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Reckitt Benckiser Pharmaceuticals Inc. v. Dr. Reddy's Laboratories S.A.

United States District Court, D. Delaware

August 31, 2017

RECKITT BENCKISER PHARMACEUTICALS INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC, Plaintiffs,
v.
DR. REDDY'S LABORATORIES S.A., and DR. REDDY'S LABORATORIES, INC., Defendants. RECKITT BENCKISER PHARMACEUTICALS INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC, Plaintiffs,
v.
PAR PHARMACEUTICAL, INC. and INTELGENX TECHNOLOGIES CORP., Defendants. RECKITT BENCKISER PHARMACEUTICALS INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC, Plaintiffs,
v.
WATSON LABORATORIES, INC. and ACTA VIS LABORATORIES UT, INC., Defendants.

          Mary W. Bourke, Dana K. Severance, Daniel M. Attaway, WOMBLE CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE. Attorneys for Plaintiffs.

          Daniel A. Ladow, James M. Bollinger, Timothy P. Heaton, J. Magnus Essunger, TROUTMAN SANDERS LLP, New York, NY; Charanjit Brahma, TROUTMAN SANDERS LLP, San Francisco, CA; Robert E. Browne, Jr., TROUTMAN SANDERS LLP, Chicago, IL; Puja Patel Lea, TROUTMAN SANDERS LLP, Atlanta, GA; Jeffrey B. Elikan, Jeffrey Lerner, Erica N. Andersen, Ashley M. Kwon, COVINGTON & BURLING LLP, Washington, DC Attorneys for Plaintiffs Reckitt Benckiser Pharmaceuticals Inc. and RB Pharmaceuticals Limited

          James F. Hibey, Timothy C. Bickham, STEPTOE & JOHNSON LLP, Washington, DC; David L. Hecht, Cassandra A. Adams, STEPTOE & JOHNSON LLP, New York, NY Attorneys for Plaintiff MonoSol Rx, LLC

          Richard D. Kirk, Stephen B. Brauerman, Sara E. Bussiere, BAYARD, P.A., Wilmington, DE; Elaine H. Blais, Robert Frederickson, III, Molly R. Grammel, Alexandra Lu, Kathryn, Kosinski, GOODWIN PROCTER LLP, Boston, MA; Ira J. Levy, Robert V. Cerwinsky, GOODWIN PROCTER LLP, New York, NY; John Coy Stall, GOODWIN PROCTOR LLP, Washington, DC Attorneys for Defendants Dr. Reddy's Laboratories S.A. and Dr. Reddy's Laboratories, Inc.

          Steven J. Fineman, Katharine L. Mowery, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Daniel G. Brown, LATHAM & WATKINS LLP, New York, NY; Jennifer Koh, B. Thomas Watson, LATHAM & WATKINS LLP, San Diego, CA; Emily C. Melvin, Brenda L. Danek, LATHAM & WATKINS LLP, Chicago, IL; Terry Kearney, Michelle Woodhouse, Jie Wang, LATHAM & WATKINS LLP, Menlo Park, CA; B. Thomas Watson, LATHAM & WATKINS LLP, San Diego, CA. Attorneys for Defendants Par Pharmaceutical, Inc. and IntelGenx Technologies Corp.

          John C. Phillips, Jr., Megan C. Haney, PHILLIPS, GOLDMAN & SPENCE, P.A., Wilmington, DE; George C. Lombardi, Michael K. Nutter, WINSTON & STRAWN LLP, Chicago, IL; Stephen Smerek, David P. Dalke, Jason C. Hamilton, WINSTON & STRAWN LLP, Los Angeles, CA. Attorneys for Defendants Watson Laboratories, Inc. and Actavis Laboratories UT, Inc.

          TRIAL OPINION

          ANDREWS, U.S. DISTRICT JUDGE.

         Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc., [1] RB Pharmaceuticals Limited, [2] and MonoSol Rx, LLC (collectively, "Plaintiffs") bring this suit against Defendants Dr. Reddy's Laboratories S.A. and Dr. Reddy's Laboratories, Inc. (collectively, "DRL"), [3] Defendant Watson Laboratories, Inc.[4] ("Watson"), and Defendants Par Pharmaceutical, Inc. and IntelGenx Technologies Corporation (collectively, "Par"). This opinion addresses allegations of infringement and invalidity with respect to U.S. Patent Nos. 8, 603, 514 ("the '514 patent") and 8, 900, 497 ("the '497 patent").

