GlaxoSmithKline Consumer Healthcare Holdings US LLC v. Cipla Ltd

1. Case Identification

• Case #: IPR2020-00371
• Patent #: 9,901,585
• 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: Nasal Spray Formulations
• Brief Description: The ’585 patent is directed to aqueous nasal spray formulations that combine the antihistamine azelastine hydrochloride and the corticosteroid fluticasone propionate for treating conditions such as allergic rhinitis.

3. Grounds for Unpatentability

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

• Prior Art Relied Upon: PDR 1999 (Physicians' Desk Reference, 1999) and Segal (WO 98/48839).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that PDR 1999 disclosed all limitations of the independent claims, albeit in two separate, commercially available, and FDA-approved products. Astelin® was a nasal spray containing 0.1% azelastine hydrochloride (within the claimed range) along with claimed excipients like preservatives (benzalkonium chloride, edetate disodium) and a thickening agent. Flonase® was a nasal spray containing 0.05% fluticasone propionate (within the claimed range) along with claimed excipients like a surfactant (polysorbate 80) and thickening agents. Petitioner asserted that Segal explicitly taught combining the same two active ingredients—azelastine and fluticasone propionate—into a single nasal spray formulation containing preservatives and isotonic agents to treat nasal conditions.
  • Motivation to Combine: Petitioner contended a person of ordinary skill in the art (POSA) would combine the teachings of PDR 1999 based on Segal’s express disclosure. Segal provided the motivation by teaching the benefits of a single co-formulation, including convenient administration, improved patient compliance, and the potential for additive and synergistic therapeutic effects. Combining the known, safe, and effective components of Astelin® and Flonase® as taught by Segal was presented as a logical and advantageous step for a POSA.
  • Expectation of Success: Petitioner argued a POSA would have a reasonable expectation of success. The individual products detailed in PDR 1999 were already known to be safe and effective for treating allergic rhinitis. Segal further supported this expectation by disclosing that such co-formulations can be conveniently administered to achieve the desired therapeutic effect. The petition asserted that preparing the combined formulation would involve only routine techniques well known in the pharmaceutical arts.

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

• Prior Art Relied Upon: Cramer (European Application # EP 0,780,127 A1) and PDR 1999 (Physicians' Desk Reference, 1999).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Cramer taught the core invention by disclosing nasal spray formulations comprising a combination of a glucocorticoid (expressly naming fluticasone) and a leukotriene-inhibiting antihistamine (expressly naming azelastine). Cramer taught concentration ranges for both active ingredients that overlap with the claimed ranges and disclosed the use of all required excipient types, including preservatives, thickening agents, surfactants, and tonicity adjusters. Cramer’s Example 3 provided a specific formulation with azelastine HCl and noted that other glucocorticoids like fluticasone could be substituted to achieve similar results. PDR 1999 was used to supplement this teaching by providing the specific formulations of the well-known, successful commercial products Astelin® and Flonase®.
  • Motivation to Combine: The primary motivation, according to Petitioner, came from Cramer itself, which taught that combining a nasal corticosteroid with an antihistamine results in "improved intranasal compositions" that provide "improved relief of symptoms." A POSA would combine Cramer's teaching of a co-formulation with the specific, proven components and concentrations disclosed in PDR 1999 for Astelin® and Flonase® to create an optimized, safe, and effective product.
  • Expectation of Success: Petitioner asserted a strong expectation of success. Cramer explicitly disclosed that such combinations provide improved therapeutic relief and could be prepared using conventional mixing techniques. This was reinforced by PDR 1999, which demonstrated that both azelastine and fluticasone were individually safe and effective in their respective FDA-approved nasal spray products. Combining these known components as taught by Cramer would have been a predictable endeavor for a POSA.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) would be inappropriate. Although the examiner considered Cramer during prosecution of the ’585 patent, the rejection was overcome based solely on alleged objective indicia of nonobviousness. Petitioner contended that these indicia, upon proper review, failed to demonstrate nonobviousness.
• The petition also noted that a prior inter partes review (IPR) on a related patent, the Argentum IPR, was instituted by the Board based on similar prior art and arguments, suggesting the grounds have merit. That IPR was terminated due to settlement before a Final Written Decision (FWD) was issued.

5. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 1-30 of Patent 9,901,585 as unpatentable.