Ariosa Diagnostics, Inc. v. Sequenom, Inc.

banc, that this will it is ORDERED case en be reheard banc. SUPPLY, Dana RAILROAD DANA’S Jewelry LLC, Lee Har Jackson, TM Furniture,

per, Discount Tallahassee Palmer, Sportland, Eric Cook’s

Duana

Cook, Plaintiffs-Appellants,

v. GENERAL, State ATTORNEY Natera, DIAGNOSTICS, INC., ARIOSA FLORIDA, Defendant- Inc., Plaintiffs-Appellees. Appellee. Center, Inc., Diagnostics DNA No. 14-14426. Counterclaim Defendant- Appeals, Court of United States Appellee Eleventh Circuit.

Jan. SEQUENOM, INC., Sequenom Center Medicine, LLC, For Molecular PLLC, Deepak Gupta, Gupta Wessler Defendants-Appellants. Frank, DC, Michael Washington, David PA, Frank, David Tallahas- Law Office of Limited, Innovation Defendant. Isis see, FL, Plaintiffs-Appellants. 2014-1139, Nos. 2014-1144. Winsor, Bondi, Attorney Pam Allen C. Appeals, States United FL, Office, Tallahassee, for De- General’s Federal Circuit. fendanh-Appellee.

Dec. CARNES, Judge,

Before ED Chief MARCUS, WILSON,

TJOFLAT, HULL, PRYOR, MARTIN, JORDAN, WILLIAM LLP, Maleeek, Kaye J. Scholer Michael CARNES, ROSENBAUM, JULIE CA, Alto, petition Palo filed a for rehear- PRYOR, Judges. JILL ing for defendants-appellants. en banc Root; E. Aton represented by Also Peter EN ORDER ON REHEARING BANC CA; Arbisser, Angeles, Los Thomas Gold- BY THE COURT: Russell, Citron, stein, F. Eric Goldstein & P.C., Bethesda, MD. petition rehearing having A been Gindler, Irell & Manella in active David Isaac filed and a member this Court CA, LLP, Angeles, response filed a requested poll on whether Los having service Ariosa plaintiff-appellee case should reheard An- banc, majority Diagnostics, represented by Inc. sitting and a Also Gordon; Naini, Iancu, drei Amir judges in on this Court hav- Joshua active service Rabat, Los CA. rehearing August Angeles, en Russ & against granting voted Gibson, Perry, Mark Andrew Dunn & ers Association. Also represented by Phil- LLP, D.C, Washington, Johnson, Crutcher filed a ip Staton Johnson, Johnson & response petition to the for .plaintiff-appel- Brunswick, NJ; New Rhodes, Kevin H. ,3M Natera, represented by lee Inc. Also Tra- Innovative Properties Company, St. Davies, Rosenthal, B. cey Brett Paul, Michael A. MN; JR., Herbert Wamsley, Clare Valek, Dallas, TX. -Property Intellectual Association, Owners Washington, DC. Schuck, Bartko,. Zankel,

William Paul Miller, Francisco, CA, Bunzel & San for Dowd, Matthew James Andrews Kurth counterclaim defendant-appellee DNA Di- LLP, DC, Washington, for amicus curiae Center, agnostics Inc. Jyant Technologies, Inc. represented Also Schor, Gideon A. Wilson Sonsini Good- by Gutkin, Robert A. Sushila Chanana. Rosati, PC, York, N.Y., rich & New for Lefstin,- Jeffrey University of California amici -curiae Amarantus Bioscience Hold- , Hastings Law, College Francisco, San Inc., Personalis, Inc., ings, Population Di- CA, for Lefstin, amici curiae Jeffrey Peter agnostics, Inc. Also represented by Maya S. Menell. Skubatch, Alto, CA; Palo Richard Torc- zon, Andres, Murnane, Jr., Charles John D. Washington, Fitzpatrick, Celia, J. Harper Scinto, York, N.Y., DC. & New for amicus curiae New York Prop- Intellectual Gladstein, Lana McClennen & Nutter erty Law Association. Also represented by LLP, Boston, MA, Fish for amicus.curiae Russo, Alicia Austin; Alexandra Rose Erin Bioindustry Association. represented Also Auth, Dorothy R. Cadwalader, Wickers- Linnik, Konstantin M. Isaac A. Hubner. LLP, York, N.Y.; ham & Taft New Irena Holman, Christopher University Michael Royzman, Belknap Patterson Ty- Webb & City, City, Missouri-Kansas Kansas LLP, York, N.Y.; ler New Ryan, David F. MO, for amici Biotechnology curiae Indus- Croton-on-Hudson, N.Y. try Organization, Pharmaceutical Research Corey A. Salsberg, Novartis Interna- Manufacturers of America. Biotech- AG, Basel, Switzerland, tional nology Industry Organization amicus repre- .for curiae Novartis Barrett, Brian Lilly sented P. Eli AG. IN; Company, Indianapolis, Li Wester- Noonan, Kevin McDonnell Edward-

lund, Nordic, Inc.,.Redwood Bavarian City, n Boehnen LLP, Berghoff Hulbert Chica- & n CA. IL, go, for! amici Twenty-Three curiae Benjamin Jackson, Myriad Genetics, Law Professors. UT, Lake City, Salt for amicus curiae Dan Bagatell, LLP, L. Perkins Coie Century Coalition for 2Í'st Medicine. Phoenix, AZ, for amici curiae Wisconsin represented

