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Orexigen Therapeutics, Inc. v. Actavis Laboratories FL, Inc.

United States District Court, D. Delaware

October 13, 2017

OREXIGEN THERAPEUTICS, INC., Plaintiff,
v.
ACTAVIS LABORATORIES FL, INC. Defendant.

          Mary B. Graham, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP, Wilmington, DE; Rodger D. Smith II, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP, Wilmington, DE; Stephen J. Kraftschik, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP, Wilmington, DE; Chad J. Peterman, Esq., PAUL HASTINGS LLP, New York, NY; Bruce M. Wexler, Esq., PAUL HASTINGS LLP, New York, NY; Simon F. Kung, Esq., PAUL HASTINGS LLP, New York, NY; Michael F. Werno, Esq., PAUL HASTINGS LLP, New York, NY. Attorneys for Plaintiff.

          Melanie K. Sharp, Esq., YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, DE; James L. Higgins, Esq., YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, DE; Robert M. Vrana, Esq., YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, DE; Scott J. Bornstein, Esq., GREENBERG TRAURIG, LLP, New York, NY; Richard C. Pettus, Esq., GREENBERG TRAURIG, LLP, New York, NY; Jonathan D. Ball, Esq., GREENBERG TRAURIG, LLP, New York, NY; Justin A. MacLean, Esq., GREENBERG TRAURIG, LLP, New York, NY. Attorneys for Defendant.

          TRIAL OPINION

          ANDREWS, U.S. DISTRICT JUDGE.

         Plaintiff brought this patent infringement action on June 3, 2015, alleging that Defendant had infringed seven of Plaintiff s patents by filing Abbreviated New Drug Application ("ANDA") No. 208043 seeking to enter the market with a generic version of Plaintiff s Contrave product. (D.I. 1). On April 15, 2016, Plaintiff filed a First Amended Complaint alleging infringement of four patents. (D.I. 47). Prior to trial, Plaintiff withdrew one of the four patents (see D.I. 182), leaving three patents-in-suit: U.S. Patent Nos. 7, 462, 626 ("the '626 patent"), 7, 375, 111 ("the '111 patent"), and 8, 916, 195 ("the '195 patent"). The Court held a three day bench trial on June 5-7, 2017. (D.I. 178, 179, 180) ("Tr.").

         Plaintiffs Contrave product is approved by the Food and Drug Administration ("FDA") for "chronic weight management in adults" who are obese or overweight and who have "at least one weight-related comorbidity, " such as type 2 diabetes or hypertension. (D.I. 117-1 at 5, ¶ 4). Contrave is formulated as extended-release tablets with the active ingredients naltrexone hydrochloride and bupropion hydrochloride. (Id. ¶ 3).

         Bupropion was first approved by the FDA in 1996 for use as an antidepressant and in 1997 for use in smoking cessation treatment. (Tr. 422:11-13). Bupropion was known to have weight loss effects as early as 1995. (Tr. 422:18-424:11). The efficacy and safety of bupropion for weight loss had been studied extensively prior to 2003, the priority date for the invention claimed in the patents-in-suit. (Tr. 425:10-431:23). Naltrexone is an opioid agonist that is FDA approved for treating drug addiction. (Tr. 432:112-433:10). At least as early as 2002, naltrexone was known to reduce carbohydrate cravings in patients with diabetes. (Tr. 433:21-434:19).

         The '626 patent is directed to methods of treating overweight or obesity using a combination of naltrexone and bupropion. Plaintiff asserts that Defendant induces infringement of dependent claims 2, 15, 26, and 31 of the '626 patent. Claims 2 and 15 depend from independent claim 1, which reads:

1. A method of treating overweight or obesity, comprising diagnosing an individual as suffering from overweight or obesity by determining said individual has a body mass index of at least 25 kg/m2, and treating said overweight or obesity by administering to said individual a first compound and a second compound in order to treat said overweight or obesity, wherein said second compound is bupropion or a pharmaceutically acceptable salt thereof in an amount effective to induce weight loss in said individual, and said first compound is naltrexone or a pharmaceutically acceptable salt thereof in an amount effective to enhance weight loss activity of said bupropion or a pharmaceutically acceptable salt thereof.

