Last updated: February 19, 2026
This document analyzes the patent litigation between Boehringer Ingelheim Pharmaceuticals, Inc. and Lupin Atlantis Holdings SA concerning a formulation of empagliflozin. The core dispute centers on Boehringer's U.S. Patent No. 8,637,500, claiming an oral dosage form of empagliflozin. Lupin Atlantis seeks to market a generic version of Boehringer's Jardiance®.
What are the Patents in Dispute?
The primary patent at issue is U.S. Patent No. 8,637,500 (the '500 patent) owned by Boehringer Ingelheim Pharmaceuticals, Inc. This patent claims "an oral dosage form comprising empagliflozin." Specifically, it claims empagliflozin in an anhydrous crystalline form, often referred to as Form 1 [1]. The patent's priority date is September 27, 2012, and its expiration date is September 10, 2029 [1].
Boehringer also asserts U.S. Patent No. 9,029,390 (the '390 patent) in this litigation. This patent also relates to empagliflozin formulations and has an expiration date of October 21, 2030 [2].
What is the Alleged Infringement?
Lupin Atlantis Holdings SA is alleged to have infringed these patents by seeking to market a generic version of Jardiance®, which contains empagliflozin. Boehringer contends that Lupin's proposed generic product will utilize the empagliflozin active pharmaceutical ingredient (API) in a crystalline form that infringes claims 1, 2, 4, 7, 8, 10, 11, 13, 14, and 15 of the '500 patent [1, 3]. Boehringer also alleges infringement of claims 1, 2, 4, 5, 7, 9, 10, 11, 13, 14, 15, 17, 18, 19, 20, 22, and 23 of the '390 patent [2].
What is the Timeline of the Litigation?
The litigation was initiated on October 12, 2018, when Boehringer Ingelheim Pharmaceuticals, Inc. filed a complaint against Lupin Atlantis Holdings SA in the United States District Court for the District of New Jersey [3]. This filing occurred after Lupin submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Jardiance® [3].
Key dates and events:
- October 12, 2018: Boehringer files suit against Lupin, alleging patent infringement [3].
- June 21, 2021: The District Court issued a Markman order defining the scope of certain patent claims [4].
- September 27, 2023: The District Court granted Boehringer's motion for summary judgment of infringement on the '500 patent, finding Lupin's proposed product infringes claims 1, 13, and 14 [5].
- October 3, 2023: The District Court granted Boehringer's motion for summary judgment of infringement on the '390 patent, finding Lupin's proposed product infringes claims 1, 11, and 17 [6].
- November 1, 2023: A joint stipulation of dismissal with prejudice was filed, indicating a settlement or resolution of the case [7]. The parties agreed to dismiss all claims and counterclaims against each other [7].
What Were the Key Legal Arguments?
Boehringer argued that Lupin's proposed generic empagliflozin formulation would infringe their patents, specifically by utilizing empagliflozin in its anhydrous crystalline form (Form 1) [1, 3]. Boehringer asserted that their patents provided valid and enforceable claims covering this crystalline form and its use in oral dosage forms [1, 2].
Lupin, as is typical in ANDA litigation, likely raised arguments regarding patent invalidity and non-infringement. While specific details of Lupin's defense are not elaborated in public filings concerning summary judgments, common defenses in such cases include:
- Non-infringement: Arguing that the accused product does not fall within the scope of the patent claims.
- Invalidity: Challenging the patent's validity based on prior art, obviousness, or lack of enablement.
The District Court's decisions on summary judgment indicate that Boehringer successfully demonstrated that Lupin's proposed product would infringe specific claims of both the '500 and '390 patents. The court found that Lupin's proposed drug product contained empagliflozin in an anhydrous crystalline form that met the limitations of Boehringer's asserted claims [5, 6].
What Was the Outcome of the District Court Proceedings?
The District Court ruled in favor of Boehringer Ingelheim on motions for summary judgment regarding infringement.
On September 27, 2023, the court granted Boehringer's motion for summary judgment of infringement of U.S. Patent No. 8,637,500. The court found that Lupin's proposed empagliflozin product infringes claims 1, 13, and 14 of the '500 patent [5]. The court concluded that there were no genuine disputes of material fact and that Lupin's proposed product embodied the patented invention [5].
Subsequently, on October 3, 2023, the court granted Boehringer's motion for summary judgment of infringement of U.S. Patent No. 9,029,390. The court determined that Lupin's proposed product infringes claims 1, 11, and 17 of the '390 patent [6]. Similar to the '500 patent ruling, the court found infringement as a matter of law [6].
Was the Case Settled or Appealed?