Also by David Carter Hoff- Foundation, Alumni Research Marshfield man, Health, Inc., Genomic City, Redwood Clinic, MCIS, represented Inc.’ Also CA. Madison, WI; Michelle Marie Umberger, Zuhn, Jr., Donald Louis McDonnell Osterhoff, Michael Robert Chicago, IL. LLP, Berghoff Boehnen Hulbert & Chica- IL, go,- for amicus curiae Paul Gilbert PROST, Before Chief Judge, Cole. NEWMAN, LOURIE, DYK, MOORE, Teige Sheehan, Heslin, P. O’MALLEY, REYNA, Rothenberg, WALLACH, Mesiti, Farley P.C., N.Y., Albany, TARANTO, CHEN, & HUGHES, STOLL, amicus curiae Intellectual Property Own- Judges. Circuit LOURIE, Judge, with whom Since Court’s decision Circuit MOORE, joins, Judge, Kappos, concurs Bilski v. Circuit petition the issue with the denial of DYK, Judge, rehearing eligibility en Circuit has been of banc. adjudication key importance pat concurs the denial in the NEWMAN, cases, rehearing particularly banc. of soft ent the field the Judge, dissents from denial of Mayo, The in As ware. Court’s decisions for petition rehearing en banc. Pathology v. Molecular sociation for Inc., Genetics, U.S. -,

Myriad ORDER (2013), and International, Corp. Bank Alice v. CLS PER CURIAM. -, 134 S.Ct. 573 U.S. rehearing was petition A for en banc brought by defendants-appellants Sequenom, filed diag the focus onto the field medical Sequenom Inc. and for Molecular Center nostics. Medicine, rehearing petition LLC. The in Mayo deter- that heard panel was first referred to that claims in that “set mined thereafter, the circuit appeal, and to It in forth laws nature.” further held regular who in service. judges are active Mayo steps setting additional to those response A invited the court and was in a process forth laws of nature claimed Diag- by plaintiffs-appellees filed Ariosa “that something pat- must add in terms of nostics, Natera, poll Inc. Inc. A and objectives law’s taken, significance” ha[ve] ent requested, and failed. laws, steps the natural such that those thereof, Upon consideration transform the into an inventive IT ORDERED THAT: IS of those laws. 132 S.Ct. Mayo, (1) petition rehearing en banc Moreover, rejected at 1299. the Court is denied. “post-solution activity purely con- is significant ventional or as not obvious” The mandate of court will is- enough to a claimed bring invention within sue on December matter. patent-eligible subject the realm LOURIE, Judge, Circuit with whom (internal altera- quotation marks and MOORE, joins, Judge, concurring omitted). tion rehearing in the denial of the en banc. specific excep- Alice relates to the third eligibility tion to its ideas—and

I concur the court’s denial of rehear- —abstract incorporates require- discussion also case, ing en banc in this on the based beyond ment of an “inventive concept” Services precedent Collaborative It Laboratories, steps.” “conventional held that v. Prometheus nothing that amount to more than instruc- -, 182 L.Ed.2d 321 apply tion to an abstract are not idea I do I princi- so because find no eligible, although application from distinguish basis this case pled view, may idea be. neither abstract which we are write bound. preclusions laws of con- of traditional separately express thoughts some ideas, ought pro- nature or of ideas cerning laws of nature and abstract abstract subject matter patent- patenting seem to at the heart of hibit which eligibility in the medical sciences. this case. issues samples, statements of performing prenatal of nature are exact blood a-

