Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 1 of 26 PageID #: 1495
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`INO THERAPEUTICS LLC and
`IKARIA, INC.,
`
`
`
`C.A. No. 15-170 (GMS)
`
`)))))))))))
`
`
`
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`
`
`
`PRAXAIR DISTRIBUTION, INC. and
`PRAXAIR, INC.,
`
`
`
`
`
`Defendants.
`
`
`
`
`
`PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION FOR JUDGMENT
`ON THE PLEADINGS FOR COUNTS I-V OF PLAINTIFFS’ COMPLAINT
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Derek J. Fahnestock (#4705)
`1201 North Market Street
`P. O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`dfahnestock@mnat.com
`
`Attorneys for Plaintiffs
`
`
`
`
`
`
`OF COUNSEL:
`
`Kenneth G. Schuler
`David Callahan
`Marc N. Zubick
`LATHAM & WATKINS LLP
`330 North Wabash Avenue, Suite 2800
`Chicago, IL 60611
`(312) 876-7700
`
`Melissa A. Brand
`LATHAM & WATKINS LLP
`John Hancock Tower, 27th Floor
`200 Clarendon Street
`Boston, MA 02116
`(617) 948-6000
`
`January 27, 2016
`
`
`
`000
`
`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 2 of 26 PageID #: 1496
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`
`TABLE OF CONTENTS
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`Page
`
`TABLE OF CITATIONS ........................................................................................................... ii
`
`I. 
`
`II. 
`
`NATURE AND STAGE OF PROCEEDINGS ................................................................ 1 
`
`SUMMARY OF ARGUMENT ....................................................................................... 1 
`
`III. 
`
`STATEMENT OF FACTS .............................................................................................. 2 
`
`A. 
`
`B. 
`
`The Five Challenged Patents ................................................................................ 2 
`
`Background of the Invention ................................................................................ 3 
`
`1. 
`
`2. 
`
`3. 
`
`The Prior Use of iNO in Neonates Suffering From Hypoxic
`Respiratory Failure Only Excluded Neonates Dependent on Right-
`to-Left Shunting, Not Those With Preexisting LVD ................................. 4 
`
`The Original INOT22 Study Protocol Did Not Exclude Neonates
`with Non-RTL-Dependent LVD ............................................................... 5 
`
`Unanticipated SAEs Occurred During the INOT22 Study, the
`Study Was Amended, and the Rate of SAEs Was Significantly
`Reduced ................................................................................................... 6 
`
`C. 
`
`Prosecution History .............................................................................................. 7 
`
`IV. 
`
`LEGAL STANDARDS ................................................................................................... 8 
`
`A. 
`
`B. 
`
`Rule 12(c) Motions .............................................................................................. 8 
`
`Section 101 .......................................................................................................... 9 
`
`V. 
`
`ARGUMENT ................................................................................................................ 11 
`
`A. 
`
`B. 
`
`C. 
`
`Defendants’ Motion Should Be Denied Because They Have Failed To
`Submit Evidence Required To Satisfy Their High Burden ................................. 12 
`
`Defendants’ Motion Should Be Denied Because The Parties Dispute That
`The Claims Recite a “Law Of Nature” ............................................................... 13 
`
`Defendants’ Motion Should Be Denied Because The Parties Dispute
`Whether The Claims “As A Whole” Recite Only Conventional Activity ............ 15 
`
`VI. 
