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The Medicines Co. v. Mylan Inc.

United States District Court, N.D. Illinois, Eastern Division

May 2, 2014



AMY J. ST. EVE, District Judge.

Plaintiff The Medicines Company's ("TMC") has moved to preclude the testimony and opinions of Dr. Nancy J. Linck, 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.


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 patents-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. The Court granted in part and denied in part Defendants' motion for summary judgment of non-infringement, invalidity, and willful infringement.[1] In defense of the remaining infringement claims, Mylan has asserted that TMC committed inequitable conduct during the prosecution of the 727 patent.

On February 8, 2013, Mylan served TMC with the expert report of Dr. Nancy J. Linck. Mylan seeks to offer Dr. Linck's testimony to support its claims that the co-inventors of the 727 patent, Drs. Gary Musso and Gopal Krishna, committed inequitable conduct during the prosecution of the 727 patent. Dr. Linck is a patent attorney who also holds a Ph.D. in inorganic chemistry, and has more than twenty years of experience in patent law and with the United States Patent and Trademark Office's ("Patent Office") practices and procedures. Dr. Linck was formerly the Solicitor of Patents and Trademarks at the Patent Office. She also was an Administrative Patent Judge, where she evaluated the decisions of Patent Office examiners. Dr. Linck opined on Mylan's theory of inequitable conduct based on her knowledge and expertise in the field, the 727 file history, and the record of the case.

Specifically, Dr. Linck opined that certain material information was known to Drs. Musso and Gopal Krishna during the prosecution of the 727 patent, and that the material information was either withheld from the Patent Office or misrepresented to the patent examiner. Linck concluded that an examiner would not have issued the claims of the 727 patent had the information been disclosed or had misrepresentations not been made. (R. 324-1 ¶¶ 114-34.) Dr. Linck also identified certain record evidence from which the Court could draw an inference of intent to deceive the Patent Office. ( Id. ¶¶ 135-49.)


"The admissibility of expert testimony is governed by Federal Rule of Evidence 702 and the Supreme Court's opinion in Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)." See also Apple Inc. v. Motorola, Inc., __ F.3d __, 2014 WL 1646435 at *18 (Fed. Cir. Apr. 25, 2014); Lewis v. Citgo Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009). Rule 702 provides, in the 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 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. In evaluating these issues, "[a] judge must be cautious not to overstep its gatekeeping role and weigh facts, evaluate the correctness of conclusions, impose its own preferred methodology, or judge credibility, including the credibility of one expert over another. These tasks are solely reserved for the fact finder." Apple, 2014 WL 1646435 at * 19.

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)).

In addition, as the Seventh Circuit teaches:

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, 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."). Under this approach, where the judge will serve as 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.


TMC seeks to exclude the entire testimony of Dr. Nancy J. Linck, or in the alternative, limit several of Dr. Linck's opinions on certain issues relating to the prosecution of the 727 patent. TMC asks the Court to preclude Dr. Linck's testimony alleging that she is not a qualified expert to testify on Mylan's inequitable conduct theories, and that Dr. Linck's testimony will not aid the trier of fact. Alternatively, TMC argues that the Court should preclude Dr. Linck from offering several legal and technical opinions, particularly in the area of inequitable conduct. Specifically, TMC argues that the Court should strike Dr. Linck's opinions and testimony regarding: (1) the intent or state of mind of the inventors; (2) the interpretation of patent law and court decisions; (3) conclusions of law; (4) the intent or state of mind of the Patent Office Examiner; (5) mistakes made by the Patent Office; and (6) technical matters outside Dr. Linck's expertise. The Court will address each argument in turn.

I. Dr. Nancy J. Linck

Mylan expert Dr. Nancy Linck is an attorney who has more than twenty years of experience in patent law and Patent Office practices and procedures. Dr. Linck is the former Solicitor of Patents and Trademarks, serving as general counsel and the highest-ranking lawyer at the Patent Office. She also is a former Administrative Patent Judge who was responsible for reviewing determinations of Patent Office examiners, including denials of patent applications. Additionally, she has testified before Congress, the Federal Trade Commission, and the Department of Justice regarding improvements to the U.S. patent system.

Dr. Linck received a Juris Doctor degree in 1984 from Johns Hopkins University, has been a partner at two law firms, and in-house counsel at a chemical company and a pharmaceutical company. Dr. Linck is an Adjunct Professor of Law at Georgetown University Law Center, a position she has held since 1998, and was previously an Adjunct Professor at George Washington School of Law. Dr. Linck holds a B.S. in chemistry from the University of California, Berkeley, and an M.S. and Ph.D. in inorganic chemistry from University of California, San Diego. Based on her significant legal and technical ...

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