Laws relationships, diagnosis from scien such Following deduced DNA. physical based phenomena. Mayo, of natural held that steps tific observations which certain mere- ly represented by equations, recite natural laws and that the They often remain- relationship steps sufficiently include such laws must be innovative (E=me2), laws, apart energy mass between current resis held that the relationship between case claims do not in- (Ohm’s Law), -force, patent-eligible subject between volve Ap- tance matter. mass, (F=ma), pellants Maxwell’s and amici have argued and acceleration before us motion, that a equations, range Newton’s laws briefs broad claims of laws, all agree, appear are not this sort be in many jeopardy. more. Those serious subject It patent-eligible category not be that the whole diag- and should said But methods that utilize laws of nostic claims is at risk. It also' matter. said that or claim a nature do not set forth laws of crisis medical and innova- inge us, All of human tion be physical steps may upon nature. and there seems to or natural be nuity utilize natural laws involve some truth that concern. Thus,

phenomena. steps cannot be those The claims in this perhaps case should patent-ineligible solely on that basis be be in jeopardy, not they because recite cause, reasoning, nothing in under that ideas, natural laws or abstract but because patent-eligible. physical universe would be they may be indefinite or too broad. But are, axiomatically, op- they not steps patent-ineligible Abstract should be on steps; ground they that which is not that posite tangible set forth natural laws or steps that in- are tangible is abstract. But abstractions. machines, tangible, steps

volve which are Claim is a directed to method for tangible involve transformation of a detecting paternally inherited nucleic matter, subject tangible implementa- or origin pregnant acid of fetal a female tions of ideas or abstractions should not be comprising amplifying a paternally inherit- Bilski, considered to be abstract ideas. presence ed acid detecting nucleic supported proposi- this paternally of a nucleic acid. inherited tion when it described earlier machine- our per- Claim is21 directed to a method of clue, a useful al- or-transformation test as prenatal diagnosis a forming comprising test, eligibility. beit not the only a providing sample, sepa- maternal blood non- Conversely, rating sample abstract ideas are essential- into a cellular and fraction, ly steps; they tangible detecting presence mental are not even cellular acid, a a programmed providing diagnosis. if are written down or nucleic. Alice, physical into a machine. in affirm- Both of these contain nucleus claims court, patent-eligible subject this held that claims that matter. nothing significantly amount to more than noted, phenom-. As the natural apply instruction to an abstract idea are fetal presence enon here is the of cell-free fact that patent eligible. steps not But the (“cffDNA”)' in plasma, DNA maternal well-known, although relevant to other which, subjected to conven- when certain law, statutory sections of the does important new steps, tional has led to an necessarily not make them abstract. possible development: diagnosis birth Sequenom’s pat- using highly at issue in without intrusive defects Applications phenome- detecting ent are directed means. methods natural well process “may DNA na or to a known paternally-inherited fetal in maternal laws Diehr, per- “In a method of more details added: deserving patent protection.” be using tech- prenatal diagnosis it forming And amplification, niques on its of fractionation work scientific disputed not consisting improvement important like an seems own field, maternal fraction of a blood medical non-cellular contribution to the a valuable sample.” a claim di- no one asserts that although of cffDNA is the mere existence rected in draft- Regardless, experts we are not repre- But neither of patent-eligible. proce- protect biological ing claims a law merely claims here recites sentative in a position and we are not dures or a natural hypothetical claims or rewrite review oper- or rely The claims idea. abstract against But the accusation claim. recite, phe- by, but do ate might a claim to invention such law. claimed invention or nomenon draftsmanship mere and thus considered serum, separating taking maternal involves expan- seemingly ineligible under the still it, genetic material to de- amplifying the holding of it must be said that sive cffDNA, identify running tests tect matter, composition article of process, defects; genetic these are genes or certain manufacture, and are different machine steps insignificant, and not physical, all ideas, and differentiat- implementations human requiring intervention. drafting them is a ing among in claim skill, professional necessarily too might laudable The claims be indefinite avoiding prohibitions. device for they specify that how a devious in do not broad detect, despite Supreme true the Court’s separate, how to This is amplify Alice, of this in where we detect, they perhaps affirmance court diagnose. Or held, vote, by a 7-3 that method and methods of had attempt to claim all known type finer claims in the those But the media inventions carrying steps. out of essentially the same. might § 112 suited claimed there were of be better filter questions patentabili- as of treating these focusing on we have rath- But the claims the reviewing than them under ty, rather had, those we have the might er than eligibility rules. less-defined úse are to an actual claims here directed They fractionating natural material of cffDNA. re- disputed not that It is it, for blood, DNA, analyzing practical innovative and uses amplifying cite testing: sequences diagnostic are for blood specific gene particularly to detect DNA ge- typing, screening techniques typing, in art. As all other sex known individually undisputed And it is in the claims well- netic abnormalities. steps are invention, known, amplification this of the claims that before aspect the innovative in the and detection maternal improvement to be appears from cffDNA blood, prena- char- and use of these methods determining genetic fetal routine and con- diagnoses, tal were not diagnosing acteristics or abnormalities we DNA, But are applying of use the non- ventional. consisting fetal unfortunately obliged to divorce addi- DNA obtained cellular fraction fetal phe- steps from asserted natural sample. a maternal tional from blood at a conclusion that nomenon arrive then, invention, might claim to this nothing process. to the they add innovative a so-called been better drafted as Moreover, claim, in the here are ab- which what is Jepson recites is about nothing There abstract improvement. art and what is the stract. prior read, steps actual on a might physical perhaps performing a claim Such guidance concern material. And if the must come from the physical Court, Supreme a natural this court. preemption and that is, process a novel apparently, patents are to incentivize intended