`
`CONCLUSION ............................................................................................................. 20
`
`i
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`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 3 of 26 PageID #: 1497
`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`
`
`Page(s)
`
`Accenture Glob. Servs. Gmbh v. Guidewire Software, Inc.,
`728 F.3d 1336 (Fed. Cir. 2013) .............................................................................................. 8
`
`Alice Corp. Pty. Ltd. v. CLS Bank International,
`134 S. Ct. 2347 (2014) ................................................................................................ 1, 9, 19
`
`Ameritox, Ltd. v. Millennium Health, LLC,
`88 F. Supp. 3d 885, 907 (W.D. Wisc. 2015) ........................................................................ 16
`
`Ariosa Diagnostics, Inc. v. Sequenom, Inc.,
`788 F.3d 1371 (Fed. Cir. 2015) ...................................................................................... 13, 15
`
`Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,
`133 S. Ct. 2107 (2013) ........................................................................................ 9, 10, 14, 18
`
`Ass’n For Molecular Pathology v. U.S. PTO,
`689 F.3d 1303 (Fed. Cir. 2012) ............................................................................................ 10
`
`In re Cominsky,
`554 F.3d 967 (Fed. Cir. 2009)................................................................................................ 8
`
`DDR Holdings, LLC v. Hotels.com, L.P.,
`773 F.3d 1245 (Fed. Cir. 2014) ............................................................................................ 19
`
`Diamond v. Chakrabarty,
`447 U.S. 303 (1980) ............................................................................................................ 14
`
`Diamond v. Diehr,
`450 U.S. 175 (1981) ...................................................................................................... 10, 19
`
`Endo Pharm., Inc. v. Actavis Inc.,
`Civil Action No. 14-1381-RGA, 2015 WL 5580488 (D. Del. Sept. 23, 2015),
`adopted by 2015 WL 7253674 (D. Del. Nov. 17, 2015) ................................................. 15, 19
`
`Internet Patents Corp. v. Active Network, Inc.,
`790 F.3d 1343 (Fed. Cir. 2015) ...................................................................................... 11, 17
`
`Mayo Collaborative Services v. Prometheus Laboratories, Inc.,
`132 S. Ct. 1289 (2012) ................................................................................................. passim
`
`Money Suite Co. v. 21st Century Ins. & Fin. Servs., Inc.,
`C.A. No. 1:13-cv-984-GMS, 2015 WL 436160 (D. Del. Jan. 27, 2015) ....................... 8, 9, 12
`
`ii
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`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 4 of 26 PageID #: 1498
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`
`Parks v. Booth,
`102 U.S. 96 (1880) .............................................................................................................. 19
`
`Prometheus Labs., Inc. v. Roxane Labs., Inc.,
`805 F.3d 1092 (Fed. Cir. 2015) ...................................................................................... 11, 19
`
`Vanda Pharm. v. Roxane Labs., Inc.,
`Nos. 1:13-cv-1973 & 1:14-cv-757, D.I. 148, at 1 (D. Del. Dec. 30, 2015) ........................ 8, 16
`
`Vanda Pharmaceuticals Inc. v. Roxane Laboratories, Inc.,
`Nos. 13-1973 & 14-757, D.I. 126, at 60:5-61:9, 62:14-16, 63:7-8 (D. Del.
`Sept. 2, 2015) .................................................................................................................. 1, 12
`
`Versata Dev. Grp., Inc. v. SAP Am., Inc.,
`793 F.3d 1306 (Fed. Cir. 2015) .............................................................................................. 8
`
`STATUTES
`
`35 U.S.C.
`§ 100(b)................................................................................................................................. 9
`§ 101 ............................................................................................................................ passim
`§ 102 ................................................................................................................................... 11
`§ 103 ............................................................................................................................. 11, 17
`
`
`
`iii
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`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 5 of 26 PageID #: 1499
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`
`I.
`
`NATURE AND STAGE OF PROCEEDINGS
`
`On February 19, 2015, Plaintiffs INO Therapeutics LLC and Ikaria, Inc. (collectively
`
`“Plaintiffs”) filed this suit alleging infringement of ten patents.1 On December 8, 2015,
`
`Defendants Praxair Distribution, Inc. and Praxair, Inc. (collectively “Defendants”) filed a motion
`
`pursuant to FEDERAL RULE OF CIVIL PROCEDURE 12(c) for judgment on the pleadings alleging
`
`that five asserted patents (a total of 147 claims) are ineligible under 35 U.S.C. § 101. (D.I. 36.)
`
`II.
`
`SUMMARY OF ARGUMENT
`
`1. Defendants have not even attempted to carry their heavy burden to show that the
`
`claims of the challenged patents are invalid under § 101 by clear and convincing evidence at this
`
`early stage of the litigation. Under the Supreme Court’s two-step framework laid out in Mayo
`
`Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) and Alice Corp.
