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From Intellectual Property Law Daily, November 20, 2018

Injunction barring Dr. Reddy’s from launching generic Suboxone film product vacated

By Peter Reap, J.D., LL.M.

Indivior failed to show that it is likely to succeed on the merits of its patent infringement claim against Dr. Reddy’s Laboratories in connection with Indivior’s patent for Suboxone film, a treatment for opioid addiction, the U.S. Court of Appeals for the Federal Circuit has ruled. Therefore, the federal district court in Newark abused its discretion in granting a preliminary injunction barring the launch of a generic version of the product by Dr. Reddy’s. The injunction was vacated and the case remanded to the district court for further proceedings (Indivior Inc. v. Dr. Reddy's Laboratories, S.A., November 20, 2018, Stoll, K.).

Indivior’s Suboxone Film is covered by U.S. Patent Nos. 9,931,305 and 8,603,514. The ’305 patent is the only patent at issue in this case. It is related to the ’514 patent, sharing the same specification. The patents’ shared specification discloses various methods of producing films that have drug content uniformity. The specification discloses controlled drying techniques that avoid the "rippling" problems produced by conventional drying methods.

The Delaware Case. Dr. Reddy’s (DRL’s) predecessor in interest had previously submitted two Abbreviated New Drug Applications (ANDA) to market a generic version of Suboxone Film. In response, Indivior filed suit under the Hatch-Waxman Act in the District Court for the District of Delaware (the Delaware Case), alleging infringement of several patents, including the ’514 patent. The Delaware court conducted a four-day bench trial and determined that DRL’s ANDA process does not infringe the asserted ’514 patent claims.

The current case. After the Delaware court entered its judgment of noninfringement, Indivior amended certain claims of a then-pending application that ultimately issued as the ’305 patent. Indivior amended the claims to remove the words "dried" and "drying," and to add "continuously" and "continuously cast" in their place. That same day, Indivior accused DRL’s same ANDA process of infringing the ’305 patent in the District Court for the District of New Jersey. A few months later, the FDA approved DRL’s ANDAs for its generic Suboxone Film and DRL launched the same day.

Indivior immediately moved for a temporary restraining order and a preliminary injunction, seeking to enjoin DRL from selling its product. The TRO was granted on the same day after a telephone conference. It granted the preliminary injunction shortly after.

The district court’s decision was largely based on its interpretation of the ’305 patent’s claim scope. It considered the Delaware court’s determination of specification disclaimer and declined to apply it to the ’305 claims. It concluded that the claims, which lack an express "drying" limitation, do not exclude any particular drying method. The district court credited Indivior’s expert over DRL’s and declined to import a drying step into the "continuously cast" limitation—the limitation that Indivior added during prosecution to replace the terms "drying" and "dried." According to the district court, the ’305 claims do not include a drying limitation. DRL appealed.

Likelihood of success: specification disclaimer. Because the ’305 claims do not cover conventional top air drying to produce films with the claimed content uniformity, Indivior has not shown that it is likely to succeed on the merits of its infringement claim, according to the Federal Circuit. The inventors of the ’305 patent expressly disclaimed, through remarks in the specification, solely using conventional top air drying to produce films with the claimed content uniformity. The patent distinguishes these conventional methods from the present invention and disparages their use, stating that these methods result in films that do not have content uniformity—a key feature of the invention. Under Federal Circuit case law on specification disclaimer, such statements exclude from the scope of the ’305 claims films formed using these drying methods, according to the court.

Similar to the patents at issue in SciMed and Openwave, the ’305 patent is "rife with remarks that disparage, and therefore, disclaim" solely using conventional top air drying to form films. SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, (Fed. Cir. 2001). Openwave Sys., Inc. v. Apple Inc., 808 F.3d 509, 513 at 514 (Fed. Cir. 2015). The specification instructs that using such methods produces films without content uniformity—a claim limitation and a key feature of the invention.

