Endo Pharmaceuticals Inc. v. Actavis, Inc.Endo Pharmaceuticals Inc. v. Actavis, Inc.
Lead Opinion
Endo Pharmaceuticals, Inc. (Endo) appeals from the district court’s order denying its motions for a preliminary injunction to prevent Roxane Laboratories, Inc. (Roxane), Actavis Inc., and Actavis South Atlantic LLC (Actavis) from marketing and selling their respective generic drug products during the pendency of this litigation. Because the district court erred in concluding that Roxane and Actavis (Ap-pellees) had an implied license to practice the asserted patents, and because Appel-lees do not have an express license, we vacate and remand.
Background
Endo sells Opana® ER, which are branded extended-release tablets containing a painkiller called oxymorphone. The asserted patents are listed in the Approved Drug Products with Therapeutic Equivalence Evaluatiоns (Orange Book) entry for Opana® ER. Two of the asserted patents, U.S. Patent Nos. 8,309,122 (the '122 patent) and 8,329,216 (the '216 patent), are each continuations of the same parent application and are directed to extended-release oxymorphone compositions and methods of treating pain using those compositions. The third patent-in-suit, U.S. Patent No. 7,851,482 (the '482 patent), is not related to the other two patents. It recites purified oxymorphone compositions and methods of making those compositions. The '122 and '216 patents are at issue in both appeals, and the '482 patent is at issue only in the Actavis appeal.
Prior to this litigation, Endo sued Appel-lees for patent infringement under 35 U.S.C. § 271(e)(2)(A) based on their Abbreviated New Drug Applications (AN-DAs) to market generic versiоns of Opa-na® ER-the same products as those at issue in these appeals. The first set of
(a) any [U.S.] patents that are both (i) now owned by Endo ... and (ii) issued as of the Effective Date of this Agreement, including the Opana® ER Patents,
(b) any [U.S.] patent applications that claim priority to the Opana® ER Patents, including any continuation, continuation-in-part and divisional patent applications that claim priority to Opa-na® ER Patents, and
(c) any patents resulting from the reissue or reexamination of patents or patent application of patents or patent applications comprised within clauses (a) and (b) ...
J.A. in appeal no. 2013-1662 (Roxane J.A.), at 4973 § 1.16 (emphases added). The Roxane Agreement defines “Opana® ER Patents” as U.S. Patent Nos. 5,662,-933, 5,958,456, and 7,276,250. Id. § 1.20.
Pursuant to the agreement, Endo granted Roxane a covenant that it would not assert that Roxane’s generic versions of Opana® ER “infringe[ ] the Licensed Patents” and a license “under the Licensed Patents ... to make, use, have made, sell, offer to sell, import and use” those generic products. Roxane J.A. 4978 §§ 4.1(a),(b) (emphases added); see also Roxane J.A. 4974 §§ 1.28, 1.29. Finally, the Roxane Agreement includes a “No Implied Rights” provision stating that Endo does not grant to Roxane any license or right “whether by implication, estoppel or otherwise, other than as expressly granted herein.” Rox-ane J.A. 4949 § 4.4. The settlement and license agreement between Endo and Ac-tavis (Actavis Agreement) is similar. The Actavis Agreement includes a grant of a license, a covenant not to sue, and a “No Implied Rights” provision, but covers one аdditional patent not included in the Rox-ane Agreement and not relevant to this appeal. J.A. in appeal no. 2013-1658 (Ac-tavis J.A.), at 4893-908.
The patents that are the subject of this litigation issued after Endo’s agreements with Appellees. The '122 and '216 patents issued to Endo and the '482 patent was acquired by Endo. Endo again sued Appel-lees for patent infringement under 35 U.S.C. § 271(e)(2)(A) and moved for a preliminary injunction to prevent the marketing and sales of their generic oxymorphone formulations. Appellees opposed on the theories of express license and implied license by reason of legal estoppel. With regard to the latter, Appellees argued that Endo attempted to deprive them “of the benefit of [the] earlier bargain.” Roxane J.A. 4823; see also Actavis J.A. 2717.
