No. 10-972201!

IN THE

ELI LILLY AND COMPANY,

Vo

Petitioner,

SUN PHARMACEUTICAL INDUSTRIES, LTD.,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI TO THEUNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF FOR THE PHARMACEUTICAL RESEARCHAND MANUFACTURERS OF AMERICA

AS AMICUS CURIAE IN SUPPORT OF PETITIONER

DAVID A. MANSPEIZERWILMER CUTLER PICKERING

HALE AND DORR LLP399 Park Ave.New York, NY 20006(212) 230-8800

DAVID W. OGDENCounsel of Record

DANIEL P. KEARNEY, JR.WILMER CUTLER PICKERING

HALE AND DORR LLP1875 Pennsylvania Ave., NWWashington, DC 20006(202) 663-6000david.ogden@wilmerhale.com

Blank Page

TABLE OF CONTENTS

PageTABLE OF AUTHORITIES ...........................................ii

INTEREST OF AMICUS CURIAE ..............................1

INTRODUCTION ..............................................................2

REASONS FOR GRANTING THE WRIT ...................4

I. THE FEDERAL CIRCUIT’S BROAD DOUBLEPATENTING RULE THREATENS BIOPHAR-MACEUTICAL INNOVATION .......................................... 5

A. Discovery Of Drug Therapies RequiresThe Critical Incentives Provided ByPatent Protection ..................................................5

B. The Expanded Double Patenting RuleImpairs Incentives To Develop NewDrug Therapies .....................................................9

C. The Federal Circuit’s Decision Dis-courages Scientific Disclosure--A Pri-mary Purpose Of The Patent Laws ..................14

II. THE EXPANDED DOUBLE PATENTINGRULE IS INCONSISTENT WITH THE PATENTACT ...............................................................................15

A. The New Rule Is Inconsistent WithThe Patent Act’s Obviousness Inquiry ............16

B. The Decision Conflicts With ThisCourt’s Precedent And Settled Patent-Law Principles .....................................................19

CONCLUSION .................................................................22

ii

TABLE OF AUTHORITIES

CASESPage(s)

Bonito Boats, Inc. v. Thunder Craft Boats,Inc., 489 U.S. 141 (1989) ............................................14

Eli Lilly & Co. v. Barr Laboratories, Inc., 251F.3d 955 (Fed. Cir. 2001) .......................................3, 13

General Foods Corp. v. StudiengesellschaftKohle mbH, 972 F.2d 1272 (Fed. Cir. 1992) ............20

Geneva Pharmaceuticals, Inc. v. GlaxoSmith-Kline PLC, 349 F.3d 1373 (Fed. Cir. 2003) .............20

Graham v. John Deere Co., 383 U.S. 1 (1966) .........14, 16

In re Jezl, 396 F.2d 1009 (C.C.P.A. 1968) .......................17

In re Kaplan, 789 F.2d 1574 (Fed. Cir. 1986) ............3, 20

In re Land, 368 F.2d 866 (C.C.P.A. 1966) ..................3, 17In re Longi, 759 F.2d 887 (Fed. Cir. 1985) .......................3

In re Ornitz, 376 F.2d 330 (C.C.P.A. 1967) ....................17

In re Vogel, 422 F.2d 438 (C.C.P.A. 1970) ......................20

In re White, 405 F.2d 904 (C.C.P.A. 1969) .....................17

KSR International Co. v. Tele]Tex, Inc., 127 S.Ct. 1727 (2007) .............................................................16

Kewanee Oil Co. v. Bicron Corp., 416 U. S. 470(1974) ............................................................................14

Miller v. Eagle Manufacturing Co., 151 U.S.186 (1894) .....................................................................19

Northwest Airlines, Inc. v. Transport WorkersUnion, 451 U.S. 77 (1981) ..........................................18

iii

TABLE OF AUTHORITIES--Continued

Page(s)

Proctor & Gamble Co. v. Teva Pharmaceuti-cals USA, Inc., 566 F.3d 989 (Fed. Cir.2009) .............................................................................17

Pfizer, Inc. v. Teva Pharmaceuticals USA,Inc., 518 F.3d 1353 (Fed. Cir. 2008) .........................20

