During the week of May 13-17, 2019, the Patent Trial and Appeal Board (“Board”) issued three decisions instituting IPR in Tech Center 1600.

Amneal Pharmaceuticals LLC v. Almirall, LLC, IPR2019-00207 (Decision Instituting IPR Entered May 10, 2019)

The Board granted institution on Amneal Pharmaceuticals LLC’s (“Petitioner”) petition, which challenged as unpatentable all claims of U.S. Patent No. 9,517,219 B2 (“the ’219 patent”) assigned to Almirall, LLC (“Patent Owner”). Petitioner challenged claims 1–8 on two grounds of obviousness. IPR2019-00207, Paper 13 (“’207 IPR”) at 6.

The ’219 patent relates to treatment for acne vulgaris or rosacea by administering a compound including dapsone, diethylene glycol, acrylamide/sodium acryloyldimethyl taurate copolymer (commercial name “Sepineo P 600”), and water, but excluding adapalene. The ’219 patent discloses that diethylene glycol “is a solubilizer for dapsone, thereby allowing compositions to be prepared with increased solubilized concentrations of dapsone.” ’207 IPR at 4. Additionally, the ’219 patent discloses that using “a polymeric builder minimizes the intensity of yellowing of the composition” caused by the increased solubility of dapsone in diethylene glycol and “influences dapsone crystallization” which improves aesthetics by reducing particle size minimizing a “gritty” feeling when applied. Id. (quoting ’219 patent at 2:54-61).

Both obviousness grounds asserted by Petitioner relied on WO 2009/061298 A1 (“Garrett ’298”) and a second reference—WO 2010/072958 A2 (“Nadau-Fourcade”) in Ground 1 and an article by Bonacucina et al. (“Bonacucina”) in Ground 2. Patent Owner argued that the Board should deny institution under 35 U.S.C. §§ 314(a) and 325(d).

After analyzing the General Plastic factors,[1] ’207 IPR at 10-13, the Board instituted review even though some 35 U.S.C. § 314(a) factors “e.g., factor 2 (asserted prior art was known), factor 3 (related IPR preliminary response filed and IPR instituted), and factor 4 (nearly 9 months’ time elapsed), may weigh in favor of Patent Owner’s position for discretional denial[.]” Id. at 12. The Board also found that review was proper under 35 U.S.C. § 325(d) after weighing the Becton factors.[2] ’207 IPR at 13-20. The Board reasoned that while Garrett ’298 was considered during prosecution, it was not a primary focus in the Examiner’s rejections, the Examiner cited it for different teachings, and neither secondary reference was relied on by the Examiner. Id. at 13-16. The Board also observed that the claims were allowed only after Patent Owner submitted evidence of unexpected results, but the Board found flaws with the declaration cited during prosecution to establish unexpected results. Id. at 17-20.

After rejecting Patent Owner’s arguments under sections 314(a) and 325(d), the Board concluded that Petitioner demonstrated a reasonable likelihood of success on the merits. Accordingly, the Board granted institution on both grounds. Id. at 21-25.

Foundation Medicine, Inc. v. Caris MPI, Inc., IPR2019-00166 and-00203 (Decisions Instituting IPR Entered May 14, 2019)

The Board granted institution of Foundation Medicine, Inc.’s (“Petitioner”) two petitions, which challenged all claims of U.S. Patent No. 9,292,660 B2 (“the ’660 patent”), assigned to Caris MPI, Inc. (“Patent Owner”), on obviousness grounds.

The ’660 patent relates to methods and system for using molecular profiling to identify treatments for individuals. See, e.g., IPR2019-00166, Paper 12 (“’166 IPR”) at 3. The patent discloses that molecular profiling analysis can provide more informed and effective personalized treatment options, which can result in improved patient care and enhanced treatment outcomes. Id. The ’660 patent further discloses a system that uses molecular profiling of a patient’s biological specimen to determine individualized medical intervention. Id. at 3-4. The system includes, among other things, an application program stored in a memory that is accessible by a processor, internal databases, and external databases. Id. at 5. The challenged claims are directed to a system for generating a report identifying a therapeutic agent for an individual with lung cancer. Id. at 5-6; see also IPR2019-00203, Paper 12 at 5-6.

Petitioner argued that, under their broadest reasonable interpretation, the claims would have been obvious over a combination of several prior art references.

Patent Owner challenged the status of an asserted prior art reference (Illumina) as a printed publication. ’166 IPR at 14-18; IPR2019-00203, Paper 12 at 15-19. The Board found that, at the institution stage, Petitioner had made a “threshold showing” that the disputed reference was publicly accessible prior to the effective filing date of the challenged patent for the following reasons: (1) the reference itself bears indicia that it was likely published, including a publication date and a publication number; (2) the reference is identified as a “technical bulletin” akin to a product catalog, which is the type of document intended for public dissemination, and it bears no designations, such as “draft” or “confidential” that might suggest that it was not intended for public distribution; (3) and the declaration of the Internet Archive’s Office Manager attested that the publication was archived by the Wayback Machine prior to the effective filing date, thereby confirming that it was publicly available. See, e.g., ’166 IPR at 15-16.

Because Patent Owner did not address the substance of Petitioner’s unpatentability arguments, the Board found that Petitioner had demonstrated a reasonable likelihood of prevailing with respect to the claims of the ’660 patent. Accordingly, the Board granted institution on all grounds of the petitions. See, e.g., id. at 21-22.

[1] General Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357, slip op. at 15 (PTAB Sept. 6, 2017) (Paper 19) (precedential).

[2] Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586, slip op. at 17–18 (PTAB Dec. 15, 2017) (Paper 8) (informative).