THOMAS W. THRASH, JR., District Judge.
This is a multidistrict litigation proceeding involving antitrust actions that are consolidated for pretrial proceedings. It is before the Court on Par Pharmaceutical Companies, Inc. and Paddock Laboratories, Inc.'s Motion for Summary Judgment on Objective Baselessness [Doc. 555]
This case involves the patent for AndroGel, a testosterone replacement gel that has been a huge commercial success. In 1995, Unimed Pharmaceuticals and Besins Healthcare, S.A. ("Besins") agreed to develop a testosterone replacement product designed to treat male hypogonadism
In April 1999, Solvay filed a New Drug Application ("NDA") with the Food and Drug Administration, seeking approval to commercially market AndroGel [see Doc. 587-68]. See 21 U.S.C. § 355(a). The FDA approved the NDA in February 2000, and Solvay began marketing AndroGel in June 2000. On August 30, 2000, Solvay and Besins filed a patent application with the U.S. Patent and Trademark Office ("PTO") [see Doc. 587-68]. Initially, the PTO examiner rejected Solvay's patent claims based on public use and sales of AndroGel during clinical testing, but the examiner later withdrew his rejection [Doc. 587-70]. The examiner also initially rejected Solvay's patent claims disclosing a solution "comprising of" certain ingredients [Doc. 604-70]. Solvay subsequently amended its patent application to disclose claims for a "pharmaceutical composition... consisting essentially of" certain ingredients [Doc. 587-69] (emphasis added).
On January 7, 2003, the patent application issued as U.S. Patent No. 6,503,894
AndroGel is the preferred embodiment of the '894 Patent. To that end, the specification discloses, in Table 5, the formula for AndroGel. The formula states that 100 grams of AndroGel contains: 1.0 g testosterone, 0.90 g Carbopol 980, 0.50 g isopropyl myristate, 72.5 g ethanol; Carbopol (0.9%); a gelling agent; 4.72g .1 N sodium hydroxide (0.0188%); and water. The '894 Patent states that the ingredients can be varied within certain ranges. The patent recites 42 claims. Claims 1, 9, 10, 18, and 31 are independent claims, and the remaining claims are dependent. Claims 1, 10, and 18 each describe a formulation "consisting essentially of" about 1% to about 5% sodium hydroxide. Claim 9 describes a formulation "consisting essentially of ... about 1% to about 3% sodium hydroxide." Finally, Claim 31 recites:
Thus, Claim 31, upon which Claims 32-42 are dependent, states that the composition consists essentially of only four ingredients, none of which are water or sodium hydroxide.
The initial version of the '894 Patent provided a range of sodium hydroxide concentration in the specification that appeared to be much less than the range of sodium hydroxide listed in the claims. While the specification provided for 4.72g 0.1 N sodium hydroxide (resulting in a 0.0188% sodium hydroxide concentration in AndroGel), the claims recited different ranges. Specifically, Claims 1, 10, and 18 list ranges of sodium hydroxide at 1% to 5%, Claim 9 lists a range of 1% to 3%, and Claim 31 does not mention sodium hydroxide, only a "gelling agent." On June 12, 2003, Solvay filed a request for a certificate of correction to the '894 Patent [Doc. 587-75]. The request sought to replace the term "sodium hydroxide" in Claims 1-30 with the term "0.1 N sodium hydroxide" to reflect the language in Table 5 of the specification. The PTO issued the certificate of correction on December 16, 2003 [Doc. 587-66]. See 35 U.S.C. § 255.
Before the '894 Patent issued, Watson Pharmaceuticals, Inc. ("Watson") and Paddock Laboratories, Inc. ("Paddock") (collectively, the "Generics") began developing generic versions of AndroGel. The Generics attempted to copy AndroGel "as close as humanly possible"
Solvay responded to the ANDA notices by asserting its rights under the '894 Patent, again pursuant to the procedure laid out in 21 U.S.C. § 355(j)(2)(A)(vii). In August 2003, Solvay's subsidiary, Unimed, filed patent infringement actions against Watson and Par/Paddock in this Court, and by filing automatically prevented the Generics from entering the market for 30 months. See Complaint, Unimed Pharm., Inc. v. Watson Pharm., Inc., No. 03 Civ. 2501 (N.D.Ga. Aug. 21, 2003) (2003 WL 23824320); Complaint, Unimed Pharm., Inc. v. Paddock Labs., Inc., No. 03 Civ. 2503 (N.D.Ga. Aug. 21, 2003) (2003 WL 23824347) (the "Underlying Litigation").
From late 2003 to the middle of 2005, the Underlying Litigation proceeded with discovery and other preliminary matters. By August 2005, the parties had filed claim construction motions. The parties agreed that 25 claim terms required construction. No party filed a Daubert motion in the Underlying Litigation. By December 2005, Watson and Par/Paddock had filed motions for summary judgment on the validity of the '894 Patent. They argued the certificate of correction improperly broadened the patent and that the '894 Patent did not meet the written-description requirement of 35 U.S.C. § 112. Solvay opposed summary judgment on both grounds, arguing that a skilled chemist would have understood that the certificate of correction merely fixed a drafting error and that the written description issue was a question of fact. The parties vigorously argued their positions.
