The Medicines Company v. Mylan Inc. et al

Filing 452

MEMORANDUM Opinion and Order Signed by the Honorable Amy J. St. Eve on 4/17/2014:Mailed notice(kef, )

IN THE UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
THE MEDICINES COMPANY,

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Plaintiff,
v.
MYLAN INC., MYLAN
PHARMACEUTICALS INC., and
BIONICHE PHARMA USA, LLC,
Defendants.

No. 11-cv-1285

MEMORANDUM OPINION AND ORDER
AMY J. ST. EVE, District Court Judge:
Plaintiff The Medicines Company’s (“TMC”) has moved to preclude certain opinions of
Dr. David E. Auslander offered by Defendant Mylan Inc., Mylan Pharmaceuticals Inc., and
Bioniche Pharma USA, LLC (collectively, “Mylan”), pursuant to Federal Rule of Evidence 702
and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d
469 (1993). For the reasons discussed below, the Court grants in part and denies in part TMC’s
motion.
BACKGROUND
This action arises out of a patent infringement case involving U.S. Patent No. 7,582,727
(R. 358-1, “the ‘727 Patent”) The ‘727 patent “relates to a compounding process for preparing a
pharmaceutical batch(es) of a drug product or a pharmaceutical formulation(s) comprising
bivalirudin as an active ingredient.” (Id., ‘727 patent at col. 2 ll. 29-32) Bivalirudin is the active
ingredient in TMC’s Angiomax® drug product, an injectable anticoagulant used to prevent blood
clotting during coronary procedures. TMC has sold Angiomax® since 2001. Before expiration

of the patent-in-suit, Mylan submitted Abbreviated New Drug Application (“ANDA”) No.
202471 to the U.S. Food and Drug Administration (“FDA”), seeking approval to engage in the
commercial manufacture, use, sale, offer for sale, and/or importation of a generic equivalent to
Angiomax®. TMC claimed that Mylan’s ANDA No. 202471 infringes several claims of the
patents-in-suit.
Mylan disclosed three separate expert reports of Dr. David E. Auslander in this case.1
Mylan served Dr. Auslander’s Opening Report on February 8, 2013, setting forth his opinions
regarding the invalidity and unenforceability of TMC’s ’727 patent. (R. 340-1, Auslander Open
Report) Dr. Auslander submitted a second expert report on March 8, 2013, setting forth his
opinions related to non-infringement. On April 8, 2013, Dr. Auslander served his reply to the
responsive report of TMC’s technical expert, Dr. Alexander Klibanov2, on issues of invalidity
and inequitable conduct. (R. 340-2, Auslander Reply Rpt.)
Dr. Auslander reviewed certain disclosures withheld by TMC in its application to the
Patent Office to determine whether such information would have been material to the Patent
Examiner. (R. 340-2, Auslander Reply Rpt. ¶¶ 40-41.) Following his review, Dr. Auslander
opined that information regarding the prior art would have been material to the examiner in
determining the patentability of the claims. Id. In particular, Dr. Auslander noted that in Table 6
of the ’727 Patent, TMC disclosed only that prior art batches of Angiomax had a mean Asp9
value of 0.5% (with a standard deviation of 0.4% plus or minus), and a maximum Asp9 result of
3.6%. (R. 358-1, “the ‘727 Patent” at col 22, ll. 9-20.) Dr. Auslander concluded that the
information omitted by TMC in Table 6, relating to the high rate at which the prior art batches
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The Court is only addressing Dr. Auslander’s opinions regarding the ‘727 patent.
The Court, in a previous summary judgment opinion, struck Dr. Klibanov’s opinions as
untimely, including opinions on infringement under the doctrine of equivalents. (R. 309 at
22−23.)
2

