Full opinion text
OMNIBUS ORDER ON SIX MOTIONS FOR SUMMARY JUDGMENT RE: PLAINTIFFS’ SECTION ONE (AND ANALOGOUS) CLAIMS SEITZ, District Judge. THIS MATTER is before the Court on six summary judgment motions relating to the Sherman Act Class Plaintiffs and Plaintiff Kaiser Foundation Health Plan, Inc.’s (“Kaiser”) claims arising under Section One of the Sherman Antitrust Act, 15 U.S.C. § 1. This Court previously concluded that the April 1, 1998, agreement between Defendants Abbott Laboratories (“Abbott”) and Geneva Pharmaceuticals (“Geneva”) (collectively, “Defendants”)— by which Geneva agreed to delay marketing its generic competitor to Abbott’s brand name pharmaceutical terazosin hydrochloride product, Hytrin — was a per se violation of Section One. The Eleventh Circuit reversed that ruling in September 2003, finding the Court’s per se condemnation of the Agreement to be “premature” and remanding the case to this Court for consideration of the exclusionary potential of Abbott’s ’207 patent. The Sherman Act Class Plaintiffs, Kaiser, and Defendants have each filed motions seeking a declaration from the Court as to whether the challenged provision of the Abbott-Geneva Agreement exceeded, or was within, the exclusionary scope of Abbott’s patent protections. The Sherman Act Class Plaintiffs also seek rulings that the Agreement violates Section One under either a per se or “quick look” antitrust analysis, and that they may prove their Section One claims using direct evidence of actual anticompet-itive effects in lieu of a detailed market power analysis. The Court has considered the Motions, the responses and replies thereto, the applicable case law, all supporting exhibits, and the oral argument of counsel at the July 2, 2004, and August 3, 2004, hearings. Having considered the undisputed material facts in the light most favorable to the non-moving parties, the Court concludes that: (1) the exclusionary effects of the challenged provision of the Abbott-Geneva Agreement exceeded the exclusionary potential of the ’207 patent; and (2) the Agreement is per se unlawful under Section One of the Sherman Act. Therefore, the Sherman Act Class Plaintiffs and Kaiser are entitled to summary judgment as a matter of law on their Section One and analogous claims, and Defendants’ Section One Motion must be denied. 1. FACTUAL BACKGROUND This multi-district antitrust litigation (“MDL”) originates at the intersection of antitrust and patent law. At its core, this case revolves around Abbott’s attempts to protect its patents’ exclusivity with respect to the brand name drug Hytrin, and the competing efforts of generic manufacturers to develop and launch bioequivalent drugs for entry in the terazosin hydrochloride market. Between May 31, 1977, and August 13, 1999, pursuant to several patents, Abbott exclusively manufactured and marketed terazosin hydrochloride under the brand name of Hytrin. Hytrin is a drug prescribed for the treatment of high blood pressure and benign prostatic hyper-plasia (“BPH”), an enlargement of the prostate gland that surrounds the urinary canal. Hytrin proved to be a lucrative drug for Abbott; for example, in 1998, Hytrin generated $540 million in sales, which accounted for more than twenty percent of Abbott’s sales of pharmaceutical products in the United States that year. Geneva, Zenith Goldline Pharmaceuticals, Inc. (“Zenith”), — now known as IVAX Pharmaceuticals, Inc. (“IVAX”) — and other generic drug manufacturers developed generic versions of Hytrin for sale in the United States to compete for the Hytrin market. Whereas the first generic drug manufacturer, Geneva, began the regulatory process to enter the market in January 1993, generic entry only occurred in August 1999. Generic market entry not only provides less expensive bioequivalent drugs for consumers, but also eliminates a brand name drug company’s patent monopoly. Plaintiffs Kaiser, the Sherman Act Class Plaintiffs, Individual Direct Purchasers, Indirect Purchaser Class Plaintiffs, and State Plaintiffs (collectively, “Plaintiffs”) sued Defendants alleging, inter alia, claims under Section One of the Sherman Act (“Section One”) and analogous state laws for conspiracy to restrain trade. Essentially, Plaintiffs contend that Defendants violated Section One by entering into an agreement in April 1998 that resulted in delayed domestic competition for the sale of terazosin hydrochloride, thus constituting an unreasonable restraint of trade. More specifically, Plaintiffs argue that Abbott’s agreement to pay Geneva $4.5 million per month to keep its generic terazosin hydrochloride product off the market pending final appellate resolution of the ’207 patent infringement litigation resulted in reduced output, artificially inflated prices, and eliminated competition in the market for terazosin hydrochloride. Defendants respond that the Agreement was a permissible exercise of Abbott’s rights under the ’207 patent, and that their accord represented a reasonable interim settlement of a genuine intellectual property dispute. To place the ’207 patent infringement litigation in context, it is necessary to set out the pertinent framework for drug regulation in the United States and then discuss the parties’ undisputed material facts as to Abbott’s ’207 patent, the ’207 patent litigation, and the Abbott-Geneva Agreement upon which Plaintiffs’ Section One claims are based. A. The FDA Regulatory Framework Under Hatch-Waxman A drug patent gives its owner the right to attempt to exclude others from making, using, or selling the drug in the United States for the duration of the patent. Before a drug company can sell a drug in the United States, it must apply for and obtain approval from the Food and Drug Administration (“FDA”), which regulates the domestic sale of drugs pursuant to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq. S. ¶¶ 1-2. To secure FDA approval to market a new drug, a pharmaceutical company must first file a New Drug Application (“NDA”) with the FDA and may not market a new drug until the NDA is approved. S. ¶ 3. The NDA applicant must demonstrate to the FDA that the new drug is safe and effective for its proposed use(s). S. ¶3. New drugs that are approved and marketed through the NDA-approval process, such as Hytrin, are generally referred to as “brand-name” or “pioneer” drugs. S. ¶ 4. The pharmaceutical companies that develop new drugs, such as Abbott, are generally referred to as “brand name,” “innovator,” or “pioneer” companies. S. ¶ 4. In 1984, Congress amended the laws governing pharmaceutical sales and enacted the Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. § 355, commonly known as the Hatch-Waxman Act (“Hatch-Waxman”). S. ¶ 5. This Act established an abbreviated process that shortened the time and effort needed to obtain FDA market approval for generic copies of previously approved pioneer drug products, yet also sought to protect against infringement of patents relating to pioneer drugs. As part of the legislative scheme to balance these competing interests, Hatch-Waxman provides that once the FDA approves a new drug, it is listed in a FDA publication called the “Orange Book,” which identifies both the brand name and the chemical or generic name for the drug. S. ¶ 6. The FDA also lists in the Orange Book any patents owned by the innovator that “claim the drug” or “which claim a method of using such drug” and “with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug,” along with the expiration date of such patent(s). S. ¶ 6. On the other side of the balance, Hatch-Waxman provides that five years after the FDA has approved a new drug, a generic pharmaceutical company may seek approval to sell a generic version of the drug by filing an Abbreviated New Drug Application (“ANDA”). S. ¶ 7. A generic pharmaceutical manufacturer, such as Geneva, may not market a generic drug until the FDA approves the ANDA for that company’s generic product, and must also meet certain validation requirements before it can legally market its product. S. ¶ 7. To secure FDA approval for an ANDA, a generic manufacturer must demonstrate that the proposed generic drug is the bioe-quivalent of the corresponding brand-name drug. S. ¶ 8. When filing an ANDA, FDA regulations require the ANDA applicant to certify that either: (I) no patent is listed in the Orange Book relevant to its ANDA; or (II) the patent listed in the Orange Book has expired; or (III) the listed patent will expire on a particular date, and the ANDA filer does not seek FDA approval before that date (a “Paragraph III Certification”); or (IV) the listed patent is invalid or will not be infringed by the manufacture, use, dr sale of the proposed generic drug (a “Paragraph IV Certification”). S. ¶ 9. If the ANDA filer makes a Paragraph III Certification, the ANDA cannot receive final approval until the expiration of the relevant patent(s). S. ¶ 10. If the ANDA filer makes a Paragraph IV Certification, however, it is required to provide a notice to the innovator company of the certification, including “a statement of the factual and legal basis of the applicant’s opinion that the patent is not valid or will not be infringed.” S. ¶ 11. The Hatch-Waxman and FDA regulations do not require the ANDA applicant to provide a sample of its proposed generic product. S. ¶ 11. During the time period relevant to this case, if the generic company filed a Paragraph TV Certification and the innovator company filed a patent infringement lawsuit in federal court within forty-five days of the innovator company’s receipt of the generic company’s Paragraph IV Certification, the filing of such a lawsuit would trigger a “thirty month stay” of final FDA approval. S. ¶ 12. Under Hatch-Wax-man’s stay provision, the FDA is prohibited from granting final approval for the ANDA until the earlier of: (1) thirty (30) months after the date of the innovator company’s receipt of the generic’s notice regarding its Paragraph IV Certification; or (2) issuance of a “court decision” relating to the specific ANDA that holds the patent invalid or uninfringed. S. ¶ 12. However, during the thirty month stay period, the FDA may grant “tentative approval” to an ANDA applicant if the FDA determines that the ANDA would otherwise receive final approval but for the thirty month stay. S. ¶ 14. District courts are authorized to extend or shorten the thirty month stay where either party to the action fails to reasonably cooperate in expediting the litigation. S. ¶ 12. A dismissal of the Hatch-Waxman infringement lawsuit lifts the thirty month stay. Although a patent holder can file a patent infringement action against an alleged in-fringer after that forty-five day period following receipt of the Paragraph IV Certification, such an action does not trigger a thirty month stay. B. Abbott’s ’207 Patent and the ’207 Patent Litigation Of Abbott’s numerous terazosin hydrochloride patents, only the 5,504,207 patent (“the ’207 patent”) is directly relevant to the instant motions. Abbott is the as-signee of the ’207 patent on a crystalline polymorph of anhydrous terazosin hydrochloride with a certain x-ray diffraction pattern (Form IV) and a process for the preparation of terazosin hydrochloride dihydrate using Form IV as an intermediary. S. ¶ 49. The application for the ’207 patent was filed on October 18, 1994. Id. The patent issued on April 2, 1996, and was submitted to the FDA for listing in the Orange Book on the same day. Id. Geneva fried two ANDAs for terazosin hydrochloride. It filed ANDA 74-315 on January 12, 1993, for terazosin hydrochloride tablets using Form II anhydrous tera-zosin. S. ¶ 29. In June 1995, it switched to Form IV anhydrous terazosin. S. ¶ 58. Geneva obtained tentative approval for its tablet ANDA on June 17, 1997, and final approval on December 31, 1998. S. ¶ 29. Geneva came to market with its tablet product in May 2001. Id. Geneva also filed ANDA 74-823 on December 29, 1995, for terazosin hydrochloride capsules employing Form IV anhydrous terazosin and obtained final approval on March 30, 1998. Geneva came to market with its generic capsules on August 13,1999. S. ¶ 30. In connection with these two ANDAs, Geneva provided Abbott with two notices, both dated April 29, 1996, of Paragraph IV Certifications with respect to the ’207 patent. These certifications asserted that claims 1 through 3 of the patent were not infringed and that claim 4 of the patent was invalid under 35 U.S.C. § 102(b) (the “on-sale bar”). S. ¶ 107. On June 4, 1996, Abbott sued Geneva regarding its tablet ANDA alleging infringement. S. ¶ 109. Abbott failed, however, to institute any litigation challenging Geneva’s capsule product. S. ¶ 108. While Geneva conceded that its terazosin hydrochloride tablet product contained Form IV terazosin hydrochloride as claimed by the ’207 patent, it denied that the patent was valid or enforceable. S. ¶ 110. On January 15, 1997, Geneva moved for summary judgment on the grounds that claim 4 of the ’207 patent (the only claim of the patent asserted against Geneva) was invalid under the “on-sale bar,” relying on sales of anhydrous terazosin from the early 1990s which contained Form IV terazo-sin hydrochloride. These sales occurred more than one year before Abbott filed its application for the ’207 patent and involved anhydrous terazosin that Byron Chemical Company (“Byron”) bought from its overseas supplier and then sold to Geneva in the United States. The summary judgment motion was fully briefed by April 22, 1997. In its opposition to the summary judgment motion, Abbott did not contest that these prior purchases included the same Form IV terazosin hydrochloride that Abbott claimed in its ’207 patent. However, Abbott argued that the buyers’ and seller’s alleged lack of knowledge of the existence of Form IV terazosin hydrochloride at the time of the sales prevented the triggering of the “on-sale bar.” S. ¶¶ 114-115. On September 1, 1998, the district court granted Geneva’s summary judgment motion, finding claim 4 of the ’207 patent (claiming Form IV terazosin hydrochloride) invalid because of the “on-sale bar.” Abbott Labs. v. Geneva Pharms., Inc., No. 96-C-3331, 1998 WL 566884, at *5 (N.D.Ill. Sept.l, 1998). In so finding, the district court relied on the Federal Circuit decision in J.A. LaPorte, Inc. v. Norfolk Dredging Co., 787 F.2d 1577 (Fed.Cir.1986), cert. denied, 479 U.S. 884, 107 S.Ct. 274, 93 L.Ed.2d 250 (1986). Id. The remaining claims of the ’207 patent have not been challenged and remain in force. S. ¶ 119. Abbott appealed the district court’s decision to the Federal Circuit. After Abbott filed its appeal, the Supreme Court, on November 10, 1998, issued it opinion in Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998) (rejecting the “totality of the circumstances” test for