No. 18-817
`
`IN THE
`Supreme Court of the United States
`__________
`HIKMA PHARMACEUTICALS USA INC., AND WEST-WARD
`PHARMACEUTICALS INTERNATIONAL LTD., N/K/A HIKMA
`PHARMACEUTICALS INTERNATIONAL LTD.,
`Petitioners,
`
`v.
`
`VANDA PHARMACEUTICALS INC.,
`Respondent.
`__________
`ON PETITION FOR A WRIT OF CERTIORARI TO THE
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`__________
`BRIEF IN OPPOSITION
`__________
`
`Nicholas Groombridge
`Counsel of Record
`Eric Alan Stone
`Kira Alexis Davis
`Josephine Young
`Daniel J. Klein
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PAUL, WEISS, RIFKIND, WHARTON
`
`& GARRISON LLP
`
`1285 Avenue of the Americas
`
`New York, NY 10019
`
`(212) 373-3212
`
`ngroombridge@paulweiss.com
`
`FEBRUARY 12, 2019 Counsel for Respondent
`
`
`
`
`
`
`
`IN THE
`Supreme Court of the United States
`__________
`HIKMA PHARMACEUTICALS USA INC., AND WEST-WARD
`PHARMACEUTICALS INTERNATIONAL LTD., N/K/A HIKMA
`PHARMACEUTICALS INTERNATIONAL LTD.,
`Petitioners,
`
`v.
`
`VANDA PHARMACEUTICALS INC.,
`Respondent.
`__________
`ON PETITION FOR A WRIT OF CERTIORARI TO THE
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`__________
`BRIEF IN OPPOSITION
`__________
`
`Nicholas Groombridge
`Counsel of Record
`Eric Alan Stone
`Kira Alexis Davis
`Josephine Young
`Daniel J. Klein
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PAUL, WEISS, RIFKIND, WHARTON
`
`& GARRISON LLP
`
`1285 Avenue of the Americas
`
`New York, NY 10019
`
`(212) 373-3212
`
`ngroombridge@paulweiss.com
`
`FEBRUARY 12, 2019 Counsel for Respondent
`
`
`
`
`
`
`
`
`QUESTION PRESENTED
`
`
`Hikma’s Petition wrongly asserts that the
`Federal Circuit declared all method-of-treatment
`claims to be “automatically” patent-eligible under
`Section 101, and asks this Court to decide:
`Whether patents that claim a method of
`medically treating a patient automatically
`satisfy Section 101 of the Patent Act, even if
`they apply a natural law using only routine
`and conventional steps.
`That Question is not presented by the decision
`below or any other decision.
`
`
`
`
`
`
`
`
`
`
`
`
`
`ii
`PARTIES TO THE PROCEEDINGS
`The caption identifies all parties. Petitioners
`are Hikma Pharmaceuticals USA Inc., and West-
`Ward Pharmaceuticals International Ltd., N/K/A
`Hikma
`Pharmaceuticals
`International
`Ltd.
`(together, “Hikma”). The Respondent is Vanda
`Pharmaceuticals Inc.
`
`
`
`
`
`
`
`
`
`
`
`
`
`iii
`CORPORATE DISCLOSURE STATEMENT
`Vanda is publicly traded on the NASDAQ
`(symbol: VNDA). No publicly traded entity owns
`more than 10% of Vanda’s stock.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`iv
`TABLE OF CONTENTS
`
`Page
`QUESTION PRESENTED ........................................ i
`PARTIES TO THE PROCEEDINGS ....................... ii
`CORPORATE DISCLOSURE STATEMENT ......... iii
`BRIEF IN OPPOSITION ......................................... 1
`STATEMENT OF THE CASE ................................. 4
`A.
`Iloperidone and QTc Prolongation ...... 4
`B.
`Vanda’s Invention and FDA
`Approval .............................................. 4
`The District Court Proceedings .......... 7
`C.
`The Federal Circuit Decision .............. 8
`D.
