`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`Case No. 19‐CV‐1760 (PJS/TNL)
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`ORDER
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`VASCULAR SOLUTIONS LLC; ARROW
`INTERNATIONAL, INC.; TELEFLEX LLC;
`and TELEFLEX LIFE SCIENCES LIMITED;
`
`
`Plaintiffs,
`
`v.
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`MEDTRONIC, INC. and MEDTRONIC
`VASCULAR, INC.,
`
`Defendants.
`
`J. Derek Vandenburgh, Tara C. Norgard, Joseph W. Winkels, Alexander S.
`Rinn, and Shelleaha L. Jonas, CARLSON, CASPERS, VANDENBURGH &
`LINDQUIST, P.A., for plaintiffs.
`
`Kurt J. Niederluecke, Lora M. Friedemann, Laura L. Myers, and Anne E.
`Rondoni Tavernier, FREDRIKSON & BYRON, P.A., for defendants.
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`Plaintiffs Vascular Solutions, LLC, Arrow International, Inc., Teleflex LLC, and
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`Teleflex Life Sciences Limited (collectively “Teleflex”) bring this patent‐infringement
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`action against defendants Medtronic, Inc. and Medtronic Vascular, Inc. (collectively
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`“Medtronic”). Teleflex claims that Medtronic’s Telescope catheter infringes claims in
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`seven patents that are directed to guide extension catheters used in interventional
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`IPR2020-00131
`Medtronic v. Teleflex
`Medtronic Exhibit 1888 - Page 1
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`CASE 0:19-cv-01760-PJS-TNL Document 247 Filed 04/09/20 Page 2 of 17
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`cardiology procedures.1 Medtronic counterclaims for declarations of non‐infringement
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`and invalidity.
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`This matter is before the Court on Teleflex’s motion for a preliminary injunction.
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`For the reasons that follow, the motion is denied.
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`A. Standard of Review
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`A court must consider four factors in deciding whether to grant a preliminary
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`injunction: (1) the movant’s likelihood of success on the merits; (2) the threat of
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`irreparable harm to the movant if the injunction is not granted; (3) the balance between
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`that harm and the harm that granting the injunction will inflict on the other parties; and
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`(4) the public interest. Dataphase Sys., Inc. v. C L Sys., Inc., 640 F.2d 109, 114 (8th Cir.
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`1981).2 Preliminary injunctions are extraordinary remedies, and the party seeking such
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`relief bears the burden of establishing its entitlement to an injunction under the
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`Dataphase factors. Watkins Inc. v. Lewis, 346 F.3d 841, 844 (8th Cir. 2003).
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`1The technology is described in a Markman order entered in another case
`involving some of the same patents. See QXMédical, LLC v. Vascular Sols., LLC,
`No. 17‐CV‐1969 (PJS/TNL), 2018 WL 5617568 (D. Minn. Oct. 30, 2018).
`
`2Generally speaking, the Federal Circuit applies regional circuit law when
`reviewing the grant or denial of a preliminary injunction. Metalcraft of Mayville, Inc. v.
`The Toro Co., 848 F.3d 1358, 1363 (Fed. Cir. 2017). But the Federal Circuit gives
`“dominant effect to Federal Circuit precedent insofar as it reflects considerations
`specific to patent issues.” Id. (citation and quotation marks omitted).
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`Medtronic v. Teleflex
`Medtronic Exhibit 1888 - Page 2
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`B. Likelihood of Success
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`For purposes of this motion, Teleflex argues that it is likely to succeed in showing
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`that Medtronic infringes claims in four of its patents: U.S. Patent Nos. RE45,380
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`(“RE’380”), RE45,776 (“RE’776”), RE47,379 (“RE’379”), and RE45,760 (“RE’760”).
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`“To establish a likelihood of success on the merits, a patentee must show that it
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`will likely prove infringement of the asserted claims and that its infringement claim will
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`likely withstand the alleged infringer’s challenges to patent validity and enforceability.”
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`Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1364 (Fed. Cir. 2017). The
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`likelihood of success must be considered “in light of the presumptions and burdens that
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`will inhere at trial on the merits.” Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1259
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`(Fed. Cir. 2012).
