`
`IN THE
`Supreme Court of the United States
`
`
`CUBIST PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`
`Respondent.
`
`
`ON PETITION FOR A WRIT OF CERTIORARI TO THE
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`PETITION FOR A WRIT OF CERTIORARI
`
`
`WILLIAM MCELWAIN
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`(202) 663-6000
`
`WILLIAM F. LEE
` Counsel of Record
`LISA J. PIROZZOLO
`MARK C. FLEMING
`JOHN C. POLLEY
`STEPHANIE T. NEELY
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`william.lee@wilmerhale.com
`
`
`
`
`
`
`
`Fresenius-Kabi Exhibit 1037
`IPR2015-00223
`
`
`
`
`
`QUESTIONS PRESENTED
`
`In Graham v. John Deere Co. of Kansas City, 383
`U.S. 1 (1966), this Court recognized the relevance of
`“objective indicia” of nonobviousness (also known as
`“secondary considerations”)—including the long-felt
`need for the patented invention, the failure of others to
`arrive at the invention, and the invention’s subsequent
`commercial success—in determining whether a patent’s
`claims were obvious to a person of ordinary skill in the
`art. In this case, the district court created, and the
`Federal Circuit affirmed, two categorical limitations on
`the consideration of objective indicia of nonobviousness
`that exist nowhere in the Patent Act or this Court’s ju-
`risprudence.
`The questions presented are:
`1. Whether a court may categorically disregard
`objective indicia of a patent’s nonobviousness merely
`because the considerations apply to one commercial
`embodiment of a patented invention, rather than all
`embodiments.
`2. Whether a court may categorically disregard
`objective evidence of a long-felt need for a patented in-
`vention merely because the need is not expressly recit-
`ed in the patent claims.
`
`(i)
`
`
`
`
`
`RULE 29.6 DISCLOSURE STATEMENT
`
`Cubist Pharmaceuticals LLC (formerly known as
`Cubist Pharmaceuticals, Inc.) is a wholly-owned subsid-
`iary of Merck & Co., Inc. Merck & Co., Inc. is not
`owned by any parent corporation and, to its knowledge,
`no other publicly held corporation owns 10% or more of
`its stock.
`
`
`(ii)
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`QUESTIONS PRESENTED ............................................ i
`RULE 29.6 DISCLOSURE STATEMENT ................... ii
`TABLE OF AUTHORITIES ........................................... v
`OPINIONS BELOW .......................................................... 1
`JURISDICTION ................................................................. 2
`INTRODUCTION .............................................................. 2
`STATEMENT ..................................................................... 5
`A. Cubist’s
`Inventions
`And
`The
`Development Of Cubicin ...................................... 5
`1. Invention Of The Method of
`Administration Patents ................................ 6
`2. Invention Of The High Purity
`Patents ............................................................. 9
`B. District Court Proceedings ................................ 11
`C. Federal Circuit Proceedings ............................. 13
`REASONS FOR GRANTING THE PETITION .......... 14
`I. THE COURT SHOULD GRANT CERTIORARI
`TO RESTORE THE PROPER ROLE OF
`OBJECTIVE INDICIA OF NONOBVIOUSNESS ............ 14
`A. Evaluation Of Objective Indicia Of
`Nonobviousness Is A Critical And
`Required Step In The Obviousness
`Analysis ................................................................ 15
`
`(iii)
`
`
`
`iv
`
`TABLE OF CONTENTS—Continued
`
`Page
`
`B. Contrary To The Federal Circuit’s
`Holding, It Is Error To Disregard
`Objective Indicia Of Nonobviousness
`Merely Because They Do Not Apply To
`All Embodiments ................................................ 17
`II. THE COURT SHOULD GRANT CERTIORARI
`TO DISAPPROVE
`THE ERRONEOUS
`REQUIREMENT THAT LONG-FELT NEED IS
`NOT TO BE CONSIDERED UNLESS
`EXPRESSLY RECITED IN A PATENT’S
`CLAIMS ......................................................................... 22
`CONCLUSION ................................................................. 26
`APPENDIX A: Opinion of the United States
`Court of Appeals for the Federal Circuit,
`dated November 12, 2015 .......................................... 1a
`APPENDIX B: Erratum to the November 12,
`2015 Opinion of the United States Court of
`Appeals for the Federal Circuit, dated
`December 23, 2015 .................................................... 35a
`APPENDIX C: Memorandum Opinion of the
`United States District Court
`for the
`District of Delaware, dated December 8,
`2014 ............................................................................. 37a
`APPENDIX D: Order of the United States
`Court of Appeals for the Federal Circuit
`denying petition for panel rehearing and
`rehearing en banc, dated January 22, 2016........... 97a
`
`
`
`
`
`
`
`v
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`Al-Site Corp. v. VSI International, Inc.,
`174 F.3d 1308 (Fed. Cir. 1999) .................................. 22
`Inc.
