DCT
1:14-cv-01574
Reckitt Benckiser Pharma Inc v. Watson Laboratories Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Reckitt Benckiser Pharmaceuticals Inc. (Delaware) and MonoSol Rx, LLC (Delaware)
- Defendant: Watson Laboratories, Inc. (Delaware)
- Plaintiff’s Counsel: Womble Carlyle Sandridge & Rice, LLP; Troutman Sanders LLP; Steptoe & Johnson LLP
- Case Identification: 1:14-cv-01574, D. Del., 12/31/2014
- Venue Allegations: Venue is alleged to be proper based on Defendant's incorporation in Delaware, its continuous and systematic contacts within the district, and its marketing and sales activities.
- Core Dispute: Plaintiffs allege that the manufacturing process for Defendant's proposed generic version of Suboxone® sublingual film will infringe two patents related to methods for creating pharmaceutical films with a substantially uniform distribution of components.
- Technical Context: The technology concerns manufacturing processes for orally dissolvable pharmaceutical films, a dosage form that serves as an alternative to traditional pills and tablets for delivering active pharmaceutical ingredients.
- Key Procedural History: This action was filed in the context of the Hatch-Waxman Act, following Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA. The parties are concurrently involved in separate litigation (C.A. 13-1674) concerning different patents listed in the FDA's Orange Book as covering the Suboxone® product itself, whereas this case focuses on process patents.
Case Timeline
| Date | Event |
|---|---|
| 2001-10-12 | Earliest Patent Priority Date ('497 and '277 Patents) |
| 2010-08-30 | FDA approves NDA for Suboxone® sublingual film |
| 2014-12-02 | U.S. Patent No. 8,900,497 issues |
| 2014-12-09 | U.S. Patent No. 8,906,277 issues |
| 2014-12-31 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,900,497 - "Process for Making a Film Having a Substantially Uniform Distribution of Components," Issued December 2, 2014
The Invention Explained
- Problem Addressed: The patent describes that prior art methods for creating drug-delivery films suffered from the aggregation and conglomeration of active ingredients during the manufacturing process, resulting in non-uniform films that could not ensure accurate dosing (Compl. ¶18; ’497 Patent, col. 2:25-44). Conventional drying techniques, such as high-temperature air ovens, exacerbate this by forming a "skin" on the film's surface, which traps moisture and leads to a "ripple effect" and an uneven final product (’497 Patent, col. 3:37-62).
- The Patented Solution: The invention claims a process for making films that maintains a "non-self-aggregating uniform heterogeneity" by using a controlled and rapid drying process (’497 Patent, Abstract). A key aspect of this solution is drying the film in a manner that avoids the formation of a surface skin, for instance by applying heat to the bottom surface of the film while minimizing top-side air flow, which allows for uniform evaporation and prevents particle migration (’497 Patent, col. 7:5-13). This rapid drying "locks-in" the components, ensuring the active ingredient is evenly distributed throughout the final film product (’497 Patent, col. 57:5-8).
- Technical Importance: This process was designed to overcome the critical barrier of non-uniformity, enabling the production of oral films that can meet the stringent dosage accuracy standards required by regulatory bodies like the FDA (’497 Patent, col. 2:45-53).
Key Claims at a Glance
- The complaint asserts "one or more claims" of the patent (Compl. ¶25). Independent claim 1 is representative and includes the following essential elements:
- (a) forming a flowable polymer matrix comprising an edible polymer, a solvent, and an active, with a substantially uniform distribution;
- (b) casting the flowable polymer matrix;
- (c) rapidly evaporating a portion of the solvent to form a visco-elastic film within about the first 4.0 minutes to lock-in the uniform distribution;
- (d) further drying the film to form a self-supporting edible film;
- wherein the final uniformity is such that equally sized unit doses do not vary by more than 10% of the desired amount of active.