STATUTES

Patent Act. 35 U.S.C. § 103 ..........................................2, 16

OTHER AUTHORITIES

Ashburn, Ted T. & Karl B. Thor, Drug Reposi-tioning: Identifying and Developing NewUses for Existing Drugs, 3 Nature Re-views 673 (Aug. 2004) ................................................11

Barfield, Claude & John E. Calfee, Biotechnol-ogy and the Patent System: Balancing In-novation and Property Rights (2007) ........................7

Calfee, John, The Golden Age of Medical Inno-vation, The American (Mar./Apr. 2007) ..................11

Chan, Stephen, et al., Boston Healthcare WhitePaper, Recognizing Value in Oncology In-novation (Mar. 2010) ..................................................11

Congressional Budget Office, Research andDevelopment in the Pharmaceutical In-dustry (2006) ...............................................................10

DiMasi, Joseph A. & Henry G. Grabowski, TheCost of Biopharmaceutical R&D: Is Bio-tech Different?, 28 Manage. & Decis. Econ.469 (2007) ...................................................................5, 6

iv

TABLE OF AUTHORITIES---Continued

Page(s)DiMasi, Joseph A., et al., The Price of Innova-

tion: New Estimates of Drug DevelopmentCosts, 22 J. Health Econ. 151 (2003) ..........................6

Grabowski, Henry G. & Margaret Kyle, Ge-neric Competition and Market ExclusivityPeriods in Pharmaceuticals, 28 Manage. &Decis. Econ. 491 (2007) ................................................7

Grabowski, Henry G. & Jeffrey L. Moe, Impactof Economic, Regulatory, and Patent Poli-cies on Innovation in Cancer Chemopre-vention, Cancer Prevention Research(2008) ............................................................................12

Grabowski, Henry G., Patents and New Prod-uct Development in the Pharmaceuticaland Biotechnology Industries, in Science &Cents: Exploring the Economics of Bio-technology (John V. Duca & Mine K. Yticeleds., 2002) ......................................................................6

Grabowski, ttenry G., Patents, Innovation andAccess to New Pharmaceuticals, 5 J. Int’lEcon. L. 849 (2002) .......................................................7

http://www.clinicaltrials.gov/ct2/results?term=avastin&spons=Genentech (last visitedFeb. 28, 2011) ..............................................................11

http://www.phrma.org/about/member-companies (last visited Feb. 28, 2011) .......................1

V

TABLE OF AUTHORITIES--Continued

Page(s)

Lichtenberg, Frank R., Nat’l Bureau of Econ.Research Working Paper No. 10328, TheExpanding Pharmaceutical Arsenal in theWar on Cancer (Feb. 2004) .........................................8

Lichtenberg, Frank R., Nat’l Bureau of Econ.Research Working Paper No. 9754, TheImpact of New Drug Launches on Longev-ity (2003) ........................................................................8

PhRMA, Fact Sheets and Policy Papers, athttp://www.phrma.org/research/publications/fact-sheets-and-policy-papers (last visitedFeb. 28, 2011) ................................................................8

PhRMA, Pharmaceutical Industry Profile(2010), available at http://www.phrma.org/sites/default/files/159/profile_2010_F INAL.pdf ......................................................................1, 5, 6, 8

Said, Maya, et al., Boston Consulting GroupWhite Paper, Continued Development ofApproved Biological Drugs: A Quantita-tive Study of Additional Indications Ap-proved Postlaunch in the United States(2007) ......................................................................10, 12

Tufts Center for the Study of Drug Develop-ment, Impact Report 8, No. 3, New DrugsEntering Clinical Testing in Top 10 FirmsJumped 52% in 2003-2005 (May/June 2006) .............6

Tufts Center for the Study of Drug Develop-ment, Impact Report 10, No. 1, GrowingProtocol Design Complexity Stresses In-vestigators, Volunteers (2008) ....................................7

Blank Page

INTEREST OF AMICUS CURIAE1

The Pharmaceutical Research and Manufacturersof America ("PhRMA") is a voluntary, nonprofit asso-ciation representing the nation’s leading research-based pharmaceutical and biotechnology companies.PhRMA’s members are the primary source of the manynew drugs and biologics introduced each year. In 2009,biopharmaceutical companies, including PhRMA’smembers, invested more than $65 billion in discoveringand developing new medicines. See PhRMA, Pharma-ceutical Industry Profile, at 26 (2010), available athttp://www.phrma.org/sites/default/files/159/profile_2010_final.pdf.