determining whether an invention was on sale before the critical date). On July 1, 1999, a panel of the Federal Circuit affirmed the district court and cited Pfaff in its opinion; it also cited several pre-Pfajf Federal Circuit decisions, including LaPorte. S. ¶ 122; see Abbott Labs. v. Geneva Pharms., Inc., 182 F.3d 1315 (Fed. Cir.1999). Rehearing was denied on August 6, 1999, the Federal Circuit’s mandate issued on August 12, 1999, and the U.S. Supreme Court denied certiorari on January 10, 2000. S. ¶122. C. The Abbott-Geneva Agreements On April 1, 1998, when Geneva’s motion for summary judgment had been fully briefed for nearly one year, Abbott and Geneva entered into the agreement that is the subject of Plaintiffs’ claims (“Agreement” or “Abbott-Geneva Agreement”). S. ¶ 178. The Agreement provided, in relevant part, that: Geneva shall not sell, offer for sale, donate, or otherwise distribute in the United States any Terazosin Hydrochloride Product until after the earlier of (1) the Generic Entry Date, or (2) the Appellate Judgment. S. ¶ 179. The term “Generic Entry Date,” as used in the Agreement, was defined as the earlier of the date of sale of generic Hytrin by a third party, or the expiration date of Abbott’s ’532 patent for dihydrate terazosin hydrochloride — February 18, 2000. S. ¶ 180. In turn, the term “Appellate Judgment” referred to the conclusion of the pending ’207 litigation, and meant a final, unappealable judgment, including any appeal or petition for certiorari to the United States Supreme Court. S. ¶ 181. The Agreement provided, inter alia, that Abbott would pay Geneva $4.5 million per month beginning on April 30, 1998. The Agreement also provided that in the event of “Final Judgment in Geneva’s Favor,” Abbott’s monthly payments to Geneva would stop and Abbott would pay into escrow $4.5 million per month until the earlier of the “Generic Entry Date,” the “Appellate Judgment,” or the date of “Final Judgment in Abbott’s Favor.” The Agreement further provided that Geneva would receive the amount in escrow if Geneva prevailed in any appeal. Otherwise, the amount in escrow would be returned to Abbott. Under the Agreement, upon a Final Judgment in Abbott’s favor, Abbott would have no obligation to make any payment to Geneva. S. ¶ 182. Finally, the Agreement provided that Abbott had the option to terminate payments if the Generic Entry Date had not occurred on or before February 18, 2000. S. ¶ 183. In August 1999, Abbott and Geneva terminated the Agreement. As of the date of termination, Abbott had paid a total of $49.5 million into escrow. As part of the termination agreement, $45 million in escrow funds were returned to Abbott. Had Geneva launched on August 13, 1999, without first having terminated the Agreement, Abbott would have asserted that Geneva was in breach of the Agreement. S. ¶ 186. Geneva launched its generic product on August 13, 1999. S. ¶ 187. Since going to market with a generic form of terazosin hydrochloride in August 1999, Geneva has been an actual competitor of Abbott. S. ¶ 188. The activities of Abbott and Geneva being challenged in this action have occurred in, and have had a substantial effect on, interstate commerce. S. ¶ 189. D. The December 2000 Per Se Ruling and the Eleventh Circuit’s Reversal On December 13, 2000, this Court granted Plaintiffs’ motion for partial summary judgment, concluding that the Abbott-Geneva Agreement was a per se violation of Section One. See In re Terazosin Hydrochloride Antitrust Litig., 164 F.Supp.2d 1340 (S.D.Fla.2000). In making that determination, the Court characterized the Agreement as a geographic market allocation arrangement between horizontal competitors, essentially allocating the entire United States market for terazosin drugs to Abbott. Id. On September 15, 2003, the Eleventh Circuit Court of Appeals reversed, finding that this Court’s condemnation of the Abbott-Geneva Agreement as a per se violation of Section One was “premature.” Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294, 1304 (11th Cir.2003). The Eleventh Circuit premised its ruling on the fact that Abbott, as owner of the ’207 patent, had “the lawful right to exclude others.” Id. Recognizing that the patentee’s exclusionary right cannot be exploited in every way, the Eleventh Circuit concluded that this Court nonetheless needed to consider the exclusionary scope of the patent before making any determination as to whether the alleged restraint is per se illegal. Id. at 1306 (citing In re Ciprofloxacin Hydrochloride Antitrust Litig., 261 F.Supp.2d 188, 249 (E.D.N.Y.2003)). The Eleventh Circuit, therefore, remanded the case for further proceedings consistent with its opinion. E. The Parties ’ Motions Based on these undisputed facts, the parties collectively filed six motions for summary judgment relating to Plaintiffs’ Section One claims. These motions can be divided into two categories: those that relate to the threshold examination of the exclusionary potential of the ’207 patent, and those that relate to the subsequent antitrust scrutiny of the anticompetitive impact of the challenged restraint. Falling into the first category are: (1) the Sherman Act Class Plaintiffs’ Motion for Partial Summary Judgment for an Order Declaring that the Abbott-Geneva Agreement Exceeded the Exclusionary Potential of the ’207 Patent; (2) Kaiser’s Motion for Summary Judgment on Section One Claims; and (3) Defendants’ Motion for Summary Judgment on Sherman Act Section One (and Analogous) Claims. In their motions, the Sherman Act Class Plaintiffs and Kaiser argue that the Abbott-Geneva Agreement exceeded the scope of the ’207 patent by delaying generic competition for terazosin hydrochloride through the date of a final appellate judgment as to the validity of the ’207 patent. Defendants’ motion, in turn, contends that the Agreement was within the potential exclusionary power of the patent because: (a) it only limited competition for a small subset of the natural life of the patent, which at the time of the Agreement had not been invalidated and was not set to expire until October 2014; and (b) it was reasonably likely that Abbott could have obtained a preliminary injunction or stay pending appeal to keep Geneva off the market past the date of the district court’s order invalidating the patent. These Section One motions require, pursuant to the Eleventh Circuit’s opinion and its instructions on remand, the development of an appropriate framework for assessing the exclusionary potential of the ’207 patent. In the second category of motions are: (1) the Sherman Act Class Plaintiffs’ Motion for Partial Summary Judgment for a Finding that the Abbott-Geneva Agreement Violates Section One of the Sherman Act or in the Alternative for a Finding that a “Quick-Look” Analysis Applies to the Agreement (hereinafter, “the Quick-Look Motion”); and (2) the Sherman Act Class Plaintiffs’ Motion for Partial Summary Judgment for a Ruling that Proof of Actual Anticompetitive Effects is Sufficient to Establish a Violation of Section One of the Sherman Act (hereinafter, “the Direct Evidence Motion”). In the former motion, the Sherman Act Class Plaintiffs argue that the Agreement’s restraint on generic competition in the terazosin hydrochloride market constitutes a per se violation of Section One, as it is a horizontal market allocation that has the great tendency to diminish output and