U.S. Patent No. 8,906,277 - "Process for Manufacturing a Resulting Pharmaceutical Film," Issued December 9, 2014
The Invention Explained
- Problem Addressed: The "’277 Patent" addresses the same technical problems as the ’497 Patent, focusing on the challenge of achieving uniform component distribution in pharmaceutical films to ensure accurate dosing (Compl. ¶19; ’277 Patent, col. 2:40-53).
- The Patented Solution: The solution is also a controlled manufacturing and drying process. This patent, however, adds specific requirements for the rheological properties of the initial mixture, describing it as a "Non-Newtonian visco-elastic polymer matrix" that is a "shear-thinning pseudoplastic fluid" (’277 Patent, col. 39:60-65). Controlling these fluid properties before and during casting is presented as another mechanism to prevent particle settling and ensure uniformity, in conjunction with the controlled drying process described in the ’497 patent (’277 Patent, col. 9:1-10).
- Technical Importance: By specifying the fluid dynamics of the film matrix, the invention provides an additional layer of control over the manufacturing process, further ensuring the final product's uniformity and suitability for pharmaceutical use (’277 Patent, col. 9:36-42).
Key Claims at a Glance
- The complaint asserts "one or more claims" of the patent (Compl. ¶29). Independent claim 1 is representative and includes the following essential elements:
- (a) forming a Non-Newtonian visco-elastic polymer matrix that is a shear-thinning pseudoplastic fluid;
- (b) casting the polymer matrix;
- (c) conveying the matrix through a drying apparatus and rapidly drying it to form a visco-elastic film;
- (d) forming the resulting film by further controlling the drying process;
- wherein the final film has a uniform distribution of the active such that it varies by no more than 10% from the desired amount.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the process used to manufacture Defendant's generic buprenorphine hydrochloride and naloxone hydrochloride sublingual film (Compl. ¶¶ 20, 22).
Functionality and Market Context
- The complaint alleges that Defendant submitted ANDA No. 20-4383 to the FDA seeking approval to manufacture and sell a generic version of Plaintiffs' Suboxone® sublingual film, a product used for the maintenance treatment of opioid dependence (Compl. ¶¶ 10, 13, 20). The complaint alleges, "on information and belief," that the manufacturing process used to produce this generic product is a method protected by the patents-in-suit (Compl. ¶22). The complaint does not provide specific technical details about the accused manufacturing process itself, instead basing its infringement theory on the inference that a bioequivalent product would be made by an infringing process.
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint does not provide a detailed, element-by-element infringement analysis or a claim chart. The allegations are made generally "on information and belief" (Compl. ¶22). The following tables summarize the infringement theory by mapping the conclusory allegation of infringement to the elements of the representative independent claims.
8,900,497 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) forming a flowable polymer matrix comprising an edible polymer, a solvent and a desired amount of at least one active, said matrix having a substantially uniform distribution of said at least one active; | The complaint alleges on information and belief that the process used to manufacture Defendant's generic product includes this step. | ¶22 | col. 9:56-61 |
| (b) casting said flowable polymer matrix; | The complaint alleges on information and belief that the process used to manufacture Defendant's generic product includes this step. | ¶22 | col. 26:5-15 |
| (c) rapidly evaporating at least a portion of said solvent upon initiation of drying to form a visco-elastic film within about the first 4.0 minutes to maintain said substantially uniform distribution...by locking-in or substantially preventing migration of said at least one active...; | The complaint alleges on information and belief that the process used to manufacture Defendant's generic product includes this step. | ¶22 | col. 27:27-45 |
| (d) further drying said visco-elastic film to form a self-supporting edible film having a substantially uniform distribution of said at least one active component... | The complaint alleges on information and belief that the process used to manufacture Defendant's generic product includes this step. | ¶22 | col. 27:6-9 |
8,906,277 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) forming a Non-Newtonian visco-elastic polymer matrix...said polymer matrix is a shear-thinning pseudoplastic fluid...; | The complaint alleges on information and belief that the process used to manufacture Defendant's generic product includes this step. | ¶29 | col. 9:1-8 |
| (b) casting said polymer matrix; | The complaint alleges on information and belief that the process used to manufacture Defendant's generic product includes this step. | ¶29 | col. 26:5-15 |
| (c) conveying said polymer matrix through a drying apparatus and rapidly drying said polymer matrix...to form a visco-elastic film...; | The complaint alleges on information and belief that the process used to manufacture Defendant's generic product includes this step. | ¶29 | col. 13:36-54 |
| (d) forming the resulting pharmaceutical film from said visco-elastic film by further controlling drying... | The complaint alleges on information and belief that the process used to manufacture Defendant's generic product includes this step. | ¶29 | col. 27:6-9 |
Identified Points of Contention:
- Evidentiary Questions: The central issue will be factual. The complaint provides no evidence regarding Defendant’s actual manufacturing process. A key question for the court will be what evidence emerges during discovery to support the "information and belief" allegations for each claimed step.