The medical advances made by PhRMA’s membersrequire enormous investments in research and devel-opment; the protections of patent law provide incen-tives for companies to take on the huge risks of drugdevelopment. Biopharmaceutical innovation requires ameasure of stability and predictability in patent law be-cause patent filing decisions often must be made yearsin advance of developing and marketing an FDA-approved drug.

1 The parties have consented to the filing of this brief. Coun-sel of record for all parties received notice at least 10 days prior tothe due date of the intention of PhRMA to file this brief. No coun-sel for a party authored this brief in whole or in part, and no court-sel or party made a monetary contribution intended to fund thepreparation or submission of this brief. No person other thanamicus or their counsel made a monetary contribution to its prepa-ration or submission. Petitioner Eli Lilly and Company is aPhRMA member company. A complete list of PhRMA’s membercompanies is available online at http://www.phrma.org/about/member-companies.

2

The Federal Circuit’s recent expansion of the obvi-ousness-type double patenting doctrine not only upsetsthat stability, but threatens innovation by severely im-pairing incentives companies like PhRMA’s membersotherwise have to invest in research and developmentof new therapeutic uses of existing drug compounds.PhRMA accordingly supports the petition for certiorariin this case.

INTRODUCTION

The Federal Circuit’s decision below disrupts es-tablished patent law and introduces significant new un-certainties into investment in biopharmaceutical re-search and development. Its new categorical doublepatenting rule ignores the reality of biopharmaceuticalinnovation, where new and non-obvious uses for exist-ing compounds are often discovered long after the com-pound is first discovered. The decision impairs eco-nomic incentives for researchers to investigate and de-velop new biopharmaceutical therapies, potentially de-priving the public of important new treatments forcomplex diseases such as cancer. Moreover, this newbright-line rule erodes the patent laws’ core policy ofpromoting scientific disclosure. This Court’s review isnecessary to define the scope of the double patentingdoctrine and to restore critical patent-law incentivesfor future biopharmaceutical innovation.

The judicially-created obviousness-type doublepatenting doctrine has long performed a gap-filling rolein cases where the statutory obviousness inquiry under§ 103 of the Patent Act, 35 U.S.C. § 103, did not operateto prevent the same patent owner from obtaining a sec-ond patent on a trivial variation of a patented inven-tion. In those circumstances, the obviousness-typedouble patenting rule serves the purpose of preventing

3

a party from obtaining an improper time-wise exten-sion of the right to exclude through claims in a laterpatent that are not patentably distinct from claims in acommonly owned earlier patent. See Eli Lilly & Co. v.Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001); seealso In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985).

But this judicially crafted, gap-filling doctrine hasbeen bounded by common sense in three ways: First, apatent that is not obvious under the statutory obvious-ness requirements of § 103 is also not obvious under themore circumscribed inquiry of obviousness-type doublepatenting. See In re Land, 368 F.2d 866, 884 (C.C.P.A.1966). Second, because the doctrine is concerned onlywith what was claimed in the two patents, the specifi-cation of the earlier patent may not be used as "priorart" against the later claimed invention. See In re Kap-lan, 789 F.2d 1574, 1579 (Fed. Cir. 1986). Third, thedoctrine does not confuse "domination" of one patentover another with double patenting.2 Id. at 1577-1578

The Federal Circuit’s decision below upends thisestablished framework by adopting a categorical rulebarring the same party from obtaining a patent on anyuse of a compound previously disclosed in that party’spatent claiming the compound. See Pet. App. 12a. This

2 A patent on a chemical compound may be said to "dominate"all uses of the compound, because no one may use the compound inany way without infringing the patent. Upon expiration of thatpatent, however, others may use the compound except for anyspecific uses on which patent protection continues; a later patenton a specific use of the compound would not extend the patentrights on the compound itself. The case at issue concerns a speocific use of the compound gemcitabine. Upon expiration of thepatent on the compound, others were free to use it for any purposeother than the specific anticancer use patented by petitioner.