`
`Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014), Defendants must prove both that
`
`(a) the claims are directed to a natural law and (b) the series of claimed steps, as a whole,
`
`comprises conventional activity previously practiced in the field. Defendants did not submit any
`
`evidence in support of either proposition, a failure of proof that alone requires that this Court
`
`deny Defendants’ motion for judgment on the pleadings, just as it did in Vanda Pharmaceuticals
`
`Inc. v. Roxane Laboratories, Inc., Nos. 13-1973 & 14-757, D.I. 126, at 60:5-61:9, 62:14-16,
`
`63:7-8 (D. Del. Sept. 2, 2015) (attached as Ex. A).2
`
`2.
`
`At step one of the Mayo/Alice analysis, the parties dispute whether the claims are
`
`directed to a “natural law” at all. Defendants assert (without citing any evidence) that the
`
`challenged claims are allegedly directed to the “natural law” that “administration of nitric oxide
`
`1 On January 25, 2016, the parties filed a Joint Stipulation adding Plaintiff Mallinckrodt
`Hospital Products IP Ltd. as a plaintiff. (D.I. 50).
`2 Exhibits A-V are attached to this opposition brief. Exhibits 1-11 are attached to the
`Declaration of Dr. Rosenthal (Ex. B).
`
`1
`
`001
`
`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 6 of 26 PageID #: 1500
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`to children with a condition known as left ventricular dysfunction (‘LVD’) can cause pulmonary
`
`edema.” (D.I. 36 at 1.) But Plaintiffs point to unrebutted evidence showing that there is no such
`
`“natural law” in any relevant sense under controlling precedent. At a minimum, that issue
`
`presents a factual dispute that precludes granting Defendants’ premature motion.
`
`3.
`
`Regardless, at step two of the Mayo/Alice analysis, the parties also dispute
`
`whether, in addition to the purported natural law, the claims recite only a series of conventional
`
`steps that were routinely performed prior to the inventions described and claimed in the
`
`challenged patents. Defendants make such an assertion, but all of the evidence—the patent
`
`specification, prosecution history, and extrinsic evidence (including the lone piece of evidence
`
`that Defendants did submit)—demonstrates that, far from being conventional, the combination of
`
`steps was contrary to the well-established scientific view at the time. The claimed inventions are
`
`precisely of the type that Mayo itself and other cases have repeatedly made clear remain patent
`
`eligible: modified uses of an existing drug. But, at a minimum, that is yet another factual issue
`
`that precludes granting Defendants’ premature motion.
`
`III.
`
`STATEMENT OF FACTS
`
`A.
`
`The Five Challenged Patents
`
`Defendants’ motion challenges five of the patents Plaintiffs assert in this action: U.S.
`
`Patent Nos. 8,282,966 (“the ’966 patent”), 8,293,284 (“the ’284 patent”), 8,431,163 (“the ’163
`
`patent”), 8,795,741 (“the ’741 patent”), and 8,846,112 (“the ’112 patent”) (collectively the
`
`“challenged patents”). The dates of issuance for the challenged patents range from October 9,
`
`2012, to September 30, 2014—all of which were after the Supreme Court’s March 2012 decision
`
`in Mayo and two of which were after the Supreme Court’s June 2014 decision in Alice.
