DCT
1:18-cv-00499
Indivior Inc v. Actavis Laboratories Ut Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Indivior Inc. (Delaware) and Indivior UK Limited (United Kingdom)
- Defendant: Actavis Laboratories UT, Inc. (Delaware)
- Plaintiff’s Counsel: Ray Quinney & Nebeker P.C.
- Case Identification: 2:17-cv-01034, D. Utah, 09/14/2017
- Venue Allegations: Venue is based on Defendant’s principal place of business in Utah, along with its continuous and systematic business contacts, registration to do business, and marketing and sales activities within the judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s Suboxone® sublingual film constitutes an act of infringement of a patent covering the film's composition.
- Technical Context: The technology concerns orally dissolvable films for delivering combination drugs, specifically an opioid agonist (buprenorphine) and an antagonist (naloxone), designed to treat opioid dependence while minimizing the potential for intravenous abuse.
- Key Procedural History: This is a Hatch-Waxman action initiated after Defendant Actavis provided Plaintiff with Paragraph IV certifications alleging U.S. Patent No. 9,687,454 is invalid, unenforceable, or will not be infringed by its proposed generic product. The complaint was filed within the 45-day statutory window, triggering a 30-month stay of FDA approval for Defendant's ANDA. Subsequent to the filing of this complaint, in an Inter Partes Review (IPR2019-00329), the U.S. Patent and Trademark Office cancelled claims 1-5, 7, and 9-14 of the patent, leaving only claim 8 as patentable.
Case Timeline
| Date | Event |
|---|---|
| 2009-08-07 | ’454 Patent Priority Date |
| 2010-08-30 | FDA approves NDA for Plaintiff's Suboxone® sublingual film |
| 2017-06-27 | ’454 Patent Issue Date |
| 2017-08-02 | Date of first Notification Letter from Actavis |
| 2017-08-24 | Date of second Notification Letter from Actavis |
| 2017-09-14 | Complaint Filing Date |
| 2018-11-13 | IPR (IPR2019-00329) filed against the ’454 Patent |
| 2022-09-30 | IPR Certificate issued, cancelling claims 1-5, 7, and 9-14 |
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 addresses the potential for abuse of combination opioid-agonist/antagonist drugs when delivered in tablet form. A user could feign ingestion, remove the tablet, and then chemically extract the agonist for intravenous injection, bypassing the oral-only antagonist. ('454 Patent, col. 2:1-9).
- The Patented Solution: The invention is a self-supporting, orally dissolving film that contains both buprenorphine (an agonist) and naloxone (an antagonist). The film is designed to be "mucoadhesive," making it difficult for a user to remove from the mouth once administered. ('454 Patent, col. 2:12-17). Furthermore, the film's formulation includes a buffer to control the local pH in the mouth, which is engineered to optimize the absorption of the buprenorphine while simultaneously inhibiting the absorption of the naloxone. ('454 Patent, col. 12:5-10, 65-67).
- Technical Importance: This film-based delivery system offers a potential reduction in the risk of diversion and abuse, a significant challenge in the clinical management of opioid dependence. ('454 Patent, col. 2:16-17).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" without specifying which ones (Compl. ¶23). Claim 1 is the first independent claim of the patent.
- Essential elements of independent Claim 1 include:
- An oral, self-supporting, mucoadhesive film
- Comprising (a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix
- Comprising (b) about 2 mg to about 16 mg of buprenorphine
- Comprising (c) about 0.5 mg to about 4 mg of naloxone
- Comprising (d) an acidic buffer
- Wherein the weight ratio of buprenorphine to naloxone is about 4:1
- Wherein the weight ratio of acidic buffer to buprenorphine is from 2:1 to 1:5
- Wherein oral application results in specific pharmacokinetic profiles (Cmax and AUC) for both buprenorphine and naloxone
- The complaint does not explicitly reserve the right to assert dependent claims, but the broad allegation of infringing "one or more claims" may be interpreted as such.
III. The Accused Instrumentality
Product Identification
The generic buprenorphine hydrochloride and naloxone hydrochloride sublingual film for which Defendant Actavis seeks FDA approval via ANDA Nos. 204383 and 207087 (Compl. ¶20-21).
Functionality and Market Context
The complaint alleges that Defendant’s product is a generic version of Plaintiff’s Suboxone® sublingual film (Compl. ¶1). The ANDA filings purport to contain data showing the bioequivalence of the accused generic product with the Suboxone® film (Compl. ¶21). As a generic equivalent to a product for treating opioid dependence, the accused product is aimed at the same market and therapeutic use (Compl. ¶1, ¶11).
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart. The infringement theory is based on the premise that by filing an ANDA for a product that is a bioequivalent copy of Plaintiff's Suboxone® film, which is listed in the FDA's Orange Book as being covered by the ’454 Patent, Defendant has committed a statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶12, ¶24).