('626 patent, claim 1). Dependent claim 2 adds the limitation that the naltrexone and bupropion "are administered together." Dependent claim 15 adds the limitation that the naltrexone and bupropion "are administered in a single oral dosage form."

         Claim 26 depends from independent claim 25, which reads:

25. A method of treating overweight or obesity, comprising administering a weight loss effective amount of a first and second compound to an individual who has been diagnosed as suffering from overweight or obesity in order to treat said overweight or obesity, wherein said first compound is bupropion, or a pharmaceutically acceptable salt thereof, and said second compound is naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the weight loss activity of said first and second compounds is enhanced compared to the administration of the same amount of either compound alone.

('626 patent, claim 25). Claim 26 adds the limitation that the naltrexone and bupropion "are administered together." Asserted claim 31 depends from claim 30, which is not asserted and which depends from claim 25. Claim 30 adds the limitation that the naltrexone and bupropion "are in a sustained-release formulation." Asserted claim 31 adds the limitation that the naltrexone and bupropion "are administered in a single oral dosage form."

         The '111 patent is directed to compositions for use in weight loss treatments comprising a combination of sustained release formulations of bupropion and naltrexone. Plaintiff asserts that Defendant directly infringes claim 1 of the '111 patent. Claim 1 reads:

1. A composition for affecting weight loss comprising:
(a) a sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof in an amount effective to induce weight loss in an individual; and
(b) a sustained release formulation of naltrexone or a pharmaceutically acceptable salt thereof in an amount effective to enhance the weight loss effect of the bupropion or salt thereof; wherein said composition is in a single oral dosage form fixed combination.

('111 patent, claim 1).

         The '195 patent is directed to methods of treating overweight or obesity using a combination of naltrexone and bupropion. Plaintiff asserts that Defendant directly infringes claim 11 of the '195 patent. Claim 11 reads:

11. A method of treating overweight or obesity having reduced adverse effects comprising orally administering daily about 32 mg of naltrexone and about 360 mg of bupropion, or pharmaceutically acceptable salts thereof, to a person in need thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained-release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is administered as a sustained-release formulation, and wherein said sustained-release formulation of naltrexone has an in vitro naltrexone dissolution profile in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37° C. of:
a) between 39% and 70% of naltrexone released in one hour;
b) between 62% and 90% of naltrexone released in two hours; and
c) at least 99% in 8 hours;
wherein about 16 mg of said sustained-release formulation of naltrexone or a pharmaceutically acceptable salt thereof is administered twice daily, and about 180 mg of said sustained-release formulation of bupropion or a pharmaceutically acceptable salt thereof is administered twice daily.

('195 patent, claim 11).

         Defendant contends that it does not infringe any of the asserted claims. Defendant also argues that claim 11 of the '195 patent is invalid for lack of written description and all asserted claims of the '111 and '626 patents are invalid as obvious in view of the prior art.

         I. MOTION TO STRIKE THE GADDE FAX

         Plaintiff moves to strike Defendant's exhibits DTX-48 and DTX-180, a fax sent by Dr. Kishore Gadde to Orexigen on November 19, 2003 ("Gadde Fax" or "Fax"), as inadmissible hearsay. (D.I. 155 at 2). The Fax consists of a table which contains brief descriptions of patients Dr. Gadde treated for obesity in 1997 and 2000. (DTX-180 at GADDE0000010). According to the table, Dr. Gadde treated four patients in 1997 with a combination of fluoxetine and naltrexone and two patients in 2000 with a combination of bupropion and naltrexone. (Id.). Dr. Gadde testified at trial that he prepared the table in 2003 "by reviewing the patient charts." (Tr. 715:16-18, 768:19-21). The original patient charts were not produced as evidence in this case. (D.I. 155 at 3).

