Full opinion text
OPINION AND FINAL ORDER REBECCA BEACH SMITH, District Judge. On March 24, 2010, Pfizer, Inc., Pfizer, Ltd., and Pfizer Ireland Pharmaceuticals Partnership (collectively “Pfizer”) filed suit in this court against Teva Pharmaceuticals USA, Inc. (“Teva”) alleging imminent infringement of Pfizer’s United States Patent No. 6,469,012 (“the '012 patent”), entitled “Pyrazolopyrimidinones for the Treatment of Impotence.” United States Patent No. 6,469,012 (filed May 13, 1994) (issued Oct. 22, 2002), Plaintiffs Exhibit (hereinafter referred to as “PTX”) 0001. The '012 patent claims the use of certain chemical compounds as a method of treating erectile dysfunction (“ED”). Only Claims 25 and 26 of the '012 patent are in dispute in this case. See Pfizer, Inc. v. Teva Pharms. USA, Inc., No. 2:10cv128, 803 F.Supp.2d 459, 463-64, 2011 WL 3610654 (E.D.Va. Jan. 18, 2011) (noting that only these claims are at issue in this case), Docket # 77. One of the especially preferred compounds of the '012 patent is sildenafil, the active ingredient in the ED drug Viagra. On October 25, 2004, Teva filed an Abbreviated New Drug Application with the Food and Drug Administration (“FDA”) seeking approval to market a generic equivalent of Viagra containing sildenafil citrate. See PTX 238. On April 24, 2007, the FDA granted Teva tentative approval to do so. Pfizer alleges in its Amended Complaint that Teva’s planned generic drug will infringe the '012 patent, and seeks a declaration from the court to that effect. On April 29, 2010, Teva answered the Complaint and filed a Counterclaim against Pfizer seeking a declaration that Teva’s planned drug will not infringe the '012 patent and that the claims of the '012 patent are invalid. Teva subsequently sought, and was granted, leave of the court to file an Amended Answer and Counterclaim, which amendment added an allegation that the '012 patent is invalid because of inequitable conduct committed during its prosecution before the Patent and Trademark Office (“PTO”). On December 13, 2010, this court held a hearing pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 372, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), and issued an opinion on March 17, 2011, construing the disputed terms of the patent. See Pfizer, Inc. v. Teva Pharms. USA, Inc., 803 F.Supp.2d 397, 2011 WL 996794 (E.D.Va.2011). A bench trial in this ease commenced on June 15, 2011, lasting for twelve days. At trial, Teva stipulated to infringement, and therefore this issue is not before the court. See Docket # 330. On July 17, 2011, after final arguments had concluded, this court took all outstanding issues under advisement. This Opinion and Final Order addresses and resolves all remaining motions and merits determinations. I. Factual Overview The patent in suit in this case is the '012 patent, and in particular Claims 25 and 26, which claim: 25. A method of treating erectile dysfunction in a male human, comprising orally administering to a male human in need of such treatment an effective amount of a compound selected from: [listing nine different chemical compounds] or a pharmaceutically acceptable salt thereof; or a pharmaceutical composition containing either entity. 26. A method as defined in claim 25, wherein said compound is [listing a chemical compound] or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition containing either entity. '012 patent col. 10, lines 1-39, PTX 0001. Thus, these claims of the patent teach the oral administration of sildenafil and other compounds for the treatment of ED. The '012 patent will expire on October 22, 2019. See Final Pretrial Order ¶ 9, Docket # 267. As the patent in suit concerns the treatment of ED, bringing with it a host of technical terminology and a background of underlying knowledge, this court will first review the biology and physiology of erections and then will move to a description of the invention and patents concerned. A. The penis of a male human contains erectile tissue called the corpus cavernosum, consisting of two corpora cavernosa that run its length. The corpus eavernosum is smooth muscle tissue that is spongy and composed of cavernosal spaces which can expand and fill with blood to produce an erection. The corpus cavernosum is surrounded by fibrous tissue known as the tunica albuginea. When the penis is in a flaccid state, the corpus cavernosum is contracted. An erection is produced when the corpus cavernosum relaxes so that it expands and fills with blood. As the corpus cavernosum relaxes, the tunica albuginea compresses the veins that drain blood from the penis, thus preventing blood from flowing out and raising pressure inside the penis, producing an erection. Detumescence of the penis occurs when the corpus cavernosum contracts and bloods flows out of the penis. An erection is controlled by the nervous system. There are three neurotransmission pathways in the human body: the adrenergic nerves; the cholinergic nerves; and the non-adrenergic, non-cholinergic (“NANC”) nerves. The NANC nerves control erectile function. When a male human reacts to sexual stimuli, the NANC nerves send a signal to the penis. The neurotransmitter in this case is nitric oxide (“NO”). Thus, when the NANC nerves send a signal to the penis, they synthesize NO from L-arginine in the endothelial cells of the vascular system. The NO travels into the smooth muscle cells of the corpus cavernosum where it activates an enzyme known as guanylate cyclase. Guanylate cyclase synthesizes another enzyme, cyclic guanosine monophosphate (“cGMP”) by interacting with guanosine triphosphate. cGMP is the signaling enzyme that cues smooth muscle tissue, in this case the corpus cavernosum, to relax. This entire process is known as the L-arginine-nitric oxide-cyclic GMP pathway. cGMP is a cyclic nucleotide, a form of enzyme. Enzymes, as is evident from cGMP’s function in the smooth muscle described above, are proteins that catalyze chemical reactions in the body. cGMP is degraded by cGMP phosphodiesterase (“PDE”), another enzyme, which binds to cGMP and breaks it down into GMP. GMP does not have the same signaling effect in smooth muscle as cGMP. At the time the '012 patent was filed, there were five known types of PDEs: PDE1, PDE2, PDE3, PDE4, and PDE5. PDE1 and PDE5 both degrade cGMP and, thus, are termed cGMP PDEs. cGMP PDE can be inhibited by cGMP PDE inhibitors. An inhibitor functions in the same was that cGMP PDE itself functions with cGMP, by binding to it to block or decrease the activity of the enzyme. In other words, cGMP PDE inhibitors bind to cGMP PDE so that it, in turn, cannot bind to cGMP. The effectiveness of a PDE inhibitor is measured in terms of its potency, the amount of the inhibitor required to effectively inhibit the PDE, and its selectivity, i.e., the ratio at which the inhibitor prefers one PDE over another. B. Beginning in 1985, Pfizer researchers in Sandwich, England were working on the creation of cGMP PDE inhibitor drugs to treat cardiovascular diseases such as hypertension and angina. Dr. Peter Ellis was the head of the team of biologists on the project, while Dr. Nicholas Terrett led the chemists. Pfizer hoped that cGMP PDE inhibitors would be able to treat these cardiovascular diseases by-causing relaxation of the smooth muscle tissue in the arteries, thereby lessening stress on the cardiovascular system. In particular, Pfizer aimed to create compounds that would inhibit cGMP