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`Ultimately, however, the burden remains with the patentee to establish its
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`entitlement to a preliminary injunction. If the non‐movant “raises a substantial
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`question concerning either infringement or validity, i.e., asserts an infringement or
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`invalidity defense that the patentee cannot prove lacks substantial merit, the
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`preliminary injunction should not issue.” Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
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`239 F.3d 1343, 1350‐51 (Fed. Cir. 2001) (citation and quotations omitted). “The showing
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`of a substantial question as to invalidity . . . requires less proof than the clear and
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`convincing showing necessary to establish invalidity itself.” Id. at 1359.
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`Medtronic v. Teleflex
`Medtronic Exhibit 1888 - Page 3
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`1. Written Description
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`Medtronic argues that all of the asserted claims in the RE’776, RE’379, and RE’760
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`patents are invalid for lack of a written description.3 In particular, Medtronic argues
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`that the original written description of the invention discloses a side opening only in the
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`substantially rigid portion of the catheter, yet Teleflex’s asserted claims place the side
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`opening outside of the substantially rigid portion.
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`The written‐description requirement is set forth in 35 U.S.C. § 112(a):
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`The specification shall contain a written description of the
`invention, and of the manner and process of making and
`using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or
`with which it is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the
`inventor or joint inventor of carrying out the invention.
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`Section 112(a) therefore requires both (1) a written description of the invention and (2) a
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`written description of the manner and process of making and using it. Ariad Pharms.,
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`Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010) (en banc). In the context of a
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`reissued patent, the necessary disclosure must appear in the original specification.
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`Revolution Eyewear, Inc. v. Aspex Eyewear, Inc., 563 F.3d 1358, 1366 (Fed. Cir. 2009).
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`3For purposes of this motion, Teleflex asserts the following claims in these three
`patents: claims 25, 36, and 37 of the RE’776 patent; claims 25, 33, 34, 38, and 44 of the
`RE’379 patent; and claims 25, 28, 29, 32, and 48 of the RE’760 patent.
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`The purpose of requiring a written description of the invention “is to prevent an
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`applicant from later asserting that he invented that which he did not; the applicant for a
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`patent is therefore required to recount his invention in such detail that his future claims
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`can be determined to be encompassed within his original creation.” Amgen Inc. v.
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`Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1330 (Fed. Cir. 2003) (citation and quotation
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`marks omitted).
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`The test for determining the adequacy of the written description is whether it
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`“reasonably conveys to those skilled in the art that the inventor had possession of the
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`claimed subject matter as of the filing date.” Ariad, 598 F.3d at 1351. The adequacy of
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`the written description is a question of fact and “varies depending on the nature and
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`scope of the claims and on the complexity and predictability of the relevant
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`technology.” Id.
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`Medtronic’s expert, Dr. Paul Zalesky, opines that the written description for the
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`asserted patents does not reasonably convey to a person of ordinary skill in the art that
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`the inventor had possession of catheters with openings in locations other than the
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`substantially rigid portion. Zalesky Decl. ¶¶ 68‐85. Pointing to the prosecution history
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`of the RE’379 patent, Dr. Zalesky notes that the patent examiner rejected some of the
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`Medtronic Exhibit 1888 - Page 5
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`proposed claims on the basis that the original specification is “very clear” that the side
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`opening must be located in the rigid portion. Zalesky Decl. ¶ 82; ECF No. 117 at 18‐19.4
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`In response, Teleflex does not address whether a person of ordinary skill in the
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`art would understand, based on the written description, that the inventor had
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`possession of the claimed subject matter (that is, catheters with side openings outside of
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`the substantially rigid portion) as of the filing date. Instead, Teleflex asserts that “there
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`is nothing improper about presenting claims that are broader than the preferred
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`embodiments” and that the only exceptions to this “general rule” are where the
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`technology area is “highly unpredictable” and where the specification makes clear that
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`the unclaimed aspect is “critical to the invention.” ECF No. 183 at 16.
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`Teleflex mischaracterizes the law. While predictability and criticality can be
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`relevant to the adequacy of the written description, the focus is on what the disclosure
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`conveys to persons of ordinary skill in the art. Ariad, 598 F.3d at 1351. This
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`inquiry—which, again, is a question of fact for the jury, id. at 1355—“will necessarily
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`vary depending on the context,” id. at 1351, and “the precedential value of cases in this
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`area is extremely limited,” Amgen Inc. v. Sanofi, 872 F.3d 1367, 1377 (Fed. Cir. 2017)
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`(citation and quotation marks omitted). As the Federal Circuit stated in Ariad,
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`4When citing documents by ECF number, the Court cites the page number
`generated by the electronic docketing system rather than the document’s internal
`pagination.