`REASONS FOR DENYING THE PETITION ......... 9
`I. THE FEDERAL CIRCUIT FAITHFULLY
`APPLIED—AND ANNOUNCED NO
`CATEGORICAL EXEMPTION FROM—THIS
`COURT’S SECTION 101 PRECEDENTS .........12
`II. THE ’610 PATENT CLAIMS ARE PATENT-
`ELIGIBLE UNDER THIS COURT’S
`PRECEDENT .....................................................22
`
`
`
`
`
`
`
`
`
`
`
`
`
`v
`III.THE DECISION BELOW WILL NOT DELAY
`ACCESS TO GENERIC DRUGS OR HARM
`SOCIETY ............................................................31
`IV. THE PATENT OFFICE HAS NOT CREATED
`A CATEGORICAL EXCEPTION FOR
`METHODS-OF-TREATMENT TO THIS
`COURT’S PRECEDENTS ..................................34
`CONCLUSION ........................................................38
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`vi
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`CASES
`Alice Corp. Pty. v. CLS Bank Int’l,
`573 U.S. 208 (2014) .................................... passim
`Ass’n for Molecular Pathology v.
`Myriad Genetics, Inc.,
`569 U.S. 576 (2013) ......................................18, 32
`Athena Diagnostics, Inc. v. Mayo
`Collaborative Servs., LLC,
`No. 2017-2508, 2019 WL 453489
`(Fed. Cir. Feb. 6, 2019) .................................20, 21
`Bilski v. Kappos,
`561 U.S. 593 (2010) ................................ 13, 15, 28
`BSG Tech LLC v. BuySeasons, Inc.,
`899 F.3d 1281 (Fed. Cir. 2018).......................... 20
`Burnett v. Panasonic Corp.,
`741 F. App’x 777 (Fed. Cir. 2018) ..................... 21
`Caraco Pharm. Labs., Ltd. v. Novo
`Nordisk A/S,
`566 U.S. 399 (2012) ........................................... 32
`Data Engine Techs. v. Google LLC,
`906 F.3d 999 (Fed. Cir. 2018) ........................... 20
`Diamond v. Diehr,
`450 U.S. 175 (1981) .......................... 15, 16, 28, 29
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`vii
`Dolbear v. Am. Bell Tel. Co. (The
`Telephone Cases),
`126 U.S. 1 (1888) ............................................... 13
`In re Downing,
`No. 2018-1795, 2018 WL 6436437
`(Fed. Cir. Dec. 7, 2018) ...................................... 21
`In re Eberra,
`730 F. App’x 916 (Fed. Cir. 2018) ..................... 21
`Eibel Process Co. v. Minn. & Ont.
`Paper Co.,
`261 U.S. 45 (1923) ............................................ 14
`Erlenbaugh v. U.S.,
`409 U.S. 239 (1972) ........................................... 13
`Funk Bros. Seed Co. v. Kalo Inoculant
`Co.,
`333 U.S. 127 (1948) ........................................... 13
`Glasswall Sols. Ltd. v. Clearswift Ltd.,
`No. 2018-1407, 2018 WL 6720014
`(Fed. Cir. Dec. 20, 2018) .................................... 21
`Gottschalk v. Benson,
`409 U.S. 63 (1972) ............................................ 29
`Interval Licensing LLC v. AOL, Inc.,
`896 F.3d 1335 (Fed. Cir. 2018).......................... 20
`In re Marco Guldenaar Holding B.V.,
`911 F.3d 1157 (Fed. Cir. 2018).......................... 20
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`viii
`Mayo Collaborative Servs. v.
