MEMORANDUM ORDER

CHRISTOPHER J. BURKE, Magistrate Judge.

On April 2, 2019, the parties in these consolidated Hatch-Waxman actions filed a "Motion for Teleconference to Resolve Discovery Dispute" ("Motion") regarding their various requests that: (1) certain material be stricken from the parties' expert reports; and (2) the parties be precluded from raising the stricken subject matter at trial.1 (D.I. 391) In this Memorandum Order, the Court considers the portion of Defendants Sawai Pharmaceutical Co., Ltd., Sawai USA Inc. (together with Sawai Pharmaceutical Co. Ltd., "Sawai"), Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd.'s (together with Zydus Pharmaceuticals (USA) Inc., "Zydus") (collectively, Defendants") Motion relating to their request to strike Plaintiffs Astellas Pharma Inc., Astellas Ireland Co., Ltd. and Astellas Pharma Global Development, Inc.'s (collectively, "Astellas" or "Plaintiffs") expert opinions on secondary considerations of non-obviousness ("SC").2 (D.I. 392 at 1-3; D.I. 409 at 1-3) With respect to this issue,3 the Court has considered the parties' letter briefs, (D.I. 392, 399, 409), and the parties' arguments made during the April 17, 2019 telephonic argument, (D.I. 420 (hereinafter, "Tr.")).4

I. LEGAL STANDARD

Federal Rule of Civil Procedure 37(c)(1) provides that "[i]f a party fails to provide information . . . as required by Rule 26[ ](e), the party is not allowed to use that information . . . to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless." In considering whether to exclude evidence relating to an untimely or otherwise improper disclosure, the United States Court of Appeals for the Third Circuit has directed district courts to weigh certain factors, known as "the Pennypack factors": (1) the surprise or prejudice to the moving party; (2) the ability of the moving party to cure any such prejudice; (3) the extent to which allowing the testimony would disrupt the order and efficiency of trial; (4) bad faith or willfulness in failing to comply; and (5) the importance of the testimony sought to be excluded. See Meyers v. Pennypack Woods Home Ownership Ass'n, 559 F.2d 894, 904-05 (3d Cir. 1977), overruled on other grounds, Goodman v. Lukens Steel Co., 777 F.2d 113 (3d Cir. 1985); see also Konstantopoulos v. Westvaco Corp., 112 F.3d 710, 719 (3d Cir. 1997). Because "[t]he exclusion of critical evidence is an extreme sanction," the Third Circuit has explained that it should be reserved for circumstances amounting to "willful deception or flagrant disregard of a court order by the proponent of the evidence." In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 791-92 (3d Cir. 1994) (internal quotation marks and citations omitted).

II. DISCUSSION

The present dispute relating to SC is a "continuation" of a previous discovery dispute addressed by the Court in October 2018. (D.I. 392 at 1) In connection with that previous discovery dispute, Sawai sought to strike Plaintiffs' Second Supplemental Response to Defendants' Interrogatory No. 14, in which Plaintiffs had belatedly provided, for the first time, meaningful articulations of their contentions regarding SC. (See D.I. 346 at 1-3)5 In an October 24, 2018 Memorandum Order (the "October 2018 Order"), the Court ruled on the dispute as follows:

(Id. at 5) The Court further permitted Sawai to take "targeted discovery relating to secondary considerations." (Id.)

Now, Defendants assert that Plaintiffs have violated the October 2018 Order by including "new details, evidence, and theories" relating to SC (i.e., beyond the content found in Plaintiffs' Third Supplement) in four rebuttal expert reports served in February 2019.7 (D.I. 392 at 1) Accordingly, Defendants argue that "the entire issue of SC" should be excluded from this case. (Id. at 3 (emphasis omitted)) Alternatively, if the Court finds that SC in its entirety should not be excluded, Defendants seek to strike the portions of the rebuttal expert reports that raise new SC theories, arguments and evidence beyond the Third Supplement. (Id. at 3 n.15) Specifically, Defendants list out six SC8 for which Plaintiffs' experts purportedly included new details, evidence and theories beyond that set out in the Third Supplement. (Id. at 1-2) For each of these, Defendants also cite to the relevant page number(s) of the Third Supplement and the paragraphs of the various expert rebuttal reports purportedly containing new content beyond that found in the Third Supplement. (Id. at 1-2 & nn. 5-10)