increase prices. As an alternative motion, the Sherman Act Class Plaintiffs argue that the Agreement should be evaluated under a “quick look” approach in lieu of a full-blown “rule of reason” analysis. Finally, in the event that the Court does not apply a truncated analysis that presumes the Agreement’s anticompetitive impact, the Sherman Act Class Plaintiffs ask the Court to rule that it may establish the actual anticompetitive effects of the Agreement through direct evidence, thus eliminating the need for an extensive, time-consuming analysis of market power. The Court will begin with the first category of motions, addressing the exclusionary potential of the ’207 patent, in Section III of this Order. The latter category of motions will be considered in Section IV, below. II. SUMMARY JUDGMENT STANDARD Summary judgment is appropriate, in accordance with Fed.R.Civ.P. 56, when “the pleadings ... show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Once the moving party demonstrates the absence of a genuine issue of material fact, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’ ” Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (quoting Fed.R.Civ.P. 56(e)). Accepting the record evidence as truthful, the Court must view the record and all factual inferences therefrom in the light most favorable to the non-moving party and decide whether “ ‘the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.’ ” Allen v. Tyson Foods, Inc., 121 F.3d 642, 646 (11th Cir.1997) (quoting Anderson, 477 U.S. at 251-52, 106 S.Ct. 2505). The moving party is entitled to summary judgment where the “record taken as a whole could not lead a rational trier of fact to find for the non-moving party.” Matsushita, 475 U.S. at 587, 106 S.Ct. 1348. These standards apply equally to antitrust cases, where “the usual entanglement of legal and factual issues ... may be particularly well-suited for Rule 56 utilization.” Thompson Everett, Inc. v. Nat’l Cable Adver., L.P., 57 F.3d 1317, 1322 (4th Cir.1995); see also Bayou Bottling, Inc. v. Dr. Pepper Co., 725 F.2d 300, 303 (5th Cir.1984) (citing Aladdin Oil v. Texaco, Inc., 603 F.2d 1107, 1111 (5th Cir.1979)) (“simply because a case is based upon the antitrust laws does not suspend the application of Rule 56.”). Because “ ‘[t]he very nature of antitrust litigation encourages summary disposition of such cases when permissible,’ ” courts have recognized that “summary judgment is an important tool for dealing with antitrust cases.” Oksanen v. Page Mem’l Hosp., 945 F.2d 696, 708 (4th Cir.1991) (quoting Collins v. Associated Pathologists, Ltd., 844 F.2d 473, 475 (7th Cir.1988)). As the instant motions are not ones in which “motive and intent play important roles in determination of factual issues,” but rather involve legal questions for the Court to decide as a matter of law, disposition of these matters on summary judgment is appropriate. See Doctor’s Hosp. of Jefferson, Inc. v. Southeast Med. Alliance, Inc., 897 F.Supp. 290, 292 (E.D.La.1995) (citing Aladdin Oil, 603 F.2d at 1111). III. THE EXCLUSIONARY POTENTIAL OF THE PATENT The Eleventh Circuit found this Court’s characterization of the AbbotWGeneva Agreement as a per se violation of Section One to be “premature” absent consideration of the protections afforded by the ’207 patent. Valley Drug Co., 344 F.3d at 1304. This patent, the Eleventh Circuit held, “gave Abbott the right to exclude others from making, using, or selling anhydrous terazosin hydrochloride until October of 2014, when it is due to expire.” Id. at 1305. Because “[t]he effect of the Geneva Agreement on the production of Geneva’s infringing generic ter-azosin product may have been no broader than the potential exclusionary effect of the ’207 patent,” the Eleventh Circuit directed this Court to evaluate the protections afforded by the ’207 patent in determining whether the Agreement constitutes a violation of Section One. Id. at 1305, 1310; see also United States v. Studienge-sellschaft Kohle, m.b.H, 670 F.2d 1122, 1128 (D.C.Cir.1981) (holding that “the protection of the patent laws and the coverage of the antitrust laws are not separate issues.”). Specifically, the Eleventh Circuit held that “[t]he appropriate analysis on remand will likely require an identification of the protection afforded by the patents and the relevant law and consideration of the extent to which the [Geneva Agreement reflects] a reasonable implementation of these.” Id. at 1312. After such an analysis has been completed, “[a]ny provisions of the Agreement[] found to have effects beyond the exclusionary effects of Abbott’s patent may then be subject to traditional antitrust analysis to assess their probable anticompetitive effects in order to determine whether those provisions violate § 1 of the Sherman Act.” Id. (citing Standard Oil Co. v. United States, 283 U.S. 163, 175, 51 S.Ct. 421, 75 L.Ed. 926 (1931)). Although earlier in this case, Plaintiffs challenged several provisions of the Ab-botWGeneva Agreement, since the Eleventh Circuit’s decision they have narrowed their Section One claims to a single provision of the Agreement — the prohibition of Geneva’s marketing its generic terazosin products between the September 1, 1998, district court judgment in the ’207 patent litigation and the Federal Circuit’s mandate on August 12, 1999 (hereinafter, “the challenged provision” or “the appellate-stay provision”). With regard to that provision, the Eleventh Circuit considered that “[t]he ’207 patent may have allowed Abbott to obtain preliminary injunctive relief or a stay of an adverse judgment pending appeal, which also would have prevented Geneva from marketing its ter-azosin hydrochloride products during this period.” Id. at 1305. In so ruling, the Eleventh Circuit did not articulate any particular legal framework for this Court’s analysis of the Geneva Agreement on remand. It did note, however, that to evaluate the legality of the Agreement, its provisions “should be compared to the protections afforded by the preliminary injunction and stay mechanisms and considered in light of the likelihood of Abbott’s obtaining such protections.” Id. at 1312. In the absence of an articulated analytical framework from the Eleventh Circuit, the Court finds guidance in the writings of Professor Herbert Hovenkamp. In a recent article on the antitrust implications of settlements in intellectual property (“IP”) disputes, Professor Hovenkamp addresses the complex issues that arise when parties enter into a settlement agreement that would potentially constitute an antitrust violation in the absence of claimed IP rights. In such a situation, “once conduct is found that would likely be an antitrust violation in the absence of a settlement, some care must be taken to ensure (1) that the parties did have a bona fide dispute, (2) that the settlement is a reasonable accommodation, and (3) that the settlement is not more anticompetitive than a likely outcome of the litigation.” See Herbert Hovenkamp, Mark D. Janis & Mark A. Lemley, The Interface Bettveen Intellectual Property Law and Antitrust Law: Anticompetitive Settlement of Intellectual Property Disputes, 87 Minn. L.Rev. 1719, 1727 (2003). Like the Eleventh Circuit’s decision, Professor Hovenkamp’s three-part test urges this Court to consider the likely outcomes of the underlying patent litigation, and in so doing, requires at least a limited inquiry into the