DCT
1:25-cv-00233
Astellas Pharma Inc v. Deva Holding AS
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Astellas Pharma Inc. (Japan), Astellas Ireland Co., Ltd. (Ireland), and Astellas Pharma Global Development, Inc. (Delaware)
- Defendant: Deva Holding A/S (Turkey)
- Plaintiff’s Counsel: McCarter & English, LLP
- Case Identification: 1:25-cv-00233, D. Del., 02/28/2025
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a foreign corporation with sufficient contacts in the United States as a whole, making it subject to personal jurisdiction in the district pursuant to federal law.
- Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Plaintiff’s Myrbetriq® product constitutes an act of infringement of four U.S. patents related to modified-release pharmaceutical formulations.
- Technical Context: The technology concerns extended-release oral tablet formulations for the drug mirabegron, which is used to treat overactive bladder, a prevalent medical condition.
- Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following a Notice Letter, dated January 14, 2025, in which Defendant notified Plaintiff of its ANDA submission containing a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by its proposed generic product. The complaint also notes that a Request for a Certificate of Correction was filed for U.S. Patent No. 12,059,409 to correct a typographical error in a claim.
Case Timeline
| Date | Event |
|---|---|
| 2008-09-30 | Earliest Priority Date for ’780 and ’409 Patents |
| 2010-03-29 | Earliest Priority Date for ’451 and ’189 Patents |
| 2012-06-28 | FDA approves NDA for Myrbetriq® Tablets |
| 2020-11-24 | U.S. Patent No. 10,842,780 Issues |
| 2023-07-25 | U.S. Patent No. 11,707,451 Issues |
| 2024-08-13 | U.S. Patent No. 12,059,409 Issues |
| 2024-09-24 | U.S. Patent No. 12,097,189 Issues |
| 2025-01-14 | Defendant sends ANDA Notice Letter to Plaintiff |
| 2025-02-28 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,842,780 - "Pharmaceutical Composition for Modified Release" (Issued Nov. 24, 2020)
The Invention Explained
- Problem Addressed: The patent’s background section states that in a clinical trial, conventional formulations of the active ingredient, mirabegron, showed that "pharmacokinetic data unexpectedly varied according to the presence or absence of the intake of food" (’780 Patent, col. 6:50-54). This phenomenon, known as a "food effect," can lead to inconsistent drug efficacy and safety profiles.
- The Patented Solution: The invention is a modified-release pharmaceutical composition designed to reduce this food effect by controlling the drug's release rate (’780 Patent, col. 6:1-10). It achieves this by combining the active ingredient in a "sustained release hydrogel-forming formulation" that comprises two key components: a "hydrogel-forming polymer" and a highly water-soluble "additive" that "ensures penetration of water into the pharmaceutical composition" (’780 Patent, Abstract; col. 7:6-14). This combination is designed to create a consistent, slow release of the drug, making its absorption less dependent on whether the patient has eaten.
- Technical Importance: Developing formulations that mitigate the food effect is significant in pharmaceutical science as it can improve patient compliance (by removing dietary restrictions) and lead to more predictable and reliable therapeutic outcomes.
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the ’780 Patent without specifying claims (Compl. ¶73). Independent claim 1 is the broadest composition claim.
- Essential Elements of Independent Claim 1:
- A pharmaceutical composition comprising 10 mg to 200 mg of mirabegron.
- The composition is a sustained release hydrogel-forming formulation.
- The formulation comprises a hydrogel-forming polymer with an average molecular weight of 100,000 to 8,000,000, selected from a specific list including polyethylene oxide and HPMC.
- The formulation also comprises an additive with a water solubility of at least 0.1 g/mL at 20±5° C, selected from a specific list including polyethylene glycol.
- The composition must exhibit a specific dissolution profile: 39% or less release after 1.5 hours and at least 75% release after 7 hours under specified USP test conditions.
U.S. Patent No. 12,059,409 - "Pharmaceutical Composition for Modified Release" (Issued Aug. 13, 2024)
The Invention Explained
- Problem Addressed: Similar to the ’780 Patent, this patent addresses the food effect observed with conventional formulations of mirabegron, which causes undesirable variability in its pharmacokinetic profile (’409 Patent, col. 6:50-54).
- The Patented Solution: The patented solution is a tablet with a modified-release formulation that controls the drug's release rate. The core inventive concept remains a hydrogel-forming formulation comprising a polymer and a highly soluble additive to ensure water penetration and achieve a slow, sustained release of mirabegron (’409 Patent, Abstract). Claim 1 of this patent is more specific than Claim 1 of the ’780 Patent, narrowing the polymer to polyethylene oxide and the additive to polyethylene glycol.
- Technical Importance: This patent appears to claim a specific embodiment of the broader invention disclosed in the ’780 Patent, providing more targeted protection for a particular successful formulation.
