Indivior Inc v. Mylan Tech Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Indivior Inc. (Delaware) and Indivior UK Limited (United Kingdom)
  • Defendant: Mylan Technologies Inc. (West Virginia), Mylan Pharmaceuticals Inc. (West Virginia), and Mylan N.V. (Netherlands)
  • Plaintiff’s Counsel: Simmerman Law Office, PLLC
• Case Identification: 1:17-cv-00157, N.D.W. Va., 09/14/2017
• Venue Allegations: Venue is alleged to be proper based on Defendants Mylan Technologies Inc. and Mylan Pharmaceuticals Inc. being West Virginia corporations with continuous and systematic business contacts within the judicial district.
• Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Suboxone® sublingual film constitutes an act of patent infringement under the Hatch-Waxman Act.
• Technical Context: The technology relates to orally dissolvable film formulations for treating opioid dependence, specifically designed to deliver a therapeutic combination of an agonist and an antagonist in a manner that deters abuse.
• Key Procedural History: Subsequent to the filing of this complaint, the asserted '454 patent was the subject of an Inter Partes Review (IPR2019-00329). The proceeding resulted in a certificate issued on September 30, 2022, which cancelled claims 1-5, 7, and 9-14. This action left only the narrow dependent claim 8 as patentable, significantly focusing the scope of any potential infringement analysis.

Case Timeline

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

U.S. Patent No. 9,687,454, "Sublingual and Buccal Film Compositions", Issued June 27, 2017

The Invention Explained

• Problem Addressed: The patent describes challenges with existing oral treatments for narcotic dependence. These include the potential for abuse, where a patient might not swallow a tablet but instead later extract the active opioid agonist for injection, and the difficulty of co-administering an agonist (like buprenorphine) and an antagonist (like naloxone) to achieve proper differential absorption when taken sublingually (’454 Patent, col. 1:31-40, col. 2:1-9).
• The Patented Solution: The invention is a self-supporting, mucoadhesive oral film designed to deliver buprenorphine and naloxone. The film contains a buffer that creates a specific local pH in the mouth upon application. This controlled pH environment is engineered to optimize the buccal absorption of the buprenorphine (the agonist) while simultaneously inhibiting the absorption of the naloxone (the antagonist), which is then swallowed and metabolized (’454 Patent, col. 2:20-39). The film's adhesive quality makes it difficult to remove once placed in the mouth, which serves as an abuse-deterrent feature (’454 Patent, col. 2:13-18).
• Technical Importance: This formulation provided a method to achieve specific pharmacokinetic profiles for two different active agents from a single dosage form, while also incorporating a physical feature (mucoadhesion) intended to reduce the product's potential for diversion and abuse (’454 Patent, col. 11:41-48).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims of the '454 patent" (Compl. ¶24). Subsequent to the complaint's filing, an Inter Partes Review cancelled all asserted claims except dependent claim 8 (’454 Patent, IPR Certificate).
• The sole surviving claim, Claim 8, depends from cancelled claims 7 and 1. Its scope is defined by the combination of all three claims.
• Independent Claim 1 (Cancelled Base Claim): The essential elements included:
  • An oral, self-supporting, mucoadhesive film comprising:
  • (a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;
  • (b) about 2 mg to about 16 mg of buprenorphine;
  • (c) about 0.5 mg to about 4 mg of naloxone;
  • (d) an acidic buffer;
  • wherein the weight ratio of buprenorphine to naloxone is about 4:1;
  • wherein the weight ratio of the acidic buffer to buprenorphine is from 2:1 to 1:5; and
  • wherein application of the film results in specified Cmax and AUC pharmacokinetic profiles for both drugs.
• Dependent Claim 7 (Cancelled): This claim narrowed the polymeric matrix limitation of claim 1 to "about 48.2 wt % to about 58.6 wt %."
• Dependent Claim 8 (Surviving Asserted Claim): This claim further narrows the polymeric matrix limitation of claim 7 to a specific value: "about 48.2 wt %."