4

new bright-line rule thus violates these long-standingcommon sense boundaries. Under the new rule, thestatutory test for obviousness is irrelevant to obvious-ness-type double patenting; the patent specification canbe used for all it teaches; and double patenting is con-fused with domination. This radical expansion of thisjudge-made doctrine is inconsistent with establishedlaw and warrants review and reversal by this Court.

REASONS FOR GRANTING THE WRIT

The decision below warrants this Court’s reviewfor two principal reasons.

First, the Federal Circuit’s unwarranted expansionof the double patenting rule threatens to undermineeconomic incentives to invest in research and develop-ment of potentially significant new biopharmaceuticaltherapies. The new bright-line rule upsets settled in-vestment-backed expectations of the innovation com-munity and presents a significant obstacle to the pat-enting of new therapeutic uses for existing compounds.It thus risks cutting off potentially critical develop-ments for the treatment of serious diseases, such asAlzheimer’s disease, Parkinson’s disease, and manyforms of cancer, to the detriment of patients in need ofinnovative medical therapies. The decision also signifi-cantly undermines the patent laws’ purpose of promot-ing scientific disclosure.

Second, the decision below expands the common-law double patenting rule well beyond its original pur-poses, and brings the rule into direct conflict with thePatent Act. The Federal Circuit has adopted a cate-gorical rule barring the same entity from obtaining apatent for any new use of a compound that was dis-closed in the specification of a patent claiming the com-pound. Not only does that rule depart from precedent;

5

it is also inconsistent with the Patent Act’s statutoryobviousness inquiry, and conflicts with this Court’sprecedent addressing obviousness in the double patent-ing context.

I. THZ FEDERAL CIRCUIT’S BROAD DOUBLE PATENTINGRULE THREATENS BIOPHARMACEUTICAL INNOVATION

Biopharmaceutical research and development issubject to enormous economic uncertainty, and patent-law incentives are critical to promoting innovation inthis area. The Federal Circuit’s decision disrupts thoseincentives, and discourages research into developingnew therapeutic uses for existing biopharmaceuticalcompounds. This Court’s review and reversal of theFederal Circuit’s decision is warranted to maintain pat-ent-law incentives that encourage biopharmaceuticalinnovation.

A. Discovery Of Drug Therapies Requires TheCritical Incentives Provided By Patent Pro-tection

The Federal Circuit’s erroneous expansion of dou-ble patenting doctrine impairs incentives for discoveryof new drug therapies by denying critical patent pro-tection for newly developed uses of previously patentedcompounds.

Biopharmaceutical research and development is anextremely costly and risky enterprise. The biopharma-ceutical industry spends more than $65 billion dollarsannually on research and development. See PhRMA,Pharmaceutical Industry Profile 2010, at 26. Recentstudies estimate that it costs on average approximately$1.3 billion to bring a new therapeutic product to mar-ket. See DiMasi & Grabowski, The Cost of Biopharma-

6

ceutical R&D: Is Biotech Different?, 28 Manage. & De-cis. Econ. 469, 477 (2007)

Apart from the cost, the process of developing drugtherapies is lengthy and subject to a high degree of un-certainty. For every drug therapy that makes its wayinto human testing, thousands of potential therapeuticsfail in research. See PhRMA, Pharmaceutical IndustryProfile 2010, at 27; Grabowski, Patents and New Prod-uct Development in the Pharmaceutical and Biotech-nology Industries, in Science & Cents: Exploring theEconomics of Biotechnology, 87, 89 (Duca & Yficel eds.,2002). Even the very few compounds that make it thatfar must then undergo years of clinical trials costinghundreds of millions of dollars. Four of five compoundsthat even reach clinical trials will fail, and thus only theremaining one-fifth ultimately receive approval by theFood and Drug Administration (FDA). See Tufts Cen-ter for the Study of Drug Development, Impact Report8, No. 3, New Drugs Entering Clinical Testing in Top10 Firms Jumped 52% in 2003-2005 (May/June 2006).