         Defendant argues that the Gadde Fax is not hearsay because it qualifies as an adoptive admission under Federal Rule of Evidence 801(d)(2)(B).[1] (D.I. 159 at 2; Tr. 722:10-12). According to Defendant, Plaintiff shared the data in the Gadde Fax with the FDA to help demonstrate safety and efficacy of the combination of bupropion and naltrexone. (D.I. 159 at 2; Tr. 722:12-19). As support for this contention, Defendant produced a clinical study report submitted to the FDA as part of Orexigen's Investigational New Drug ("IND") Application for fluoxetine or bupropion SR in combination with naltrexone. (DTX-154). In relevant part, the report stated, "When naltrexone was added to fluoxetine or bupropion SR therapy, additional weight loss was observed in 2 of 6 patients; no adverse events other than nausea were reported (K Gadde, personal communication)." (DTX-154 at OREXC0748915).

         During trial I found the Gadde Fax to be admissible as an adoptive admission, but allowed the parties to present additional arguments about its admissibility in post-trial briefing. (Tr. 731:1-4). I found that, while "not an absolute certainty, " it was "a fair inference" that the paragraph Defendant pointed to was referring to the chart in the Gadde Fax. (Tr. 730:11-14). I also stated that it seemed clear that the paragraph's reference to additional weight loss referred to patients 2 and 3 on the fax, which are patients who received the fluoxetine/naltrexone combination therapy. (Tr. 728:15-729:2).

         My opinion that the Gadde Fax is admissible as an adoptive admission has not changed. I think there is sufficient detail in the FDA report to support the inference that the "personal communication" referred to was the Fax. I disagree with Plaintiffs contention that this paragraph was merely a reference to the Fax and a repetition of the hearsay contained in the Fax. (D.I. 155 at 5-6). Orexigen presented this information to the FDA in support of its IND Application. I find it difficult to believe Orexigen would have done so if it did not believe in the trustworthiness of the contents of the communication. As to Plaintiffs argument that Defendant must show that each statement in the Fax was separately adopted (D.I. 155 at 7), I think this is satisfied by the statement that "additional weight loss was observed in 2 of 6 patients." It seems to me that this refers to the six patients reported in the Fax and I think the only reasonable interpretation is that the Fax was adopted in its entirety.

         This does not mean, however, that the Gadde Fax is admissible as substantive evidence of anything that Dr. Gadde did in 1997 or 2000. The parties agreed that any allegations of public use by Dr. Gadde in 2000 would be subject to the corroboration requirement for inventor testimony. (Tr. 950:17-23). Defendant stated at trial that the purpose of Dr. Gadde's testimony and the Gadde Fax was not to prove prior use, but to prove secondary considerations, such as motivation to combine. (Tr. 951:13-17). Defendant argued that motivation to combine was not subject to the corroboration requirement. (Tr. 954:17-955:5). As I discuss below, I disagree. The Gadde Fax is not admissible to show that Dr. Gadde treated patients with the combinations of drugs reported in the Fax in 1997 and 2000, or as evidence of anything that occurred prior to the date the Fax was prepared.

         For the foregoing reasons, Plaintiffs Motion to Strike (D.I. 155) is denied. The Gadde Fax is admissible for the limited purpose of showing that Dr. Gadde shared the data reported in the Fax with Orexigen in 2003.

         II. WRITTEN DESCRIPTION

         The written description requirement contained in 35 U.S.C. § 112, ¶ 1 requires that the specification "clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." Ariad Pharm., Inc., v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (alteration in original). "In other words, 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 date." Id. "A party must prove invalidity for lack of written description by clear and convincing evidence." Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682 (Fed. Cir. 2015).