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "generic buprenorphine hydrochloride and naloxone hydrochloride sublingual film" described in Mylan's Abbreviated New Drug Application No. 207607 (Compl. ¶16).

Functionality and Market Context

The complaint alleges that Mylan's ANDA "refers to and relies on Plaintiffs' NDA for Suboxone® sublingual film" and "purports to contain data showing bioequivalence" (Compl. ¶23). This implies the accused product is designed to have the same active ingredients, dosage form, and therapeutic effect as Plaintiff's branded product. The product is intended for the U.S. market as a lower-cost generic alternative to Suboxone® film upon receiving FDA approval (Compl. ¶¶ 1, 22). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed claim chart or an element-by-element breakdown of its infringement theory. The infringement allegation is statutory, based on the act of filing an ANDA for a product that, if approved and marketed, would infringe the patent (Compl. ¶¶ 24-25). The analysis below outlines how the elements of the sole surviving claim, Claim 8, would map onto the allegations.

'454 Patent Infringement Allegations

• Identified Points of Contention:
  • Technical Question: The central dispute will likely be a narrow factual one: does the composition of Mylan's proposed generic film, as specified in its confidential ANDA, contain "about 48.2 wt % of a water-soluble polymeric matrix"? Given the cancellation of all broader claims, Plaintiff's case for infringement appears to depend entirely on whether Mylan's product meets this highly specific limitation.
  • Scope Questions: A primary legal question will be the proper construction of the term "about 48.2 wt %." The court will need to determine if "about" provides any range of tolerance around the 48.2% figure and, if so, how wide that range is. The patent's specification and the prosecution history, including the IPR proceeding that invalidated broader claims, will be critical evidence in this determination.

V. Key Claim Terms for Construction

• The Term: "about 48.2 wt %"
• Context and Importance: This term is the sole limitation added by surviving Claim 8 to the otherwise-cancelled Claim 7. Its construction is therefore dispositive for infringement. Practitioners may focus on this term because the invalidation of all broader claims during the IPR makes this precise numerical constraint the linchpin of the entire infringement case.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent's use of the word "about" suggests the patentee did not intend the claim to be limited to the exact numerical value. The specification describes polymer concentrations in ranges (e.g., "from about 20% to 100% by weight") and acknowledges manufacturing variability, which could support a construction that includes a reasonable tolerance around 48.2% (’454 Patent, col. 8:36-39).
  • Evidence for a Narrower Interpretation: The structure of the claims suggests a deliberate narrowing. Claim 1 recites a broad range ("about 40 wt % to about 60 wt %"). Cancelled Claim 7 narrows this to "about 48.2 wt % to about 58.6 wt %." Surviving Claim 8 narrows this range further to a single value, "about 48.2 wt %." This progression may be argued to show an intent to claim a very specific composition, limiting the scope of "about." Furthermore, the IPR outcome, which upheld only this very specific claim, could be used to argue that patentability rests on this precise formulation, warranting a narrow interpretation.

VI. Other Allegations

• Indirect Infringement: The complaint's prayer for relief seeks to enjoin inducing infringement (Compl. Prayer for Relief ¶C). However, the substantive count for infringement is based on 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA as a statutorily-created, artificial act of infringement. A separate factual analysis for inducement is not required for this claim.
• Willful Infringement: The complaint does not contain a separate count for willful infringement. It does, however, request a judgment that this is an "exceptional case" under 35 U.S.C. § 285, which would entitle Plaintiffs to attorneys' fees, but does not plead specific facts to support this request (Compl. Prayer for Relief ¶E).

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

1. A core issue will be one of evidentiary proof: does the precise formulation of Mylan's proposed generic film, as confidentially described in its ANDA, meet the "about 48.2 wt %" water-soluble polymeric matrix limitation of the '454 patent's sole surviving claim?
2. The case will likely turn on a question of claim construction: what is the scope of the term "about" as used in "about 48.2 wt %"? The resolution will depend on whether the court interprets it as allowing for standard manufacturing tolerances or as a very narrow range, given that this specific limitation is what allowed the claim to survive an IPR challenge that invalidated all broader claims.