’454 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oral, self-supporting, mucoadhesive film... | The complaint alleges Defendant’s ANDA product is a generic version of Plaintiff's Suboxone® sublingual film, and thus is an oral, self-supporting film. | ¶1, ¶21 | col. 12:26-27 |
| (a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix; | The complaint alleges the ANDA product is covered by the claims, implying its formulation includes a polymeric matrix within the claimed weight percentage range. | ¶23 | col. 24:2-4 |
| (b) about 2 mg to about 16 mg of buprenorphine...; and (c) about 0.5 mg to about 4 mg of naloxone... wherein the weight ratio of (b):(c) is about 4:1 | The complaint alleges the ANDA product concerns dosages of a generic product bioequivalent to Suboxone® film, which is marketed in dosage strengths consistent with these ranges and ratio. | ¶21 | col. 24:5-13 |
| (d) an acidic buffer; | The complaint alleges the ANDA product is covered by the claims, implying its formulation includes an acidic buffer. | ¶23 | col. 24:11 |
| wherein application of the film... results in differing absorption between buprenorphine and naloxone, with a buprenorphine Cmax from about 0.624 ng/ml to about 5.638 ng/ml... and a naloxone Cmax from about 41.04 pg/ml to about 323.75 pg/ml... | The complaint states the ANDA purports to contain data showing bioequivalence, which would require the generic product to exhibit a pharmacokinetic profile falling within the patented parameters. | ¶21 | col. 24:18-28 |
No probative visual evidence provided in complaint.
- Identified Points of Contention:
- Quantitative Scope: A central question is whether the precise formulation of Defendant's generic product, as detailed in its confidential ANDA, meets the specific quantitative limitations of the claims, including the weight percentages of the polymeric matrix (limitation 'a') and the ratio of the acidic buffer to buprenorphine (a sub-part of limitation 'd').
- Pharmacokinetic Scope: A key factual dispute will concern whether the pharmacokinetic data submitted in the ANDA demonstrates bioequivalence in a manner that also falls squarely within the Cmax and AUC ranges required by the final limitation of Claim 1 for both active ingredients.
V. Key Claim Terms for Construction
The Term: "mucoadhesive"
Context and Importance: The alleged novelty of the invention lies in creating a film that is difficult to remove, thereby preventing abuse. The degree of adhesion required to be "mucoadhesive" is not quantitatively defined and is critical to the scope of infringement. Practitioners may focus on this term because Defendant could argue its film is sufficiently dissolvable so as not to be "mucoadhesive" in the manner taught by the patent, or that the term is indefinite.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes a desire for the film to have "sufficient buccal adhesion" and "good adhesion" but does not set a specific threshold, which could support a construction covering any level of adhesion to the oral mucosa. ('454 Patent, col. 2:27-28; col. 9:16).
- Evidence for a Narrower Interpretation: The problem statement focuses on preventing abuse by making the film "difficult to remove once placed in the mouth," suggesting "mucoadhesive" requires a specific, high level of adhesion that actively hinders removal. ('454 Patent, col. 2:15-17).
The Term: "acidic buffer"
Context and Importance: The buffer's function—optimizing buprenorphine absorption while inhibiting naloxone absorption—is a core technical feature. The definition of "buffer" (i.e., whether it requires a conjugate acid-base pair or simply an acid, and what buffering capacity is required) will be critical to determining if the accused formulation infringes.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims require only "an acidic buffer," without specifying its components or capacity. The specification lists "sodium citrate, citric acid, and combinations thereof" as potential buffers, which could support a broad definition. ('454 Patent, col. 13:40-42).
- Evidence for a Narrower Interpretation: The patent repeatedly emphasizes the buffer's functional role in maintaining a specific local pH to "optimize absorption" and "inhibit the absorption," suggesting the term requires a composition with sufficient buffering capacity to achieve this specific differential absorption effect when placed in the mouth. ('454 Patent, col. 2:23-28; col. 12:65-67).
VI. Other Allegations
- Indirect Infringement: While the prayer for relief seeks to enjoin inducement of infringement (Prayer ¶C), the single count in the complaint is for direct infringement under 35 U.S.C. § 271(e)(2), which is based on the statutory act of filing the ANDA, not on allegations of induced infringement in the marketplace.
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. It does, however, request a finding that the case is "exceptional" to warrant an award of attorneys' fees under 35 U.S.C. § 285 (Prayer ¶E).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of quantitative compliance: does the specific formulation disclosed in Defendant's confidential ANDA meet all the numerical limitations of the asserted claims, including the weight percentages of the polymer matrix, the ratio of buffer to active ingredient, and the specific pharmacokinetic Cmax and AUC ranges?
- The most significant issue in the case will be one of claim viability: given the post-filing cancellation of all independent claims and most dependent claims by the USPTO, the dispute now rests entirely on the patentability and infringement of the sole surviving, narrowly defined dependent Claim 8. The primary question for the court will be whether Plaintiff can prove that Defendant's product infringes this single, highly specific claim.