`Prometheus Labs., Inc.,
`566 U.S. 66 (2012) ...................................... passim
`Miller v. Bridgeport Brass Co.,
`104 U.S. 350 (1881) ........................................... 27
`O’Reilly v. Morse,
`56 U.S. (15 How.) 62 (1854) .............................. 13
`Parker v. Flook,
`437 U.S. 584 (1978) ......................... 14, 15, 28, 29
`Praxair Distrib., Inc. v. Mallinckrodt
`Hosp. Prods. IP Ltd.,
`890 F.3d 1024 (Fed. Cir. 2018).......................... 20
`Roche Molecular Sys., Inc. v. Cepheid,
`905 F.3d 1363 (Fed. Cir. 2018).......................... 20
`SAP Am., Inc. v. InvestPic, LLC,
`898 F.3d 1161 (Fed. Cir. 2018).......................... 20
`In re Villena,
`745 F. App’x 374 (Fed. Cir. 2018) ..................... 21
`Voter Verified, Inc. v. Election Sys. &
`Software LLC,
`887 F.3d 1376 (Fed. Cir. 2018).......................... 21
`In re Wang,
`737 F. App’x 534 (Fed. Cir. 2018) ..................... 21
`STATUTES
`21 U.S.C. § 355(b)(1) ............................................... 33
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ix
`35 U.S.C. § 101................................................. passim
`35 U.S.C. § 271(e)(2)(A) ........................... 3, 10, 12, 32
`35 U.S.C. § 271(e)(2)(C) .....................................12, 33
`42 U.S.C. § 262(l)(3)(A) ......................................13, 33
`OTHER AUTHORITIES
`2019 Revised Patent Subject Matter
`Eligibility Guidance,
`84 Fed. Reg. 50 (Jan. 7, 2019) .......... 11, 35, 36, 37
`Sup. Ct. Rule 10 ...................................................... 22
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`BRIEF IN OPPOSITION
`I. INTRODUCTION
`Hikma’s Petition rests on the premise that the
`overruled” Mayo
`Federal Circuit
`“effectively
`Collaborative Services v. Prometheus Laboratories,
`Inc., 566 U.S. 66 (2012) by exempting all method-of-
`treatment claims from 35 U.S.C. § 101 scrutiny,
`declaring all such claims “automatically” patent
`eligible. Pet. at Question Presented.
`That premise is wrong. The Federal Circuit did
`not announce a categorical rule of patent eligibility
`for method-of-treatment patents.
`Instead, the Federal Circuit faithfully applied
`this Court’s precedents, including Mayo, to just the
`’610 patent claims, and held that those claims are
`not “directed to” a law of nature itself, but to a
`patent-eligible “appl[ication]” of such laws. Alice
`Corp. Pty. v. CLS Bank Int’l, 573 U.S. 208, 217
`(2014) (citing Mayo, 566 U.S. at 71, 75-79). In
`dissent, Chief Judge Prost differed only as to the
`outcome of this case, and did not suggest that the
`majority was creating a new categorical rule. When
`the Federal Circuit denied Hikma’s petition for
`review en banc, no judge (including Chief Judge
`Prost) dissented from that denial or warned that the
`court was trenching on this Court’s decisions. And
`the Federal Circuit has considered patent eligibility
`in sixteen cases since the panel decision below, and
`found claims to be ineligible in fifteen of them.
`There is no crisis of patent eligibility at the Federal
`Circuit requiring this Court’s review.
`
`
`
`
`
`
`
`
`
`
`
`
`
`2
`
`
`Nor has the Patent Office run amok by declaring
`all methods of treatment eligible for patenting, as
`Hikma warns. On the contrary. After Hikma filed
`this Petition the Patent Office issued proposed
`patent-eligibility guidance that treats the decision
`below as just one of many Federal Circuit decisions
`implementing—not
`overruling—this
`Court’s
`precedents. The public comment period for that
`guidance extends until March of 2019.
`This case is therefore a poor vehicle to review
`Hikma’s Question Presented, because the decision
`below does not present that question and because
`these issues are percolating appropriately in the
`lower courts and the Patent Office.
`This case is also a poor candidate for review on
`its facts. The ’610 patent is exactly the kind of
`innovation the patent laws are intended to promote.
`It covers methods of safely administering one drug,
`iloperidone, to treat schizophrenia by administering
`specific doses to specified patient populations.
`Schizophrenia is a devastating, incurable condition
`with few approved treatments. The approved drugs
`can have debilitating side effects, and psychiatrists
`must often try several before finding one that a
`patient can tolerate. Over time, a drug can cease to
`work for an individual patient, requiring a switch to
`a new one. Iloperidone was an important addition
`to their armamentarium, both as another effective
`antipsychotic and because it has a markedly lower
`risk of a side effect called akathisia, a sense of inner
`restlessness so profound that it can induce suicide.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`3
`The invention of the ’610 patent allowed this
`much-needed medicine to come to market. During
`early clinical development, certain patients taking
`iloperidone developed a potentially fatal cardiac side
`effect.
` Novartis, which owned the rights to
`iloperidone at the time, terminated the development
`program. FDA approved iloperidone only after
`Vanda’s scientists determined which patients face
`that cardiac risk, why they face that risk, and
`whether there was any dosage that would be both
`safe and effective for those patients.
