VALUE DRUG COMPANY v. TAKEDA PHARMACEUTICALS, U.S.A., INC.

                  IN THE UNITED STATES DISTRICT COURT 
              FOR THE EASTERN DISTRICT OF PENNSYLVANIA 
VALUE DRUG COMPANY              :   CIVIL ACTION 
                v.                      NO.  21-3500 
TAKEDA PHARMACEUTICALS, 
U.S.A., INC., 

                             MEMORANDUM 
KEARNEY, J.                                                  February 28, 2023 
     A wholesaler purchaser of colchicine claims the brand name patent holder manufacturer 
conspired with three generic manufacturers to artificially inflate the price for colchicine from 
2017 until 2020 by ordering market entry of generic colchicine as part of settling three patent 
infringement/invalidity  cases  about  to  go  to  trial  before  Chief Judge  Sue  L.  Robinson.  The 
wholesaler hopes  to  show the  generics  enjoyed  at  least  an  eighty-five  percent  likelihood  of 
invalidating the patent which would allow them bring their generic colchicine to market in a few 
months  and  reduce  the  price  for  colchicine.  But,  according  to  the  wholesaler,  the  generic 
manufacturers  instead  withdrew  their  patent  invalidity  claims  right  before  trial  as  part  of a 
conspiracy  to  guarantee  their  staged  entry  into  the  colchicine  market  while  maintaining  the 
patent and precluding later generic manufacturers from entering the market and lowering the 
price. The wholesaler attempts to prove its theory of antitrust impact by, among other things, 
having  a  patent  litigation  expert,  attorney  Glen  P.  Belvis,  opine  at  least  one  of the  generic 
manufacturers enjoyed an eighty-five percent or greater likelihood of persuading Judge Robinson 
to invalidate the brand manufacturer’s patent. 

     The  brand  and  generic  manufacturers  now  move  to  preclude  Attorney  Belvis  from 
opining  the  generic  manufacturers  had  an  eighty-five  percent  or  greater  chance  of  Judge 
Robinson invalidating the patent. We held an extensive evidentiary hearing. Counsel focused on 
Attorney Belvis’s methodology employed to find an eighty-five percent or greater likelihood of 
success  for  the  generic  manufacturers.  The  patent  litigation  expert  could  offer  little  or  no 
methodology.  He  started  his  analysis  at  a  seventy-five  percent  benchmark  suggesting  the 
generics enjoyed, from the first day, a seventy-five percent likelihood of invalidating the patent. 
He then increased the likelihood of success in invalidating the patent by ten percentage points 
notwithstanding  completed  discovery  informing  the  parties  of the  strengths  and  weaknesses 
leading to the imminent trial dates (including settling one case on the morning of trial) or without 
considering the likelihood of success in invalidating this patent specifically in the District of 
Delaware or before Judge Robinson. 
     We grant the brand and generic manufacturers’ Motion to preclude Attorney Belvis from 
opining  as  to  an  eighty-five  or  greater  percent  likelihood  of  success  for  the  generic 
manufacturers.  We allow him to generally opine regarding  a likelihood of success subject to 
fulsome cross-examination without referencing a numerical figure upon finding: 
                        I.     Findings of Fact 
     l.     We  denied  Value  Drug  Company’s  first motion  for class  certification  without 
prejudice  on November  23,  2022  because  Value  Drug  adduced  no  evidence  supporting  the 
counsel-instructed assumption the generic manufacturers would have persuaded Judge Robinson 
to invalidate the colchicine patent held by Takeda Pharmaceuticals, U.S.A., Inc.