Before the Court could resolve these issues, Solvay, Watson, and Par/Paddock settled the Underlying Litigation [see Docs. 604-87, 604-88, 604-89, 604-91, 604-90, 604-92, 604-93, & 604-94, collectively, the "Settlement and License Agreements"]. Under the Settlement and License Agreement with Watson, Solvay agreed to voluntarily dismiss the Underlying Litigation, and Watson agreed not to market generic AndroGel until the earlier of August 31, 2015, or the date another company marketed generic AndroGel. Under the Settlement and License Agreements between Solvay and Par/Paddock, Solvay agreed to a consent judgment dismissing the infringement action, and Par/Paddock agreed not to market generic AndroGel until the earliest of August 31, 2015, but only if Watson did not assert its 180-day generic exclusivity period, or the date another company launched generic AndroGel, or February 28, 2016. No other generic manufacturer has entered the market.
The Settlement and License Agreements prompted an investigation by the Federal Trade Commission (FTC) for violations of antitrust laws. In 2009, the FTC and a number of private parties filed these antitrust actions against Solvay, Watson, Par, and Paddock. All the actions were filed in other federal district courts and then transferred to this Court either by change of venue or by order of the United States Judicial Panel on Multidistrict Litigation. All of the Plaintiffs alleged that the Defendants violated various federal antitrust laws. See Sherman Antitrust Act §§ 1-2, 15 U.S.C. §§ 1-2; Federal Trade Commission Act § 5(a), 15 U.S.C. § 45(a). The Indirect Purchaser Plaintiffs also alleged that the Defendants violated the common law and antitrust laws of about forty states. All of the Plaintiffs asserted antitrust claims based on the settlements. They alleged that Solvay paid Watson, Par, and Paddock millions of dollars for agreeing not to sell generic AndroGel before August 31, 2015. The Plaintiffs claim that Solvay filed sham infringement actions against Watson and Paddock; Solvay improperly listed the '894 Patent in the Orange Book; all of the Defendants participated in a scheme to monopolize the market for generic AndroGel; and Watson, Par, and Paddock agreed not to compete with each other in the market for generic AndroGel.
In 2009, Par/Paddock and Solvay filed Motions to Dismiss [Docs. 8, 9, 22, 23, 24, 25, 26, 27, 28, & 29]. On February 22, 2010, the Court granted in part and denied in part the Defendants' motions [Doc. 50]. See In re AndroGel, 687 F.Supp.2d 1371 (N.D.Ga.2010). Specifically, the Court dismissed the Private Plaintiffs' and the FTC's claims that the reverse payments encompassed in the settlement agreements were antitrust violations. The Court noted that, under Eleventh Circuit precedent, the First Amendment protects the Settlement and License Agreements unless the Underlying Litigation was a sham. See id. at 1379-80. Therefore, the remaining claims, and the current motions for summary judgment, rest on whether the Private Plaintiffs can show that the Underlying Litigation and the settlements were a sham.
On January 20, 2012, Par/Paddock filed a Motion for Summary Judgment on Objective Baselessness [Doc. 555]. On February 15, 2012, Par/Paddock filed a Motion for Summary Judgment on Improper Subjective Motivation [Doc. 567]. On February 17, 2012, Par/Paddock filed a Motion for Summary Judgment on Plaintiffs' Substantive Antitrust Claims [Doc. 574]. On February 21, 2012, Watson filed a Motion for Summary Judgment on Plaintiffs' Conspiracy Claims for Lack of Subjective Bad Faith [Doc. 579]. On February 21, 2012, Solvay filed a Motion for Summary Judgment on Objective Baselessness [Doc. 587] and a Motion for Summary Judgment on Subjective Bad Faith [Doc. 589]. On February 21, 2012, the Direct Purchaser Plaintiffs filed a Motion to Exclude Portions of Dr. Norman Weiner's Expert Report [Doc.
Summary judgment is appropriate only when the pleadings, depositions, and affidavits submitted by the parties show that no genuine issue of material fact exists and that the movant is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c). The court should view the evidence and any inferences that may be drawn in the light most favorable to the nonmovant. Adickes v. S.H. Kress & Co., 398 U.S. 144, 158-59, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970). The party seeking summary judgment must first identify grounds that show the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323-24, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The burden then shifts to the nonmovant, who must go beyond the pleadings and present affirmative evidence to show that a genuine issue of material fact does exist. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 257, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
As noted, the Court has previously dismissed the Plaintiffs' "reverse-payment" claims. See In re AndroGel, 687 F.Supp.2d at 1379. In its order, the Court noted, however, that "the Eleventh Circuit's Hatch-Waxman cases allow antitrust Plaintiffs to assert a claim of `sham litigation' in the context of reverse payment patent infringement settlements." Id.