`v. Advanced
`Applied Materials,
`Semiconductor Materials America, Inc.,
`98 F.3d 1563 (Fed. Cir. 1996) .................................... 18
`Brown & Williamson Tobacco Corp. v. Philip
`Morris Inc., 229 F.3d 1120 (Fed. Cir. 2000) ............ 18
`Eli Lilly & Co. v. Zenith Goldline
`Pharmaceuticals, Inc., 471 F.3d 1369 (Fed.
`Cir. 2006) ................................................................ 23, 25
`Expanded Metal Co. v. Bradford, 214 U.S. 366
`(1909) ........................................................................ 3, 16
`Gillette Co. v. S.C. Johnson & Son, Inc.,
`919 F.2d 720 (Fed. Cir. 1990) .................................... 21
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) ..................................... 2, 3, 15, 16, 22
`re
`Cyclobenzaprine Hydrochloride
`Extended-Release
`Capsule
`Patent
`Litigation, 676 F.3d 1063 (Fed. Cir. 2012) .............. 16
`In re DBC, 545 F.3d 1373 (Fed. Cir. 2008) ..................... 18
`In re Fielder, 471 F.2d 640 (C.C.P.A. 1973) ................... 16
`In re Glatt Air Techniques, Inc., 630 F.3d 1026
`(Fed. Cir. 2011) ..................................................... 18, 19
`Keystone Manufacturing Co. v. Adams,
`151 U.S. 139 (1894) ................................................. 3, 17
`
`In
`
`
`
`
`
`vi
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`KSR International Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................... 15, 22
`Leo Pharmaceutical Products, Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ............................ 20, 25
`Monroe Auto Equipment Co. v. Heckethorn
`Manufacturing & Supply Co., 332 F.2d 406
`(6th Cir. 1964) .............................................................. 16
`Pfizer Inc. v. Teva Pharmaceuticals U.S.A.,
`Inc., 882 F. Supp. 2d 643 (D. Del. 2012) ................... 25
`Pro-Mold & Tool Co. v. Great Lakes Plastics,
`Inc., 75 F.3d 1568 (Fed. Cir. 1996) ........................... 17
`Co.
`v.
`Procter
`&
`Gamble
`Teva
`Pharmaceuticals USA, Inc., 566 F.3d 989
`(Fed. Cir. 2009) ......................................... 20, 21, 23, 24
`Rambus Inc. v. Rea, 731 F.3d 1248 (Fed Cir.
`2013) ............................................................................. 21
`Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d
`1530 (Fed. Cir. 1983) .................................................. 17
`
`STATUTES
`
`21 U.S.C.
`§ 355 .............................................................................. 11
`§ 355a ............................................................................ 21
`28 U.S.C.
`§ 1254 .............................................................................. 2
`§ 1331 .............................................................................. 2
`§ 1338 .............................................................................. 2
`§ 2201 .............................................................................. 2
`§ 2202 .............................................................................. 2
`
`
`
`
`
`vii
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`
`35 U.S.C.
`§ 103 .............................................................................. 15
`§ 112 .............................................................................. 23
`Orphan Drug Act, Pub. L. No. 97-414, 96 Stat.
