DCT

2:19-cv-00148

UCB Inc v. Mylan Tech Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-00148, D. Del., 03/24/2017
  • Venue Allegations: Plaintiffs allege venue is proper in Delaware because Defendant entities are registered to do business there, maintain registered agents, hold state-issued licenses to distribute pharmaceutical products, and have engaged in systematic and continuous contacts with the state, rendering them "at home" in the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) for generic versions of the Neupro® transdermal patch constitutes an act of infringement of five patents related to transdermal delivery systems for the drug rotigotine.
  • Technical Context: The technology concerns transdermal patches designed for the continuous, multi-day delivery of rotigotine, a dopamine agonist used to treat the symptoms of Parkinson's disease and Restless Legs Syndrome.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a Paragraph IV Notice Letter, dated on or about February 27, 2017, in which Defendants sought FDA approval to market their generic products prior to the expiration of Plaintiffs' patents. The complaint notes that the branded product, Neupro®, was first approved by the FDA in May 2007, with a new formulation receiving approval in April 2012.

Case Timeline

Date Event
1998-03-30 Earliest Priority Date for '434 and '747 Patents
2002-07-30 Earliest Priority Date for '979, '980, and '591 Patents
2005-04-26 '434 Patent Issued
2007-05-01 Neupro® Initial FDA Approval (approx. May 2007)
2008-08-19 '747 Patent Issued
2012-04-01 Neupro® New Formulation FDA Approval (approx. April 2012)
2012-08-21 '979 Patent Issued
2012-08-21 '980 Patent Issued
2013-12-31 '591 Patent Issued
2017-02-27 Defendants' Paragraph IV Notice Letter Sent (approx.)
2017-03-24 Complaint Filed

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

U.S. Patent No. 6,884,434 - "Transdermal Therapeutic System Which Contains a D2 Agonist and Which is Provided for Treating Parkinsonism, and a Method for the Production Thereof"

  • Patent Identification: U.S. Patent No. 6,884,434, "Transdermal Therapeutic System Which Contains a D2 Agonist and Which is Provided for Treating Parkinsonism, and a Method for the Production Thereof," issued April 26, 2005 (Compl. ¶22).

The Invention Explained

  • Problem Addressed: The patent's background describes the difficulty of administering the dopamine agonist rotigotine. Oral delivery is inefficient due to high "first-pass" metabolism by the liver, and prior transdermal systems were based on the drug's hydrochloride salt, which required a complex two-phase matrix that was difficult to manufacture and resulted in poor skin permeation (’434 Patent, col. 1:57-2:24).
  • The Patented Solution: The invention is a transdermal patch with a simplified, non-aqueous, single-phase adhesive matrix. The key is using the free base form of rotigotine, which is more readily absorbed by the skin, dissolved in a specific acrylate-based or silicone-based polymer adhesive system that has a high solubility (at least 5% w/w) for the drug. This system is also "substantially free of inorganic silicate particulates," which were a necessary component of the prior art's two-phase system (’434 Patent, Abstract; col. 2:35-43). The complaint provides a chemical diagram illustrating the structure of rotigotine, the active pharmaceutical ingredient (Compl. p. 6).
  • Technical Importance: This formulation aimed to improve the transdermal delivery of rotigotine by using the more permeable free base form in a simplified, easier-to-manufacture matrix, thereby enabling a more efficient and consistent release of the active drug through the skin (’434 Patent, col. 5:6-14).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-3, 5, 7, and 14-15, with Claim 1 being the sole independent claim among them (Compl. ¶36).
  • Independent Claim 1 requires:
    • A transdermal therapeutic system with a self-adhesive matrix layer containing the free base form of rotigotine.
    • The matrix is based on an acrylate-based or silicone-based polymer adhesive with a solubility of ≥5% (w/w) for the rotigotine free base.
    • The free base is present in the matrix in the absence of water.
    • The system includes a backing layer and a removable protective foil.

