Gregory M. Sleet, UNITED STATES DISTRICT JUDGE.
In this patent infringement action, plaintiffs Pfizer Inc., Pharmacia & Upjohn Company, Pharmacia & Upjohn Company LLC, Sugen, Inc., C.P. Pharmaceuticals International C.V., Pfizer Pharmaceuticals LLC, and PF Prism C.V. (collectively, "Pfizer") allege that pharmaceutical products proposed by defendant Mylan Pharmaceuticals Inc. ("Mylan") infringe the asserted claims of the patents-in-suit. (D.I.1.) The court held a four-day bench trial in this matter on November 26 through November 29, 2012. (D.I.148-151.) Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning the validity of the patents-in-suit, specifically whether the asserted claims are invalid as obvious under 35 U.S.C. § 103. (D.I.152, 153.)
Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire record in this case and the applicable law, the court concludes that: (1) all asserted claims of the patents-in-suit are not invalid due to obviousness; and (2) Pfizer's Rule 52(c) motion is granted, and Mylan's Rule 52(c) motion is denied. These findings of fact and conclusions of law are set forth in further detail below.
The court has subject matter jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331, 1338, and 2201. Venue is proper in this court under 28 U.S.C. §§ 1391 and 1400(b). The only issue remaining is whether the asserted claims of the patents-in-suit are invalid due to obviousness. After having considered the entire record in this case, the substantial evidence in the record, the parties' post-trial submissions, and the applicable law, the court concludes that: (1) none of asserted claims of the patents-in-suit are invalid due to obviousness; and (2) Pfizer's Rule 52(c) motion is granted, and Mylan's Rule 52(c) motion is denied. The court's reasoning follows.
The defendants challenge the validity of each of the asserted claims, arguing that they are obvious in light of the prior art. The court finds, for the reasons that follow, that the defendants have failed to establish by clear and convincing evidence that the patents-in-suit are obvious.
35 U.S.C. § 103(a) provides that a patent may not be obtained "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 to a person having ordinary skill in the art." 35 U.S.C. § 103(a).
"A patent shall be presumed valid." 35 U.S.C. § 282. A party seeking to challenge the validity of a patent based on obviousness must demonstrate by "clear and convincing evidence"
"Obviousness does not require absolute predictability of success," but rather, requires "a reasonable expectation of success." See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed.Cir. 2006) (quoting In re O'Farrell, 853 F.2d 894, 903-04 (Fed.Cir.1988)). To this end, obviousness "cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed.Cir.2007). Moreover, while the Federal Circuit has noted that pharmaceuticals can be an "unpredictable art" to the extent that results may be unexpected, it also recognizes that, per KSR, evidence of a "finite number of identified, predictable solutions" or alternatives "might support an inference of obviousness." See Eisai Co. Ltd. v. Dr. Reddy's Labs. Ltd., 533 F.3d 1353, 1359 (Fed.Cir.2008).
A person of ordinary skill in the art with respect to the patents-in-suit would have: (1) the skills of a Ph.D.-educated medicinal chemist, with knowledge and experience regarding kinase targets and chemical scaffolds as they relate to anti-angiogenesis drugs;
Although there are four asserted claims in the patents-in-suit, the controlling question for each of the claims is whether synthesizing sunitinib malate would have been obvious to one skilled in the art as of the priority date. Mylan argues that the asserted claims are obvious for two reasons: (1) a nearly identical analog of sunitinib was disclosed in Patent Application WO 99/61422 ("the '422 application"); and (2) the lead compounds available as of the priority date would have motivated one skilled in the art to derive the claimed sunitinib malate. The court addresses each of these arguments in turn.
Mylan argues that the '422 Application discloses a "generic preparation" for a "large number of potential oxindoles," among which is a structurally similar analog of sunitinib: dimethyl sunitinib.
Mylan relies on Merck & Co. v. Biocraft Laboratories, Inc. for this proposition. 874 F.2d 804 (Fed.Cir.1989). In Merck, the Federal Circuit distinguished between compounds that are merely "obvious to try" — which are not barred by § 103 — versus compounds with an expectation of success, i.e., compounds that will work for their intended purpose. Id. at 807. When a prior art reference lists a number of combinations, all of which should achieve the desired result, "routine" alterations or optimization will not preclude a finding of obviousness. Id. at 809.