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`Medtronic Exhibit 1888 - Page 6
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`[W]e do not try here to predict and adjudicate all the factual
`scenarios to which the written description requirement
`could be applied. Nor do we set out any bright‐line rules
`governing, for example, the number of species that must be
`disclosed to describe a genus claim, as this number
`necessarily changes with each invention, and it changes with
`progress in a field.
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`Ariad, 598 F.3d at 1351.
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`Teleflex next argues that the specification explicitly discloses side openings in
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`portions other than the “substantially rigid” portion, pointing to Figure 1 of the
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`specification as an example. As can be seen in Figures 4 and 12 through 16, however,
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`the side opening is actually in the rigid portion. Am. Compl. Ex. G Figs. 1, 4, 12‐16; see
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`also Hr’g Tr. 182 (“All of the embodiments disclose [the side opening] in what the patent
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`is calling the rigid portion.”).
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`Teleflex also points to Figures 10 and 11, which depict relief cuts in the rigid
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`portion. Am. Compl. Ex. G Figs. 10, 11. Teleflex reasons that, because the relief cuts
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`render the rigid portion more flexible, this amounts to a disclosure that the side opening
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`need not be located in the rigid portion. The fact remains, however, that the only
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`disclosed location for the side opening is in the rigid portion. Teleflex offers no
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`evidence that the possibility of increasing the flexibility of the rigid portion would
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`convey to a person of ordinary skill in the art that the side opening could be placed
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`somewhere other than in that rigid portion.
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`Medtronic Exhibit 1888 - Page 7
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`Teleflex also points to the language of ¶ 8 of the written description, which states
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`that the rigid portion “may” include a cutout and full‐circumference portion (i.e., a side
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`opening), suggesting that use of the permissive “may” indicates that the location of the
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`side opening is not critical to the invention. See Am. Compl. Ex. G at 3:49‐51. But rather
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`than being an elliptical way of indicating that the side opening can appear outside of
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`the rigid portion, the permissive language is more naturally read as indicating that the
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`device may or may not include a side opening. In other words, while this language
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`may suggest that the existence of a side opening is not critical, it cannot easily be read to
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`indicate that, when a side opening exists, its placement is irrelevant. Setting that aside,
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`criticality is simply one possible factor among many in the overall inquiry concerning
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`whether a person of ordinary skill in the art would recognize, based on the written
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`description, that Teleflex had possession of catheters with side openings located outside
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`of the substantially rigid portion.
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`Although the record is somewhat thin, and although the Court is mindful of the
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`parties’ respective burdens on this issue, Medtronic has nevertheless raised a
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`substantial question regarding the adequacy of the written description. Medtronic
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`offers unrebutted expert testimony that the written description is inadequate and points
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`out that a patent examiner was troubled by the same issue, which is at least
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`circumstantial evidence of a problem. While it is true that the examiner ultimately
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`allowed the application, she did not offer a word of explanation for her volte‐face on the
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`written‐description issue.
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`In contrast to Medtronic’s evidence, Teleflex offers no evidence of what a person
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`of ordinary skill in the art would understand the written description to disclose. To the
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`contrary, Teleflex failed to address that issue in its memoranda or even identify it as the
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`governing standard. As Medtronic has raised a substantial question with respect to the
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`adequacy of the written description, and as Teleflex has offered nothing relevant in
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`response, the Court cannot find that Teleflex is likely to succeed in defeating
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`Medtronic’s written‐description validity challenge to the asserted claims of the RE’776,
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`RE’379, and RE’760 patents.
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`2. Anticipation
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`Medtronic contends that most of the asserted claims are invalid as anticipated by
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`U.S. Patent No. 7,736,355 (“Itou”). Niederluecke Decl. Ex. 1. For purposes of this
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`motion, the parties agree that, if Itou qualifies as prior art, all asserted claims of the
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`RE’380 patent5 (as well as all other asserted claims, save three) would be anticipated by
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`Itou. The parties’ dispute, therefore, centers on whether Itou is prior art.