`
`The challenged patents share a common specification and generally recite (or relate to)
`
`new methods for safely treating critically ill infants who are candidates for inhaled nitric oxide
`
`2
`
`002
`
`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 7 of 26 PageID #: 1501
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`(“iNO”) treatment while reducing the risk that the treatment will result in pulmonary edema and
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`other serious adverse events (“SAEs”).3 Specifically, the patents disclose a solution to the
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`previously unknown problem that pediatric patients suffering from hypoxic respiratory failure
`
`who also suffer from left ventricular dysfunction (“LVD”) have a greater risk of SAEs if they are
`
`administered iNO. (See, e.g., Ex. 1, ’966 patent at 13:16-14:3.)4
`
`The challenged patents have a total of 147 claims. For example, claim 1 of the ’966
`
`patent provides:
`
`1. A method of reducing the risk of occurrence of pulmonary edema
`associated with a medical treatment comprising inhalation of 20 ppm nitric oxide
`gas, said method comprising::
`(a) performing echocardiography to identify a child in need of 20 ppm inhaled
`nitric oxide treatment for pulmonary hypertension, wherein the child is not
`dependent on right-to-left shunting of blood;
`(b) determining that the child identified in (a) has a pulmonary capillary
`wedge pressure greater than or equal to 20 mm Hg and thus has left
`ventricular dysfunction, so is at particular risk of pulmonary edema upon
`treatment with inhaled nitric oxide; and
`(c) excluding the child from inhaled nitric oxide treatment based on the
`determination that the child has left ventricular dysfunction and so is at
`particular risk of pulmonary edema upon treatment with inhaled nitric oxide.
`
`B.
`
`Background of the Invention
`
`The inventions disclosed in the challenged patents arose from observations made during
`
`the INOT22 clinical study (Example 1 in the specification) which involved administering
`
`INOmax® (Plaintiffs’ iNO product) to pediatric patients. (Ex. 1, ’966 patent at 9:20-14:3.)
`
`Designed by the leading experts in the field and consistent with the state of the art at the time, the
`
`INOT22 study did not exclude patients with pre-existing LVD. (Id. at 9:20-64.) Only after
`
`
`3 The ’112 patent recites methods of providing “pharmaceutically acceptable gas” to those who
`will safely treat critically ill infants who are candidates for iNO treatment along with information
`designed to reduce the risk that the treatment will result in pulmonary edema and other SAEs.
`4 For convenience, citations are to the ’966 patent specification unless otherwise noted.
`
`3
`
`003
`
`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 8 of 26 PageID #: 1502
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`significant numbers of SAEs occurred did it become clear that administering iNO to patients
`
`with LVD could be risky, leading to the claimed methods for safely providing iNO to pediatric
`
`patients, including term and near-term infants (known as “neonates”). (Id. at 9:20-14:3.)
`
`1.
`
`The Prior Use of iNO in Neonates Suffering From Hypoxic
`Respiratory Failure Only Excluded Neonates Dependent on Right-to-
`Left Shunting, Not Those With Preexisting LVD
`
`Plaintiffs’ INOmax® product is FDA-approved for administration by inhalation to
`
`neonates suffering from hypoxic respiratory failure (abnormally low levels of oxygen in the
`
`bloodstream) associated with clinical or echocardiographic evidence of pulmonary hypertension
`
`(high pressure in the blood vessels going to the lungs), known as persistent pulmonary
`
`hypertension of the newborn (“PPHN”). (Ex. B, Rosenthal Decl. at ¶ 6; Ex. 8, Current INOmax®
`
`Label.) In such neonates, the pulmonary vessels fail to adequately relax, and there is insufficient
`
`gas exchange. (Ex. B, Rosenthal Decl. at ¶ 6.) iNO relaxes the small vessels that are in close
`
`proximity to the aerated parts of the lung, increasing blood flow to the lungs. (Id.)
`
`However, administering iNO has significant risks. (Id. ¶ 7.) Some neonates have a
`
`severe congenital heart disease that prevents the left side of the heart from pumping blood to the
`
`rest of the body. (Id.) For these neonates, pulmonary vasoconstriction (normally problematic as
`
`discussed above) is actually beneficial (indeed, life-saving) because it creates a right-to-left shunt
`
`that allows the right ventricle to take on the role of the nonfunctioning left ventricle by pumping
`
`adequately oxygenated blood directly to the systemic circulation. (Id.) These neonates are
`
`described as being dependent upon right-to-left shunting of blood (“RTL-Dependent”).
