Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page1 of 21
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`Gregory L. Diskant (admitted pro hac vice)
`Eugene M. Gelernter (admitted pro hac vice)
`Maggie Wittlin (admitted pro hac vice)
`PATTERSON BELKNAP WEBB & TYLER LLP
`1133 Avenue of the Americas
`New York, NY 10036
`Telephone: (212) 336-2000
`Facsimile: (212) 336-2222
`gldiskant@pbwt.com
`emgelernter@pbwt.com
`mwittlin@pbwt.com
`Charles D. Hoffmann (admitted pro hac vice)
`Sean Marshall (admitted pro hac vice)
`HOFFMANN MARSHALL STRONG LLP
`116 W 23rd Street, Suite 500
`New York, NY 10011
`Telephone: (212) 851-8403
`Facsimile: (646) 741-4502
`charlie@hmscounsel.com
`sean@hmscounsel.com
`
`Susan Roeder (S.B. #160897)
`O’MELVENY & MYERS LLP
`2765 Sand Hill Road
`Menlo Park, CA 94025
`Telephone: (650) 473-2600
`Facsimile: (650) 473-2601
`sroeder@omm.com
`
`Attorneys for Plaintiffs LIFESCAN, INC.
`and LIFESCAN SCOTLAND, LTD.
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`SAN FRANCISCO DIVISION
`
`LIFESCAN, INC. and LIFESCAN
`SCOTLAND, LTD.,
`
`Plaintiffs,
`
`Case No. CV11-04494-WHO
`
`OPPOSITION TO DEFENDANTS’ MOTION
`FOR JUDGMENT ON THE PLEADINGS
`
`v.
`
`SHASTA TECHNOLOGIES, LLC,
`CONDUCTIVE TECHNOLOGIES, INC.,
`DECISION DIAGNOSTICS CORP. and
`PHARMATECH SOLUTIONS, INC.,
`
`Defendants.
`
`(ECF No. 399)
`
`Date:
`Time:
`Place:
`Judge:
`
`May 14, 2014
`2 p.m.
`17th Floor, Courtroom 2
`Hon. William H. Orrick
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`OPPOSITION TO DEFENDANTS’ MOTION
`FOR JUDGMENT ON THE PLEADINGS
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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page2 of 21
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`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ................................................................................................................ ii
`
`A.
`
`B.
`
`Introduction................................................................................................................................1
`
`Factual Background ...................................................................................................................1
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`The ‘105 Patent..............................................................................................................1
`
`The Parties’ Products .....................................................................................................2
`
`Procedural History .........................................................................................................2
`
`The Federal Circuit Decision.........................................................................................4
`
`Evidence and Arguments Not Considered at the Preliminary Injunction Stage
`Show that the Meters Do Not Embody the ‘105 Patent’s Inventive Aspects ................6
`
`C.
`
`This Court Should Deny Defendants’ Motion for Judgment on the Pleadings .........................9
`
`1.
`
`2.
`
`3.
`
`4.
`
`Defendants Cannot Meet the Standard for Judgment on the Pleadings.........................9
`
`Defendants Cannot Meet the Summary Judgment Standard .......................................11
`
`The Federal Circuit Decision Does Not Bar the Presentation of Additional
`Evidence on Patent Exhaustion....................................................................................12
`
`Collateral Estoppel Does Not Bar LifeScan from Litigating the Exhaustion
`Issue on the Merits.......................................................................................................14
`
`a.
`
`b.