Plaintiffs, for their part, respond that their experts offered opinions on SC "consistent with what was fairly raised" in the Third Supplement. (D.I. 399 at 2) Beyond that, they contend that many of the objected-to paragraphs of their experts' reports were not limited to SC, but were "in direct response to Defendants' experts' alleged prima facie obviousness or nonenablement analyses[.]" (Id. at 3) The October 2018 Order did not preclude Plaintiffs' experts from rebutting Defendants' experts' invalidity opinions set out in their opening reports, and Plaintiffs therefore assert that such rebuttal opinions and evidence are proper. (Id.)

The Court will take up each of the six SC highlighted by Defendants in turn.9

A. Teaching Away

Defendants first assert that Plaintiffs violated the October 2018 Order by including new content in their experts' reports relating to the "supposed `teaching away' of references other than [Plaintiffs' United States Patent No. 6,346,532 B1 (the "'532 patent")] mentioned in the [Third] Supplement[.]" (D.I. 392 at 1 & n.5)10 The Court does not agree.

In the Third Supplement, Plaintiffs first take up teaching away with respect to the '117 and '049 patents. For those patents, Plaintiffs assert that had a person of ordinary skill in the art ("POSA") been motivated to develop a mirabegron drug product, the POSA would have been motivated to use the dihydrochloride crystal form of mirabegron disclosed in the '532 patent, not the crystalline free base form of mirabegron recited in the '117 and '049 patents. (D.I. 394, ex. H (hereinafter, "Third Supp.") at 30) In the next paragraph, Plaintiffs argue that:

(Id.) Plaintiffs do not cite to any materials in support of this statement.

Turning to the four paragraphs of Dr. Michel's report called out by Defendants, (D.I. 392 at 1 n.5 (citing D.I. 394, ex. C at ¶¶ 190-94)), they discuss how the prior art taught away from the potential use of β3 AR agonists to treat OAB. Dr. Michel contends that a key concern "would have been cardiovascular side effects, most importantly an increased heart rate" as well as muscular tremors, and he cites to various references in support. (D.I. 394, ex. C at ¶¶ 191-94)

The Court finds that such content was "fairly raised" in the Third Supplement. (See D.I. 399 at 2) When pressed during telephonic argument as to why the objected-to paragraphs of Dr. Michel's report go beyond the content of the Third Supplement, Sawai's counsel noted that Dr. Michel "relies on a bunch of new evidence that was not cited to us." (Tr. at 59) Defendants' understanding of the Third Supplement had been that Plaintiffs were relying therein only on the '532 patent as support for the teaching away argument relating to the '474 and '872 patents. Defendants thus say they were surprised to see the "many articles" referenced in the relevant paragraphs of Dr. Michel's report. (Id. at 61-62) In the Court's view, however, this was not a particularly reasonable assumption. Plaintiffs reference the '532 patent with regard to teaching away in the Third Supplement with respect to different patents (the '117 and '049 patents), and a different issue. Defendants should therefore not have been very surprised to see other references cited in Plaintiffs' experts' reports to support their opinions for teaching away with respect to the '474 and '872 patents.11 And with respect to the substance of Dr. Michel's report, it does not seem to be asserting new theories or arguments as to why the prior art taught away from the inventions disclosed in the '474 and '872 patents.

