PTAB

IPR2018-00272

Mylan Pharmaceuticals Inc v. Horizon Pharma USA Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Method for Delivering a Pharmaceutical Composition to Patient in need thereof
  • Brief Description: The ’208 patent describes a method for treating arthritis and other conditions by orally administering a coordinated-release pharmaceutical composition. The composition combines delayed-release naproxen (an NSAID) and immediate-release esomeprazole (a proton pump inhibitor) in specific dosages, and the claims recite achieving particular pharmacokinetic (PK) and pharmacodynamic (PD) parameters.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-7 under 35 U.S.C. §102 over the ’285 patent

  • Prior Art Relied Upon: Patent 8,557,285 (’285 patent).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the ’285 patent, which shares a common inventor and priority lineage with the ’208 patent, explicitly discloses all elements of the claimed method. It teaches a unit dose form combining naproxen and esomeprazole, including the specific 500mg naproxen and 20mg esomeprazole doses recited in claim 1, within disclosed ranges. It also teaches twice-daily administration for chronic conditions like arthritis. Petitioner asserted that the structural elements of the multilayer tablet recited in dependent claims 5-7 are also expressly disclosed in the ’285 patent’s specification and examples.
    • Key Aspects: The central argument for this ground is inherency. Petitioner contended that the PK and PD parameters recited in the claims are not inventive features but are the natural, inherent result of administering the formulation disclosed in the ’285 patent. They argued that once a known formulation is administered according to a known method, the resulting serum concentrations and gastric pH effects are an inherent property of that drug, making the claims unpatentable even if those specific PK/PD values were not previously documented.

Ground 2: Obviousness of Claims 1-7 under 35 U.S.C. §103 over the ’285 patent

  • Prior Art Relied Upon: Patent 8,557,285 (’285 patent).
  • Core Argument for this Ground:
    • Prior Art Mapping: As an alternative to anticipation, Petitioner argued that all claims are obvious over the ’285 patent alone. The ’285 patent discloses dose ranges for naproxen (200-600mg) and esomeprazole (5-100mg) that overlap with and suggest the claimed doses. Petitioner asserted that selecting the specific 20mg esomeprazole dose would have been obvious, as it was a known marketed dose, and the ’285 patent taught that 250-500mg of naproxen was preferred.
    • Motivation to Combine (for §103 grounds): The motivation is explicitly provided by the ’285 patent itself, which teaches combining an NSAID and a PPI to reduce NSAID-induced gastric injury.
    • Expectation of Success (for §103 grounds): Petitioner argued that even if the PK/PD values were not inherent, they were the predictable result of routine testing. A person of ordinary skill in the art (POSA) would have been able to perform standard clinical trials on the known formulation from the ’285 patent and would have had a high expectation of success in determining its PK/PD profile, with the resulting data being the obvious outcome of such routine experimentation.

Ground 3: Obviousness of Claims 1-7 under §103 over the ’285 patent in view of the EC-Naprosyn® label and Howden 2005

  • Prior Art Relied Upon: Patent 8,557,285 (’285 patent), the EC-Naprosyn® Label (Jan. 2007), and Howden 2005 (a review article on immediate-release PPIs).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presents an argument that even if the PK/PD values are not inherent, a POSITA would have been motivated to target them. The ’285 patent provides the foundational teaching of a coordinated-release tablet combining naproxen and esomeprazole. The EC-Naprosyn® label, for a product identical to the naproxen component, disclosed PK values (Cmax and Tmax) that overlap with and teach the naproxen PK parameters recited in claim 1. Howden 2005, which discusses the marketed immediate-release PPI product Zegerid®, disclosed PK (AUC) and PD (gastric pH > 4.0) values that overlap with and teach the esomeprazole PK/PD parameters recited in claim 1.
    • Motivation to Combine (for §103 grounds): A POSITA, starting with the combination tablet concept from the ’285 patent, would combine the teachings of the secondary references to ensure efficacy. Petitioner argued a POSITA would be motivated to design a formulation that achieves the PK/PD values of known, effective, and marketed drugs like EC-Naprosyn® and Zegerid®. This provided a clear roadmap to arrive at the claimed PK/PD targets.
    • Expectation of Success (for §103 grounds): A POSITA would have a reasonable expectation of success in targeting these known effective PK/PD values when developing the combination formulation taught by the ’285 patent.

4. Key Claim Construction Positions

  • "Target" means "with the goal of obtaining": Petitioner argued that the term "target" as used in the claims does not require that the specified PK/PD values actually be achieved, only that the formulation be designed with the goal of achieving them. This construction is based on the plain and ordinary meaning of the word and is supported by data in the ’208 patent’s specification, which shows experimental variations far greater than the ±20% recited in the claims. This construction is central to the Ground 3 argument that a POSITA would be motivated to set the PK/PD values of known effective drugs as a goal or "target."

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and cancellation of claims 1-7 of Patent 9,393,208 as unpatentable.