      2.     Value  Drug  retained  Glen  P.  Belvis,  Esquire  to  opine  on  the  generic 
manufacturers’ likelihood of success in persuading Judge Robinson to invalidate the patent as a 
basic premise for Value Drug’s theory of antitrust impact. 
      3.     Attorney  Belvis  is  a  thirty-year  experienced  intellectual  property  attorney  and 
judges have found him qualified to offer an opinion in patent law and litigation. 
      4.     Attorney Belvis concluded the generic manufacturers had an overall eighty-five 
percent or greater likelihood of prevailing in the underlying patent litigation against Takeda. 
      5.     Attorney Belvis relied on historical data finding patent owners like Takeda only 
prevail in patent litigation approximately twenty-five to thirty percent of the time and his own 
experiences to reach his opinions. 
      6.     Attorney Belvis began his analysis with a starting benchmark of a seventy-five 
percent chance of success in invalidating patents. 
      7.     He  then  found  the  generics  had  an  eighty-five  percent  overall  likelihood  of 
success in the days and weeks before their trials against Takeda after reviewing the case record. 
      8.     Attorney Belvis did not include in his analysis generic success rates in the District 
of Delaware, generic success rates before Judge Robinson, and the fact patentees (like Takeda) 
won 60.7% of bench and jury trials across all Districts between 2009 and 2013. 
      9.     Attorney Belvis provides no formula, calculation, or replicable methodology of 
how and why  he  adjusts  his  seventy-five  percent  success  benchmark upward by  at  least ten 
percent.

                         II.    Conclusions of Law 
     10.    Attorney Belvis’s opinion the generic manufacturers had an overall eighty-five 
percent  or  greater  likelihood  of persuading  Judge  Robinson  to  invalidate  the  patent  is  not 
supported by a  reliable methodology. 
     11.   | We exclude Attorney Belvis’s testimony “the generic defendants had an overall 
85% or greater likelihood of prevailing in the underlying [patent] litigation” against Takeda. 
     12.    We allow Attorney Belvis to testify as to his professional opinion regarding the 
generic manufacturers’  likelihood of success without referencing a figure and subject to cross- 
examination. 
                               II.   Analysis 
     Colchicine  manufacturers  Takeda,   Amneal   Pharmaceuticals  LLC,   and  Watson 
Laboratories, Inc. move to exclude “[Attorney] Belvis’s opinion that the generic defendants had 
an overall  85% or greater likelihood of prevailing in the underlying  [patent]  litigation.”!  We 
reviewed  Value  Drug’s  opposition.  We  preclude  Attorney  Belvis  from  opining  the  generic 
manufacturers enjoyed an eighty-five percent or greater chance of invalidating Takeda’s patent 
in the imminent trials before Judge Robinson. But he may testify as to his professional opinion 
regarding the generics’ likelihood of success without referencing a percentage. 
     We must ensure a witness offering an expert opinion possesses adequate “knowledge, 
skill, experience, training, or education” to support the opinion.” We act “as a ‘gatekeeper’  to 
ensure that ‘any and all expert testimony or evidence is not only relevant, but also reliable.’”” 
Congress, through Rule of Evidence 702, “usually favors admissibility.”* Rule 702 embodies a 
“trilogy of restrictions on expert testimony: qualification, reliability[,] and fit.”> The burden is on 
the party offering expert testimony to show it meets the standards for admissibility.®

     Rule  702’s  trilogy  of restrictions  “incorporates  to  some  extent  a consideration  of the 
dangers, particularly the danger of unfair prejudice, enumerated in” Rule 403.’  Rule 403  still 
independently applies to expert testimony.® We should exclude evidence under Rule 403 if “its 
probative value is substantially outweighed by a danger of one or more of the following: unfair 
prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly 
presenting cumulative evidence.” 
     Takeda, Amneal, and Watson argue Attorney Belvis’s opinion “the generic defendants 
had an overall 85% or greater likelihood of prevailing in the underlying [patent]  litigation” is 
unreliable and does not fit with Value Drug’s theory the generic manufacturers settled imminent 
trials they  were  “certain to  win.”!°  They do  not  challenge  Attorney  Belvis’s  qualifications.’! 
They instead contend Attorney Bevis cherry-picks data and has no replicable methodology for 
arriving at a minimum ten percent upward adjustment from his unreliable seventy-five percent 
starting  point.'*  Value  Drug  counters  Attorney  Belvis’s  methodology  is  reliable  and judges 
“routinely” endorse patent litigation experts’ use of percentages when testifying to likelihood of 
success in underlying patent litigations.!° 
     We  agree  with  Takeda,  Amneal,  and  Watson.  Attorney  Belvis’s  opinion  the  generic 
manufacturers enjoyed an eighty-five percent or more likelihood of invalidating Takeda’s patent 
lacks a reliable methodology. We must exclude this quantification absent a reliable methodology 
consistent with our gatekeeping role under Daubert." 
     Ensuring reliability of expert opinion requires we examine “the process or technique the 
expert used  in  formulating the  opinion.”!*  Attorney  Belvis’s  opinion  must be  based  on  “the 
‘methods  and  procedures  of  science’  rather  than  on  ‘subjective  belief  or  unsupported 
speculation.’”!® “In other words, the expert must have ‘good grounds’ for his belief.”!’ In cases