`In the Hatch-Waxman Act, Congress specifically
`contemplated that patents like the ’610 patent that
`claim “the use of” a molecule would be infringed by
`the submission of an Abbreviated New Drug
`Application (“ANDA”) seeking approval for a generic
`drug. 35 U.S.C. § 271(e)(2)(A). Generic drug
`companies may, of course, argue that those patents
`are obvious, or not novel, and that they lack the
`required written description of a patent. Hikma
`made those arguments, lost at trial, and abandoned
`those defenses on appeal. What remains is a case-
`specific argument that these specific patent claims
`were ineligible for patenting under Section 101. The
`Federal Circuit’s rejection of
`that argument
`warrants no review in this Court.
`The Petition should be denied.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`4
`STATEMENT OF THE CASE
`A. Iloperidone and QTc Prolongation
` Iloperidone very nearly did not come to market,
`and would not have done so without the invention
`claimed by the ’610 patent.
`When
`the pharmaceutical giant Novartis
`initially
`tried
`to
`develop
`iloperidone
`for
`schizophrenia, patients began to show a side effect
`known as “QTc prolongation.”
`The Q and T waves are parts of the cardiac
`rhythm—picture two peaks on an EKG—and the
`“QTc interval” is the time between them, corrected
`(“c”) for the patient’s heart rate. An elongated QTc
`interval can cause sudden death. When QTc
`prolongation is observed in a clinical trial, the
`pharmaceutical company usually abandons the drug
`in development.
`That happened here. When iloperidone was
`shown to cause QTc prolongation in some patients
`and Novartis could not determine the cause or
`devise a means to mitigate it, Novartis abandoned
`its years of development efforts despite having
`already invested hundreds of millions of dollars.
`Novartis sold the rights to develop iloperidone to
`Vanda in 2004 for just $500,000.
`B. Vanda’s Invention and FDA Approval
`Vanda’s scientists set out to determine the
`causes of iloperidone-induced QTc prolongation,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`5
`safe
`its
`for
`to develop a method
`hoping
`administration that preserved its efficacy and would
`satisfy FDA.
`Their efforts proved fruitful. They discovered
`that iloperidone and one of its metabolites, known
`as P88, inhibited an electric channel in the heart
`called the “hERG channel” that could cause
`prolongation of the QT interval, while another
`iloperidone metabolite, known as P95, did not.
`Importantly, and unrelated to their effects on the
`heart, iloperidone and P88 are active in the brain in
`treating schizophrenia while P95 is not. Vanda’s
`scientists also discovered that patients who, because
`of a genetic mutation, produce a lower-than-normal
`amount of a liver enzyme known as CYP2D6 (so-
`called “CYP2D6 poor metabolizers”) appeared to be
`more
`at
`risk
`of
`iloperidone-induced QTc
`prolongation than patients with normal CYP2D6
`metabolic function.
`Among other things, the CYP2D6 enzyme is
`responsible for breaking down both iloperidone and
`P88, and for producing P95. They also found a
`correlation between QTc prolongation and the ratio
`of P88 to P95 in the blood, and a correlation with
`the ratio of (P88+iloperidone) to P95.
` They
`concluded that a patient with decreased CYP2D6
`metabolism will have a substantially higher ratio of
`P88 to P95 than would a normal metabolizer, and
`can therefore be treated with less iloperidone to
`achieve therapeutic efficacy. Separately, because
`both P88 and iloperidone create the risk of QTc
`prolongation, while P95 does not, a CYP2D6 poor
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6
`increased risk of
`metabolizer would have an
`iloperidone-induced QTc prolongation given the
`same iloperidone dosage that a normal CYP2D6
`metabolizer would have.
`independent
`several
`By
`combining
`these
`discoveries, Vanda’s scientists were able
`to
`formulate a safe and effective treatment regimen: a
`specific dosage range at which a CYP2D6 poor
`metabolizer
`can be effectively
`treated with
`iloperidone without an
`increased risk of QTc
`prolongation.
`These discoveries were a breakthrough, and
`Vanda succeeded where Novartis had tried and
`failed. The district court found that Vanda’s
`successes paved the way to FDA approval: “Vanda
`was able to obtain FDA approval for iloperidone
`based, at least in part, on the invention disclosed in
`the ’610 patent . . . .” App. 4a. Demonstrating the
`value of Vanda’s work, Novartis paid Vanda $200
`million to re-acquire the rights to iloperidone after
`FDA approval, or 400 times what Vanda had paid
`Novartis for those rights just five years earlier.