         The Court held a four-day bench trial relating to these patents. (D.I. 299; D.I. 300; D.I. 301; D.I. 302).[5] The parties filed proposed findings of fact (D.I. 275), post-trial briefing with respect to infringement (D.I. 279; D.I. 285; C.A. No. 14-1574, D.I. 184; C.A. No. 14-1573, D.I. 203; D.I. 295), and post-trial briefing with respect to invalidity (D.I. 278; D.I. 288; D.I. 293). I have also considered letters submitted regarding Medicines Co. v. Mylan, Inc., 853 F.3d 1296 (Fed. Cir. 2017). (D.I. 309; D.I. 310). Having considered the documentary evidence and testimony, I make the following findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).

         I. BACKGROUND

         Plaintiff Reckitt Benckiser Pharmaceuticals, Inc. is the holder of approved New Drug Application No. 22-410 for Suboxone® sublingual film, which is indicated for maintenance treatment of opioid dependence. (D.I. 228-2, Admitted Fact Nos. 13-14, 20). The active ingredients of Suboxone® sublingual film are buprenorphine hydrochloride and naloxone hydrochloride. (D.I. 228-2, Admitted Fact No. 15). Suboxone® sublingual film is available in four dosage strengths (buprenorphine hydrochloride/naloxone hydrochloride): 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg. (D.I. 228-2, Admitted Fact Nos. 16-18). Since the approval of NDA No. 22-410, Suboxone® sublingual film has been exclusively manufactured in the United States by Plaintiff MonoSol and exclusively sold in the United States by Plaintiff Reckitt Benckiser Pharmaceuticals, Inc. (D.I. 228-2, Admitted Fact No. 19).

         The '514 patent, entitled "Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions, " issued on December 10, 2013. (D.I. 228-2, Admitted Fact No. 21). The '514 patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalences Evaluations (the "Orange Book") as covering Suboxone® sublingual film. (D.I. 228-2, Admitted Fact No. 23).

         The '497 patent, entitled "Process for Making a Film Having a Substantially Uniform Distribution of Components, " issued on December 2, 2014. (D.I. 228-2, Admitted Fact No. 27). Plaintiff MonoSol owns the '514 and '497 patents and Plaintiff Reckitt Benckiser Pharmaceuticals, Inc. is an exclusive licensee of the '514 and '497 patents. (D.I. 228-2, Admitted Fact Nos. 22, 28).

         Plaintiffs are asserting claims 62-65, 69, 71, and 73 of the '514 patent against DRL. (D.I. 228-2, Admitted Fact No. 91; D.I. 279 at 1 n.1). Claim 62 of the '514 patent is an independent claim. Claims 63, 64, 65, 69, 71, and 73 all depend from claim 62. (D.I. 228-2, Admitted Fact No. 92). The '514 patent was separately tried against Watson and Par. (C.A. No. 13-1674, D.I. 446).

         The asserted independent claim of the '514 patent reads as follows.

         62. A drug delivery composition comprising:

(i) a cast film comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers; and a desired amount of at least one active; wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix;
(ii) a particulate active substantially uniformly stationed in the matrix; and
(iii) a taste-masking agent selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste-masking of the active;
wherein the particulate active has a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; and
wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active.

(JTX-2, claim 62) (emphases added).

         Plaintiffs are asserting claim 24 of the '497 patent against all Defendants. (D.I. 228-2, Admitted Fact Nos. 30, 64, 95). Claim 24 of the '497 patent depends from claim 1. (D.I. 228-2, Admitted Fact No. 96). Claims 1 and 24 of the '497 patent reads as follows.

1. A process for making a film having a substantially uniform distribution of components, comprising the steps of:
(a) forming a flowable polymer matrix comprising an edible polymer, a solvent and a desired amount of at least one active, said matrix having a substantially uniform distribution of said at least one active;
(b) casting said flowable polymer matrix;
(c) rapidly evaporating at least a portion of said solvent upon initiation of drying to form a visco-elastic film within about the first 4.0 minutes to maintain said substantially uniform distribution of said at least one active by locking-in or substantially preventing migration of said at least one active within said visco-elastic film;
(d) further drying said visco-elastic film to form a self-supporting edible film having a substantially uniform distribution of said at least one active component; and wherein said substantially uniform distribution of said at least one active component is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active.

(JTX-3, claim 1) (emphases added).

24. The process of claim 1, wherein said active is in the form of a particle.

(JTX-3, claim 24).