B. Failure of Others

Next, Defendants assert that Plaintiffs violated the October 2018 Order by including new content in their experts' reports relating to "drugs other than Detrol® to show supposed `failure of others[.]'" (D.I. 392 at 1 & n.6) In the Third Supplement, Plaintiffs first generally note that others tried and failed to develop therapies for the treatment of OAB that avoided the side effects of dry mouth, headache, dyspepsia and constipation. (Third Supp. at 29) Plaintiffs next note that Myrbetriq is a "first-in-class drug" and to date the only beta-3 adrenergic agonist that is FDA-approved for the treatment of OAB. Finally, Plaintiffs state that "[f]or example, the anticholinergic drug Detrol (tolterodine tartrate) was FDA approved prior to the priority date of the '474 and '872 [p]atents for the treatment of patients with the symptoms of urinary frequency, urgency or urge incontinence, but the use of [Detrol] resulted in the aforesaid side effects." (Id. at 29-30)

Turning to the objected-to paragraphs of Plaintiffs' experts' reports, many of them relate to how mirabegron is a first-in-class drug, (D.I. 394, ex. B at ¶¶ 8, 62, 118, 123, 129; id., ex. C at ¶¶ 12-15, 21, 23, 96-99, 195-201, 231, 333 (citing ¶ 231)), or to Detrol (tolterodine tartrate), (id., ex. B at ¶ 128), which is "argument fairly raised" in the Third Supplement. Aside from those paragraphs, with respect to Dr. Nitti's report, Paragraph 83 seems to reference both Detrol (tolterodine) and another drug, oxybutynin. (See id., ex. B at ¶ 83; see also, e.g., id. at ¶ 65 (noting that the two most widely used drugs for OAB in 2002 "were the antimuscarinics oxybutynin (brand name DITROPAN®) and tolterodine (brand name DETROL®")) Because Plaintiffs did not reference oxybutynin in their Third Supplement, they may not rely on those portions of paragraph 83 in support of their failure of others argument.12 Paragraph 84 relates to antimuscarinics generally, of which Detrol is one, and thus Plaintiffs may rely on such content in support of SC. Paragraph 127 generally notes that others tried and failed to develop a treatment for OAB that minimized side effects, and cites in support to two prior sections of the report, which relates to content fairly raised in the Third Supplement.13 With respect to Dr. Michel's report, the highlighted portions of paragraphs 66 and 71 reference drugs other than Detrol, and Plaintiffs therefore may not rely on this content in support of failure of others. (Id., ex. C at ¶¶ 66, 71)

C. Praise by Others

Third, Defendants assert that Plaintiffs violated the October 2018 Order by including new content in their experts' reports relating to "supposed `praise by others' beyond the three awards explicitly cited in the [Third] Supplement[.]" (D.I. 392 at 1-2 & n.7) In the Third Supplement, Plaintiffs generally asserted that "Myrbetriq® (mirabegron) has received industry recognition and praise because of, inter alia, the properties of the crystalline form of mirabegron claimed in [certain asserted claims] and "because of the approval and use of Myrbetriq® for the methods of treatment claimed in [certain asserted claims]." (Third Supp. at 28) Plaintiffs then list three awards that Myrbetriq has received, "[f]or example[:]" (1) the Okochi Memorial Technology Award from the Okochi Memorial Foundation; (2) the Pharmaceutical Society of Japan Award for Drug Research and Development from the Pharmaceutical Society of Japan; and (3) the Japan Institute of Invention and Innovation Tokyo Excellence Award from the Japan Institute of Invention and Innovation. (Id.)

The paragraph called out by Defendants in Dr. Nitti's report regarding praise by others asserts that the launch of Plaintiffs' Myrbetriq in 2012 received praise by others, including: (1) certain statements previously discussed in Dr. Nitti's report; and (2) certain awards discussed previously in the report. (D.I. 394, ex. B at ¶ 134) The "awards" that Dr. Nitti references here are the same three awards discussed in the Third Supplement. (Id. at ¶¶ 93-96)14 However, the "statements" referenced in this paragraph were those made in conjunction with clinical studies on Myrbetriq, such as investigators' conclusions regarding the low level of side effects, as well as statements in journal articles praising the drug. (Id. at ¶¶ 79-92) Because such statements do not constitute "evidence/argument fairly raised" in the "praise by others" section of Plaintiffs' Third Supplement, as even Plaintiffs acknowledge, (see Tr. at 71),15 Plaintiffs may not rely on these paragraphs in support of their arguments regarding praise by others.16

