DCT

1:17-cv-01696

Shire Development LLC v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01696, D. Del., 11/22/2017
  • Venue Allegations: Venue is alleged based on Defendant Teva Pharmaceuticals USA, Inc.'s incorporation in Delaware, its business contacts within the state, and the fact that upon approval, the accused product would be marketed and sold in Delaware.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's ADHD drug, MYDAYIS®, constitutes an act of infringement of three patents related to controlled-release amphetamine salt formulations.
  • Technical Context: The technology concerns pharmaceutical compositions designed to control the release of amphetamine salts over an extended period to provide all-day therapeutic coverage for Attention Deficit Hyperactivity Disorder (ADHD).
  • Key Procedural History: The lawsuit is a Hatch-Waxman action triggered by Defendants’ submission of ANDA No. 210876 with a Paragraph IV certification. This certification asserts that the patents-in-suit, which are listed in the FDA's "Orange Book" as covering MYDAYIS®, are invalid or will not be infringed by Defendants' proposed generic product.

Case Timeline

Date Event
2002-09-24 U.S. Patent No. 6,913,768 Priority Date
2005-07-05 U.S. Patent No. 6,913,768 Issue Date
2006-05-12 U.S. Patent Nos. 8,846,100 & 9,173,857 Priority Date
2014-09-30 U.S. Patent No. 8,846,100 Issue Date
2015-11-03 U.S. Patent No. 9,173,857 Issue Date
2017-06-20 Plaintiff’s MYDAYIS® Product Approved by FDA
2017-10-12 Defendants Send Paragraph IV Notice Letter to Plaintiffs
2017-11-22 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 6,913,768 - Sustained Release Delivery of Amphetamine Salts

  • Patent Identification: U.S. Patent No. 6,913,768, "Sustained Release Delivery of Amphetamine Salts," issued July 5, 2005.

The Invention Explained

  • Problem Addressed: The patent seeks to create a once-a-day amphetamine formulation using sustained-release (SR) technology that can replicate the therapeutic effect and in vivo plasma concentration profile of more complex pulsatile-release formulations (e.g., ADDERALL XR®) (Compl. Ex. A, ’768 Patent, col. 1:14-25).
  • The Patented Solution: The invention is a pharmaceutical composition comprising amphetamine salts within a sustained-release coating or matrix. Rather than claiming a specific physical structure, the patent claims a functional outcome: the formulation must be "effective to achieve continuous sustained release" that results in a "mean plasma concentration profile... which is substantially the same as" a specific target profile depicted in the patent's Figure 1 (’768 Patent, col. 1:14-25, col. 14:50-64, Fig. 1).
  • Technical Importance: This approach aimed to provide the clinical benefits of a sophisticated, multi-pulse drug release profile while potentially using simpler, more conventional sustained-release manufacturing techniques.

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying which are asserted (Compl. ¶57). Independent claim 1 is representative of the invention.
  • Essential elements of Independent Claim 1 include:
    • A pharmaceutical composition comprising a mixture of dextro- and levo-amphetamine salts.
    • A sustained release coating or matrix comprising specific types of polymers (e.g., polyvinyl acetate, cellulose acetate).
    • The coating or matrix must be effective to achieve a "continuous sustained release" of the amphetamine salts.
    • This release must provide a "mean plasma concentration profile in human ADHD patients which is substantially the same as the ... profile of FIG. 1" for a given dose.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,846,100 - Controlled Dose Drug Delivery System

  • Patent Identification: U.S. Patent No. 8,846,100, "Controlled Dose Drug Delivery System," issued September 30, 2014.

The Invention Explained

  • Problem Addressed: The patent's background notes that existing 12-hour ADHD medications are often insufficient for adolescents and adults who have "longer day demands" and require therapeutic coverage for 14-16 hours. Augmenting a morning dose with a later immediate-release dose is described as inconvenient (Compl. Ex. B, ’100 Patent, col. 3:34-49).
  • The Patented Solution: The invention is a single oral dosage form containing three different populations of drug-releasing beads to create a multi-stage release profile. The capsule contains: (1) an immediate-release (IR) bead population, (2) a delayed-release (DR) bead population with an enteric coating that provides a second pulse of the drug, and (3) a second delayed-release bead population that provides a third, sustained release of the drug (’100 Patent, col. 4:54-58, Fig. 3). This third bead population has a unique, "atypical" structure where a sustained-release coating is layered on top of a delayed-release (enteric) coating (’100 Patent, col. 4:45-53).
  • Technical Importance: This three-bead system was designed to provide therapeutic coverage for up to 16 hours from a single morning dose, eliminating the need for a second, separately administered dose later in the day.