`2049 (1983) ................................................................... 21
`
`
`
`
`
`
`
`
`
`IN THE
`Supreme Court of the United States
`
`No. 15-
`
`
`CUBIST PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`
`Respondent.
`
`
`ON PETITION FOR A WRIT OF CERTIORARI TO THE
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`PETITION FOR A WRIT OF CERTIORARI
`
`
`Petitioner Cubist Pharmaceuticals LLC (formerly
`known as Cubist Pharmaceuticals, Inc.) respectfully
`petitions for a writ of certiorari to review the judgment
`of the United States Court of Appeals for the Federal
`Circuit in this case.
`
`OPINIONS BELOW
`The opinion of the United States Court of Appeals
`for the Federal Circuit (App. 1a-34a) is reported at 805
`F.3d 1112. The Federal Circuit’s erratum correcting its
`original opinion (App. 35a) is unreported. The Federal
`Circuit’s denial of Cubist’s combined petition for panel
`rehearing and rehearing en banc (App. 97a-98a) is un-
`reported. The memorandum opinion of the United
`
`
`
`
`
`2
`
`States District Court for the District of Delaware find-
`ing the asserted claims of Cubist’s patents invalid as
`obvious (App. 37a-96a) is reported at 75 F. Supp. 3d
`641.
`
`JURISDICTION
`The district court had subject-matter jurisdiction
`over this case under 28 U.S.C. §§ 1331, 1338, 2201, and
`2202. The Federal Circuit’s judgment was entered on
`November 12, 2015. App. 1a. Cubist filed a timely
`combined petition for panel rehearing and rehearing en
`banc on December 14, 2015, which was denied on Janu-
`ary 22, 2016. App. 97a-98a. This Court’s jurisdiction is
`invoked pursuant to 28 U.S.C. § 1254(1).
`
`INTRODUCTION
`This case concerns significant and unwarranted
`changes to the standard for evaluating the obviousness
`of patent claims. Through the decisions below, the dis-
`trict court and Federal Circuit have effectively re-
`moved from consideration a key element in the obvi-
`ousness test that this Court set out in Graham v. John
`Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966)—
`objective indicia of nonobviousness—in a sizable share
`of patent cases, including the case at bar. The changes
`announced below will restrict a patent owner’s ability
`to rely on relevant, probative evidence bearing on pa-
`tent validity, particularly when claims recite a genus of
`multiple embodiments not all of which have the same
`characteristics.
`The patents at issue in this case relate to daptomy-
`cin, a powerful antibiotic for the treatment of life-
`threatening bacterial infections. Although the prior art
`disclosed daptomycin, it was Cubist that first discov-
`ered particular methods for administering, and pro-
`
`
`
`
`
`3
`
`cesses for manufacturing, daptomycin in a way that
`made it consistently safe and effective for use in pa-
`tients. Cubist’s commercial embodiment of the claimed
`inventions, Cubicin®, was widely recognized as a
`breakthrough treatment for serious bacterial infec-
`tions. Many follow-on manufacturers, including re-
`spondent Hospira, sought to capitalize on Cubist’s dis-
`covery, and Cubist brought suit to protect its intellec-
`tual property.
`At trial in the district court, Hospira argued that
`Cubist’s asserted patent claims were invalid as obvious.
`In response, Cubist presented extensive, real-world
`evidence that this was not so. Specifically, Cubist
`showed that there was a long-felt need for the claimed
`inventions, that the inventions displayed unexpected
`properties, that drug development leader Eli Lilly had
`tried and failed to discover safe and effective methods
`of administering daptomycin, and that Cubicin has been
`a great commercial success.
`Such evidence, generally called “objective indicia”
`or “secondary considerations” of nonobviousness, is
`highly relevant when adjudicating an obviousness de-
`fense. It is one of four factors this Court identified for
`evaluation in assessing obviousness, stating that it may
`“serve to ‘guard against slipping into use of hindsight.’”