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the ’409 Patent (Compl. ¶83). Independent claim 1 is the broadest composition claim.
- Essential Elements of Independent Claim 1:
- A tablet comprising 10 mg to 200 mg of mirabegron.
- The tablet is a sustained release hydrogel-forming formulation.
- The formulation comprises a hydrogel-forming polymer that is specifically polyethylene oxide with an average molecular weight of 200,000 to 7,000,000.
- The formulation comprises an additive that is specifically polyethylene glycol, having a water solubility of at least 0.1 g/mL.
- The tablet must exhibit a specific dissolution profile: 39% or less release after 1.5 hours and at least 75% release after 7 hours under specified USP test conditions.
U.S. Patent No. 11,707,451 - "Pharmaceutical Composition for Modified Release" (Issued July 25, 2023)
- Technology Synopsis: The patent addresses the food effect associated with mirabegron administration (’451 Patent, col. 2:50-59). It claims a method for treating overactive bladder with a reduced food effect by administering a tablet comprising mirabegron in a sustained release formulation that provides a continuous drug release for at least four hours after oral administration (’451 Patent, Abstract).
- Asserted Claims: The complaint generally asserts "one or more claims"; independent claim 1 is a method claim (’451 Patent, col. 45:41-61).
- Accused Features: The complaint alleges that Defendant’s proposed product comprises a sustained release formulation providing continuous drug release for at least four hours and that its label will instruct and encourage healthcare professionals to practice the claimed method of treating overactive bladder (Compl. ¶¶95, 97, 70).
U.S. Patent No. 12,097,189 - "Pharmaceutical Composition for Modified Release" (Issued Sep. 24, 2024)
- Technology Synopsis: This patent also targets the food effect problem with mirabegron by claiming a method of treatment defined by a specific pharmacokinetic outcome (’189 Patent, col. 17:50-59). It claims a method for treating overactive bladder with a reduced food effect by administering a tablet where the reduction is defined as a difference in the rate of decrease of Cmax (maximum plasma concentration) of 10% or more compared to an immediate-release formulation (’189 Patent, Abstract).
- Asserted Claims: The complaint generally asserts "one or more claims"; independent claim 16 is a method claim (’189 Patent, col. 45:1-12).
- Accused Features: The complaint alleges Defendant’s product is a sustained release formulation that achieves the claimed reduction in food effect, including the specified Cmax decrease, and that its label will instruct this infringing use (Compl. ¶¶107-109).
III. The Accused Instrumentality
- Product Identification: The accused products are Defendant Deva’s "mirabegron extended-release oral tablets, 25 mg and 50 mg," for which it submitted ANDA No. 219941 ("Deva ANDA Products") (Compl. ¶6).
- Functionality and Market Context: The complaint alleges that the Deva ANDA Products are generic versions of Plaintiff's Myrbetriq® extended-release tablets and that, to gain FDA approval, they must be bioequivalent to Myrbetriq® (Compl. ¶¶6, 60, 63). The complaint's infringement theory rests on the assertion that to achieve this required bioequivalence and match the Myrbetriq® dissolution profile, Deva must have "copied from the Myrbetriq® Tablets formulation" and will necessarily use a "sustained release hydrogel-forming formulation" with equivalent properties to those claimed in the patents-in-suit (Compl. ¶¶75-76, 85-86). The proposed product label for Deva's ANDA Products is expected to be substantially identical to the Myrbetriq® label, indicating treatment for overactive bladder and that the product can be taken with or without food (Compl. ¶¶66, 68-69). The complaint includes a table from the FDA website outlining the dissolution testing requirements for mirabegron ANDA filers to establish bioequivalence with Myrbetriq® Tablets (Compl. ¶58).