PDEs, thereby enhancing the action of cGMP within smooth muscle and causing smooth muscle relaxation. The project first started with the chemistry team creating compounds. Such compounds were based off other compounds known to inhibit cGMP PDE, and the chemistry team worked to make such compounds more selective, in terms of which enzyme they inhibited, and more potent in their inhibitory capability. Once the compounds were made, the biology team tested the compounds in assays it designed to determine their selectivity and potency for cGMP PDE. The chemistry team then received feedback and modified the compounds further, if necessary, to improve their biological activity. The chemistry team also ran tests to assess the safety of the compounds, while the pharmacokinetic team studied the compounds to determine their absorption, distribution, metabolism, and excretion in the human body. The chemistry team first synthesized sildenafil in 1989, and it quickly became a “lead compound,” after the biology and pharmacokinetic tests had been run. The results were so encouraging that the team working on the project recommended that Pfizer begin clinical development of sildenafil for the treatment of angina. See PTX 354. A year later, in July 1991, Pfizer began its first clinical trial using sildenafil, Study 201. Trial Tr. 695:21-697:14. As this clinical trial was a Phase I study, the subjects were healthy volunteers, in this case males, and the goal was to assess the safety of the drug and further determine its pharmacokinetic properties. This initial study, and several others after it, all tested single doses of sildenafil. In 1992, Pfizer began a multiple dose study of sildenafil, again using healthy male volunteers, Study 207. Trial Tr. 697:21-699:9. The volunteers were administered three doses of sildenafil or a placebo daily for ten days. At the conclusion of the study, volunteers reported several side effects; the most common were myalgia, headaches, and spontaneous erections. The Early Candidate Management Team (“ECMT”), the team charged with the initial testing and development of sildenafil that included Dr. Ellis, was surprised to hear that a common side effect was spontaneous erections, as such a side effect had never been previously reported in Pfizer clinical trials. As a result of this report from the volunteers, the ECMT decided to run a clinical trial with sildenafil directed toward the treatment of ED. The first Phase II clinical study with sildenafil, Study 350, began on July 28, 1993, and concluded on November 15, 1993. See PTX 471. As it was a Phase II study, its volunteers were males with the targeted disease, i.e., men who suffered from ED. The volunteers were orally administered either sildenafil or a placebo three times a day for seven days. They recorded any erectile activity experienced during the first six days. On the seventh day, while each volunteer was provided sexual stimulation by watching an erotic video, rigidity and circumference of his penis was measured using a Rigisean. The results showed that sildenafil significantly improved erections for those men in the test with ED. Pfizer then commenced a single dose Phase II study, Study 351, on February 24, 1994, concluding May 30, 1994. Trial Tr. 706:21-707:20. In this study, male volunteers with ED were given a single dose of sildenafil on one occasion, and a Rigiscan was administered. The same volunteers were then given sildenafil once a day for seven days, and they made note of their erectile activity. The results were encouraging and showed a correlation between the administration of sildenafil and improved erectile function for men with ED. Based on the results of the studies described, Pfizer applied to the FDA for approval of Viagra, sildenafil citrate. Viagra was approved by' the FDA in 1998 in New Drug Application No. 20-895 as a drug to treat ED. Viagra works, as the '012 patent states, because it is a PDE5 inhibitor that prevents PDE5 from binding to cGMP and rendering cGMP inactive in the L-arginine-nitric oxide-cyclic GMP pathway, thus increasing the level of cGMP in the corpus cavernosum. Viagra’s introduction on the market in 1998 generated a flurry of publicity and interest from scientists and consumers alike. Experts from both parties admitted that Viagra revolutionized the treatment of ED, making the treatment both more effective and accessible. Since its introduction in 1998, Viagra has generated cumulative sales of over $10 billion. C. After successfully creating sildenafil and other related compounds, Pfizer filed a series of applications for patents. Initially, Pfizer filed several compound patents. The first was European Patent Number 0463756A1 (“EP ’756”) entitled “Pyrazolopyrimidinone Antianginal Agents,” filed June 7, 1991, and published February 1, 1992. PTX 0352. EP '756 first disclosed sildenafil, among other compounds, and claimed such compounds as selective cGMP PDE inhibitors which elevate the levels of cGMP. See EP '756, 3:5-7, PTX 0352. The specification of the patent discloses: [T]he compounds have utility in the treatment of a number of disorders, including stable, unstable and variant (Prinzmetal) angina, hypertension, congestive heart failure, atherosclerosis, conditions of reduced blood vessel patency e.g. postpercutaneous transluminal coronary angioplasty (post-PTCA), peripheral vascular disease, stroke, bronchitis, chronic asthma, allergic asthma, allergic rhinitis, glaucoma, and diseases characterized by disorders of gut motility, e.g. irritable bowel syndrome (IBS). EP '756, 3:9-14, PTX 0352. Of the compounds in Claims 25 and 26 of the patent in suit, EP '756 disclosed five, including sildenafil. Pfizer next filed European Patent Number 0526004A1 (“EP '004”), also entitled “Pyrazolopyrimidinone Antianginal Agents,” on February 7, 1992. EP '004 was published on March 2, 1993. PTX 0066. EP '004 claimed additional potent and selective cGMP PDE inhibitors useful in the treatment of: [Sjtable, unstable and variant (Prinzmetal) angina, hypertension, pulmonary hypertension, congestive heart failure, atherosclerosis, conditions of reduced blood vessel patency e.g. postpercutaneous transluminal coronary angioplasty (postPTCA), peripheral vascular disease, stroke, bronchitis, chronic asthma, allergic asthma, allergic rhinitis, glaucoma, and diseases characterized by disorders of gut motility, e.g. irritable bowel syndrome (IBS). EP '004, 2:10-14, PTX 0066. EP '004 disclosed four of the compounds in Claim 25 of the '012 patent. Finally, Pfizer filed United States Patent Number 5,250,534 (“the '534 patent”) on May 14, 1992. PTX 0002. The '534 patent is the U.S. equivalent of EP '756 and, thus, is also entitled “Pyrazolopyrimidinone Antianginal Agents” and shares the same specification and characteristics of EP '756 described above, including the diseases the compounds were believed to be useful in treating. The '534 patent likewise covers five of the compounds listed in Claims 25 and 26 of the '012 patent, including sildenafil. The '534 patent issued on October 5, 1993. Each of these compound patents — EP '756, EP '004, and the '534 patent — disclosed oral administration of the relevant compounds. After Pfizer had filed the compound patents for sildenafil and the other cGMP PDE inhibitors, it filed the patent in suit directed to a method of treating ED using some of the compounds from EP '756 and EP '004. Claims 25 and 26 specifically claim oral