MonoSol RX LLC v. BioDelivery Sciences Intl Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: MonoSol Rx, Inc. (New Jersey)
  • Defendant: BioDelivery Sciences International, Inc. (Delaware)
  • Plaintiff’s Counsel: Steptoe & Johnson LLP
• Case Identification: 1:17-cv-01307, D.N.J., 01/13/2017
• Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant transacts business in the district, has committed alleged acts of infringement there, and has previously consented to jurisdiction in the district in other litigation. Plaintiff's principal place of business is also in New Jersey.
• Core Dispute: Plaintiff alleges that Defendant’s BELBUCA® (buprenorphine) buccal film infringes a patent related to the formulation and manufacture of rapidly dissolving oral films that provide uniform drug distribution and include anti-tacking agents.
• Technical Context: The technology concerns oral film drug delivery systems, which serve as an alternative to traditional tablets by providing consistent dosing in a self-supporting, non-sticky film.
• Key Procedural History: The complaint highlights a significant litigation history between the parties over the same patent. In 2014, MonoSol sued BDSI for infringement of the patent-in-suit with respect to a different product (Bunavail™). Following that suit, BDSI filed inter partes review (IPR) petitions challenging the patent's validity, which the Patent Trial and Appeal Board (PTAB) declined to institute. The complaint leverages this history to support allegations of pre-suit knowledge and willful infringement regarding the currently accused product.

Case Timeline

Date	Event
2001-10-12	U.S. Patent No. 8,765,167 Earliest Priority Date
2014-07-01	U.S. Patent No. 8,765,167 Issued
2014-09-22	Prior lawsuit filed by MonoSol against BDSI on '167 Patent
2014-10-13	BDSI served in prior lawsuit, establishing alleged actual notice
2014-10-28	BDSI filed IPR petitions challenging '167 Patent
2015-05-20	PTAB denied institution of BDSI's IPR petitions
2015-10-23	FDA approved BELBUCA New Drug Application
2017-01-13	Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,765,167 - "Uniform Films for Rapid-dissolve Dosage Form Incorporating Anti-tacking Compositions"

• Issued: July 1, 2014

The Invention Explained

• Problem Addressed: The patent describes challenges with historical methods of creating drug-delivery films, where conventional, slow drying processes can cause active ingredients to clump together (self-aggregate). This leads to non-uniform films where the dosage in one piece may differ significantly from another, creating potential patient safety issues and failing to meet regulatory standards ('167 Patent, col. 1:56-col. 2:21). An additional problem is that such films can be tacky, making them difficult to handle and package ('167 Patent, col. 4:1-6).
• The Patented Solution: The invention claims to solve these problems through a combination of specific formulations and manufacturing processes. The solution involves using particular water-soluble polymers with anti-tacking agents and forming the film through a "controlled drying process." This process is described as rapidly creating a "viscoelastic matrix" that "lock[s]-in" the active component, thereby ensuring a "substantially uniform distribution" throughout the final, self-supporting film ('167 Patent, Abstract; col. 6:16-40).
• Technical Importance: The described technology aimed to produce oral films with sufficient dosage uniformity (e.g., less than 10% variation) to satisfy strict regulatory requirements, thereby making them a viable commercial alternative to pills and tablets ('167 Patent, col. 2:11-21).

Key Claims at a Glance

• The complaint asserts infringement of numerous claims, with a focus on independent claim 95 (Compl. ¶2, ¶17).
• The essential elements of independent claim 95 are:
  • An oral film for delivery of an active component.
  • An ingestible, water-soluble polymer matrix comprising a polymer from a specific group (hydroxyethylcellulose, hydroxypropylcellulose, carboxymethyl cellulose, or combinations).
  • At least one anti-tacking agent comprising sodium benzoate.
  • A substantially uniform distribution of the active component within the matrix.
  • The film is formed by a "controlled drying process" that rapidly forms a viscoelastic matrix to lock in the active component.
  • The film is self-supporting and the uniform distribution is defined as individual unit doses not varying by more than 10% of the desired active amount.
• The complaint reserves the right to assert other claims, including a large number of dependent claims that add further limitations (Compl. ¶28).

III. The Accused Instrumentality

Product Identification

• The accused product is BELBUCA® (buprenorphine) buccal film (Compl. ¶2).

Functionality and Market Context

• BELBUCA is a pharmaceutical product designed for transmucosal delivery of buprenorphine hydrochloride, an opioid analgesic, through a film applied to the inside of the cheek (Compl. ¶21, ¶23). It is sold in multiple dosage strengths, from 75 mcg to 900 mcg (Compl. ¶20).
• The complaint includes a table from the BELBUCA prescribing information that details the different dosage strengths and their corresponding film sizes. This table, "Table 6: BELBUCA Identifier & Size," illustrates how the film's physical dimensions are tied to its dosage strength (Compl. ¶22).
• The complaint alleges that BELBUCA's list of ingredients includes carboxymethylcellulose sodium, hydroxyethylcellulose, hydroxypropylcellulose, and sodium benzoate, which directly correspond to the polymer and anti-tacking agent limitations of asserted claim 95 (Compl. ¶23).
• It is alleged that at least $125 million has been invested in the development and making of BELBUCA (Compl. ¶26).

