PTAB

IPR2017-01621

Watson Laboratories Inc v. United Therapeutics Corp

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Method of Treating Pulmonary Hypertension
  • Brief Description: The ’240 patent discloses a method for treating pulmonary hypertension by administering a specific dose of a treprostinil formulation to a patient via inhalation using a pulsed ultrasonic nebulizer equipped with an "opto-acoustical trigger."

3. Grounds for Unpatentability

Ground 1: Obviousness over Voswinckel, Patton, and Ghofrani - Claims 1-9 are obvious over Voswinckel in view of Patton and Ghofrani.

  • Prior Art Relied Upon: Voswinckel (a 2004 journal abstract), Patton (WO 93/00951), and Ghofrani (a 2005 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the primary reference, Voswinckel, disclosed the core of the invention: a method of treating pulmonary hypertension by inhaling treprostinil (at a 600 µg/ml concentration) using a pulsed ultrasonic nebulizer (the OptiNeb®) in 3 breaths. This met several limitations of independent claim 1. To supply the remaining limitations, Petitioner asserted that Patton taught a nebulizer that delivered a "defined amount of medicant" (a fixed amount per pulse) and used a "light and/or an audible signal" to prompt the user, which constituted the claimed opto-acoustical trigger. For the total dosage range (15-90 µg), Petitioner pointed to Ghofrani, a study closely related to Voswinckel, which explicitly disclosed administering treprostinil starting at 15 µg and increasing up to 90 µg.
    • Motivation to Combine (for §103 grounds): A POSITA would combine Voswinckel's method with Patton's well-known nebulizer features to achieve reliable, efficient, and synchronized drug delivery. A POSITA would have been further motivated to use the specific dosage range from Ghofrani with the Voswinckel method because Ghofrani demonstrated this range was therapeutically effective and the two studies were closely related, sharing authors and subject matter.
    • Expectation of Success (for §103 grounds): A POSITA would have had a high expectation of success because the combination involved applying known nebulizer features (triggers, fixed-dose pulsing) to a known drug administration method and using a dosage range proven effective in a nearly identical clinical context.

Ground 2: Obviousness over Voswinckel, Patton, and OptiNeb® User Manual - Claims 1-9 are obvious over Voswinckel in view of Patton and the OptiNeb® User Manual.

  • Prior Art Relied Upon: Voswinckel (a 2004 journal abstract), Patton (WO 93/00951), and the OptiNeb® User Manual (a 2005 product manual).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented an alternative to Ghofrani for establishing the claimed dosage range. The arguments for combining Voswinckel and Patton to teach the base method, the pulsed nebulizer, and the opto-acoustical trigger remained the same as in Ground 1. To arrive at the 15-90 µg total dose, Petitioner argued that a POSITA, knowing from Voswinckel that an OptiNeb® nebulizer was used, would consult its User Manual. The manual specified a nebulization rate of 0.6 ml/min. Using this rate with Voswinckel's 600 µg/ml solution and a standard inhalation time of 2-3 seconds per breath, a POSA could easily calculate that the 3-breath regimen in Voswinckel would deliver a total dose of 36-54 µg, which falls squarely within the claimed 15-90 µg range.
    • Motivation to Combine (for §103 grounds): A POSITA seeking to replicate or build upon the method in Voswinckel would be directly motivated to consult the user manual for the specific device named (OptiNeb®) to understand its precise operating parameters and calculate the exact dose being administered.
    • Expectation of Success (for §103 grounds): The expectation of success was high, as it involved a straightforward application of basic mathematical calculations based on parameters disclosed in the device's own operating manual.

Ground 3: Obviousness over Voswinckel, Ghofrani, and EU Community Register - Claims 1-9 are obvious over Voswinckel in view of Ghofrani and the EU Community Register.

  • Prior Art Relied Upon: Voswinckel (a 2004 journal abstract), Ghofrani (a 2005 journal article), and the EU Community Register (a 2005 regulatory filing for Ventavis®).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented an alternative to Patton for establishing the nebulizer features. The arguments for using Voswinckel and Ghofrani to teach the base method and dosage range remained the same as in Ground 1. To teach the fixed amount per pulse and the opto-acoustical trigger, Petitioner cited the EU Community Register for Ventavis®, a different inhaled prostacyclin drug. This regulatory document described the approved Venta-Neb nebulizer, which delivered a fixed dose per cycle and prompted the user to inhale "by an optical and an acoustic signal."
    • Motivation to Combine (for §103 grounds): A POSITA would combine the teachings because both the Venta-Neb (from the EU Register) and the OptiNeb® (from Voswinckel) were manufactured by the same company (Nebu-Tec) for delivering similar inhaled prostacyclins. This common origin would suggest that features from one device, particularly those with regulatory approval, could be readily incorporated into the other.
    • Expectation of Success (for §103 grounds): There would be a reasonable expectation of success in combining features from two nebulizers made by the same manufacturer for a similar therapeutic purpose.

4. Key Claim Construction Positions

  • "an opto-acoustical trigger": Petitioner asserted this term should be construed as "a trigger with an optical element (e.g., light) and an acoustical element (e.g., sound)." This construction was noted as being consistent with an agreement reached in parallel district court litigation. The construction was critical to Petitioner's obviousness arguments, as it allowed prior art teaching separate light and sound signals (like Patton) to be mapped onto this limitation.

5. Key Technical Contentions (Beyond Claim Construction)

  • Rebuttal of Secondary Considerations: Petitioner preemptively refuted arguments of non-obviousness that the Patent Owner had made during prosecution. Petitioner argued that the alleged "unexpected results," such as a long duration of action and tolerability of high doses, were not surprising in view of the combined teachings of Voswinckel and Ghofrani. Petitioner also contended that the commercial success of the related product, Tyvaso®, was attributable to dosing convenience already present in the prior art and did not support the non-obviousness of the claimed invention.

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-9 of the ’240 patent as unpatentable under 35 U.S.C. §103.