`
`There is No Final Judgment on the Merits in a Previous Action.....................15
`
`LifeScan Did Not Have an Opportunity to Fully Develop the Evidence
`at the Preliminary Injunction Stage..................................................................15
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`CONCLUSION....................................................................................................................................16
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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page3 of 21
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`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Altana Pharma AG v. Teva Pharms. USA Inc.,
`566 F.3d 999 (Fed. Cir. 2009)..................................................................................................12
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001)..................................................................................................5
`
`Anderson v. Liberty Lobby, Inc.,
`477 U.S. 242 (1986).................................................................................................................11
`
`Apple, Inc. v. Samsung Elecs. Co.,
`920 F. Supp. 2d 1079 (N.D. Cal. 2013) .....................................................................................9
`
`Aro Manufacturing Co. v. Convertible Top Replacement Co.,
`365 U.S. 336 (1961)...............................................................................................................3, 8
`
`Atari Games Corp. v. Nintendo of Am.,
`Nos. C 88-4805, C 89-0027, 1993 U.S. Dist. LEXIS 8183 (N.D. Cal. Apr. 15, 1993)...........13
`
`Cornell Univ. v. Hewlett-Packard Co.,
`No. 01-cv-1974, 2008 U.S. Dist. LEXIS 60209 (N.D.N.Y. Aug. 1, 2008).........................9, 12
`
`Ctr. for Biological Diversity v. Salazar,
`706 F.3d 1085 (9th Cir. 2013) .......................................................................................4, 12, 13
`
`Fleming v. Pickard,
`581 F.3d 922 (9th Cir. 2009) ...................................................................................................10
`
`Freedman Seating Co. v. Am. Seating Co.,
`420 F.3d 1350 (Fed. Cir. 2005)................................................................................................14
`
`Fresenius USA, Inc. v. Baxter Int’l, Inc.,
`721 F.3d 1330 (Fed. Cir. 2013)................................................................................................13
`
`Genentech, Inc. v. Novo Nordisk A/S,
`108 F.3d 1361 (Fed. Cir. 1997)................................................................................................13
`
`Gilligan v. Jamco Dev. Corp.,
`108 F.3d 246 (9th Cir. 1997) ...................................................................................................10
`
`Glaxo Grp. Ltd. v. Apotex, Inc.,
`376 F.3d 1339 (Fed. Cir. 2004)................................................................................................13
`
`Haberman v. Gerber Prods. Co.,
`236 F. App’x 592 (Fed. Cir. 2007) ..........................................................................................14
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`

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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page4 of 21
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`Hansen Beverage Co. v. Vital Pharm., Inc.,
`No. 08-CV-1545, 2008 U.S. Dist. LEXIS 105447 (S.D. Cal. Dec. 30, 2008).........................15
`
`Heuft Systemtechnik GmbH v. Indus. Dynamics Co.,
`282 F. App’x 836 (Fed. Cir. 2008) ..........................................................................................14
`
`In re iPhone 4S Consumer Litig.,
`No. C 12-1127 CW, 2013 U.S. Dist. LEXIS 103058 (N.D. Cal. July 23, 2013) ....................10
`
`In re King,
`801 F.2d 1324 (Fed. Cir. 1986)..................................................................................................7
`
`Kemin Foods v. Pigmentos Vegetales Del Centro S.A. De C.V.,
`No. 4:02-cv-40327, 2004 U.S. Dist. LEXIS 31188 (S.D. Iowa Sept. 9, 2004) .......................13
`
`Kendall v. Visa USA, Inc.,
`518 F.3d 1042 (9th Cir. 2008) ...........................................................................................14, 15
`
`Keurig, Inc. v. Sturm Foods, Inc.,
`732 F.3d 1370 (Fed. Cir. 2013)................................................................................................10
`
`LifeScan Scotland, Ltd. v. Shasta Technologies, LLC,
`734 F.3d 1361 (Fed. Cir. 2013)........................................................................................ passim
`
`Loctite Corp. v. Ultraseal Ltd.,
`781 F.2d 861 (Fed. Cir. 1985)....................................................................................................7
`
`Minebea Co. v. Papst,
`374 F. Supp. 2d 202 (D.D.C. 2005)...........................................................................................9
`
`Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368 (Fed. Cir. 2005)..................................................................................................7
`
`Purdue Pharma L.P. v. Boehringer Ingelheim GmbH,
`237 F.3d 1359 (Fed. Cir. 2001)................................................................................................12
`
`Quanta Computer, Inc. v. LG Electronics, Inc.,
`553 U.S. 617 (2008)......................................................................................................... passim
`
`Scott v. Harris,
`550 U.S. 372 (2007).................................................................................................................11
`
`Scott v. Kuhlmann,
`746 F.2d 1377 (9th Cir. 1984) .................................................................................................10
