DCT
2:19-cv-00128
UCB Inc v. Mylan Tech Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: UCB, Inc. (Delaware), UCB Pharma GmbH (Germany), and LTS Lohmann Therapie-Systeme AG (Germany)
- Defendant: Mylan Technologies, Inc. (West Virginia)
- Plaintiff’s Counsel: Dinse P.C.
- Case Identification: 2:19-cv-00128, D. Vt., 08/12/2019
- Venue Allegations: Venue is based on Defendant's principal place of business being located in the District of Vermont, where it also allegedly developed the accused product and submitted the associated regulatory filing.
- Core Dispute: Plaintiffs allege that Defendant's filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Neupro® transdermal patch constitutes infringement of patents covering specific formulations for stabilizing the drug rotigotine.
- Technical Context: The technology concerns pharmaceutical formulations for transdermal drug delivery systems, specifically addressing the chemical stability of the active ingredient rotigotine, a dopamine agonist used to treat Parkinson's disease and Restless Legs Syndrome.
- Key Procedural History: This is a Hatch-Waxman action initiated within 45 days of Plaintiffs' receipt of a Paragraph IV certification notice letter from the Defendant, dated on or about July 29, 2019. The patents-in-suit are listed in the FDA's "Orange Book" for Plaintiffs' Neupro® product.
Case Timeline
| Date | Event |
|---|---|
| 2007-05-01 | Plaintiffs' Neupro® product initially approved by FDA |
| 2009-12-22 | Earliest Priority Date for '589 and '174 Patents |
| 2012-04-01 | FDA approves new formulation of Plaintiffs' Neupro® |
| 2018-11-20 | '589 Patent Issued |
| 2019-07-16 | '174 Patent Issued |
| 2019-07-29 | Defendant sends Paragraph IV Notice Letter to Plaintiffs |
| 2019-08-12 | Complaint Filed |
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 (Issued Nov. 20, 2018)
The Invention Explained
- Problem Addressed: The patent's background describes how rotigotine, the active drug, can be unstable in transdermal patches. Specifically, the non-crystalline (or amorphous) form of the drug, which is desirable for delivery, tends to convert into more stable but less effective crystalline forms during long-term storage, reducing the drug's release rate from the patch. ('589 Patent, col. 2:61-67).
- The Patented Solution: The invention uses polyvinylpyrrolidone (PVP), a polymer, as a stabilizing agent. The patent claims to have discovered that incorporating PVP into the patch's adhesive matrix within a specific weight ratio relative to the rotigotine prevents the drug from crystallizing, thereby ensuring long-term stability and a consistent release profile, even at room temperature. ('589 Patent, Abstract; col. 3:28-36).
- Technical Importance: This solution addresses a significant logistical and usability challenge for transdermal rotigotine patches by potentially eliminating the need for cold storage, which was required for earlier formulations to prevent drug crystallization. ('589 Patent, col. 3:1-11).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 2. (Compl. ¶28).
- Independent Claim 1 recites a method with two key elements:
- A method for stabilizing rotigotine by providing a solid dispersion comprising polyvinylpyrrolidone and a non-crystalline form of rotigotine free base.
- The weight ratio of rotigotine free base to polyvinylpyrrolidone is in a range from about 9:4 to about 9:6.
- The complaint reserves the right to assert additional claims. (Compl. ¶29).
U.S. Patent No. 10,350,174 - Polyvinylpyrrolidone for the Stabilization of a Solid Dispersion of the Non-Crystalline Form of Rotigotine (Issued Jul. 16, 2019)
The Invention Explained
- Problem Addressed: The '174 Patent, a continuation of the application that led to the '589 Patent, addresses the identical technical problem of rotigotine crystallization in transdermal systems, which compromises long-term stability and performance. ('174 Patent, col. 2:61-67).
- The Patented Solution: The '174 Patent also claims a solution based on using PVP to stabilize non-crystalline rotigotine. It claims a specific composition for a "stable solid dispersion" that includes rotigotine and PVP in a defined weight ratio, intended for use in a transdermal patch. ('174 Patent, Abstract; col. 5:45-50).