         Defendant argues that claim 11 of the '195 patent is invalid for lack of written description because the ranges given for the claimed dissolution profile "were improperly cobbled together" and were measured using a different method than that required by the claim. (D.I. 162 at 10). Specifically, Defendant argues that the lower bounds of the dissolution ranges at one and two hours recited in the claim were not obtained using the USP Apparatus 2 Paddle Method required by the claim. (Id. at 10). Defendant further argues that there is no evidence in the specification as to which method was used to obtain the 99% dissolution profile stated in the claim for the eight hour range. (Id.). Finally, Defendant argues that the upper bounds of the one and two hour ranges were picked from "a boilerplate paragraph without any sensible reason or industry custom/practice for their random selection." (Id.).

         Plaintiff responds that simply because the claims draw support from different parts of the specification does not mean that a person of ordinary skill would not believe that the inventor was in possession of the invention. (D.I. 164 at 30). Plaintiff also argues that there is no legal requirement that all claim limitations be set out in a single place in the specification. (Id. at 31). Plaintiff points to the prosecution history, which shows the applicant cited to specific portions of the specification as support for claim 11, resulting in a notice of allowance for this claim. (Id.).

         Claim 11 of the '195 patent claims a method of treating overweight or obesity using a sustained released formulation of bupropion and naltrexone. Claim 11 includes the limitation that the naltrexone have a specific dissolution profile measured "in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37°C." The dissolution profile recited requires "a) between 39% and 70% of naltrexone released in one hour; b) between 62% and 90% of naltrexone released in two hours; and c) at least 99% in 8 hours."

         As support for the claimed dissolution profile, Plaintiff points to Table 10 in the specification. (Id. at 32). Table 10 provides dissolution data for naltrexone in one embodiment described in the specification. ('195 patent at 19:60-67). Table 10 indicates that, after one hour, 67%) of naltrexone was released, after two hours, 85% of naltrexone was released, and after 8 hours, 99% of naltrexone was released. ('195 patent at 20:1-10). These values fall squarely within the ranges in claim 11. Defendant argues that this data is not relevant as it was not obtained using the USP Apparatus 2 method. (D.I. 162 at 11). In response, Plaintiff points to a portion of the specification that it argues constitutes a definition of a "standard dissolution test." (D.I. 164 at 32; '195 patent at 6:49:55).

         I agree with Plaintiff that the specification would indicate to a person of ordinary skill that all of the dissolution data reported in the patent was obtained "using Apparatus 2 ... at a spindle rotation speed of 100 rpm and a dissolution medium of water, at 37° C, or other test conditions substantially equivalent thereto." ('195 patent at 6:52-55). Plaintiffs expert, Dr. Treacy, testified that a person of ordinary skill would recognize that the inventors had possession of an embodiment representative of the invention, as described in Table 10. (Tr. 660:21-661:1). Dr. Treacy further testified that a person of ordinary skill "would find reasonable support for the claim limitations in the written description, " specifically the upper and lower limits for each of the ranges. (Tr. 660:12-20). Dr. Treacy also opined that, in the context of the patent, a person of ordinary skill would understand that the inventors had possession of the claimed invention regardless of whether the USP Apparatus 2 method or a "substantially equivalent" method were used. (Tr. 663:3-9).

         Defendant's expert, Dr. Mayersohn, testified at trial that the paddle method and the USP Apparatus 1 basket method were different in that the hydrodynamics were different and that a person of ordinary skill would expect the two methods to yield different results. (Tr. 602:23-604:20). Dr. Mayersohn did not, however, perform any actual tests on the tablets claimed in this patent. (Tr. 640:19-22). Furthermore, in his expert report, Dr. Mayersohn provided an opinion on obviousness for this claim in which he relied on a prior art reference that used the USP Apparatus 1 basket method. (Tr. 637:8-640:13). It seems to me that Dr. Mayersohn's theoretical opinion that the methods would yield different results is at odds with his reliance on a prior art reference using the basket method to argue that claim 11, which specifies the paddle method, was obvious.