`
`Storage Tech. Corp. v. Custom Hardware Engineering & Consulting, Ltd.,
`02-12102, 2006 U.S. Dist. LEXIS 43690 (D. Mass. June 28, 2006).......................................13
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc,
`617 F.3d 1296 (Fed. Cir. 2010)................................................................................................14
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`iii
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`OPPOSITION TO DEFENDANTS’ MOTION
`FOR JUDGMENT ON THE PLEADINGS
`CASE NO. CV11-04494-WHO
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`Pharmatech Solutions, Inc: EXHIBIT 1030 - 4
`IPR2013-00247, U.S. Pat. No. 7,250,105
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`

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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page5 of 21
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`Turner v. Cook,
`362 F.3d 1219 (9th Cir. 2004) .................................................................................................10
`
`Ugine & ALZ Belgium v. United States,
`452 F.3d 1289 (Fed. Cir. 2006)................................................................................................12
`
`Univ. of Tex. v. Camenisch,
`451 U.S. 390 (1981).....................................................................................................12, 15, 16
`
`Weisbuch v. County of Los Angeles,
`119 F.3d 778 (9th Cir. 1997) ...................................................................................................10
`
`Wolfson v. Brammer,
`616 F.3d 1045 (9th Cir. 2010) .................................................................................................14
`
`STATUTES
`
`35 U.S.C. § 103................................................................................................................................2
`
`35 U.S.C. § 271(c) ...........................................................................................................................8
`
`OTHER AUTHORITIES
`
`Bernard Chao, Breaking Aro’s Commandment: Recognizing that Inventions Have Heart, 20
`Fordham Intell. Prop. Media & Ent. L.J. 1183 (2010)...............................................................8
`
`Fed. R. Civ. P. 56(a) ......................................................................................................................11
`
`Fed. R. Civ. P. 12(c) ............................................................................................................9, 10, 11
`
`Thomas G. Hungar, Observations Regarding the Supreme Court’s Decision in Quanta
`Computer v. LG Electronics, Inc., 49 IDEA 517 (2009)...........................................................8
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`iv
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`OPPOSITION TO DEFENDANTS’ MOTION
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`CASE NO. CV11-04494-WHO
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`A.
`
`Introduction
`
`Defendants have moved for judgment on the pleadings dismissing the claims of
`
`infringement of U.S. Patent No. 7,250,105 (the ‘105 patent) in reliance on the Federal Circuit’s
`
`decision in this case reversing the grant of a preliminary injunction. LifeScan Scotland, Ltd. v.
`
`Shasta Technologies, LLC, 734 F.3d 1361 (Fed. Cir. 2013). Plaintiffs LifeScan Inc. and LifeScan
`
`Scotland, Ltd. (collectively, “LifeScan”) oppose that motion.
`
`On the limited record presented at the preliminary injunction stage, the panel majority
`
`in LifeScan v. Shasta “conclude[d] that LifeScan is not likely to prevail on the patent exhaustion
`
`issue . . . .” Id. at 1370 n.3. The Federal Circuit decision does not bar LifeScan from asserting
`
`infringement on a more complete record. Defendants’ motion for judgment on the pleadings should
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`be denied.
`
`B.
`
`Factual Background
`
`1.
`
`The ‘105 Patent
`
`The ‘105 patent is addressed to a method of measuring blood glucose levels. Persons
`
`with diabetes periodically test their blood glucose levels by placing a drop of blood onto a disposable
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`test strip that has been inserted into a meter. The meter determines the blood glucose level in the
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`sample by measuring the electrical current generated when the presence of glucose triggers an
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`electrochemical reaction in the strip. Earlier measuring devices could provide inaccurate results,
`
`e.g., if there was insufficient blood in the sample or manufacturing defects in the test strip. See
`
`Declaration of Mark Meyerhoff, Ph.D., dated April 17, 2014 (“Meyerhoff Decl.”), Ex. B at col.
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`1:25-64 (‘105 patent).
`
`The ‘105 patent discloses a “measuring device” comprising a test strip with two
`
`working sensors, with the second sensor downstream of the first. Because of the arrangement of the
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`sensors, the blood sample must completely cover the first working sensor before it begins to cover
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`the second. If there is too little blood in the sample, a lower current is generated in the second sensor
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`than in the first, and the meter provides an error message. Likewise, if one of the sensors is
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`defective, the currents generated in the sensors will differ and the user will be alerted of a problem.