D. Commercial Success

Fourth, Defendants assert that Plaintiffs violated the October 2018 Order by including new content in their experts' reports relating to "different bases for the supposed `commercial success' of Myrbetriq®[.]" (D.I. 392 at 2 & n.8) In the Third Supplement, Plaintiffs asserted that Myrbetriq is commercially successful because of the claimed properties of the crystalline form of mirabegron recited in the asserted claims of the '117 and '049 patents, and because mirabegron is approved, sold and used for the methods of treatment claimed in the asserted claims of the '474 and '872 patents. (Third Supp. at 26-27) Plaintiffs then cited to illustrative documents produced demonstrating the commercial success of their drug, and noted that "[f]or example," certain documents show an increase in net sales and the total number of prescriptions recorded per month for Myrbetriq in the United States from October 2012 through June 2018. (Id. at 27)

Turning first to the objected-to paragraphs of Plaintiffs' expert Dr. Vellturo's report, certain of them reflect argument that was fairly raised in the Third Supplement, including the increase in prescriptions for Myrbetriq, (D.I. 394, ex. D at ¶ 39), and the assertion that Myrbetriq is a first-class drug and that it is the commercial embodiment of the '474 and '872 patents, (id. at ¶¶ 8, 45-50). Certain other of the objected-to paragraphs of Dr. Vellturo's report appear to rebut opinions raised in Defendants' opening expert reports on invalidity regarding the '532 patent, (id. at ¶¶ 61-62), which is proper content in Plaintiffs' experts' reports, (D.I. 399 at 3 (Plaintiffs noting that while the Court ordered that Plaintiffs could not rely on evidence/argument that were not "`fairly raised'" in their Third Supplement for SC, the Court "did not preclude Astellas' experts from rebutting opinions and evidence raised in [D]efendants' opening invalidity expert reports") (certain emphasis in original)). And yet others simply seem to be providing background information with regard to OAB and the treatment of OAB; these need not be stricken. (D.I. 394, ex. D at ¶¶ 15-23, 25, 27, 30) The remaining objected-to paragraphs of Dr. Vellturo's report, (id. at ¶¶ 9-10, 36, 52-55 and 60), do not discuss content fairly raised by Plaintiffs' Third Supplement. Therefore, Plaintiffs may not rely on these paragraphs for the SC of commercial success.

Defendants next object to several paragraphs found in Dr. Nitti's report. (D.I. 392 at 2 n.8 (citing D.I. 394, ex. B at ¶¶ 56-87, 124-25)) Yet most of these paragraphs do not seem directly related to commercial success17 and it is not clear to the Court that Plaintiffs intend to rely on them with respect to this SC. Indeed, many of these paragraphs are not highlighted in blue, which leads the Court to wonder if Defendants inadvertently cited to them in their letter with respect to commercial success. Paragraphs 56-57 seem to just provide background regarding the economic burden of OAB as of November 7, 2002. Paragraph 58 discusses the cause of OAB as of November 7, 2002. Paragraph 59 generally notes how it was difficult to develop new treatments for OAB, an assertion fairly raised in the Third Supplement's discussion of failure of others. Paragraphs 60-62, 75-78 and 85-87 relate to how Myrbetriq was a first-in-class drug with low side effects, points that are addressed in the Third Supplement's discussion of other SC. Paragraphs 63-74 and 83-84 relate to other treatments for OAB. Paragraphs 79-82 relate to clinical studies regarding Myrbetriq. In light of the uncertainty with respect to these paragraphs, the Court declines to strike them on these grounds.18