`Graham, 383 U.S. at 17, 36. Indeed, the Court has ac-
`corded significant weight to objective indicia of nonob-
`viousness for over a century. See, e.g., Expanded Metal
`Co. v. Bradford, 214 U.S. 366, 381 (1909); Keystone Mfg.
`Co. v. Adams, 151 U.S. 139, 143-145 (1894).
`The district court nonetheless categorically disre-
`garded Cubist’s strong objective indicia evidence,
`based on two unprecedented bright-line rules nowhere
`
`
`
`
`
`4
`
`supported by the Patent Act or this Court’s jurispru-
`dence:
`• First, the court held that all objective indicia of
`nonobviousness must be “coextensive” with the
`scope of the claims at issue to receive significant
`weight in the obviousness analysis (App. 79a).
`• Second, the court held that patent claims must
`expressly recite the long-felt need met by the
`claimed invention (App. 92a).
`The Federal Circuit affirmed the district court’s ruling,
`holding that the district court did not commit “reversi-
`ble error” with respect to Cubist’s method of admin-
`istration patents, and “sustain[ing] the district court’s
`determination” with respect to its patents on manufac-
`turing high purity daptomycin. App. 26a, 33a, 35a.
`Under these rules, courts could disregard evidence
`of objective indicia of nonobviousness unless it related
`to commercial embodiments that practice the full scope
`of a patent’s claims, and any long-felt need would have
`to be recited in the claims themselves before it could be
`given weight in an obviousness analysis. Such rigid
`rules have no basis in law or common sense; the effect in
`this case was to disregard Cubist’s extensive and proba-
`tive objective indicia that its methods of manufacturing
`and administering Cubicin were groundbreaking and
`not obvious to skilled artisans. More broadly, a re-
`quirement that objective indicia be “coextensive” with a
`claim’s full scope will almost always be unmet whenever
`asserted claims have multiple embodiments—a frequent
`characteristic not only of pharmaceutical patents, but of
`patents in other fields as well. The new requirement
`that claims specifically recite any long-felt need will al-
`most never be satisfied, as patent claims are supposed
`
`
`
`
`
`5
`
`to recite the patented invention, not prior art problems
`that the invention solves.
`This Court has not considered the doctrine of ob-
`jective indicia in decades, likely because the lower
`courts were generally able to apply it faithfully. The
`decisions below signal an unwarranted diversion from
`this Court’s precedent that cannot stand. This Court
`should grant the petition, vacate the judgment below,
`and remand for further consideration of Cubist’s objec-
`tive indicia of nonobviousness.
`
`STATEMENT
`A. Cubist’s Inventions And The Development Of
`Cubicin
`Cubicin is an antibiotic used to treat serious infec-
`tions caused by a bacterium called methicillin-resistant
`Staphylococcus aureus, or MRSA. App. 39a. MRSA
`bacteria infect approximately 80,000 Americans each
`year, resulting in 11,000 deaths. CAJA 1143-1144. Pri-
`or to the discoveries at issue here, only one antibiotic—
`vancomycin—was available to treat serious MRSA in-
`fections. Vancomycin did not work for everyone, and
`when vancomycin failed, patients died. App. 17a;
`CAJA 488, 763-765, 1144.
`The active ingredient in Cubicin is daptomycin, a
`potent antibacterial agent for treating MRSA. App.
`39a. Prior to the inventions at issue, no daptomycin
`treatment was commercially available, even though
`skilled artisans had been trying to develop daptomycin
`treatments since the early 1980s. Despite a long-felt
`need for a serious MRSA treatment, and despite eight
`years of ultimately failed efforts by drug development
`expert Eli Lilly, no safe and effective dosing regimen
`had been found, and no commercially scalable purifica-
`
`
`
`
`
`6
`
`tion method had been discovered. CAJA 764, 887-888,
`2242. After Cubist arrived at surprising solutions to
`both problems, Cubist was able to develop daptomycin
`into a commercially available drug to treat
`life-
`threatening infections. Since the FDA’s approval of
`Cubicin in 2003, gross revenues of Cubicin have totaled
`over $3 billion. App. 40a; CAJA 1346.