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`CASE NO. CV11-04494-WHO
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`This system—involving two measurements for every blood sample—protects against errors and
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`provides increased accuracy in blood glucose measurements. Id. at col. 5:52-59.
`
`2.
`
`The Parties’ Products
`
`LifeScan distributes the leading blood glucose measurement system, the OneTouch
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`Ultra system. That system includes OneTouch Ultra meters and OneTouch Ultra test strips. The test
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`strips are disposable, i.e., they are used only once and are not re-used.
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`Defendants’ GenStrip product is designed to work with LifeScan’s OneTouch Ultra
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`meters, as a substitute for LifeScan’s OneTouch Ultra test strips. LifeScan alleges in this case that
`
`using the GenStrip with LifeScan’s OneTouch Ultra meters infringes the ‘105 patent, and that
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`Defendants induce and contribute to that infringement.
`
`3.
`
`Procedural History
`
`In its initial complaint, LifeScan accused Defendants of infringing two other LifeScan
`
`patents, U.S. Patent Nos. 6,241,862 and 5,708,247.
`
`On December 5, 2012, this Court granted LifeScan’s motion for leave to amend its
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`complaint to add allegations of infringement of the ‘105 patent. ECF No. 169.
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`On December 10, 2012, LifeScan filed its First Amended Complaint, adding the ‘105
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`patent to this case. ECF No. 170 (Count III).
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`Four days later, on December 14, 2013, LifeScan moved for a preliminary injunction
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`against Defendants’ infringement of the ‘105 patent. ECF No. 176. Defendants opposed the
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`preliminary injunction motion on January 31, 2013. ECF No. 203. In their opposition, Defendants
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`argued at length that the ‘105 patent is invalid as obvious under 35 U.S.C. § 103. ECF No. 203 at
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`21-33. Their expert’s declaration was devoted almost entirely to that issue. ECF No. 206 at ¶¶ 29-
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`100. Defendants also argued that LifeScan’s OneTouch Ultra meters embody the “essential
`
`features” of the ‘105 invention and that LifeScan’s distribution of meters therefore exhausts its rights
`
`in the ‘105 patent under Quanta Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617, 632-33
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`(2008). ECF No. 203 at 9.
`
`Quanta holds that the doctrine of patent exhaustion applies to method claims if the
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`steps of the method practiced by a product distributed by the patent holder “all but completely
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`practice” or “embody” the “essential” or “inventive” features of the method patent. Id. The Court
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`found that chips sold by the patentee exhausted the asserted method patent “because they had no
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`reasonable noninfringing use and included all the inventive aspects of the patented methods.” Id. at
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`638. The Court specifically noted that it was not addressing a situation, as in Aro Manufacturing Co.
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`v. Convertible Top Replacement Co., 365 U.S. 336, 344-45 (1961), where none of the components of
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`a combination patent is independently patentable. Rather, the Quanta Court observed that “Aro’s
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`warning that no element can be viewed as central to or equivalent to the invention is specific to the
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`context in which the combination itself is the only inventive aspect of the patent.” 553 U.S. at 635.
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`After receiving Defendants’ opposition to the preliminary injunction motion,
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`LifeScan had two weeks to reply. Like Defendants’ opposition, LifeScan’s reply brief and
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`supporting evidence focused on validity issues and the prior art Defendants cited. On the exhaustion
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`issue, LifeScan briefly argued that the meter did not by itself embody the method claims and that the
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`test strips embodied key inventive aspects of the ‘105 patent. ECF No. 215 at 6-7. It did not address
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`whether LifeScan could have obtained patent claims on the meter or the test strip by themselves.
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`Nor did it discuss the Aro issue—whether the inventive aspect of the ‘105 patent lies in the
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`combination of the test strip and meter, rather than either component alone.
