KEVIN McNULTY, District Judge.
In this patent infringement suit, the plaintiffs, Indivior Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. (collectively, unless otherwise specified, "Indivior"), seek a preliminary injunction against defendants, Dr. Reddy's Laboratories S.A. and Dr. Reddy's Laboratories, Inc. (collectively, unless otherwise specified, "DRL"). Indivior holds and practices a patent on Suboxone film, a "rapidly dissolving film that adheres to the underside of a patient's tongue or the inside of a patient's cheek." The film contains and is a means of administering buprenorphine and naloxone, drugs used in the treatment of opioid addiction. DRL recently received approval from the Food and Drug Administration ("FDA") for an Abbreviated New Drug Application ("ANDA") for a generic version of Suboxone and plans to launch this generic "at risk." Indivior claims that this generic will infringe a continuation patent (known as the '305 patent") granted to Aquestive by the Patent Office in April 2018, and seeks to enjoin DRL's launch of the generic. For the reasons explained below, I will grant the preliminary injunction.
The remainder of the discussion in this Opinion expands upon and supports the foregoing findings of fact and conclusions of law.
The following facts were developed at a one-day hearing on June 28, 2018. Both sides declined to present live testimony. They presented their cases by means of oral argument, supplemented by PowerPoint presentations citing to the filed affidavits and exhibits. Many of the underlying historical facts were not in dispute.
Indivior, along with Aquestive, developed Suboxone film, a type of buprenorphine-containing transmucosal product for opioid dependence ("BTOD"). (Simkin ¶ 7.) It is essentially a rapidly dissolving film that adheres to the underside of a patient's tongue or the inside of a patient's cheek and combines two active pharmaceutical ingredients: (1) buprenorphine, a partial opioid agonist that decreases a patient's need for opioids, and (2) naloxone, an opioid antagonist that deters abuse. (Id.) Suboxone competes with several other drugs in the BTOD market, including tablets and buccal films. It maintains its position in that market partly because its generic competitors are not ABrated—that is, pharmacies cannot substitute generics at the point of sale when a patient is prescribed Suboxone. (Id. ¶ 9.)
Indivior initially participated in the tablet market, having received approval from the FDA to market Suboxone in tablet form in 2002. (Hoffman Decl. ¶ 45.) It had "orphan drug exclusivity" for the drug in tablet form until October 2009. (Id.)
During this time, Indivior developed the film version of Suboxone with Aquestive. On December, 10, 2013, the Patent Office issued Patent No. 8,603,514 ("'514 Patent") for "Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Making Compositions" to Aquestive.
DRL (as well as several other pharmaceutical companies, including Watson Laboratories, Par Pharmaceutical, Inc., Alvogen Pine Brook, Inc., Teva Pharmaceutical, Inc., Sandoz Inc. and Mylan Technologies, Inc.), sought to enter the film market as a generic competitor. They submitted ANDAs to the FDA for generic versions of the Suboxone film. (Hoffman Decl. ¶ 14.) In 2015, Indivior responded by filing actions against these companies under the Hatch-Waxman Act in the United States District Court for the District of Delaware. (Id.) In August 2017, Judge Richard Andrews held that Indivior failed to meet its burden of showing that DRL's generic version infringed the claims of the '514 Patent for Suboxone film. See infra. Judge Andrews had earlier construed the one of the claims in the '514 Patent to mean "dried without solely employing conventional convection air drying from the top" and found that there was not enough evidence to show that DRL's procedures "amount[ed] to an unconventional process" for drying. See infra.
Indivior responded to that decision by returning to the Patent Office. On April 3, 2018, the Patent Office issued Patent No. 9,931,305 ("'305 Patent") to Aquestive. (Patent '305 at [45].) According to the '305 patent:
This '305 continuation patent is a "child" of the '514 patent, the one that was the subject of the previous Delaware litigation between DRL and Indivior. The two largely overlap, except as to the language of Claim 26 of the '305 Patent and Claim 62 of the '514 Patent. The two pertinent revisions are as follows. First, the '514 Patent claims "(i) a cast film," but the '305 Patent claims "(i) a continuously cast film produced on a manufacturing line? Second, the '514 Patent makes claims that "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 at least on active." The '305 patent contains the same language, except that the italicized language became "continuously cast on the manufacturing line" and "continuously cast film," respectively.
