Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals LP

Prosecution History analysis

Examiner Search analysis

Invalidity Framework analysis

Petition

Petition summary

## 1. Case Identification
- Case Number: IPR2024-00056
- Patent #: [11,260,061](https://ai-lab.exparte.com/patent/11260061)
- Filed: October 24, 2024
- Petitioner(s): [Dr. Falk Pharma GMBH](https://ai-lab.exparte.com/party/dr-falk-pharma-gmbh)
- Patent Owner(s): [Ellodi Pharmaceuticals, L.P.](https://ai-lab.exparte.com/party/ellodi-pharmaceuticals-lp)
- Challenged Claims: 1-30

## 2. Patent Overview
- Title: Orally Disintegrating Tablet Comprising a Corticosteroid
- Brief Description: The [’061](https://ai-lab.exparte.com/patent/11260061) patent relates to orally disintegrating tablets (ODTs) for treating eosinophilic esophagitis. The tablets comprise a topically acting corticosteroid (e.g., budesonide, fluticasone) that is adsorbed onto a carrier, has a mean particle size on the micron scale (100 nm to 100 µm), and disintegrates within 60 seconds.

## 3. Grounds for Unpatentability
#### Ground 1: Claims 1-30 are obvious over Perrett
  - **Prior Art Relied Upon:** [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057) (Application # [2011/0081411](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057)).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner argued that [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057), which shares a common inventor with the [’061](https://ai-lab.exparte.com/patent/11260061) patent, discloses all limitations of the challenged claims. [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057) teaches ODTs comprising corticosteroids like budesonide and fluticasone for treating eosinophilic esophagitis. It explicitly discloses formulations with corticosteroid particle sizes of about 5-50 µm, drug amounts from 0.5 mg to 10 mg, and a disintegration time of "within 60 seconds" using the [USP <701>](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1016) test. Critically, Petitioner contended that [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057)’s disclosed manufacturing process—which involves granulating and blending the corticosteroid with carriers like microcrystalline cellulose—inherently results in the corticosteroid being "adsorbed onto" the carrier, a position supported by a decision from the [European Patent Office](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1062) ([EPO](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1062)) on a related patent.
    - **Motivation to Combine (for §103 grounds):** As a single-reference ground, the motivation was to combine the various disclosed embodiments within [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057). Petitioner asserted that a person of ordinary skill in the art (POSA) would be motivated to use [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057)’s disclosed carriers, particle sizes, and disintegration properties to create the claimed ODT, as doing so would be a matter of routine optimization to achieve a stable and effective formulation.
    - **Expectation of Success (for §103 grounds):** A POSA would have a high expectation of success because [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057) provides detailed examples and formulation parameters for creating ODTs with the claimed characteristics, and the underlying processes like blending and granulation were well-understood in the art.

#### Ground 2: Claims 1-2, 4-11, 17-20, 22, and 29-30 are obvious over Dohil2009 in view of the knowledge of a POSA
  - **Prior Art Relied Upon:** [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058) (Application # [2009/0191275](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058)) and general knowledge of a POSA, as represented by the [FDA Guidance on ODTs](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1005).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner argued that [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058) discloses topically acting corticosteroid (budesonide, fluticasone) tablets that "dissolve rapidly in the mouth" to treat esophageal conditions. [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058) teaches grinding the corticosteroid to a particle size of less than 10 microns and using dosage amounts from less than 1 mg to 10 mg. Petitioner asserted that [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058)'s process of combining corticosteroids with solid excipients like cellulose and starches results in adsorption. Any potential gaps, particularly the specific disintegration time and test method, were filled by the general knowledge of a POSA.
    - **Motivation to Combine (for §103 grounds):** A POSA would be motivated to formulate the rapidly dissolving tablet of [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058) to meet the specific standards for ODTs prevalent at the time. The 2008 [FDA Guidance on ODTs](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1005), representing the knowledge of a POSA, recommended a disintegration time of 30 seconds or less when tested using the [USP <701>](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1016) method. A POSA seeking to develop a commercial ODT product based on [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058)'s disclosure would have been motivated to follow this FDA guidance to ensure regulatory approval and patient compliance.
    - **Expectation of Success (for §103 grounds):** A POSA would have reasonably expected success in achieving the claimed disintegration time, as formulating ODTs to dissolve in under a minute was a routine exercise by 2013, supported by many commercially available products and established formulation techniques.