what I awarded for. The here also language Mayo is clear. The that uses for there were other noted Mayo found that prior Court prenatal and other methods cffDNA decisions “insist that a that testing using cffDNA do -that upon focuses the use of a natural steps not involve the recited in various contain other elements or a combination sufficiently That fact ad- claims. should elements, sometimes referred to an ‘in improperly tying up concern of dress concept,’ ventive sufficient to ensure phenomena use of natural and laws. future practice in signifi amounts to sum, it a rule that In is unsound to have cantly than a patent upon more the natural inventions of this nature out of the takes Mayo law itself.” Collaborative Servs. v. patent-eligibility grounds realm — Labs., Inc., U.S. -, Prometheus only they phenomenon plus claim a natural 182 L.Ed.2d 321 claim steps, or that ab- conventional Flook, (quoting Parker concepts. agree pan- stract But I (1978)). 57 L.Ed.2d 451. not err in el its conclusion did Patent claims directed to laws of nature no precedent option it had when, under 35 U.S.C. than to affirm the court. other district themselves) “(apart the natural laws routine, [they] well-understood, involve- DYK, Judge, concurring activity previously engaged conventional rehearing denial researchers the field.” banc. - added). Reviewing the Court’s earlier decision, of rehear- concur court’s denial Flook Court deter banc. ing en view the framework of mined that Flook’s claim to a chemical ingredient an Mayo process applying “apparently Alice is essential an novel 1298, healthy patent system, allowing algorithm,” the of a mathematical id. at high- § of improperly ineligible steps invalidation issued 101 because the anticompetitive known,’ all ly patents without the the “were “well to the where, protracted litiga- point putting the the expensive need to formula side, tion. Yet share the of some of was no in concept’ concerns there ‘inventive formula,” my colleagues that a too restrictive test for of the id. claimed Flook, 594, eligibility at 98 (quoting under 35 U.S.C. 1299 437 U.S. at (reflected 2522) added). respect (emphasis “[S]imply to laws of nature S.Ct. language may steps, of the dis- at Mayo) appending specified some conventional na courage development high generality, a and disclosure level laws ture, phenomena, methods in therapeutic natural and abstract laws, sciences, phenomena, the life which are often driven ideas cannot make those discovery phenom- of new natural at patentable.” laws and and ideas Id. words, Mayo This that that inven ena. leads me to think some other states scope necessary eligibility illumination must concept as to the tive step at Mayo application analyzed would be beneficial in one limited come in the two, At the that than from the aspect. same time I think we rather Mayo, and' of nature itself. language are bound confirmed that for its unmistakable hold subsequently decision] Alice to arrive Mayo ing” interpretation” articulated in at a “novel two-step framework Lines, “for that decision. Thurston Motor Inc. unitary applies equally a rule Ltd., Rand, K. that claim laws of v. Jordan 460 U.S. distinguishing patents 534-35, 1343, 75 and abstract S.Ct. phenomena, natural (1983) curiam). (per recog As we have patent-eligible that claim ideas from those court, nized, a Alice subordinate federal we concepts.” “[a]s of those applications —Int’l, may easily not so Pty. Bank U.S. dismiss Corp. [the Ltd. v. CLS 2355, 189 -, statements as dicta but are bound Court’s] S.Ct. Pharm., follow explained, Alice them.” Ariad Inc. v. Eli (citing Mayo). Co., (Fed.Cir. Lilly & 598 F.3d First, we whether the claims determine 2010) (en banc). (citing Stone Container at to one of those issue are directed States, Corp. v. United 229 F.3d so, concepts.- If we patent-ineligible (Fed.Cir.2000)). 1349-50 ask, then else is there in the claims what step before us? ... We described panel correctly Mayo held thus an analysis two as a search controlling governs precedent concept i.e., inventive an element panel’s opinion aptly outcome here. The — combination of elements that is suffi- states and framework applies two-step prac- cient ensure Mayo. “First, we determine whether significantly tice more than amounts claims at patent- issue are directed to a ineligible patent upon concept itself. Ariosa concept.” Diagnostics, added) Sequenom, Inc. v. citations, (alterations, (Fed.Cir.2015) (citing omitted). Mayo quotation marks “At 1292). at -, at two, “[T]he step we must examine the elements issue, the specification, informed claim to it contains determine whether generally detecting directed to ‘trans- concept’ ‘inventive sufficient presence naturally of a occurring thing or a pat- form’ claimed abstract idea into (em- cffDNA mater ent-eligible application.” Id. at 2357 nal omitted). plasma or serum.... claimed added) [T]he phasis (quotation marks begins naturally and ends Thus Alice holds that con- .with occurring phenomenon.” Id. at At cept must found at of the step two Mayo framework, step the second framework. determined that method at “[t]he unambiguously has announced general issue here amounts to a instruction generally applicable determining test for routine, to apply doctors conventional subject-matter § eligibility under 101 with techniques seeking when detect respect to laws of and we cffDNA.” Id. at 1377. The there it. bound follow We cannot confine patent fore found that the claims were Mayo to its facts or cabin a otherwise eligible under 101.Id. at 1378. clear statement from the Court. Supreme spoken, has it is the “[0]nce II duty respect of other courts to that under- standing of governing Mayo/Alice rule of law.” framework works well Inc., v. Roadway Express, Rivers 511 U.S. when the or nature in abstract idea law of 298, 312, 1510, 114 274 and question longstanding, S.Ct. 128 L.Ed.2d is well known (as A appeals court of “con- in Mayo must not as was itself situation below), the factual contours fus[e] discussed earlier [a