The court finds, however, that Mylan's reliance on Merck goes too far. In Merck, the prior art reference disclosed individual diuretic agents that could be co-administered to achieve the desired properties. Id. at 807. The Federal Circuit found the patent-in-suit obvious in light of the prior art reference because the patentee had merely followed the instructions and optimized the dosage levels. Id. at 808-09. Similarly, in Mylan's other cited case, the claimed compound was simply a salt form of one of the compounds disclosed in the prior art, a step which was in fact suggested by the prior art reference. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1367 (Fed.Cir.2007) ("[T]he prior art provided not only the means of creating acid addition salts but also predicted the results, which Pfizer merely had to verify through routine testing.") The court is not convinced that the steps needed to go from
Pfizer and Mylan both provide a list of "lead" compounds — compounds known in the art that would have served as logical "starting points[] for further development efforts." See Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1291 (Fed. Cir.2012); see also Takeda, 492 F.3d at 1357-60. To establish a prima facie case of obviousness, Mylan must first establish that one skilled in the art would have selected a given lead compound. See Takeda, 492 F.3d at 1360; Eli Lilly & Co. v. Zenith Goldline Pharm., Inc., 471 F.3d 1369 (Fed.Cir.2006). If one skilled in the art would have chosen the lead, Mylan must then prove that modification of the lead compound to arrive at the claimed compound would have been obvious to one skilled in the art. Takeda, 492 F.3d at 1360-63.
Pfizer argues that its proffered leads — Compounds 11f, 9a, and 9b; SU6668; PTK-787; ZD 4190; PD-74 and PD-85 — take into account the entire state of the art, including compounds developed by other companies, and best illustrate trends in anti-angiogenesis research at the time. (D.I. 153 at 4-6; Tr. at 321-25 (Lydon).) Compounds 11f, 9a, and 9b were Sugen's "second-generation" oxindole compounds, developed on the heels of SU5416, which had gone to clinical trials with mixed success. (D.I. 153 at 4-5.) Sugen believed these second-generation compounds would overcome the shortcomings of SU5416; in particular, these second-generation compounds improved VEGFR potency and addressed solubility and oral bioavailability problems. (Id.) Based on Sugen's structural-activity relationship research, each of these compounds incorporated a propionic acid group on the pyrrole ring, which Sugen believed was "required" for potency. (Id.; JTX-113 at 7; Tr. at 648(Sun).)
Pfizer next highlights SU6668 as a possible lead. (D.I. 153 at 5.) SU6668 was Sugen's second-generation clinical candidate.
Finally, Pfizer provides several non-oxindole compounds that were developed by competitor companies to address angiogenesis in tumors. (D.I. 153 at 5-6.) PTK-7878 (developed by Novartis), ZD 4190 (developed by AstraZeneca), and PD-75 and PD-85 (developed by Parke-Davis) all showed notable improvements over SU5416. (Id.) Given the apparent success of these compounds, Pfizer argues that one skilled in the art would not have limited the scope of potential leads to only oxindole compounds.
In contrast, Mylan proposes three possible lead compounds: SU5416, SU5408, and dimethyl sunitibin. As already noted, SU5416 was Sugen's first-generation compound and the first small molecule demonstrating RTK inhibition to reach clinical trials. (D.I. 152 at 8-9.) Mylan argues that Sugen itself had used SU5416 as a scaffold in developing other possible formulations, including SU6668, thus confirming its status as a lead compound, notwithstanding its oral bioavailability and metabolism concerns. (Id. at 10)
Mylan also lists SU5408 as a possible lead compound. (Id. at 10.) SU5408 was another first-generation compound, structurally similar to both SU5416 and SU6668. It demonstrated strong VEGF potency, and its electronic-withdrawing ethyl ester group at C-4' position of the pyrrole ring would have helped reduce metabolism in the body. (Id. at 11.) Mylan argues that one skilled in the art would have recognized the promising base properties of SU5408 and would have modified it to achieve additional improvements. (Id.)
Finally Mylan suggests one skilled in the part would have selected dimethyl sunitinib as a lead compound. (Id. at 11-12.) As noted above, this compound is drawn from the '422 Application, which provided a list of oxindoles and aldehydes that could be combined to create a possible RTK inhibitor. (Id.; Tr. at 158-59 (Denny).) The list provides for approximately 1200 distinct combinations. Mylan argues that dimethyl sunitinib would have been selected as a lead compound from among the various possible combinations contemplated by the '422 Application because of the common core structure it shared with SU5416 and SU6668, and also because it would have addressed the metabolism and solubilization problems. (D.I. 152 at 12.)