- Technical Importance: As with the '589 Patent, the invention provides a formulation for a room-temperature-stable rotigotine patch, improving upon prior art that required refrigeration. ('174 Patent, col. 3:1-11).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶41).
- Independent Claim 1 recites a composition with three key elements:
- A stable solid dispersion comprising a silicone dispersing agent (a two-part mixture of solution-based silicones) and a dispersed phase.
- The dispersed phase comprises rotigotine free base and polyvinylpyrrolidone.
- A weight ratio of rotigotine free base to polyvinylpyrrolidone is about 9:4 to about 9:6.
- The complaint reserves the right to assert additional claims. (Compl. ¶42).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant's "Mylan ANDA Products" for which it seeks FDA approval under Abbreviated New Drug Application No. 209982. (Compl. ¶1). These products are identified as "Rotigotine Transdermal System" in various strengths (1 mg/24 hours to 8 mg/24 hours). (Compl. ¶8).
Functionality and Market Context
The Mylan products are alleged to be generic versions of Plaintiffs' Neupro® transdermal system. (Compl. ¶1). The complaint alleges that the products are designed to provide continuous delivery of rotigotine for 24 hours to treat Parkinson's disease and Restless Legs Syndrome. (Compl. ¶¶9, 11). The complaint includes a diagram showing the chemical structure of rotigotine, the active pharmaceutical ingredient in both Plaintiffs' and Defendant's alleged products. (Compl. p. 4, Figure). The submission of the ANDA is the statutorily defined act of infringement alleged in the complaint. (Compl. ¶28).
IV. Analysis of Infringement Allegations
The complaint does not include a detailed claim chart but alleges that the Mylan ANDA Products will infringe because they are generic versions of the Neupro® product, whose formulation is protected by the patents-in-suit.
'589 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for stabilizing rotigotine, the method comprising providing a solid dispersion comprising polyvinylpyrrolidone and a non-crystalline form of rotigotine free base, | The Mylan ANDA Products are alleged to be solid dispersions that embody the claimed stabilized formulation. Defendant is alleged to perform the claimed method during the manufacture of its products. | ¶28, ¶29 | col. 3:42-47 |
| wherein the weight ratio of rotigotine free base to polyvinylpyrrolidone is in a range from about 9:4 to about 9:6. | The Mylan ANDA Products, as generic versions of Neupro®, are alleged to contain rotigotine and polyvinylpyrrolidone within the claimed weight ratio. The chemical structure of rotigotine is identified in the complaint. (Compl. p. 4, Figure). | ¶28, ¶29 | col. 15:42-47 |
'174 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A stable solid dispersion comprising a silicone dispersing agent which is a two-part mixture of solution-based silicones and a dispersed phase, | The Mylan ANDA Products are alleged to be stable solid dispersions containing the claimed silicone dispersing agent. | ¶41, ¶42 | col. 5:8-12 |
| said dispersed phase comprising rotigotine free base and polyvinylpyrrolidone, | The Mylan ANDA Products are alleged to contain a dispersed phase of rotigotine and polyvinylpyrrolidone. | ¶41, ¶42 | col. 9:50-57 |
| wherein a weight ratio of rotigotine free base to polyvinylpyrrolidone is about 9:4 to about 9:6. | The Mylan ANDA Products, as generic versions of Neupro®, are alleged to contain rotigotine and polyvinylpyrrolidone within the claimed weight ratio. The complaint identifies the chemical structure of rotigotine, the active ingredient. (Compl. p. 4, Figure). | ¶41, ¶42 | col. 15:42-47 |
- Identified Points of Contention:
- Scope Questions: A central dispute may revolve around the scope of the term "about" as it modifies the claimed weight ratio of "9:4 to about 9:6." The case may explore whether Mylan's formulation, even if slightly outside this precise numerical range, falls within a reasonable interpretation of "about."
