DCT
1:24-cv-00622
Pfizer Inc v. Aurobindo Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Pfizer Inc. (Delaware) and Pfizer Ireland Pharmaceuticals (Ireland)
- Defendant: Aurobindo Pharma Limited (India), Aurobindo Pharma U.S.A., Inc. (Delaware), and Apitoria Pharma Private Limited (India)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; White & Case LLP
- Case Identification: Pfizer Inc. v. Aurobindo Pharma Ltd., 1:24-cv-00622, D. Del., 05/23/2024
- Venue Allegations: Venue is alleged to be proper for Aurobindo Pharma and Apitoria as non-U.S. residents, and for Aurobindo USA based on its incorporation in Delaware.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Pfizer's NURTEC ODT® (rimegepant sulfate) constitutes an act of infringement of a patent directed to fast-dispersing pharmaceutical compositions.
- Technical Context: The technology concerns oral drug delivery formulations, specifically orally disintegrating tablets (ODTs) designed to provide rapid relief for conditions like migraine.
- Key Procedural History: This action arises under the Hatch-Waxman Act, initiated after Defendants provided Pfizer with a Paragraph IV Notice Letter on April 17, 2024, asserting that their proposed generic product would not infringe the patent-in-suit. The patent is subject to a terminal disclaimer.
Case Timeline
| Date | Event |
|---|---|
| 2018-03-25 | U.S. Patent No. 11,083,724 Priority Date |
| 2021-08-10 | U.S. Patent No. 11,083,724 Issue Date |
| 2024-04-17 | Defendants' Paragraph IV Notice Letter to Plaintiff |
| 2024-05-23 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 11,083,724, "Rimegepant for CGRP Related Disorders," issued August 10, 2021.
The Invention Explained
- Problem Addressed: The patent background describes a "significant unmet medical need" for migraine treatments. (’724 Patent, col. 2:50-53). It notes that triptans, a common treatment, have limitations such as incomplete efficacy and are contraindicated in patients with cardiovascular disease due to vasoconstriction risks. (’724 Patent, col. 2:38-50).
- The Patented Solution: The patent claims a pharmaceutical composition with a CGRP receptor antagonist, such as rimegepant, formulated as an "oral solid molded fast-dispersing dosage form." (’724 Patent, col. 27:26-31). This formulation is designed to disintegrate rapidly in the mouth (e.g., within 1 to 10 seconds) upon contact with saliva, which is advantageous for migraine patients who may suffer from nausea. (’724 Patent, col. 10:1-8). The use of a CGRP antagonist avoids the cardiovascular side effects associated with triptans.
- Technical Importance: This technology offers a method of delivering a new class of migraine drugs (CGRP antagonists) in a rapid-delivery format suitable for patients with cardiovascular conditions for whom older treatments were unsafe. (’724 Patent, col. 2:46-53).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, with a specific example citing independent claim 1. (Compl. ¶¶ 35, 38).
- Independent Claim 1 requires:
- A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a CGRP receptor antagonist, or a pharmaceutically acceptable salt thereof,
- wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form.
- The complaint’s general allegation suggests the right to assert other claims, including dependent claims, is preserved.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the proposed generic rimegepant orally disintegrating tablet described in Defendants’ Abbreviated New Drug Application (ANDA) No. 219328. (Compl. ¶¶ 1, 12).
Functionality and Market Context
- The complaint alleges that the "Aurobindo ANDA Product" is a generic copy of Pfizer's NURTEC ODT® and relies on Pfizer's New Drug Application for approval, purporting to be bioequivalent. (Compl. ¶¶ 14-15).
- The product is alleged to contain "rimegepant sulfate," which is a salt of the CGRP receptor antagonist rimegepant. (Compl. ¶ 39).
- Critically, the product is alleged to be in "a form of an oral solid molded fast-dispersing dosage form." (Compl. ¶ 39). As a generic entrant, the product would compete directly with Pfizer's branded drug upon potential FDA approval and market launch.
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'724 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a CGRP receptor antagonist, or a pharmaceutically acceptable salt thereof... | Aurobindo’s ANDA Product is alleged to contain "a pharmaceutical composition comprising a therapeutically effective amount of rimegepant sulfate, which is a pharmaceutically acceptable salt of the CGRP receptor antagonist rimegepant." | ¶39 | col. 8:40-49 |
| ...wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form. | The pharmaceutical composition of Aurobindo’s ANDA Product is alleged to be "in a form of an oral solid molded fast-dispersing dosage form." | ¶39 | col. 10:1-8 |
- Identified Points of Contention:
- Scope Questions: A central dispute may concern the meaning of "molded." The complaint's allegation that Aurobindo's product is "molded" is made on information and belief. The question for the court will be whether the manufacturing process described in Aurobindo's confidential ANDA filing results in a dosage form that falls within the scope of the term "molded" as used in the patent.
- Technical Questions: Does the manufacturing process for Aurobindo's product create the specific physical structure implied by the patent's disclosure? The ’724 patent describes a process of subliming a solvent from a composition held within a mold (i.e., freeze-drying), which creates the fast-dispersing network. (col. 10:11-26). The infringement analysis will depend on whether Aurobindo's process is the same or equivalent.
V. Key Claim Terms for Construction
- The Term: "oral solid molded fast-dispersing dosage form"
- Context and Importance: Practitioners may focus on this term because its construction will likely be dispositive of infringement. The term "molded" appears to be the key feature distinguishing the claimed invention from other fast-dissolving tablets that might be made by different methods, such as direct compression. The case will likely turn on whether Aurobindo's manufacturing process, as detailed in its ANDA, creates a "molded" form.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party seeking a broader interpretation might argue that "molded" is not explicitly defined and should be given its plain and ordinary meaning, covering any process that imparts a shape to the final tablet.
- Evidence for a Narrower Interpretation: The patent specification provides strong evidence for a narrower meaning tied to a specific manufacturing process. It states the dosage form's network is "obtained by subliming solvent from a composition in the solid state," and that the "composition can be contained in a mold during the freeze-drying process to produce a solid form in any desired shape." (’724 Patent, col. 10:11-26). The patent also incorporates by reference a U.K. patent that describes this specific lyophilization process, further anchoring the term to this technology. (’724 Patent, col. 10:17-19).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants' commercial manufacture and sale of the ANDA product would induce and contribute to infringement. (Compl. ¶ 37). This is based on allegations that Defendants know the product is "especially made or adapted for use in infringing" the patent and has no substantial non-infringing use, and that they will specifically intend infringement through their marketing and labeling. (Compl. ¶¶ 40-42).
- Willful Infringement: Willfulness is alleged based on Defendants' "full knowledge of the '724 patent" prior to the lawsuit, as evidenced by their April 17, 2024 Paragraph IV Notice Letter, and their continued intent to market the product notwithstanding that knowledge. (Compl. ¶¶ 16, 40).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim construction: How will the court define the term "oral solid molded fast-dispersing dosage form"? The resolution will depend on whether the court finds the term is limited to the specific lyophilization-in-a-mold process detailed in the patent's specification or if it can encompass other manufacturing methods for orally disintegrating tablets.
- A key evidentiary question will be one of factual infringement: Based on the confidential details in ANDA No. 219328, does the manufacturing process for Aurobindo's proposed generic rimegepant product fall within the court's construction of the term "molded"? The answer to this question will likely determine the outcome of the case.