DCT
1:17-cv-01840
Shire Development LLC v. Rhodes Pharma LP
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Shire Development LLC (Delaware), Shire LLC (Kentucky), and Shire US Inc. (New Jersey)
- Defendant: Rhodes Pharmaceuticals L.P. (Delaware)
- Plaintiff’s Counsel: Richards, Layton & Finger, PA; Haug Partners LLP
- Case Identification: 1:17-cv-01840, D. Del., 12/21/2017
- Venue Allegations: Venue is alleged to be proper based on Defendant's incorporation as a Delaware limited partnership and its purposeful direction of activities toward the state, including the anticipated marketing, distribution, and sale of the accused product within Delaware.
- Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of ADDERALL XR® constitutes an act of infringement of two patents covering a pulsed-dose drug delivery system.
- Technical Context: The technology concerns oral extended-release formulations for mixed amphetamine salts, primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), which allow for a single daily dose to provide therapeutic effects over a full day.
- Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendant's filing of ANDA No. 210651 with a "Paragraph IV" certification. This certification asserts that the patents-in-suit are invalid or will not be infringed by the proposed generic product. The complaint states that Plaintiffs received a "Notice Letter" from the Defendant on November 9, 2017, and alleges this letter did not contain invalidity or unenforceability contentions. The patents-in-suit are listed in the FDA's "Orange Book" as covering the branded drug ADDERALL XR®.
Case Timeline
| Date | Event |
|---|---|
| 1998-10-21 | Priority Date for ’148 and ’096 Patents |
| 2001-10-11 | FDA Approval for certain strengths of ADDERALL XR® |
| 2002-05-22 | FDA Approval for additional strengths of ADDERALL XR® |
| 2010-02-23 | U.S. Patent No. RE41,148 Issued |
| 2011-02-01 | U.S. Patent No. RE42,096 Issued |
| 2017-11-09 | Plaintiff receives Defendant's Paragraph IV Notice Letter |
| 2017-12-21 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Reissue Patent No. RE41,148 - "Oral Pulsed Dose Drug Delivery System"
The Invention Explained
- Problem Addressed: The patent describes the inconvenience and potential for non-compliance associated with multi-dose daily drug regimens, particularly for children with ADHD who may need a second dose of amphetamine salts administered during the school day, 4-6 hours after the morning dose (’148 Patent, col. 3:17-30).
- The Patented Solution: The invention is a single oral dosage form containing a "multiple unit pulsed dose" system. This system combines an immediate-release component for initial therapeutic effect with a delayed-release component that releases a second pulse of the drug after a predetermined time lag (’148 Patent, Abstract; col. 3:34-40). This design aims to replicate the plasma concentration profile of taking two separate pills hours apart, as illustrated in the patent's target profile figure (’148 Patent, Fig. 1).
- Technical Importance: This technology sought to improve patient adherence and convenience by consolidating a twice-daily regimen into a single, once-daily capsule, a significant practical benefit for long-term treatment of conditions like ADHD (’148 Patent, col. 3:20-30).
Key Claims at a Glance
- The complaint does not identify specific asserted claims, alleging infringement of "one or more claims" of the patent (’148 Patent, Compl. ¶32). Independent claim 1 is representative of the formulation technology.
- Essential elements of independent claim 1 include:
- A pharmaceutical formulation for delivering a mixture of four specific amphetamine base salts.
- An immediate release dosage form.
- A delayed enteric release dosage form.
- The formulation is sufficient to maintain an effective level of the drug for at least 8 hours.
- The peak plasma concentration from the delayed release portion exceeds the peak from the immediate release portion.
- A 20 mg total dose produces a plasma concentration curve with an Area Under the Curve (AUC) between approximately 467 and 714 ng·hr/ml.
- The complaint reserves the right to assert additional claims.
U.S. Reissue Patent No. RE42,096 - "Oral Pulsed Dose Drug Delivery System"
The Invention Explained
- Problem Addressed: Similar to the ’148 patent, the ’096 patent addresses the need for a drug delivery system that can provide a second, delayed pulse of amphetamine salts to avoid the inconvenience of a mid-day dose (’096 Patent, col. 3:4-15).
