DCT

1:19-cv-00474

UCB Inc v. Actavis L

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00474, D. Del., 03/06/2019
  • Venue Allegations: Venue is asserted in the District of Delaware based on the Defendant being a Delaware corporation.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the Neupro® transdermal patch constitutes an act of infringement of a patent covering a stabilized formulation of the active ingredient, rotigotine.
  • Technical Context: The technology concerns pharmaceutical compositions for transdermal patches designed to prevent the active drug, rotigotine, from crystallizing during storage, which would otherwise compromise the drug's stability and therapeutic effectiveness.
  • Key Procedural History: The complaint notes prior litigation between the parties over different patents related to the same Neupro® drug product. This action was initiated under the Hatch-Waxman Act, following Defendant's submission of a Paragraph IV certification notice for the patent-in-suit, which is listed in the FDA's "Orange Book" for Neupro®. The complaint alleges it was filed within the 45-day statutory window, triggering a potential 30-month stay of FDA approval for the generic product.

Case Timeline

Date Event
2007-05-01 FDA initial approval of Neupro® drug product (NDA 021829)
2009-12-22 ’589 Patent Priority Date
2012-04-01 FDA approval of a new formulation of Neupro®
2014-07-08 Defendant's predecessor sends notice for other patents
2018-11-20 ’589 Patent Issue Date
2019-02-20 Defendant sends Paragraph IV Notice Letter for ’589 Patent
2019-03-06 Complaint Filing Date

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

U.S. Patent No. 10,130,589 - Polyvinylpyrrolidone for the Stabilization of a Solid Dispersion of the Non-Crystalline Form of Rotigotine

  • Patent Identification: U.S. Patent No. 10,130,589, "Polyvinylpyrrolidone for the Stabilization of a Solid Dispersion of the Non-Crystalline Form of Rotigotine," issued November 20, 2018. (Compl. ¶14).

The Invention Explained

  • Problem Addressed: The patent addresses a critical stability issue with the drug rotigotine when used in transdermal therapeutic systems (TTS), or patches. The therapeutically useful non-crystalline (amorphous) form of rotigotine is "only metastable and easily converts into crystals" over time, especially at room temperature. ('589 Patent, col. 3:11-16). This crystal growth can reduce the patch's effectiveness by lowering the drug release rate, potentially "falling below the specified values." ('589 Patent, col. 2:62-66).
  • The Patented Solution: The invention claims to solve this stability problem by creating a "solid dispersion" that uses polyvinylpyrrolidone (PVP) as a stabilizing agent. The core of the invention is the discovery that a specific weight ratio of rotigotine to PVP, ranging from about 9:4 to about 9:6, can "unexpectedly" prevent re-crystallization and provide long-term stability at room temperature, without negatively impacting the drug's performance. ('589 Patent, col. 4:27-38, Abstract). The patent's Figure 2 visually demonstrates this effect, showing rotigotine patches with a 9:4 ratio remaining clear of crystals after nine months, while patches with lower PVP ratios show visible crystallization. ('589 Patent, FIG. 2).
  • Technical Importance: This specific formulation provides sufficient long-term storage stability at room temperature, obviating the need for cold storage and more complicated handling instructions for patients. ('589 Patent, col. 3:1-10).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims of the ’589 Patent. (Compl. ¶26). The independent claims defining the composition and the final product are Claims 2 and 8.
  • Independent Claim 2 (Composition):
    • A solid dispersion comprising a dispersing agent and a dispersed phase,
    • said dispersed phase comprising rotigotine free base and polyvinylpyrrolidone,
    • wherein the weight ratio of rotigotine free base to polyvinylpyrrolidone is in a range from about 9:4 to about 9:6.
  • Independent Claim 8 (System):
    • A transdermal therapeutic system comprising at least one amine-compatible silicone pressure sensitive adhesive,
    • about 0.1 to about 3.15 mg/cm2 of rotigotine free base,
    • and polyvinylpyrrolidone,
    • wherein the weight ratio of rotigotine free base to polyvinylpyrrolidone is in a range from about 9:4 to about 9:6.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant's "Rotigotine Transdermal System" products, for which approval is sought under Abbreviated New Drug Application (ANDA) No. 206348. (Compl. ¶17).

Functionality and Market Context

  • The accused ANDA Products are "purported generic versions of Neupro®," a transdermal patch for treating Parkinson's disease and Restless Legs Syndrome. (Compl. ¶1, ¶8). The complaint provides the chemical formula for rotigotine, the active pharmaceutical ingredient at issue. (Compl. ¶9). As generic equivalents, the ANDA Products are intended to provide continuous transdermal delivery of rotigotine over 24 hours, similar to the brand-name Neupro® product. (Compl. ¶10). The Defendant seeks to market these products prior to the expiration of the ’589 Patent, which is the statutory basis for this infringement action. (Compl. ¶1).