Sham litigation is an exception to the general principle that "[t]hose who petition government for redress are generally immune from antitrust liability." Professional Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49, 56, 113 S.Ct. 1920, 123 L.Ed.2d 611 (1993) ("PRE"). However, this immunity does not extend to activity that "is a mere sham to cover what is actually nothing more than an attempt to interfere directly with the business relationships of a competitor and the application of the Sherman Act would be justified." Eastern R.R. Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127, 144, 81 S.Ct. 523, 5 L.Ed.2d 464 (1961). "[T]o be a `sham,' litigation must meet a two-part definition." PRE, 508 U.S. at 60, 113 S.Ct. 1920:
Id. at 60-61, 113 S.Ct. 1920 (quoting Noerr, 365 U.S. at 144, 81 S.Ct. 523 and
All parties have moved for summary judgment with respect to objective baselessness arguing that there are no issues of material fact. "A finding of objective baselessness is to be determined by the record made in the infringement proceedings." iLOR, LLC v. Google, Inc., 631 F.3d 1372, 1380 (Fed.Cir.2011). When there is no dispute over the predicate facts of the underlying suit, objective baselessness is a question of law to be decided by the Court. See Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc., 682 F.3d 1003, 1007-08 (Fed.Cir.2012).
The Plaintiffs must satisfy a heavy burden to show that the Underlying Litigation was objectively baseless. "Under this exacting standard, the plaintiff's case [in the Underlying Litigation] must have [had] no objective foundation." iLOR, 631 F.3d at 1377. "If an objective litigant could conclude that the suit is reasonably calculated to elicit a favorable outcome, the suit is immunized under Noerr, and an antitrust claim premised on the sham exception must fail." PRE, 508 U.S. at 60, 113 S.Ct. 1920.
"When a court has found that an antitrust defendant claiming Noerr immunity had probable cause to sue, that finding compels the conclusion that a reasonable litigant in the defendant's position could realistically expect success on the merits of the challenged lawsuit." Id. at 63, 113 S.Ct. 1920. "Probable cause to institute civil proceedings requires no more than a `reasonabl[e] belie[f] that there is a chance that [a] claim may be held valid upon adjudication.'" Id. at 62-63, 113 S.Ct. 1920 (quoting Hubbard v. Beatty & Hyde, Inc., 343 Mass. 258, 262, 178 N.E.2d 485 (1961)). "The court must remember that `[e]ven when the law or the facts appear questionable or unfavorable at the outset, a party may have an entirely reasonable ground for bringing suit.'" PRE, 508 U.S. at 60 n. 5, 113 S.Ct. 1920 (quoting Christiansburg Garment Co. v. EEOC, 434 U.S. 412, 422, 98 S.Ct. 694, 54 L.Ed.2d 648 (1978)). Importantly, "when the antitrust defendant has lost the underlying litigation, a court must `resist the understandable temptation to engage in post hoc reasoning by concluding' that an ultimately unsuccessful `action must have been unreasonable or without foundation.'" PRE, 508 U.S. at 60 n. 5, 113 S.Ct. 1920 (quoting Christiansburg, 434 U.S. at 421-422, 98 S.Ct. 694). "Neither the bringing of an unsuccessful suit to enforce patent rights, nor the effort to enforce a patent that falls to invalidity, subjects the suitor to antitrust liability." C.R. Bard, Inc. v. M3 Systems, Inc., 157 F.3d 1340, 1369 (Fed. Cir. 1998). Further, "the legality of objectively reasonable petitioning directed toward obtaining government action is not at all affected by any anticompetitive purpose the actor may have had." PRE, 508 U.S. at 59, 113 S.Ct. 1920 (quoting Noerr, 365 U.S. at 140, 81 S.Ct. 523). Indeed, even in the absence of supporting authority, a litigant may reasonably offer a "good faith argument for the extension, modification, or reversal of existing law" without incurring sham liability. Id. at 65, 113 S.Ct. 1920 (quoting Fed.R.Civ.P. 11); see also In re Terazosin Hydrochloride Antitrust Litigation, 335 F.Supp.2d 1336, 1359-60 (S.D.Fla.2004) (finding that legal argument "was a stretch, [but] it did not exceed the pale of an aggressive attempt to extend the existing law, and thus was not objectively baseless."); Honeywell International, Inc. v. Universal Avionics Systems Corp., 343 F.Supp.2d 272, 325-26 (D.Del. 2004) (finding suit was objectively reasonable when plaintiffs offered a qualified expert who was ultimately discredited); VAE
The Plaintiffs contend that each of the Defendants in the present suit took an objectively baseless position in litigating and settling the underlying suit. The Plaintiffs contend that Solvay chose to file an Orange Book listing for the '894 Patent despite the plain certainty that the '894 Patent did not cover AndroGel or its generic replicants. The Plaintiffs also contend that Watson and Par/Paddock's decisions to settle the claims were objectively baseless because an objective litigant would have discerned that the '894 Patent was so blatantly invalid that victory was assured. See FTC v. Watson, 677 F.3d 1298, 1308 (11th Cir.2012) ("[A] court must judge the antitrust implications of a reverse payment settlement as of the time that the settlement was executed."). Thus, all of the Plaintiffs' arguments with respect to objective baselessness contend that the '894 Patent was either invalid or not infringed. The Plaintiffs offer several theories as to why the patent was so facially invalid that an objective litigant would not have attempted to enforce the patent, and those arguments are addressed in turn below.