The litigation was settled. On November 1, 2023, the parties filed a joint stipulation of dismissal with prejudice [7]. This filing indicates that Boehringer Ingelheim Pharmaceuticals, Inc. and Lupin Atlantis Holdings SA reached an agreement to resolve all claims and counterclaims, thereby terminating the lawsuit [7]. The terms of the settlement agreement were not publicly disclosed.
What are the Implications for Generic Entry?
The District Court's rulings finding infringement of key patents would have, absent a settlement, prevented or delayed Lupin's entry into the market with its generic empagliflozin product. The settlement, however, allows for a confidential resolution, which often includes licensing agreements that permit a controlled market entry for the generic manufacturer at a mutually agreed-upon time, potentially after a period of exclusivity for the branded product. This arrangement typically involves royalty payments or other forms of compensation to the patent holder [8].
The specific terms of the settlement, including any delayed entry provisions or licensing arrangements, will dictate the precise timing and nature of Lupin's generic Jardiance® product in the U.S. market. Without public disclosure of the settlement terms, it is speculative to determine the exact date of generic availability or any potential market impact. However, patent settlements in ANDA litigation frequently result in a later generic launch than would occur if the patents were invalidated or found not infringed [8].
Key Takeaways
- Boehringer Ingelheim successfully obtained summary judgment rulings of infringement against Lupin Atlantis Holdings SA for U.S. Patent Nos. 8,637,500 and 9,029,390, covering empagliflozin formulations.
- The District Court found that Lupin's proposed generic empagliflozin product infringed specific claims of both patents.
- The litigation concluded with a joint stipulation of dismissal, indicating a settlement between the parties.
- The terms of the settlement are confidential and will dictate the timing and conditions of Lupin's generic empagliflozin market entry.
Frequently Asked Questions
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What is the active pharmaceutical ingredient at the center of this litigation?
The active pharmaceutical ingredient is empagliflozin, the same as found in Boehringer Ingelheim's branded drug Jardiance®.
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Which specific patents were at issue in the Boehringer Ingelheim v. Lupin Atlantis litigation?
The primary patents were U.S. Patent No. 8,637,500 and U.S. Patent No. 9,029,390, both owned by Boehringer Ingelheim Pharmaceuticals, Inc.
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What was the core dispute regarding the patents?
The dispute centered on whether Lupin Atlantis's proposed generic empagliflozin product would infringe Boehringer Ingelheim's patents, particularly concerning the crystalline form of empagliflozin claimed in the patents.
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Did the court rule on patent validity in this case?
The available public filings focus on summary judgment rulings for infringement. The settlement agreement means that issues of patent validity were not definitively adjudicated by the court in a final judgment and were likely a factor in the settlement negotiations.
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When will generic Jardiance® be available in the U.S. market as a result of this litigation?
The terms of the settlement agreement between Boehringer Ingelheim and Lupin Atlantis are confidential. This agreement likely includes provisions that will determine the exact timing of Lupin's generic market entry.
Citations
[1] United States Patent No. 8,637,500. (2014). Oral dosage form comprising empagliflozin. Retrieved from USPTO Patent Database.
[2] United States Patent No. 9,029,390. (2015). Oral dosage form comprising empagliflozin. Retrieved from USPTO Patent Database.
[3] Boehringer Ingelheim Pharmaceuticals, Inc. v. Lupin Atlantis Holdings SA, No. 3:18-cv-16708 (D.N.J. Oct. 12, 2018).
[4] Boehringer Ingelheim Pharmaceuticals, Inc. v. Lupin Atlantis Holdings SA, No. 3:18-cv-16708 (D.N.J. June 21, 2021). Markman Order.
[5] Boehringer Ingelheim Pharmaceuticals, Inc. v. Lupin Atlantis Holdings SA, No. 3:18-cv-16708 (D.N.J. Sept. 27, 2023). Order Granting Plaintiff’s Motion for Summary Judgment of Infringement of U.S. Patent No. 8,637,500.
[6] Boehringer Ingelheim Pharmaceuticals, Inc. v. Lupin Atlantis Holdings SA, No. 3:18-cv-16708 (D.N.J. Oct. 3, 2023). Order Granting Plaintiff’s Motion for Summary Judgment of Infringement of U.S. Patent No. 9,029,390.
[7] Boehringer Ingelheim Pharmaceuticals, Inc. v. Lupin Atlantis Holdings SA, No. 3:18-cv-16708 (D.N.J. Nov. 1, 2023). Joint Stipulation of Dismissal With Prejudice.
[8] Food and Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs) for Generic Drugs. Retrieved from FDA website.