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`Administering iNO to such a neonate (lowering pulmonary vascular resistance) reduces blood
`
`flow to the body and coronary arteries and puts the infant at high risk of, among other things,
`
`severe acidosis, cardiogenic shock, and sudden death. (Id.) For these reasons, when the FDA
`
`4
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`004
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`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 9 of 26 PageID #: 1503
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`first approved INOmax® as safe and effective, it was contraindicated for RTL-Dependent
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`neonates. (Id.; Ex. 2, 2000 INOmax® Label.)
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`INOmax® was not contraindicated for any other class of neonates including those with
`
`LVD, but who were not RTL-Dependent (“non-RTL-Dependent”). This was consistent with the
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`prior clinical studies submitted in support of the original FDA approval of INOmax® that
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`administered iNO to pediatric patients, including neonates, which did exclude non-RTL-
`
`Dependent neonates suffering from LVD. (Ex. B, Rosenthal Decl. at ¶ 8; Ex. 3; Ex. 4.)
`
`2.
`
`The Original INOT22 Study Protocol Did Not Exclude Neonates with
`Non-RTL-Dependent LVD
`
`Beginning in 2004, Plaintiff INO Therapeutics LLC (“INOT”) sponsored a clinical trial
`
`(the “INOT22 Study”) that compared the use and side effects of oxygen, iNO, and a combination
`
`of oxygen and iNO for determining pulmonary reactivity. (Ex. 1, ’966 patent at 9:65-67.) The
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`INOT22 Protocol did not exclude pediatric patients with other types of pre-existing LVD. (Id. at
`
`9:43-55; Ex. B, Rosenthal Decl. at ¶ 9; Ex. 5 at ¶¶ 9, 11; Ex. 6 at ¶ 7.) The INOT22 study was
`
`designed by INOT and a committee of “internationally recognized experts” in pediatric heart and
`
`lung disease (“the INOT22 Steering Committee”). (Ex. B, Rosenthal Decl. at ¶ 9; Ex. 5 at ¶¶ 7-
`
`8; Ex. 6 at ¶ 8.) Before the study began, the INOT22 protocol was carefully reviewed by more
`
`than 115 individuals “experienced in and responsible for the review of clinical trial protocols for
`
`patient safety”—including institutional review boards, independent ethics committees, the
`
`U.S. Food & Drug Administration (“FDA”), and equivalent agencies in other countries. (Ex, B,
`
`Rosenthal Decl. at ¶ 9; Ex. 6 at ¶ 11.) Not one suggested that iNO might increase the likelihood
`
`of adverse events in pediatric patients with non-RTL-Dependent LVD. (Id.)
`
`
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`5
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`005
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`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 10 of 26 PageID #: 1504
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`3.
`
`Unanticipated SAEs Occurred During the INOT22 Study, the Study
`Was Amended, and the Rate of SAEs Was Significantly Reduced
`
`Despite the review by these renowned experts in the field, five SAEs were observed in
`
`the first 24 subjects enrolled in the INOT22 study, a rate much higher than the INOT22 Steering
`
`Committee and INOT expected. (Ex. 1, ’966 patent at 12:30-13:5; Ex. B, Rosenthal Decl. at
`
`¶ 10; Ex. 5 at ¶ 12.) The SAEs were cardiovascular events, including pulmonary edema
`
`(accumulation of fluid in the lungs), cardiac arrest and hypotension (low blood pressure); one
`
`child who developed pulmonary edema died. (Ex. 1, ’966 patent at 12:30-13:5) Some of the
`
`“patients suffering [SAEs] had severe [LVD] . . . and exhibited during their right-sided cardiac
`
`catheterizations an increased pulmonary capillary wedge pressure (‘PCWP’) of greater than
`
`20 mm Hg, indicative of elevated pressures in the upper chamber of the left side of the heart (the
`
`left atrium).” (Ex. C at ¶ 21.) From these results, the inventors determined that “pediatric
`
`patients with left ventricular dysfunction” could be at “an increased risk of adverse events when
`
`inhaled NO was administered.” (Ex. D at ¶ 11; Ex. B, Rosenthal Decl. ¶ 11.)