not involving scientific testimony,  “the relevant reliability concerns may  focus upon personal 
knowledge or experience.”!® 
     We are partially guided by our colleagues’  earlier analysis of whether patent litigation 
lawyers, including Attorney Belvis, can testify as experts on the likelihood of success on the 
merits in a case after the Supreme Court’s decision in F.7.C. v. Actavis, Inc.'? We do not agree 
with Value Drug characterizing the earlier review as judges “routinely” endorsing a percentage 
of likelihood of success.  Especially when the expert cannot offer a methodology. 
     Judges  allow patent litigation experts to  offer a specific  estimate  of the  likelihood  of 
success  in  an  underlying  patent  invalidity  trial  if  they  rely  on  a  sufficiently  testable 
methodology.”° Judge Leinenweber, for example, allowed Attorney Belvis to opine the generic 
manufacturer had a “greater than 85% overall chance of ultimately prevailing at trial and through 
appeal.””!  The  challenge  in In  re  Opana  focused  on the “85%  chance  determination falsely 
denote[d] a level of mathematical precision not present in [Attorney] Belvis’s opinion... □□□□ 
The Daubert challenge focused less on Attorney Belvis’s lack of methodology and more on his 
translating  his percentage  into  an opinion  of “very  likely”  to  win the underlying  litigation.” 
Judge Leinenweber held “to the extent the [pharmaceutical] defendants wish to argue that ‘very 
likely’  should  be  a  different  percentage,  they  will  have  the  opportunity  to  do  so  on  cross- 
examination before the jury.””4 
     Judge Burroughs more directly faced the issue we do today  in Jn re Intuniv Antitrust 
Litigation where the patent litigation expert did not provide a methodology for how he arrived at 
a  ninety-five  percent  likelihood  of success  in  the  underlying  patent  litigation.??>  The  expert 
testified he did not use a formula or equation, but relied upon his experiences and review of the 
record.”* Judge Burroughs allowed the expert “to testify as to his professional opinion” but could

not “provide any specific percentage of likelihood, as he provided no concrete methodology for 
how he reached this figure.””’ 
      We are also aware of Judge Thrash, Jr.’s analysis allowing a patent litigation expert to 
opine to  a  specific  percentage  based  on  a  detailed  methodology  in Jn  re Androgel Antitrust 
Litigation (No. II).’* The patent litigation expert before Judge Thrash, Jr. identified the average 
win-rate for a plaintiff in Hatch-Waxman cases,  analyzed the generics’  case finding it weaker 
than  the  average  suit,  and  discounted  the  average  projection  to  identify  the  likelihood  of 
success.”” Judge Thrash, Jr. found the expert identified  a methodology and weaknesses in the 
methodology could be fleshed out on cross-examination.>° 
      Our question is whether Attorney Belvis’s eighty-five percent or greater opinion should 
be precluded or instead subject to fulsome cross-examination. We are not facing a “very likely” 
characterization. We, like Judge Leinenweber, prefer to allow fulsome cross-examination to poke 
holes in analysis. But we cannot allow an opinion on a numerical likelihood of success absent 
methodology to enter the jury’s consideration. We are persuaded by Judges Burroughs’s analysis 
when facing a specific calculation absent an identified methodology. We cannot find Attorney 
Belvis employed a  reliable or replicable methodology for expressing his opinion “the generic 
defendants  had  overall  85%  or  greater  likelihood  of prevailing  in  the  underlying  [patent] 
litigation” against Takeda.! 
      We  are particularly  troubled  by  Attorney  Belvis  offering  no  methodology  of how he 
moves  from  his  seventy-five  percent  generic  win-rate  starting  benchmark  to  the  eighty-five 
percent or greater overall chance the generic manufacturers would have been successful in the 
underlying patent litigation against Takeda before Judge Robinson.  Attorney  Belvis  does not 
explain  how  “the  significant  and  multiple  problems  and  weaknesses”  with  Takeda’s  case