         I do not think it matters whether the two methods would yield exactly the same results. I find credible Dr. Treacy's testimony that a person of ordinary skill would understand, in the context of the patent, that the inventors possessed the claimed invention. The embodiments disclosed in a patent are intended to be exemplary and it is clear to me that the inventors possessed at least one embodiment that falls squarely within the claimed ranges, as evidenced by Table 10. Furthermore, Defendant's emphasis on the purported differences between the two methods of measuring dissolution profiles seems to me to be misplaced as even its own expert was willing to favorably compare the two methods when it was to Defendant's benefit to do so. Therefore, whether the dissolution data reported in the specification was obtained using the basket method or the paddle method is not relevant to whether the inventors had possession of the invention.

         Defendant also argues that the lower bounds of the one and two hour ranges lack written description support because they were pulled from Table 5, which reports data on specific embodiments which includes different amounts of the polymer excipient hydroxypropylmethyl cellulose ("HPMC"). (D.I. 162 at 12). Defendant contends that the data from the 15% HPMC formulation was "randomly selected" and "improperly picked from amongst a plethora of other possible options." (Id. at 12-13). I disagree. As Plaintiff points out, claim 11 calls for a "sustained-release formulation." (D.I. 164 at 34). Both Dr. Mayersohn and Dr. Treacy testified that the data from the 5% and 10% HPMC formulations indicated that both were "essentially immediate release" and the 15% formulation was "the first one . . . where you see a sustained release profile." (Tr. 615:6-19, 655:10-17). For this reason, it seems clear that these are appropriate data points to support the claimed lower bounds for the one and two hour ranges.

         Dr. Mayersohn's main criticism of using the data in Table 5 was that there was no eight-hour value and, in his opinion, the data provided indicated that the dissolution profile would plateau and never reach the claimed 99% at eight hours. (Tr. 615:20-616:3). I am not convinced. There is no data provided at all in Table 5 for the dissolution at eight hours. I do not think there is sufficient evidence to support Dr. Mayersohn's plateau theory to a clear and convincing standard for invalidating this patent claim. In contrast, as Plaintiff notes, there is an embodiment reported in Table 10 that has a dissolution profile falling squarely within the claimed ranges. (D.I. 164 at 32).

         Defendant also argues that the inventor did not possess the eight-hour limitation by attempting to characterize this limitation as a range, wherein "at least 99%" necessarily "extends up to and includes 100%." (D.I. 162 at 13). Defendant suggests that to show the inventor possessed the invention, Plaintiff must establish written description support "for the upper end of the claimed range above 99%." (Id. at 15). I disagree. Dr. Treacy opined that "at least 99%" would be understood by a person of ordinary skill to mean "essentially complete dissolution." (Tr. 653:5-12). I find this testimony credible. It seems clear to me that "at least 99%" means "at least 99%" rather than "between 99% and 100%." I think it is sufficient that the inventors showed possession by disclosing an embodiment that falls squarely within all of the claimed ranges, including "at least 99%" at eight hours.

         Defendant also criticizes the upper bounds of the one and two hour ranges as lacking written description support because these bounds come from "a boilerplate paragraph containing multiple theoretical ranges." (D.I. 162 at 14). As an initial matter, there is no definitive evidence that these ranges were "theoretical." More importantly, I see nothing odd or invalidating about the inventors looking to different tables of dissolution data and other places in the specification to determine the ranges for the claimed dissolution profile. A single test on a single tablet could provide only a single data point at each time; rather, multiple tests are necessarily required to establish a range.