Mylan bears the burden in proving that one skilled in the art would have considered its proposed lead compounds. See Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc., 923 F.Supp.2d 602, 654 (D.Del.2013). To avoid the possibility of hindsight bias, "the patent challenger must point to more than mere structural similarity as a reason to select a compound as a lead." Id. (citing Daiichi Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346, 1354 (Fed.Cir.2010). Moreover, even if the compounds Mylan suggests are shown to be viable leads, Mylan must then establish that one skilled in the art would have found it obvious to modify the lead compounds to arrive ultimately at claimed compound: sunitinib malate. After considering the parties' submissions and the evidence on the record, the court is not
The court finds that, although SU5416 represented a breakthrough in anti-angiogenesis cancer treatment at the time it was first disclosed, as of the priority date in October 2000, one skilled in the art would have acknowledged its shortcomings and looked to more recent advances in the field. Sugen published its SU5416 data in 1998, but already by 1999 Sugen had published research on second-generation compounds that addressed SU5416's lack of oral bioavailability. By October 2000, SU6668 had also reached clinical trials and demonstrated improvements over SU5416 in several respects. (Tr. at 383 (Lydon).) Sugen's publications disclosed that the presence of a propionic acid group was a necessary element for potency, and therefore taught away from SU5416, which lacked a propionic acid group. In considering lead compounds, one skilled in the art would not ignore these teachings and discount the improvements and progress that had been made in the field in favor of SU5416, simply because it was first. The art had advanced beyond SU5416 by October 2000. The court concludes one skilled in the art would not have chosen SU5416 as a lead compound.
The court finds that SU5408 also would not have been selected by one skilled in the art as a lead compound. Mylan's choice of SU5408 as a lead compound appears largely the result of hindsight. SU5408, like SU5416, was one of Sugen's first-generation compounds. Although it demonstrated strong potency against VEGF in vitro, there is no in vivo data available for SU5408; indeed Mylan's expert Dr. Denny acknowledged that "[v]ery little work was done with SU5408." (Tr. at 207 (Denny).) Mylan once again relies on a snapshot of the state of the art as it existed in 1998 when Sugen disclosed its first-generation compounds. (Tr. at 151 (Denny).) But as already stated, the field moved forward, and one skilled in the art would have kept pace with such progress in selecting lead compounds. Whereas SU5416 at least made it to clinical trials and yielded significant data, SU5408 never made it out of the lab. The data are very limited. One skilled in the art would not have had any particular motivation for selecting SU5408, especially in light of the second-generation compounds and their much more promising and complete data, which was widely available as of October 2000.
Finally Mylan argues that dimethyl sunitinib — a hypothetical compound listed as one of approximately 1200 possible combinations in the '422 Application — would have been a lead compound for one skilled in the art. The court finds that Mylan's choice of dimethyl sunitinib as a lead compound cannot be characterized by anything other than hindsight bias. The compound, which is referred to here as dimethyl sunitinib only for the sake of convenience, had no name, had no chemical structure, had never actually been synthesized, and of course had no data demonstrating its properties. The only hint that this compound could exist came from the '422 Application's list of components, and there was nothing to suggest that this particular combination would yield promising results as a lead. (Tr. at 201-02 (Denny).) Dr. Denny's choice of dimethyl sunitinib as a lead was informed by a "logic chain." (Id. at 202-03.) The court finds, however, that one skilled in the art would not have ignored actual, synthesized compounds
In the previous discussion, the court explained that the claimed sunitinib malate is not obvious in light dimethyl sunitinib because more than routine optimization would have been needed to achieve the claimed compound. Similarly, the court now concludes that, under a lead compound analysis, one skilled in the art also would not have chosen dimethyl sunitinib as a lead compound. As quoted above, "the patent challenger must point to more than mere structural similarity as a reason to select a compound as a lead." Bristol-Myers Squibb, 923 F.Supp.2d at 654. The court is not persuaded by Dr. Denny's "logic chain" rationale that resulted in selecting the almost identical structural analog of sunitinib malate. The court concludes that this post-hoc reconstruction of events is entirely informed by hindsight bias.