`Importantly, the invention of the ’610 patent is
`limited to iloperidone. Whether genetic variations
`in CYP2D6 efficacy will alter the safety profile or
`the efficacy of any other drug depends on many,
`drug-specific factors: the extent to which the drug is
`processed by CYP2D6, whether other metabolic
`pathways will compensate
`for poor CYP2D6
`metabolism, and whether the resulting metabolites
`will have effects similar to, stronger than, or weaker
`than the original drug. 1 C.A. App. 7216-7217.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`7
`C. The District Court Proceedings
`the
`for
`After FDA approved
`iloperidone
`treatment of schizophrenia, Hikma’s predecessor
`filed an Abbreviated New Drug Application seeking
`FDA-approval to sell iloperidone. Vanda sued,
`asserting the ’610 patent and the now-expired
`patent on the iloperidone molecule.
`The district court presided over a five-day bench
`trial, after which it found the asserted claims of the
`’610 patent infringed, non-obvious, not invalid for
`lack of written description, and not invalid for lack
`of patent-eligible subject matter. App. 69a-90a.
`As relevant here, the district court found that
`under Step One of this Court’s Section 101 test, the
`claims of the ’610 patent “depend upon laws of
`nature,” but that under Step Two “the process of
`using . . . genetic test[s] to inform the dosage
`adjustment recited in the claims was not routine or
`conventional . . . .” App. 76a-78a.
`law-of-nature
`Notably, Hikma
`presented
`arguments
`in the district court that
`it then
`abandoned. Initially, Hikma posited a supposed
`natural
`law
`that
`“where a patient poorly
`metabolizes a drug, the patient should receive less
`drug.” 1 C.A. App. 7323-7324. Hikma abandoned
`that because it is wrong as a matter of science; for
`some drugs, poor metabolizers should receive higher
`doses, not lower doses. Id. at 7323. Then Hikma
`suggested that the natural law is that “the more
`iloperidone you have in your system the higher the
`side effects would be.” Id. That, too, is wrong; some
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`8
`iloperidone side-effects are not dose-dependent at
`all. Id. at 7323-7324.
`D. The Federal Circuit Decision
`At the Federal Circuit, Hikma posited yet
`another natural law: that “the asserted claims are
`directed
`to a natural
`relationship between
`iloperidone, CYP2D6 metabolism,
`and QT
`prolongation.” C.A. Dkt. No. 24 at 47.
`The Federal Circuit exhaustively examined this
`Court’s patent-eligibility precedents. The majority
`opinion held that the ’610 patent claims—unlike the
`diagnostic-method
`claims
`in Mayo—are not
`“directed to” a law of nature, but to a concrete
`method of treating specific patients with specific
`dosages:
`At bottom, the claims here are directed to a
`specific method of treatment for specific
`patients using a specific compound at specific
`doses to achieve a specific outcome. They are
`different from Mayo. They recite more than
`the natural relationship between CYP2D6
`metabolizer genotype and the risk of QTc
`prolongation.
`App. 35a. “Thus, the ’610 patent claims are ‘a new
`way of using an existing drug’ that is safer for
`patients because
`it reduces the risk of QTc
`prolongation.” App. 32a.
`Chief Judge Prost dissented, and would have
`held that these claims are ineligible for patenting.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`9
`Notably, the dissent did not suggest that the
`majority was creating any new categorical rule for
`method-of-treatment claims. Chief Judge Prost
`simply would have reached a different outcome in
`this case. And it was central to the dissent that the
`use of iloperidone to treat schizophrenia “long
`predated the ’610 patent,” as in Mayo where the
`thiopurine drugs were in use long before the Mayo
`patent. App. 47a-48a. Respectfully, the undisputed
`record evidence contradicted that premise: The
`priority date of the ’610 patent is five years before
`FDA approved iloperidone, and thus physicians did
`not use iloperidone to treat schizophrenia “long” (or,
`at all) before the ’610 patent.
`Hikma sought en banc review. The Federal
`Circuit denied that request, without dissent. App.
`93a-94a.
`REASONS FOR DENYING THE PETITION
`Hikma’s petition rests on the false premise that
`the Federal Circuit held that all method-of-
`treatment patent claims are “automatically” eligible
`for patenting under Section 101, see Pet. at
`Question Presented, supposedly overruling this
`Court’s Section 101 precedents.