At a joint hearing, the distriсt court commented that “this is a highly unfair and unjust situation if ... infringement of the new patents would stop the marketing and permitting process that was going on by Actavis and Roxane.” Actavis J.A. 6411. The court held that “as a matter of law ... Endo is estopped from claiming that the activity of Actavis and Roxane, which has gone on for a substantial period of time, is now suddenly barred because of these new patents.” Id. The court therefore denied Endo’s motions. Endo Pharm., Inc. v. Actavis Inc., C.A. No. 12-cv-8985-TPG (S.D.N.Y. Sept. 18, 2013), ECF No. 35.
Endo appeals. We have jurisdiction under 28 U.S.C. § 1292(a)(1).
Discussion
We review decisions to grant or deny a preliminary injunction for an abuse of discretion, which may be established
I. Express License
Endo argues that the district court abused its discretion in denying Endo’s motions for a preliminary injunction. Endo contends that the plain language of the agreements, which limit “Licensed Patents” to several enumerated patents and applications claiming priority to them, does not grant Appellees an express license to practice the asserted patents. It argues that the “No Implied Rights” provision further makes clear that the agreements do not cover the asserted patents. In the district cоurt, both Actavis and Roxane argued that they have an express license to practice these newly issued patents. In this appeal, Actavis no longer presents this argument, although Roxane continues to do so. The district court did not decide the question of express license, stating that “I do not feel, for the purposes of a preliminary injunction motion, that I am able to make any findings on the issues that I have just described.” Actavis J.A. 6438.
Roxane responds that the express terms of the settlement and license agreement grant it a license to practice the asserted patents because the previously licensed U.S. Patent No. 7,276,250 ('250 patent) claims priority to U.S. Provisional Application No. 60/303,357 ('357 application), and the '122 and '216 patents also claim priority to that рrovisional application. It contends that the word “including” in § 1.16(b) of the Roxane Agreement shows that the agreement covers more than just continuation, continuation-in-part, and divisional applications that claim priority to the Opana® ER Patents. Roxane argues that this section “necessarily embraces any patent applications that claim priority to any applications and provisional applications” to which the licensed patents likewise claim priority. Roxane Br. 29. It contends that Endo’s interpretation reads out the word “including” and other license terms, and argues that the common provisional application teaches subject matter that “binds” the '250 patent to the asserted '122 and '216 patents.
Roxane’s express license arguments are meritless. Section 1.16(b) of the Roxane Agreement covers U.S. patent applications that “claim priority to the Opana® ER Patents [e.g., any of the licensed patents], including any continuation, continuation-in-part and divisional patent applications that claim priority to Opana® ER Patents.” Roxane J.A. 4973 § 1.16(b). There can be no dispute that the '122 and '216 patents are not continuations of any of the licensed patents.
Roxane’s argument that the word “including” somehow broadens what it means “to claim priority to’-’ another patent is unpersuasive. The Roxane Agreement covers “any applications that claim priority to the ['250 patent], including any continuation, continuation-in-part and divisional” patent applications. Roxane J.A. 4973. Claiming priority to a licensed patent is a prerequisite for the license, and “including” by no means eviscerates that requirement. There is no reading of this language that extends cоverage to patents that merely have a provisional application in common with the licensed patents. The figure reproduced below, which is part of the record, shows this clearly. See Roxane J.A. 5232. The '122 and '216 patents claim priority to the '357 provisional application, and the '250 patent claims priority to the '357 application as well. The '122 and '216 patents do not claim priority to the '250 patent. Although the language is clear on its face, the fact that Endo and Roxane considered including in their agreement a grant of a license to “any application claiming a common priority date as the licensed patents” reinforces this conclusion. Roxane J.A. 4864-65 (emphasis added). Because the '122 and '216 patents have a provisional application in common with the '250 patent, the “common priority date” language would have expressly covered the '122 and '216 patents. See 35 U.S.C. § 119(e)(1) (2012). But that language does not appear in the final version of the Roxane Agreement.