In the District of Delaware, Plaintiffs and DRL had earlier litigated the validity and potential infringement of the '514 Patent (as well as similar patents held by plaintiffs) by DRL's ANDA product. See Reckitt Benckiser Pharm. Inc. v. Teva Pharm. USA Inc., ("Reckitt I') Nos. 14-1451, 14-1573, 14-1574, 2016 WL 3621632 (D. Del. June 29, 2016) (construing the claims of multiple terms of several patents, including the '514 patent pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (1996)); Reckitt Benckiser Pharm. Inc. v. Dr. Reddy's Labs. S.A., ("Reckitt If) Nos. 14-1451, 14-1573, 14-1574, 2017 WL 3837312 (D. Del. Aug. 31, 2017), appeal docketed, No. 18-1115 (Fed. Cir. Oct. 27, 2017) (addressing the allegations of infringement and invalidity with respect to the '514 Patent after a four-day bench trial).
In Reckitt II, Judge Richard Andrews, after a four-day bench trial, found that the defendants had failed to demonstrate by clear and convincing evidence that the asserted claims in the '514 patents were invalid as obvious. He also found, however, that Indivior failed to meet its burden to show that DRL's product infringed certain claims of the '514 patent. 2017 WL 3837312, at *20. In an earlier opinion, Judge Andrews had construed the claim in the '514 patent, "dried," to mean "dried without solely employing conventional convection air drying from the top."
Instead, Indivior obtained the continuation '305 patent, in which it sought to claim around the "drying" problem. The "dried/drying language" was dropped from the continuation patent, which was intended to have a broader scope in that it would no longer disclaim "conventional" drying methods. Indivior then brought this action against DRL here in the District of New Jersey, this time claiming infringement of the new '305 patent. (See ECF no. 1 ("Complaint for Patent Infringement").) Upon learning of DRL's plans to launch the ANDA product "at risk," Indivior moved for temporary restraints and a preliminary injunction to prevent DRL from launching its generic product. (ECF no. 70.) (This application was made on an emergent basis, because the 30-month stay granted by Hatch-Waxman had already been exhausted.)
I granted a temporary restraining order enjoining DRL from launching in order to preserve the status quo during the resolution of this motion. (ECF no. 78.) On June 28, 2018, 1 conducted a hearing on the preliminary injunction application.
A preliminary injunction has been called "a drastic and extraordinary remedy." Bayer CropScience AG v. Dow AgroSciences LLC, 851 F.3d 1302, 1308 (Fed. Cir. 2017) (quoting Nat'l Steel Car, Ltd. v. Canadian Pacific Railway, 357 F.3d 1319, 1324-25 (Fed. Cir. 2004)) "A plaintiff seeking a preliminary injunction must establish (1) that he is likely to succeed on the merits, (2) that he is likely to suffer irreparable harm in the absence of preliminary relief, (3) that the balance of equities tips in his favor, and (4) that an injunction is in the public interest." Winter v. Natural Res. Del Council, Inc., 55 U.S. 7, 20 (2008) (numbering added); accord Am. Express Travel Related Servs. v. Sidamon-Eristoff 669 F.3d 359, 366 (3d Cir. 2012); Kos Pharm., Inc. v. Andrx. Corp., 369 F.3d 700, 708 (3d Cir. 2004); see Adams v. Freedom Forge Corp., 204 F.3d 475, 486 (3d Cir. 2000) (movant bears the burden of establishing these elements).
A patentee need not address invalidity, an affirmative defense, as an initial matter in filing for a preliminary injunction. Gaymar Industries, Inc. v. Cincinnati Sub Zero Products, Inc., 790 F.3d 1369, 1375 n.7 (Fed. Cir. 2015). However, when the alleged infringer "raise[s] substantive issues respecting the validity and enforceability of the [patent-in-suit]," then the patentee carries the burden of showing likelihood of success on the merits with respect to the patent's validity, enforceability, and infringement. Id. (quoting and distinguishing Nutrition 21 v. United States, 930 F.2d 867, 869 (Fed. Cir. 1991)).
DRL believes that the path to defeating this application for a preliminary injunction has been smoothed by rulings in prior proceedings. It contends that Indivior is barred from asserting these patent claims by the doctrines of claim preclusion and issue preclusion.