The Plaintiffs contend that Solvay could not rely upon the certificate of correction to correct fatal errors in the patent as issued. Originally, Claims 1-30 disclosed a formulation "consisting essentially of" about 1% to about 5% "sodium hydroxide" [Doc. 587-66]. On December 16, 2003, the PTO issued a certificate of correction that changed the words "sodium hydroxide" in Claims 1-30 to ".1 N sodium hydroxide."
Specifically, the Plaintiffs argue that an objective litigant would have known that the certificate of correction did not apply to Solvay's claims against Watson and Par/Paddock in the Underlying Litigation because the certificate was issued six months after the lawsuit was filed. Without the certificate of correction, the Plaintiffs argue, the ranges of sodium hydroxide listed in Claims 1-30 obviously cannot encompass AndroGel or its generic replicates. The Patent Act provides for obtaining a certificate of correction as follows:
35 U.S.C. § 255. At the time of the Underlying Litigation, the Federal Circuit had held that a certificate of correction does not apply to causes of action arising before its issuance. Southwest Software, Inc. v. Harlequin Inc., 226 F.3d 1280, 1295 (Fed.Cir.2000). The Plaintiffs argue that an objective litigant in Solvay's position would have known that a certificate of correction would not apply to the Underlying Litigation because the action was filed before the certificate was issued.
However, recent developments in case law show that Solvay's reliance upon the certificate of correction in the Underlying Litigation was not objectively unreasonable. In E.I. du Pont de Nemours & Co. v. MacDermid Printing Solutions, LLC, 525 F.3d 1353 (Fed.Cir.2008), the plaintiff sued for infringement of a patent supplemented with a certificate of correction. The defendant countered that the certificate of correction had issued after the cause of action accrued. The court held that the certificate of correction covered all acts of infringement that occurred after the certificate of correction issued, despite the date the cause of action accrued. The court distinguished Southwest Software, noting that "only [the defendant's] future conduct (i.e., prospective infringement occurring after the issuance of the certificate of correction) is at issue." Id. at 1362; see also Eagle Iron Works v. McLanahan Corp., 429 F.2d 1375 (3d Cir.1970) (noting that certificate of correction may be "given retroactive application in order that intervening rights may not be alleged.").
Similarly, in Central Admixture Pharmacy Services, Inc. v. Advanced Cardiac Solutions, P.C., No. CV-00-2430, 2006 WL
The District of Delaware recently decided Pfizer Inc. v. Teva Pharmaceuticals U.S.A., Inc., 882 F.Supp.2d 643, 698-99, 2012 WL 2951367, at *44 (D.Del.2012), a case, like the Underlying Litigation, involving a certificate of correction and an ANDA filing. That court concluded that "because infringement [under a Paragraph IV suit] is hypothetical and, therefore, cannot occur prior to the filing of a complaint, a certificate of correction can be applied where the defendants' ANDA products will prospectively infringe the patents-in-suit." Id. The court noted that "relevant case law has instructed that, for the purposes of determining whether a certificate of correction applies, the date on which the infringing conduct will occur, rather than the date a complaint is filed, dictates." Id. Notably, no party has identified a case decided before the Underlying Litigation involving a certificate of correction issued after an ANDA filing. The decisions in Central Admixture, E.I. du Pont, and Pfizer demonstrate that reasonable litigants have argued successfully for application of certificates of correction after a lawsuit was filed. As the court in Pfizer noted, under 35 U.S.C. § 271(e)(2)(A), actual sales of generic AndroGel were artificially represented by Watson and Par/Paddock's ANDA applications. Thus, the Underlying Litigation represented a "hypothetical case ... to determine whether the drug that will be sold upon approval of the ANDA will infringe the ['894 Patent]." In re Brimonidine Patent Litig., 643 F.3d 1366, 1377 (Fed.Cir.2011). Based on the lack of factually similar precedent, a litigant could reasonably expect a chance that the certificate of correction would apply to Solvay's claims. See PRE, 508 U.S. at 62-63, 113 S.Ct. 1920 (argument not objectively baseless if litigant has "reasonabl[e] belie[f] that there is a chance that [a] claim may be held valid upon adjudication."); In re Terazosin, 335 F.Supp.2d 1336, 1360-61 (finding that legal argument "was a stretch, [but] it did not exceed the pale of an aggressive attempt to extend the existing law, and thus was not objectively baseless."). For these reasons, Solvay's argument that the certificate of correction applied to its claims was not objectively baseless. By extension, Par/Paddock and Watson acted as objectively reasonable litigants when they recognized that the certificate of correction might apply in the Underlying Litigation and considered settlement.