`The Federal Circuit did not exempt method-of-
`treatment claims
`from Section 101 scrutiny.
`Instead, as Vanda shows below in Section I, the
`Federal Circuit exhaustively reviewed this Court’s
`Section 101 decisions and sought to apply them to
`the facts of only this case. It made no statements
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`10
`announcing a broad exemption for all method-of-
`treatment patents.
`And as Vanda shows below in Section II, the
`majority opinion was correct on the merits. The ’610
`patent claims are exactly the type of claims that are
`patent-eligible under Section 101. Unlike the claims
`in Mayo, these claims do not simply describe a
`natural relationship in the human body and tell
`doctors to consider whether a dosage adjustment is
`indicated. The ’610 patent claims require doctors to
`give specific dosages of iloperidone to specific
`patient populations. That the inventors discovered
`the physiological processes that make the dosages
`safe and effective does not convert their patent into
`a monopolization of the underlying physiological
`processes themselves. The scientific discoveries
`disclosed in the patent are available to all.
`Hikma’s and its amici’s fears of a sea change if
`the Federal Circuit’s decision is not reversed are
`unfounded, as Vanda shows in Section III. Hikma
`warns that drug companies will now list more
`method-of-treatment patents in the FDA’s Orange
`Book and thereby improperly obtain 30-month stays
`of FDA approval for generic drugs. But Congress
`specifically
`contemplated
`that method-of-use
`patents would be infringed by the submission of a
`generic’s ANDA, see 35 U.S.C. § 271(e)(2)(A), drug
`companies are already required to list method-of-
`treatment patents
`in the Orange Book, and
`thousands of method-of-treatment patents are
`already listed.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`11
`Hikma’s and its amici’s purported concerns
`reveal what is really at stake here: The generic-
`drug industry wants this Court to hold that all
`method-of-treatment patents are ineligible under
`Section 101 because they depend on the body’s
`physiological response to a foreign substance. That
`would defy this Court’s recognition that a “new way
`of using an existing drug” could be patent-eligible.
`Mayo, 566 U.S. at 87. And it would defy Congress’s
`intent to make submission of an ANDA an act of
`infringement of method-of-use patents.
`Finally, Hikma’s and its amici’s stated concerns
`about the Patent Office are also misplaced, as
`Vanda shows in Section IV. The Patent Office
`memorandum on which Hikma relies says only that
`method-of-treatment claims that “apply” natural
`relationships, “as opposed to being ‘directed to’
`them,” are eligible for patenting.
` App. 98a
`(emphasis in original). Since Hikma filed its
`Petition, the Patent Office has promulgated new
`proposed Section 101 rules, and they say nothing
`about an exemption for all method-of-treatment
`claims.
` 2019 Revised Patent Subject Matter
`Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019).
`In sum, everything is percolating in the lower
`courts as this Court instructed. Certiorari is not
`warranted.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`12
`THE FEDERAL CIRCUIT FAITHFULLY
`APPLIED—AND ANNOUNCED NO
`CATEGORICAL EXEMPTION FROM—THIS
`COURT’S SECTION 101 PRECEDENTS
`This Court’s Section 101 precedents distinguish
`between (i) patents that are “directed to” (that is,
`they seek to monopolize) laws of nature, which may
`not be eligible for patenting, and (ii) patents that
`simply apply laws of nature (which nearly all
`patents do), and which pose no eligibility concerns.
`The distinction between claims that seek to
`monopolize laws of nature and claims that apply
`such laws reverberates through the Court’s late-
`twentieth-century Section 101 jurisprudence and
`supports the two-step test of Alice and Mayo. See
`Alice, 573 U.S. at 217; Mayo 566 U.S. at 75-79.
`1. That method-of-treatment claims may be
`patented is clear from Section 101 itself. The Patent
`Act begins by declaring that claims to a “process”—
`that is, method claims—are patentable:
`Whoever invents or discovers any new and
`useful process, machine, manufacture, or
`composition of matter, or any new and useful
`improvement thereof, may obtain a patent
`therefor, subject to the conditions and
`requirements of this title.