- The Patented Solution: The invention is a composition with both immediate-release and delayed-release components. This patent emphasizes specific formulation structures to ensure the integrity of the delayed-release mechanism, such as using an enteric coating of a "defined minimum thickness" or incorporating a "protective layer" between the active drug and the enteric coating to prevent premature drug leakage (’096 Patent, Abstract; col. 4:10-18). The layered structure is depicted conceptually in the patent's figures (’096 Patent, Fig. 2A).
- Technical Importance: The focus on specific coating thicknesses and protective layers aimed to create a more reliable and robust delayed-release system, ensuring the second drug pulse occurs at the intended time and location within the gastrointestinal tract (’096 Patent, col. 4:30-43).
Key Claims at a Glance
- The complaint does not identify specific asserted claims, alleging infringement of "one or more claims" of the patent (’096 Patent, Compl. ¶44). Independent claim 1 is representative of the composition.
- Essential elements of independent claim 1 include:
- A pharmaceutical composition comprising mixed amphetamine salts.
- A component with one or more salts covered with an immediate release coating.
- A component with one or more salts covered with an enteric release coating that provides for "delayed pulsed enteric release."
- The enteric coating releases essentially all of the coated salts within about 60 minutes after the delayed pulse is initiated.
- The complaint reserves the right to assert additional claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant’s "ANDA Product," identified as ANDA No. 210651 for dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules in various strengths (5 mg to 30 mg) (Compl. ¶9).
Functionality and Market Context
- The complaint alleges that the ANDA Product is a generic version of Plaintiffs’ ADDERALL XR® drug, which is indicated for the treatment of ADHD (Compl. ¶9, ¶15). As a proposed generic equivalent, its functionality is alleged to be a bioequivalent, pulsed-release formulation of mixed amphetamine salts. The filing of the ANDA is alleged to be an act of infringement under 35 U.S.C. § 271(e)(2), seeking FDA approval to market this product prior to the expiration of the patents-in-suit (Compl. ¶19, ¶31).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint provides a generalized theory of infringement based on the Defendant's filing of an ANDA for a generic version of ADDERALL XR®, asserting that the ANDA product is "a product claimed in the...patent[s]" (Compl. ¶28, ¶40). The following summary is based on this theory, as the complaint does not contain a detailed claim chart or map specific product features to claim elements.
RE41,148 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation for delivery of a mixture of amphetamine base salts...comprising: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate... | Defendant’s ANDA Product is described as a formulation containing the same four mixed amphetamine salts. | ¶9 | col. 13:36-41 |
| an immediate release dosage form that provides immediate release upon oral administration to said patient... | The ANDA Product is an extended-release formulation which, as a generic of ADDERALL XR®, is alleged to have an immediate release component to provide an initial therapeutic effect. | ¶9, ¶28 | col. 4:1-3 |
| a delayed enteric release dosage form that provides delayed release upon oral administration to said patient... | The ANDA Product is an extended-release formulation which, as a generic of ADDERALL XR®, is alleged to have a delayed release component to provide a second pulse of medication. | ¶9, ¶28 | col. 4:6-10 |
| the peak plasma concentration...reached after release of said delayed enteric release dosage form exceeds the peak plasma concentration...after release of said immediate release dosage form... | The complaint does not provide pharmacokinetic data for the ANDA product but alleges it is a "product claimed in the '148 patent." A bioequivalent product would be expected to produce a plasma profile where the second peak is higher than the first, consistent with the patent's disclosure. | ¶28 | col. 13:45-51 |
RE42,096 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts, comprising: (a) one or more...salts covered with an immediate release coating... | Defendant's ANDA Product is an extended-release formulation of mixed amphetamine salts alleged to contain an immediate-release component. | ¶9, ¶40 | col. 4:45-47 |
| (b) one or more...salts that are covered with an enteric release coating that provides for delayed pulsed enteric release... | Defendant's ANDA Product is an extended-release formulation alleged to contain a delayed-release component that utilizes an enteric coating. | ¶9, ¶40 | col. 4:48-55 |
| wherein said enteric release coating releases essentially all of said one or more...salts...within about 60 minutes after initiation of said delayed pulsed enteric release... | The complaint alleges that the ANDA Product is "a product claimed in the '096 patent," which implies that its delayed-release component provides the rapid, pulsed release required by the claim. | ¶40 | col. 19:59-65 |
Identified Points of Contention
- Technical Questions: Since the complaint lacks specific factual allegations mapping the ANDA product to the claims, a primary question for the court will be whether the specific formulation detailed in the confidential ANDA filing actually meets every claim limitation. This includes whether the release kinetics, coating materials, and coating thicknesses of the accused product align with the patent claims.
