DCT
1:17-cv-00728
Noden Pharma DAC v. Anchen Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Noden Pharma DAC (Ireland)
- Defendant: Anchen Pharmaceuticals, Inc. (Delaware); Par Pharmaceutical, Inc. (Delaware)
- Plaintiff’s Counsel: McCarter & English, LLP; Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
- Case Identification: 1:17-cv-00728, D. Del., 06/12/2017
- Venue Allegations: Venue is asserted based on both Defendants being incorporated in Delaware and allegedly conducting systematic and continuous business within the state.
- Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's TEKTURNA® hypertension drug constitutes an act of infringement of a patent covering a high-concentration formulation of the drug aliskiren.
- Technical Context: The lawsuit concerns "galenic" formulations, a field of pharmaceutics focused on preparing and compounding medicines to create stable, effective, and manufacturable dosage forms.
- Key Procedural History: This is a Hatch-Waxman action initiated in response to a Notice Letter and Paragraph IV certification from Defendant Anchen, dated April 28, 2017, which asserted that the patent-in-suit is invalid, unenforceable, or will not be infringed by its proposed generic product. The complaint was filed within the 45-day statutory window, triggering a 30-month stay of FDA approval for the Defendants' ANDA.
Case Timeline
| Date | Event |
|---|---|
| 2004-03-17 | ’595 Patent Priority Date |
| 2013-12-31 | ’595 Patent Issue Date |
| 2017-04-28 | Date of Defendants' ANDA Notice Letter to Plaintiff |
| 2017-06-12 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,617,595 - "Galenic Formulations of Organic Compounds"
- Patent Issued: December 31, 2013
The Invention Explained
- Problem Addressed: The patent's background section describes the active ingredient, aliskiren, as being difficult to formulate into tablets ('595 Patent, col. 2:1-3). Its physical properties—such as a needle-shaped crystal habit, poor compression behavior, high hygroscopicity, and potential for polymorphism changes in the presence of water—make creating a robust, high-dose tablet challenging ('595 Patent, col. 2:7-26). Specifically, the specification notes that tablets with a drug load higher than approximately 35% were previously found not to be robust ('595 Patent, col. 2:36-40).
- The Patented Solution: The invention is a solid oral dosage form that solves these problems by enabling a high concentration of aliskiren—specifically, "more than 46% by weight" ('595 Patent, Abstract). This is achieved through a specific combination of excipients arranged in a two-part structure: an "inner phase" containing the active ingredient, and an "outer phase" ('595 Patent, col. 7:55-64). This structure, combined with a manufacturing process that uses organic solvents instead of water for granulation, is described as yielding a stable and robust tablet at high drug loads ('595 Patent, col. 7:35-38).
- Technical Importance: The claimed formulation allows for the creation of a commercially viable solid oral tablet containing a high dose of aliskiren, overcoming significant manufacturing and stability hurdles that previously limited the drug's load in a single tablet ('595 Patent, col. 2:43-48).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 19 and 20 (Compl. ¶23).
- Independent Claim 1 recites a solid oral tablet comprising:
- A therapeutically effective amount of aliskiren in an amount of more than 46% by weight of the total dosage form.
- An "inner phase" comprising aliskiren, microcrystalline cellulose, polyvinylpyrrolidone, and crosslinked polyvinylpyrrolidone.
- An "outer phase" comprising crosslinked polyvinylpyrrolidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.
- Specific weight percentage ranges for each of the non-aliskiren components.
- The complaint reserves the right to assert additional claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the 150 mg and 300 mg "generic aliskiren products" (aliskiren hemifumarate tablets) that are the subject of Defendants' Abbreviated New Drug Application (ANDA) No. 206665 (Compl. ¶1).
Functionality and Market Context
- The complaint alleges that by filing the ANDA, Defendants have represented to the FDA that their generic products have the same active ingredient, method of administration, dosage form, and strengths as Plaintiff's branded drug, TEKTURNA®, and are bioequivalent to it (Compl. ¶18). The purpose of the ANDA is to gain FDA approval to commercially manufacture and sell these tablets in the United States as a generic alternative to TEKTURNA® for the treatment of hypertension (Compl. ¶1, ¶17). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a detailed element-by-element infringement analysis. The central allegation is that because Defendants' ANDA product is a generic version of TEKTURNA® and is represented as bioequivalent, it will necessarily infringe the claims of the '595 patent upon manufacture and sale (Compl. ¶18, ¶23).