treatment of ED, and the specification of the patent states that oral administration is the preferred route. '012 patent, col. 5, lines, 62-65, PTX 0001. In the specification of the patent, Pfizer discloses that the compounds of the '012 patent have been found to be potent and selective inhibitors of PDE5 such that they enhance cGMP levels in the corpus cavernosum. Id. col. 5, lines 33-35, 39-44, PTX 0001. The '012 patent issued, after overcoming numerous rejections, on October 22, 2002. With the pertinent factual underpinnings of the case set out, this court turns to the substantive issues remaining before it. II. Teva’s Motion to Dismiss for Lack of Standing During trial on July 6, 2011, Teva filed a Motion to Dismiss for Lack of Standing. See Docket # 412. Teva argues that Pfizer has failed to carry its burden to demonstrate that each plaintiff has standing to sue for infringement of the patent in suit because it has failed to prove that any plaintiff has sufficient interest in the patent to sue for infringement. Per a briefing schedule set by the court, Pfizer responded in opposition on July 15, 2011, see Docket # 435, and Teva replied on July 20, 2011, see Docket #451. The motion is now ripe for decision. A. The issue of standing in this case is bound up with the evidence on the issue of ownership, and thus the court reviews the evidence as to both presented at trial. Looking first to the patent in suit itself, Pfizer, Inc. is named as the owner-assignee on the face of the '012 patent. PTX 0001. Pfizer, Inc. received the assignment of rights to the patent from the patent’s inventors, Drs. Nicholas Terrett and Peter Ellis, on October 10, 1995. PTX 0363. In the assignment, Drs. Terrett and Ellis agreed to: [S]ell, assign, and transfer unto PFIZER, INC .... the entire right, title, and interest in and to our application for Letters Patent of the United States ... entitled PYRAZOLOPYRIMIDI-NONES FOR THE TREATMENT OF IMPOTENCE and our entire right, title, and interest in the United States in and to all our inventions, whether joint or sole, disclosed in said application for Letters Patent, and in all and to all United States patents granted on the foregoing inventions. Id. at 1. On the same day, Pfizer, Ltd., whose employment of Drs. Terrett and Ellis entitled it to claim full rights to the patentable inventions, consented to the assignment, noting that “PFIZER LIMITED desires that PFIZER INC. receive the full benefits of the foregoing assignment by its aforesaid employee(s).” Id. at 3. Previously on August 9, 1993, Pfizer, Inc. and Pfizer, Ltd. entered into a Patent Filing Agreement. PTX 0322. The Patent Filing Agreement memorialized “the procedures to be applied in respect of the filing of patent applications resulting from research carried out under the Cost Sharing Agreement [between Pfizer, Inc. and Pfizer, Ltd.] and the procedure applicable to patent applications resulting from other research carried on by LIMITED.” Id. at 2. Specifically: LIMITED Property patent applications will be filed by PFIZER [INC.] in the USA.... In filing such applications, PFIZER [INC.] will act as agent for LIMITED, so that such applications and any patents issued thereon shall be held by PFIZER [INC.] in trust for LIMITED, as the beneficial owner thereof. Id. at 3^1. In addition, to effectuate the filing of patents, Pfizer, Ltd. agreed that it would be “deemed to assign PFIZER [INC.] ... all rights necessary ... to file patent applications hereunder.” Id. at 5. In consideration for its filing of the patent applications, Pfizer, Inc. could receive from Pfizer, Ltd. “a non-exclusive license ... with respect to any such LIMITED Property in the USA.” Id. at 6. After the application for the '012 patent was filed, but before it was issued by the PTO, Pfizer, Ltd. executed a license agreement with Pfizer Pharmaceuticals Production Corporation, effective as of January 1, 1997. PTX 0324. The license agreement concerned patents for sildenafil, either issued or currently pending, including both the '534 patent and the '012 patent. Id. at 13. Therein, Pfizer, Ltd. granted to Pfizer Pharmaceuticals Production Corporation “(1) an exclusive license under the U.S. Patent Rights to make, use, sell, and offer for sale Licensed Product in the Commercial Territory, and to import Licensed Product into the Commercial Territory and (2) an exclusive license to use the Technical Information in the Commercial territory in connection with the activities referred to [above].” Id. at 4. “Commercial Territory” was defined as the United States of America, id. at 2, and “Licensed Product” was defined as “any drug for human use containing the Compound, [sildenafil].” Id. at 3. Thus, Pfizer Pharmaceuticals Production Corporation received, in essence, an exclusive license to manufacture and sell sildenafil in the United States. This exclusive license was subject to Pfizer, Ltd.’s retained “Conversion Right,” the right “to convert the exclusive license granted ... to a non-exclusive license” at any time when at least 20% remains on the patent term. Id. at 2-4. In return for the exclusive license, Pfizer Pharmaceuticals Production Corporation would pay Pfizer, Ltd. royalties based on net sales in a schedule set out in the agreement. Id. at 6. In the case of infringement of any of the patents covered by the agreement, Pfizer, Ltd. had “the initial right to bring suit in its own name” with Pfizer Pharmaceuticals Production Corporation’s cooperation, but if Pfizer, Ltd. failed to bring suit within thirty (30) days, Pfizer Pharmaceuticals Production Corporation could bring suit in its own name, joining Pfizer, Ltd. and Pfizer, Inc. as necessary. Id. at 7-8. The license agreement for sildenafil has since “changed hands” several times due to changes in ownership of the entity holding it. First, on January 15, 1998, Pfizer Pharmaceuticals Production Corporation entered into a Sale Agreement with Pfizer Pharmaceuticals Production Corporation, Ltd. for the “entire Irish business and Irish assets of Pfizer Pharmaceuticals Production Corporation.” PTX 0325, at 1. As part of the Sale Agreement, Pfizer Pharmaceuticals Production Corporation transferred all of its assets, including all licenses. Id. at 2, 4. The license for sildenafil was specifically noted as one of the licenses that would transfer to the new entity. Id. at 13. Subsequently, on November 14, 2000, Pfizer Pharmaceuticals Production Corporation, Ltd. entered into an “Agreement for Sale of Business and Assets” with Pfizer Ireland Pharmaceuticals. PTX 0326. Again, as part of this Agreement for Sale, Pfizer Pharmaceuticals Production Corporation, Ltd. transferred to Pfizer Ireland Pharmaceuticals all assets, id. at 4, including contracts and agreements, id. at 5, one of which was the license agreement for sildenafil. Id. at 10. The license was transferred yet again on November 28, 2003, via an “Agreement for Sale of Business and Assets” between Pfizer Ireland Pharmaceuticals and Pfizer Ireland Pharmaceuticals Partnership. PTX 0209. Pfizer Ireland Pharmaceuticals agreed to transfer to Pfizer Ireland Pharmaceuticals Partnership all of its assets and business, including contracts. Id. at 5. Contracts was defined to include all license agreements undertaken by Pfizer Ireland Pharmaceuticals. Id. at 2. This Agreement for Sale did not, however, list the particular licenses to be transferred. Finally, on January 10, 2011, Pfizer Ireland Pharmaceuticals