With respect to the two objected-to paragraphs of Dr. Michel's report, they too do not violate the Court's October 2018 Order. Paragraph 234 states that Myrbetriq has been a "very significant commercial success" because of the unexpected attributes of improved safety and efficacy. (D.I. 394, ex. C at ¶ 234) This content is fairly raised by the Third Supplement, which asserts that Myrbetriq is commercially successful because of the properties of the crystalline form of mirabegron claimed in the patents. Paragraph 333 is a general paragraph referencing prior discussion of various SC, including paragraph 234, and stating that such SC support the opinion that the inventions set out in the asserted claims would not have been obvious to a POSA. (Id. at ¶ 333)

E. Long-felt Need

Fifth, Defendants assert that Plaintiffs violated the October 2018 Order by including new content in their experts' reports regarding the '474 and '872 patents relating to "post-patent filing data (e.g., clinical trials) to show mirabegron met a supposed `long-felt but unmet need[.]'" (D.I. 392 at 2 & n.9)19 In Plaintiffs' Third Supplement with respect to long-felt need, Plaintiffs assert that Myrbetriq is "the only FDA-approved mirabegron product" and "[t]o date, no other crystalline or non-crystalline form of mirabegron has been FDA-approved." (Third Supp. at 28) Plaintiffs note that Myrbetriq is FDA-approved for the treatment of OAB with particular symptoms and administered by physicians and patients for such treatment. (Id. at 28-29) Plaintiffs also reiterate that Myrbetriq is the only FDA-approved beta-3-adrenergic agonist for the treatment of OAB, and prior to the priority date of the '474 and '872 patents, the available FDA-approved oral pharmaceutical treatments for OAB had significant side effects. (Id. at 29)

Turning to the objected-to paragraphs of Dr. Nitti's report, Defendants object to paragraph 133 of Dr. Nitti's report, which references three prior sections as supporting his opinion that mirabegron satisfied a long-felt unmet need. (D.I. 394, ex. B at ¶ 133) Of the paragraphs in those three sections, paragraphs 79-92 are the ones relating to post-patent filing data (e.g., clinical trials), which subject matter Defendants particularly call out as going beyond the Third Supplement's discussion of long-felt need. (D.I. 392 at 2) Upon review, the Court finds that these paragraphs relate to content fairly raised in the Third Supplement. Dr. Nitti's discussion of clinical trials and studies in these paragraphs relate to: (1) Myrbetriq's FDA-approval for OAB; and (2) how prior to Myrbetriq's entrance on the market, the available FDA-approved treatments for OAB had certain significant side effects which adversely impacted their use and patient compliance. (D.I. 394, ex. B at ¶¶ 79-92)20

As for Dr. Michel's report, certain of the objected-to paragraphs contain content "fairly raised" in the Third Supplement. Paragraph 64 generally summarizes how OAB and its symptoms had been difficult to satisfactorily treat by November 7, 2002, a point that is asserted in the Third Supplement. (Id., ex. C at ¶ 64) Paragraphs 67-69 discuss how available FDA-approved oral treatments for OAB had significant side effects that meant that patient compliance when taking such treatments was poor. (Id. at ¶¶ 67-69) Paragraph 86 relates to how Myrbetriq is the only FDA-approved beta-3-adrenergic agonist for the treatment of OAB. (Id. at ¶ 86) Paragraph 333 is a general paragraph referencing prior discussion of various SC, including paragraph 233 which relates to long-felt need. (Id. at ¶ 333)

The remaining objected-to paragraphs, (id. at ¶¶ 65-66, 70-85), however, do seem to stretch beyond the content fairly raised in the Third Supplement in addressing potential drug targets and treatments beyond those that were FDA-approved prior to the priority date of the '474 and '872 patents. Plaintiffs may not rely on these paragraphs in support of the SC of long-felt need.