- Technical Questions: A key factual question will be whether the Mylan ANDA product is, in fact, a "non-crystalline" or "stable solid dispersion" as defined by the patents. This raises the question of what level of crystallinity, if any, is permissible under the claims and what evidence exists from Mylan's ANDA filing regarding the physical state of the rotigotine in its product over time.
V. Key Claim Terms for Construction
The Term: "a range from about 9:4 to about 9:6"
Context and Importance: This ratio is presented as the core of the invention, distinguishing it from prior art that was unstable or had poor release characteristics. The interpretation of "about" will be critical to determining the boundary of infringement. Practitioners may focus on this term because even a small deviation in the formulation of the Mylan ANDA product could form the basis of a non-infringement defense.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the claimed range as yielding "optimum results," which may suggest that ranges close to, but not exactly within, 9:4 to 9:6 could still function as intended. ('589 Patent, col. 15:42-47). The use of the word "about" itself implies some degree of flexibility beyond the strict numerical endpoints.
- Evidence for a Narrower Interpretation: The patent presents experimental data showing that ratios outside the claimed range, such as 9:3, exhibit crystal formation, while a ratio of 9:4 does not. ('589 Patent, Table 3; FIGS. 2-4). This data could be used to argue that the range is a critical parameter and that "about" should be construed very narrowly to exclude formulations that would be expected to crystallize.
The Term: "non-crystalline form of rotigotine"
Context and Importance: The claims require this specific physical form of the drug. The infringement analysis will depend on whether Mylan's product contains rotigotine in a "non-crystalline" state. Practitioners may focus on this term because the patent itself acknowledges that the "amorphous form of rotigotine... is only metastable and easily converts into crystals." ('589 Patent, col. 3:14-16).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent defines "stabilization" in a way that permits some level of crystallization over a two-year period (not to exceed 10%, and preferably less). ('589 Patent, col. 5:60–col. 6:4). This suggests that "non-crystalline" does not mean "perfectly and completely amorphous at all times" but rather "substantially amorphous and stable against significant crystallization."
- Evidence for a Narrower Interpretation: The background clearly distinguishes between the desired amorphous form and two known crystalline polymorphic forms, I and II. ('589 Patent, col. 1:49-54). This distinction could support an argument that the term requires a complete or near-complete absence of any detectable crystalline structure at the time of manufacture.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon FDA approval, Mylan will actively induce and contribute to infringement of the asserted claims. (Compl. ¶¶29, 42). The basis for inducement would likely be the product's labeling and instructions for use as submitted in the ANDA, which would instruct physicians and patients on the use of the infringing product.
- Willful Infringement: The complaint alleges that Mylan had actual notice of the patents and that its infringement is willful, rendering the case "exceptional" under 35 U.S.C. § 285. (Compl. ¶¶30, 43). The allegations are based on Mylan's Paragraph IV certification and its Notice Letter, in which Mylan allegedly "did not contest its infringement" of the '589 Patent and "only contested infringement of Claims 7 and 16" of the '174 Patent, suggesting a lack of a good-faith belief of non-infringement for other asserted claims. (Compl. ¶¶30, 43).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "about," as applied to the "9:4 to about 9:6" weight ratio, be construed to encompass the specific formulation in Mylan's ANDA? The outcome will depend on how the court weighs the patent's emphasis on this "optimum" range against the inherent flexibility of the word "about."
- A second central question will be technical and evidentiary: does Mylan's proposed generic product in fact contain a "non-crystalline form of rotigotine" that remains stable as required by the claims? This will likely involve a detailed factual inquiry into Mylan's manufacturing process and the stability data submitted in its ANDA.
- Finally, the willfulness claim raises a key question of pre-litigation conduct: did Mylan's failure to contest infringement of certain claims in its Paragraph IV notice letter constitute a lack of a reasonable, good-faith basis for proceeding with its ANDA, potentially exposing it to enhanced damages and attorney fees?