Partnership sold all of its assets to Pfizer Ireland Pharmaceuticals Unlimited Liability Co. (“Pfizer Ireland Pharmaceuticals Co.”). PTX 0210. Pfizer Ireland Pharmaceuticals Partnership agreed to transfer all of its assets, including its interest in contracts, id. at 7, which was defined to include all license agreements. Id. at 2. Again, there was no schedule listing the specific license agreements transferred. Pfizer Ireland Pharmaceuticals Co. currently holds the license for sildenafil in the United States. B. Standing is a jurisdictional requirement for any federal case and may never be waived by the parties. E.g., Sicom Systems, Ltd. v. Agilent Techs., Inc., 427 F.3d 971, 975 (Fed.Cir.2005); Pandrol USA L.P. v. Airboss Ry. Prods., Inc., 320 F.3d 1354, 1367 (Fed.Cir.2003) (“It is well-established that any party, and even the court sua sponte, can raise the issue of standing for the first time at any stage of the litigation, including on appeal.”). The party asserting the infringement has the burden to prove that it has standing to do so. Mentor H/S, Inc. v. Med. Device Alliance, Inc., 240 F.3d 1016, 1017 (Fed.Cir.2001) (per curiam). In patent cases, the law of standing has its sources both in constitutional law and the Patent Act. Beam Laser Sys., Inc. v. Cox Commc’ns, Inc., 117 F.Supp.2d 515, 520 (E.D.Va.2000). The Patent Act provides: “A patentee shall have remedy by civil action for infringement of his patent.” 35 U.S.C. § 281 (2006). “Patentee” is defined under the Act to include “not only the patentee to whom the patent was issued but also the successors in title to the patentee.” Id. at § 100; see also Morrow v. Microsoft, 499 F.3d 1332, 1339 (Fed.Cir.2007) (“The ‘successor! ] in title’ is the party holding legal title to the patent.” (emphasis in original)). Beyond the requirement that a plaintiff must be a “patentee” under the statute to sue for infringement, there is also the constitutional requirement that the party alleging infringement show an injury-in-fact. Morrow, 499 F.3d at 1339. The Federal Circuit has held that there are three types of parties for standing purposes as concerns patents: “those that can sue in their own name alone; those that can sue as long as the patent owner is joined in the suit; and those that cannot even participate as a party to an infringement suit.” Id. There are three entities that meet the requirements for the first category. It is clear from the statute that the patentee, owner of the patent, is a party that may sue on its own for infringement. 35 U.S.C. § 281; Sicom, 427 F.3d at 976. Additionally, if a patentee assigns its rights in a patent, the assignee may sue for infringement in its own name, Sicom, 427 F.3d at 976, as the assignee has legal title to the patent. Morrow, 499 F.3d at 1339. Finally, an exclusive licensee who has all substantial rights in the patent is treated like an assignee for the purposes of standing. Sicom, 427 F.3d at 976. The court must look to the license agreement to determine if the licensee in fact holds all substantial rights. Ortho Pharm. Corp. v. Genetics Inst., Inc., 52 F.3d 1026, 1030 (Fed.Cir.1995). The second category, parties who may sue if the owner of the patent is joined, includes exclusive licensees that do not have all substantial rights in the patent. Indep. Wireless Tel. Co. v. Radio Corp. of Am., 269 U.S. 459, 468, 46 S.Ct. 166, 70 L.Ed. 357 (1926); Sicom, 427 F.3d at 980; Abbott Labs. v. Diamedix Corp., 47 F.3d 1128, 1132 (Fed.Cir.1995). “An exclusive licensee receives more rights than a nonexclusive licensee, but fewer than an assignee. An example of an exclusive licensee is a licensee who receives the exclusive right to practice an invention but only within a given limited territory.” Sicom, 427 F.3d at 976 (citing Rite-Hite Corp. v. Kelley Co., Inc., 56 F.3d 1538, 1552 (Fed.Cir.1995)). Thus, crucial to the determination of whether an entity is an exclusive licensee is whether the licensee holds exclusionary rights to the patent, the right to “prevent others from practicing the invention.” Morrow, 499 F.3d at 1340. “To have co-plaintiff standing in an infringement suit, a licensee must hold some of the proprietary sticks from the bundle of patent rights, albeit a lesser share of rights in the patent than for an assignment and standing to sue alone.” Ortho Pharm., 52 F.3d at 1031. In other words, to have standing at all, a licensee must have “beneficial ownership of some of the patentee’s proprietary rights.” Id. at 1034. Again, the court looks to the license agreement to determine if a licensee is an exclusive licensee. The final type of entity for standing purposes is a nonexclusive licensee that cannot even join an infringement suit. The Federal Circuit has been clear that “[a] holder of such a nonexclusive license suffers no legal injury from infringement and, thus, has no standing to bring suit or even join in a suit with the patentee.” Ortho Pharm., 52 F.3d at 1031. Nonexclusive licensees are “those that hold less than all substantial rights to the patent and lack exclusionary rights under the patent statutes to meet the injury-in-fact requirement.” Morrow, 499 F.3d at 1340. Such entities do not meet the statutory or constitutional requirements of standing and may not join with other parties in pursuing an infringement suit. The three categories of plaintiffs enumerated above are well-settled in Federal Circuit precedent for establishing standing in suits at law for damages. Moreover, there is one other type of entity that may have standing to sue in equity, in other words for injunctive relief. In Arachnid, Inc. v. Merit Industries, Inc., 939 F.2d 1574 (Fed.Cir.1991), the Federal Circuit distinguished between entities with standing in law and entities with standing in equity. It held that when an entity has equitable ownership of a patent, that entity may seek only prospective relief in equity, not damages for infringement. Id. at 1579. A party “seeking to recover money damages for infringement of a United States patent (an action ‘at law’) must have held the legal title to the parent during the time of the infringement.” Id. (emphasis omitted). Conversely, if a party only has equitable title, “a federal district court has jurisdiction to consider claims for equitable relief stemming from the alleged infringement.” Id. at 1580 (emphasis omitted). This court has recognized the Federal Circuit precedent supporting the conclusion that a party having equitable title to a patent may sue in equity to prevent further infringements. Beam Laser, 117 F.Supp.2d at 520. With these legal underpinnings, the court turns to the standing issue raised by Teva. C. Teva argues that all of the remaining Pfizer entities lack standing to sue for infringement of the patent. For the sake of clarity, the court will consider each of the parties individually. First, Teva argues that Pfizer has failed to prove that Pfizer, Inc. has standing to sue because it has not shown Pfizer, Inc. has an ownership interest in the patent sufficient to establish standing. In particular, Teva submits that the Patent Filing Agreement between Pfizer, Inc. and Pfizer, Ltd., in which Pfizer, Inc. holds the filed patents in trust for Pfizer, Ltd. as the beneficial owner, demonstrates that Pfizer, Inc. has no substantial ownership rights in the patent. Pfizer responds that such ownership is evident and unassailable from the fact that Pfizer, Inc. is listed on the face of the '012 patent as the assignee of the inventors and, thus, is recognized as owner of the patent. The court agrees with Pfizer, as it is not open for debate that Pfizer, Inc. is the legal owner of the '012 patent. The assignment agreement, as reflected in the patent itself, rendered Pfizer, Inc. the legal title holder of the patent. See 35 U.S.C. § 100. Furthermore, there is no evidence that Pfizer, Inc. has assigned its interest to any other party such that it would lose its presumptive right to enforce the patent. Accordingly, Pfizer, Inc. has standing to sue in its own name on the patent. Next, Teva argues that Pfizer, Ltd. lacks standing to sue on the patent, either because Pfizer has failed to demonstrate that the Patent Filing Agreement was utilized for the application for the '012 patent, or because Pfizer has failed to establish that Pfizer, Ltd., as a beneficial owner of the patent, has sufficient proprietary rights to enforce it. Pfizer responds that Pfizer, Ltd. has standing to enforce the patent, both because it is the equitable owner of the patent seeking equitable relief, and because per the explicit terms of the Patent Filing Agreement, it has the right to exclude others from practicing the invention. At the outset, the court disagrees with Teva that the assignment and application for the '012 patent were done outside the parameters of the Patent Filing Agreement. The evidence in this case demonstrates that the assignment and application specifically were done in keeping with the Patent Filing Agreement. In particular, the inventors, whose invention would normally have been property of their employer, Pfizer, Ltd., assigned all of their rights in the invention to Pfizer, Inc. for the purposes of filing a patent application. See PTX 363. This assignment follows the terras of the Patent Filing Agreement, because therein the parties agreed that the inventions, which would be the property of Pfizer, Ltd., would be held in trust by Pfizer, Inc., so that Pfizer, Inc. could prosecute the patent in the United States. See PTX 0322, at 3-4. In order to facilitate this process, Pfizer, Ltd. consented to the assignment. In other words, the evidence of an assignment is not proof that the Patent Filing Agreement was ignored by the parties; rather it is proof that it was in effect, because without the assignment from the inventors, Pfizer, Inc. could not have prosecuted the application for Pfizer, Ltd. Although the court has determined that the '012 patent is subject to the Patent Filing Agreement, it remains for the court to determine what rights Pfizer, Ltd. retained in the patent under that agreement and whether such rights are sufficient to create standing. As stated in the Patent Filing Agreement, Pfizer, Ltd. is considered the “beneficial owner” of the patent. See PTX 0322, at 4. Additionally, Pfizer, Ltd. retained the right to grant licenses to the patents prosecuted. Id. at 6. Finally, both Pfizer, Ltd. and Pfizer, Inc. have the right to enforce patents and agreed to cooperate in doing so. Id. at 5. “Beneficial owner” is not defined in the Patent Filing Agreement, and it specifically provides that it is to be interpreted under the laws of England. Id. at 8. The court has undertaken a review of English law and found that “beneficial owner” is often used to describe an entity that gathers the benefits of an asset, business, or agreement without necessarily holding legal title. E.g., AK Investment CJSC v. Kyrgyz Mobil Tel Ltd., [2011] 1 C.L.C. 205, 211 (P.C.) (referring in the recitation to the facts to the differences between the “beneficial owner” and the “ultimate owner”); Shell U.K., Ltd. v. Total U.K. Ltd., [2010] 1 C.L.C. 343 (Ct. of App.) (discussing the ability of a beneficial owner to recover in tort for damage caused by negligence). From the court’s research, it appears that the- terra “beneficial owner” has similar meanings in both English and American law. This is not surprising given that “beneficial owner” in both countries sounds in equity, which evolved from mutual roots in the common law. Black’s Law Dictionary, noting the term’s origins in the Eighteenth Century, defines “beneficial owner” as “[o]ne recognized in equity as the owner of something because use and title belong to that person, even though legal title may belong to someone else.... Also termed equitable owner.... A person or entity who is entitled to enjoy the rights in a patent, trademark, or copyright even though legal title is vested in someone else.” Black’s Law Dictionary 1214 (9th ed. 2009); see also Beam Laser, 117 F.Supp.2d at 520. Further, “[t]he beneficial owner has standing to sue for infringement.” Black’s Law Dictionary 1214. Thus, it appears that, under the general definition of “beneficial owner,” such an entity has most to all of the traditional property rights of the owner, except for actual legal title to the property. The terms of the Patent Filing Agreement do not contradict this meaning of the rights of a beneficial owner. Under that agreement, Pfizer, Inc. holds the patents in trust for Pfizer, Ltd., while Pfizer, Ltd. has the right to grant licenses and enforce the patent. Therefore, this court concludes that Pfizer, Ltd. has sufficient proprietary rights in the patent to confer standing to sue in its name alone. However, even if the court were to conclude otherwise, Pfizer, Ltd. certainly has sufficient proprietary rights to sue for infringement in concert with the owner of the patent, as it has done here with Pfizer, Inc. Finally, Teva argues that Pfizer Ireland Pharmaceuticals Co. does not have standing to sue, either because the license it holds for sildenafil is invalid because Pfizer, Ltd. lacks the right to grant licenses, or because it is only a nonexclusive licensee. Pfizer replies that the Patent Filing Agreement clearly contemplated that Pfizer, Ltd. would grant licenses such that this particular license is valid, and Pfizer Ireland Pharmaceuticals Co.’s exclusive license to make and sell sildenafil in the United States renders it an exclusive licensee with standing to sue in concert with the owner of the patent. First, the court has already concluded that the Patent Filing Agreement explicitly gave Pfizer, Ltd. the power to grant licenses. PTX 0322, at 6. Thus, there is no basis for the assertion that the license itself is null and void ab initio. Second, the court must determine if the license granted to Pfizer Ireland Pharmaceuticals Co. constitutes an exclusive license such that it has standing to join a suit where the owner of the patent, Pfizer, Inc., is a party. As recounted above, the Federal Circuit has held that “[a]n exclusive licensee receives more rights than a nonexclusive licensee, but fewer than an assignee. An example of an exclusive licensee is a licensee who receives the exclusive right to practice an invention but only within a given limited territory.” Sicom, 427 F.3d at 976 (emphasis added). The Federal Circuit has directed courts considering this question to carefully parse the license agreement and the rights granted to the licensee, paying attention to whether the licensee has exclusive rights in a territory, id.; Ortho Pharm., 52 F.3d at 1031-32; whether the licensor has retained the right to grant further licenses, Morrow, 499 F.3d at 1342; whether the licensee has the right to sue for infringement, Sicom, 427 F.3d at 979; and whether the licensor retains rights to develop and market the