U.S. Patent No. 7,413,747 - "Transdermal Therapeutic System for Treating Parkinsonism"

  • Patent Identification: U.S. Patent No. 7,413,747, "Transdermal Therapeutic System for Treating Parkinsonism," issued August 19, 2008 (Compl. ¶23).

The Invention Explained

  • Problem Addressed: This patent, a continuation of the '434 patent, also addresses the challenges of delivering rotigotine. It specifically focuses on silicone-based adhesives, which have a comparatively low capacity to dissolve many drugs, limiting the amount of active ingredient that can be loaded into a patch (’747 Patent, col. 4:13-19).
  • The Patented Solution: The invention is a transdermal system with a silicone-based adhesive matrix that includes a specific solubility-enhancing additive: polyvinylpyrrolidone (PVP). The addition of PVP to an amine-resistant silicone adhesive is described as increasing the matrix's capacity to dissolve the rotigotine free base to between 10-15%, allowing for a higher drug load (claimed as 5% to 40% by weight) than would otherwise be possible (’747 Patent, col. 4:21-30).
  • Technical Importance: The use of PVP as a solubility enhancer enabled the creation of a high-concentration rotigotine patch using a silicone adhesive, which is desirable for its skin compatibility, while also improving the physical properties of the adhesive by reducing "cold flow" (’747 Patent, col. 4:41-52).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-6, 8-11, and 13, with Claim 1 being an independent claim (Compl. ¶43).
  • Independent Claim 1 requires:
    • A transdermal therapeutic system with a self-adhesive matrix comprising a silicone-based polymer adhesive.
    • The matrix has the rotigotine free base distributed within it in an amount of about 5% to 40% by weight.
    • The adhesive system "consisting essentially of" (a) an amine-resistant silicone adhesive and (b) polyvinylpyrrolidone in an amount of about 1.5% to 5% by weight.

U.S. Patent No. 8,246,979 - "Transdermal Delivery System for the Administration of Rotigotine"

  • Patent Identification: U.S. Patent No. 8,246,979, "Transdermal Delivery System for the Administration of Rotigotine," issued August 21, 2012 (Compl. ¶24).
  • Technology Synopsis: This patent seeks to enhance drug delivery by controlling the drug's physical state within the patch. The invention describes a system where rotigotine free base is incorporated into a multitude of "microreservoirs" dispersed within a silicone-based adhesive matrix. The matrix is engineered to be highly permeable to the drug's free base form but substantially impermeable to its protonated (salt) form, which can form upon contact with the skin, thereby improving drug flux and preventing back-diffusion ('979 Patent, col. 1:44-2:12).
  • Asserted Claims: Claims 1-5 and 7-18 are asserted (Compl. ¶50). Independent claims are 1 and 17.
  • Accused Features: The complaint alleges that Defendants' ANDA Products, as generic equivalents of Neupro®, will infringe by utilizing a transdermal system with these claimed features (Compl. ¶¶49-51).

U.S. Patent No. 8,246,980 - "Transdermal Delivery System"

  • Patent Identification: U.S. Patent No. 8,246,980, "Transdermal Delivery System," issued August 21, 2012 (Compl. ¶25).
  • Technology Synopsis: This patent is a counterpart to the '979 patent but claims the technology more broadly for any "amine-functional drug." The disclosed technical solution is the same: incorporating the free base of an amine drug into microreservoirs within a matrix that is selectively permeable to the free base. This structure is intended to enhance delivery across the skin for a class of drugs, not just rotigotine ('980 Patent, col. 1:47-2:15).
  • Asserted Claims: Claim 17 is asserted (Compl. ¶57). Independent claims are 1 and 17.
  • Accused Features: The complaint alleges Defendants' ANDA Products, which contain the amine-functional drug rotigotine, infringe these claims (Compl. ¶¶56-58).

