PTAB

IPR2014-00325

BioDelivery Sciences Intl Inc v. RB Pharmaceuticals Ltd

Log In
Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Film Compositions Comprising an Opioid Agonist and Antagonist
  • Brief Description: The ’832 patent relates to an orally dissolving film formulation containing buprenorphine (an opioid agonist) and naloxone (an opioid antagonist). The invention is presented as a film dosage form that is bioequivalent to the commercially available Suboxone® sublingual tablet.

3. Grounds for Unpatentability

Ground 1: Anticipation over Suboxone Tablet Label - Claims 15-19 are anticipated by the Suboxone Tablet Label.

  • Prior Art Relied Upon: Suboxone Tablet Label (revised September 2006).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the Suboxone Tablet Label disclosed every element of the challenged claims. Independent claim 15 recites an "orally dissolving film formulation" comprising buprenorphine and naloxone that provides specific in vivo plasma profiles (Cmax ranges). Petitioner contended that the Suboxone tablet itself is an "orally dissolvable" formulation containing the same active ingredients. Crucially, Petitioner asserted that the components listed on the Suboxone Tablet Label (e.g., povidone, starch) are described in the ’832 patent itself as suitable for making films. Therefore, the tablet's composition anticipates the claimed "film formulation." Petitioner further argued the claimed Cmax and AUC ranges were calculated by the patentee to be 80-125% of the values from the Suboxone tablet, and thus the Suboxone tablet inherently anticipates these recited pharmacokinetic parameters.

Ground 2: Anticipation over Labtec - Claims 15-19 are anticipated by Labtec.

  • Prior Art Relied Upon: Labtec (International Publication No. WO 2008/040534).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Labtec, which was not considered during prosecution, explicitly addressed the same problem as the ’832 patent: creating a film product that mimics the pharmacokinetics of the Suboxone tablet. Labtec disclosed orally disintegrating film dosage forms containing both buprenorphine and naloxone. It also disclosed preferred pharmacokinetic parameters, including Cmax and AUC values for both drugs, that fall squarely within the ranges recited in claims 15-17. Labtec further taught adjusting the pH to modify drug absorption, directly contradicting the patentee's arguments during prosecution that such a concept was surprising and absent from the prior art. Petitioner contended Labtec discloses films made from film formulations, directly anticipating the claims even under a narrower construction than Petitioner proposed.

Ground 3: Obviousness over Suboxone Tablet Label and Yang - Claims 15-19 are obvious over Suboxone Tablet Label in view of Yang.

  • Prior Art Relied Upon: Suboxone Tablet Label (revised September 2006) and Yang (Patent 7,357,891).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground was presented as an alternative to the anticipation argument in Ground 1. Petitioner argued that the Suboxone Tablet Label disclosed all claim elements except for an explicit teaching of forming its components into a film. Yang, which was incorporated by reference in the ’832 patent, taught specific processes for making ingestible films using the same types of polymers (e.g., polyvinyl pyrrolidone) and ingredients found in the Suboxone tablet formulation.
    • Motivation to Combine (for §103 grounds): A POSITA would combine the known Suboxone tablet formulation with Yang’s film-making methods to gain market advantage. Specifically, creating a new dosage form like a film provides a period of market exclusivity for an existing drug product, a well-known strategy in the pharmaceutical industry.
    • Expectation of Success (for §103 grounds): A POSITA would have had a high expectation of success because the ’832 patent itself admitted that the components of the Suboxone tablet were suitable for making films and that the film-forming processes of Yang were suitable for use.

  • Additional Grounds: Petitioner asserted numerous additional challenges, including anticipation and obviousness grounds based on Euro-Celtique (WO 2008/025791) and various combinations including Birch (Application # 2005/0085440). These arguments largely paralleled the core contentions that the claimed formulation and pharmacokinetic profiles were already known or obvious from prior art seeking to create a generic or alternative version of the Suboxone tablet.

4. Key Claim Construction Positions

  • "film formulation": Petitioner argued this term should be construed as "a combination of components capable of being used to prepare a single film." This construction was central to the anticipation arguments, as it allowed the formulation of the prior art tablet (Suboxone Tablet Label) to anticipate the claims, given that the tablet's components were acknowledged as suitable for making films.
  • "provides an in vivo plasma profile": Petitioner asserted that this phrase, which introduces the Cmax and AUC limitations, recited a desired result of administering the formulation, not a structural or compositional property of the formulation itself. Citing Supreme Court precedent, Petitioner argued this "wherein" clause was not entitled to patentable weight and could not distinguish the claims from prior art compositions that lacked an explicit recitation of the resulting pharmacokinetic data.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 15-19 of Patent 8,475,832 as unpatentable.