`
`After these unexpected SAEs, the INOT22 study protocol was amended to exclude
`
`patients with pre-existing non-RTL-Dependent LVD, i.e., those having a PCWP greater than
`
`20 mm Hg. (Ex. 1, ’966 patent at 12:24-38; Ex. B, Rosenthal Decl. at ¶ 12; Ex. 5 at 13.)
`
`Thereafter, “the rate of [SAEs] (including [SAEs] associated with heart failure) was significantly
`
`reduced.” (Ex. 5 at ¶ 14; Ex. B, Rosenthal Decl. at ¶ 12.) While five SAEs were reported in the
`
`first 24 patients of the study, only two SAEs were reported in the 100 patients after the protocol
`
`was amended. (Ex. 5 at ¶ 14; Ex. B, Rosenthal Decl. at ¶ 12.) On August 28, 2009, at INOT’s
`
`request, the FDA approved a change to the INOmax® label to provide a warning that the use of
`
`iNO in patients with pre-existing LVD could cause SAEs, such as pulmonary edema. (Ex. 5 at
`
`¶¶ 15-16; Ex. 2, 2000 Label; Ex. 8, Current Label; Ex. B, Rosenthal Decl. at ¶ 15.)
`
`6
`
`006
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`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 11 of 26 PageID #: 1505
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`Dr. David Wessel, chair of the INOT22 Steering Committee, stated that “[a]t the time of
`
`the design of the INOT22 Study protocol, neither [he], the other Steering Committee members,
`
`nor the study Sponsor appreciated or anticipated that a child with left ventricular dysfunction
`
`who is not dependent on right-to-left shunting of blood would be at additional risk when treated
`
`with [iNO]. This is the reason such children were not originally excluded from the INOT22
`
`Study entry criteria.” (Ex. 7 at ¶ 6.) Had the adverse events been obvious, Dr. Wessel would
`
`have had to have “act[ed] either negligently or intentionally to harm babies, and [he] most
`
`certainly [did] not.” (Id. at ¶ 8.) The same applies to the “at least 115 individuals experienced in
`
`and responsible for the review of clinical trial protocols for patient safety,” as well as the FDA
`
`and European Health Authorities that reviewed the original INOT22 protocol. (Ex. 6, ¶ 11.)
`
`None raised a concern about increased risk of using iNO in children with LVD who were non-
`
`RTL-Dependent. (Id.; Ex. B, Rosenthal Decl. at ¶ 9.) As inventor Dr. Baldassarre stated, prior
`
`to the INOT22 Study, it defied “common sense to any expert in this field” to not utilize iNO with
`
`this patient population. (Ex. 5 at ¶ 11.)
`
`C.
`
`Prosecution History
`
`On June 30, 2009, based on the surprising results of the INOT22 study showing that safe
`
`use of iNO could warrant excluding neonates with non-RTL-Dependent LVD, INOT filed U.S.
`
`Patent Application No. 12/494,598, which ultimately issued as the five challenged patents.
`
`Throughout the prosecution history, and in particular after the Supreme Court’s decision
`
`in Mayo, the examiner thoroughly considered the patent-eligibility of the claims under § 101, in
`
`consultation with the U.S. Patent and Trademark Office’s (“PTO”) § 101 specialists and
`
`supervisors. (See, e.g., Ex. E at INO_19251, Ex. F. at INO_19441, Ex. G at INO_20242
`
`(’112 patent file history excerpts).) Post-Mayo, with further input and direction from the PTO,
`
`the applicant amended certain claims specifically to avoid any possible § 101 problems and to
`
`7
`
`007
`
`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 12 of 26 PageID #: 1506
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`overcome §101 rejections. (See Ex. H at INO_11813, Ex. I at INO_11829 (’966 patent file
`
`history excerpts); Ex. J at INO_15323 (’284 patent file history excerpt); Ex. K at INO_19816,
`
`Ex. L at INO_20196 (’112 patent file history excerpts).)
`
`IV.
`
`LEGAL STANDARDS
`
`A.
`
`Rule 12(c) Motions
`
`On a motion for judgment on the pleadings, “the court ‘accept[s] all factual allegations as
`
`true, construe[s] the complaint in the light most favorable to the plaintiff, and determine[s]
`
`whether, under any reasonable reading of the complaint, the plaintiff may be entitled to relief.’”