According to DRL, Indivior is barred by claim preclusion from asserting in this District the "same cause of action" it earlier asserted against DRL under the '514 patent, and lost, in the U.S. District Court for the District of Delaware. (Def. Opp. at 8.) Further, DRL argues, Indivior is estopped by the Delaware proceedings from relitigating the issue of whether DRL's methods for drying its film are "conventional" and, by extension, whether those methods infringe Indivior's '305 patent. (Id. at 14.)
I will address the question of claim preclusion first. In general, the Federal Circuit applies the claim preclusion law of the regional circuit in which the district court sits. SimpleAir, Inc. v. Google LLC, 884 F.3d 1160, 1165 (Fed. Cir. 2018). Claim preclusion bars a suit where there has been: "(1) a final judgment on the merits in a prior suit involving (2) the same parties or their privies and (3) a subsequent suit based on the same cause of action." Walthour v. Hen-on, 720 F. App'x 130, 132 (3d Cir. 2017) (quoting Lubrizol Corp. v. Exxon Corp., 929 F.2d 960, 963 (3d Cir. 1991)). The first two requirements are met, in that I have before me a final judgment on the merits from the District of Delaware between the same two parties. See Reckitt II, 2017 WL 3837312. The third requirement—that the prior judgment concern the "same cause of action" as the one now before this court—is peculiar to patent law and is therefore governed by Federal Circuit precedent. Acumed LLC v. Stryker Corp., 525 F.3d 1319, 1323 (Fed. Cir. 2008) ("Whether two claims for patent infringement are identical" is governed by the law of the Federal Circuit, because this question is "particular to patent law.")
In SimpleAir, Inc. v. Google LLC, 884 F.3d 1160 (Fed. Cir. 2018), the Federal Circuit Court of Appeals addressed the issue of what constitutes the "same cause of action" with respect to actions involving separate patents. SimpleAir initiated a series of patent infringement lawsuits against Google and its cloud messaging services. SimpleAir, 894 F.3d at 1163. The patents held by SimpleAir consisted of a parent patent and several child patents which all shared a common specification. Id. Google succeeded in obtaining three separate judgments in its favor. Id. Its fourth complaint, however, was dismissed by the district court on grounds of claim preclusion. Id. at 1164. The district court reasoned that "because the [patents] shared the same title and specification with the previously adjudicated continuation patents, and the filing of a terminal disclaimer to overcome the PTO's obviousness-type double patenting rejections indicated that the PTO believed the content of the patents in suit to be patentably indistinct from the earlier patents." Id.
The Federal Circuit vacated the decision of the district court and remanded. Id. at 1171. The district court, it reasoned, never actually compared the claims of the patents involved in the fourth complaint to those of the previously adjudicated patents. Id. at 1164. It was necessary to perform such a comparison to determine whether the causes of action in current and prior actions were identical. Id. at 1166. What defined a cause of action, held SimpleAir, were the transactional facts from which the cause of action arose Id. at 1165 (citing Restatement (Second) of Judgments (1982); Senju Pharm. Co., Ltd. v. Apotex Inc., 746 F.3d 1344, 1349 (Fed. Cir. 2014)). The facts that make up a "transaction" in a given case, it acknowledged, are not capable of a mathematically precise definition. Id. (citing Restatement § 24 cmt. b.).
SimpleAir propounded a standard and method of analysis of claim preclusion in connection with continuation patents:
The filing of a terminal disclaimer poses particular issues in connection with continuation patents. Id. at 1167. Terminally disclaimed continuation patents, the Court reasoned, could actually "provide larger claim scope to a patentee than the patentee had under" the parent patent. Id. (citing Senju, 746 F.3d at 1353). A terminal disclaimer, said the SimpleAir Court, did not wholly foreclose the question of claim preclusion, and could not be treated as rising to the level of a presumption. SimpleAir held that such a disclaimer is nevertheless relevant, however, and provides a "strong clue" that the claims are essentially the same, or patentably indistinct. Id. at 1168.