- Scope Questions: The infringement analysis may turn on the construction of terms like "delayed pulsed enteric release." A question for the court will be whether the release mechanism in Defendant's "extended-release" product meets the patent's requirement for a "pulsed" release, which the patent describes as "rapid and complete" release after a time lag (’096 Patent, col. 4:62-65).
V. Key Claim Terms for Construction
The complaint does not identify any terms for construction. However, based on the technology and the nature of the dispute, the following terms may become central to the case.
- The Term: "delayed pulsed enteric release" (’096 Patent, Claim 1)
- Context and Importance: This term defines the character of the second drug release. The distinction between a "pulsed" release and a more general "extended" or "sustained" release will be critical. Practitioners may focus on this term because the Defendant's product is described as "extended-release" (Compl. ¶9), and whether that mechanism constitutes a "pulsed" release as claimed will be a key infringement question.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's background explains the goal is to mimic a second dose taken 4-6 hours later, which may support an interpretation focused on the timing and therapeutic effect rather than a specific release profile (’096 Patent, col. 3:11-15).
- Evidence for a Narrower Interpretation: The patent specification describes the release as "rapid and complete," with the "entire dose" being released within "about 30-60 minutes" after the lag time, which may support a narrower construction requiring a distinct burst that is unlike a gradual extended release (’096 Patent, col. 4:62-65).
- The Term: "a protective layer" (’096 Patent, Claim 13)
- Context and Importance: While not in independent claim 1, this term appears in dependent claims that may be asserted. Its construction would be dispositive for those claims. Practitioners may focus on this term because the presence, absence, and function of any intermediate layers in the accused product's bead structure will be a key factual issue for infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes this layer as being applied "prior to applying the enteric coating," suggesting its primary definition may be locational—any distinct layer separating the drug from the enteric coating could qualify (’096 Patent, col. 5:5-7).
- Evidence for a Narrower Interpretation: The specification provides examples of "suitable materials for the protective layer," such as specific cellulose derivatives (’096 Patent, col. 8:3-10). This could support an argument that the term is limited to layers made of such materials and having the primary function of protection, rather than some other function.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement under 35 U.S.C. § 271(b). The factual basis alleged is that Defendant, upon approval, will distribute the ANDA Product with "corresponding labeling, package insert, and/or medication guide," which will instruct physicians and patients to use the product in a manner that directly infringes the patent claims (e.g., by taking the single dosage form for a full day's therapeutic effect) (Compl. ¶35, ¶47).
- Willful Infringement: The complaint alleges that infringement will be willful. This is based on Defendant's alleged knowledge of the patents-in-suit, as evidenced by its filing of an ANDA that specifically referenced the patents in its Paragraph IV certification and its sending of a notice letter to Plaintiffs (Compl. ¶34, ¶46). The complaint claims Defendant acted "without a reasonable basis for believing that they would not infringe" (Compl. ¶37, ¶49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual correspondence: as this is a Hatch-Waxman case initiated with a bare-bones complaint, the dispute will hinge on whether the specific formulation, composition, and release-controlling structures detailed in Defendant's confidential ANDA submission fall within the scope of the asserted patent claims. The outcome will depend on a direct technical comparison that is not possible from the public complaint alone.
- A key legal question will be one of definitional scope: can the term "delayed pulsed enteric release," which the patent specification links to a "rapid and complete" release, be construed to read on the "extended-release" mechanism of the accused generic product? The construction of this term will likely determine the infringement outcome for a significant portion of the asserted claims.
- An underlying procedural question will be the significance of the allegedly deficient notice letter: the complaint alleges Defendant’s Paragraph IV notice letter failed to include invalidity or unenforceability contentions (Compl. ¶23-24). While this does not go to the merits of infringement, it raises questions about compliance with the statutory requirements of the Hatch-Waxman Act and may influence early case management and discovery.