Litigation Details for Gilead Sciences, Inc. v. Lupin Limited (D. Del. 2021)

Gilead Sciences, Inc. v. Lupin Limited (D. Del. 2021)

Docket		Date Filed	2021-11-16
Court	District Court, D. Delaware	Date Terminated	2025-02-18
Cause	35:1 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	None	Referred To
Parties	MSN LIFE SCIENCES PRIVATE LTD.
Patents	10,039,718; 10,786,518
Attorneys	Irena Royzman
Firms	Phillips, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for Gilead Sciences, Inc. v. Lupin Limited (D. Del. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-11-16				External link to document
2021-11-16	1	Complaint	U.S. Patent No. 10,039,718 (the “’718 patent”) and U.S. Patent No. 10,786,518 (the “’518 patent”) (together…Orange Book Patents- In-Suit”), and U.S. Patent No. 8,497,396 (the “’396 patent”) and U.S. Patent No. 9,428,473…“’473 patent”) (together, the “Process Patents-In-Suit”) (all patents collectively, the “Patents-In- …the expiration of the ’718 patent, ’518 patent, ’396 patent and ’473 patent (including such actions by… infringement of the ’718 patent, ’518 patent, ’396 patent and ’473 patent under 35 U.S.C. §§ 271 (a)	External link to document
2021-11-16	141	Notice of Service	Invalidity Contentions Regarding U.S. Patent No. 10,039,718 (the 718 Patent) filed by Lupin Limited, Lupin Pharmaceuticals…16 November 2021 1:21-cv-01621 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2021-11-16	149	Notice of Service	Daniel R. Kuritzkes, M.D. Regarding U.S. Patent No. 10,039,718, (5) Opening Expert Report of Leah Appel…Appel, Ph.D., Regarding Validity of U.S. Patent No. 10,039,718 filed by Gilead Sciences Ireland UC, Gilead… Kuritzkes, M.D. Regarding Infringement of U.S. Patent No. 10,786,518 and Objective Indicia of Non-obviousness…Regarding Objective Indicia of Nonobviousness of U.S. Patent No. 10,786,518, (3) Expert Report of Gregory K.…16 November 2021 1:21-cv-01621 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2021-11-16	150	Notice of Service	.D., Sc. Regarding the Validity of U.S. Patent No. 10,039,718 filed by Lupin Limited, Lupin Pharmaceuticals…Lynne Thio, M.D. Regarding the Validity of U.S. Patent No. 10,786,518, the [CONFIDENTIAL] Expert Report…. Regarding the Enablement of Prior Art to U.S. Patent No. 10,786,518, and the [CONFIDENTIAL] Expert report…16 November 2021 1:21-cv-01621 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2021-11-16	180	Notice of Service	Expert Report of Leah Appel, Ph.D., Regarding U.S. 10,039,718; (2) Rebuttal Expert Report of Dr. Daniel R. …. Kuritzkes, M.D. Regarding Validity of U.S. Patent No. 10,786,518; and (3) Rebuttal Expert Report of …Williams III, Ph.D., Regarding the Validity of U.S. Patent No. 10,786,518 filed by Gilead Sciences Ireland…16 November 2021 1:21-cv-01621 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2021-11-16	181	Notice of Service	Regarding Secondary Considerations of US Patent 10,039,718; [CONFIDENTIAL] Rebuttal Report of Graham …Buckton Regarding Secondary Considerations of US Patent 10,786,518; [CONFIDENTIAL] Rebuttal Expert Report…Infringement and Secondary Considerations of US Patent 10,786,518 filed by Lupin Limited, Lupin Pharmaceuticals…16 November 2021 1:21-cv-01621 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Gilead Sciences, Inc. v. Lupin Limited: A Comprehensive Litigation Summary and Analysis

Background of the Litigation

The litigation between Gilead Sciences, Inc. and Lupin Limited, among other generic drug manufacturers, revolves around patent infringement claims related to several of Gilead's pharmaceutical products. Here, we focus on the specific case filed in the Delaware District Court, case number 1:21-cv-01621.

Nature of the Action

This lawsuit is an action for patent infringement under the U.S. patent laws, specifically targeting Lupin Limited and other defendants for submitting Abbreviated New Drug Applications (ANDAs) to the FDA. These ANDAs seek approval to market generic versions of Gilead's patented medications before the expiration of Gilead's patents[3][4].