merits of the parties’ respective positions regarding the application of the “on-sale bar” and the validity of the ’207 patent, viewed as of the date on which the Agreement was entered into. Taking into account both the Eleventh Circuit’s opinion and Professor Hoven-kamp’s analytical approach, the Court has adopted a three-part test to evaluate whether the challenged provision of the AbbotNGeneva Agreement was a reasonable implementation of the exclusionary potential of the ’207 patent. First, the Court will examine the exclusionary scope of the ’207 patent, and determine the extent of the protections afforded to Abbott by its patent and the relevant law. Because this determination, as discussed more fully below, requires an analysis of the underlying patent litigation and the potential for Abbott to extend its terazosin monopoly by requesting a preliminary injunction, step two requires an evaluation of the likely outcomes of the ’207 patent litigation, including the likelihood of Abbott obtaining injunctive relief to keep Geneva off the market pending appeal of the patent validity issue, judged as of April 1, 1998. Finally, once the likelihood of such relief has been addressed, the Court next must determine whether the settlement represented a reasonable implementation of the protections afforded by the ’207 patent, in light of the applicable law, the then-pending litigation, and the general policy justifications supporting settlements of intellectual property disputes. Ultimately, if the challenged provision of the Agreement is deemed to have effects that exceed the exclusionary potential of the patent or any reasonable implementation of the patent’s protections, the challenged provision can be subjected to traditional antitrust analysis in accordance with the Eleventh Circuit’s decision. A. The Exclusionary Scope of the ’207 Patent The starting point for the Court’s analysis on remand is to define the exclusionary scope of the ’207 patent. As a basic matter of patent law, the ’207 patent granted Abbott the lawful right to exclude others. See Valley Drug, 344 F.3d at 1304 (citing 35 U.S.C. §§ 271(a) & 283); see also Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176, 215, 100 S.Ct. 2601, 65 L.Ed.2d 696 (1980) (“[T]he essence of a patent grant is the right to exclude others from profiting by the patented invention.”). This exclusionary right is granted to allow the patentee to exploit whatever degree of market power it might gain thereby as an incentive to induce investment in innovation and the public disclosure of inventions. See id. (citing Bonito Boats, Inc. v. Thunder Craft Boats. Inc., 489 U.S. 141, 150-51, 109 S.Ct. 971, 103 L.Ed.2d 118 (1989) & Studiengesellschaft, 670 F.2d at 1127); see also Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100, 135, 89 S.Ct. 1562, 23 L.Ed.2d 129 (1969) (noting that a patentee may lawfully “prevent other[s] from utilizing his discovery without his consent.”). However, the patent’s exclusionary right cannot be exploited in every way. Id. (citations omitted); see also Carl Shapiro, Antitrust Limits to Patent Settlements, 34 RAND J. Econ. 391, 395 (2003) (theorizing that a patent “does not give the patentee ‘the right to exclude’ but rather the more limited ‘right to try to exclude’ by asserting its patent in court”). It is well-settled that a patent holder’s protections are limited by the precise terms of the patent grant, and cannot be extended by agreement. See Valley Drug, 344 F.3d at 1312 (citing United States v. Line Material, 333 U.S. 287, 300, 68 S.Ct. 550, 92 L.Ed. 701 (1948) (“the precise terms of the grant define the limits of a patentee’s monopoly and the area in which the patentee is freed from competition of price, service, quality or otherwise”)); see also United States v. Masonite Corp., 316 U.S. 265, 277, 62 S.Ct. 1070, 86 L.Ed. 1461 (1942) (“The owner of a patent cannot extend his statutory grant by contract or agreement. A patent affords no immunity for a monopoly not fairly or plainly within the grant.”). Further, intellectual property law does not offer pharmaceutical patentees a guaranteed insulation from competition, without the risk that the patent later will be held invalid. See Hovenkamp, et al, 87 Minn. L.Rev. at 1761. Rather than providing such unconditional protection from generic competition, “[t]he legitimate exclusion value of a pharmaceutical patent [like the ’207 patent] is the power it actually confers over competition, which is in turn a function of the scope of the patent and its chance of being held valid.” Id.; see also Shapiro, 34 RAND J. Econ. at 395 (noting that “the patentholder’s rights are calibrated according to the likelihood that the patentholder would win the patent litigation, and the extent of exclusion that such a victory would permit.”). The exclusionary value of the patent, therefore, cannot be defined by looking at the patent terms in a vacuum; instead, when litigation is pending as to the validity of the patent, the chances that the patent will be held valid must be considered as part of the analysis. Id. The legal scope of the ’207 patent, like that of any patent, is measured by its numbered claims. See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1374 (Fed.Cir.2003); see also Motion Picture Patents Co. v. Universal Film Mfg. Co., 243 U.S. 502, 510, 37 S.Ct. 416, 61 L.Ed. 871 (1917) (“The patent law simply protects [the patent holder] in the monopoly of that which he has invented and has described in the claims of his patent”). However, in this case, the Court need not define the legal scope of the patent by analyzing the terms of the patent’s numbered claims and assessing whether the patent’s protections extended to the Agreement’s prohibition of marketing all forms of terazosin hydrochloride. Instead, because the only provision of the Agreement that Plaintiffs challenge is the prohibition of Geneva’s marketing its generic product until after appellate resolution of the ’207 patent litigation, in analyzing the exclusionary scope of the ’207 patent in accordance with the Eleventh Circuit’s instructions, the relevant issue is the temporal breadth of the patent’s protections. The focus of this analysis, therefore, is on the period of time for which the patent would continue to protect Abbott from generic competition. As their summary judgment submissions reflect, the parties disagree as to whether the temporal scope of the patent’s exclusions may be defined merely by reference to its expiration date, or whether a more searching analysis of the strength of the patent in the face of validity challenges is required. Defendants argue that the exclusionary scope of the patent permitted Abbott to keep Geneva’s generic product off the market through appellate review of the District Court’s patent validity ruling by virtue of the fact that the patent was not set to expire until October 2014. Abbott notes that “the ’207 patent had the potential ‘to exclude others from making, using or selling anhydrous terazosin hydrochloride until October of 2014, when it [was] due to expire.’ ” See Defs.’ Sect. One Brief at 7 (citing Valley Drug Co., 344 F.3d at 1305). As of April 1, 1998 — the date of the Agreement — the ’207 patent had never been held invalid and, therefore, still enjoyed the presumption of validity. Abbott concludes, therefore, that as of April 1, 1998, the exclusionary scope of the patent protected it from generic competition up to and including October 2014, without regard to the patent validity issues being litigated in the Northern District of Illinois. As further support for construing the patent as protecting Abbott from generic competition through the patent’s natural expiration date, Abbott notes that the patent examiner at the United States Patent and Trademark Office (“PTO!’) had already considered and rejected the very argument regarding the “on-sale bar” on which Geneva based its only validity challenge. Id. Plaintiffs, in turn, respond that Defendants’ approach would render the Eleventh Circuit’s instructions on remand inconsequential, as there would be no need to analyze the exclusionary potential of the patent and consider the likelihood of Abbott obtaining injunctive relief if the matter were as simple as looking at the patent’s expiration date. Defendants’ argument, however facially appealing, represents an overly simplistic approach to the Eleventh Circuit’s opinion. It fails to take into account the advanced stage of the underlying patent litigation and the substantial questions that Geneva had asserted regarding the ’207 patent’s validity. At the time that the Agreement was entered into, Defendants were nearly two years into their patent infringement litigation, and Geneva’s Motion for Summary Judgment — in which it asserted a strong legal challenge to the validity of the ’207 patent under the “on-sale bar” — had been fully briefed for approximately one year. As will be addressed more fully in step two of the Court’s analysis, Geneva’s challenge to the patent represented a substantial question as to validity, and was premised' on solid legal precedent ~ in the Federal Circuit. The chance that the ’207 patent would be held valid' — an essential part of the equation for defining the legitimate exclusionary value of the patent — was not high as of April 1, 1998. Given the significant likelihood that Geneva would prevail and that the patent would be held invalid, the mere fact that the patent was, at the time, not set to expire until October 2014 cannot immunize Defendants from antitrust scrutiny of their Agreement. Indeed, any construction of the patent’s exclusionary scope as of April 1, 1998, that fails to take into account the chances of the patent being held invalid would essentially afford pioneer drug manufacturers an unbridled power to exclude others without regard to the strength of their patent rights. Such an interpretation would give the patent holder rights beyond those granted by the Patent Act, and beyond the structure contained in the Hatch-Waxman Act. Further, Abbott’s reliance on the PTO examiner’s prior rejection of Geneva’s “on-sale bar” argument is unpersuasive. First, “the question whether the on sale bar applies is a question of law, UMC Elecs. Co. v. United States, 816 F.2d 647, 657 (Fed.Cir.1987). The Patent Office’s decisions on questions of law are reviewed ‘without deference to the views of the Agency.’ ” Abbott Labs. v. Geneva Pharms., Inc., No. 96 C 3331, 1998 WL 566884, at *5 n. 9 (N.D.Ill. Sept.1, 1998) (citing In re Brana, 51 F.3d 1560, 1568 (Fed.Cir.1995)). Therefore, the Court need not attribute any particular weight to the PTO examiner’s analysis of this legal question. Second, as addressed in the Court’s Order on Plaintiffs’ Section Two claims, the PTO Examiner’s review of the ’207 patent was based on a one-sided, ex parte presentation of the issue; Geneva was not given the opportunity to present the PTO with its position on the validity of the ’207 patent, and Abbott’s patent lawyer did not provide the PTO examiner with the citation to LaPorte, which was relied on by the District Court in ruling the patent invalid. See DE-1419 at 24. Although this Court, in its Section Two Order, concluded that there was insufficient evidence that the failure to cite LaPorte was knowing or willful — such that it could rise to the level of Walker Process fraud or attempt to defraud the PTO — this failure does substantially undermine Defendants’ reliance on the PTO’s decision. Further, the ex parte nature of the process renders its ultimate result, particularly on questions of law, unworthy of deference. See In re Brana, 51 F.3d at 1568. The Court, therefore, must reject Defendants’ argument that further analysis of the scope of the patent’s protections is unnecessary in light of the patent’s October 2014 expiration date and the PTO’s rejection of the “on-sale bar” challenge. B. The Likely Outcomes of the Patent Litigation For the reasons stated above, it is clear that any definitive construction of the exclusionary scope of the patent requires at least a limited assessment of the underlying patent infringement case. Therefore, the second step of the Court’s analysis focuses on the likely outcomes of the patent litigation that was pending at the time the parties entered into the Agreement. See Valley Drug, 344 F.3d at 1312. By exploring the likely outcomes of the litigation, the Court can delineate the protections afforded by the patent with due consideration for the significant challenge to the ’207 patent’s validity that Geneva raised in the infringement action. 1. The Preliminary Injunction Analogy To evaluate the likely outcomes of the patent infringement litigation, the Eleventh Circuit specifically directed this Court to consider the analogy of the Agreement being like a preliminary injunction or stay pending appeal. Specifically, the Eleventh Circuit considered that “the ’207 patent may have allowed Abbott to obtain preliminary injunctive relief or a stay of an adverse judgment pending appeal, which also would have prevented Geneva from marketing its terazosin hydrochloride products during [the relevant] period.” Valley Drug, 344 F.3d at 1305. The Eleventh Circuit was careful to note the significance of the word “may” in this comment; in so doing, the Court emphasized that it did “not hold that the ’207 patent would have allowed Abbott to obtain a preliminary injunction or a stay of an adverse judgment pending appeal. [The Eleventh Circuit meant] only that these are among the considerations that the district court should address on remand.” Id. at n. 17. As discussed above, Defendants theorize that the Court need not reach this preliminary injunction analogy because the temporal scope of the patent’s protections extended through its expiration date in October 2014, without regard to the pending infringement action. Having already considered and rejected that argument, the Court turns to Defendants’ alternative theory, that Abbott could have obtained a preliminary injunction or stay pending appeal to keep Geneva’s product off the market until after an appellate court ruling on the patent’s validity. Defendants argue that such provisional relief would have had an exclusionary effect reasonably equivalent to that of the Geneva Agreement and, therefore, the challenged provision of the Agreement should not be subject to antitrust analysis. Plaintiffs, however, argue that at the time the Agreement was entered into, Abbott had no chance of obtaining a preliminary injunction to keep Geneva off the market even if the district court in the ’207 patent case later held the patent invalid on summary judgment. As a threshold matter, the parties fundamentally disagree as to what degree of certainty is required for Abbott to establish that it