`
`On March 19, 2013, this Court granted LifeScan’s motion for a preliminary
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`injunction. ECF No. 246 (Davila, J.). As to likelihood of success, this Court found, inter alia, that:
`
`(i) Defendants’ GenStrip product “cop[ies]” the relevant features of LifeScan’s OneTouch Ultra test
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`strip and is “nearly identical” to the OneTouch Ultra test strips; (ii) “consumers likely practice the
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`‘105 patent when they use GenStrips in a OneTouch Ultra meter”; and (iii) Defendants “likely”
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`induce and contribute to that infringement. See ECF No. 246 at 25. This Court also found that
`
`“Plaintiffs have demonstrated a likelihood of overcoming Defendants’ patent exhaustion challenge
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`… because the meters alone do not substantially embody the ‘105 patent.” Id. The Court found that
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`LifeScan’s OneTouch Ultra test strips “are significant to the novelty of the ‘105 invention, and that
`
`the meters alone cannot ‘all but completely practice’ or embody the ‘essential’ or ‘inventive’ feature
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`of the ‘105 patent as required by Quanta, 553 U.S. at 632-33.” ECF No. 246 at 14.
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`Defendants appealed from the grant of a preliminary injunction.
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`OPPOSITION TO DEFENDANTS’ MOTION
`FOR JUDGMENT ON THE PLEADINGS
`CASE NO. CV11-04494-WHO
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`Pharmatech Solutions, Inc: EXHIBIT 1030 - 8
`IPR2013-00247, U.S. Pat. No. 7,250,105
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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page9 of 21
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`On October 8, 2013, this Court granted Defendants’ motion to stay proceedings in
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`this case concerning the ‘105 patent pending completion of an inter partes review (“IPR”) in the
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`Patent Office challenging the validity of the ‘105 patent, which Defendants initiated after the grant
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`of the preliminary injunction. ECF No. 372. On February 18, 2014, this Court gave Defendants
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`permission to file this motion and ruled that the stay pending completion of the IPR otherwise should
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`remain in effect. ECF No. 398. The IPR remains ongoing in the Patent Office.
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`4.
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`The Federal Circuit Decision
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`On November 4, 2013, a divided Federal Circuit panel reversed the grant of a
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`preliminary injunction and remanded for further proceedings. LifeScan v. Shasta, 734 F.3d 1361.
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`The panel stated that to obtain a preliminary injunction, LifeScan needed to “establish[ ] that [it] is
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`likely to succeed on the merits . . . .” Id. at 1366. It determined that LifeScan had not met this
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`burden: “[W]e conclude that LifeScan is not likely to prevail on the patent exhaustion issue . . . .”
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`Id. at 1370 n.3.
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`Defendants rely heavily on a sentence in the Federal Circuit’s decision stating
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`“‘[b]ecause we conclude that Shasta has established a patent exhaustion defense as a matter of law,
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`we reverse the grant of a preliminary injunction without reaching other issues in this case,’” ECF
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`No. 399 at 8 (quoting LifeScan, 734 F.3d at 1366), and on a similar sentence at the end of majority
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`opinion. Id. (quoting LifeScan, 734 F.3d at 1377) (stating “‘that LifeScan’s OneTouch Ultra meters
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`substantially embody the methods claimed in the ‘105 patent and that their distribution therefore
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`exhausts LifeScan’s patent rights.’”). As set forth below, the quoted passages cannot, and do not,
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`resolve the many exhaustion issues, both factual and legal, not fully presented on the appeal of a
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`preliminary injunction. At most, they constitute restatements—on the limited record presented—of
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`the Court’s conclusion that LifeScan did not meet its burden in the preliminary injunction
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`proceeding of demonstrating that is likely to prevail on the patent exhaustion issue at trial. But, as
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`we describe below, LifeScan will have much more in the way of evidence and arguments to present
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`at trial, which will make “the law declared at the preliminary stage . . . no longer relevant to the
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`different post-trial finding of facts.” Ctr. for Biological Diversity v. Salazar, 706 F.3d 1085, 1091
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`(9th Cir. 2013).