`
`1.
`
`Invention Of The Method of Administra-
`tion Patents
`Cubicin is indicated to treat complicated skin and
`skin structure infections, bloodstream infections (bac-
`teremia) and heart infections (endocarditis) caused by
`MRSA. App. 39a-40a; CAJA 1144. These are serious
`infections that require hospitalization and, particularly
`in the case of bacteremia and endocarditis, can be fatal
`if untreated. CAJA 488, 1144. Before Cubicin, vanco-
`mycin was the only available treatment for these seri-
`ous infections. CAJA 1144.
`Clinicians had long felt a need to develop an alter-
`native to vancomycin for treating serious MRSA infec-
`tions. Not all patients responded to vancomycin, and
`those that failed to respond risked death. Moreover,
`clinicians expected that MRSA might eventually devel-
`op resistance to vancomycin, as it had with prior antibi-
`otics. When that happened, unless another treatment
`was available, there would be no way to treat these
`deadly infections. CAJA 488, 763-765, 1143-1145.
`Eli Lilly, one of the world’s leading pharmaceutical
`companies, spent years and significant resources trying
`to develop daptomycin into a safe and effective drug to
`treat serious MRSA infections. After discovering dap-
`tomycin, Lilly spent approximately eight years trying
`to develop it, founding a team in 1983 of chemists, toxi-
`
`
`
`
`
`7
`
`cologists, pharmacologists, microbiologists, and clini-
`cians. CAJA 764, 825-826, 6846. Lilly conducted nine-
`teen human clinical trials, along with numerous in vitro
`and animal studies. CAJA 2178-2179, 2242, 6725-6783.
`Despite this effort, Lilly failed to find a dosing reg-
`imen for daptomycin that could treat serious infections
`without causing toxicity. CAJA 776-779. Lilly first
`tried administering 2 mg/kg1 of daptomycin once daily
`to patients, but patients suffering from serious infec-
`tions did not respond to treatment and Lilly was forced
`to suspend the study before it was completed. App. 20a;
`CAJA 768-770, 5936, 5939. Lilly then tripled the daily
`dose to 3 mg/kg every 12 hours, but that regimen still
`failed to treat patients with S. aureus endocarditis.2
`App. 20a-21a; CAJA 771-774, 6490. Finally, Lilly tried
`administering 4 mg/kg every 12 hours, but this dose led
`to serious unexplained skeletal muscle toxicity which,
`again, forced Lilly to halt its study. App. 21a; CAJA
`777-779. After Lilly informed the FDA of these serious
`adverse events, the agency put all daptomycin clinical
`studies on hold, forbidding the further administration of
`daptomycin to patients. CAJA 779-780, 6847.
`Lilly could not determine the cause of this skeletal
`muscle toxicity, and thus was unable to develop a dos-
`ing regimen that could safely and effectively treat seri-
`
`1 The term “mg/kg” refers to the amount of daptomycin in
`milligrams (mg) administered per kilogram (kg) weight of the pa-
`tient. CAJA 768.
`2 Lilly recognized that it was particularly important that dap-
`tomycin be able to treat endocarditis, because patients with bacte-
`remia are predisposed to endocarditis, and clinicians are unable to
`tell whether a patient has only a lower grade infection or also en-
`docarditis. Because untreated endocarditis can be fatal, daptomy-
`cin’s clinical and commercial success required effectiveness against
`endocarditis. CAJA 488, 800-801, 1138-1141, 1292-1293.
`
`
`
`
`
`8
`
`ous infections. Lilly eventually suspended further de-
`velopment of daptomycin and turned its attention to
`other candidates for treatment of MRSA. App. 17a;
`CAJA 778-783, 837-839, 6846.
`In 1997, six years after Lilly ceased work on dap-
`tomycin, Cubist licensed the compound from Lilly.
`Cubist initially planned to develop an oral or topical
`treatment that would avoid skeletal muscle toxicity.