invention. Fieldturf, Inc. v. Southwest Recreational Indus., Inc., 357 F.3d 1266, 1269 (Fed.Cir.2004). None of these factors are individually determinative, and the court must make a fact-specific decision of whether the license creates an exclusive license. Sicom, 427 F.3d at 976. In this case, it is clear that Pfizer Ireland Pharmaceuticals Co. is not an assignee because it has not received all substantial rights in the patent. It is a close question, however, whether it has sufficient rights to be considered an exclusive licensee under the Federal Circuit’s precedent. The factors cut both ways. First, Pfizer Ireland Pharmaceuticals Co. has the exclusive right to make and sell sildenafil within the United States. Second, it has the right to enforce the patent and compel the participation of other parties necessary for the suit. Both of these facts favor Pfizer Ireland Pharmaceuticals Co. being considered an exclusive licensee because it has the right to exclude and the right to enforce the patent. However, there are two considerations that cut the other way. First, Pfizer Ireland Pharmaceuticals Co.’s exclusive license is subject to Pfizer, Ltd.’s retained “Right of Conversion;” Pfizer, Ltd., at any time when there is at least 20% remaining in the patent term, may revoke the exclusive license to create a nonexclusive license for the remaining term of the patent. See PTX 0324, at 2-4. Second, while Pfizer Ireland Pharmaceuticals Co. has a right to enforce the patent, that right is subject to Pfizer, Ltd.’s primary right of enforcement, as Pfizer, Ltd. has the initial right to enforce the patent and ultimate control over the litigation. Pfizer Ireland Pharmaceuticals Co. may only bring its own suit, joining Pfizer, Ltd. and Pfizer, Inc., if Pfizer, Ltd. fails to bring suit within thirty (30) days from the discovery of the infringement. See id. at 8. On the balance, the court finds that under the Federal Circuit’s precedent, Pfizer Ireland Pharmaceuticals Co. does not have sufficient proprietary rights in the '012 patent to be joined in the suit as an exclusive licensee. Rather, the court finds that Pfizer Ireland Pharmaceuticals Co. is a nonexclusive licensee that does not meet the injury-in-fact requirement for standing. While at the time of this suit, Pfizer Ireland Pharmaceuticals Co. enjoys an exclusive license to make and sell the invention in the United States and is joined in a consensual suit to challenge infringement by Teva, these rights are ephemeral, as Pfizer, Ltd. could revoke the exclusive license at any time, and it wields ultimate control over the litigation. D. For the reasons stated above, the court FINDS that Pfizer, Inc. and Pfizer, Ltd. have standing to sue for infringement of the '012 patent, while Pfizer Ireland Pharmaceuticals Co. lacks such standing. Accordingly, the court DENIES IN PART and GRANTS IN PART Teva’s Motion to Dismiss for Lack of Standing and DISMISSES Pfizer Ireland Pharmaceuticals Co. from the litigation. III. Teva’s Motion for Leave to File its Proposed Second Amended Answer and Counterclaim The other outstanding motion the court must take up is Teva’s Motion for Leave to File its Proposed Second Amended Answer and Counterclaim (“Second Motion to Amend”), filed at the end of the third day of trial, Friday, June 17, 2011. See Docket # 345. Teva sought leave from the court to again amend its Answer and Counterclaim to change the allegations therein concerning inequitable conduct. On a briefing schedule set by the court, Pfizer responded in opposition on June 24, 2011, see Docket #378, and Teva replied on June 27, 2011. See Docket # 398. By oral order during trial, the court denied the Second Motion to Amend, in part, on June 29, 2011, and in its entirety on July 6, 2011. The court memorialized its denial of the Second Motion to Amend in a written Order on July 7, 2011, and reserved the option to issue a written opinion detailing its ruling. See Docket # 428. A. On November 12, 2010, Teva filed its first Motion for Leave to File an Amended Answer and Counterclaim (“First Motion to Amend”). See Docket # 55. In particular, Teva sought leave of the court to amend its Answer and Counterclaim to add the allegation that the '012 patent was invalid because Pfizer engaged in inequitable conduct during the patent’s prosecution and reexamination. After the First Motion to Amend was fully briefed and argued, the court issued an opinion allowing the amendment on January 18, 2011. Pfizer, Inc. v. Teva Pharms. USA, Inc., No. 2:10cv128, 803 F.Supp.2d 459, 2011 WL 3610654 (Jan. 18, 2011), Docket # 77. Specially, the court found that, “[tjhough it [was] a close question, ... Teva ha[d] met the [pleading] requirements of [Federal] Rule [of Civil Procedure] 9(b).” Id., at 463. The court held that Teva had specifically named the who, what, and when of the alleged misrepresentation before the PTO and that the allegations concerning intent to deceive the PTO, while tenuous, were sufficient at the initial pleading stage. Id. at 462-63. Thus, the court directed Teva to file its Amended Answer and Counterclaim. On June 17, 2011, Teva again moved to amend its Answer and Counterclaim, seeking to change its allegations regarding the inequitable conduct claim. Previously, in its First Amended Answer and Counterclaim, Teva alleged that four individuals— Dr. Peter Ellis, an inventor of the '012 patent; Gregg C. Benson and James T. Jones, internal counsel for Pfizer; and Gerard M. O’Rourke, Pfizer’s external counsel — committed inequitable conduct during the prosecution of the '012 patent. The substance of the inequitable conduct claim was that “Pfizer actively prosecuted the '012 patent to include claims that the treatment would benefit a ‘male animal’ with ED.” Pfizer, Inc. v. Teva Pharms. USA, Inc., No. 2:10cv128, 803 F.Supp.2d at 462. This allegedly amounted to “inequitable conduct because Pfizer knew that the animal claims were overbroad and unpatentable; Pfizer withheld information from the PTO that demonstrated the unpatentability of the claims; and Pfizer continued to espouse the animal claims in the reexamination of the patent.” Id. at 462. As evidence of this knowledge of overbreadth, Teva pointed to the fact that Pfizer disclaimed the animal claims in the Canadian version of the '012 patent when challenged in a Canadian court. These facts are the basis of the inequitable conduct claim currently before the court. Teva now seeks to amend the factual allegations concerning inequitable conduct. The content of the inequitable conduct claim is still generally the same, as it is tied to the disclaimer of the animal claims in Canada, but the individuals and the specifics of their actions are different. Teva now details two separate, but related, courses of inequitable conduct. First, Teva alleges that “Pfizer in-house attorneys Watson McMunn and Dr. Peter Richardson, and Pfizer’s outside counsel Daniel DiNapoli of the Kaye Scholer law firm, engaged in inequitable conduct during the prosecution of the application for the '012 patent.” Mem. of Law in Supp. of Mot. for Leave to File Proposed Second Am. Áns. & Countercl., Ex. A, Proposed Second Am. Countercl. ¶ 15, Docket # 347. Specifically, Mr. McMunn, Dr. Richardson, and Mr. DiNapoli were aware that a Pfizer competitor, Bayer Aktiengesellschaft and Bayer, Inc., filed a claim in Canada (“the Bayer Statement of Claim”), arguing that the claims of the Canadian patent directed to the treatment