         II. LEGAL STANDARDS

         A. Infringement

         A patent is infringed when a person "without authority makes, uses, offers to sell, or sells any patented invention, within the United States .. . during the term of the patent...." 35 U.S.C. § 271(a). A two-step analysis is employed in making an infringement determination. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). First, the court must construe the asserted claims to ascertain their meaning and scope. See Id. The trier of fact must then compare the properly construed claims with the accused infringing product. See Id. This second step is a question of fact. Bai v. L &L Wings, Inc., 160F.3d 1350, 1353 (Fed. Cir. 1998).

         "Literal infringement of a claim exists when every limitation recited in the claim is found in the accused device." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir. 1998). "If any claim limitation is absent from the accused device, there is no literal infringement as a matter of law." Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). If an accused product does not infringe an independent claim, it also does not infringe any claim depending thereon. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir. 1989). However, "[o]ne may infringe an independent claim and not infringe a claim dependent on that claim." Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 1359 (Fed. Cir. 2007). The patent owner has the burden of proving infringement by a preponderance of the evidence. See SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988).

         B. Obviousness

         The presumption that all patents are valid is the starting point for any obviousness determination. 35 U.S.C. § 282. A patent claim is invalid as obvious under 35 U.S.C. § 103 "if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains." Id. § 103(a); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406-07 (2007). Obviousness is a question of law that depends on the following factual inquiries: (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the relevant art; and (4) any objective indicia of nonobviousness. See KSR, 550 U.S. at 406; see also Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1347 (Fed. Cir. 2012). A court is required to consider secondary considerations, or objective indicia of nonobviousness, before reaching an obviousness determination, as a "check against hindsight bias." See In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1078-79 (Fed. Cir. 2012). Relevant secondary considerations include commercial success, long felt but unsolved needs, failure of others, praise, unexpected results, and copying, among others. Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966); Ruiz v. A.B. Chance Co., 234 F.3d 654, 662-63 (Fed. Cir. 2000); Tex. Instruments, Inc. v. U.S. Int'l Trade Comm % 988 F.2d 1165, 1178 (Fed. Cir. 1993).

         "Generally, a party seeking to invalidate a patent as obvious must demonstrate . . . that a skilled artisan would have had reason to combine the teaching of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success from doing so." In re Cyclobenzaprine Hydrochloride, 676 F.3d at 1068- 69. "The Supreme Court has warned, however, that, while an analysis of any teaching, suggestion, or motivation to combine known elements is useful to an obviousness analysis, the overall obviousness inquiry must be expansive and flexible." Id. at 1069. The improvement over prior art must be "more than the predictable use of prior art elements according to their established functions." KSR, 550 U.S. at 417. Evidence of obviousness, however, especially when that evidence is proffered in support of an "obvious-to-try" theory, is insufficient unless it indicates that the possible options skilled artisans would have encountered were "finite, " "small, " or "easily traversed, " and "that skilled artisans would have had a reason to select the route that produced the claimed invention." In re Cyclobenzaprine Hydrochloride, 676 F.3d at 1072. Obviousness must be proven by clear and convincing evidence. Id. at 1078.

         III. DISCUSSION

         A. Infringement

         1. DRL

         a) Findings of Fact

         1. DRL uses the CL02 and CL03 dryers where the sole source of heat is hot air coming from air nozzles over the liner.

         2. DRL's proposed ANDA manufacturing process (hereinafter, "ANDA process") is extensively controlled to achieve drug content uniformity.

         3. DRL's ANDA process is designed to avoid the "rippling effect." 4. The extent of bottom drying employed by DRL is conventional.

         5. General testimony that DRL's method is unconventional is conclusory and not credible.

         6. There is insufficient evidence for me to conclude that DRL's ANDA process utilizes unconventional drying.

         7. DRL does not infringe the "drying" limitation of the '497 patent or the "dried" limitation of the '514 patent.

         8. About four minutes after "drying, " the majority of the wet matrix is still water.

         9. Dr. Prud'homme's testimony that a visco-elastic solid results after about four minutes of drying is given little to no weight.

         10. DRL does not infringe the visco-elastic solid film limitation of the '497 patent.

         11. DRL's AND As report drug content uniformity measurements across the 12 mg/3 mg, 8 mg/2 mg, 4 mg/1 mg, and 2 mg/0.5 mg dosage strengths.

         12. The '514 and the '497 patents do not require that Plaintiffs use the "three sigma rule" standard to establish infringement.

         13. Plaintiffs establish that DRL infringes the drug content uniformity limitation of the asserted claims of both patents.