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying which are asserted (Compl. ¶71). Independent claim 1 is representative of the invention.
  • Essential elements of Independent Claim 1 include:
    • An immediate release bead comprising an amphetamine salt.
    • A first delayed release bead comprising an amphetamine salt and an enteric coating to provide a pulsed release.
    • A second delayed release bead comprising an amphetamine salt to provide a sustained release.
    • The second delayed release bead has a specific structure: a core, a delayed release (enteric) coating layered on the core, and a sustained release coating layered on the delayed release coating.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,173,857 - Controlled Dose Drug Delivery System

  • Patent Identification: U.S. Patent No. 9,173,857, "Controlled Dose Drug Delivery System," issued November 3, 2015.
  • Technology Synopsis: This patent is in the same family as the ’100 patent and claims a method of treating ADHD by administering the three-component drug delivery system. The system combines immediate, delayed pulsed, and delayed sustained release beads in a single dosage form to provide therapeutic coverage for 14-16 hours (Compl. Ex. C, ’857 Patent, col. 4:54-58).
  • Asserted Claims: The complaint alleges infringement of "one or more claims"; independent claim 1 is a representative method of treatment claim (Compl. ¶85).
  • Accused Features: The accused feature is the anticipated use of Defendants' ANDA Product by physicians and patients for the treatment of ADHD, which would allegedly practice the steps of the claimed method (Compl. ¶89, ¶91).

III. The Accused Instrumentality

Product Identification

"Defendants' ANDA Product," which is a generic version of "Mixed Salts of a Single-entity Amphetamine Extended-release Capsules" in 12.5 mg, 25 mg, 37.5 mg, and 50 mg strengths, for which Defendant Teva USA filed Abbreviated New Drug Application (ANDA) No. 210876 (Compl. ¶21).

Functionality and Market Context

The ANDA product is intended as a generic equivalent to Plaintiff's branded drug, MYDAYIS® (Compl. ¶35). The complaint alleges that MYDAYIS® contains "three types of drug-releasing beads, an immediate release and two different types of delayed release beads" to provide extended treatment for ADHD (Compl. ¶35-36). As a generic, the ANDA Product is alleged to have the same composition and functionality (Compl. ¶54, ¶71, ¶85). Defendants are described as major participants in the generic pharmaceutical market (Compl. ¶6, ¶8).

  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not specify which claims of the patents-in-suit are asserted or provide claim charts. The infringement allegations are based on the premise that Defendants' ANDA product is a generic equivalent of MYDAYIS® and will therefore have the same composition and produce the same clinical effects covered by the patents. The following tables summarize the infringement theory for representative independent claims.

U.S. Patent No. 6,913,768 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising a mixture of dextro- and levo-amphetamine and/or salt(s) thereof... Defendants' ANDA Product is comprised of mixed amphetamine salts. ¶21 col. 14:50-52
...and a sustained release coating or matrix which comprises an amount of [a polymer] effective to achieve continuous sustained release... The ANDA Product is an extended-release formulation alleged to provide sustained delivery of the drug. ¶21 col. 14:52-58
...to provide a mean plasma concentration profile in human ADHD patients which is substantially the same as the ... profile of FIG. 1... The ANDA Product, as a generic equivalent to MYDAYIS®, is alleged to produce a plasma concentration profile that meets this limitation. ¶54, ¶58 col. 14:58-64

Identified Points of Contention:

  • Scope Questions: A central dispute may arise over the term "substantially the same as the ... profile of FIG. 1." The parties may contest whether this pharmacokinetic (PK) limitation is met by a product that is bioequivalent to MYDAYIS®, which was developed later.
  • Technical Questions: A key question may be whether the accused product, which likely uses a three-bead pulsatile system like MYDAYIS®, can be said to achieve its PK profile via a "continuous sustained release" as required by claim 1. The patent specification distinguishes its sustained-release invention from "pulsatile release formulations," suggesting a potential mismatch between the accused product's mechanism and the claim language (’768 Patent, col. 1:20-22).