1289 cases,1 in many and of our own recent tinguishing between new and established cases where we have found claims abstract ideas. § 101.2

ineligible under Where the ab- But, it, Ias see there is a problem with stract idea or law of nature is well known Mayo insofar as it concludes that inventive longstanding, and there is no basis concept cannot come from discovering attributing novelty to that aspect of the e.g., identifica something new in nature — claimed invention. tion previously of a unknown natural rela Also, it Mayo/Alice seems to me that the tionship property. view, In my framework respect works well with to ab did fully take into account the fact that view, stract In ideas. claims to busi concept can just come not processes ness methods and other creative, unconventional application merely organize activity human law, should not of a natural but also from the creativi eligible any ty novelty circum of the law Alice, (So stances. See 134 S.Ct. at 2360 itself. This is especially true the life Bilski, In re J., tomayor, concurring); sciences, 545 where development of useful new (Fed.Cir.2008) (en banc) 943, F.3d 972 therapeutic methods is driv J., (Dyk, event, In concurring). any de investigation of complex biological Mayo/Alice parting from the framework systems. worry that method claims that (as respect opposed apply newly abstract ideas discovered natural laws and phenom discoveries of natural laws and phenomena in somewhat conventional ena) would create serious ways risks of undue the Mayo test. are screened out preemption difficulty because of the in dis- In I think that Mayo may not regard See, 593, 611, e.g., Kappos, tailoring Bilski v. 561 U.S. advertising stract to individ idea— (2010) ("Hedging 130 S.Ct. 3218 ais funda ual customers—which "had often been” used practice long prevalent mental economic Techs., before); Amazon.com, Inc., OIP Inc. v. system taught our of commerce and 1359, 1362, (Fed.Cir.2015) (in 788 F.3d class.”) introductory (quoting finance re validating computerized claims to methods of Bilski, 943, (Fed.Cir.2008) 545 F.3d price optimization offer-based noting (Rader, J., added); dissenting)) (emphasis Di implicated the abstract idea was a "funda Diehr, 175, 2, amond v. 450 U.S. 177 n. Ultramercial, concept[]”); mental economic (1981) (noting 67 L.Ed.2d 155 Hulu, LLC, (Fed.Cir. Inc. v. 772 F.3d equation long the Arrhenius “has been 2014) routine, (invalidating a claim to con used to calculate the cure time in rubber- ventional of the abstract idea of added); molding processes”) (emphasis Funk "using advertising exchange as an or curren Co., Bros. Seed Co. v. Kalo Inoculant cy” rejecting patentee’s argument 127, 129, 92 L.Ed. 588 new); buySAFE, that the idea was Inc. v. ("Methods selecting strong strains [of (Fed. Google, nitrogen-fixing root-nodule and of bacteria] Cir.2014) (invalidating a claim to a method of producing a bacterial culture from them have guaranteeing party’s performance in an on known.”) added); long been see finding line transaction that the abstract English patent also the influential case dis implicated "beyond question idea of an cussed in 132 S.Ct. at Neilson v. SmartGene, lineage”); cient Harford, Inc. v. Advanced Webster’s Patent Cases Labs., SA, (1841) ("We (Fed. Biological Fed.Appx. think the case must be consid Cir.2014) principle ered promotes (invalidating computer as if the hot air a [that claim to ignition better than cold air is] well known application ized of a mental for treat ....”) added). patients medical that "doctors do routine ly”). See, e.g., 2. Capi Intellectual Ventures I LLC v. Bank, 1363, (Fed.Cir. tal One 1369 2015) (invalidating applied claims that an ab- 1290 E=mc2.” Supreme his celebrated law that 132 consistent with ent entirely