’595 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A solid oral dosage form comprising a therapeutically effective amount of aliskiren...in an amount of more than 46% by weight based on the total weight of the oral dosage form... | The complaint alleges the ANDA product, as a generic version of TEKTURNA®, will contain aliskiren in an amount greater than 46% by weight. | ¶18, ¶23 | col. 11:50-54 |
| wherein the oral dosage form is in the form of a tablet and comprises a) an inner phase which is comprising aliskiren...microcrystalline cellulose, polyvinylpyrrolidone, and crosslinked polyvinylpyrrolidone... | The complaint alleges on information and belief that the ANDA product will have the claimed inner phase structure and composition. | ¶23 | col. 11:55-60 |
| and b) an outer phase which is comprising crosslinked polyvinylpyrrolidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate... | The complaint alleges on information and belief that the ANDA product will have the claimed outer phase structure and composition. | ¶23 | col. 11:61-65 |
| wherein the amount of microcrystalline cellulose in the dosage form ranges from 20 to 32% by weight... | The complaint alleges on information and belief that the ANDA product will meet the claimed weight percentage for microcrystalline cellulose. | ¶23 | col. 12:1-3 |
| the amount of crosslinked polyvinylpyrrolidone in the dosage form ranges from 13.5 to 16% by weight... | The complaint alleges on information and belief that the ANDA product will meet the claimed weight percentage for crosslinked polyvinylpyrrolidone. | ¶23 | col. 12:3-5 |
| the amount of polyvinylpyrrolidone in the dosage form ranges from 3 to 4% by weight... | The complaint alleges on information and belief that the ANDA product will meet the claimed weight percentage for polyvinylpyrrolidone. | ¶23 | col. 12:5-7 |
| the amount of colloidal silicon dioxide...ranges from 0.4 to 0.6% by weight, and the amount of magnesium stearate...ranges from 0.2 up to 5% by weight. | The complaint alleges on information and belief that the ANDA product will meet the claimed weight percentages for these components. | ¶23 | col. 12:7-12 |
- Identified Points of Contention:
- Technical Questions: A primary question for discovery will be factual: does the specific formulation detailed in the confidential sections of ANDA No. 206665 actually meet all the structural ("inner phase"/"outer phase") and compositional (specific weight percentages) limitations of Claim 1? The complaint pleads this on "information and belief," and the accuracy of that belief will be central to the direct infringement case for Claim 1.
- Scope Questions: The dispute may turn on the definition of the tablet's structure. Does the Defendants' manufacturing process for its generic tablet create the distinct "inner phase" and "outer phase" as contemplated by the patent, or is there a legally significant difference in the structure or method of manufacture?
V. Key Claim Terms for Construction
- The Term: "inner phase" / "outer phase"
- Context and Importance: These terms define the core structure of the claimed tablet. Infringement of Claim 1 hinges on whether the accused generic product can be shown to possess this specific two-phase structure. Practitioners may focus on these terms because their construction could determine whether the manufacturing process is integral to the definition of the final product.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the terms should be given their plain meaning, referring simply to the location of components, without importing process limitations. Claim 1 itself is a composition claim that lists the components "comprising" each phase, which a defendant might argue does not require a specific method of creation (Compl. ¶23; ’595 Patent, col. 11:56-65).
- Evidence for a Narrower Interpretation: A party could argue that the specification gives these terms a specific meaning tied to the manufacturing process. The patent repeatedly describes a process where "inner phase excipients" are first granulated and dried, and then mixed with "outer phase" components before compression ('595 Patent, col. 7:55-8:8). This process is explicitly recited in dependent claim 20, suggesting the phases are defined by their method of formation ('595 Patent, col. 14:1-15).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon FDA approval, Defendants will actively induce and contribute to infringement by others (Compl. ¶24). This allegation appears to be directed at infringement of method-of-use claim 19, where the product's label would instruct physicians and patients to administer the generic drug for treating hypertension, thereby inducing infringement of the patented method.
- Willful Infringement: The complaint does not use the word "willful," but it establishes a basis for future allegations by pleading that Defendants had pre-suit knowledge of the '595 patent. This is evidenced by their sending of the Notice Letter on April 28, 2017, which included a Paragraph IV certification regarding the patent (Compl. ¶16, ¶19).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual correspondence: Following discovery of the confidential ANDA, will the Defendants' proposed generic formulation be found to contain the exact excipients within the specific weight-percentage ranges recited in Claim 1 of the ’595 patent?
- The case may also depend on a question of claim construction and structural definition: Do the terms "inner phase" and "outer phase" merely describe the location of components in a finished tablet, or must they be construed more narrowly to require the specific two-step granulation and mixing process detailed in the patent’s specification and dependent process claims? The answer will determine what evidence is required to prove the accused product has the claimed structure.