Additionally, a reasonable litigant could have argued for a judicial correction of the '894 Patent in the Underlying Litigation. A district court can correct a patent error "if (1) the correction is not subject to reasonable debate based on consideration of the claim language and the specification and (2) the prosecution history does not suggest a different interpretation of the claims." Novo Indus., L.P. v. Micro Molds Corp., 350 F.3d 1348, 1354 (Fed.Cir.2003). District courts have the power to correct errors that would be obvious "from the point of view of one skilled in the art." CBT Flint Partners, LLC v. Return Path, Inc., 654 F.3d 1353, 1358 (Fed.Cir.2011) (quoting Ultimax Cement Manufacturing Corp. v. CTS Cement Manufacturing Corp., 587 F.3d 1339, 1353 (Fed.Cir.2009)). Here, Solvay's expert, Dr. Weiner, testified that someone skilled in the art "would understand that the concentration
Next, the Plaintiffs argue that the certificate of correction should have appeared invalid to an objective litigant because it enlarged the scope of the '894 Patent. See 35 U.S.C. § 255 (certification of "correction [may] not involve such changes in the patent as would constitute new matter or would require re-examination."). Certificates of correction, like patent claims, are entitled to a presumption of validity. Superior Fireplace Co. v. Majestic Prods. Co., 270 F.3d 1358, 1367 n. 1 (Fed.Cir.2001) (noting that presumption "is related to the presumption that the PTO does its job properly."). However, "[a] mistake in a claim the correction of which broadens the scope of coverage of that claim and is not clearly evident from the specification, drawings, and prosecution history is not a `mistake of a clerical or typographical nature' subject to correction under 35 U.S.C. § 255." Id. at 1376.
Here, Table 5 of the '894 Patent accurately discloses the formulation of AndroGel, including "0.1 N sodium hydroxide" [Doc. 587-66]. Thus, without correction, Claims 1-30 would exclude AndroGel, the '894 Patent's preferred embodiment. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed.Cir.1996) (interpreting patent to exclude preferred embodiment "is rarely, if ever, correct and would require highly persuasive evidentiary support."). However, Solvay's expert, Dr. Weiner, testified that someone skilled in the art "would understand that the concentration of water and sodium hydroxide would be in the form of a 0.1 N solution because this is the concentration disclosed in Table 5 of the '894 Patent" [Doc. 555, Ex. 31]. Dr. Weiner also testified that "[t]he skilled person knows [that] ... sodium hydroxide would not be used in the range [given in uncorrected Claims 1-30] because it would highly irritate or even burn the skin" [Doc. 555, Ex. 29]. Thus, based on the specification, there was evidence that someone skilled in the art would have realized that the term "sodium hydroxide" was a clerical error. See 35 U.S.C. § 255. Although Dr. Weiner's opinion may not have been ultimately persuasive, the Plaintiffs have not overcome the presumption that the certificate of correction is valid and have not shown that the parties' litigation positions, which recognized that the certificate of correction might apply, were unreasonable. For these reasons, it was not objectively baseless for Solvay to seek to enforce its rights pursuant to the certificate of correction in the Underlying Litigation.
The Plaintiffs argue that Claims 1-30 should have been invalid to an objectively reasonable litigant for lack of a written description. Specifically, the Plaintiffs contend that the percentage of each ingredient listed in Table 5 does not support the ranges provided in Claims 1-30. However, "[t]he written description does not have to describe the invention exactly." Nelson v. K2 Inc., No. C07-1660, 2008 WL 4603409, at *1 (W.D.Wash. Oct. 15, 2008). Rather, "the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing
The Court concludes that a reasonable litigant could have sought a determination finding that the written description requirement was satisfied. In Union Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989 (Fed.Cir.2000), the defendant argued that a patent for automobile fuel did not meet the written description requirement. "[T]he patent claim[ed] its inventive products in terms of ranges of chemical properties, which work[ed] in combination with ranges of other chemical properties to produce a gasoline that reduce[d] emissions." Id. at 997. The specification disclosed a broader range for certain ingredients than was disclosed in the claims. The court, however, held that "the specification supported the claimed range, even though the precise range of the claim was not repeated verbatim in the specification." Id. at 1000. The court reasoned "that it would `let form triumph over substance' if it allowed the written description requirement to eviscerate claims that are narrowed during prosecution, simply because the patent applicant broadly disclosed in the original patent application but then narrowed his claims during prosecution." Id. (quoting In re Wertheim, 541 F.2d 257, 265 (CCPA 1976)).
Here, as amended by the certificate of correction, Claims 1-30 describe a composition containing 1%-5% 0.1 N sodium hydroxide. Table 5 refers only to 4.72% sodium hydroxide — the amount present in AndroGel. As in Union Oil, Dr. Weiner testified that someone skilled in the art would be able to determine the appropriate range of sodium hydroxide based on the information in the specification [Doc. 555, Ex. 26, ¶ 48]. Specifically, Dr. Weiner noted that the range of Carbopol listed in the specification would allow someone skilled in the art to determine the appropriate range of sodium hydroxide. The Direct Purchaser Plaintiffs' expert, Dr. Bozena Michniak-Kohn, admitted that someone skilled in the art would be able to divine a range of sodium hydroxide given the ranges of other ingredients
Nevertheless, the Plaintiffs cite Nelson v. K2 Inc., No. C07-1660, 2008 WL 4603409 (W.D.Wash. Oct. 15, 2008), in support of their contention that Solvay's written description argument was a sham. In Nelson, the claimed ranges for length and width of the subject invention were narrower than those disclosed in the specification. The court found that the lack of specificity in the specification rendered the patent invalid. Importantly, the defendant also brought a motion for fees, arguing that the plaintiff's infringement arguments were frivolous. See Nelson v. K2 Inc., 2009 WL 1160092 (W.D.Wash. April 27, 2009). The court found that although the plaintiff had lost the written description issue, it "was entitled to a judicial determination of this important issue and was not required to abandon the ... patent simply because his competitors challenged its validity." Id. at *1. In the absence of controlling authority, and relying on Union Oil, it was not objectively baseless for Solvay to seek the same determination in the Underlying Litigation. For these reasons, Solvay's legal argument regarding the written description was not a sham.