be v. (quoting at 1293 Diamond Chakra S.Ct. Myriad.3 decision Court’s 2204, 303, 309, 447 100 barty, U.S. S.Ct. 65 patent applicant discov Myriad Flook, (1980)); 144 also 437 see phe unknown natural a previously ered 591, 2522; at 98 Gottschalk v. U.S. S.Ct. sequences of the BRCA1 nomenon: Benson, 63, 72, 409 U.S. 93 S.Ct. 34 genes their connection BRCA2 (1972) that claims (holding L.Ed.2d 273 Ass’n Patholo cancer. Molecular with a mathematical al methods — U.S. -, Genetics, Inc., gy Myriad v. unpatentable were because gorithm 2107, 2112-13, 124 186 L.Ed.2d 133 patent effect practical “in would be the Court found While itself’). itself algorithm Myriad re occurring naturally claims to Myriad’s “[gjroundbreaking, us that innova minded it that “new sequences, suggested gDNA tive, not or brilliant does even knowledge about applications satisfy Myriad, inquiry.” itself genes” general could and BRCA2 BRCA1 Ariosa, 2117; at also 133 S.Ct. see 21 of with to claim ly eligible, be reference at 1379. F.3d (discussed 5,753,441 fur Patent No. U.S. patent on a primary concern with below).4 Myriad at thus Id. 2120. ther preemption of nature is law undue —the recognize an inventive appeared applica that others’ future fear innovative from discov concept can sometimes come law tions of the will be foreclosed. See unknown ery phenomenon, of an natural Morse, O’Reilly v. 56 U.S. How. just from unconventional (1853); Mayo, 14 L.Ed. 601 132 S.Ct. emphasized, As phenomenon. Myriad Mayo at As “there emphasized, knowledge of a law of party the first grant patents danger tie or abstract use will up the[ ] [of nature] laws inhibit “in an position excellent idea should upon innovation premised future applications knowledge.” claim 1301; them....” S.Ct. at see id. Pathology v. (quoting Ass’n Molecular at “the kind of risk that (highlighting (Fed.Cir. USPTO, F.3d exception, underlies the of nature 2012) J., (Bryson, concurring part namely patent the risk that a on the law dissenting part)). significantly impede would future innova tion”).

Ill Morse, O’Reilly As far back as course, newly I do not that a suggest Of unpatentable found law of should be discovered nature sweeping “marking to all or Morse’s claim entirety. eligible characters, its Laws of nature signs, printing intelligible [of] such, letters, as first patentable never even when at “the use distances” via As applicant. power galvan- discovered the motive of the electric or current, recognized, pat- electromagnetism,” ic which call Mayo “Einstein could States, 252-53, Myriad Any tension between does course, (citation not, omitted). change obligation our to re- sweeping precedent spect did. "decisions remain applications” 4. The "new referred binding precedent fit applications Court] see[s] until [the Court must meant them, regardless newly genes reconsider of whether than discovered rather subsequent step Mayo/Alice concepts cases have raised doubts about frame- two continuing vitality.” v. United their Hohn work.

1291 broad, claim is and be. holding narrowly that ‘‘the too should invalid unless tailored by at law.” 56 U.S. particular application warranted to the of the law that Morse, Mayo, like was concerned developed. has been Claims that extend building with of the preemption undue far beyond utility the by demonstrated the t ingenuity. blocks of human he “[W]hile patent applican practice and reduced to against shuts the door inventions other invalid, be they should “too broadly persons, would able to patentee the preempt the use” of underlying by the idea in the avail himself of discoveries 1294; others. 132 at see also S.Ct. properties electro-magne- powers and Diehr, v. 191-92, U.S. Diamond might bring tism which men to scientific .1048, light.” Id. at 113. But, long-as so a claim narrowly tailored patent to the applicant what has actually original Similarly, aspect in an of our and practice, invented reduced to there is by Myriad decision was not-reversed risk of preemption undue limited Court, the Ass’n Molecular — underlying Myriad idea. In the Genetics, Pathology Myriad noted, 133 S.Ct. at that an example U.S. -, might a meritorious claim be claim 21 of in our In again court’s recent Patent, (“the 5,753,441 Myriad’s U.S. No. Hereditary re BRCAl- & BRCAZ-Based patent”), '441 which at was not issue in the decision, genetic Cancer Test we found Bryson which Judge case and discussed in testing sought to “all capture claims that concurring opinion his on our court’s comparisons patient’s between the BRCA deci below, sion Ass’n Pathology, Molecular genes wild-type genes” and the BRCA J., (Bryson, concurring). be overbroad and thus 21 of patent Claim '441 covers a meth noting compari that “[t]he covered detecting any specific od of .of several mu sons are not purpose restricted tations gene, newly BRCAl discov being alteration de comparison ered (Fed.Cir. applicant and shown tected.” 774 F.3d 2014). person’s developing par increase risk of cancers, using ticular conventional . meth However, claim if the breadth of the BRCA2, ods. See re BRCA1 & sufficiently specific to a application limited at, F.3d of the new law nature discovered patent applicant practice, and reduced to approach appears This also to be sup- novelty think that ported by Morse. The enough supply necessary should be established Morse that the extent concept. My proposed approach patentee can is the which claim extent to require would claimed actually which he has some made concrete be both scope actually narrow in re- the discovery use of and reduced it to duced to practice, merely .“construc- practice. specification paten- “The of this tively” practice by filing reduced to of a tee his or discovery, describes invention patent application replete with prophetic manner construct- examples. it; ... and his covers view, Morse,