F. Unexpected Results

Finally, Defendants assert that Plaintiffs violated the October 2018 Order by including new content in their experts' reports relating to "any previously undisclosed `unexpected results[.]'" (D.I. 392 at 2 & n. 10) In the Third Supplement, Plaintiffs state that the crystalline form of mirabegron claimed in certain claims of the '117 and '049 patents demonstrated unexpected results to a POSA, such as, "[f]or example," unexpected stability, bioavailability, and exhibition of "a lack of hygroscopicity as compared to other solid state forms of mirabegron, including the dihydrochloride salt of mirabegron and the B-form crystalline form of mirabegron free base." (Third Supp. at 31) With respect to the claimed methods in the asserted claims of the '474 and '872 patents, they were said to have also demonstrated unexpected results such as, "[f]or example[:]" (1) particular action strengths as compared to the control compounds in certain isolated rat bladder smooth muscle relaxation tests; (2) mirabegron is exceptionally selective for beta-3-adrenergic receptors in human bladder tissue; (3) mirabegron is unexpectedly safe and effective in treating OAB, including the symptoms of urgency, urge urinary incontinence and urinary frequency; and (4) mirabegron has a low incidence and severity of side effects at therapeutically effective doses.

Upon review of the objected-to paragraphs of Plaintiffs' experts' reports, they seem to either be mistakenly cited to by Defendants, or they do not contain content beyond that fairly raised by the Third Supplement. Defendants cite first to paragraphs 67-71 of Dr. Michel's report. These paragraphs discuss how other treatments for OAB had frequent adverse side effects. (D.I. 394, ex. C at ¶¶ 67-71) They are not referenced in the specific paragraph of the report discussing unexpected results, (id. at ¶ 232), nor expressly cited therein. This paragraph, paragraph 232, explains that the fact that mirabegron had desirable properties among the entire class of disclosed β3 AR agonists could not have been predicted, since mirabegron was the first and only drug approved by the FDA as safe and effective, and no other drug from this class has been approved since. If paragraphs 67-71 relate to this class of drugs, then the content therein is fairly raised by the Third Supplement, since the Third Supplement discusses how it was unexpected that mirabegron would be safe and effective and have low incidence and severity of side effects. If they do not, then the Court is unsure how they relate to unexpected results and whether Plaintiffs are even relying on them for this SC. (See, e.g., D.I. 399 at 2 (Plaintiffs' letter not citing these paragraphs in reference to unexpected results)) Defendants next object to paragraph 232 of Dr. Michel's report, though the discussion in this paragraph contains argument "fairly raised" in the Third Supplement as it discusses mirabegron's unexpected desirable properties, including how it was found to be a safe and effective treatment for OAB. (D.I. 394, ex. C at ¶ 232) Objected-to paragraph 333 is a paragraph in which Dr. Michel cites back to the paragraphs in which he discussed SC, including paragraph 232, which support his opinion that the inventions were not obvious. Finally, Defendants object to paragraph 130 of Dr. Nitti's report. This paragraph cites to other sections of the report which demonstrate how Plaintiffs' discovery that mirabegron would usefully treat OAB with a low incidence and severity of side effects was an unexpected result, (id., ex. B at ¶ 130), a result referenced in the Third Supplement.21

III. CONCLUSION

For the foregoing reasons, Defendants' Motion is GRANTED-IN-PART and DENIED-IN-PART. Plaintiffs may not rely on the paragraphs identified above as going beyond the content of the Third Supplement in support of their particular SC arguments.

Because this Memorandum Order may contain confidential information, it has been released under seal, pending review by the parties to allow them to submit a single, jointly proposed, redacted version (if necessary) of the Memorandum Order. Any such redacted version shall be submitted no later than May 31, 2019, for review by the Court, along with a motion for redaction that includes a clear, factually detailed explanation as to why disclosure of any proposed redacted material would "work a clearly defined and serious injury to the party seeking closure." Pansy v. Borough of Stroudsburg, 23 F.3d 772, 786 (3d Cir. 1994) (internal quotation marks and citation omitted). The Court will subsequently issue a publicly-available version of its Memorandum Order.