IV. Analysis of Infringement Allegations
’780 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition, comprising 10 mg to 200 mg of...mirabegron... | Defendant's ANDA Products contain either 25 mg or 50 mg of mirabegron in extended-release tablets. | ¶74 | col. 7:15-16 |
| in a sustained release hydrogel-forming formulation... | Defendant's ANDA Products allegedly use a sustained release hydrogel-forming formulation to match the Myrbetriq® dissolution profile for bioequivalence. | ¶76 | col. 7:17-21 |
| comprising a hydrogel-forming polymer having an average molecular weight of 100,000 to 8,000,000... | Defendant's product is alleged to be bioequivalent to Myrbetriq®, which contains polyethylene oxide with an average molecular weight of 200,000 to 7,000,000. | ¶¶44-45, 75 | col. 7:22-29 |
| and an additive having a water solubility of at least 0.1 g/mL at 20±5° C.... | Defendant's product is alleged to be bioequivalent to Myrbetriq®, which contains polyethylene glycol having a water solubility of at least 0.1 g/mL at 20±5° C. | ¶¶44, 46, 75 | col. 10:7-15 |
| wherein a drug dissolution rate...is 39% or less after 1.5 hours, and at least 75% after 7 hours... | Defendant's ANDA Products will have dissolution properties equivalent to Myrbetriq® Tablets, which meet this dissolution profile, in order to establish bioequivalence. | ¶¶48, 76 | col. 8:28-34 |
’409 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A tablet comprising 10 mg to 200 mg of...mirabegron... | Defendant's ANDA Products contain either 25 mg or 50 mg of mirabegron in extended-release tablets. | ¶84 | col. 7:15-16 |
| in a sustained release hydrogel-forming formulation... | Defendant's ANDA Products allegedly use a sustained release hydrogel-forming formulation to match the Myrbetriq® dissolution profile for bioequivalence. | ¶86 | col. 7:17-21 |
| comprising a hydrogel-forming polymer [which] is polyethylene oxide having an average molecular weight of 200,000 to 7,000,000... | Defendant's product is alleged to be bioequivalent to Myrbetriq®, which contains polyethylene oxide with an average molecular weight of 200,000 to 7,000,000. | ¶¶44-45, 85 | col. 7:22-29 |
| and an additive [which] is polyethylene glycol, having a water solubility of at least 0.1 g/mL... | Defendant's product is alleged to be bioequivalent to Myrbetriq®, which contains polyethylene glycol with a water solubility of at least 0.1 g/mL. | ¶¶44, 46, 85 | col. 10:7-15 |
| wherein a drug dissolution rate...is 39% or less after 1.5 hours, and at least 75% after 7 hours... | Defendant's ANDA Products will have dissolution properties equivalent to Myrbetriq® Tablets, which meet this dissolution profile, in order to establish bioequivalence. | ¶¶48, 86 | col. 8:28-34 |
- Identified Points of Contention:
- Technical Questions: A central question is whether achieving bioequivalence with Myrbetriq® requires practicing the claimed invention. The complaint alleges that because Deva must match the reference drug's dissolution profile, it must use the same or an equivalent hydrogel-forming formulation (Compl. ¶¶76, 86). The case may turn on whether a skilled formulator could design a product that is bioequivalent to Myrbetriq® but uses a different technology that falls outside the scope of the asserted claims (e.g., a different polymer, a different type of additive, or a non-hydrogel release mechanism).
- Scope Questions: The analysis will raise the question of how broadly the term "sustained release hydrogel-forming formulation" will be construed. The dispute may focus on whether this term is limited to the two-component (polymer plus specific additive) structure described in the patent or if it can read on other formulations that form a hydrogel to achieve sustained release.
V. Key Claim Terms for Construction
- The Term: "sustained release hydrogel-forming formulation"
- Context and Importance: This term appears in the preamble of the asserted composition claims and is foundational to the patents' description of the invention. Its construction will be critical because it defines the type of drug delivery system covered by the patents. The dispute will likely center on whether Defendant's formulation, once revealed, falls within the scope of this term.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patents state the invention relates to a composition where an active ingredient is combined with "specific ingredients to control a releasing rate" (’780 Patent, col. 6:3-6). This could support an interpretation covering any formulation that uses specific ingredients to form a hydrogel for sustained release.
- Evidence for a Narrower Interpretation: The patents consistently describe the solution as comprising a combination of "(2) at least one additive which ensures penetration of water...and (3) a hydrogel-forming polymer" (’780 Patent, col. 7:8-14). This language may support a narrower construction requiring the presence of both a distinct polymer and a distinct, highly soluble additive, as opposed to a single-excipient system or a different mechanism.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all four patents-in-suit. The allegations are based on the contention that Defendant's product label will instruct physicians and patients to administer the tablets for the treatment of overactive bladder, which will directly infringe the asserted method claims (Compl. ¶¶78, 97, 109). The complaint further alleges that the Deva ANDA Products are a material part of the claimed invention and are not staple articles of commerce suitable for substantial non-infringing use, forming the basis for contributory infringement (Compl. ¶¶79, 98, 110).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical necessity versus design choice: must the Defendant’s generic product, in order to be bioequivalent to Myrbetriq®, necessarily embody the specific combination of a hydrogel-forming polymer and a highly soluble additive as defined in the composition claims, or could bioequivalence be achieved through an alternative, non-infringing formulation?
- A key evidentiary question will be one of functional definition: for the method claims, does the act of administering a bioequivalent generic product inherently result in the claimed "reduced food effect" (as defined by a Cmax decrease of 10% or more in the ’189 Patent) and "continuous drug release for at least 4 hours" (as claimed in the ’451 Patent), or is there a functional distinction in how the generic product achieves its pharmacokinetic profile?