could have obtained a preliminary injunction. Central to their arguments is the language from the Eleventh Circuit’s opinion suggesting that the challenged provision “should be compared to the protections afforded by the preliminary injunction and stay mechanisms and considered in light of the likelihood of Abbott’s obtaining such protections.” Valley Drug Co., 344 F.3d at 1312 (emphasis added). From the word “likelihood,” Plaintiffs infer that the Agreement will be found to exceed the exclusionary potential of the ’207 patent unless Defendants show that it was more probable than not that Abbott would have obtained an injunction with exclusionary effects equal to the restraints in the Agreement. Plaintiffs cite both Webster’s New Collegiate Dictionary and Black’s Law Dictionary for the proposition that “the plain meaning of ‘likelihood’ is ‘probability.’” Next, Plaintiffs note that Black’s Law Dictionary further defines “probability” as “a condition or state created when there is more evidence in favor of the existence of a given proposition than there is against it.” See Turnpike Nissan, Inc., v. Nissan Motor Corp., 150 B.R. 345, 346 (Bkrtcy.M.D.Pa.1992). Defendants, on the other hand, interpret the Eleventh Circuit’s opinion to require only that provisional relief be a “reasonable possibility” in the ’207 litigation. Defendants base their interpretation, in part, on a section of the Hovenkamp treatise cited in the Eleventh Circuit’s opinion. In section 2046 of Antitrust Law: An Analysis of Antitrust Principles and their Application (1999), Hovenkamp began with the premise that the legal system encourages settlement of conflicting intellectual property claims, especially “where the settlement is certainly no more anti-competitive than [a] possible outcome” of the litigation and whei'e “each party’s claim seemed reasonably legitimate but also seemed subject to a reasonable risk of failure — that is, each party was in a position where settlement seemed to be a reasonable act.” Id. at 262-64. Because Ho-venkamp focused on the reasonableness of the settlement and the 'possible outcomes of litigation, Defendants conclude that the appropriate interpretation of the Eleventh Circuit’s decision is whether injunctive relief is a reasonable possibility. There is some degree of ambiguity in the word “likelihood,” and there is no clear guidance in the Eleventh Circuit’s opinion as to which of the parties’ interpretations is more accurate. The Court therefore looks to prior opinions of this Circuit for guidance on the appropriate use of the word “likelihood.” The Eleventh Circuit and the former Fifth Circuit have previously held, albeit in different contexts, that “the word likelihood is synonymous with probability.” Shatel Corp. v. Mao Ta Lumber & Yacht Corp., 697 F.2d 1352, 1356 n. 2 (11th Cir.1983); see also Faciane v. Starner, 230 F.2d 732, 738 (5th Cir.1956) (using the words “likelihood” and “probability” eoextensively in addressing the degree of consumer confusion necessary to support a trademark infringement action). However, in defining the word “probability,” the Eleventh Circuit has recognized that it is capable of two definitions: a lower “reasonable probability” standard, or a higher “more likely than not” standard. Johnson v. Singletary, 938 F.2d 1166, 1200 n. 6 (11th Cir.1991). But ultimately, the definition most often applied in this Circuit’s precedent is the “more likely than not” standard. See Mercantile Tex. Corp. v. Bd. of Governors of Fed. Reserve Sys., 638 F.2d 1255, 1268 (5th Cir.1981) (“A probability signifies that an event has a better than fifty percent chance of occurring”). Although support exists for both interpretations, it is the Plaintiffs’ proposed definition that is best suited for this Court’s analysis on remand. Therefore, in assessing the likelihood that Abbott could have obtained a preliminary injunction or stay pending appeal, the Court must determine whether it was more probable than not that Abbott would be entitled to such relief. 2. The Federal Circuit’s Standard for Injunctive Relief Having resolved the meaning of the word “likelihood” in the Eleventh Circuit’s opinion, the Court turns to one of the primary issues presented on remand: whether it was more likely than not that Abbott could have obtained a preliminary injunction or stay pending appeal to keep Geneva off the market until after the Federal Circuit had reviewed the District Court’s invalidity decision. Because any motion for injunctive relief would have been reviewed by the Federal Circuit, it is undisputed that Federal Circuit law provides the appropriate precedent for this analysis. In the Federal Circuit, the party seeking the “extraordinary relief’ of a preliminary injunction must demonstrate: (1) a reasonable likelihood of success on the merits; (2) irreparable harm if the injunction were not granted; (3) the balance of the hardships; and (4) the impact of the injunction on the public interest. Reebok Int’l Ltd. v. J. Baker, Inc., 32 F.3d 1552, 1555 (Fed.Cir.1994) (citing Hybritech, Inc. v. Abbott Labs., 849 F.2d 1446, 1451 (Fed. Cir.1988)); see also Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1350-51 (Fed.Cir.2000). Although Plaintiffs generally dispute Abbott’s ability to demonstrate any of the four requisite elements for obtaining injunctive relief, the dominant focus of the parties’ briefs is the requirement that the movant establish a reasonable likelihood of success on the merits. a. Likelihood of Success on the Merits for Patent Injunctions In the patent context, “a reasonable likelihood of success” requires a showing of validity and infringement. Reebok, 32 F.3d at 1555 (citing Hybritech, 849 F.2d at 1451). Thus, Abbott had to show that, in light of the presumptions and burdens that will inhere at trial on the merits, (1) it will likely prove that Geneva’s ANDA infringes the ’207 patent, and (2) its infringement claim will likely withstand Geneva’s challenges to the validity of the ’207 patent. Genentech, Inc. v. Novo Nordisk, A/S, et al., 108 F.3d 1361, 1364 (Fed.Cir.1997) (citing New England Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878, 882-83 (Fed.Cir.1992)). In the ’207 litigation, it was undisputed that Geneva’s proposed generic product infringed the ’207 patent. Thus, the case presented none of the complicated claims construction issues that mark some patent infringement actions. The focus, instead, was on a single legal issue regarding the validity of the ’207 patent in light of Geneva’s challenge based on the “on-sale bar.” In such cases, if the alleged infringer — here, Geneva — raises a “substantial question” concerning validity (i.e., asserts a defense that the patentee cannot show “lacks substantial merit”) the preliminary injunction should not issue. Id.; see also Helifix, 208 F.3d at 1351. For Geneva to raise a “substantial question” on validity for injunctive purposes, it need not demonstrate to a legal certainty that it would ultimately win at trial. Indeed, “[v]alidity questions during preliminary injunction proceedings can be successful, that is, they may raise substantial questions of invalidity, on evidence that would not suffice to support a judgment of invalidity at trial .... Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial.” Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343,1358-59 (Fed.Cir.2001) (citations omitted). Abbott argues, however, that if it alleges irreparable harm that is “sufficiently serious, it is only necessary that there be a fair chance of success on the merits.” See Standard Havens Prods, v. Gencor Indus., Inc., 897 F.2d 511, 513 (Fed.Cir.1990) (citing William Inglis & Sons Baking Co. v. ITT Cont’l Baking Co., 526 F.2d 86, 88 (9th Cir.1975)). It is true that a patent is presumed valid, 35 U.S.C. § 282 (1994), and a party challenging validity must prove invalidity by clear and convincing evidence. “However, the presumption does not relieve a patentee who moves for preliminary injunction from carrying the normal burden of demonstrating that it will likely succeed on all disputed liability issues at trial, even when the issue concerns the patent’s validity.” Helifix, 208 F.3d at 1351 (citing New England Braiding, 970 F.2d at 882). Therefore, had it moved for a preliminary injunction to keep Geneva off the market pending appeal of the district court’s invalidity ruling, Abbott would still have been held to the requirement of demonstrating a reasonable likelihood of success on the merits. An assessment of the likelihood that Abbott could have obtained injunctive relief, therefore, requires that this Court consider the likelihood of Abbott prevailing on the merits of the ’207 patent litigation, gauged as of the date on which the Agreement was entered into. See Valley Drug Co., 344 F.3d at 1306 (“We begin with the proposition that the reasonableness of agreements under the antitrust laws are to be judged at the time the agreements are entered into.”) (citations omitted). To situate this analysis in the proper temporal framework, it is important to note that as of April 1, 1998, the ’207 patent litigation had been pending for nearly two years, and Geneva’s Motion for Summary Judgment had been fully briefed for just short of one year. Geneva, in its summary judgment motion, asserted that the ’207 patent was invalid because the claimed invention was “on sale” more than one year prior to the patent’s earliest filing date. Abbott challenged the application of the “on-sale bar” on the grounds that “the presence of Form IV anhydrous terazosin hydrochloride in the transactions at issue here was, at most, an unintended accident to which both the buyer and seller were wholly indifferent.” See Pis.’ Mot. for Partial Summ. J., Vol. II, Ex. 5 at AL00019057. Of particular relevance to Abbott’s present argument is whether Geneva’s “on-sale bar” argument raised a “substantial question” concerning the patent’s validity, and whether Abbott could demonstrate that the asserted defense “lacks substantial merit.” See Genentech, 108 F.3d at 1364; see also Helifix, 208 F.3d at 1351. Because the reasonableness of the Agreement is to be assessed as of the date on which it was entered into, this Court may not rely on the District Court’s analysis of the ’207 patent or on its ultimate conclusion that the patent was invalid under the “on-sale bar.” To a certain extent, this Court is placed in the difficult position of having to “unring the bell”; although the District Court and Federal Circuit decisions in the underlying ’207 patent litigation have been scrutinized in relation to other portions of this case, for purposes of this analysis, the Court must, in essence, act as if they had not yet been issued. Indeed, the Court cannot be swayed by the subsequent invalidity of the patent. See Valley Drug, 344 F.3d at 1306-07 (“the mere subsequent invalidity of the patent does not render the patent irrelevant to the appropriate antitrust analysis.”). However, the analysis that this Court must undertake in deciding whether the “on-sale bar” issue would have entitled Abbott to a preliminary injunction pending appeal is far more limited than that which the District Court, hearing the underlying ’207 patent dispute, was required to undertake. There, the Court had to analyze a broad range of cases in the Federal Circuit interpreting the parameters of the “on-sale bar.” Here, the relevant issue is simply whether Geneva’s “on-sale bar” challenge raised “substantial questions” as to the validity of the ’207 patent, and whether Abbott had, as of April 1, 1998, demonstrated that Geneva’s challenge was significantly without merit. b. The “Ortr-Sale Bar” Issue in the ’207 Suit The primary issue presented in Geneva’s motion for summary judgment in the patent infringement action was whether the “on-sale bar” of 35 U.S.C. § 102(b) invalidated claim 4 of the ’207 patent. Under § 102(b), a patent is invalid if the invention it claims was offered for sale or sold in the United States more than one year prior to the filing date of the patent application. The “on-sale bar” does not require sustained commercial activity, advertising, or displays. On the contrary, a single sale or even a single offer to sell is sufficient to trigger the statutory bar. In re Caveney, 761 F.2d 671, 676 (Fed.Cir.1985). Moreover, the sale or offer for sale need not be made by the inventor or by the patent owner. A sale or offer for sale by a third party is just as effective a bar as a sale or offer by the inventor. Id.; see also LaPorte, 787 F.2d at 1581 (the “bar is not limited to sales by the inventor or one under his control, but may result from the activities of a third party”). The application for the ’207 patent was filed on October 18, 1994. Therefore, the critical date for purposes of the “on-sale bar” was October 18, 1993. Through its summary judgment submissions, Geneva effectively demonstrated that prior to October 18, 1993, there had been at least three sales involving anhydrous terazosin hydrochloride that Byron Chemical Company (“Byron”) bought from its overseas supplier and then sold to Geneva in the United States. In light of those sales, it is evident that the “on-sale bar” applied absent some exception to the rule. Once Geneva raised this substantial question regarding the validity of the patent, Abbott — in order to avoid invalidation of the ’207 patent — had the burden of challenging the application of the “on-sale bar” based on the pre-1993 sales. In a creative effort to meet that burden, Abbott argued that: (1) application of the bar to this case was not supported by any of the policies underlying § 102(b); (2) the subject matter of the sales did not fully anticipate the claimed invention; and (3) Geneva did not demonstrate that the invention was complete and “known to work for its intended purpose,” in accordance with Seal-Flex, Inc. v. Athletic Track & Court Constr., 98 F.3d 1318, 1324 (Fed.Cir.1996). However, none of Abbott’s challenges to the application of the “on-sale bar” in the ’207 patent litigation demonstrated that Geneva’s position lacked substantial merit. As to the policy issue, the first policy underlying § 102(b) — the only one that was implicated in the ’207 patent litigation — clearly supported application of the bar. The first policy underlying § 102(b) is to “diseourag[e] removal of in-ventions from the public domain that the public reasonably has come to believe are freely available.” In re Mahurkar Double Lumen Hemodialysis Catheter, 71 F.3d 1573, 1577 (Fed.Cir.1995). As part of its policy issue argument, Abbott argued that there was no fear that the public would be deprived of Form IV terazosin hydrochloride because neither the buyers nor the sellers were aware that they were purchasing that particular invention. Abbott’s contention