IV. Analysis of Infringement Allegations

'167 Patent Infringement Allegations

Claim Element (from Independent Claim 95)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
An oral film for delivery of a desired amount of an active component...	BELBUCA is a buccal film that delivers buprenorphine hydrochloride.	¶21	col. 1:40-42
an ingestible, water-soluble polymer matrix comprising a polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose and carboxymethyl cellulose and combinations thereof;	The publicly listed ingredients for BELBUCA include hydroxyethylcellulose, hydroxypropylcellulose, and carboxymethylcellulose sodium.	¶23	col. 16:40-50
at least one anti-tacking agent comprising sodium benzoate;	The publicly listed ingredients for BELBUCA include sodium benzoate.	¶23	col. 19:28-30
a substantially uniform distribution of said desired amount of said active component within said polymer matrix... wherein said active component is selected from... pharmaceutical agents...	BELBUCA contains the active pharmaceutical ingredient buprenorphine hydrochloride and is alleged to have a uniform distribution.	¶17, ¶23	col. 2:1-21
said film being formed by a controlled drying process which rapidly forms a viscoelastic matrix to lock-in said active... and maintain said substantially uniform distribution;	The complaint alleges that BELBUCA is manufactured in a way that infringes this process limitation, but does not provide specific facts regarding Defendant's manufacturing method.	¶17, ¶28	col. 6:21-30
wherein said film is self-supporting and the active component is substantially uniformly distributed, whereby said substantially uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10%...	The complaint alleges that BELBUCA meets this functional limitation concerning dosage uniformity, but does not provide supporting test data.	¶17, ¶28	col. 2:15-21

Identified Points of Contention

• Technical Questions: A key factual dispute may concern the manufacturing process. The complaint does not provide evidence on how BELBUCA is made, raising the question of whether its manufacturing method constitutes the "controlled drying process" required by the claim. The case may depend on evidence from discovery to establish whether BELBUCA meets the functional requirement that dosage units "do not vary by more than 10%."
• Scope Questions: While the complaint maps BELBUCA's ingredients to specific claim elements, the infringement analysis will turn on whether the product as a whole, and the process used to make it, falls within the scope of the patent's more functional and process-oriented limitations.

V. Key Claim Terms for Construction

• The Term: "controlled drying process"
• Context and Importance: This term is central to the patent's asserted novelty over conventional film manufacturing. The definition of this process limitation will be critical for determining infringement, as it distinguishes the invention from prior art methods that allegedly cause non-uniformity. Practitioners may focus on this term because the plaintiff will likely argue it covers a range of advanced techniques, while the defendant may argue it is limited to the specific bottom-up drying embodiments described.

Intrinsic Evidence for Interpretation

• Evidence for a Broader Interpretation: The specification provides several examples of what may constitute a controlled process, including the use of specific apparatus (e.g., Magoon '837 patent), "hot air impingement," and "controlled radiation drying," suggesting it is not limited to a single method (ʻ167 Patent, col. 6:21-30).
• Evidence for a Narrower Interpretation: The specification repeatedly emphasizes the goal of avoiding a "skin" on the film's top surface by drying from the bottom first. It states that this may be achieved "by applying heat to the bottom surface of the film with substantially no top air flow" ('167 Patent, col. 6:40-44). This language may support a narrower construction that requires a bottom-up heat application.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced and contributory infringement, stating BDSI knowingly encourages infringement and that BELBUCA is not a staple article of commerce suitable for substantial noninfringing use (Compl. ¶36-37). The factual support for these claims is not detailed but would likely be developed through discovery of marketing materials and user instructions.
• Willful Infringement: The willfulness allegation is heavily emphasized and appears to be a central component of the plaintiff's strategy. It is based on alleged pre-suit, actual knowledge of the '167 patent stemming from a 2014 lawsuit between the same parties over a different product. The complaint further alleges that BDSI's failed attempt to invalidate the patent's claims via IPR proceedings demonstrates a lack of any good-faith belief that the patent was invalid, strengthening the willfulness claim (Compl. ¶4, ¶32-33).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of process and proof: Can MonoSol produce evidence, likely through discovery, that BDSI's confidential manufacturing process for BELBUCA is functionally equivalent to the "controlled drying process" that the '167 patent claims as its key innovation for achieving dosage uniformity?
• A second central question will be one of factual compliance: Does the final BELBUCA product meet the quantitative uniformity standard recited in the claim—that is, do its unit doses "not vary by more than 10%" in their active content? The outcome may depend on competing expert analyses of the accused product.
• Finally, a significant question with respect to potential damages will be one of intent: Given the documented history of prior litigation and a failed PTAB challenge over the very same patent, a court will need to determine whether BDSI's decision to launch a new product with an allegedly similar formulation constitutes willful infringement from the date of first sale.