translates to a ten percent (or greater) increase from a seventy-five percent starting benchmark.*? 
Attorney Belvis did not consider contrary data including generic manufacturers’ success rates in 
the District of Delaware, their success rates in front of the vastly experienced Judge Robinson, 
and patentees (like Takeda) won 60.7% of trials.*7 Comprehensive statistical analysis of district 
court  litigation  across  the  country  published  approximately  one  year before  Takeda’s  patent 
litigation settlements found patentees won 60.7% of bench and jury trials.74 We cannot identify a 
reliable  or  replicable  methodology  Attorney  Belvis  used  to  warrant  a ten  percent  or  greater 
upward adjustment to the benchmark figure, especially given Takeda settled with Watson on the 
morning of trial.> We agree with Judge Burroughs’s reasoning the patent litigation expert did 
not provide a methodology for how he arrived at the statistical figure. We similarly only allow 
Attorney Belvis to testify as to his professional opinion without reference to overall likelihood of 
success figure.*° 
     We are not persuaded by the reasoning allowing this type of quantified opinion in Jn re 
Opana  ER  Antitrust  Litigation  because  we  are  not  concerned  with  the  term  “very  likely” 
equating  to  eighty-five  percent  overall  chance  of  likelihood  of  success  for  the  generic 
manufacturers.*’  The  patent holders in In re  Opana Er Antitrust Litigation did not challenge 
methodology.  They  challenged whether the  term “very  likely” reflects an eighty-five percent 
likelihood of success.?® We do not have the same issue here. The primary Daubert challenge here 
focuses on Attorney Belvis’s methodology leading him to define the statistical number and goes 
directly to his reliability. We do not have the same credibility and cross-examination challenges 
Judge Leinenweber addressed. We also distinguish In re Androgel Antitrust Litigation (No. I]).°? 
Judge Thrash, Jr.  found the expert identified a reliable methodology and weaknesses or flaws 
could be manifest in cross-examination.*? We cannot allow a jury to consider Attorney Belvis’s

credibility on his statistical figure when we cannot find, after an evidentiary hearing, he identifies 
a reliable methodology to reach the statistical figure in the first place. 
     We grant the Defendants’ motion to preclude Attorney Belvis from opining the generic 
manufacturers  enjoyed  an  eighty-five  percent  or  greater  likelihood  of success  in persuading 
Judge Robinson to invalidate Takeda’s colcitrine patent in late 2015 or early 2016. 

' ECF Doe. No. 741 at 1. 
 Fed. R. Evid. 702. 
3 Pineda v. Ford Motor Co., 520 F.3d 237, 243 (3d Cir. 2008) (quoting Kannankeril v. Terminix 
     Inc., 128 F.3d 802, 806 (3d Cir. 1997)). 
4 Honeywell, Inc. v. Am. Standards Testing Bureau, Inc., 851 F.2d 652, 656 (3d Cir. 1988). 
> Calhoun v.  Yahama Motor Corp., U.S.A., 350 F.3d 316, 321 (3d Cir. 2003) (quoting Scheider v. 
Fried, 320 F.3d 396, 405 (3d Cir. 2003)). 
6 B.  Braun Melsungen AG v.  Terumo Med.  Corp.,  749 F.  Supp.  2d 210,  222  (D.  Del.  2010) 
(citing Daubert v. Merrell Dow Pharms. Inc., 509 U.S. 579, 592 n.  10 (1993); In re TMI Litig., 
193 F.3d 613, 663 (3d Cir. 1999)). 
7 United States v. Downing, 753 F.2d 1224, 1242 (3d Cir. 1985). 
8 See id. 
 Fed. R. Evid. 403. 
10 ECF Doc. No. 741 at 1. We do not address whether Attorney Belvis’s opinion the generics had 
an eighty-five percent or greater overall  likelihood  of success  against Takeda “fits” the  case 
because we grant the motion to preclude the quantification of the success based on unreliability. 
'! The first category of restrictions—qualification—requires “that the witness possess specialized 
expertise.” Pineda, 520 F.3d at 244 (quoting Schneider ex rel. Estate of Schneider v. Fried, 320 
F.3d 396, 404 (3d Cir. 2003)). Our Court of Appeals interprets this requirement “liberally.” /d. 
“[A] broad range of knowledge,  skills,  and training qualify an expert.” In re Paoli R.R.  Yard 
PCB  Litig.,  35  F.3d  717,  741  (3d  Cir.  1994).  We  should  not  “impos[e]  overly  rigorous 
requirements of expertise”; “more generalized qualifications” suffice. /d. 
'2  ECF  Doc.  No.  741-1  at  5-10  (using  the  pagination  assigned  by  the  CM/ECF  docketing 
system).