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actually met the 0.6% Asp9 maximum of the ’727 patent claims, would have been material and
misleading to the Patent Examiner’s determination. (R. 340-2, Auslander Reply Rpt. ¶ 40.)
LEGAL STANDARD FOR DAUBERT MOTIONS
“The admissibility of expert testimony is governed by Federal Rule of Evidence 702 and
the Supreme Court’s opinion in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579,
113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993).” Lewis v. Citgo Petroleum Corp., 561 F.3d 698, 705
(7th Cir. 2009). Rule 702 provides, in relevant part, that “[i]f scientific, technical or other
specialized knowledge will assist the trier of fact[,] . . . a witness qualified as an expert by
knowledge, skill, experience, training or education, may testify thereto in the form of an
opinion. . . .” Id. See also Happel v. Walmart Stores, Inc., 602 F.3d 820, 824 (7th Cir. 2010).
Under the expert-testimony framework, courts perform the gatekeeping function of
determining whether the expert testimony is both relevant and reliable prior to its admission at
trial. See id.; Power Integrations, Inc. v. Fairchild Semiconductor Intern., Inc., 711 F.3d 1348,
1373 (Fed. Cir. 2013); United States v. Pansier, 576 F.3d 726, 737 (7th Cir. 2009) (“To
determine reliability, the court should consider the proposed expert’s full range of experience
and training, as well as the methodology used to arrive [at] a particular conclusion.”). In doing
so, courts “make the following inquiries before admitting expert testimony: first, the expert must
be qualified as an expert by knowledge, skill, experience, training, or education; second, the
proposed expert must assist the trier of fact in determining a relevant fact at issue in the case;
third, the expert’s testimony must be based on sufficient facts or data and reliable principles and
methods; and fourth, the expert must have reliably applied the principles and methods to the facts
of the case.” Lees v. Carthage College, 714 F.3d 516, 521-22 (7th Cir. 2013); see also Stollings

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v. Ryobi Tech., Inc., 725 F.3d 753, 765 (7th Cir. 2013); Power Integrations, 711 F.3d at 1373;
Pansier, 576 F.3d at 737.
It is clear that “genuine expertise may be based on experience or training.” United States
v. Conn, 297 F.3d 548, 556 (7th Cir. 2002) (quoting Tyus v. Urban Search Mgmt., 102 F.3d 256,
263 (7th Cir. 1996)). “[W]hile extensive academic and practical expertise in an area is certainly
sufficient to qualify a potential witness as an expert, Rule 702 specifically contemplates the
admission of testimony by experts whose knowledge is based on experience.” Trustees of
Chicago Painters & Decorators Pension, Health & Welfare, & Deferred Sav. Plan Tr. Funds v.
Royal Int’l Drywall & Decorating, Inc., 493 F.3d 782, 787-88 (7th Cir. 2007) (citations and
quotations omitted). As such, courts “consider a proposed expert’s full range of practical
experience, as well as academic or technical training, when determining whether that expert is
qualified to render an opinion in a given area.” Id. (quoting Smith v. Ford Motor Co., 215 F.3d
713, 718 (7th Cir. 2000)).
The Seventh Circuit has also noted:
Where the gatekeeper and the factfinder are one and the same – that is, the judge
– the need to make such decisions prior to hearing testimony is lessened. See
United States v. Brown, 415 F.3d 1257, 1268-69 (11th Cir. 2005). That is not to
say that the scientific reliability requirement is lessened in such situations; the
point is only that the court can hear the evidence and make its reliability
determination during, rather than in advance of, trial. Thus, where the factfinder
and the gatekeeper are the same, the court does not err in admitting the evidence
subject to the ability later to exclude it or disregard it if it turns out not to meet the
standard of reliability established by Rule 702.
In re Salem, 465 F.3d 767, 777 (7th Cir. 2006); see also Metavante Corp. v. Emigrant Sav. Bank,
619 F.3d 748, 760 (7th Cir. 2010) (observing that “the court in a bench trial need not make
reliability determinations before evidence is presented” because “the usual concerns of the rule –
keeping unreliable expert testimony from the jury – are not present in such a setting”); Brown,

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415 F.3d at 1269 (“There is less need for the gatekeeper to keep the gate when the gatekeeper is
keeping the gate only for himself.”). Where the judge will be the trier of fact at trial, the Court
may choose to (1) allow the presentation of borderline testimony, (2) subject the testimony to the
rigors of cross-examination, and (3) decide later whether the testimony is entitled to some
consideration or whether it should be excluded as irrelevant, unreliable, or both. Nevertheless, at
some point before disposition of the case, the court “must provide more than just conclusory
statements of admissibility or inadmissibility to show that it adequately performed its
gatekeeping function.” Metavante Corp., 619 F.3d at 760.
ANALYSIS
TMC seeks to exclude certain opinions of Dr. David Auslander. First, TMC asks the
Court to preclude Dr. Auslander’s testimony regarding what the Patent Office Examiner would
have done or thought had the Examiner had different information during the prosecution of the
patents-in-suit. Second, TMC seeks to preclude Dr. Auslander from testifying in reliance on
statistics expert, Dr. Ian McKeague’s, “unreliable” Table 6 statistical analysis. The Court will
address each argument in turn.
I.

