PTAB

IPR2025-00056

DR Falk Pharma GmbH v. Ellodi Pharmaceuticals LP

Key Events

Petition

petition

Title: Orally Disintegrating Corticosteroid Tablets
Brief Description: The ’061 patent discloses orally disintegrating tablets (ODTs) containing a topically acting corticosteroid, such as budesonide or fluticasone propionate. The claimed invention involves micron-scale corticosteroid particles adsorbed onto a pharmaceutically acceptable carrier, formulated to disintegrate within 60 seconds.

Prior Art Relied Upon: Perrett (Application # 2011/0081411).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Perrett, which shares a common inventor with the ’061 patent, discloses all limitations of the challenged claims. Perrett teaches ODTs comprising corticosteroids (budesonide, fluticasone propionate) for treating eosinophilic esophagitis. It discloses preparing these ODTs by granulating or blending micron-sized corticosteroid particles (e.g., 5-50 µm) with pharmaceutically acceptable carriers (e.g., microcrystalline cellulose, starches). Petitioner asserted that these standard blending and granulating processes inherently result in the corticosteroid being adsorbed onto the carrier. Perrett also explicitly teaches formulating tablets to disintegrate "within 60 seconds" using the USP <701> test method.
- Motivation to Combine: As a single-reference ground, Petitioner contended that a person of ordinary skill in the art (POSA) would have been motivated to combine the various disclosed embodiments within Perrett to arrive at the claimed invention, as doing so would not require a leap of inventiveness.
- Expectation of Success: A POSA would have had a high expectation of success, as Perrett provides detailed examples and formulation parameters for creating the claimed ODTs.

Prior Art Relied Upon: Dohil2009 (Application # 2009/0191275).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued Dohil2009 discloses dissolving tablets containing topically acting corticosteroids (budesonide, fluticasone) with micron-sized particles (less than 10 microns) for treating esophageal conditions. It teaches combining these corticosteroids with solid excipients (carriers) like cellulose and starch. Petitioner asserted that this mixing process would be understood by a POSA to result in adsorption. While Dohil2009 teaches tablets that "dissolve rapidly," it does not specify a time.
- Motivation to Combine: The "knowledge of a POSA," represented by the 2008 FDA Guidance on ODTs, would have motivated a formulator to ensure Dohil2009’s "rapidly dissolving" tablet met the industry-standard disintegration time of 60 seconds or less (specifically, approximately 30 seconds). Formulating for FDA compliance would be a strong motivation.
- Expectation of Success: A POSA would have had a high expectation of success in achieving the claimed disintegration time, as formulating ODTs to meet this standard was a routine exercise by 2013, supported by numerous commercially available products.

Prior Art Relied Upon: Dohil2009 (Application # 2009/0191275) and Venkatesh (Application # 2005/0232988).
Core Argument for this Ground:
- Prior Art Mapping: This ground uses Dohil2009 as a base reference for a corticosteroid dissolving tablet and supplements it with Venkatesh, which also shares an inventor with the ’061 patent. Petitioner argued that to the extent Dohil2009 has any deficiencies, Venkatesh supplies the missing elements. Venkatesh expressly discloses ODTs made of "rapidly dispersing microgranules" that disintegrate in "preferably less than 60 seconds" and use micronized drug particles (less than 50 µm) to achieve a desirable "smooth creamy mouthfeel" without grittiness.
- Motivation to Combine: A POSA would combine Dohil2009's corticosteroid formulation with Venkatesh's teachings on ODT manufacturing techniques. The motivation would be to improve patient compliance by achieving the superior mouthfeel and well-defined rapid disintegration properties taught by Venkatesh, which were known and desirable goals for ODTs.
- Expectation of Success: Success would be reasonably expected because Venkatesh provides detailed formulation techniques that "don't require a special pharmaceutical production technique" and are suitable for any therapeutic agent, including the corticosteroids of Dohil2009.

"Adsorbed Onto A Pharmaceutically Acceptable Carrier": This term was central to Petitioner's arguments. Petitioner contended the term should be given its plain and ordinary meaning, which includes "the reversible disposition of a corticosteroid particle on the surface of a pharmaceutically acceptable carrier." Critically, Petitioner argued that this physical state is the natural and inherent result of well-known pharmaceutical processes like blending, mixing, or granulating fine, cohesive drug powders (like micronized corticosteroids) with larger, coarse carrier particles, as taught by the prior art references.

Petitioner argued that discretionary denial under §325(d) would be inappropriate. While the asserted prior art references (Perrett, Dohil2009, and Venkatesh) were before the USPTO during prosecution, they were never applied as primary references against the claims.
Petitioner asserted that the Examiner was misled by Patent Owner's arguments against a different primary reference and therefore "erred in a manner material to the patentability of the challenged claims." Specifically, Petitioner argued that Perrett and Dohil2009 clearly disclose the key features (micronized, adsorbed corticosteroids in ODTs) that the Patent Owner successfully argued were missing from the art, and the Examiner overlooked these dispositive teachings.
Further, Petitioner noted that the Examiner did not have the benefit of a decision from the European Patent Office (EPO), which found a related European patent obvious over Perrett.

Petitioner requests institution of IPR and cancellation of claims 1-30 of the ’061 patent as unpatentable.