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The infringement theory is based on 35 U.S.C. § 271(e)(2), where the submission of an ANDA for a drug claimed in a patent is a statutory act of infringement. The core allegation is that the product described in Defendant's ANDA, if approved and sold, would infringe the ’589 Patent. (Compl. ¶25-26). The complaint makes the notable allegation that in its Paragraph IV notice letter, "Actavis did not contest its infringement of the '589 Patent." (Compl. ¶27).

’589 Patent Infringement Allegations

Claim Element (from Independent Claim 2) Alleged Infringing Functionality Complaint Citation Patent Citation
A solid dispersion comprising a dispersing agent and a dispersed phase The ANDA Products are generic versions of Neupro®, which is described as a "matrix-type transdermal system"—a form of solid dispersion. ¶10, ¶17 col. 4:17-21
said dispersed phase comprising rotigotine free base and polyvinylpyrrolidone The ANDA Products contain rotigotine and are intended to be bioequivalent to Neupro®. The ’589 Patent, titled for its use of polyvinylpyrrolidone, teaches that PVP is the key stabilizer in the improved Neupro® formulation. ¶9, ¶14, ¶17 col. 4:22-26
wherein the weight ratio of rotigotine free base to polyvinylpyrrolidone is in a range from about 9:4 to about 9:6 The complaint alleges that the ANDA Products will infringe and that Defendant did not contest infringement, suggesting the formulation specified in the ANDA falls within the claimed ratio. ¶25, ¶27 col. 4:40-47

Identified Points of Contention

  • Validity Questions: Given the allegation that infringement is not contested, the central dispute is likely to be over the validity of the ’589 Patent. The key question for the court will be whether the claimed weight ratio range of "about 9:4 to about 9:6" is non-obvious in light of prior art related to rotigotine formulations.
  • Scope Questions: Should the validity defense fail, a secondary dispute may arise over the meaning of the term "about." The court would need to determine the permissible deviation from the "9:4" and "9:6" endpoints, which could be critical if the defendant's formulation is close to but not precisely within that range.

V. Key Claim Terms for Construction

  • The Term: "a range from about 9:4 to about 9:6"
  • Context and Importance: This numerical range defines the core of the patented invention. The entire dispute over both infringement and validity will likely center on this limitation. Practitioners may focus on this term because the patent's own data attempts to show a sharp, unexpected improvement in stability within this precise range, making its boundaries critical.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the word "about" inherently suggests the patentee did not intend for the range to be interpreted with strict mathematical precision. A party might argue that the term covers any ratio that achieves the same stabilizing function and is consistent with the patent's teachings. ('589 Patent, col. 4:27-30).
    • Evidence for a Narrower Interpretation: The patent specification provides experimental data contrasting the successful "9:4" ratio with the unsuccessful "9:3" ratio, which showed crystal formation within one week. ('589 Patent, Table 3, col. 15). A party could argue this demonstrates a "critical" boundary and that "about 9:4" should be construed very narrowly to exclude ratios that behave like the prior art "9:3" formulation. The patentee’s characterization of the discovery as "surprisingly found" further supports the argument that the specific range is critical and not merely an example. ('589 Patent, col. 4:27-30).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Actavis will actively induce and contribute to infringement by selling the ANDA Products in the United States. (Compl. ¶21, ¶26). The basis for this allegation is the filing of the ANDA itself with the intent that the product be prescribed by doctors and used by patients for its intended, and allegedly infringing, purpose. (Compl. ¶(B), p. 8).
  • Willful Infringement: The complaint alleges that Defendant has "actual knowledge of the '589 Patent" and "no reasonable basis for asserting" non-infringement, particularly because it allegedly did not contest infringement in its notice letter. (Compl. ¶27). This conduct is alleged to make the case "exceptional" under 35 U.S.C. § 285, which could entitle Plaintiffs to an award of attorneys' fees. (Compl. ¶28, ¶(E)).

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

  1. A central issue will be one of patent validity: Can the defendant demonstrate with clear and convincing evidence that selecting a rotigotine-to-PVP weight ratio of "about 9:4 to about 9:6" to stabilize a transdermal patch was obvious to a person of ordinary skill in the art, particularly in light of the patent’s assertion that this specific range yields unexpectedly superior stability?
  2. A key legal question will be one of definitional scope: How will the court construe the term "about" as it modifies the claimed numerical range? The outcome of this construction could be dispositive if the defendant's formulation lies at the edge of the claimed range.
  3. A significant procedural and financial question will be one of exceptionality: Do the plaintiff's allegations—specifically that the defendant knew of the patent and did not contest infringement in its pre-suit communications—suffice to render this an "exceptional case" under 35 U.S.C. § 285, thereby exposing the defendant to liability for attorneys' fees?