PTAB

IPR2022-00886

Novartis Pharmaceuticals Corp v. Shilpa Pharma Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Crystalline Forms of Fingolimod Hydrochloride
  • Brief Description: The ’816 patent claims a specific crystalline polymorph of fingolimod hydrochloride, designated "Form-β," which is characterized by specific X-ray powder diffraction (XRPD) and differential scanning calorimetry (DSC) data. Fingolimod hydrochloride is an immunosuppressant used to treat multiple sclerosis.

3. Grounds for Unpatentability

Ground 1: Anticipation by Mutz - Claims 1-4 are anticipated by Mutz under 35 U.S.C. §102.

  • Prior Art Relied Upon: Mutz (WO 2010/055028).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Mutz expressly discloses a crystalline form of fingolimod hydrochloride called "Form I," which is identical to the claimed "Form-β." The petition provided a detailed mapping showing that the set of seven characteristic XRPD 2θ° peaks recited in claim 1 are all present in the XRPD data for Form I disclosed in Mutz. Similarly, Petitioner asserted that the four endothermic DSC peaks recited in claims 2 and 3 fall squarely within the ranges disclosed by Mutz for Form I, including three specific phase transitions and an onset of decomposition at "ca. 260 °C," which corresponds to the fourth claimed peak range of 265-270 °C. For claim 4, Petitioner contended that the XRPD and DSC patterns in Mutz are so similar to those in the '816 patent's figures that Mutz's Form I is inherently "characterized by" those figures.
    • Key Aspects: Petitioner emphasized that the Patent Owner, in a parallel district court action, relied on the data from Mutz to allege infringement, effectively admitting that Mutz’s Form I possesses the characteristics of the claimed Form-β.

Ground 2: Obviousness over Mutz and the '005 Patent - Claims 1-4 are obvious over Mutz, alone or in view of the '005 patent, under 35 U.S.C. §103.

  • Prior Art Relied Upon: Mutz (WO 2010/055028) and the ’005 patent (Patent 8,766,005).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that, to the extent the Board finds Mutz does not explicitly anticipate every limitation, the claims are obvious. Mutz’s XRPD figure discloses all seven claimed peaks, making claim 1 obvious even if not all peaks were tabulated in Mutz’s text. For the DSC peaks in claims 2-4, Mutz explicitly discloses three transitions and an "onset of decomposition" at ca. 260°C, which would make the existence of a fourth endothermic peak in the 265-270°C range obvious to a person of ordinary skill in the art (POSITA). The '005 patent confirms this by explicitly showing a DSC scan with all four endothermic peaks, including one at 266°C.
    • Motivation to Combine: A POSITA would combine Mutz and the '005 patent because both references are in the same technological field—characterizing crystalline fingolimod hydrochloride—and address the same subject matter. A POSITA seeking to fully understand the polymorphic behavior of the compound disclosed in Mutz would have been motivated to consult other contemporaneous disclosures like the '005 patent to confirm or clarify its properties.
    • Expectation of Success: A POSITA would have a reasonable expectation of success in confirming the properties of Mutz's Form I by looking to the '005 patent. Both references use standard analytical techniques (XRPD and DSC) on the same compound, making their data directly comparable and predictable.

Ground 3: Anticipation by the '005 Patent - Claims 1-4 are anticipated by the '005 patent under 35 U.S.C. §102.

  • Prior Art Relied Upon: ’005 patent (Patent 8,766,005).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Example 2 of the '005 patent discloses a process for preparing "crystalline fingolimod hydrochloride" that results in a mixture of two polymorphs (Mutz's Form I and Form II). The XRPD and DSC data presented in the '005 patent for this mixture contain all the characteristic peaks required by claims 1-4 of the '816 patent. Specifically, the XRPD pattern in Figure 1 of the '005 patent includes peaks matching all those recited in claim 1, and the DSC scan in Figure 2 shows endothermic peaks at approximately 41°C, 67.16°C, 107.6°C, and 266°C, satisfying the limitations of claims 2-4.
    • Key Aspects: Petitioner argued that the disclosure of the claimed polymorph within a mixture, with accompanying analytical data that confirms its presence by showing all its characteristic peaks, is sufficient to anticipate the claims to the polymorph itself.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial would be improper. Against denial under Fintiv, Petitioner asserted that the co-pending district court litigation was in its infancy, with fact discovery just beginning and a trial date not scheduled until late 2023. Against denial under §325(d), Petitioner contended that the examiner made a material error by failing to substantively consider Mutz or the '005 patent during prosecution. Petitioner alleged this error was caused by the applicant's misleading statements in the '816 patent's specification, which incorrectly characterized the prior art as lacking disclosure of any "exact crystalline form" when, in fact, Mutz provided extensive XRPD and DSC data.

5. Relief Requested

  • Petitioner requests institution of IPR and cancellation of claims 1-4 of Patent 9,266,816 as unpatentable.