`35 U.S.C. § 101 (emphasis added). Among the
`patentable processes are uses of drugs for therapy;
`those patents are specifically called out for inclusion
`in patent litigation over both generic drugs and
`biosimilars. See 35 U.S.C. § 271(e)(2)(A), (e)(2)(C);
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`13
`42 U.S.C. § 262(l)(3)(A). All of these provisions
`must be read in pari materia. See Erlenbaugh v.
`U.S., 409 U.S. 239, 243-44 (1972).
`To be sure, this Court has held that despite the
`facial breadth of Section 101, one cannot patent, and
`thus monopolize, naturally occurring phenomena,
`because they are not “new,” Bilski v. Kappos, 561
`U.S. 593, 602 (2010), and one cannot patent, and
`thus monopolize, fundamental laws of nature or
`abstract ideas, which are concepts that should be
`reserved for “the storehouse of knowledge of all
`men,” Funk Brothers Seed Co. v. Kalo Inoculant Co.,
`333 U.S. 127, 130 (1948).
`Courts must “tread carefully in construing this
`exclusionary principle,” however, “lest it swallow all
`of patent law.” Alice, 573 U.S. at 217. That is
`because, “[a]t some level, ‘all inventions . . . embody,
`use, reflect, rest upon, or apply laws of nature,
`natural phenomena, or abstract ideas.’” Id. (quoting
`Mayo, 566 U.S. at 71).
`To take a classic example, while Samuel Morse
`could not patent, and thus monopolize, the innate
`power of electro-magnetism to send messages at a
`distance (which Hikma highlights, Pet. at 6), he
`could patent the telegraph machines that depended
`on that innate power (which Hikma omits). See
`Dolbear v. Am. Bell Tel. Co. (The Telephone Cases),
`126 U.S. 1, 534 (1888); O’Reilly v. Morse, 56 U.S. (15
`How.) 62 (1854).
`2. The distinction between patents “directed to”
`laws of nature and patents that merely apply those
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`14
`natural laws reverberated through the Court’s late-
`twentieth-century Section 101 cases.
`In Parker v. Flook, on which Hikma focuses, the
`patent was directed to a method for updating
`numerical “alarm limits” during petrochemical and
`oil-refining catalytic-conversion processes, but the
`“only novel
`feature of the method” was the
`“mathematical formula” itself. 437 U.S. 584, 585
`(1978).1 The patent did not “purport to contain any
`disclosure relating to the chemical processes at
`work, the monitoring of process variables, or the
`means of setting of an alarm or adjusting an alarm
`system.” Id. at 586. And it did not “purport to
`explain how to select the appropriate margin of
`safety, the weighting factor, or any of the other
`variables.” Id. The Court analogized the claims to a
`patent on applying the formula for “determining the
`circumference of a wheel” or on the Pythagorean
`theorem, with “a final step indicating that the
`formula, when solved, could be usefully applied to
`existing surveying techniques.” Id. at 590, 595.
`Such a patent would be directed to, and monopolize,
`the law of nature itself.
`On the other hand, the Court stressed that “it is
`equally clear that a process is not unpatentable
`simply because it contains a law of nature or a
`mathematical algorithm.”
` 437 U.S. at 590
`(emphasis added) (citing Eibel Process Co. v. Minn.
`& Ont. Paper Co., 261 U.S. 45 (1923)). The claim in
`
`1 Hikma chides the Federal Circuit for not citing Flook.
`Pet. at 19. Neither party relied on Flook in the lower courts, or
`cited it other than in passing.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`15
`improvement on a
`Eibel Process was to “an
`papermaking machine that made use of the law of
`gravity.” Flook, 437 U.S. at 590 n.12. A claim that
`merely relies on the actions of, but does not attempt
`to monopolize, a law of nature is eligible for
`patenting; what is ineligible, the Court held, is a
`patent claim “directed essentially to” an ineligible
`concept. Flook, 437 U.S. at 595 (emphasis added).
`“Very simply, our holding today is that a claim for
`an improved method of calculation, even when tied
`to a specific end use, is unpatentable subject matter
`under § 101.” Id. at 595 n.18 (emphasis added).
`This Court’s subsequent decision in Diamond v.
`Diehr, 450 U.S. 175 (1981), “established a limitation
`on the principles articulated in Benson and Flook.”