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`6396534v3
`6709372v.9
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`4
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`OPPOSITION TO DEFENDANTS’ MOTION
`FOR JUDGMENT ON THE PLEADINGS
`CASE NO. CV11-04494-WHO
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`IPR2013-00247, U.S. Pat. No. 7,250,105
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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page10 of 21
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`Relying on the record at the preliminary injunction stage, the panel majority
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`concluded that LifeScan had not shown as a factual matter that the test strips embody the inventive
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`aspects of the ‘105 patent. The Court emphasized that LifeScan had not been able to obtain patent
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`claims on the test strips alone. LifeScan, 734 F.3d. at 1370. Instead, analyzing the facts in the
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`record, the panel majority concluded that the evidence “suggest[s]” that “the claimed inventive
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`concept of the method claims of the ‘105 patent lies in the meter, rather than the strips . . . .” Id. In
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`so ruling, the Court did not consider whether LifeScan could have obtained patent claims on the
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`meter alone—an issue not addressed by either party on appeal. (As the dissent noted, “while the
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`majority devotes significant attention to the patentability of the test strip, it fails to demonstrate that
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`LifeScan’s meter is separately patentable.” Id. at 1380.) Nor did the Court consider whether the
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`inventive aspects of the invention actually lie in combination of the meter and test strips, rather than
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`either component separately—again, an issue not addressed by either party on appeal. And, of
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`course, the Court’s analysis was, in its entirety, limited to the evidence presented at the preliminary
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`injunction hearing. Having analyzed whether Defendants “‘raise[d] a substantial question
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`concerning . . . infringement,’” id. at 1366 (quoting Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
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`239 F.3d 1343, 1350-51 (Fed. Cir. 2001)), and concluding that they did, the panel majority reversed
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`this Court’s grant of a preliminary injunction and “remand[ed] for further proceedings consistent
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`with this opinion,” id. at 1377.
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`Judge Reyna dissented. He stated that “the test strips, and not the meters, embody
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`[the] essential features” of the ‘105 patent. Id. at 1378 (Reyna, J., dissenting). He emphasized that
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`prior art test strips used only one working electrode, whereas the test strip taught in the ‘105 patent
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`has two, and “[b]ut for the specialized test strips required by LifeScan’s patented method, the blood
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`glucose meter alone could not perform the ‘comparing’ and ‘giving an indication of error’ steps
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`viewed by the majority as essential to the patented method.” Id. at 1379. Further, he stated that “[a]
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`diabetic patient with a LifeScan test strip, a pencil, a pad of paper, and an ammeter” could perform
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`the patented method without using a blood glucose meter, and that the steps performed by the meter
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`are “common and noninventive.” Id. at 1379-80.
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`6396534v3
`6709372v.9
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`5
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`OPPOSITION TO DEFENDANTS’ MOTION
`FOR JUDGMENT ON THE PLEADINGS
`CASE NO. CV11-04494-WHO
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`IPR2013-00247, U.S. Pat. No. 7,250,105
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`

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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page11 of 21
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`The Court also rejected LifeScan’s separate argument that free distribution of meters
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`does not implicate the exhaustion doctrine. (LifeScan distributes half of its meters for free in starter
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`kits containing ten sample test strips.) LifeScan will no longer rely on that argument as the case
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`goes forward, and it is irrelevant to the exhaustion arguments that LifeScan will present. As Judge
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`Reyna observed in dissent, “[i]t is immaterial that LifeScan distributes the first ten test strips for free
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`because it intends for the patient to use those strips to perform its patented method. . . . Rather,
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`LifeScan insists that its patent rights are not exhausted with respect to additional strips that a patient
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`combines with the meter after the initial ten strips have been consumed.” Id. at 1381 n.5.
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`5.
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`Evidence and Arguments Not Considered at the Preliminary Injunction Stage
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`Show that the Meters Do Not Embody the ‘105 Patent’s Inventive Aspects
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`Additional factual evidence—not presented in the preliminary injunction phase and
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`not considered by the Federal Circuit—will permit a reasonable jury to conclude that the meters do
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`not embody the inventive aspects of the ‘105 patent, as required for the distribution of the meter to
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`constitute patent exhaustion. Rather, either the inventive aspects of the claimed method lie in test
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`strips (even if the strips are not patentable in and of themselves) or, alternatively, the inventive
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`aspects lie in the combination of meter and test strips. In view of the prior art, LifeScan could not
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`have obtained a patent on the meter alone or the steps it performs; the design of the test strip is a
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`critical part of what distinguishes the '105 patent method claims from the prior art. On these facts, a
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`reasonable jury could conclude that LifeScan’s distribution of meters does not constitute distributing
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`products that “all but completely practice” or “embody” the “essential” or “inventive” features of the
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`method patent, so that the defense of patent exhaustion is not applicable under Quanta, 553 U.S. at
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`632-33.