The Plaintiffs also attack the credibility of the Defendants' expert testimony with respect to Claims 1-30. Specifically, the Plaintiffs contend that the amount of sodium hydroxide present in AndroGel is "the minimum workable amount." (See Pls.' Resp. In Opp'n to Par/Paddock's Mot. for Summ. J. on Objective Baselessness, at 17.) Further, the Plaintiffs argue that Dr. Bowman's calculations regarding the level of sodium hydroxide taught by the specification are arbitrary and ignore important scientific principles. (Id. at 18.) This evidence tends to discredit Dr. Bowman's and Dr. Weiner's testimony. It does not, however, establish that there was no chance a reasonable litigant could hope the finder of fact would credit the Defendants' experts. See PRE, 508 U.S. at 65, 113 S.Ct. 1920; Honeywell, 343 F.Supp.2d at 325-26 (concluding action was not objectively baseless even when qualified expert had been discredited). Further, as discussed above, Dr. Michniak-Kohn testified that it was possible to determine a broad range of sodium hydroxide based on the specification [see Doc. 587-36, ¶¶ 64-65]. For these reasons, Solvay's patent claims with respect to Claims 1-30 were not objectively baseless.
The Plaintiffs argue that Solvay's arguments regarding Claims 31-42 of the '894 Patent were objectively baseless because Claims 31-42 exclude water and sodium hydroxide as ingredients.
First, the Plaintiffs contend that the "gel" state of the '894 Patent is a basic and novel property of the invention. The Plaintiffs assert that water and sodium hydroxide affect the gel composition of the claimed invention, and thus affect its basic and novel properties. In response, the Defendants rely on Dr. Weiner's expert testimony. Dr. Weiner testified that "the basic and novel properties of the invention disclosed and claimed in the '894 Patent include the unique and unexpected pharmacokinetic profile as well as the low incidence of skin irritation that results [from] the use of the compositions described and claimed in the '894 Patent" [Doc. 555, Ex. 31]. Dr. Weiner stated that "sodium hydroxide has no effect on these basic and novel properties." Further, Dr. Weiner opined that "[t]he formation of a gel and the viscosity of the gel are not `basic and novel' properties of the invention" [Doc. 598-2]. Similarly, Dr. William Barr, Solvay's expert in the Underling Litigation, testified that "the basic and novel characteristics of the claimed invention include the unique and unexpected pharmacokinetic profile, as well as the low incidence of skin irritation" [Doc. 555, Ex. 30].
The Plaintiffs, however, point to certain inconsistencies in Dr. Weiner's testimony as rendering Solvay's arguments objectively baseless. Specifically, the Plaintiffs contend that during Dr. Weiner's deposition, he admitted that the gel state was a basic and novel characteristic of the invention [see Doc. 598-8]. Reviewing the deposition transcript, however, Plaintiffs' counsel repeatedly asks Dr. Weiner whether a gel state is a basic and novel property of the invention. In response, Dr. Weiner repeatedly states his opinion that while the preferred embodiment of the '894 Patent — AndroGel — is a gel, the basic and novel properties of the invention are the "pharmacokinetics and the lack of irritation" [Doc. 620-5, at 243-49]. Dr. Weiner repeatedly states his opinion that "once you accept that you do have a gel and you accept that this is a new invention, from that point forward, the only basic and novel properties are the pharmacokinetics and lack of irritation" [id. at 249]. Contrary to the Plaintiffs' assertions, Dr. Weiner does not admit that a gel state is a basic and novel property of the claimed invention. Indeed, Dr. Weiner explains his position that a gel state is not a basic and novel property of the invention several times [see id., at 244-249]. In any event, by pointing out mild inconsistency or confusion in Dr. Weiner's testimony the Plaintiffs have not established that no reasonable litigant would believe there was a chance Dr. Weiner's testimony would be credited. PRE, 508 U.S. at 62-63, 113 S.Ct. 1920 ("Probable cause to institute civil proceedings requires no more than a `reasonabl[e] belie[f] that there is a chance that [a] claim may be held valid upon adjudication.'"); Honeywell, 343 F.Supp.2d at 325-26 (concluding action was not objectively baseless when plaintiff's qualified expert had been discredited).
Indeed, the '894 Patent itself lends some support to Dr. Weiner's expert opinion. Claim 37 of the '894 Patent is a dependent claim that adds the limitation "wherein the composition is in the form of a gel" [Doc. 587-66]. "[T]he presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation
The Plaintiffs also claim that it was objectively baseless to argue that sodium hydroxide and water do not affect the pharmacokinetics of the claimed invention.
The Plaintiffs argue that the Underlying Litigation was objectively baseless because the '894 Patent was invalid under the "on-sale bar."