U.S. Patent No. 8,846,100 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) an immediate release bead comprising at least one amphetamine salt; Defendants' ANDA Product is alleged to contain an immediate-release bead component. ¶35, ¶71 col. 32:60-61
(b) a first delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release...and...comprise[s] an enteric coating. Defendants' ANDA Product is alleged to contain a second bead population with an enteric coating for delayed, pulsed release. ¶35, ¶71 col. 32:62-65
(c) a second delayed release bead comprising at least one amphetamine salt...[which] provides sustained release...[and comprises] a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating... Defendants' ANDA Product is alleged to contain a third bead population with the claimed layered structure for delayed, sustained release. ¶35, ¶71 col. 32:1-12

Identified Points of Contention:

  • Scope Questions: The analysis may focus on whether the components of the accused product meet the structural definitions of the three distinct "beads" required by the claim.
  • Technical Questions: Infringement will likely depend on a factual analysis of the accused product's physical structure. A key question for discovery will be whether the third bead population in Defendants' product possesses the specific, "atypical" structure of a sustained-release coating layered on top of an enteric (delayed release) coating, as required by the claim (’100 Patent, col. 4:45-53).

V. Key Claim Terms for Construction

  • The Term: "a mean plasma concentration profile...which is substantially the same as the...profile of FIG. 1" (’768 Patent, claim 1)

  • Context and Importance: This term is the primary functional limitation of the ’768 Patent's independent claims. The entire infringement case for this patent will depend on whether the PK profile generated by Defendants' product falls within the scope of this language.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification suggests that two profiles are "substantially the same" if their key PK parameters, AUC (area under the curve) and Cmax (maximum concentration), are "±20% of each other" (’768 Patent, col. 2:41-45). Plaintiff may argue this provides a clear, numerical standard for infringement.
    • Evidence for a Narrower Interpretation: The specification also states that plasma curves can "follow even more closely the course of a target curve" by matching "initial rising slope, post-peak curve shapes, Tmax values, etc." (’768 Patent, col. 2:57-60). A defendant may argue that "substantially the same" requires a closer match of the entire curve shape, not just the two primary PK parameters.

  • The Term: "a sustained release coating layered onto the delayed release coating" (’100 Patent, claim 1)

  • Context and Importance: This phrase defines the unique structure of the third bead population, which provides the final, sustained release of the drug. The patent itself characterizes this structure as "atypical" and "counter-intuitive," distinguishing it from conventional formulations where an enteric coat would be outside a sustained-release coat (’100 Patent, col. 4:15-18, col. 4:45-46). Proving this precise structure in the accused product is critical to the infringement case for the ’100 patent.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party might argue the term should be interpreted functionally, covering any structure where a sustained release layer operates after a delayed release function is complete, regardless of the precise physical arrangement.
    • Evidence for a Narrower Interpretation: The plain language strongly suggests a specific physical sequence of layers that must be present. The specification's emphasis on this construction being "atypical" and its contrast with "a usual or typical sustained release construction" would support an argument that the claim requires this exact layering sequence (’100 Patent, col. 4:15-18).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents. Inducement is alleged based on Defendants' intent for third parties (e.g., physicians, patients) to use the ANDA product as instructed on the product labeling, thereby infringing the claims (Compl. ¶61, ¶77-78, ¶91). Contributory infringement is alleged on the basis that the ANDA product constitutes a material part of the patented inventions, is not a staple article of commerce, and is specifically made for an infringing use (Compl. ¶62, ¶92).
  • Willful Infringement: The complaint does not use the term "willful infringement" but does allege that Defendants' conduct renders the case "exceptional" under 35 U.S.C. § 285, which could entitle Plaintiffs to attorneys' fees (Compl. ¶66, ¶80, ¶94). This allegation is based on Defendants' awareness of the patents, at least as of the date of the October 12, 2017 Notice Letter (Compl. ¶43, ¶66).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of mechanistic versus functional infringement: Can the '768 patent, which claims a PK profile achieved via a "continuous sustained release" mechanism, be infringed by an accused product that achieves a similar profile through a different, multi-pulsatile mechanism as described in the '100 and '857 patents?
  • A central evidentiary question will be one of structural identity: Will discovery and reverse engineering of Defendants' ANDA product reveal the specific three-bead population structure claimed in the '100 patent, particularly the "atypical" sequence of an enteric coating followed by a sustained-release coating on the third bead?
  • A key question of claim scope will be the interpretation of "substantially the same" in the '768 patent. The case may turn on whether this requires only bioequivalence on high-level metrics like AUC and Cmax, or a more holistic similarity in the shape of the entire plasma concentration curve.