Dr. Auslander
Dr. David Auslander operates Deatech Associates, a worldwide pharmaceutical

development consulting company. Deatech Associates focuses on pharmaceutical product and
process development strategies, including process improvements, scale up, commercialization,
and validation efforts. Dr. Auslander obtained a Masters of Science in Pharmaceutics from
Columbia University in 1965 and a Ph.D. in Pharmaceutical Sciences from Rutgers University in
1973. Dr. Auslander has over 35 years of experience in drug development, drug formulations,
and the role of scale up and validation for successful implementation of pharmaceutical products

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meeting both good manufacturing procedures and FDA regulatory requirements. He has worked
extensively in the pharmaceutical industry on process development related to pharmaceutical
drug products, including injectables. (R. 340-1, Auslander Opening Report ¶¶ 4-10.)
Based on his expertise in the pharmaceutical industry, Dr. Auslander opined in his first
and third expert reports that the ’727 patent is unenforceable due to TMC’s failure to disclose
material information to the Patent Office during prosecution of the patent. In particular, the ’727
patent purports to claim pharmaceutical batches of bivalirudin drug product having certain
maximum impurity levels. (R. 358-1, “the ‘727 Patent” at col. 25, l. 55 - col 28, l. 24.) For
example, claim 1 recites pharmaceutical batches having a maximum Asp9-bivalirudin impurity
level of “about 0.6%.” (Id. col 25, ll. 55-64.) TMC relied upon this maximum Asp9 impurity
level in distinguishing its prior art Angiomax® product and obtaining allowance of the ’727
patent claims over that prior art. (R. 278-8, at MEDMYL0001284.)
II.

Dr. Auslander May Rely on Dr. Ian McKeague’s Analysis
TMC first argues that the Court should preclude Mylan expert Dr. David E. Auslander

from testifying in reliance on statistics expert Dr. Ian McKeague’s Table 6 statistical analysis
and conclusions. As described in greater detail in the Court’s Memorandum Opinion and Order
regarding the Daubert motion to preclude testimony of Dr. McKeague, his expert statistical
analysis of Table 6 in the ‘727 patent is reliable. (R. 408) An expert need not base his testimony
on first-hand knowledge or research actually conducted by the expert. See Daubert, 509 U.S. at
592; Walker v. Soo Line R.R., 208 F.3d 581, 588 (7th Cir. 2000) (“Indeed, courts frequently have
pointed to an expert’s reliance on the reports of others as an indication that their testimony is
reliable.”); Kimberly-Clark Worldwide, Inc., v. First Quality Baby Prods., LLC, No. 1:09-CV1685, 2013 WL 6230484, at *2-3 (M.D. Penn. Dec. 2, 2013) (expert may render opinions in

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reliance on other expert’s opinions). Thus, Dr. Auslander can rely on testimony and reports from
Dr. McKeague’s analysis of Table 6 in formulating his own expert opinions.
In addition, Dr. Auslander independently opined on Table 6 based on his technical
expertise. Dr. Auslander stated that “[b]ased upon [his] own independent review of that data and
Table Six” that he agrees with Dr. McKeague’s opinion that Table 6 of the ’727 Patent provides
misleading and incomplete information concerning TMC’s prior art Angiomax® product. (R.
340-2, Auslander Reply Rpt. ¶ 40.) TMC’s motion on this issue is therefore denied.
III.