         14. DRL's polymer matrix is specified to range between 5, 000 to 20, 000 centipoise for the 12 mg/3 mg, 8 mg/2 mg, 4 mg/1 mg, and 2 mg/0.5 mg dosage strengths.

         15. Dr. Davies offers credible testimony as to whether DRL's ANDA process is "sufficient to provide little to no aggregation of the active within the film."

         16. Plaintiffs establish that DRL infringes the viscosity limitation of the asserted claims of the'514 patent

         17. DRL does not infringe any asserted claim of the '497 and '514 patents.

         b) Conclusions of Law

         (1) Dried/Drying

         DRL argues that it does not infringe the "dried" limitation of the asserted claims of the '514 patent or the "drying" limitation of the asserted claim of the '497 patent. I construed "dried" in the '514 patent to mean "dried without solely employing conventional convection air drying from the top." (C.A. No. 15-1016, D.I. 87 at 5). I further clarified this construction as follows:

"[D]ried without solely employing conventional convection air drying from the top" is meant to exclude drying techniques that are associated with the problem of the "rippling effect." This problem takes place when the initial drying of the upper surface of the film leads to the trapping of moisture inside the film, causing the top surface to be ripped open and reformed when the moisture trapped inside later evaporates. This does not necessarily exclude techniques where the only direct sources of air are from the top. This also should not be understood to require techniques to use direct sources of air from the bottom.

(Id. at 5-6). "Drying" in the '497 patent is construed similarly. (Id. at 8-9). DRL argues that their ANDA process is "conventional" because (1) the drying method used by DRL was ordinary and commonplace in the web coating industry as of 2001, (2) DRL's ANDA products are dried solely using top air, and (3) no bottom air or heat is used during the drying of DRL's products.

         In conventional coating and drying equipment, a POSA could control the temperature, line speed, air velocity, and the direction of air nozzles. (See, e.g., Tr. 785:6-10, 784:17-24, 785:1-5, 799:18-21). It would be conventional to adjust these settings in order to produce a desired product. (Tr. 1066:19-22, 784:17-785:10). Dr. Gogolin opines that it was conventional for an operator in 2001 to control a top air impingement dryer to prevent defects like rippling. (Tr. 1344:1-14). I agree with Plaintiffs that merely employing a conventional oven does not necessarily mean that a drying technique is conventional.

         DRL uses the CL02 and CL03 dryers where the sole source of heat is hot air coming from air nozzles over the liner. (Tr. 1353:20-1354:2, 1360:16-1361:4). In both the CL02 and CL03, there are no air nozzles below the liner. (D.I. 228-2, Admitted Fact No. 121). DRL's ANDA process is extensively controlled. (See, e.g., Tr. 577:7-14). DRL's ANDAs state, "The most critical aspect during coating and drying for this product is to achieve content uniformity in the master roll." (JTX-59 at 32). To meet that objective, DRL's ANDA process regularly monitors the oven temperature, fan speeds, supply dampers, and exhaust dampers in each zone. (JTX-59 at 32).

         Plaintiffs' evidence shows that DRL's ANDA process is designed to avoid the "rippling effect." To avoid rippling, DRL's drying parameters are such that lower temperatures and air velocities are employed at the beginning and higher temperatures and air velocities are used toward the end of the drying process. (Tr. 982:1-983:3). DRL's ANDAs suggest that their films did not have visual defects. (JTX-12 at 11). DRL's technique employs low airflow at the surface of the web during the initial drying phase, such that the amount of heat transfer from the bottom web approaches the amount of heat transfer from the top.[6] (Tr. 830:12-831:4). This is consistent with a technique that is associated with minimizing the rippling effect. This is not dispositive because my construction left open the possibility as to whether conventional convection air drying techniques could also avoid the "rippling effect." Whether a technique causes rippling is only a factor as to whether a technique constitutes conventional convection air drying.

         Plaintiffs argue that DRL's ANDA process is unconventional because it employs bottom drying. I am not persuaded that the extent of DRL's bottom drying is unconventional. No measurements were taken of the temperature of the metal rollers. (Tr. 558:19-559:19). The CL02 and CL03 dryers use a conventional exhaust system, which suggests that any bottom drying is at most a conventional amount. (D.I. 228-2, Admitted Fact Nos. 122-124; Tr. 1410:18-1411:2, 1352:2-19, 1356:8-21, 1358:9-1359:12, 1353:3-1354:13, 1360:3-15). I think that DRL's use of "bottom drying" is essentially that the inside of the oven simply gets hot and as a result, the bottom of film is incidentally heated. This is a conventional bottom drying method. (See, e.g., JTX-24 at 4:37-42, Fig. 2; Tr. 1367:19-1368:19).