The process of discovering therapeutic uses ofdrugs has only grown more expensive and uncertain inrecent years. The estimated cost of developing andbringing a drug to market has increased more than 60%between 2000 and 2005 alone. See PhRMA, Pharma-ceutical Industry Profile 2010, at 29. Research and de-velopment efforts are now more focused on seriouschronic or degenerative diseases that often posegreater scientific obstacles to drug discovery. Studiesestimate that it now takes, on average, ten to fifteenyears to bring a successful new drug to market. SeeDiMasi et al., The Price of Innovation: New Estimatesof Drug Development Costs, 22 J. Health Econ. 151, 153(2003).

7

Recent changes in the regulatory environment forbiopharmaceuticals have also increased the cost anduncertainty of investment in drug research and devel-opment. Biopharmaceutical companies now face sig-nificant post-market surveillance and other post-approval requirements, which increase the time periodfor a drug to break even on the substantial investmentnecessary. In addition, the complexity of clinical trialsand number of procedures required has increased sub-stantially over time with the number of procedures pertrial protocol increasing 65% between 1999 and 2005and the average clinical trial length increasing 70%over the same period. Tufts Center for the Study ofDrug Development, Impact Report 10, No. 1, GrowingProtocol Design Complexity Stresses Investigators,Volunteers (2008). Changes in the regulatory and eco-nomic environment have also led to substantial compe-tition from generic drugs, significantly reducing re-turns to biopharmaceutical innovators. See Grabowski& Kyle, Generic Competition and Market ExclusivityPeriods in Pharmaceuticals, 28 Manage. & Decis.Econ. 491,500-501 (2007) (finding that "a larger numberof drugs [are] experiencing initial generic entry andgeneric competition now encompasses even very mod-est selling drugs").

Given the enormous cost and uncertainty of bio-pharmaceutical research, patent protection is vital.The risk of investment must be rewarded if new drugtherapies are to be developed. Patent protection is sig~nificantly more important to finding new medicines anddrug therapies than to innovation in most other indus-tries. See generally Grabowski, Patents, Innovationand Access to New Pharmaceuticals, 5 J. Int’l Econ. L.849, 850-858 (2002); Barfield & Calfee, Biotechnologyand the Patent System 24-36 (2007).

8

The returns on investment made possible by patentprotection for the relatively few successful productshave led to remarkable advancements in drug therapiesin the last several decades. The public has benefittedsignificantly from new medicines that have led togreater life expectancies and improved quality of lifefor those suffering from disease. One study has esti-mated that new drug treatments are responsible for 50to 60 percent of the increase in cancer survival ratessince 1975. See Lichtenberg, Nat’l Bureau of Econ. Re-search Working Paper No. 10328, The ExpandingPharmaceutical Arsenal in the War on Cancer 2(2004). Indeed, new drug treatments are estimated toaccount for 40 percent of the overall increase in humanlife expectancy between 1986 and 2000. See Lichten-berg, Nat’l Bureau of Econ. Research Working PaperNo. 9754, The Impact of New Drug Launches on Lon-gevity 21 (2003) (new drugs accounted for nearly tenmonths of a two-year increase in longevity among thepopulation of the fifty-two sample countries).

Patent-law incentives continue to spur biopharma-ceutical innovation in a range of areas, including effortsto develop therapies for cancer and other serious dis-eases. Biopharmaceutical companies currently havenearly 3000 medicines in development, see PhRMA,Pharmaceutical Industry Profile 2010, at i, includingmore than 800 medicines that may treat various formsof cancer, more than 500 medicines that may addressneurological disorders such as Parkinson’s disease andAlzheimer’s disease, and approximately 300 medicinesthat may treat heart disease and stroke. See PhRMA,Fact Sheets and Policy Papers, at http://www.phrma.org/researclVpublications/fact-sheets-and-policy-papers(last visited Feb. 28, 2011). These and other medicines

9

under development could lead to vital new drug thera-pies for patients.