SimpleAir further held that the claims were not barred by the doctrine of Kessler v. Eldred, 206 U.S. 285 (1907). Id. at 1170. Under Kessler, assertions of a patent against post-judgment activity are precluded if the earlier judgment held that "essentially the same" accused activity did not infringe the patent. SimpleAir, 884 F.3d at 1170 (citing Brian Life, LLC v. Elekta Inc., 746 F.3d 1045, 1057-58 (Fed. Cir. 2014), and noting that this doctrine was meant to prevent repeated post-judgment harassment of the judgment winner). This issue, too, Simple Air remanded to the district court, with the following instruction: "[I]f, on remand, the district court determines that the claims . . . are patentably indistinct from those previously adjudicated, and are therefore claim-precluded . . ., then the Kessler doctrine would also bar SimpleAir's assertions of those patents against Google's provision of essentially the same . . . services post-judgment." Id. at 1170. Thus the claim preclusion and Kessler issues tended to merge, at least under the circumstances of that case.
The underlying inventions in SimpleAir (cloud technology) and in this case (vehicles for opioid addiction medication) could not be any more different. The procedural histories of that action and this case, however, are similar.
A terminal disclaimer was filed with the '305 patent. ('305 Patent at (*i.) Under SimpleAir, I must take this into account, but it is not in itself dispositive. A terminal disclaimer is not an automatic, implied concession that the two patents are the same; it is, however, a "strong clue that a patent examiner and, by concession, the applicant, thought the claims in the continuation lacked a patentable distinction over the patent." SimpleAir, 884 F.3d at 1168. The existence of the terminal disclaimer, then, tilts in favor of DRL, but I must consider it in light of the claims of the relevant patents.
The '305 and '514 patents make many claims, which for the most part overlap, and I do not consider them in detail. This case centers around a single point of distinction: the meaning of the removal of the terms "drying/dried" from the '514 parent patent and their replacement with the term "continuously cast on the manufacturing line" in the '305 child patent. Indivior says that the claim language in the '305 patent is clear, and that it does include a limitation of "unconventional" drying. Such a limitation, says Indivior, if it was ever present in the '514 patent, has now been removed, and should not be read back into the text of the claims of the '305 patent. (PI/TRO Hrg. Tr. at 40:25-41:15.) DRL argues that this was a change of wording, but not of substance; the process by which Suboxone film is manufactured under the '305 patent, and particularly the drying process, remains unchanged. (Def. Opp. at 9.)
"Courts are required . . . to `look at the words of the claims themselves . . . to define the scope of the patented invention.'" Aventis Pharm. Inc. v. Amino Chemicals Ltd., 715 F.3d 1362, 1373 (Fed. Cir. 2013) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Here, the '305 patent clearly does not contain the terms "dried" or "drying." Can Judge Andrews's construction of those terms as "dried without solely employing conventional convection drying from the top," Reckitt II, 2017 WL 3837312, at *4, nevertheless be deemed to be present in the term "continuously cast" in the '305 patent? I must answer that question in the negative. I find that I cannot automatically carry over this construction from the earlier '514 patent. Such a limitation on a claim must be anchored in some textual reference in the '305 patent claims to the method by which the film is dried. See MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1330-31 ("However, we cannot endorse a construction analysis that does not identify a `textual reference in the actual language of the claim with which to associate a proffered claim construction. Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed Cir. 1999) . . ."). Within the relevant claim of the '305 patent, there is no such textual reference, and no express limitation of how the film is dried, whether conventionally or unconventionally.
I observe parenthetically that "conventional" vs. "unconventional," while employed as a useful shorthand, is not precisely the distinction drawn by Judge Andrews. He referred, rather, to "conventional convection drying from the top," and found that it had been disavowed, leaving other claimed methods intact.
DRL stresses that "drying is incorporated within the concept of continuously cast film or continuously cast film on a manufacturing line" and that "if drying is occurring, . . . all the disavowals on which Judge Andrews relied would apply to the drying which is available in this process." (PI/TRO Hrg. Tr. 66:1-11.) In other words, drying is still necessary to the process of the '305 patent, and Indivior therefore has not really changed its claims. (See id. at 66:12-20.) To find a limitation, however, it is not enough to find that certain methods or characteristics are functionally required. See Markem-Imaje Corp. v. Zipher Ltd., 657 F.3d 1293, 1301 (Fed. Cir. 2011) ("That a device will only operate if certain elements are included is not grounds to incorporate those elements into the construction of those claims."). Similarly, patent specifications do not automatically translate to limitations within the claims, though they may be useful in understanding them. See Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed Cir. 2005). The court's focus must be "on understanding how a person of ordinary skill in the art would understand the claim terms. For instance, although the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments." Id. (citations omitted).