The Aetavis Agreement likewise does not cover the '122, '216, and '482 patents at issue in the Aetavis appeal. It contains the same “continuations, continuations-in-part or divisionals” language as the Rox-ane Agreement. See Aetavis J.A. 4893, 4895, 4898. For the reasons discussed above, the asserted patents are not continuations, continuations-in-part, or division-als of the licensed patents. See MPEP §§ 201.06-.08. Finally, the '482 patent is completely unrelated to any of the previously licensed patents, and is likewise not covered by the agreement. We hold that Appellees do not have an express license to practice any of the patents asserted in this litigation.
II. Implied License
Endo argues that the district court legally erred in concluding that Appellees are impliedly licensed to practice the asserted patents due to legal estoppel. It contends that the court’s recognition of an implied license defense is incorrect. It argues that the specifications of the asserted patents are different from those of the previously licensed patents, and that the claims cover different subject matter. Endo points out that the previously licensed patent (the '250 patent) that claims priority to the same provisional application as the '122 and '216 patents was not even asserted in the previous litigation, and only added to the final settlement and license agreements because Endo realized that Appellees did not infringe it. Endo argues that, in contrast, the '122 and '216 patents — and the unrelated '482 patent— cover the accused generic tablets. Endo argues that the cases relied upon by Ap-pellees regarding estoppel are distinguishable because they involved continuations and because the licenses in those cases included products as well as patents. Endo argues that, by ignoring the language of the agreements and the parties’ intent, the district court’s approach violates the sanctity of contract and thus implicates serious public policy concerns.
Appellees respond that they have an implied license to practice the asserted patents based on the principle thаt equity does not permit the licensor to detract from its grant of a property right. Appel-lees contend that Endo granted them a license to market their accused generic
Appellees contend that the facts here are analogous to those in TransCore, LP v. Electronic Transaction Consultants Corp., where we held that the patentee was legally estopped from bringing a second infringement action even though the еarlier settlement agreement stated that it “shall not apply to any other patents.”
We hold that Appellees’ broad reading of TransCore is incorrect and agree with Endo that the district court erred as a matter of law in finding legal estoppel in favor of Actavis and Roxane. We begin with the well-established proposition, recognized in TransCore, that a patent license does not convey to the licensee “an absolute right” to make, use, or sell a product “because not even the patentee ... is given that right.” Spindelfabrik Suessen-Schurr, Stahlecker & Grill GmbH v. Schubert & Salzer Maschinenfabrik Aktienge-sellschaft,
The doctrine of legal estoppel does not nullify these general principles. Instead, it “refers to a narrow category of conduct encompassing scenarios where a patentee has licensed or assigned a right, received consideration, and then sought to derogate from the right granted.” Trans-Core,
Our subsequent cases confirm the limited scope of TransCore. In General Pro-techt Group, Inc. v. Levitón Manufacturing Co., Inc., we found an implied license where the asserted patents had “[t]he same inventive subject matter [as that] disclosed in the licensed patents” and “[t]he same products were accused.”
Endo is not estopped from asserting the patents at issue in these appeals because none of the asserted patents is a continuation of any of the licensed patents. The only familial relationship between the asserted and licensed patents is that the '122 and '216 patents claim priority to the same provisional application as the '250 patent. That, however, does not make these patents continuations of the '250 patent. See MPEP § 201.07. The '482 patent is not related to any of the licensed patents. The lack of a continuation relationship between any of the asserted and licensed patents and explicit disclaimer of any other licenses not within the literal terms of the contract are dispositive.
Appellees rely heavily on the general rule that “[t]he grantor is estopped from taking back in any extent that for which he has already received consideration.” Actavis Br. 27 (quoting TransCore,
Here, rather than grant a license to an “idea,” Endo has granted to Appellees a license and covenant not to sue limited to specific patents and patent applications. If Appellees wanted to market and sell their accused generic products free from any threat of being sued by Endo for patent infringement, they could have negotiated for the appropriate language in the settlement and license agreements. As we observed in Spindelfdbrik, “patent license agreements can be written to convey different scopes of promises not to sue, e.g., a promise not to sue under a specific patent or, more broadly, a promise not to sue under any patent the licensor now has or may acquire in the future.”