`
`Money Suite Co. v. 21st Century Ins. & Fin. Servs., Inc., C.A. No. 1:13-cv-984-GMS, 2015 WL
`
`436160, at *1 (D. Del. Jan. 27, 2015) (citation omitted).
`
`Patent-eligibility under § 101 “is a question of law based on underlying facts,” as this
`
`Court recently recognized. Ex. U, Vanda Pharm. v. Roxane Labs., Inc., Nos. 1:13-cv-1973 &
`
`1:14-cv-757, D.I. 148, at 1 n.1 (D. Del. Dec. 30, 2015) (material issues of fact precluded finding
`
`certain medical treatment method claims ineligible under §101) (citing In re Cominsky, 554 F.3d
`
`967, 975 (Fed. Cir. 2009)); see also Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 F.3d 1306,
`
`1334, 1336 (Fed. Cir. 2015) (upholding trial forum’s “underlying fact findings and credibility
`
`determinations” regarding what constitutes conventional activity for § 101 analysis); Accenture
`
`Glob. Servs. Gmbh v. Guidewire Software, Inc., 728 F.3d 1336, 1341 (Fed. Cir. 2013) (§ 101
`
`eligibility is legal issue that “may contain underlying factual issues”) (citation omitted). And this
`
`Court has explained that a patent claim will not be found directed towards patent-ineligible
`
`subject matter at the pleading stage unless, under “‘the only plausible reading of the patent[,] …
`
`there is clear and convincing evidence of ineligibility.’” Money Suite Co., 2015 WL 436160, at
`
`*2 (citation omitted).
`
`
`
`
`
`8
`
`008
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`

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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 13 of 26 PageID #: 1507
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`B.
`
`Section 101
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`Section 101 of the Patent Act provides that “[w]hoever invents or discovers any new and
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`useful process, machine, manufacture, or composition of matter, or any new and useful
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`improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of
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`this title.” 35 U.S.C. § 101. Such patent-eligible subject matter “includes a new use of a known
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`process, machine, manufacture, composition of matter, or material.” 35 U.S.C. § 100(b).
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`These broad classifications are limited by three exceptions. “Laws of nature, natural
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`phenomena, and abstract ideas are not patentable.” Alice, 134 S. Ct. at 2354 (quoting Ass’n for
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`Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116 (2013)). But the Supreme
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`Court has eschewed bright line rules in applying these exceptions, cautioning that courts must
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`“tread carefully in construing this exclusionary principle lest it swallow all of patent law”
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`because “[a]t some level, ‘all inventions . . . embody, use, reflect, rest upon, or apply laws of
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`nature, natural phenomena, or abstract ideas.’” Alice, 134 S. Ct. at 2354 (quoting Mayo,
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`132 S. Ct. at 1293.)); see also, e.g., Money Suite Co., 2015 WL 436160, at *2 (quoting same).
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`In Mayo and Alice, the Supreme Court provided a two-part framework for determining
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`patent eligibility under § 101. Mayo, 132 S. Ct. at 1294, 1296-98; Alice, 134 S. Ct. at 2355,
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`2360. First, this Court “determine[s] whether the claims at issue are directed to one of those
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`patent-ineligible concepts.” Alice, 134 S. Ct. at 2355 (citation omitted). Second, if so, the Court
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`determines whether the claims are nonetheless eligible because they include something more—
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`often called an “inventive concept.” Id. In assessing whether the claims are inventive, the Court
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`“consider[s] the elements of each claim both individually and as an ordered combination to
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`determine whether the additional elements transform the nature of the claim into a patent-eligible
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`application.” Id. (internal quotations and citation omitted). Claims are eligible if, “as a whole,”
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`they recite more than “well-understood, routine, conventional activity previously engaged in by
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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 14 of 26 PageID #: 1508
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`scientists who work in the field.” Mayo, 132 S. Ct. at 1298. Such claims do not “risk
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`disproportionately tying up the use of the underlying ideas . . . and therefore remain eligible for
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`the monopoly granted under our patent laws.” Alice, 134 S. Ct. at 2354-55 (citation omitted).