Even accepting Mylan's choices as lead compounds, the court finds that Mylan has not established by clear and convincing evidence that modifying the leads to yield sunitinib malate would have been obvious to one skilled in the art or that one skilled in the art would have had a reasonable expectation of success. See Daiichi Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346, 1352 (Fed.Cir.2010) ("Proof of obviousness based on structural similarity requires clear and convincing evidence that a medicinal chemist of ordinary skill would have been motivated to select and then to modify a prior art compound (e.g., a lead compound) to arrive at a claimed compound with a reasonable expectation that the new compound would have similar or improved properties compared with the old." (emphasis added)).
To obtain sunitinib from dimethyl sunitinib, one skilled in the art only would have had to replace the dimethylamine solubilizing group with a diethylamine group. The court is not convinced, however, that even this single modification would have been obvious. Dr. Denny's testimony confirmed that a diethylamine group was similarly susceptible to the problem of dealkylation as a dimethylene group. (Tr. at 258 (Denny).) And Pfizer's expert Dr. Stafford testified that one skilled in art — if faced with a dealkyation problem (referred to as "demethylation" in his testimony) — would not have turned to a diethylamine group for the solution. (Tr. at 538-39 (Stafford).) Rather, several other structural changes, such as creating a cyclic version, would have been appealing next steps. (Id. at 539.) The court is not convinced that one skilled in the art — assuming dealkylation were recognized as a problem at all — would have expected the addition of diethylamine to solve the apparent problem.
As for SU5416 and SU5408, both require several sequential modifications to arrive at sunitinib. The modification chain is largely the same for both except than one additional step is needed initially to modify SU5416 to create SU5048. This first step requires adding an electron-withdrawing ester to the pyrrole ring of SU5416. Dr. Denny argues that one skilled in the art would have found it obvious to lower the electron density of the pyrrole ring (by introducing an electron-withdrawing group) in order to improve activity and reduce metabolism. (Tr. at 164 (Denny).) The court disagrees with this conclusion. First, the statement is contrary to the Sugen's explicit teachings that propionic acid, an electron-donating group, was "required" for high potency. (JTX 113 at 7.) One skilled in the art would not discount data published by the very researchers working with SU5416. Second, one skilled in the art would not have modified a relatively successful compound
In addition, the court finds Mylan also fails to show that the remaining modifications from SU5408 to sunitinib would have been obvious. Dr. Denny maintains that one skilled in the art would have replaced the C-5 hydrogen with fluorine to reduce metabolism of the oxindole. (Tr. at 174-75 (Denny).) But both Dr. Denny and Dr. Stafford testified that there were no data available for any oxindole compound with fluorine at the C-5 position. (Tr. 254-55 (Denny); Tr. at 510 (Stafford).) Moreover, it is not clear that metabolism at the C-5 position presented a major problem that required a substitution; after all, in its next clinical candidate, SU6668, Sugen made no substitution to the C-5 position. (Tr. at 503-504 (Stafford).) Even assuming that metabolism was a problem to be addressed, the court is not convinced that choosing fluorine to do so would have been an obvious modification to one skilled in the art, as opposed to any other blocking group placed at the C-5 position. (Id. at 556-57.) Mylan only points to the dimethyl sunitinib to support its assertion that a fluorine at the C-5 position would have been an obvious modification; the court is not persuaded that this hypothetical compound in the '422 Application that had never been synthesized is sufficient to render the modification obvious.
Mylan next argues that replacing the ester at the C-4' position with an amide would have been obvious in order to increase stability because of the potential for ester hydrolysis in the bloodstream and liver. (Tr. 153-54 (Denny).) In the context of SU5416, this would require substituting the ester that had just been added in the previous step with an amide, an exercise that defies logic. But even in the SU5408 scenario, the court is not convinced that such a substitution would have been obvious. Many successful drugs have esters, and it would be very difficult to predict whether ester hydrolysis would pose a problem for any particular compound without test data. (Tr. at 482-83 (Stafford).) As noted above, there was no in vivo data for SU5408 to prompt one skilled in the art to worry about ester hydrolysis.