Specific Medications and Patents Involved

The litigation involves Gilead's medications such as Descovy, Vemlidy, and Odefsey, which are used to treat HIV infections. The patents-in-suit include U.S. Patent Nos. 7,390,791; 8,754,065; and 9,296,769. These patents are crucial for Gilead's intellectual property protection and are central to the dispute[5].

Defendants and Their Actions

Lupin Limited, along with other defendants such as Apotex Inc., Cipla Ltd., MacLeods Pharmaceuticals Ltd., and Hetero Labs Ltd., filed ANDAs with the FDA to market generic versions of Gilead's medications. This action prompted Gilead to file a patent infringement lawsuit, alleging that the generic versions would infringe on their patents if approved and marketed before the patents' expiration[3][5].

Jurisdiction and Venue

The lawsuit was filed in the U.S. District Court for the District of Delaware. The court's jurisdiction over Lupin Limited, a foreign corporation, is established under 28 U.S.C. § 1391(c)(3), as Lupin has substantial contacts with the state of Delaware, including intentions to market and sell the generic products in Delaware[3].

Settlement and Outcome

On the eve of a scheduled bench trial, Gilead Sciences, Inc. settled the patent infringement lawsuit with the generic-drug makers. The settlement agreement allows the generic manufacturers to receive non-exclusive licenses to Gilead's patents for Descovy and Vemlidy starting October 31, 2031, and for Odefsey starting January 31, 2032. This effectively delays the release of generic alternatives until at least 2031. Both parties agreed to cover their own court costs and attorney fees[5].

Legal and Business Implications

The settlement has significant implications for both Gilead and the generic-drug manufacturers. For Gilead, it extends the exclusivity period for its patented medications, allowing the company to maintain market dominance and revenue streams for several more years. For the generic manufacturers, it provides a clear timeline for when they can enter the market with their generic versions, which can help in planning and resource allocation[5].

Industry Impact

This litigation and its outcome reflect the broader landscape of pharmaceutical patent disputes. It highlights the importance of patent protection for innovator companies like Gilead and the strategies generic manufacturers employ to enter the market. The delayed entry of generics can impact patient access to affordable medications, but it also ensures that innovator companies can recoup their investment in research and development[5].

Key Takeaways

• Patent Protection: The case underscores the critical role of patent protection in the pharmaceutical industry.
• Generic Entry: The settlement delays the entry of generic versions, impacting both the innovator company's revenue and patient access to affordable medications.
• Legal Strategies: The litigation demonstrates the legal strategies employed by both innovator and generic drug manufacturers to protect and challenge patents.
• Market Impact: The outcome affects the market dynamics, allowing Gilead to maintain exclusivity while providing a timeline for generic entry.

FAQs

Q: What medications are involved in the Gilead Sciences, Inc. v. Lupin Limited litigation?

A: The medications involved are Descovy, Vemlidy, and Odefsey, which are used to treat HIV infections.

Q: What is the nature of the lawsuit filed by Gilead Sciences?

A: The lawsuit is for patent infringement, alleging that Lupin Limited and other defendants' ANDAs would infringe on Gilead's patents if approved and marketed before the patents' expiration.

Q: Why was the lawsuit filed in the Delaware District Court?

A: The court has jurisdiction over Lupin Limited due to its substantial contacts with the state of Delaware, including intentions to market and sell the generic products there.

Q: What was the outcome of the litigation?

A: The parties settled on the eve of the bench trial, allowing generic manufacturers to receive non-exclusive licenses to Gilead's patents starting in 2031 and 2032.

Q: How does this settlement impact the pharmaceutical industry?

A: It extends Gilead's exclusivity period, delays generic entry, and affects patient access to affordable medications while ensuring innovator companies can recoup their R&D investments.

Cited Sources

1. Gilead Sciences Files Patent Infringement Lawsuit Against Lupin Limited - Gilead Sciences, Inc.
2. LegalMetric Individual Judge Report - LegalMetric
3. Gilead Sciences, Inc. et al v. Lupin Limited et al - RPX Insight
4. Gilead Sciences, Inc. et al v. Lupin Limited et al - Justia Dockets
5. Gilead Settles HIV Drugs Patent Suit on Eve of Bench Trial - Law360