U.S. Patent No. 8,617,591 - "Transdermal Delivery System for the Administration of Rotigotine"

  • Patent Identification: U.S. Patent No. 8,617,591, "Transdermal Delivery System for the Administration of Rotigotine," issued December 31, 2013 (Compl. ¶26).
  • Technology Synopsis: This patent describes a system where the self-adhesive matrix is "saturated" with rotigotine free base, which is also present as a multitude of microreservoirs. Saturation ensures maximum thermodynamic activity, driving a high and stable flux of the drug. The matrix is also claimed to be highly permeable to the free base form but impermeable to the protonated form ('591 Patent, Abstract).
  • Asserted Claims: Claims 1-3, 6-17, and 20-30 are asserted (Compl. ¶64). Independent claims are 1 and 15.
  • Accused Features: The complaint alleges Defendants' ANDA Products infringe by having a matrix saturated with rotigotine and containing microreservoirs (Compl. ¶¶63-65).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendants' proposed generic "Rotigotine Transdermal System" products, for which approval is sought via Abbreviated New Drug Application (ANDA) No. 209982 (Compl. ¶¶1, 28).

Functionality and Market Context

  • The complaint alleges the ANDA Products are "purported generic versions of Neupro®" (Compl. ¶28). As such, they are intended to be therapeutic equivalents that provide continuous delivery of rotigotine for 24 hours to treat Parkinson's disease and Restless Legs Syndrome (Compl. ¶¶16-18, 28). The act of infringement alleged is the submission of the ANDA itself under 35 U.S.C. § 271(e)(2), which seeks FDA approval to market these products before the expiration of the patents-in-suit (Compl. ¶36). The complaint does not provide specific details on the formulation of the ANDA products, as is typical at this stage of litigation.

IV. Analysis of Infringement Allegations

’434 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A transdermal therapeutic system comprising a self-adhesive matrix layer containing the free base (-)-5,6,7,8-tetrahydro-6-[propyl-1[2-(2-thienyl)ethyl]amino]-1-naphthalenol in an amount effective for the treatment of the symptoms of Parkinson's syndrome... The complaint alleges the ANDA Products are generic versions of Neupro®, which contains rotigotine for treating Parkinson's disease and is based on the free form of the drug. ¶¶16, 28, 37 col. 4:28-35
wherein the matrix is based on a an acrylate-based or silicone-based polymer adhesive system having a solubility of ≥5% (w/w) for the free base... The complaint alleges that by seeking to market a generic version of Neupro®, a transdermal patch, the ANDA Products will necessarily include a polymer adhesive matrix with the claimed properties. ¶¶18, 28, 37 col. 2:35-43
all of said free base being present in the matrix in the absence of water... The complaint alleges infringement based on the ANDA submission for a generic version of Neupro®, which is described as being based on a non-aqueous system to improve permeation of the free base. ¶¶18, 37 col. 2:38-39

’747 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A transdermal therapeutic system (TTS) comprising a self-adhesive matrix that comprises a silicone-based polymer adhesive system having distributed therein (-)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]amino]-1-naphthalenol free base as active substance in an amount of about 5% to 40% by weight of the matrix... The complaint alleges the ANDA Products are generic versions of Neupro® and will therefore contain rotigotine free base in a silicone-based adhesive matrix within the specified concentrations. ¶¶28, 44 col. 3:55-59
said adhesive system consisting essentially of (a) an amine-resistant silicone adhesive and (b) polyvinylpyrrolidone in an amount of about 1.5% to 5% by weight of the matrix. The complaint alleges that Defendants' ANDA products infringe the claim, which implies they will contain the specified components and amounts to achieve bioequivalence with the branded Neupro® product. ¶¶28, 44 col. 4:13-30

Identified Points of Contention

  • Factual Questions: The central point of contention will be factual: what is the actual, specific formulation of Defendants' ANDA product? Because the complaint was filed before discovery, it relies on the premise that a generic equivalent must practice the patented technology. The case will depend on whether Defendants' product, once its composition is revealed, contains every element of the asserted claims.
  • Scope Questions: For the '747 patent, a key legal question will be the scope of the phrase "consisting essentially of." If Defendants' formulation includes any additional, unlisted excipients, the dispute will center on whether those components "materially affect the basic and novel properties" of the claimed invention (i.e., the enhanced drug solubility and stability provided by the specific combination of an amine-resistant silicone adhesive and PVP).