Mylan next contends that after substituting the amide, one skilled in the art would have appended an additional solubilizing group to the C-4' amide in order improve solubility. (Tr. at 167 (Denny).) Dr. Denny testified that a diethylamine would have been the obvious choice because amides were generally preferred over acid solubilizing groups and diethylamine groups were commonly used for this purpose. (Id. at 165-67, 171.) But again, Mylan fails to establish that one skilled in the art would have assumed there to be a solubility problem in the first place. Dr. Stafford's testimony reveals that theoretical solubility of the unmodified compound would have fallen within the acceptable range. (Tr. at 490-91 (Stafford).) The court finds that, without data demonstrating a solubility concern, one skilled in the art would have had no reason (and therefore it was not obvious) to add a solubilizing amide. See Takeda, 492 F.3d at 1356-57. Moreover, even if one skilled in the art were motivated to address solubility, the court finds that the natural choice would have been to use propionic acid, as taught by Sugen's publications. Dr. Denny acknowledged that acid solubilizing agents could be equally if not more effective than base agents in some cases. (Tr. at 249 (Denny).) The court is not convinced that that one skilled in the art would have found it obvious to select this particular amide side chain as opposed to
For attaching the diethylamine solubilizing side chain to the C-4' amide, Mylan argues a two-carbon linker would have been used because it was the minimal stable linker length between the two nitrogens, and it was the most conservative change. (Tr. at 174 (Denny).) But Dr. Denny also testified that the length of the carbon linkage could affect the potency of the compound. (Id. at 248.) One skilled in the art would not have arbitrarily chosen a two-carbon chain because it was the most conservative. Rather, one skilled in the art would have looked to test data to determine the optimal linker length to maximize activity. The court finds that, without any data, there was no reason for one skilled in the art to assume two carbons was the obvious length for the linkage, and there was no way of having a reasonable expectation of success.
The last required modification for each of Mylan's proposed lead compounds — SU5416, SU5408, and dimethyl sunitinib — is to create the malate salt form of sunitinib. The court finds that one skilled in the art would not have found this particular salt form obvious. Assuming one skilled in the art would have been motivated to try a sunitinib salt, there is no explanation for why one skilled in the art would have found malate to be an obvious choice. Dr. Denny testified that in his salt selection experience, he would limit tests to three or four options, and never had he selected malate. (Tr. at 261 (Denny).) He confirmed that malate is one of the rarest salts in pharmaceutical compounds. (Id.) Despite this testimony, Mylan asserts that selecting malate would have been the result of routine optimization. The court finds that Mylan misinterprets the case law on this topic. As discussed briefly in the previous section, Mylan's reliance on Pfizer is misplaced. 480 F.3d 1348. In Pfizer, the Federal Circuit held that the patentee's creation of an acid salt was obvious because it was the result of "routine testing." Id. at 1367. But the court was careful to emphasize that its holding was based on the "particularized facts of this case" because the prior art had specifically "predicted the results." Id. (emphasis in original). Here, unlike in Pfizer, there was nothing in the prior art to suggest to one skilled in the art that malate was one of a limited subset of salts to choose, or even that a salt form of sunitinib would be beneficial.
The court has already explained that Mylan's choice of lead compound would not have been selected by one skilled in the art. Nonetheless, the court also concludes that the requisite modifications needed to go from the lead compounds to sunitinib malate would not have been obvious to one skilled in the art.
Pfizer contends that Mylan has failed to make a prima facie showing of obviousness under § 103, or, in the alternative, that the secondary considerations of non-obviousness rebut Mylan's prima facie showing. See Graham, 383 U.S. at 17-18, 86 S.Ct. 684. The court has found that Mylan failed to establish a prima facie case of obviousness. Assuming Mylan had satisfied its initial burden, however, the court finds that Pfizer's secondary considerations — unexpected properties, long-felt need, failure of others, commercial success, skepticism, and acceptance and praise — support a determination of non-obviousness.
The court agrees that the claimed compounds, including sunitinib, possessed unexpected properties, thus weighing in favor of a non-obviousness finding. First, the activity of sunitinib compared with the previous clinical candidates, SU5416 and SU6668, was "certainly much more potent" against each of the target RTKs in vitro. (Tr. at 267 (Denny); Tr. at 542 (Stafford).) Considering that sunitinib was synthesized with entirely different goals in mind, the court finds its significant activity to be unexpected. (Tr. at 667-670 (Sun).)