`CAJA 2242, 5113. But Cubist scientists, impressed by
`daptomycin’s potential, decided to study its toxicity by
`conducting a series of studies in dogs. These studies
`showed that, surprisingly, larger doses of daptomycin
`administered once daily were less toxic than smaller
`doses administered multiple times a day. App. 17a;
`CAJA 189-190, 1161-1166. This was unexpected; at the
`time of the invention, persons of ordinary skill in the
`art generally understood that smaller, more frequent
`doses of a drug would be safer and more effective than
`larger doses administered less frequently. Specifically,
`it was thought that larger doses would lead to higher
`concentrations of drug in the blood, which would in-
`crease toxicity, and longer intervals would lead to low-
`er trough concentrations of drug in the blood between
`doses, which would decrease efficacy. CAJA 782, 784,
`813-814, 1147.
`The results of Cubist’s dog studies, and of subse-
`quent clinical trials which demonstrated the safety and
`efficacy of once-daily daptomycin dosing in humans,
`were published in prestigious journals including Anti-
`microbial Agents and Chemotherapy, Clinical Infec-
`tious Diseases, and The New England Journal of Med-
`icine. Cubist’s results surprised the field; it was
`thought at the time that daptomycin simply could not
`be used to treat serious infections, since doses large
`
`
`
`
`
`9
`
`enough to be effective also appeared to be toxic. CAJA
`1146-1149, 5766-5774, 5775-5787, 6849-6854.
`Cubist obtained two patents (the Method of Admin-
`istration Patents) covering the dosing methods it had
`discovered. Asserted claims 16, 17, 34, and 35 of U.S.
`Patent No. 6,468,967 (’967 patent) and 51 and 52 of U.S.
`Patent No. 6,852,689 (’689 patent) are directed to meth-
`ods for administering therapeutically effective amounts
`of daptomycin using larger amounts and longer inter-
`vals, which surprisingly minimize skeletal muscle tox-
`icity. App. 17a-18a; CAJA 179, 195. The dosing regi-
`mens recited in those claims are the same as those de-
`scribed in the FDA-approved label for Cubicin, and are
`also the only approved dosing regimens for daptomycin.
`
`2.
`Invention Of The High Purity Patents
`Finding a safe and effective dosing regimen for
`daptomycin was not the only challenge Cubist faced be-
`fore it could bring daptomycin to market. Cubist also
`needed to develop a purification method that would al-
`low daptomycin to be developed on a commercial scale.
`Cubist first tried producing daptomycin using a pu-
`rification method described in Lilly’s Investigational
`New Drug Application for daptomycin. That method
`resulted in a daptomycin composition containing unsafe
`levels of dangerous contaminants known as endotoxins.
`Moreover, Lilly’s method only enabled recovery of ap-
`proximately 2-5% of the daptomycin created. This yield
`was too low for daptomycin to be developed on a com-
`mercial scale. App. 85a, 91a-92a; CAJA 887-888, 890-
`891, 901, 910, 4245.
`However, as part of its effort to remove endotoxins
`so that daptomycin would be safe for use in clinical tri-
`als, Cubist made a surprising discovery: daptomycin
`
`
`
`
`
`10
`
`molecules aggregate into clumps or “micelles” at acidic
`pH, and break apart into single molecules again at neu-
`tral pH. App. 28a-29a, 93a; CAJA 901-902. By taking
`advantage of this unexpected property, Cubist devel-
`oped a purification method that reduced endotoxins to
`undetectable levels. CAJA 117, 901-904, 906-907, 973-
`974. This method also increased the yield of daptomy-
`cin from 2-5% to 25-35%. This increase in yield enabled
`daptomycin production on a commercial scale. App.
`91a-92a; CAJA 910-911, 1121-1122.
`Cubist obtained two patents (the High Purity Pa-
`tents) that describe the commercial-scale manufactur-
`ing methods that Cubist invented: U.S. Patent Nos.