V. Key Claim Terms for Construction

The Term: "substantially free of inorganic silicate particulates" ('434 Patent, Claim 1)

Context and Importance

  • This term is used to distinguish the claimed invention from a prior art system (disclosed in WO 94/07468) that required hydrated silicate to create a two-phase matrix (’434 Patent, col. 2:8-13). The definition of "substantially free" will be critical for determining the boundary between the patented invention and the prior art, and thus for both infringement and validity analyses.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification does not provide a quantitative threshold, which may support an interpretation that the term means the absence of intentionally added silicates or amounts that would form a functional two-phase system as described in the prior art.
  • Evidence for a Narrower Interpretation: The patent explicitly contrasts the invention with a system containing "hydrated silicate dispersed therein for taking up the hydrophile drug salt" (’434 Patent, col. 2:11-13). This could support an interpretation that "substantially free" means lacking an amount of silicate sufficient to perform this specific function, even if trace amounts are present.

The Term: "consisting essentially of" ('747 Patent, Claim 1)

Context and Importance

  • Practitioners may focus on this term because it restricts the claim to the listed components (amine-resistant silicone adhesive and PVP) and any unlisted components that do not materially affect the "basic and novel properties" of the invention. The infringement analysis will hinge on whether any other excipients in Defendants' product alter the fundamental characteristics of the claimed adhesive system. The importance of this phrase is underscored by a Certificate of Correction for the '747 patent, which amended a related claim to change "comprising" to "consisting essentially of."

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation (Plaintiff's View): The specification identifies the key properties as increasing the dissolving capacity for the rotigotine free base and reducing adhesive cold flow (’747 Patent, col. 4:21-52). A plaintiff may argue that any unlisted ingredients that do not materially interfere with these specific functions fall within the claim's scope.
  • Evidence for a Narrower Interpretation (Defendant's View): A defendant may argue that if its formulation includes an additional, unlisted excipient that also affects drug solubility or adhesive properties, that component "materially affects" the invention's characteristics, thereby placing the product outside the claim's scope.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that upon FDA approval, Defendants will actively induce infringement by marketing and distributing the ANDA Products with a product label and insert that will include instructions for physicians and patients to apply the patches, thereby performing the steps of the asserted claims (Compl. ¶¶38, 45, 52, 59, 66).

Willful Infringement

  • The complaint alleges that Defendants had pre-suit knowledge of the patents-in-suit and were aware that filing an ANDA to market a generic version of Neupro® would constitute infringement. The complaint further alleges that Defendants have no reasonable basis for their assertions of non-infringement and/or invalidity, and asks the court to declare the case "exceptional" under 35 U.S.C. § 285 to permit an award of attorneys' fees (Compl. ¶¶39, 46, 53, 60, 67-68).

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

  • A primary question will be one of factual correspondence: Does the specific formulation of Defendants' ANDA product, once disclosed in discovery, meet every limitation of the asserted claims, particularly with respect to the form of the drug (free base), the type and properties of the polymer adhesives, and the presence and characteristics of any microreservoirs?
  • A dispositive issue will be one of claim construction: For the '747 patent, can the phrase "consisting essentially of" be interpreted to read on Defendants' formulation if it contains unlisted excipients, and what evidence will define the "basic and novel properties" of that invention?
  • The case may also turn on a question of validity: Are the claimed improvements—such as the use of PVP as a solubility enhancer in a silicone matrix or the specific "microreservoir" structures—non-obvious developments over the prior art, or do they represent routine optimizations that would have been apparent to a skilled formulator at the time?