GlaxoSmithKline Consumer Healthcare Holdings US LLC v. Cipla Ltd

1. Case Identification

• Case #: IPR2020-00370
• Patent #: 9,259,428
• Filed: January 31, 2020
• Petitioner(s): GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Patent Owner(s): Cipla Ltd.
• Challenged Claims: 1-30

2. Patent Overview

• Title: Pharmaceutical Compositions Comprising Azelastine and Fluticasone
• Brief Description: The ’428 patent describes methods for treating allergic rhinitis by administering a nasal spray formulation that combines the antihistamine azelastine hydrochloride and the corticosteroid fluticasone propionate into a single composition.

3. Grounds for Unpatentability

Ground 1: Claims 1-30 are obvious over PDR 1999 in view of Segal.

• Prior Art Relied Upon: PDR 1999 (the 1999 Physicians' Desk Reference) and Segal (International Publication No. WO 98/48839).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that PDR 1999 disclosed all elements of the claimed invention, albeit in two separate, commercially successful products. PDR 1999 described Astelin®, a nasal spray containing azelastine hydrochloride, preservatives, a thickening agent, and tonicity agents. It also described Flonase®, a nasal spray containing fluticasone propionate, preservatives, a thickening agent, a surfactant, and tonicity agents. Petitioner asserted that a person of ordinary skill in the art (POSITA) would look to these FDA-approved products as starting points for formulating a nasal spray for allergic rhinitis. Segal then explicitly taught the combination of a topical anti-inflammatory agent like fluticasone propionate with an additional therapeutic agent like azelastine.
  • Motivation to Combine: Petitioner contended that a POSITA would combine the teachings of PDR 1999 in light of Segal’s express disclosure. Segal taught that co-formulating these agents into a single nasal spray composition provides benefits such as convenient administration, improved patient compliance, and the potential for additive or synergistic effects in treating allergic rhinitis. This provided a clear reason to combine the well-known Astelin® and Flonase® formulations.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because both azelastine and fluticasone were already known from PDR 1999 to be safe and effective for treating allergic rhinitis when administered via nasal spray. Combining two known, effective treatments for the same condition into a single dosage form was a predictable and routine path for drug development, and Segal confirmed the suitability of such a combination.

Ground 2: Claims 1-30 are obvious over Cramer in view of PDR 1999.

• Prior Art Relied Upon: Cramer (European Patent Application Publication No. EP 0,780,127 A1) and PDR 1999.
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Cramer disclosed a nasal spray formulation for treating allergic rhinitis comprising both a glucocorticoid (expressly naming fluticasone) and a leukotriene-inhibiting antihistamine (expressly naming azelastine). Cramer taught that these formulations could contain various excipients, including preservatives, thickening agents, surfactants, and tonicity adjusting agents, thus teaching all components required by the independent claims. Cramer's Example 3 provided a specific co-formulation of azelastine HCl with another corticosteroid, and Cramer stated that "substantially similar results" would be obtained by substituting other glucocorticoids like fluticasone.
  • Motivation to Combine: The primary motivation was inherent in Cramer itself, which explicitly taught combining azelastine and fluticasone for improved relief of allergic rhinitis symptoms. PDR 1999 supplemented Cramer by providing knowledge of the specific, successful, and FDA-approved formulations of the individual components (Astelin® and Flonase®), reinforcing the choice of excipients and concentrations. A POSITA would combine Cramer's teaching of the active ingredient combination with the well-established formulation knowledge from PDR 1999.
  • Expectation of Success: A POSITA would have a strong expectation of success. Cramer expressly taught that the combination would result in "improved intranasal compositions" and could be "conveniently administered nasally." The established safety and efficacy profiles of the individual components, as detailed in PDR 1999, would further assure a POSITA that combining them would be a predictable and successful endeavor for treating allergic rhinitis.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that the petition should not be denied under 35 U.S.C. §325(d). Although the examiner considered Cramer during the original prosecution, the rejection was overcome based on declarations alleging objective indicia of nonobviousness. Petitioner contended that this evidence was flawed and did not actually demonstrate nonobviousness, meaning the prior art was not substantively reviewed in the correct context. Furthermore, a prior IPR on a related patent (the Argentum IPR) was instituted on similar grounds but settled before a final written decision, so the Board had not yet issued a determinative ruling on the merits of these invalidity arguments.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-30 of the ’428 patent as unpatentable.