The ’305 patent also discloses two examples that further disparage the use of conventional drying. In Example CG, the films were dried "according to conventional drying techniques, rather than via the uniform drying process of the present invention." In contrast, employing a furnace filter to uniformly distribute heat produced a uniform film. In Example CH, the films were dried in an air oven "by conventional top and bottom drying means," which resulted in aggregations and non-uniformity similar to that in Example CG. Like SciMed and Openwave, the specification distinguishes conventional methods from the present invention, the court noted.

Indivior argued that the ’305 claims are not limited to any particular drying method because "dried/drying has no textual basis" in the claims. The Federal Circuit disagreed with Indivior and concluded that the ’305 claims exclude conventional top air drying. The drying limitation has a textual basis in the term "continuously cast film," which appears in claims 1 and 26 of the ’305 patent. The "continuously cast film" in claims 1 and 26 requires drying as the film starts out as a liquid and ends up as a solid that can be cut into individual dosages. In any event, even if the claims did lack a textual hook for drying, precedent does not require such a hook under the circumstances in this case, the court reasoned.

Indivior agreed that the claimed films are solid and have been dried, however, it disagreed that a dried film limits the ’305 claims by how the film is dried. The appellate court rejected this argument. The specification warns that one cannot obtain the claimed level of drug content uniformity in the final cast film by using only conventional top air drying. As such, the express disclaimer of conventional top air drying in the specification disavows not just a process step from process claims, but also films produced by these drying methods from the scope of the ’305 composition claims.

The claims themselves describe "continuously cast film" in terms of processes as well. Further, Indivior’s patent specification makes clear that the drying process is an essential part of the ’305 claimed invention. If, as the specification explains, content uniformity cannot be achieved using conventional drying methods, then using non-conventional drying methods is necessarily a part of the claimed invention—it is essential.

The ’305 claims exclude films produced solely by conventional top air drying methods. Thus, Indivior did not show that it is likely to succeed on the merits under this construction.

Likelihood of success: claim preclusion. The parties and the accused products are the same here as in the Delaware Case, where there was a final judgment on the merits. The only claim preclusion element at issue here was whether this case is based on the same cause of action as the Delaware Case. It is, the court determined.

The ’305 patent has the same specification as the ’514 patent. The only difference between the ’305 claims asserted here and the ’514 claims asserted in the Delaware Case is that the ’305 claims contain the term "continuously cast" in place of "dried" and "drying." The specification limits the scope of the "continuously cast" limitation in the ’305 claims as it limited the scope of the "drying" limitation in the ’514 claims. While the language of the claim terms changed, the scope of the claims did not materially change. The claims of the ’305 patent are thus patentably indistinct from those of the ’514 patent. That conclusion was furthered by Indivior’s filing of a terminal disclaimer, the court reasoned.

The ’305 claims are patentably indistinct from the ’514 claims and claim preclusion is likely to apply. As a result, Indivior has not shown that it is likely to succeed on the merits of its infringement claim against DRL.

Dissent. In her dissenting opinion, Circuit Judge Pauline Newman argued that the district court’s ruling should be sustained. She asserted that the majority made appellate findings of the merits of infringement, although there has been no trial of infringement. The majority erroneously applied a decision of the district court in Delaware on a different patent with different claims, although that decision is pending on appeal.

Further, the majority erred in its finding of "specification disclaimer," according to Judge Newman. The majority erroneously required that the claims of the ’305 patent be read as including the "drying process limitation" that was cancelled from the claims. In Judge Newman’s view, reading these terms back into the claims is contrary to the patentee’s clear intent.

This case is No. 18-2167.

Attorneys: Jeffrey B. Elikan (Covington & Burling LLP) for Indivior Inc. and Indivior UK Ltd. James Francis Hibey (Steptoe & Johnson, LLP) for Aquestive Therapeutics, Inc. Kevin Paul Martin (Goodwin Procter LLP) for Dr. Reddy's Laboratories, S.A. and Dr. Reddy's Laboratories, Inc.

Companies: Indivior Inc.; Indivior UK Ltd.; Aquestive Therapeutics, Inc.; Dr. Reddy's Laboratories, S.A.; Dr. Reddy's Laboratories, Inc.

MainStory: TopStory Patent FedCirNews

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