The Plaintiffs argue that the 1995 Supply Agreement constituted a commercial offer for sale and that reasonable litigants would have known that the '894 Patent was invalid because the patent was not applied for until August 30, 2000.
The Court concludes it was not objectively baseless for Solvay to bring suit despite the 1995 Supply Agreement. In Elan Corp. v. Andrx Pharmaceuticals, Inc., 366 F.3d 1336 (Fed.Cir.2004), a patentee sued a generic drug manufacturer for patent infringement, and the generic manufacturer argued that the on-sale bar invalidated the patent. The patentee had written a letter to another company offering to license the drug. The letter suggested that the companies would partner in testing and eventually marketing the drug. The price would be determined by market conditions when and if the drug went on sale. The Federal Circuit concluded that the on-sale bar did not apply. The court noted that the letter was not an offer to sell the patented drug, but rather an "opportunity to become [a] partner in the clinical testing and eventual marketing of [the drug] at some indefinite point." Id. at 1341. The court reasoned that "[t]he [alleged offer] lacked any mention of quantities, time of delivery, place of delivery, or product specifications beyond the general statement that the potential product would be a 500 mg once-daily tablet containing naproxen." Id.
Here, as in Elan, the 1995 Supply Agreement joined Unimed and Besins as "partner[s] in the clinical testing and eventual marketing of [a testosterone replacement drug] at some indefinite point." Id. at 1341. Indeed, at the time they entered into the 1995 Supply Agreement, neither Besins nor Unimed had invented AndroGel. Even when AndroGel was invented, all sales were explicitly contingent upon Besins "hav[ing] complied with all relevant requirements from the appropriate Government Agencies to Manufacture and sell the Product in the respective jurisdiction (e.g., for sales of Product in the United States, UNIMED shall have obtained FDA approval ... under the NDA)" [Doc. 587-87, § 2.3]. As in Elan, "[t]he [1995 Supply Agreement] lacked any mention of
The Plaintiffs contend that it was objectively baseless to argue that AndroGel was not in public use before the critical date, August 30, 1999.
The Plaintiffs cite several instances in which AndroGel placebo was publicly distributed. (See Pls.' Resp. in Opp'n to Solvay's Mot. for Summ. J. on Objective Baselessness, at 70-73.) The placebo was allegedly applied to physicians, distributed at conferences, and shown in a Petri dish on television. Although these public uses of AndroGel did not teach its formulation, the Plaintiffs contend that these public uses inherently disclosed the formulation of the AndroGel placebo. Also, the Plaintiffs contend that in 1998, Solvay published that AndroGel was a "1% hydroalcoholic gel preparation of testosterone (T)." (Id. at 71.) Thus, the Plaintiffs contend that it would be obvious to someone skilled in the art to combine these instances of prior art to create the formulation for AndroGel.
In the obviousness context, inherent properties of prior art are relevant only where "that inherency would have been obvious to those skilled in the art when the invention ... was made." Kloster Speedsteel AB v. Crucible Inc., 793 F.2d 1565, 1576 (Fed.Cir.1986); see also DONALD S. CHICHISUM ON PATENTS § 5.03[3][a][i][A] ("An inherent feature may be relied upon to establish obviousness only if the inherency would have been obvious to one of ordinary skill in the art."); In re Rijckaert, 9 F.3d 1531, 1534 (Fed.Cir.1993) (quoting In re Spormann, 53 C.C.P.A. 1375, 363 F.2d 444, 448, 150 USPQ 449,
Here, Solvay had a reasonable argument that the inherent properties in the AndroGel placebo were not obvious based on prior public use. AndroGel placebo was supplied to physicians, distributed at conferences, and shown in a Petri dish on television. From these prior uses, the composition of AndroGel placebo arguably would not "have been obvious to those skilled in the art when the invention ... was made." Kloster, 793 F.2d at 1576. It would therefore not have been obvious to someone skilled in the art to combine the inherent and untaught formulation for AndroGel placebo with 1% testosterone. For this reason, a reasonable litigant could have expected some chance that the '894 Patent was not invalid based on prior public use.
All parties have moved for summary judgment as to the Defendants' subjective motivation in the Underlying Litigation. "Only if challenged litigation is objectively meritless may a court examine the litigant's subjective motivation." PRE, 508 U.S. at 60, 113 S.Ct. 1920. Here, as discussed above, the Court has concluded that the Underlying Litigation was not objectively baseless. Thus, the Court need not examine the Defendants' subjective motivations.
"Proof of a sham merely deprives the defendant of immunity; it does not relieve the plaintiff of the obligation to establish all other elements of his claim." PRE, 508 U.S. at 61, 113 S.Ct. 1920. As discussed above, however, the Court has concluded the Underlying Litigation was not objectively baseless. For this reason, Par/Paddock's Motion for Summary Judgment on the Plaintiffs' Substantive Antitrust Claims is moot.
The Plaintiffs have moved to exclude portions of Dr. Norman Weiner's Report. Under Federal Rule of Evidence 702, "before admitting expert testimony a court must consider: (1) whether the expert is qualified to competently testify regarding the matters he intends to address; (2) whether the methodology used to reach his conclusions is sufficiently reliable; and (3) whether the testimony is relevant, in that it assists the jury to understand the evidence or determine a fact in issue." Watt v. Butler, 744 F.Supp.2d 1315, 1319 (N.D.Ga.2010) (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)).