CONCLUSION
We have considered the parties’ remaining arguments and do not find them to be persuasive. We vacate the district court’s denials of a preliminary injunction in both cases and remand for further proceedings.
VACATED AND REMANDED
Opinion dissenting in part filed by Circuit Judge DYK.
Notes
. We note that counsel for Actavis repeatedly argued to the district court that the '122 and '216 patents are continuations of the '250 patent and are therefore expressly licensed. See, e.g., Actavis J.A. 2716 ("Endo's '122 patent and '216 patent are continuations of a patent called out by number as licensed in the 2009 settlement and license agreement.”). This is flatly wrong, and it is difficult to believe that this argument was made given what
Dissenting Opinion
dissenting in part.
I agree with the majority that Roxane did not have an express or implied license to practice the '122 and '216 patents. Roxane was aware of Endo’s applications for those patents at the time of the settlement with Endo, and the parties agreed not to include them in the settlement agreement. This, it seems to me, is inconsistent with an implied license. I also agree that Actavis does not have an implied license to the '482 patent, which Endo did not own at the time of the Acta-vis settlement agreement.
I part company with the majority on the question of whether Actavis has an implied license to the '122 and '216 patents. At the time of their settlement agreement, Endo owned those patent applications, which claimed priority to the same provisional application that provided priority to a patent covered by the settlement agreement (the '250 patent). During the settlement negotiations, Endo did not disclose the '122 and '216 patent applications, but rather licensed Actavis to produce the product at issue here. Furthermore, there are material differences between the Acta-vis and Roxane agreements and negotiations. Under these circumstances, I conclude that Actavis has an implied license to practice the '122 and '216 patents with respect to the product covered by the ANDA that was the subject of the settlement agreement. I respectfully dissent from the majority’s contrary conclusion.
I
Under the Hatch-Waxman Act, pharmaceutical manufacturers filing a New Drug Application (NDA) must list patents in the FDA’s Orange Book that “could reasonably be asserted” against a competing generic producer. 21 U.S.C. § 355(b)(1); 21 C.F.R. § 314.53(c)(2)(ii). Endo filed an NDA for a pain relief medication called
On February 14, 2008, Actavis sent Endo notice that it had filed an Abbreviated.New Drug Application (ANDA) seeking FDA approval to market a generic version of Opana® ER, as did Roxane on December 21, 2009. After receiving these notices, Endo sued Actavis and Roxane (which had also filed a similar ANDA) in the United States District Court for the District of New Jersey, claiming that Aeta-vis and Roxane’s ANDA filings constituted an act of infringement. See 35 U.S.C. § 271(e)(2)(A). Endo asserted only the '456 patent in the complaint.
Before the litigation could proceed to trial, Endo entered into seрarate settlement and license agreements with Actavis in 2009 and Roxane in 2011, permitting these companies to sell generic versions of Opana® ER pursuant to their ANDA filings. Sections 4.1(a) and (b) of Actavis’s agreement with Endo granted Actavis a license to produce and sell generic versions of Opana® ER under the '456 patent and specified that “Endo ... covenant[s] not to sue [ie., licenses] Actavis ... for infringement of ... the Opana® ER Patents [ie., the '250, '933, and '143 patents] based on the manufacture, use, import, sale or offer for sale of any Opana® ER Generic Products .... ” Actavis J.A. 3305. The Actavis agreement defined “Opana® ER Generic Product” as “any product that is ... sold under the Actavis ANDA.” Actavis J.A. 3302. Sections 4.1(a) and (b) of Roxane’s settlement agreement with Endo were similar.
The FDA approved both Actavis’s and Roxane’s ANDAs, and those companies have been selling generic versions of Opa-na® ER under their ANDAs since 2011.
