PTAB

IPR2024-00834

EncUbe Ethicals Pvt Ltd v. dermAVant Sciences GmbH

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Method for Treating Mild to Severe Plaque Psoriasis
  • Brief Description: The ’088 patent discloses a method for treating mild to severe plaque psoriasis by topically administering a composition containing about 1.0% tapinarof to affected areas once a day. The patent asserts the surprising discovery that once-daily application is as effective as twice-daily treatment, resulting in a specific improvement in Physician Global Assessment (PGA) score.

3. Grounds for Unpatentability

Ground 1: Anticipation over Sonti - Claims 1-4, 6, 8-9, 16, 18, and 22 are anticipated by Sonti.

  • Prior Art Relied Upon: Sonti (Application # 2016/0338973).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Sonti, a single prior art reference, expressly or inherently discloses every limitation of the challenged claims. Sonti teaches treating “moderate to severe plaque psoriasis” with topical emulsion compositions containing “1%... by weight” of tapinarof, applied “once daily” to affected areas. Critically, Sonti explicitly describes using PGA scores as a clinical endpoint, teaching that an embodiment of its invention is a patient “reaching a PGA score of 0 or 1” after treatment, which meets the core efficacy limitation of claim 1. Petitioner further contended that Sonti’s detailed formulation examples, which are incorporated by reference into the ’088 patent itself, disclose the specific oil-in-water emulsion components required by dependent claims 2, 3, and 4.

Ground 2: Obviousness over Bissonnette, Sonti, and/or Chen - Claims 1-4, 6-10, 16, 18, and 21-22 are obvious over Bissonnette in view of Sonti and/or Chen.

  • Prior Art Relied Upon: Bissonnette (a 2012 journal article), Sonti (Application # 2016/0338973), and Chen (Patent 7,868,047).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner asserted that Bissonnette, a Phase II clinical trial report, discloses nearly every element of the challenged claims. Bissonnette teaches treating patients with mild to severe plaque psoriasis by topically applying a 1% tapinarof cream and demonstrates treatment efficacy by showing patients achieved a PGA score of 0 or 1, or an improvement of at least two grades. The only element Bissonnette does not disclose is the "once a day" administration, as its trial protocol used a twice-daily regimen.
    • Motivation to Combine: A POSITA would combine Bissonnette’s teachings with the once-daily regimen taught by Sonti and Chen. The references address the exact same technical problem (treating plaque psoriasis) with the same active ingredient (tapinarof) at the same 1% concentration. Petitioner argued a POSITA would be motivated to reduce the dosing frequency from twice-daily to once-daily for well-known reasons: to improve patient compliance, reduce the risk of side effects, and lower treatment costs.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because both Sonti and Chen already taught that a once-daily 1% tapinarof composition was highly effective for treating plaque psoriasis, with Chen reporting "complete[] clearance" in seven days. Modifying Bissonnette's regimen from twice-daily to the known-effective once-daily frequency would have been a predictable optimization, not an inventive step.

  • Additional Grounds: Petitioner asserted that claims 1-4, 6-10, 16, 18, and 21-22 are also obvious over Sonti alone (Ground 2), arguing that even if Sonti did not explicitly teach every combination, a POSITA would have been motivated to combine its disclosed elements with a reasonable expectation of success. Petitioner also asserted an alternative obviousness challenge for claims 7, 9-10, and 21 based on Sonti in view of Bissonnette (Ground 3), arguing Bissonnette provides additional explicit support for using percent body surface area (BSA) as a metric.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not deny institution under 35 U.S.C. §325(d). It was contended that the primary prior art and arguments are new and were not previously before the U.S. Patent and Trademark Office. Specifically, the Bissonnette reference, which forms the basis of a primary ground, was never considered during prosecution. Furthermore, while Sonti was cited in the ’088 patent, its teachings regarding the method of treating plaque psoriasis and using PGA scores were never presented to or considered by the examiner; the examiner only considered Sonti for its formulation disclosures. Petitioner argued the examiner materially erred by overlooking these key teachings, which addressed the very elements the patent owner relied upon to overcome prior art rejections.

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and the cancellation of claims 1-4, 6-10, 16, 18, and 21-22 of the ’088 patent as unpatentable.