The parties have submitted competing expert declarations on that subject. According to DRL's expert, "a person of ordinary skill in the art would understand that drying and theology (including viscosity) are essential aspects of the invention [and that] that the invention provides for unconventional drying and viscosity" (see, e.g., Amiji ¶ 85); according to Indivior's expert, the specifications merely describe a number of ways to making uniform films using conventional and unconventional methods and "do not recite a particular drying method." (See, e.g., Langer Supp. ¶¶ 17-21.)
The parties did not offer up their experts for live testimony or an assessment of credibility. On a cold record, for purposes of this preliminary prediction of likelihood of success, I am persuaded by Indivior's interpretation. Indivior is likely to prevail on its contention that neither the practicalities of production nor the '305 patent language import such an implied "drying" limitation into the "continuously cast" claim.
The cause of action here involves a continuation patent with a terminal disclaimer. Nevertheless, the terms of that '305 patent do not include "dried/drying." That was the at the core of the claim decided by the Reckitt decisions, which was distinct from the claim presented here. Therefore, I believe that it is likely that plaintiffs will be able to show that the claims of the '305 patent are not "patentably indistinct" from the '514 patent and that this cause of action is not barred by the doctrine of claim preclusion.
"Collateral estoppel, also known as issue preclusion, prohibits relitigation of an issue that has been fully and fairly litigated previously." Karns v. Shanahan, 879 F.3d 504, 514 n.3 (3d Cir. 2018). The elements of issue preclusion are that (1) the issue to be precluded is the same as that involved in the prior action; (2) the issue was actually litigated; (3) the issue was determined by a final and valid judgment; and (4) the determination was essential to the prior judgment. Id. (quoting Nat'l R.R. Passenger Corp. v. Pa. Pub. Util. Comm'n, 342 F.3d 242, 252 (3d Cir. 2003)).
In Reckitt I and Reckitt II, Judge Andrews defined the term "dried/drying" as "dried without solely employing conventional convection air drying from the top" and found after a bench trial that the drying methods employed by DRL were non-infringing as to the '514 patent. Reckitt I, 2016 WL 3621632, at *10-*11; Reckitt II, 2017 WL 3837312, at *6. This finding, DRL believes, estops Indivior from relitigating in connection with the '305 patent the issue of whether Indivior disclaimed films dried using conventional methods. The problem is that the previous litigation construed the "dried/drying" language of the '514 patent, language which is not present in the '305 patent. That earlier language was critical to Judge Andrews's decision to find that DRL did not infringe the '514 patent.
DRL attempts to get around this problem by arguing, through evidence in the declarations, that drying is still part of the process of "mak[ing] a continuously cast film" and that the specification in the patent "repeatedly states that drying is part of `the present invention.'" (Def. Opp. at 15.) Because of this, DRL argues, Judge Andrews's determination binds Indivior in this case as well, and DRL's ANDA product should be deemed non-infringing.
I am unpersuaded. An apparatus claim need not recite every method of manufacturing the device, see Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859, 873 (Fed. Cir. 2010), and I am wary of "reading specific process limitations into an apparatus claim" unless they are truly present, Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1344 (Fed. Cir. 2008). The '305 patent does not contain the terms "drying/dried" in the relevant part of the claim language. This fails the first element of the issue preclusion test: that the issue to be precluded in this case be the same as the issue in the previous case. The precise words of the claim are paramount; the inquiry into claim construction "begins and ends in all cases with the actual words of the claim." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). The '305 patent and its claims contain different language and that language requires its own distinct construction. For many of the same reasons discussed above in relation to claim preclusion, the '305 patent language presents a different issue from the one that was litigated under the '514 patent.
Because DRL fails to establish that the issue to be decided in this case is the same as the one in the previous action, plaintiffs are likely to succeed in showing that they are not precluded/estopped from litigating whether DRL's product infringes on the '315 patent.
DRL next argues that Indivior, through this litigation, is attempting to broaden what the specification says the inventors invented, in a manner prohibited by the "written description" requirement.