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`5As the Court has already found that Medtronic has raised a substantial question
`with respect to the validity of the asserted claims in the RE’776, RE’379, and RE’760
`patents, the RE’380 patent is the only remaining patent at issue. For purposes of this
`motion, Teleflex asserts infringement of claims 12, 13, and 15 of the RE’380 patent.
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`IPR2020-00131
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`Medtronic Exhibit 1888 - Page 9
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`CASE 0:19-cv-01760-PJS-TNL Document 247 Filed 04/09/20 Page 10 of 17
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`Itou’s September 23, 2005 filing date predates the May 3, 2006 filing date of
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`Application No. 11/416,629, the common application from which the RE’380 patent and
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`the other asserted patents descend. Under the applicable6 version of 35 U.S.C. § 102,
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`however, it is the invention date, not the filing date, that determines priority.
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`Specifically, a patentee may claim priority to either of two earlier dates: (1) the date the
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`invention was reduced to practice; or (2) the date that the inventor first conceived the
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`invention, if the inventor thereafter exercised reasonable diligence in reducing it to
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`practice. Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996). “Reasonable
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`diligence must be shown throughout the entire critical period, which begins just prior to
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`the competing reference’s effective date and ends on the date of the invention’s
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`reduction to practice.” Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d
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`1004, 1007 (Fed. Cir. 2016).
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`As Medtronic has come forward with evidence of art that indisputably predates
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`the RE’380 patent’s filing date, Teleflex bears the burden of production to offer evidence
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`showing an earlier invention date. Mahurkar, 79 F.3d at 1576‐77. To be sure, Medtronic
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`will bear the ultimate burden at trial to persuade the jury, by clear and convincing
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`evidence, that Teleflex’s invention date does not precede September 23, 2005. Id.
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`6Because the common application that led to the family of patents at issue in this
`case was filed before March 16, 2013, the pre‐America Invents Act version of § 102
`applies. Quest Integrity USA, LLC v. Cokebusters USA Inc., 924 F.3d 1220, 1225 n.1 (Fed.
`Cir. 2019).
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`at 1578. As noted, however, Medtronic’s burden is somewhat lower at this stage;
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`Medtronic need only raise a substantial question as to invalidity that Teleflex cannot
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`prove lacks substantial merit. In that regard, it is important to recognize that Medtronic
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`has already cleared a major hurdle, as it is undisputed that, if Itou does constitute prior
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`art, it anticipates the RE’380 patent.
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`Teleflex relies on the testimony of Howard Root, one of the inventors of the
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`patented device. But to establish an earlier invention date, an inventor’s testimony
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`must be supported by corroborating evidence. Id. at 1577 (conception); Perfect Surgical,
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`841 F.3d at 1007 (diligence); Loral Fairchild Corp. v. Matsushita Elec., 266 F.3d 1358, 1363
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`(Fed. Cir. 2001) (reduction to practice). The parties dispute whether Teleflex has offered
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`sufficient evidence to corroborate Root’s testimony regarding diligence and reduction to
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`practice.
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`Root attests that the invention was conceived by the beginning of 2005 and that it
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`had been reduced to practice by at least August 2005, at which point the inventors had
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`built and tested multiple different prototypes. Root Decl. ¶¶ 6‐7, 42. To corroborate
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`Root’s testimony, Teleflex offers various invoices, lab notes, memos, photographs, and
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`other supporting documents.
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`Medtronic points out, however, that during 2005 and 2006, the inventors were
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`working on two different types of catheters: an over‐the‐wire (“OTW”) version and a
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`rapid‐exchange (“Rx”) version. Root Decl. ¶ 11; see Zalesky Decl. ¶¶ 21‐22 (describing
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`the difference between the two types). The invention at issue here is the Rx version of
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`the catheter, but, as Medtronic correctly notes, much of Root’s declaration, and much of
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`the supposedly corroborating documentation, speaks generically of the GuideLiner
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`catheter without specifying whether it is referring to the OTW version or the Rx version.