B. The Expanded Double Patenting Rule Im-pairs Incentives To Develop New Drug Thera-pies

The Federal Circuit’s new rule threatens to un-dermine economic incentives for research and devel-opment of new medical therapies, particularly for com-plex diseases. In particular, the rule fails to account forthe unpredictable reality of biopharmaceutical re-search, which often involves the investigation and de-velopment of new therapeutic uses for a compound longafter the compound and its possible uses are first iden-tified.

The success or failure of a compound for a particu-lar therapeutic purpose cannot be predicted from theoutset. A biopharmaceutical compound is typically firstpatented as a compound in connection with its use fortreating one or more particular conditions. But thereare strong odds against any compound’s success intreating any condition, and therefore few patentedcompounds ultimately succeed with respect to theirfirst potential indications.

Indeed, that is what happened with the drug inquestion in this case, demonstrating the often surpris-ing and unpredictable character of biopharmaceuticaldiscovery. Gemcitabine was first thought useful as ananti-viral therapy, and Lilly sought a patent on that ba-sis. But the compound did not succeed in its originallyintended use. Subsequent investigation of the com-pound revealed, however, that gemcitabine had anti-cancer properties, much to the surprise of the re-searchers. See Pet. 10.

10

Even after a drug is approved, research and devel-opment on that drug typically continues, and new usesfor the drug are often discovered after its initial ap-proval. For example, biotherapeutics such as Enbrel®,Remicade®, and Humira®, approved for the treatmentof rheumatoid and psoriatic arthritis, were subse-quently approved to treat a variety of conditions, in-cluding Crohn’s disease, ulcerative colitis, and ankylos-ing spondylitis. The Congressional Budget Office hasobserved that "approved new on-label uses can becomethe primary source of demand for a drug, suggestingthat the new use is more valuable to patients than theoriginal use." Congressional Budget Office, Researchand Development in the Pharmaceutical Industry 15(2006); see also Said et al., Boston Consulting GroupWhite Paper, Continued Development of ApprovedBiological Drugs: A Quantitative Study of AdditionalIndications Approved Postlaunch in the United States3 (2007) (47% of approved biologics had at least one newapproved indication after initial approval). New usesare often developed long after approval of a drug’s ini-tial indication, making patent protection for the newuse especially important. See Said et al., supra, at 3(finding that "[one] third of new indications were ap-proved more than seven years after the approval of theinitial indication")

This dynamic character of drug research and de-velopment is particularly apparent in efforts to treatcomplex diseases such as cancer. Indeed, the process ofdeveloping effective cancer therapies generally contin-ues even long after initial approval of a medicine by theFDA for human use. One study has observed that "thetrue clinical value of a therapy often cannot be fullycaptured in the clinical trial data submitted for initialFDA approval." Chan et al., Boston Healthcare White

11

Paper, Recognizing Value in Oncology Innovation 1(Mar. 2010). Once further post-approval investigationis undertaken, it is often true that a cancer therapy’sfull clinical value is "much greater than recognized atthe time of initial FDA approval." Id. For example,according to the National Institutes of Health website,the company that developed the drug Avastin® hasundertaken 286 clinical trials involving the drug (morethan 100 of which are ongoing today, years after thedrug’s initial approval to treat colorectal cancer in2004), including clinical trials for ovarian, pancreatic,and esophageal cancers. Seehttp://www.clinicaltrials.gov/ct2/results?term=avastin&spons=Genentech (last visited Feb. 28, 2011).

The development of new valuable medical therapiesencompasses both newly approved as well as olderdrugs. For example, researchers have developed a usefor galantamine, originally intended to treat polio andparalysis, in the treatment for Alzheimer’s disease. SeeAshburn & Thor, Drug Repositioning: Identifying andDeveloping New Uses for Existing Drugs, 3 NatureReviews 673, 678 (Aug. 2004). Ropinrole, which wasoriginally developed for hypertension, is now marketedas a therapy to treat symptoms of Parkinson’s disease.See id. Developments such as these are by no meansuncommon. As one commentator has observed, "[i]nthis new era, the most important advances in treatmentoften come from products which have been on the mar-ket for a while but whose properties were not com-pletely understood until intensive research after thedrug was introduced." Calfee, The Golden Age ofMedical Innovation, The American (Mar./Apr. 2007).