Under 35 U.S.C. § 112, "[t]he specification [of a patent] shall contain a written description of the invention, and the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention." This is known as the "written description requirement." See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1136, 1351 (Fed. Cir. 2010) ("Since its inception, this court has consistently held that § 112, first paragraph, contains a written description requirement separate from enablement, and we have articulated a `fairly uniform standard,' which we no affirm."). The test for sufficiency of this provision is "whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Id. (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562-63 (Fed. Cir. 1991)).
DRL argues that the '305 patent does not describe the use of conventional drying to retain the claimed levels of uniformity in a cast film. (Def. Opp. at 17.) In fact, DRL says, the examples discussed in the patent's specification "reveal that when the inventors tried to achieve drug content uniformity using `conventional' drying, they failed." (Id.) It claims that plaintiffs, through this litigation, are attempting to broaden what the specification says the inventors invented; the '305 patent, they say, lacks a written description of an invention that would encompass production by conventional means of drying. (Id.)
lndivior, on the other hand, observes that its '305 patent makes extensive disclosures about the films formed without regard to how they were dried, and discloses embodiments and ways of making films that possess the necessary uniformity. (Langer Supp. ¶¶ 7-12, 21) A person of ordinary skill in the art would understand that Indivior possessed the resulting invention. (PI. Reply at 7.)
Indivior points to two examples in the '305 patent (CG and CH) which do not specify a drying process. (Pl. Reply at 7 (citing '305 Patent, 53:39-55:8)) Indivior's expert, Dr. Robert Langer, states that "the ['305] Patent is clear that using any one particular drying method is only one option that can be used to create the desired uniform films" and that la] person of ordinary skill in the art would therefore understand that a particular type of controlled drying is not required to create the drug content uniformity in the Patent." (Pl. Reply. at 7; Langer. Supp. ¶ 14).
DRL, in contrast, cites to particular sections of the specifications of the '305 patent which state that "conventional" methods of drying would not be able to retain uniformity (Def. Opp. at 17 (citing '305 Patent 3:29-30; 29:38-39)). DRL's expert, Dr. Mansoor Amiji, opines that, based on the evidence of the '305 patent, plaintiffs were not in possession of the invention, i.e., a uniform film produced by means of conventional drying. (Def. Opp. at 17 (e.g., Amiji Decl. ¶ 90 ("As these passages make clear, a person of ordinary skill in the art reviewing the specification would not understand the inventors to have invented uniform films that were manufactured using `conventional' drying.")
Two experts have advanced contradictory interpretations, but once again their live testimony has not been offered and I am not equipped to assess their credibility. Thrown back on the inherent plausibility of those opinions, I find that, in this preliminary posture, the opinion of Indivior's expert is more persuasive in that it is tied more closely to the patent language. The primary basis for my conclusion, however, is the face of the '305 patent itself, which, I find, has disclosed films without regard to how they were dried. While a full trial record could demonstrate otherwise, I find that plaintiffs have put forward sufficient preliminary evidence to show that they are likely to prove that they were in possession of the invention described in the patent and have thus satisfied the written description requirement.
DRL argues that, should Indivior be correct that the claims of the '305 patent do not require unconventional drying (or rule out conventional drying) as part of the process of making the film, DRL would have "strong anticipation, non-infringement, and written description defenses." (Def. Opp. at 19.) That, of course, is the other side of the continuation-patent coin; by claiming more broadly, Indivior may have exposed its claims to further challenges.
The parties have touched only lightly on the issue of obviousness. (PI/TRO Hrg. Tr. at 82:11-15 ("[DRL:] We didn't raise an obviousness argument because we think this claim, if it's as broad as they say it is, [it's] anticipated by the Schmidt reference.").) Relying on Reckitt II and the declaration of Dr. Amiji, DRL argues that a previous patent ("Schmidt") "disclose[d] most other limitations of the '305 Patent's independent claims," and that the only way past this prior art would be to read a "solid" limitation into the claims, and that assuming "solid" simply means "dried," then the patent was anticipated. (Id. (citing Amiji ¶¶ 93-133); PI/TRO Hrg. Tr. 82:24-83:3.) Plaintiffs dispute this and say that DRL, by not challenging novelty or nonobviousness, has not sufficiently questioned the patent's validity: "Because the cast films of the '305 Patent are solid films, not a wet matrix, DRL's contingent arguments about alleged anticipation of the claims if directed to wet matrices is inapposite." (Id. Pl. Reply at 7 & n.3.)