#### Ground 3: Claims 1-30 are obvious over Dohil2009 and Venkatesh in view of the knowledge of a POSA
  - **Prior Art Relied Upon:** [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058) (Application # [2009/0191275](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058)) and [Venkatesh](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020) (Application # [2005/0232988](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020)).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** This ground asserted that to the extent [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058) does not explicitly teach every element, [Venkatesh](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020) provides the missing disclosures. [Venkatesh](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020), which also shares an inventor with the [’061](https://ai-lab.exparte.com/patent/11260061) patent, explicitly discloses ODTs made of "rapidly dispersing microgranules" that disintegrate in "preferably less than 60 seconds." It teaches using micronized drug particles (less than 50 microns) to achieve a "smooth creamy mouthfeel" and discloses the use of carriers (mannitol, microcrystalline cellulose), disintegrants, and specific manufacturing methods.
    - **Motivation to Combine (for §103 grounds):** A POSA would combine the teachings of [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058) and [Venkatesh](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020) to optimize the ODT formulation. [Venkatesh](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020) provides specific solutions (e.g., rapidly dispersing microgranules, specific particle sizes) to known ODT formulation challenges like grittiness and disintegration speed. A POSA starting with [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058)'s corticosteroid ODT concept would have been motivated to incorporate [Venkatesh](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020)'s established techniques to improve patient experience and manufacturability.
    - **Expectation of Success (for §103 grounds):** Success was predictable because [Venkatesh](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020) teaches that its ODT formulations "don't require a special pharmaceutical production technique" and can be made with normal equipment, reinforcing that the combination was a matter of applying known methods to a known drug formulation.

## 4. Key Claim Construction Positions
- **"Adsorbed Onto A Pharmaceutically Acceptable Carrier" (Claims 1, 19, 30):** Petitioner argued this term should be given its plain and ordinary meaning, which it proposed as "the reversible disposition of a corticosteroid particle on the surface of a pharmaceutically acceptable carrier." This construction is central to Petitioner's case, as it supports the argument that conventional pharmaceutical processes like blending and granulating, which are disclosed in [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057) and [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058), inherently result in adsorption and thus meet the claim limitation without requiring a more complex or specific process.

## 6. Arguments Regarding Discretionary Denial
- Petitioner argued that discretionary denial under §325(d) would be inappropriate. Although the asserted prior art ([Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057), [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058), [Venkatesh](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1020)) was before the Examiner during prosecution, the arguments presented in the petition are substantially different. Petitioner contended the Examiner did not apply [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057) or [Dohil2009](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1058) as primary references and was misled by the Patent Owner's arguments that the art failed to disclose adsorption. Petitioner asserted that the Examiner erred in a manner material to patentability by overlooking key disclosures in these references. This error is highlighted by a subsequent [EPO](https://ai-lab.exparte.com/case/ptab/IPR2024-00056/doc/1062) decision that found similar claims obvious over [Perrett](https://ai-lab.exparte.com/docs/ptab/IPR2025-00056/1057), a decision the USPTO Examiner did not have the benefit of considering.

## 7. Relief Requested
- Petitioner requests institution of an inter partes review and cancellation of claims 1-30 of the [’061](https://ai-lab.exparte.com/patent/11260061) patent as unpatentable.

Corticosteroid ODT patent faces 3 obviousness challenges: Perrett & Dohil cited against all 30 claims for eosinophilic esophagitis treatment.