Moreover, the malate salt form of sunitinib solved several manufacturing problems that posed a major barrier to bringing sunitinib to market. (Tr. at 695 (Myerson).) Malate was not among the initial screen of salts. (Id. at 691-92.) None of the salts from this screen were selected. (Id. at 691.) Researchers, however, discovered that the freebase sunitinib possessed "terrible filtration and drying properties," which persuaded them to do an additional salt screen. (Id. at 692.) For this second screen, malate was chosen "just for kicks," and it turned out that sunitinib malate had superior properties across the board compared to other salts; such properties made it possible to commercialize sunitinib. (Id. at 695-96.) The court finds that one skilled in the art would not have expected sunitinib malate to outperform the other salts in all categories.
The court also agrees that sunitinib malate satisfied a long-felt need in the market for treatments for renal cell carcinoma ("RCC") and pancreatic neuroendocrine tumors ("PNET"). See Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed.Cir.2009). This need was caused largely by frequent failures of others to develop an effective treatment for these cancers. (Tr. at 724 (Bukowski) ("[I]f you want to show a new drug to fail, test it in kidney cancer.")) There is no question that others, including Sugent, had tried to address the question of anti-angiogenesis and failed. (Tr. at 544 (Stafford).) The evidence demonstrated that sunitinib malate provided greatly improved clinical outcomes for RCC patients, and represented a "huge paradigm shift" for the treatment of PNET. (PTX-524 at 1; Tr. at 742-43 (Bukowski); (Tr. at 790-93 (Kulke)). The court finds that, even with the competing drugs available, sunitinib malate satisfied a long-felt need in the treatment of these cancers. (Tr. at 721-24; 730 (Bukowski).)
Pfizer and Mylan presented competing experts who testified as to whether Sutent®, Pfizer's brand-name embodiment of sunitinib malate, has been a commercial success. The court finds that Sutent® has indeed been a commercial success. The court notes initially that any success Sutent® has had — whatever it may be — is attributable to the active, claimed compound, sunitinib malate, and not marketing. See Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392-93 (Fed.Cir.1988) ("A prima facie case of nexus is generally made out when the patentee shows both that there is commercial success, and that the thing (product or method) that is commercially successful is the invention disclosed and claimed in the patent.") Mylan has not rebutted this presumption.
Although the parties presented directly opposing evidence, the court finds Pfizer's testimony was the more compelling. Sutent® remains the dominant drug for RCC treatment, maintaining nearly fifty percent of the market six years after its launch, with almost twice as much market share as the nearest competitor.
Evidence of both initial skepticism and subsequent acceptance and praise after patenting are probative factors for evaluating non-obviousness. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1367-68 (Fed.Cir.2012). In this case, the court finds these factors also weigh toward a finding of non-obviousness. Several prior failed attempts at creating an effective anti-angiogenesis drug created a general sense of skepticism as to whether the concept could work in practice. See OSI Pharm., Inc. v. Mylan Pharm. Inc., 858 F.Supp.2d 341 (D.Del.2012) (noting the "almost insurmountable failure rate for new drug candidates" in evaluating skepticism). Moreover, Pfizer has presented convincing evidence that Sutent® was a breakthrough in the industry, widely praised by researchers and doctors. (PTX-524; PTX-505; Tr. at 746-47 (Bukowski); Tr. at 791 (Kulke).) "Substantial industry praise" is compelling evidence of non-obviousness. See Crocs., Inc. v. ITC, 598 F.3d 1294, 1311 (Fed.Cir.2010).
In sum, Mylan has failed to present a prima facie case that the asserted claims of the patents-in-suit are invalid as obvious. Moreover, even assuming a prima facie case had been made, the court finds that the secondary, objective indicia point towards a finding of non-obviousness. The asserted claims are not invalid as obvious.
For the reasons stated above, the court concludes that: (1) none of the asserted claims of the patents-in-suit are invalid due to obviousness; (2) Pfizer's Rule 52(c) motion is granted, and Mylan's Rule 52(c) motion is denied.
At Wilmington this 22
1. The asserted claims of the patents-in-suit are not invalid due to obviousness;
2. Plaintiffs' Rule 52(c) motion (D.I. 153) is GRANTED;
3. Defendant's Rule 52(c) motion (D.I. 152) is DENIED;
4. The Clerk of Court is directed to enter final judgment in favor of the plaintiffs.
The court's findings of fact with respect to matters that were the subject of dispute between the parties are included in Part III this opinion ("Discussion and Conclusions of Law"), preceded by the phrase "the court finds" or "the court concludes."