Patents enjoy a presumption of validity at every stage of litigation and the burden rests on the party asserting invalidity, Canon Computer Sys., Inc. v. Nu-Kate Intl, Inc., 134 F.3d 1085, 1088 (Fed Cir. 1998). Even assuming that DRL's spare arguments were enough to shift the burden, I find on the current record that Indivior is likely to show that the '305 patent is not anticipated or obvious.
As to non-infringement, Indivior puts forward a detailed explanation of how DRL's ANDA product infringes each of eight limitations set out in Claim 26 of the '305 patent. (Pl. Br. at 10-13 (citing evidence from the litigation over the '514 patent and noting that "dried" is no longer a limitation). See also Langer Decl. ¶¶ 66-105 (matching features of ANDA product to Claim 26 of '305 patent).) DRL offers little in response. It merely states that it "does not `cut' undried `continuously cast films.'" (Def. Opp. at 19 (citing Amiji ¶ 136.).) At this point in the litigation, the patent claim and the description of the allegedly infringing product sufficiently match; I find it likely on this record that Indivior will be able to show that the DRL's ANDA product would infringe the '305 patent.
The likelihood of success factor, then, tips in favor of Indivior.
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The country faces a recognized opioid addiction epidemic. (Rosenthal ¶ 21.) Buprenorphine, the active ingredient in Suboxone film, is an effective treatment for opioid addiction which does not have some of the disadvantages associated with other opioid treatment medications, such as naltrexone and methadone. (Id. ¶¶ 31-32.) Of the over 2.5 million people who suffer from opioid use disorder, only 30% receive medication. (Hofmann, ex. 28 at 4.) DRL ascribes the under-utilization of medication to Suboxone's high cost and certain insurance plans' unwillingness to cover such costs. (See Rosenthal ¶ 41-42.) A generic version of Suboxone, says DRL, would change those numbers. Prices would go down and more insurance plans would be willing to cover a lower-cost generic. (Hofmann ¶¶ 121-22.)
Indivior replies that the public interest would be disserved by the lack of an injunction in two ways. First, they argue that the public interest generally weighs in favor of protecting property rights in the absence of countervailing factors. It is always true, of course, that a generic would likely be cheaper. But the patent owner's right to exclusivity encourages innovation and provides incentives for drug companies to continue costly development efforts. (Pl. Br. at 28 (citing Apple, Inc. v. Samsung Elecs. Co., 809 F.3d 663, 647 (Fed. Cir. 2015); Syntex (U.S.A.) v. Apotex, Inc., 407 F.3d 1371, 1383-84 (Fed. Cir. 2005).) Second, Indivior states that a reduction in revenue will cause Indivior to scale back its outreach, educational, and charitable programs in the field of opioid addiction and would, in turn, reduce access to opioid addiction treatment. (See Pl. Br. at 28-30.) It also warns that research and development by Indivior in that field would be reduced. (Id. at 30.)
I find that the public interest will be served by the issuance of a preliminary injunction in this case. True, the relief requested by plaintiffs would prevent the entry of DRL's generic film—a means of delivery of medication—into the market. It will not, however, deny access to the active ingredient, which may be administered by other means. There still remain other non-film generics on the market, and neither side has stated that the issuance of injunctive relief (or the lack thereof) would prevent access to these alternatives. DRL offers only that the ease of use of the film, as opposed to, e.g., the under-tongue tablet, would naturally result in better compliance. That is not a negligible consideration, but it is not enough to tilt the balance.
Under these circumstances, the public interest tilts in favor of protecting the exclusive rights held by the patent holder, see Apple, 809 F.3d at 647. This factor, too, favors Indivior.
I have assessed the four injunctive factors, and also weighed them. For the reasons set forth above, I will grant Indivior's motion for a preliminary injunction. For the immediate present, the restraints contained in the temporary restraining order shall continue. On or before Monday, July 16, 2018, the parties shall submit an agreed form of preliminary injunction, with required security, or shall individually submit competing forms of order for the Court to consider.
An appropriate order follows.
