.

Q: Which court is handling this case? A: The U.S. District Court for the District of Delaware is handling this case.

Q: What is the significance of the 45-day period in this lawsuit? A: The 45-day period is crucial because Gilead's lawsuit was filed within this timeframe after receiving the defendants' notice letters, which triggers a stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii).

Q: Why does the court have personal jurisdiction over the defendants? A: The court has personal jurisdiction due to the defendants' systematic and continuous contacts with the state of Delaware, including their business activities and intentions to market and sell their products in the state.

Q: What are the potential outcomes of this litigation for the pharmaceutical industry? A: The outcomes could set precedents for patent protection and generic drug approvals, influencing how pharmaceutical companies navigate intellectual property disputes in the future.

Sources:

1. Law360 - Gilead Sciences, Inc. v. Lupin Ltd. et al[1]
2. RPX Insight - Fourth Amended Complaint for Patent Infringement[2]
3. RPX Insight - Complaint for Patent Infringement against Lupin Limited and MSN Laboratories[3]
4. Justia Dockets & Filings - Gilead Sciences, Inc. v. Lupin Ltd. et al[5]