First, the Plaintiffs contend that during his deposition, Dr. Weiner conceded that the gel state is a basic and novel property of the invention described in the '894 Patent. The Plaintiffs argue that this concession contradicts Dr. Weiner's expert report [see Doc. 598, at 9]. Dr. Weiner's alleged inconsistency,
Next, the Plaintiffs argue that Dr. Weiner's writings are inconsistent with his expert report regarding the effect of water in AndroGel. As discussed above, any such inconsistency may be the subject of cross examination, but does not justify exclusion under Daubert and Rule 702.
Finally, the Plaintiffs contend that Solvay's admissions in the Underlying Litigation render Dr. Weiner's testimony inadmissible. Specifically, the Plaintiffs argue that Solvay conceded that the term "sodium hydroxide" in the '894 Patent means pure sodium hydroxide. Again, the Plaintiffs' argument fails to address any of the three grounds for exclusion under Daubert. Solvay's allegedly inconsistent position affects the credibility, not the admissibility, of Dr. Weiner's opinion. For these reasons, the Plaintiffs' Motion to Exclude should be denied.
The Plaintiffs have moved to strike the declaration of Joseph Mahoney [see Doc. 708]. Mr. Mahoney was Solvay's patent counsel in the Underlying Litigation. Mr. Mahoney's declaration "purports to express Solvay's counsel's analysis regarding Solvay's decision to apply for a Certificate of Correction ... and also recites statements that the Patent Examiner allegedly made to Mr. Mahoney agreeing with his purported analysis." (Pls.' Mot. to Strike the Declaration of Joseph A. Mahoney and Limit Dr. Stanley Kaplan's Testimony, at 1.) The Plaintiffs argue that the Defendants should not be allowed to use the impressions of Solvay's counsel while invoking the protections of the attorney-client privilege. The Plaintiffs also assert that Mahoney's declaration includes inadmissible hearsay. Finally, the Plaintiffs contend that Watson and Solvay failed to identify Mahoney in accordance with Federal Rule of Civil Procedure 26.
The Court, however, does not rely on Mahoney's declaration — or the opinions of the PTO examiner — in deciding whether the Underlying Litigation was a sham. Clearly the PTO examiner believed that his interpretation of the '894 Patent was not objectively baseless. Further, the opinions of the PTO examiner are accounted for by the presumption that a patent is valid and that patent examiners act properly. See Superior Fireplace, 270 F.3d at 1367 n. 1 (noting that presumption of patent validity "is related to the presumption that the PTO does its job properly."). Thus, the Plaintiffs' request to strike Mahoney's testimony is moot.
The Direct Purchaser Plaintiffs seek to limit the testimony of Dr. Stanley Kaplan, the Indirect Purchaser Plaintiffs' expert witness. Specifically, the Direct Purchaser Plaintiffs assert that Dr. Kaplan conceded several points relevant to objective baselessness. The Direct Purchaser Plaintiffs contend that such concessions should be used only against the Indirect Purchaser Plaintiffs. The Court's objective baselessness inquiry, however, does not rely on the testimony of Dr. Kaplan. For this reason, the Direct Purchaser Plaintiffs' motion is moot.
For the reasons set forth above, the Court GRANTS Par Pharmaceutical Companies, Inc. and Paddock Laboratories, Inc.'s Motion for Summary Judgment on Objective Baselessness [Doc. 555], DENIES AS MOOT Par Pharmaceutical Companies, Inc. and Paddock Laboratories, Inc.'s Motion for Summary Judgment on Improper Subjective Motivation [Doc. 567], DENIES AS MOOT Par Pharmaceutical Companies, Inc. and Paddock Laboratories, Inc.'s Motion for Summary Judgment on Plaintiffs' Substantive Antitrust Claims [Doc. 574], DENIES AS MOOT Watson Pharmaceuticals, Inc.'s Motion for Summary Judgment on Plaintiffs' Conspiracy Claims for Lack of Subjective Bad Faith [Doc. 579], GRANTS Solvay Pharmaceuticals, Inc., Unimed Pharmaceuticals, Inc., Abbott Products, Inc., and Watson Pharmaceuticals, Inc.'s Motion for Summary Judgment on Objective Baselessness [Doc. 587], DENIES AS MOOT Solvay Pharmaceuticals, Inc., Unimed Pharmaceuticals, Inc., and Abbott Products, Inc.'s Motion for Summary Judgment on Subjective Bad Faith [Doc. 589], DENIES the Direct Purchaser Plaintiffs' Motion to Exclude Portions of Dr. Norman Weiner's Expert Report [Doc. 598], DENIES the Direct Purchaser Plaintiffs and End-Payor Class Plaintiffs' Motions for Summary Judgment on Sham Litigation [Docs. 603 & 588], and DENIES AS MOOT the Direct Purchaser Plaintiffs' Motion to Strike the Declaration of Joseph A. Mahoney and Limit Dr. Stanley Kaplan's Testimony [Doc. 708].