- Technical Questions: Assuming discovery reveals Defendant's process, technical questions will arise. For the ’497 Patent, does Defendant's drying process meet the temporal and functional requirements of "rapidly evaporating...within about the first 4.0 minutes" to "lock-in" the components? For the ’277 Patent, what are the measured rheological properties of Defendant's polymer matrix, and do they qualify as a "shear-thinning pseudoplastic fluid"?
V. Key Claim Terms for Construction
"rapidly evaporating... to form a visco-elastic film within about the first 4.0 minutes" (’497 Patent, Claim 1)
- Context and Importance: This term defines the speed and initial outcome of the patented drying process, which is central to distinguishing it from slower prior art methods. The construction of "about... 4.0 minutes" will be critical to determining infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the desired drying time more generally, stating it should occur "within about ten minutes or fewer, or more desirably within about five minutes or fewer" (’497 Patent, col. 7:31-35), which may suggest that "about 4.0 minutes" is an exemplary, rather than a rigid, timeframe for achieving the "rapid" result.
- Evidence for a Narrower Interpretation: The claim explicitly recites the "4.0 minutes" limitation. A defendant may argue that this specific timeframe was chosen to secure allowance of the patent and cannot be broadened to cover processes that are merely "fast" but fall outside this enumerated range.
"locking-in or substantially preventing migration" (’497 Patent, Claim 1)
- Context and Importance: This functional language describes the purpose of the rapid drying step. Infringement will depend on how much, if any, particle migration occurs in the accused process and whether it is "substantially prevented."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent defines the required outcome as a film where dosage units "do not vary by more than 10% of said desired amount" (’497 Patent, col. 57:12-15). A plaintiff may argue that any process achieving this level of uniformity necessarily meets the "locking-in" limitation, regardless of the precise physical mechanism.
- Evidence for a Narrower Interpretation: The specification links the "locking-in" to the rapid formation of a "visco-elastic" solid structure (’497 Patent, col. 29:20-24). A defendant may argue that the term requires proof of this specific structural change, not just the achievement of a uniform end product.
VI. Other Allegations
The complaint does not provide sufficient detail for analysis of indirect or willful infringement. The action is framed as a request for a declaratory judgment of infringement under 35 U.S.C. § 271, triggered by Defendant's ANDA filing (Compl. ¶¶ 23-26, 27-30).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case appears to depend on the answers to two primary questions:
- A core issue will be evidentiary and factual: What are the specific parameters, rheological properties, and drying mechanics of the Defendant's confidential manufacturing process, and will discovery produce evidence sufficient to substantiate the complaint's "information and belief" allegations that this process meets each limitation of the asserted claims?
- A second key issue will be one of claim construction and scope: How will the court define the boundaries of terms such as "rapidly evaporating...within about the first 4.0 minutes" and "shear-thinning pseudoplastic fluid"? The outcome will depend on whether Defendant's process, once revealed, falls within the scope of these key limitations as construed by the court.