`8,058,238 (’238 patent) and 8,129,342 (’342 patent). The
`asserted claims of the High Purity Patents—claims 91,
`98, and 187 of the ’238 patent and 23 and 53 of the ’342
`patent—are product-by-process claims directed to the
`highly pure form of daptomycin produced using Cub-
`ist’s methods of manufacture. App. 26a-28a; CAJA 119-
`121, 123-124, 158-160. The common specification of the
`High Purity Patents repeatedly emphasizes that one
`purpose of the invention was to address the need for a
`process that could be “easily scaled for commercial pro-
`duction.” CAJA 100. For example, the specification
`states that “[t]here is a need for a commercially feasible
`method to produce more highly purified daptomycin
`and, if possible, to increase its yield after purification”
`and that “[t]he instant invention addresses these prob-
`lems by providing commercially feasible methods to
`produce high levels of purified lipopeptides [such as
`daptomycin].” CAJA 101; see also CAJA 101-104 (3:50-
`66, 5:9-11, 5:56-58, 8:66-9:3, 10:34-37).
`
`
`
`
`
`11
`B. District Court Proceedings
`In 2012, Hospira filed two applications with the
`FDA seeking approval of generic versions of Cubicin.
`Both included “Paragraph IV” certifications, stating
`(inter alia) that Cubist’s Method of Administration and
`High Purity Patents were invalid. App. 51a-53a; see 21
`U.S.C. §§ 355(b)(2)(A)(iv), (j)(2)(A)(vii)(IV). Cubist
`filed the present suit in response, seeking a declaration
`that Hospira’s generic daptomycin products would in-
`fringe the asserted patents.3 Hospira counterclaimed
`that the asserted patents’ claims were invalid because,
`among other things, they would have been obvious to a
`person of skill in the art at the time of the invention.
`App. 2a-3a. Hospira subsequently stipulated to in-
`fringement of the asserted patent claims. Stip. 1-3, No.
`12-367, D.I. 88 (D. Del. July 25, 2013).
`At trial, Cubist presented extensive evidence that
`the asserted claims could not have been obvious at the
`time of the invention, given the objective, real-world
`evidence from that time. With respect to the Method of
`Administration Patents, Cubist showed that: (1) there
`had been a long-felt need for a new antibiotic to treat
`serious MRSA infections; (2) others (in particular Eli
`Lilly) tried and failed to discover a dosing regimen that
`would enable daptomycin to treat such infections safe-
`ly; (3) the invention produced the unexpected result
`that larger daptomycin doses administered less fre-
`quently were safe and effective; and (4) following FDA
`approval, the invention achieved great commercial suc-
`
`3 A fifth patent, United States Patent No. RE39,071, was also
`asserted in the present suit. The district court found that patent
`was valid and infringed, and this finding was affirmed by the Fed-
`eral Circuit. App. 16a. That patent, which is scheduled to expire
`on June 15, 2016, is not at issue in this petition. Suppl. Info. For
`Patent Cases, No. 12-367, D.I. 2 (D. Del. Mar. 21, 2012).
`
`
`
`
`
`12
`
`cess. With respect to the High Purity Patents, Cubist
`showed that (inter alia) there had been a long-felt need
`for a way to manufacture highly-pure daptomycin on a
`commercial scale, a need that was satisfied by Cubist’s
`patented invention.
`After a bench trial, the district court issued an
`opinion that disregarded Cubist’s evidence of objective
`indicia. With respect to the Method of Administration
`Patents, the district court did not deny the connection
`between each of the above objective indicia of nonobvi-
`ousness and the claimed inventions. App. 79a-82a.
`Nevertheless, because the district court found that “the
`nexus is strongest for the use of Cubicin to treat [S. au-
`reus endocarditis],” while “the claims cover bacterial
`infections generally,” it categorically refused to give
`these objective indicia substantial weight. App. 80a-
`81a; see also App. 79a-82a. That was because the court
`created a bright-line rule that objective indicia of non-
`obviousness “must be commensurate
`in scope—
`‘coextensive’—with the claimed features of the inven-
`tion.” App. 79a (emphasis added).