Dr. Auslander’s Opinions Regarding the Significance of the Asp9 Levels of Prior Art
Batches are Admissible
TMC also moves to exclude statements by Dr. Auslander regarding his opinion of what

the Patent Office Examiner would have done or thought had TMC given her different
information:


“The obviousness of TMC’s solution would have been clear to the
Patent Office Examiner had TMC fully and forthrightly described
the details of the Angiomax® prior art formulation process in its
patent application.” (R. 340-1, Auslander Opening Report ¶ 129.)
(emphasis added);



“In my opinion, the Patent Office would have found it material to
learn that the difference between the prior art Angiomax® and the
claimed invention was merely the incremental difference between a
90% success rate and a 100% success rate, in achieving Asp9 levels
at or below about 0.6%. . . .” ( R. 340-2, Auslander Reply Report ¶
41.) (emphasis added);



“Consequently, the Patent Office was led to believe that the
differences between the ‘old’ and ‘new’ compounding processes
were much greater than they actually were.” (Id.) (emphasis added);



“While Dr. Klibanov may balk that the prior art Angiomax® was
disclosed to the Patent Office, the evidence shows that TMC
concealed important aspects of its prior art compounding process,
and the results achieved by that process, from the Patent Office. In
my opinion, had those additional facts been disclosed, the Patent
Office probably would not have allowed the asserted claims to
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issue.” ( I d . ¶ 81.) (emphasis added); and


“And, would the Patent Office have allowed the claims to issue had
it been informed that this was the type of incremental difference as
to which TMC was filing for patent protection? I think the answer
to that question is no . . . .” ( I d . ¶ 105.) (emphasis added).

To satisfy the materiality standard for an inequitable conduct claim, the accused infringer
must show that “but-for” the nondisclosure of the withheld prior art, the Patent Office Examiner
would not have allowed at least one claim of the patent to issue. Therasense, Inc. v. Becton,
Dickinson & Co., 649 F.3d 1276, 1291-92 (Fed. Cir. 2011). Under Therasense, an accused
infringer asserting inequitable conduct “must provide evidence that the applicant in question (1)
misrepresented or omitted material information, and (2) did so with specific intent to deceive the
PTO.” Id. Although materiality can be inferred from indirect and circumstantial evidence, “it
must also be the single most reasonable inference able to be drawn from the evidence to meet the
clear and convincing standard.” Am. Calcar, Inc. v. Am. Honda Motor Co., Inc., 651 F.3d 1318,
1334 (Fed. Cir. 2011).
Certain statements of Dr. Auslander’s go beyond permissible opinions and speculate as to
what the Examiner would have done or thought had she been given different information. See,
e.g., Se-Kure Controls, Inc. v. Diam USA, Inc., No. 06 C 4857, 2009 WL 77463, at *2 (N.D. Ill.
Jan. 9, 2009) (curtailing the expert’s proposed testimony and explaining that experts are not
“mind-reader[s]”); Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., No.
C 92-20643, 1995 WL 261407, at *2 (N.D. Cal. Apr. 25, 1995) (“The court grants Applied’s
motion precluding Nusbaum from testifying about what the examiner would have done if
Nusbaum had been the examiner, or if the examiner had different information. The evidence
would be irrelevant speculation . . . .”). Thus, the Court grants Plaintiff’s motion to preclude Dr.

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Auslander from opining on what the Patent Office Examiner would have done or thought had she
been given different information.
Dr. Auslander, may, however, opine as to what he believes would have been material to
the patent examiner based on the statistical data generated by Dr. McKeague. Experts are
permitted to opine on materiality. CBOE v. ISE, No. 07 C 623, ECF No. 701 at 3-4 (N.D. Ill.
March 7, 2013) (citing Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363 n.5
(Fed. Cir. 2008)) (allowing relevant expert testimony from expert who did not have “ordinary
skill in the field of computer programming,” the relevant art); Bone Care Int’l LLC v. Pentech
Pharms. Inc., No. 08-CV-1083, 2010 WL 3928598, at *9 (N.D. Il.. Oct. 1, 2010) (holding
technical expert may opine on materiality). Dr. Auslander is permitted to discuss and disclose
facts, without opining on what the Patent Office Examiner would have done or thought.
Specifically, given Dr. Auslander’s uncontested and extensive expertise of pharmaceutical
industry and FDA standards, his opinions relating to Dr. McKeague’s statistical analysis and
their potential materiality are admissible. (See R. 340-2, Auslander Reply Rpt. ¶¶ 40-41.) This
aspect of the motion is therefore denied.
CONCLUSION
For the reasons discussed in detail above, the Court grants in part and denies in part
TMC’s motion to preclude certain testimony of Mylan’s expert, Dr. David Auslander.

Dated: April 17, 2014

AMY J. ST. EVE
United States District Court Judge

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