PTAB

IPR2026-00149

Sarepta Therapeutics Inc v. Genzyme Corp

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles
  • Brief Description: The ’326 patent discloses methods for analyzing recombinant adeno-associated virus (rAAV) preparations using analytical ultracentrifugation (AUC) to determine the size and concentration of viral particles containing full or fragmented genomes.

3. Grounds for Unpatentability

Ground 1: Claims 1-4, 7, 12-13, 15, and 17-18 are obvious over Le Bec and de la Maza.

  • Prior Art Relied Upon: Le Bec (WO 2014/125101) and de la Maza (a 1978 book chapter).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Le Bec taught using sedimentation velocity AUC (SV-AUC) to characterize rAAV preparations, resolving distinct populations corresponding to empty capsids (65S), particles with single-stranded genomes (90S), and particles with complete double-stranded genomes (~105S). This satisfied the core method steps of independent claim 1. The central argument was that the Patent Owner secured the patent by incorrectly asserting during prosecution that the prior art did not appreciate the linear relationship between sedimentation coefficients and genome size, a principle necessary to analyze unknown fragmented genomes. Petitioner asserted that de la Maza, published decades earlier, explicitly disclosed this foundational concept, teaching a "direct linear relationship" between AAV particle density (and thus sedimentation coefficient) and the length of the encapsidated DNA. By combining Le Bec's modern AUC method with de la Maza's established principle, a POSITA would find it obvious to determine the size of any fragmented genome by comparing its sedimentation coefficient to those of known standards (e.g., empty and full particles).
    • Motivation to Combine (for §103 grounds): A POSITA would combine these references because both concern the characterization of AAV particles. Le Bec itself cited contemporaneous work from the same research group as de la Maza, demonstrating that a POSITA would look to this foundational research to interpret modern AUC data and understand the physical properties of the particles being analyzed.
    • Expectation of Success (for §103 grounds): A POSITA would have a high expectation of success in applying the established physical principles from de la Maza to the well-known SV-AUC technique disclosed in Le Bec to determine the size of fragmented genomes.

Ground 2: Claims 5 and 8-9 are obvious over Le Bec and de la Maza, in view of Cole.

  • Prior Art Relied Upon: Le Bec (WO 2014/125101), de la Maza (a 1978 book chapter), and Cole (a 2008 book chapter on AUC methods).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built on the Le Bec and de la Maza combination by adding Cole, a general treatise on optimizing AUC methods, to address dependent claims reciting routine experimental parameters. Petitioner argued that Cole provided express teachings for these parameters. For claim 5, Cole taught that SV-AUC experiments are typically performed in the temperature range of 4°C to 20°C. For claims 8 and 9, Cole recommended centrifugation run times of approximately 2 hours to ensure sufficient data acquisition for accurate analysis. These teachings represented standard, well-known operating conditions that a POSITA would have routinely employed.
    • Motivation to Combine (for §103 grounds): A POSITA implementing the SV-AUC methods of Le Bec would be motivated to consult a standard reference like Cole for guidance on optimizing routine experimental parameters such as temperature and duration. The ’326 patent itself acknowledged that such optimization was within the purview of a skilled artisan.
    • Expectation of Success (for §103 grounds): A POSITA would expect success in applying Cole's routine optimization parameters, as they were standard and predictable for SV-AUC analysis and would result in improved data quality.

Ground 3: Claims 14, 16, 19-23, and 26-30 are obvious over Le Bec and de la Maza, in view of Sommer.

  • Prior Art Relied Upon: Le Bec (WO 2014/125101), de la Maza (a 1978 book chapter), and Sommer (a 2003 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground added Sommer to the primary combination to render claims requiring quantification of viral particles obvious. Petitioner argued that after determining the size of fragmented genomes using the teachings of Le Bec and de la Maza, a POSITA would turn to a known method for quantification. Sommer provided specific mathematical formulas for calculating the molar extinction coefficient of an rAAV particle based directly on the molecular weight of its encapsidated DNA. A POSA would then use these calculated coefficients in the standard Beer's Law equation to determine the molar concentration and relative percentage of each rAAV species, including those with fragmented genomes. Petitioner noted that the ’326 patent specification itself cited and used the formulas from Sommer, confirming their relevance and applicability.
    • Motivation to Combine (for §103 grounds): A POSITA seeking to fully characterize an rAAV preparation for applications like gene therapy would be motivated to move beyond simply identifying species (per Le Bec and de la Maza) to quantifying them. Sommer provided a well-known, direct method for this quantification and was already recognized in the field as a key reference for this calculation.
    • Expectation of Success (for §103 grounds): A POSITA would have a high expectation of success, as the process involved applying standard mathematical formulas from Sommer to data obtained from the primary combination, a straightforward and predictable task.
  • Additional Grounds: Petitioner asserted an additional obviousness challenge for claim 25 over Le Bec, de la Maza, Sommer, and Cole, relying on the same motivations and teachings.

4. Relief Requested

  • Petitioner requests institution of IPR and cancellation of claims 1-5, 7-9, 12-23, and 25-30 of Patent 12,013,326 as unpatentable.