At the time of the settlement agreements, Endo had pending patent applications for the '122 and '216 patents. This was disclosed to Roxane but not to Actavis. After Actavis and Roxane began to sell their generic versions of Opana® ER pursuant to their settlement agreements, the PTO issued the '122 and '216 patents to Endо in November and December 2012, respectively. These patents cover Opa-na® ER’s active ingredient as well as its slow release method. See U.S. Patent No. 8,309,122; U.S. Patent No. 8,329,216. Endo has now listed these new patents in the Orange Book as related to Opana® ER. The '122 and '216 patents claim priority to the same 2001 provisional application that gave priority to the '250 patent licensed under the settlement agreements.
In this case, Endo has sought to enjoin Actavis and Roxane’s production of Opa-na® ER generic products on the ground that such sales infringe the '122 and '216 patents. Thus, the question is whether, as the district court held, these companies have implied licenses to produce the disputed products under their settlement agreements with Endo.
II
In my view, the majority’s holding that Actavis has no right to an implied license
The logic driving TransCore and General Protecht is rooted in a decision of our predecessor court, AMP Inc. v. United States,
Similarly, in General Protecht, the pat-entee sued General Protecht for infringement of two patents, reached a licensе and settlement agreement with General Pro-techt allowing it to produce a defined product under the existing patents, and then, three years later, sued General Protecht again, alleging infringement of two new patents that issued after the settlement agreement. Gen. Protecht,
[the patentee] cannot deny ... that the newly asserted continuations are based on the same disclosure as the previously licensed patents and that, by definition, the continuations can claim no new invention not already supported in the earlier issued patents. Moreover, thesame products accused in the earlier suit are accused here. TransCore prohibits a patent licensor from derogating from rights granted under the license by taking back in any extent that for which it has already received consideration. In this case, [the patentee’s] actions have unquestionably derogated from [General Protecht]’s. rights under the Settlement Agreement. The same products were accused. The same inventive subject matter was disclosed in the licensed patents. If [the patentee] did not intend its license of these products to extend to claims presented in continuation patents, it had an obligation to make that clear.
Id. (emphasis added) (internal quotation marks and citation omitted) (alteration in original omitted).
Here too, if Endo succeeds on its infringement allegations, Aetavis will not be able to sell the very product for which it secured licenses in its settlement agreement. Although the '122 and '216 patents are not continuations of the licensed patents, as was the case in TransCore and General Protecht, the logic of those cases applies equally here. Under 35 U.S.C. § 119(e)(1), a patent that claims priority to a provisional application must “have the same effect, as to such invention [the provisional invention], as though filed on the date of the provisional application.” 35 U.S.C. § 119(e)(1). Thus, as we have explained in the past, “ ‘[w]hat is claimed by the patent application [claiming priority to a provisional application] must be the same as what is disclosed in the [provisional] specification.’ ” New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co.,
Since the '250 patent (covered by the license agreements) and the '122 and '216 patent applications (subsequently issued) claim priority to the same provisional application and, thus, must cover the same inventive subject matter, the agreements confer an implied license to the two new patents absent contrary evidence. In other words, under our decisions in Trans-Core and General Protecht, the settlement agreements here created a presumption that the '122 and '216 patents were impliedly licensed to Aetavis and Roxane, even though the only licenses explicitly mentioned in the settlement agreements were to the '250, '456, and '933 patents.
Ill
Nevertheless, I also think that the parties can agree to eliminate the presumption of implied licenses. Under our prior decisions, this cannot be accomplished simply by stating that the agreement does not extend to any patents beyond those listed in the agreement. TransCore and General Protecht rejected this very contention. See Gen. Protecht,
While the majority states that the language of the Actavis and Roxane agreements is “similar,” Majority Op. at 1373, there are, in fact, important differences. Compare Actavis J.A. 3300, 3302, 3305 with Roxane J.A. 4563, 4568. While both agreements provide an explicit license to produce generic versions of Opana® ER covered by Actavis’s and Roxane’s ANDAs under the '250, '456, and '933 patents, clause (c) of the agreements is different. Clause (c) of the Actavis agreement reads:
(e) For avoidance of doubt, and notwithstanding anything to the contrary in this Agreement, the License and Covenant Not to Sue do not grant to Actavis any rights or immunities with respect to any products other than the Opana® ER Generic Products, including any combination products.