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`More importantly, as Medtronic also points out, there is a remarkable
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`discrepancy between the robust documentation of the development of the OTW version
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`and the meager documentation that Teleflex has submitted to corroborate the reduction
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`to practice of the Rx version. Teleflex has not submitted any laboratory notes, testing
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`results, or prototype build records relating to an actual prototype of the Rx design.7 In
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`fact, Teleflex has not submitted any primary documents of the type that the Court
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`would expect to see to corroborate the creation of an Rx prototype. Instead, Teleflex has
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`relied primarily on invoices and payment records for component parts and other
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`materials; more than half of the 60 exhibits that Teleflex has submitted consist of such
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`documents. Yet, with respect to the majority of those documents, Teleflex does not
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`7Teleflex has submitted laboratory and other notes that document conception.
`See Root Decl. Exs. 1, 2. As noted, however, conception is not in dispute for purposes of
`this motion. Teleflex also contends that certain laboratory and other notes for the OTW
`version are also relevant to the Rx version, either because the experiments documented
`therein would be relevant to both versions, or because the “OTW” designation is
`mistaken. See Root Decl. ¶¶ 48, 57, 59 & Exs. 34, 41, 43. Teleflex may be correct, but
`there is at least a substantial question concerning the weight to be given to such
`documents.
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`claim anything more than that these components were for GuideLiner prototypes or
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`devices. See Root Decl. ¶¶ 20‐25, 27, 33‐35, 46, 54‐55, 60, 63‐66, 70‐71, 75. As it is clear
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`that Teleflex was performing substantial work on the OTW version of the Guideliner,
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`these documents do little to corroborate either diligence or reduction to practice of the
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`Rx version.
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`Aside from these records, Teleflex submits various corporate documents, such as
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`budget reports, marketing feasibility documents, legal bills, and other assorted
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`memoranda that mention GuideLiner catheters. Again, though, a number of these
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`documents appear to relate to the GuideLiner brand generally (or to the OTW version
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`specifically) without referring to the Rx version. See, e.g., Root Decl. Exs. 4, 19, 52, 58.
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`And the documents that discuss the Rx version mostly seem to indicate that work was
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`in the preliminary stages. See, e.g., Root Decl. Exs. 2, 17, 20, 28, 29, 37, 40. Notably, a
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`report dated December 1, 2005—months after Teleflex’s claimed reduction to
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`practice—states that “[t]he rapid exchange version requires additional engineering and
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`is not included in our 2006 forecasts.” Root Decl. Ex. 40.
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`To be sure, the record contains some scattered references to Rx prototypes and
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`testing. See, e.g., Root Exs. 36, 42. But these references are often ambiguous and could
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`be read to refer to other types of catheters. Moreover, the types of documents in which
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`these references appear only serve to highlight the lack of primary documentation that
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`would typically be generated during the development and testing of a medical device.
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`The dearth of such documentation, coupled with the unimpressive nature of the
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`corroborating documents that Teleflex submitted, means that Medtronic has more than
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`met its burden to raise a substantial question as to the status of Itou as prior art (and
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`therefore as to the validity of the RE‘380 patent).
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`C. Other Factors
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`Because Medtronic has raised substantial questions concerning the validity of all
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`of the asserted patent claims, Teleflex is not entitled to a preliminary injunction.
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`Metalcraft, 848 F.3d at 1364 (“A preliminary injunction should not issue if the accused
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`infringer raises a substantial question concerning either infringement or validity.”
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`(citation and quotation marks omitted)). The Court also notes that Teleflex has failed to
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`make a particularly compelling case that it is threatened with “substantial and
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`immediate irreparable injury.” Apple Inc. v. Samsung Elecs. Co., 695 F.3d 1370, 1374 (Fed.
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`Cir. 2012) (citation and quotation marks omitted).
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`Teleflex’s GuideLiner is a well‐known and trusted product in a highly
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`specialized and defined market consisting of extremely sophisticated consumers.
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`Welch Dep. 94‐96 (there are roughly 2000 “cath labs” in the United States in which
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`GuideLiner could be used, and GuideLiner is a trusted, “staple” product in all of them).
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`Teleflex claims that it has lost sales to Medtronic, but loss of sales is the quintessential
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`“reparable” injury, and Teleflex has shown itself perfectly capable of calculating the
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`resulting losses. See Welch Dep. 71, 75, 80‐82, 85, 90‐92, 196, 288; Welch Decl. ¶¶ 49, 52;
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`see also Metalcraft, 848 F.3d at 1368 (“Evidence of potential lost sales alone does not
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`demonstrate irreparable harm.”).