         Taken as a whole, this evidence is not enough to persuade me that DRL's process is unconventional. I am not persuaded that evidence of a controlled process that does not result in rippling and that achieves drug content uniformity automatically amounts to an unconventional process. Watson raises two good points that apply here. Watson argues that finding unconventionality based on this kind of evidence would be using a "results-determinative" approach. I agree. Finding infringement based on this evidence would put too much focus on whether drug content uniformity is achieved, and would gloss over whether the parameters employed are actually unconventional. This is similar to the "efficient mixing" issue that the Federal Circuit addressed in Medicines Co. v. Mylan, Inc., 853 F.3d 1296 (Fed. Cir. 2017). There, the court resisted the patentee's construction of "efficient mixing" which sought "to claim all solutions to the identified 'impurities' problem, without describing the entire range of solutions to that problem.'" Medicines Co., 853 F.3d at 1307 (citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352-53 (Fed. Cir. 2010)). If I were to find infringement, I would effectively be construing the drying limitation to claim all drying techniques that solve the drug content uniformity problem. This is not what the patents claim, however.

         Watson also argues that finding unconventionality based on this kind of evidence would read out the uniformity limitation. I agree. If showing drug content uniformity was effectively all that was required to meet the drying limitation, there would be no need for a separate uniformity limitation. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006) ("[C]laims are interpreted with an eye toward giving effect to all terms in the claim."). Thus, on these facts, Plaintiffs have not met their burden of showing that the "dried”/"drying" limitations of the '497 and '514 patents are met.[7]

         (2) Visco-Elastic

         DRL argues that its drying process does not meet the visco-elastic solid film limitation of the '497 patent. Claim 1 of the '497 patent requires "rapidly evaporating at least a portion of said solvent upon initiation of drying to form a visco-elastic film within about the first 4.0 minutes to maintain said substantially uniform distribution of said at least one active by locking-in or substantially preventing migration of said at least one active within said visco-elastic film .. . ." (JTX-3, claim 1). I construed the phrase "to maintain said substantially uniform distribution of said [pharmaceutical/at least one active] by locking-in or substantially preventing migration of said [pharmaceutical/at least one active]" to mean "to maintain a distribution of [an active/a pharmaceutical active] by drying to form a viscoelastic solid film, thereby limiting its migration such that the individual dosage units do not vary by more than 10% from the intended amount of the active for that dosage unit." (D.I. 175 at 8-9).

         DRL's proposed product would lose about 20% of volatile solvent (water and alcohol) in about four minutes. (Tr. 693:4-11). As a result, the majority of the wet matrix is still water. (Tr. 1218:2-16). Rheological testing shows that the DRL's formulation is at best a visco-elastic liquid after four minutes of drying. (Tr. 1224:3-22, 1227:17-1235:23, 773:14-774:1; JTX-488).

         Plaintiffs' criticisms of this rheological testing make some points but are not persuasive. Plaintiffs complain that the tested sample did not include buprenorphine, but it is unclear that the inclusion of buprenorphine would be enough to change the results, that is, to render the sample a visco-elastic solid. (Tr. 1232:18-1233:3). Plaintiffs complain that the wet mixture of material was left out in open air to allow evaporation of solvent. This complaint neglects that after the dehydrated sample was placed in a petri dish on a balance to monitor weight loss until it reached the target 16% volatile weight loss, the sample was then transferred to a new vial, capped, and sealed to prevent further loss. (Tr. 1199:4-21). Dr. Prud'homme concedes that the measurements were well done on the solutions DRL used. (Tr. 772:17-773:7). Dr. Prud'homme concedes that he had no criticisms of the methodology of the experiment for the ends that were measured. (Tr. 773:3-7). I think the test was somewhat representative. Testing can be probative without exactly duplicating the process being examined. Thus, I attribute some weight to the rheological tests.

         Plaintiffs argue that Dr. Prud'homme's testimony demonstrates that a visco-elastic solid results because the solvent loss leads to a resulting increase in buprenorphine particle concentration, which causes a particle network to form. Specifically, Plaintiffs argue that the citric acid in DRL's casting dispersion interacts with PEO, causing the buprenorphine particles to stick to each other to form large open aggregates of particles through micro-scale chaining and aggregation. They argue that this finds support from Dr. Prud'homme's research conducted in 2010 ...


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