In my claim nothing breadth of the more.” 56 U.S. at 119. should patent Limiting patentees be critical. Even when a applications to narrow applicant actually developed has demonstrated particu- some and reduced lar utility newly for a law of practice keeping discovered would be in practice, nature and it to claim Mayo’s “simply ap- reduced commandment underlying Requiring § steps, specified at a 101. narrow pending conventional to laws practice of claims actual reduction to high generality, level of and abstract ideas be in phenomena, would a reasonable accommodation laws, phenomena, and cannot make those permissive return for a more at patentable.” Mayo, 132 S.Ct. ideas concept requirement. approach added). (emphasis would, think, only ensure therapeutic patents limited approach, limiting- This proposed scope their claim would survive. These on new scope of based discoveries patents the world with patents provide would dis- covering applications ac- to narrow claims applications previous- closure and useful tually practice, to would allow the reduced laws, ly unknown natural and the opportu- enjoy right an exclusive to inventor to nity patents help to obtain such would put has invented and into what he himself to make those restore incentive discov- prevent practice, applica- but not patent system eries that has historical- tions of the natural others.5 This ly provided. scope that the would ensure “foreclose[ ] claims would not more future IV underlying discovery than the invention justify.” Id. reasonably could at 1301. clear, suggest To be I do not Limiting scope its incorrectly particular decided on problem would avoid -the “the more at in Mayo facts. claims issue con- abstractly process patent’s] claims are [a tributed only routine to a law stated, it is to the more difficult determine already of nature well that was known. they precisely cover.” what “At the the discoveries time embodied (quoting Christina Bohannan S.Ct. at 1302 made, patents already were scientists Hovenkamp, & Herbert Creation without patient’s in a understood that the levels Liberty Promoting and Rival- Restraint: metabolites, including, blood certain (2012)). ry in Innovation particular, individual [the metabolites methods], measured in the claimed were sure, To be determination whether correlated the likelihood that a partic- claim law of a new nature is applying dosage thiopurine ular drug could present overbroad could difficulties defi- harm ineffective.” prove But cause drawing. allowing nition line nar- added). at row While actually claims that have been reduced claims “those the field did not know the practice embody precise when those an inventive, newly discovered law nature correlations between metabolite levels and id., ineffectiveness,” likely promote policies would the fundamental harm or “scien- filing.”); suggested requirements § It at 7.04[l][e] has been 7-309-7-310.1 Pharmaceuticals, ("In Lilly description of enablement and written will Ariad Inc. v. Eli & Circuit, guard dangers against overclaiming silting Co. Federal doctrines, banc, important description law of nature. Those reaffirmed that written are, only generally require requirement that one or a the invention is a distinct from representative de- [The court] handful of embodiments be enablement.... declined to set See, rules,' e.g., 'bright-line including patentee. scribed Donald S. forth rules on the Patents, Chisum, species support gener Chisum on 7.03 at 7-15 number of needed to Ariad, claim.”) ("An enabling (citing quoting disclosure that is ic is all Therefore, 1351-52). required applicant [for enablement]. The the doctrines of en- description need actual ex- ablement not describe embodiments or and written would not Indeed, amples. prevent applicant entirely preempt need not have claims that future practice prior applications reduced the invention to of the law of nature others. patent, metabolites as routinely measured col. 4-14. Such ap- tists investigations pear impermissible their into the rela- part attempts to cap- ture the entire tionships phenomenon metabolite levels and ef- between of cffDNA rather than ficacy toxicity thiopurine any particular of com- applica- added). tions developed at 1298 thereof pounds,” actually id. re- practice by the natural law duced to Mayo, inventors. merely optimization drug routine A likely future case is to present pat- a dosage therapeutic to maximize effect.6 ent claim where the concept re- above, Mayo part As thus forms discussed newly sides a discovered law of nature a decisions long line Court phenomenon, or natural but the claim is claims invalidating patent to conventional narrowly actually drawn and reduced to applications of well-known laws of nature. practice. will, That case I hope, provide an opportunity Court with V revisit the Mayo/Alice framework in this aspect. one limited Finally, ap- it seems to me that proach suggest change would not NEWMAN, Judge, dissenting Sequenom’s challenged in this case. result from denial of the rehearing en embody newly discovered natural banc. presence paternally (cffDNA) cell-free in a inherited fetal DNA I agree colleagues that this case Judge mother’s Linn’s con- bloodstream. wrongly However, decided. I do not amplification currence notes that “the and share their view that this incorrect deci- detection of cffDNA had never before been required sion is by Supreme prece- Arioso, (Linn, J., done.” 788 F.3d dent. The diverge signif- facts of this case major concurring). But the defect is not icantly from rulings Mayo the facts -and concept that the claims lack inventive but Collaborative Services v. Prometheus Lab- — that they oratories, Inc., rather are overbroad. See -, U.S. 132 S.Ct. 1289, 132 S.Ct. at 1294. and Asso- ciation Molecular Pathology Myriad example, For claim 1 of the '540 — Genetics, -, 2107, U.S. broadly any detecting covers method 186 L.Ed.2d 124 paternally inherited cffDNA from mater- plasma amplification nal serum or via In Mayo, product both the medicinal known, detection of that patent, previously cffDNA. '540 col. and its metabolites were 23, leaving sparse 11.61-67. Even the somewhat narrow- room for innovative advance patent, using er claim of the '540 which re- diagnostic this information as a Nonetheless, performing prenatal dosage cites method of tool. rec- diagnosis presence, quantity, ognized based on the principle patent eligibility or sequence paternally inherited is. not disabled when put science is use, practical stating way cffDNA detected the method of claim that “a broadly encompasses any diagnosis existing drug” still an patent-eligible is' disease, disorder, or condition. '540 under Section 101.132 S.Ct. at 1302. obviousness, Pfizer, generally, Apotex, Inc. v. 480 F.3d in the context of "it Cf. (Fed.Cir.2007) ("[Discovery optimum of an inventive to discover the optimum ranges by pro- experimentation”) value in a known of variable workable routine Geisler, Aller, obvious.”); usually (quoting cess is In re In re 42 CCPA (Fed.Cir.1997) (1955)). (noting F.3d Op. at 5. The “breakthrough,” Panel Cone. appropri- Mayo drew or not

