PTAB

IPR2015-01495

Pharmacosmos AS v. Luitpold Pharmaceuticals Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Methods and Compositions for Administration of Iron
  • Brief Description: The ’612 patent discloses methods for treating iron deficiency by administering a single, high dose (at least 0.6 g) of an iron carbohydrate complex in a short time frame (e.g., 15 minutes or less). The invention is purported to provide a lower risk of hypersensitivity reactions compared to prior art iron dextran therapies.

3. Grounds for Unpatentability

Ground 1: Anticipation by Groman - Claims 1-5, 15, and 16 are anticipated by Groman.

  • Prior Art Relied Upon: Groman (Application # 2003/0232084).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Groman discloses every limitation of the challenged claims. Groman teaches treating anemia with iron carbohydrate complexes, specifically "carboxymethyl reduced dextran" (CMRD), which Petitioner asserted is an iron polyglucose sorbitol carboxymethyl ether complex as recited in claim 1. Groman allegedly discloses administering single doses up to 0.6 g, parenteral administration rates "substantially greater than 1 mL/min," which would include the claimed "about 15 minutes or less" for the disclosed volumes, and that its complexes are "immunosilent" with a "minimal incidence of anaphylaxis," meeting the "substantially non-immunogenic carbohydrate component" limitation. Petitioner further asserted Groman's disclosure of treating chronically iron-deprived patients, including cancer and dialysis patients, anticipates dependent claims 3-5; its teaching of complexes with a mean volume diameter of 21 nm anticipates claim 15's size limitation; and its express teaching of parenteral administration anticipates claim 16.

Ground 2: Anticipation by Marchasin - Claim 20 is anticipated by Marchasin.

  • Prior Art Relied Upon: Marchasin (a 1964 article in Blood).
  • Core Argument for this Ground:
    • Prior Art Mapping: This argument was predicated on construing the term "iron polyisomaltose complex," recited in claim 20, as being synonymous with "iron dextran." Petitioner contended this construction is mandated by the ’612 patent's specification. Marchasin allegedly discloses administering a high molecular weight iron dextran (Imferon®) to treat iron-deficiency anemia in single doses of 1000 mg and 2000-3000 mg, exceeding the "at least about 0.6 g" threshold. The administration was by injection over a 4-10 minute period, satisfying the "about 15 minutes or less" limitation. Petitioner argued that Marchasin's report of "no untoward local reactions" and its conclusion that the iron dextran preparation was "safe and well-tolerated" meets the "substantially non-immunogenic" limitation under the broadest reasonable interpretation.

Ground 3: Obviousness over Groman and Geisser - Claims 7, 11, and 12 are obvious over Groman in view of Geisser.

  • Prior Art Relied Upon: Groman (Application # 2003/0232084) and Geisser (International Publication No. WO2004037865).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner asserted Groman teaches administering "immunosilent" iron complexes at doses up to 0.6 g in a rapid timeframe (15 minutes or less), while Geisser teaches highly stable, low-toxicity iron carboxymaltose complexes suitable for high single doses of 500-1000 mg (1.0 g). The combination of Geisser's higher dosage with Groman's rapid administration method allegedly renders claim 7 (requiring at least 1.0 g) obvious. Claims 11 and 12, directed specifically to iron carboxymaltose and its chemical structure, were argued to be obvious because Geisser explicitly discloses these complexes.
    • Motivation to Combine: A POSITA would combine these references because they disclose structurally analogous iron carbohydrate complexes used for the same purpose: treating iron deficiency. Geisser's disclosure that high complex stability enables higher doses would have motivated a POSITA to administer Geisser's higher-dose (1.0 g) iron carboxymaltose using the rapid administration protocol taught by Groman for a similar low-toxicity complex.
    • Expectation of Success: A POSITA would have an expectation of success due to the known properties of the complexes in the art. The high stability and low toxicity of both the Groman and Geisser complexes would suggest that the larger doses from Geisser could be administered safely and effectively using the rapid infusion method of Groman.

  • Additional Grounds: Petitioner asserted additional challenges, including an alternative ground that claim 20 is anticipated by Groman under a narrower claim construction, and that claims 8 and 17 are obvious over Groman in view of van Zyl-Smit for even higher dosages (at least 1.5 g).

4. Key Claim Construction Positions

  • "Iron Polyisomaltose Complex": Petitioner argued this term should be construed as a synonym for "iron dextran." This position was central to the anticipation argument in Ground 2 (over Marchasin). The argument was based on the patent specification's parenthetical disclosure of "iron polyisomaltose (iron dextran)," which Petitioner contended acts as an explicit definition making the terms interchangeable.
  • Alternative Construction of "Iron Polyisomaltose Complex": For Ground 3, Petitioner proposed an alternative construction based on the Patent Owner's arguments during prosecution, which would limit the term to an "essentially purely linear" and reduced (hydrogenated) polymer with a low molecular weight. Petitioner argued that even under this narrower construction, Groman still anticipates claim 20 because it discloses iron complexes made with reduced Dextran T1, which meets these structural characteristics.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-5, 7-8, 11-12, 15-17, and 20 of Patent 8,895,612 as unpatentable.