`Bilski, 561 U.S. at 611. As in Flook, the claims in
`Diehr covered the computerized use of a well-known
`mathematical formula in a method of molding
`rubber under heat and pressure. 450 U.S. at 177-
`78. The Court reasoned that the patentee did not
`“seek to patent a mathematical formula” itself, but
`rather an industrial process for the molding of
`rubber products. Id. at 187. While the process
`“employ[ed] a well-known mathematical equation,”
`the patent would not “pre-empt the use of that
`equation,” but only prohibit others from using that
`equation “in conjunction with all of the other steps
`in [the] claimed process.” Id. The Court found the
`claims patent-eligible.
`3. The “opposite conclusions” reached in Flook
`and Diehr, Mayo, 566 U.S. at 80, are at the heart of
`the Court’s modern Section 101 decisions. In Alice,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`16
`the Court explained that the essence of the claims in
`Flook was a monopolization of the mathematical
`formula itself when deployed on a computer, while
`“the claims in Diehr were patent eligible because
`they improved an existing technological process.”
`573 U.S. at 223. And in Mayo the Court explained
`that the patent was upheld in Diehr “because of the
`way the additional steps of the process integrated
`the equation into the process as a whole.” 566 U.S.
`at 80.
`Relying on Flook and Diehr, the Court’s decisions
`in Alice and Mayo set out the modern, two-step test
`for determining patent eligibility.
`At Step One, “we determine whether the claims
`at issue are directed to one of those patent-ineligible
`concepts.” Alice, 573 U.S. at 217 (citing Mayo, 566
`U.S. at 75-79) (emphasis added). If the claim is not
`directed to an ineligible concept, it is eligible for
`patenting.
`If the claim is “directed to” an ineligible concept,
`at Step Two “we then ask, ‘what else is there in the
`claims before us.’” Alice, 573 U.S. at 217. “To
`answer that question,” a court considers the claim
`elements
`individually
`and
`as
`an
`ordered
`combination, to determine whether the elements
`beyond the claimed law of nature “‘transform the
`nature of
`the
`claim’
`into a patent-eligible
`application” of that law of nature. Id. (quoting
`Mayo, 566 U.S. at 78). The Court has described this
`as a search for “an inventive concept.” Alice, 573
`U.S. at 217.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`17
`that
`Hikma’s Question Presented asserts
`method-of-treatment claims that “apply” natural
`laws fail Step One, and that their patent eligibility
`must be determined at Step Two. See Pet. at
`Question Presented. Hikma misreads Alice and
`Mayo. If merely “apply[ing]” a natural law caused a
`claim to fail Step One, the “exclusionary principle”
`of those cases could “swallow all of patent law,”
`Alice, 573 U.S. at 217 (citing Mayo, 566 U.S. at 71),
`and the Alice/Mayo test would collapse down into
`only Step Two. That is because, as the Court
`warned in Alice and Mayo, “[a]t some level, ‘all
`inventions . . . apply laws of nature . . . .’” Alice, 573
`U.S. at 217 (quoting Mayo, 566 U.S. at 71)
`(emphases added).
`At Step One, then, a court may not merely
`determine whether the claim applies or relies on
`laws of nature—the answer to which would
`essentially always be “yes”—but must
`instead
`determine whether a patent claim is “directed to” a
`patent-ineligible concept. Alice, 573 U.S. at 217
`(emphasis added).
`The claims in Alice were directed to the abstract
`idea of an intermediated settlement, “a fundamental
`economic practice long prevalent in our system of
`commerce,” id. at 219
`(citation and
`internal
`quotation marks omitted), and sought to monopolize
`computerized implementation of that abstract idea.
`Further scrutiny at Step Two was therefore needed.
`Likewise, in Mayo, the diagnostic claims were
`directed to laws of nature, specifying and purporting
`to monopolize “relationships between concentrations
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`18
`of certain metabolites in the blood and the likelihood
`that a dosage of a thiopurine drug will prove
`ineffective or cause harm.” Mayo, 566 U.S. at 77.
`Critically, the claims did not require the doctor to
`perform any particular treatment; infringement
`occurred merely from the doctor’s measuring the
`metabolites and considering the results. Id. at 86-
`87. A doctor would infringe Mayo’s patent even if
`the “subsequent treatment decision” does not
`“change in light of the inference he has drawn using
`the correlations” described in the patent. Id. Step
`Two scrutiny was th
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