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`Relevant evidence not included in the record on the preliminary injunction motion is
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`discussed in the accompanying Declaration of LifeScan’s expert, Prof. Mark E. Meyerhoff. In his
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`declaration, Dr. Meyerhoff explains that “key inventive aspects of the ‘105 patent are embodied in
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`the test strip.” Meyerhoff Decl. ¶ 3. In addition, Dr. Meyerhoff explains that the steps performed by
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`LifeScan’s meter “cannot be viewed as embodying all or substantially all of the inventive features of
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`the ‘105 patent.” Meyerhoff Decl. ¶ 5. The claims of the ‘105 patent do not include any limitations
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`6
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`OPPOSITION TO DEFENDANTS’ MOTION
`FOR JUDGMENT ON THE PLEADINGS
`CASE NO. CV11-04494-WHO
`
`Pharmatech Solutions, Inc: EXHIBIT 1030 - 11
`IPR2013-00247, U.S. Pat. No. 7,250,105
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`

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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page12 of 21
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`concerning the structure or design of a meter. Indeed, the patent does not even require a blood
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`glucose meter. All steps of the claimed method could be performed by using a simple ammeter to
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`measure the current from each working sensor and compare the two signals by subtracting one from
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`the other. Id. ¶¶ 19-20.
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`Dr. Meyerhoff provides an extensive review of the prior art relating to measuring
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`devices, none of which was part of the preliminary injunction record or before the Federal Circuit.
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`This evidence demonstrates that the steps the meter performs were known in the art, and that
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`LifeScan would not have been able to obtain a patent on the meter or the steps it performs. As Dr.
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`Meyerhoff explains, “[t]he steps of measuring electric currents, comparing them, and giving an
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`indication of error if they differ by a given amount are not something that was new or innovative at
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`the time of the invention of the ‘105 patent. Systems that use redundancy as a reliability check have
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`existed for a long time.” Id. ¶ 24 (citing U.S. Patent No. 4,337,516 at col. 1:59-64); see also id.
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`¶¶ 25-27 (citing U.S. Patent Nos. 3,496,836; 3,667,057; and 3,895,223). The process of “measuring
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`and comparing signals and giving an indication of error was widely known and not inventive as of
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`the time of the ‘105 patent.” Id. ¶ 28 (citing six prior art patents that teach this process). When the
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`‘105 patent was filed, these steps “had already been used in conjunction with measuring the
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`concentration of a substance in a liquid.” Id. ¶ 29 (citing U.S. Patent No. 5,924,794). For these
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`reasons, LifeScan could not have obtained a patent with claims directed to meter alone or to the
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`functions it performs. Id. ¶ 32. On this evidence, the meter and the steps it performs do not—and
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`cannot—embody the inventive aspects of the ‘105 patent. Id. ¶ 35.
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`The panel majority concluded that the test strips were not patentable as a product in
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`and of themselves. But “[n]ew uses of old products … are indeed patentable subject matter.”
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`Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed. Cir. 2005). As a result, it is a
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`different question whether the test strips—whether or not independently patentable—nonetheless
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`embody the patented method. See In re King, 801 F.2d 1324, 1326 (Fed. Cir. 1986) (process patent
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`may cover a new use of an old structure); Loctite Corp. v. Ultraseal Ltd., 781 F.2d 861, 875 (Fed.
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`Cir. 1985) (“a process using a known composition in a new and unobvious way may be patentable”).
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`Based on the evidence presented by LifeScan, a reasonable jury could determine that it is the test
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`6396534v3
`6709372v.9
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`7
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`OPPOSITION TO DEFENDANTS’ MOTION
`FOR JUDGMENT ON THE PLEADINGS
`CASE NO. CV11-04494-WHO
`
`Pharmatech Solutions, Inc: EXHIBIT 1030 - 12
`IPR2013-00247, U.S. Pat. No. 7,250,105
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`

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`Case3:11-cv-04494-WHO Document410 Filed04/18/14 Page13 of 21
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`strips, and not the (unpatentable) meter, that embody the method of the ‘105 patent. Alternatively, a
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`reasonable jury could find (as in Aro) that the inventive aspects of the invention lie in “the
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`combination itself” and not in its components. Quanta, 553 U.S. at 635 (citing Aro, 365 U.S. at 344-
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`45). Either way, the meter does not