Actavis J.A. 3305 (emphasis added). Critically, the agreement defines “Opana® ER Generic Products” as “any product that is marketed and/or sold under the Actavis ANDA” Actavis J.A. 3302 (emphases added). Actavis sells the allegedly infringing product under the Actavis ANDA.
In contrast, clause (c) of the Roxane license agreement reads:
(c) ... the License and Covenant Not to Sue does not grant to Roxane any rights or immunities with respect to any products other than the Roxane Products or with respect to any patents other than the Licensed Patents.
Roxane J.A. 4568 (emphasis added). The agreement defines “Licensed Patents” as
(a) any United States patents that are both (i) now owned by Endo ... and (ii) issued as of the Effective Date of this Agreement, including the Opana® ER Patents, (b) any United States patent applications that claim priority to the Opana® ER Patents, including any continuation, continuation-in-part and divisional patent applications that claim priority to the Opana® ER Patents, and (c) any patents resulting from the reissue or reexamination of patents or parent applications comprised within clauses (а) and (b) above, in each case that Endo ... could assert would be infringing by the making, using, selling, offering to sell or importing of the Roxane Product.
Roxane J.A. 4563 (emphases added). Thus, while the Actavis license is only limited to “any product that is marketed and/or sold under the Actavis ANDA,” Actavis J.A. 3302 (emphasis added), the Roxane license specifies that it neither extends to any other “products” nor “to any patents other than the Licensed Patents,” Roxane J.A. 4568 (emphasis added), ie., the 250, '456, and '933 patents. Thus, in subsection (c), the Actavis agreement does not limit the license to specific patents as the Roxane agreement does. A comparison of the two license agreements and the different negotiation histories suggests that Actavis could reasonably conclude it had negotiated a right to sell all Opana® ER generic products despite the interim issuance of the '122 and '216 patents, not merely рractice the patents expressly licensed.
That the '122 and '216 patent applications were published at the time of the settlement negotiations should not affect this conclusion: in both General Protecht and TransCore, at least one of the new patents at issue was published as a pending application at the time of the settlement and licensing negotiations. See Gen. Protecht,
There is nothing unfair in granting an implied license in Actavis’s favor. Although Aetavis could have researched pending patent applications at the time of the settlement, placing the burden of disclosure on the party with greater access to information (here, Endo) increases the efficiency of the bargaining process. See generally Bruce L. Hay, Effort, Information, Settlement, Trial, 24 J. Legal Stud. 29, 31, 55-56, 62 (1995); Lucian Arye Bebchuk, Suing Solely To Extract a Settlement Offer, 17 J. Legal Stud. 437, 448 (1988); Lucian Arye Bebchuk, Litigation and Settlement Under Imperfect Information, 15 RAND J. Econ. 404, 414 (1984). Assigning this burden to the party with inferior access to information creates an incentive for the more knowledgeable party to hide information: the more informed party will not face repercussions for failing to disclose information, and, indeed, will benefit from such information asymmetries. See generally Bebchuk, Suing Solely, supra, at 448; Bebchuk, Litigation and Settlement, supra, at 414 (“[LJegal rules and institutions that magnify the extent to which an informational asymmetry is present might well increase the likelihood of litigation.”); Richard A. Posner, An Economic Approach to Legal Procedure and Judicial Administration, 2 J. Legal Stud. 339, 422-26 (1973). By creating inсentives to hide and obscure important information in settlement negotiations, we undermine the purpose of the settlement process: the avoidance of further litigation.
I respectfully dissent.
. The Roxane agreement defined "Opana® ER Patents” as only the '250, '456, and '933 patents because the '143 patent expired in 2008.
. With respect to the '482 patent, that patent does not claim priority to the provisional application, and the negotiating history does not suggest that Actavis could reasonably conclude that it had negotiated a license to all future patents that might be acquired by Endo relating to Opana® ER. Because the '482 patent issued to another company, Johnson Matthey, in 2010, was acquired by Endo in 2012, and does not claim priority to the provisional application, Actavis should not be treated as having an implied license to the '482 patent. Neither Endo nor Actavis could have