of non-human animals were invalid for overbreadth. Id. With the knowledge that these challenged claims were identical to the claims in the '012 patent, these individuals did not disclose to the PTO that the claims in the '012 patent were overbroad. Id. at ¶ 16. This information was allegedly material and should have been disclosed to the PTO, but instead Mr. McMunn, Dr. Richardson, and Mr. DiNapoli intentionally withheld the information from the PTO so that the '012 patent would issue as soon as possible. Id. at ¶¶ 17-18. Teva alleges that, if the information had been disclosed, the PTO would not have allowed Claims 1-19 and 21-23 of the '012 patent to issue. Id. at ¶ 65. The second course of inequitable conduct Teva now alleges concerns Mr. O’Rourke, who was named in the First Amended Answer and Counterclaim, and Rudolph Hutz, both partners at the time at the law firm of Connolly Bove Lodge & Hutz (“Connolly Bove”). Id. at ¶ 19. Connolly Bove was hired by Pfizer during the prosecution of the '012 patent to submit documents to the PTO pursuant to the duty of disclosure. Id. Initially, Teva alleges, Mr. O’Rourke and Mr. Hutz committed inequitable conduct by “dumping” documents on the PTO without regard to the materiality of the documents. Id. Teva alleges that this practice changed after Mr. Hutz and Mr. O’Rourke learned that the patent examiner was going to allow the claims of the '012 patent, in that they no longbr submitted any disclosures to the PTO. Id. Teva states that this was inequitable conduct because it was a system of “willful blindness,” the object of which was to avoid awareness of any information that would normally be disclosed to the PTO to prevent delaying the issuance of the '012 patent. Id. at ¶ 20. B. Federal Rule of Civil Procedure 15(a)(1)(A) provides, in pertinent part, that “[a] party may amend its pleading once as a matter of course ... before being served with a responsive pleading.” However, if a party seeks to amend its pleading at any other time, it may only do so “with the opposing party’s written consent or the court’s leave.” Fed.R.Civ.P. 15(a)(2). The rules require that a “court should freely give leave when justice so requires,” and the Fourth Circuit has held that “leave to amend a pleading should be denied only when the amendment would be prejudicial to the opposing party, there has been bad faith on the part of the moving party, or the amendment would have been futile.” Laber v. Harvey, 438 F.3d 404, 426 (4th Cir.2006) (emphasis added) (citing Johnson v. Oroweat Foods Co., 785 F.2d 503, 509 (4th Cir.1986) and Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962)). Delay is another important factor for the court to consider, Foman, 371 U.S. at 182, 83 S.Ct. 227, but delay alone, without prejudice, is an insufficient reason to deny a motion to amend. Davis v. Piper Aircraft Corp., 615 F.2d 606, 613 (4th Cir.1980). Conversely, “prejudice resulting to the opponent by a grant of leave to amend is reason sufficient to deny amendment.” Id. Overall, Foman directs the court’s attention to prejudice, futility, and bad faith because such concerns are related to the protection of the system or other litigants. Davis, 615 F.2d at 613. Importantly, “conjecture about the merits of the litigation should not enter into the decision whether to allow the amendment.” Id. To avoid questions of bad faith or prejudice, “a motion to amend should be made as soon as the necessity for altering the pleading becomes apparent.” Deasy v. Hill, 833 F.2d 38, 41 (4th Cir.1987) (citation and internal quotation marks omitted). Motions to amend made on the day of or close to trial “may be particularly disruptive, and may therefore be subject to special scrutiny.” Id. However, “the mere fact that an amendment is offered late in the case is not enough to bar it.” Sweetheart Plastics, Inc. v. Detroit Forming, Inc., 743 F.2d 1039, 1044 (4th Cir.1984); see also Davis, 615 F.2d at 613. As regards futility, a party seeking to amend its pleadings must meet the pleading requirements for the particular cause of action it seeks to bring to avoid denial on the basis of futility. The Federal Circuit has previously held that a party asserting a claim of inequitable conduct must plead it with the specificity required by Federal Rule of Civil Procedure 9(b). Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1328 (Fed.Cir.2009); see Fed. R.Civ.P. 9(b), Failure to plead a claim of inequitable conduct with the specificity required by Rule 9(b) will result in the amendment’s denial as futile. Exergen, 575 F.3d at 1331; United States ex rel. Wilson v. Kellogg Brown & Root, Inc., 525 F.3d 370, 376 (4th Cir.2008). Thus, the Federal Circuit has held that the party alleging inequitable conduct must “identify the specific who, what, when, where, and how of the material misrepresentation or omission committed” before the PTO to satisfy Rule 9(b). Exergen, 575 F.3d at 1328. In other words, the pleadings “must include sufficient allegations of underlying facts from which a court may reasonably infer that a specific individual (1) knew of the withheld material information or the falsity of the material misrepresentation, and (2) withheld or misrepresented this information with a specific intent to deceive the PTO.” Id. at 1328-29. C. As an initial question, the court must decide whether Exergen, decided in 2009, continues to state the standard for pleading inequitable conduct, or whether its holding has been modified by the Federal Circuit’s recent en banc decision in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed.Cir.2011) (en banc). In Therasense, the Federal Circuit granted rehearing en banc to consider “the problems created by the expansion and overuse of the inequitable conduct doctrine.” Id. at 1285. Before Therasense, a party alleging inequitable conduct had to prove by clear and convincing evidence that (1) material information was not disclosed to the PTO, and (2) the non-disclosure was done with the intent to deceive the PTO. Id. at 1287. Those two elements were then put on a sliding scale where a strong showing of one element, either materiality or intent, could override a weaker showing of the other. Id. at 1287-88. However, because of concerns about the expansion of the use of an inequitable conduct allegation as a strategic tool, the Federal Circuit revisited and recrafted the requirements for a showing of inequitable conduct. The en banc court held that “the accused infringer must prove by clear and convincing evidence that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it.” Id. at 1290 (emphasis added). The court also heightened the required showing for both materiality and intent to deceive, where a party alleging inequitable conduct must now show “but-for materiality” and that the intent to deceive is “the single most reasonable inference able to be drawn from the evidence.” Id. at 1290-92 (citation and internal quotation marks omitted). In only one instance may the court find materiality without the requisite “but-for” causation, when “the patentee has engaged in affirmative acts of egregious misconduct.” Id. at 1292. Thus, it is clear that Therasense significantly heightened the requirements for a showing of inequitable conduct on the merits, but the question remains as to whether it had any effect on the pleading standards for inequitable conduct under Rule 9(b). Rule 9(b) provides that “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake. Malice, intent, knowledge, and other conditions of a person’s mind may be alleged generally.” Fed. R.Civ.P. 9(b). In pleading the intent prong, the court evaluates whether a sufficient showing has been made under the standards of Federal Rule of Civil Procedure Rule 8(a), Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1954, 173 L.Ed.2d 868 (2009), which requires that a party state a claim for relief that is “plausible on its face.” Id. at 1949; see Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (Rule 8(a) pleading standard clarified by Iqbal); Adiscov, L.L.C. v. Autonomy Corp., 762 F.Supp.2d 826, 829 (E.D.Va.2011) (applying the Twombly and Iqbal standards in a patent case). To comply with Rule 9(b), Exergen held that a party alleging inequitable conduct “must include sufficient allegations of underlying facts from which a court may reasonably infer that a specific individual (1) knew of the withheld material information or the falsity of the material misrepresentation, and (2) withheld or misrepresented this information with a specific intent to deceive the PTO.” Exergen, 575 F.3d at 1328-29. After reviewing all of this precedent, the court finds that Exergen still states the correct elements required for pleading inequitable conduct after Therasense. A party must still “identify the specific who, what, when, where, and how of the material misrepresentation or omission committed.” Exergen, 575 F.3d at 1328. Additionally, a party must allege intent to deceive the PTO, such that the specific intent is plausible from the facts alleged pursuant to Rule 8(a). However, the court does note that after Therasense, a mere recitation that “X” individual, at “X” time, failed to turn over “X” information to the PTO that would have been material to the prosecution, with the specific intent to deceive the PTO, is insufficient under Rule 9(b). Instead, in alleging those elements, a party must make an initial showing from which it may be plausibly inferred that: (1) the individual knew of the information not disclosed; (2) the information not disclosed was but-for material to the prosecution of the patent; and (3) the intent to deceive is the single most likely explanation for the non-disclosure. See Iqbal, 129 S.Ct. at 1954 (plausibility); Therasense, 649 F.3d at at 1289-90 (specificity); Exergen, 575 F.3d at 1328 (Rule 9(b) pleading requirements). The court is mindful that at the pleading stage a party is not required to meet the clear and convincing evidence standard that applies on the merits. However, as made clear in Therasense, courts must take an active role in examining the propriety of inequitable conduct claims, Therasense, 649 F.3d at 1289-90, and without incorporating allegations of the specific elements to be proven on the merits at the pleading stage, albeit at a lower standard of plausibility at this initial juncture, courts cannot perform this function. D. With these standards in mind, the court now looks to Teva’s Second Motion to Amend. Teva argues that its Second Motion to Amend should be granted because it meets the pleading requirements of Rule 9(b); there was no delay in filing for the amendment because Teva did so as soon as it received the pertinent information; and the amendment would not prejudice Pfizer because Pfizer had notice of the substance of the allegations a month beforehand. Mem. of Law in Supp. of Mot. for Leave to File Proposed Second Am. Ans. and Countercl. at 21. Pfizer replies that the delay, which is indefensible because Teva had the information much before June 17, 2011, seriously prejudices Pfizer by forcing it to try a completely different case than the one for which it prepared. Mem. in Opp’n Mot. for Leave to File Second Am. Ans. and Countercl. at 20. Additionally, Pfizer argues that Teva’s motion should be denied as futile. Id. at 7. Beginning with considerations of delay, Teva attributes the timing of the filing of the motion to the fact that discovery concluded on June 10, 2011, five days before trial began. Teva argues that Pfizer’s discovery practices delayed Teva’s receipt of the information underlying the proposed amended inequitable conduct claim. In particular, Pfizer’s limited waiver of attorney-client privilege on February 23, 2011, Teva represents, subsequently required Teva to litigate with Pfizer to force the discovery of documents relevant to the Canadian disclaimer. Teva specifically asserts that it did not find out about the role that Dr. Richardson played until May 20, 2011, and then it was forced to make a motion to take Dr. Richardson’s deposition after discovery had concluded. Pfizer responds that Teva knew of each of the individuals in the Proposed Second Amended Answer and Counterclaim well before June 17, 2011, such that there is no excuse for this late filing. Discovery has been fully litigated before the United States Magistrate Judge in this case, and the court does not rehash it here. It suffices to say that the United States Magistrate Judge, who was deeply involved in this case and well-versed in the law of discovery, specifically declined to find that Pfizer had violated any provisions of the discovery rules and denied Teva’s Motion for Sanctions. See Docket #286. Thus, this court does not engage with the question of whether Pfizer’s productions were timely or not, but rather focuses on when Teva learned of the facts underlying its current Second Motion to Amend. Teva deposed Mr. O’Rourke on April 1, 2011, Mr. McMunn on April 8, 2011, and Mr. Hutz on May 4, 2011. Additionally, in March 2011, Teva served a subpoena on Mr. DiNapoli. In responding to Pfizer’s Motion to Quash the subpoena, see Docket # 117, Teva responded that it was seeking to depose Mr. DiNapoli because of information Pfizer had turned over in discovery regarding Mr. DiNapoli’s involvement with the decision to disclaim the animal claims in Canada. See Docket # 143. The basic facts Teva offered in support of its subpoena were the same facts which underlie the current inequitable conduct claim involving Mr. DiNapoli. Further, it is true that Teva did not seek a deposition of Dr. Richardson until May 23, 2011, as part of its Motion to Continue the Trial to allow for further depositions to be taken. See Docket # 253. Teva argues that it made such a motion for a deposition after discovery had concluded, because it had just received the information which revealed Mr. Richardson’s role. However, it is unclear for two reasons why this should be, or is, the scenario. First, Dr. Richardson’s name is on the face of the '012 patent as one of its prosecuting attorneys, such that his role in its prosecution has been evident from the inception of the litigation in this court. See PTX 0001, at 1. Second, during Mr. Richardson’s deposition on June 10, 2011, counsel for Teva conducting the deposition, in a question posed to Mr. Richardson, stated: In response to an interrogatory that Teva propounded in this lawsuit to Pfizer, in which Teva asked Pfizer to identify all the individuals associated with the filing or prosecution of the application for the '012 patent, other than the named inventors, Pfizer answered with respect to you, Dr. Richardson that Peter C. Richardson, a former Senior Vice President and Associate General Counsel at Pfizer New York as in-house U.S. patent counsel for Pfizer supervised the prosecution of U.S. patent application number 08/549792. Richardson dep. 30:12-31:08 (emphasis ad