`With respect to the High Purity Patents, the dis-
`trict court similarly disregarded Cubist’s evidence of
`the long-felt need for a commercial-scale purification
`process. The court expressly found that, “[u]sing the
`processes outlined in the purity patents, … Cubist was
`able to obtain yields between 25% and 35%, making
`daptomycin a commercially viable drug for the first
`time.” App. 92a. Nevertheless, the court held that this
`evidence did not affect the obviousness analysis be-
`cause, “[a]lthough the processes described in the purity
`patents may have ultimately led to more efficient pro-
`
`
`
`
`
`13
`
`duction, the claims themselves do not speak of yield.”
`Id. (emphasis added).4
`Ultimately, the district court held the asserted
`claims of the Method of Administration and High Puri-
`ty Patents invalid as obvious. App. 96a.5
`
`C. Federal Circuit Proceedings
`In a published opinion, the Federal Circuit affirmed
`the district court’s decision that the Method of Admin-
`istration and High Purity Patents were obvious, and
`specifically affirmed the district court’s ruling on objec-
`tive indicia of nonobviousness.
`For the Method of Administration Patents, the
`Federal Circuit acknowledged that “prior art daptomy-
`cin treatment methods had not proved effective” for
`treating S. aureus endocarditis. App. 24a-25a. Never-
`theless, it endorsed the district court’s decision not to
`give significant weight to Cubist’s evidence regarding
`long-felt need, failure of others, unexpected results, and
`commercial success, because the evidence did not apply
`to the treatment of all infections covered by the claims.
`App. 24a-26a, 79a-82a. In its original opinion, the Fed-
`
`4 The district court also found that it was “not clear why there
`would be a need to develop a commercially viable purification pro-
`cess,” because daptomycin was considered a “dead drug” due to
`Lilly’s abandonment of its development in 1991. App. 92a-93a.
`The district court did not discuss whether daptomycin was still
`considered a “dead drug” in January 2000, when the High Purity
`Patents’ provisional application was filed—nine years after Lilly
`abandoned the drug and three years after Cubist licensed it.
`CAJA 2242, 6846.
`5 Certain claims of the Method of Administration and High
`Purity Patents were also found invalid as anticipated. App. 96a.
`However, the Federal Circuit affirmed the district court’s decision
`on the basis of obviousness alone. App. 16a.
`
`
`
`
`
`14
`
`eral Circuit stated that the district court did not commit
`“legal error” in its analysis of the secondary considera-
`tion evidence. App. 26a. However, after Cubist peti-
`tioned for rehearing, the panel issued an “erratum” to
`its opinion changing the word “legal” to “reversible,”
`such that the opinion now reads: “We are not persuad-
`ed that the district court committed reversible error in
`its analysis of the secondary consideration evidence.”
`App. 26a, 35a (emphasis added). The panel neither cor-
`rected nor addressed the district court’s statement that
`objective indicia of nonobviousness must be coextensive
`with the claimed invention. Id.
`The Federal Circuit also sustained the district
`court’s holding disregarding Cubist’s evidence of long-
`felt need for a commercially viable method to manufac-
`ture daptomycin. App. 33a. In doing so, the Federal
`Circuit specifically recited the district court’s state-
`ment that “the asserted claims [of the High Purity Pa-
`tents] did not refer to production-scale purification.”
`Id. The Federal Circuit denied Cubist’s petition for re-
`hearing and rehearing en banc. App. 97a-98a.
`
`REASONS FOR GRANTING THE PETITION
`I. THE COURT SHOULD GRANT CERTIORARI TO RESTORE
`THE PROPER ROLE OF OBJECTIVE INDICIA OF
`NONOBVIOUSNESS
`Since this Court’s opinion in Graham, which con-
`firmed objective indicia of nonobviousness as one of
`four factors to be evaluated in assessing obviousness,
`the Court has not provided further guidance regarding
`the role and proper analysis of objective indicia. That is
`likely because this Court’s review was not previously
`needed: prior to the Federal Circuit’s ruling in this
`case, that court had generally applied the Graham doc-
`trine appropriately, noting that objective indi