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`Notably, in Mayo, the Supreme Court emphasized two points critical to this motion.
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`First, the Court noted that:
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`here, as we have said, the steps add nothing of significance to the natural
`laws themselves. Unlike, say, a typical patent on a new drug or a new way
`of using an existing drug, the patent claims do not confine their reach to
`particular applications of those laws.
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`132 S. Ct. at 1302 (emphasis added). Thus, the Supreme Court reiterated that “a typical patent
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`on … a new way of using an existing drug” is patent-eligible because even if it implicates a
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`natural law, its “reach” is “confined” to “particular applications” of such a law. Id. Second, the
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`Court also distinguished and reaffirmed its holding in Diamond v. Diehr, 450 U.S. 175, 185
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`(1981), where the Court found that claims on an improved method of curing rubber using a
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`known equation were patent eligible because “the combination of . . . steps” were not “in context
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`obvious, already in use, or purely conventional.” Mayo, 132 S. Ct. at 1299 (emphasis added).
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`Similarly, in Myriad, the Supreme Court emphasized that “‘the first party with
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`knowledge of [a law of nature] is in an excellent position to claim applications of that
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`knowledge’” in the form of medical methods. 133 S. Ct. at 2120 (quoting Ass’n For Molecular
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`Pathology v. U.S. PTO(“Myriad”), 689 F.3d 1303, 1349 (Fed. Cir. 2012) (Bryson, J., concurring
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`and dissenting)). The Court pointed to one such patent-eligible method for detecting a certain
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`alteration in a certain gene. See id. (agreeing with Myriad, 689 F.3d at 1349 (Bryson, J.) (citing
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`U.S. Patent No. 5,743,441, claim 21)). Also in Myriad, the Federal Circuit found eligible a
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`method of screening potential cancer therapeutics by growing host cells in the presence of and in
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`the absence of a compound and comparing the growth rate, “wherein a slower rate of growth . . .
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`Case 1:15-cv-00170-GMS Document 54 Filed 01/27/16 Page 15 of 26 PageID #: 1509
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`in the presence of said compound is indicative of a cancer therapeutic.” 689 F.3d at 1310, 1335-
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`37. The court held that the claim “does not simply apply a law of nature” but instead “applies
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`certain steps to transformed cells that . . . are a product of man, not of nature.” Id. at 1336. The
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`Supreme Court declined to review that holding.
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`Further, the Supreme Court and Federal Circuit have recognized that the § 101 inquiry
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`and the prior art inquiries of §§ 102 (novelty) and 103 (non-obviousness) “might sometimes
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`overlap,” Mayo, 132 S. Ct. at 1304, and that “pragmatic analysis of §101 is facilitated by
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`considerations analogous to those of §§ 102 and 103 as applied to the particular case,” Internet
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`Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1347 (Fed. Cir. 2015). In that vein, in a
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`§ 103 case, the Federal Circuit recently acknowledged that identifying a group of patients who
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`should not receive conventional treatment can qualify as a new way of using an existing drug:
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`[I]n the field of personalized medicine, … a particular treatment may be effective
`with respect to one subset of patients and ineffective (and even harmful) to
`another subset of patients. Singling out a particular subset of patients for
`treatment (for example, patients with a particular gene) may reflect a new and
`useful invention that is patent eligible despite the existence of prior art or a prior
`art patent disclosing the treatment method to patients generally.
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`Prometheus Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1098 (Fed. Cir. 2015) (citation
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`omitted; emphasis added).
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`V.
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`ARGUMENT
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`Defendants’ motion for judgment on the pleadings of invalidity under § 101 should be
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`denied because: (a) Defendants have a high burden to show invalidity of the challenged patents
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`by clear and convincing evidence and have not even attempted to meet that burden by submitting
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`evidence on any of the disputed factual issues, (b) the claims are not directed to an inviolable
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`natural law (or there is at least a factual dispute on that score), and (c) even if they were directed
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`to such a