While potentially less costly than developing an en-tirely new compound, developing a new therapeutic userequires substantial investment in research and devel-

12

opment costs and time, and carries a significant risk offailure. Any new therapeutic use must go throughphase II and phase III clinical trials directed at thatuse and the FDA approval process. It can take from 3to 6 years to develop and obtain approval for such anew use. See Said et al., supra, at 5. The cost of re-search to establish a new therapeutic use for an exist-ing compound typically runs to well over $100 millionand can be much greater depending on the nature ofthe clinical trials involved. See Grabowski & Moe, Im-pact of Economic, Regulatory, and Patent Policies onInnovation in Cancer Chemoprevention, Cancer Pre-vention Research 2 (2008); see also Said et al., supra, at6 (noting that post-approval development costs "arelikely high and represent an important part of theoverall R&D investment involved in researching anddeveloping new therapeutic biologics").

A sound patent protection regime needs to take ac-count of the cost and risk realities of this discoveryprocess---especially in the area of biopharmaceuticaldiscovery, where the right of exclusivity awarded bypatent protection is critical to progress and innovation.To foster the process of drug discovery and the devel-opment of new therapeutic uses, patent protectionmust not be narrowly limited by an earlier patent’s dis-closures of the inchoate or general purposes for which acompound was first thought useful. Rather, the patentlaws should incentivize innovators to continue to de-velop new non-obvious uses for compounds.

The Federal Circuit’s new categorical double pat-enting rule impairs incentives for promising researchinto new uses for existing compounds. The rule effec-tively disqualifies for patent protection any use that isdeemed to have been disclosed in some way in an ear-lier compound patent. Under this per se rule, research-

13

ers can no longer be confident that new non-obvioususes of existing compounds will receive the patent pro-tection they warrant. At a minimum, the decision in-vites still more costly litigation over double patentingissues, as parties comb compound patents to identifydisclosures that might arguably invalidate patents onlater-developed therapies.

The Federal Circuit’s decision threatens particulardisruption to the investment-backed expectations ofresearchers in the biopharmaceutical field. The signifi-cant economic risk involved in developing safe and ef-fective drug therapies requires stable and predictablepatent law protections. See Eli Lilly & Co. v. BarrLabs., Inc., 251 F.3d 955, 976 (Fed. Cir. 2001) (Newman,J., dissenting) ("In this period of unprecedented devel-opment of patent-supported biological advance, the na-tion needs a stable and comprehensible patent law").Gemcitabine and other compounds were developed un-der a patent-law regime with a double-patenting rulefocused narrowly on preventing a patentee from obtain-ing two patents claiming the same invention (or obvi-ous variations thereof). Biopharmaceutical innovatorsmanaged their patent portfolios--and made significantinvestments in research and development of new drugtherapies--in reliance on that patent-law framework.

Changing the rules in the middle of the game, asthe Federal Circuit did here, could throw into questiona broad array of biopharmaceutical patents and under-mines longstanding patent-law incentives to investigateand develop new uses for existing compounds in thetreatment of disease. As a result, patients may be de-prived of important advances in the treatment of dis-eases such as cancer and Alzheimer’s disease.

14

In addition, the Federal Circuit’s new double pat-enting rule discourages innovation by precisely theparty--the holder of the original compound patent--normally in the best position to develop new therapeu-tic uses for their drug. The original patent holder isuniquely positioned to leverage its own scientists’ ex-perience with and knowledge of the compound. Be-cause the holder of the original compound patent canprevent any new use of the compound from being mar-keted, its cooperation is critical even when anotherparty seeks to develop the new use. By specifically re-stricting the original patentee’s ability to patent newuses, the decision below impairs patent-law incentivesat the point where they are important for the develop-ment of new medicinal therapies.