         Defendant suggests that all of the purported shortcomings it has identified in the disclosure of the claimed ranges necessarily lead to the conclusion that the patent fails to provide "blazemarks" that would direct a person of ordinary skill to select those specific bounds. (D.I. 162 at 15). The cases Defendant cites to support for this failure do not support its position. (Id. at 9). Most of Defendant's cases dealt with situations where an inventor had disclosed a large genus of possible compounds. Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) ("simply describing a large genus of compounds is not sufficient to satisfy the written description requirement as to particular species or sub-genuses"); Boston Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1367 (Fed. Cir. 2011) (finding lack of written description where patent claimed "rapamycin or a macrocyclic triene analog thereof but specification "fail[ed] to disclose even a single member of either the genus of 'analogs' of rapamycin, or the more specific genus of 'macrocyclic triene analogs' of rapamycin"); In re Ruschig, 379 F.2d 990, 994 (C.C.P.A. 1967) (finding lack of written description where disclosure of genus encompassed "half million compounds within the scope of the broadest claim"). The instant case is not one of an inventor disclosing a large genus without any disclosure that certain of the species within the genus are preferred. I hold that Defendant has not proven by clear and convincing evidence that claim 11 of the '195 patent is invalid for lack of written description.

         III. OBVIOUSNESS

         Defendant argues that claims 26 and 31 of the '626 patent and claim 1 of the '111 patent are invalid as obvious over the prior art.[2] (D.I. 162 at 22, 27-28). Specifically, Defendant argues that a person of ordinary skill in the art would have been motivated to combine the teachings of the Jain and O'Malley references to administer the combination of naltrexone and bupropion for treating overweight and obesity with a reasonable expectation of success. (Id. at 28).

         A. Legal Standard

         A patent claim is invalid as obvious "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." 35 U.S.C. § 103; see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406-07 (2007). The determination of obviousness is a question of law with underlying factual findings. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1359-60 (Fed. Cir. 2012). "The underlying factual inquiries include (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the art; and (4) any relevant secondary considerations .. . ." Western Union Co. v. MoneyGram Payment Sys., Inc., 626 F.3d 1361, 1370 (Fed. Cir. 2010) (citing Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)).

         A court is required to consider secondary considerations, or objective indicia of nonobviousness, before reaching an obviousness determination, as a "check against hindsight bias." See In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1078-79 (Fed. Cir. 2012). Relevant secondary considerations include commercial success, long felt but unsolved needs, failure of others, praise, unexpected results, and copying, among others. Graham, 383 U.S. at 17-18; Ruiz v. A.B. Chance Co., 234 F.3d 654, 662-63 (Fed. Cir. 2000); Tex. Instruments, Inc. v. U.S. Int'l Trade Comm'n, 988 F.2d 1165, 1178 (Fed. Cir. 1993). Secondary considerations of nonobviousness are important because they "serve as insurance against the insidious attraction of the siren hindsight...." W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983).

         A patentee is not required to present evidence of secondary considerations. See Prometheus Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1101 (Fed. Cir. 2015). That said, if the patent challenger establishes a prima facie case of obviousness, "the patentee would be well advised to introduce evidence sufficient to rebut that of the challenger." Id. (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1360 (Fed. Cir. 2007)). There must be enough evidence, however, for a finding that a given secondary consideration exists by a preponderance of the evidence. See Apple, Inc. v. Samsung Elec. Co., Ltd., 839 F.3d 1034, 1053 (Fed. Cir. 2016) (en banc). If there is, then the probative value of each secondary consideration will be considered in light of the evidence produced. That does not mean, though, that the burden of persuasion on the ultimate question of obviousness transfers to the proponent of the secondary consideration. Pfizer, Inc., 480 F.3d at 1359. That burden stays always with the patent challenger. Id. at 1359- 60.

         A party asserting that a patent is invalid as obvious must "show by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so." Pfizer, Inc. v. Apotex, Inc.,480 F.3d 1348, 1361 (Fed. Cir. 2007). That "expectation of success need only be reasonable, not absolute." Id. at 1364. "Whether an ordinarily skilled artisan would have reasonably expected success .... is ...


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