   ECF Doc. No. 805 at 6-19 (using the pagination assigned by the CM/ECF docketing system). 
   Daubert, 509 U.S. 579 (1993). 
13 In re Paoli, 35 F.3d at 742. 
16 Walker v. Gordon, 46 F. App’x 691, 694 (3d Cir. 2002) (quoting Jn re Paoli, 35 F.3d at 742). 
'7 Td. (quoting In re Paoli, 35 F.3d at 741-42). 
'8 Betterbox Commc'ns Ltd. v. BB Techs., Inc., 300 F.3d 325, 329 (3d Cir. 2002) (quoting Kumho 
Tire Co. v. Carmichael, 526 U.S.  137, 150 (1999)). 
   570 U.S.  136 (2013). See also In re Namenda Direct Purchaser Antitrust Litig., 331  F. Supp. 
3d  152,  188  (S.D.N.Y.  2018) (“[T]estimony  by experienced lawyers about the likelihood that 
patent litigations will succeed or not succeed has been admitted in several post-Actavis reverse- 
payment cases.”) (collecting cases). 
2° In re Intuniv Antitrust Litigation, No.  16-12653, 2020 WL 5995326, at *11  (D. Mass. Oct. 9, 
2020); see also In re Zetia (Ezetimibe) Antitrust Litig., MDL No.  18-2836, 2022 WL 3344191,  at 
*11  (E.D. Va. August 3, 2022) (allowing the patent litigation expert to testify when “the court is 
assured that [the expert] had a sufficient methodology for arriving at his range of percentages”); 
In re Namenda Indirect Purchaser Litigation, No.  15-6549, 2021  WL 2403727, at *9 (S.D.N.Y. 
June 11, 2021) (holding patent lawyers expressing opinions as statistics does not mean the expert 
did not employ any ascertainable or reliable methodology in reaching his conclusions). 
2! In re Opana ER Antitrust Litigation, MDL No. 2580, 2021 WL 2291067, at *11 (N.D. Ill. June 
4, 2021). 
22 Id. 
23 Id. 
°4 Td. at *12. 
  In re Intuniv Antitrust Litig., 2020 WL 5995326, at *12. 
 Id. at *11. 
27 Id. 
  In re Androgel Antitrust Litigation (No.  II),  MDL  No, 2084, 2018  WL 2984873  (N.D.  Ga. 
June 14, 2018). 

                                      10 

29 Td. at *6. 
30 Td.  (finding the expert “clearly has a methodology, even if the Defendants believe it to be a 
weak one.”’). 
31 ECF Doc. No. 741-3 § 275. 
32 Td. 9759. 
33 See ECF Doc. No. 741-1  at 9-11  (using the pagination assigned by the CM/ECF docketing 
system). 
34 Allison, Lemley &  Schwartz,  Understanding the Realities of Modern Patent Litigation, 92 
Tex. L. Rev. 1769, 1790 (2014). 
35 ECF Doc. No. 861, N.T. February 7, 2023 hearing at 92-93. 
36 In re Intuniv Antitrust Litig., 2020 WL 5995326, at *11-12. 
37 In re Opana ER Antitrust Litig., 2021 WL 2291067, at *11-12. 
38 Iq 
° In re  Androgel  Antitrust Litig. (No. I), 2018 WL 2984873, at *6. 
40 Td. 

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