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`Teleflex is also well‐positioned to weather any short‐term losses, as GuideLiner
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`has a high profit margin and as North American sales of GuideLiner comprise only a
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`minuscule portion of Teleflex’s business. Specifically, U.S. sales of GuideLiner made up
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`less than 1.5% of Teleflex’s revenues in 2018. Welch Dep. 69, 112‐13, 259; Friedemann
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`Ex. HHH ¶ 24. Cf. TEK Glob., S.R.L. v. Sealant Sys. Int’l, Inc., 920 F.3d 777, 792 (Fed. Cir.
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`2019) (no error in finding threat of irreparable harm on basis of patentee’s lack of
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`diversification, which exposed it to a particular risk of lowered market share).8
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`Teleflex works hard to cloak reparable sales losses in irreparable garb.
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`Predictably, Teleflex complains that its reputation and goodwill are at risk. But any
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`threat appears highly speculative. Teleflex claims that doctors may attribute any
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`8Citing Robert Bosch LLC v. Pylon Manufacturing Corp., 659 F.3d 1142 (Fed. Cir.
`2011), Teleflex argues that its size and the relatively minor impact of lost GuideLiner
`sales on the company as a whole are legally irrelevant. The Court disagrees. In Bosch,
`the district court “erred in relying exclusively on the presence of additional competitors
`and on the non‐core nature of Bosch’s wiper blade business” in the face of
`“overwhelming evidence” of irreparable harm. Id. at 1150‐51 (emphasis added).
`Moreover, by emphasizing the threat allegedly posed by Medtronic’s size and
`resources, Teleflex itself put at issue its own size and the relative importance of
`GuideLiner to its overall operations.
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`IPR2020-00131
`Medtronic v. Teleflex
`Medtronic Exhibit 1888 - Page 15
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`
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`CASE 0:19-cv-01760-PJS-TNL Document 247 Filed 04/09/20 Page 16 of 17
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`problems with Medtronic’s Telescope to GuideLiner, but Teleflex does not identify any
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`such problems—and, as noted, GuideLiner is a well‐known and trusted product.
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`Teleflex also cites a litany of other potential harms, such as a reduced sales force,
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`lost sales of other Teleflex products, and a shrinking R&D budget—the types of harms
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`that could be claimed by most patentees in most cases involving lost sales. Again,
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`though, Teleflex’s claims are highly speculative. Teleflex has not actually lost any sales
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`representatives, and Teleflex cannot identify any lost sales of other Teleflex products.
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`Welch Dep. 239, 326‐27. Moreover, Teleflex’s R&D budget is based on revenue for the
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`entire North American interventional business unit, not just revenue from GuideLiner.
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`Welch Dep. 330. It therefore appears to the Court that any harm that Teleflex may
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`suffer during the pendency of this case will be reparable with money damages.
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`As for the remaining factors: In the absence of a likelihood of success on the
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`merits, the public interest weighs against limiting competition and in favor of
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`permitting the sale of potentially lifesaving medical devices. See Cardoso Decl. ¶ 9 &
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`Ex. B (survey results with positive feedback from doctors about Telescope). That leaves
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`the balance of harms. Even assuming that this factor weighs in Teleflex’s favor, it
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`cannot by itself justify a preliminary injunction.
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`For these reasons, Teleflex’s motion for a preliminary injunction is denied.
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`-16-
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`IPR2020-00131
`Medtronic v. Teleflex
`Medtronic Exhibit 1888 - Page 16
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 247 Filed 04/09/20 Page 17 of 17
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`ORDER
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`Based on the foregoing, and on all of the files, records, and proceedings herein,
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`IT IS HEREBY ORDERED THAT plaintiffs’ motion for a preliminary injunction [ECF
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`No. 73] is DENIED.
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`LET JUDGMENT BE ENTERED ACCORDINGLY.
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`Dated: April 9, 2020
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` s/Patrick J. Schiltz
`Patrick J. Schiltz
`United States District Judge
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`-17-
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`IPR2020-00131
`Medtronic v. Teleflex
`Medtronic Exhibit 1888 - Page 17
`
`