Whether pat- access to case, in view of decision to withhold particularly panel’s in that ate line by the en banc diagnostic enting, now endorsed specificity case, is devoid this decision does refusal to rehear developed, court’s that was a different line drawing support. require the In the case now facts. quite different diagnos- patenting of this new Nor does us, was not the claimed method before study of this preempt tic method known, nor previously science, of additional development nor the by the implemented knowledge and benefit does, however, fa- Patenting applications. method. provision benefit of public cilitate the accompanied the Court’s caveats Similar diagnostic through medical Pa- Molecular in Association decision for commerce, remaining than a labora- rather Genetics, with the Court thology Myriad v. tory curiosity. “this case does not involve stating that un- subject ineligible matter is not knowledge This applications of patents on new standard genes.” der Section but warrants the BRCA1 and BRCA2 about original). analysis compliance The for with the re- legal 133 S.Ct. at is, holding, stating patentability, its novel- explained quirements unobviousness, genes and the written de- merely ty, specificity that: hold “We enablement, etc., not they encode are and whether scription, information ¡because limited, simply eligible appropriately the claims are surrounding O’Reilly isolated from many years ago have been discussed (1853) (“We Morse, per- material.” Id. genetic objection to the de- ceive no well-founded bar, the inventors are In the case inven- scription given which is of the whole fact of the claiming the scientific right his separate parts, tion and its nor to preg- DNA in the blood of a paternal inventions to a for the first seven woman; they claiming are the discov- nant specification of his set forth diagnostic of a new ery development claims.”). this information. As the method of “breakthrough,” is a panel recognized, this dissent col- respectfully information can now be learned for this leagues’ conclusion that period only gestation earlier 101 excludes this in- precedent on Section available, but without previously than was eligibility patenting. vention from required inva- previously risks of the subject matter should be reviewed the amniot- penetrating procedures sive compliance with Sections ic sac. provisions relevant other all require does not dis- Precedent patent law. phenomena or their

coveries of ways or for new uses new patenting; the Court has against generalizations.

cautioned such hold for the case at bar.

Such caution takes novel method here is unforeseen, profound public and is significant contribution to

benefit—“a field,” Maj. Op. Panel at 16-—a

medical

Case Details

Case Name: Ariosa Diagnostics, Inc. v. Sequenom, Inc.

Court Name: Court of Appeals for the Federal Circuit

Date Published: Dec 2, 2015

Citation: 809 F.3d 1282

Docket Number: 2014-1139, 2014-1144

Court Abbreviation: Fed. Cir.