C. The Federal Circuit’s Decision DiscouragesScientific Disclosure~A Primary Purpose OfThe Patent Laws

The Federal Circuit’s decision also undermines thepatent laws’ core policy of promoting scientific disclo-sure. See Bonito Boats, Inc. v. Thunder Craft Boats,Inc., 489 U.S. 141, 151 (1989) ("the ultimate goal of thepatent system is to bring new designs and technologiesinto the public domain through disclosure"); KewaneeOil Co. v. Bicron Corp., 416 U. S. 470, 489 (1974) (withrespect to a patentable invention, "the federal interestin disclosure is at its peak; these inventions, novel, use-ful and nonobvious, are ’the things which are worth tothe public the embarrassment of an exclusive patent’"(quoting Graham v. John Deere Co., 383 U.S. 1, 9 (1966)(quoting Thomas Jefferson))).

Disclosure is meant to spur innovation by addinginformation to public knowledge. This is particularlyimportant in research intensive industries, like the bio-

15

pharmaceutical industry. However, the new doublepatenting rule discourages patent applicants from pro-viding full disclosure of the potential uses of a com-pound or any other invention. The rule instead incen-tivizes patent applicants to include the minimum disclo-sure necessary to demonstrate patentability out of con-cern for the likely impact of such disclosure on the pat-entability of future discoveries. That incentive, anti-thetical to the purpose of the patent law, is evident inthis case: the decision below effectively punished thepetitioner for disclosing in its patent application forgemcitabine the possible anticancer use. Such disclo-sures, which might have been built upon by others inthe future, are likely to disappear from future patentdisclosures. That result is both inconsistent with a cen-tral purpose of the patent laws, and highlights the es-sential error of the court of appeals’ new per se doublepatenting rule.

This Court should grant review to reverse theFederal Circuit’s decision and restore appropriate pat-ent-law incentives in this area.

II. THE EXPANDED DOUBLE PATENTING RULE IS INCON-SISTENT WITH THE PATENT ACT

Beyond deterring the development of potentiallybeneficial drug therapies, the new "double patenting"rule announced by the Federal Circuit is inconsistentwith governing precedent and sound public policy. Thecourt’s categorical bar on the patentability of new usesof existing compounds based solely on a previous pat-ent disclosure of the use runs counter to the statu-tory-and appropriately contextual--"obviousness" in-quiry prescribed by the Patent Act. The Federal Cir-cuit’s decision also departs significantly from control-ling precedent.

16

A. The New Rule Is Inconsistent With The Pat-ent Act’s Obviousness Inquiry

The Federal Circuit’s decision expands obvious-ness-type double patenting well beyond its traditionalnarrow bounds, bringing the doctrine into conflict withthe broader statutory obviousness inquiry under thePatent Act. The Court should grant review to re-establish the bounds of double patenting doctrine.

Section 103 of the Patent Act defines the statutorystandard for obviousness. Under § 103, an invention isnot patentable "if the differences between the subjectmatter sought to be patented and the prior art are suchthat the subject matter as a whole would have been ob-vious at the time the invention was made to a personhaving ordinary skill in the art to which said subjectmatter pertains." 35 U.S.C. § 103. Courts apply amulti-faceted analysis to determine whether an inven-tion is non-obvious over the prior art. The analysistakes into account (1) "the scope and content of theprior art;" (2) "differences between the prior art andthe claims at issue;" (3) "the level of ordinary skill inthe pertinent art;" and (4) "secondary considerations"such as "commercial success, long felt but unsolvedneeds, failure of others [that] give light to the circum-stances surrounding the origin of the subject mattersought to be patented." KSR Int’l Co. v. Teleflex Inc.,550 U.S. 398, 406 (2007) (quoting Graham, 383 U.S. at17-18).

Obviousness-type double patenting, by contrast, isa limited, judicially created doctrine that reflects theprinciple in § 101 of the Patent Act that each inventionis entitled only to a single patent. The doctrine hasthus been recognized to present "the same basic ques-tion as [obviousness under] § 103 ... but in narrower

17

aspect." In re Jezl, 396 F.2d 1009, 1013 (C.C.P.A. 1968)(emphasis added); see also In re Ornitz, 376 F.2d 330,334 (C.C.P.A. 1967) ("Where it is possible to conductthe broader inquiry permitted by sections 102(e) and103 because the references are ’prior art,’ it does notmake sense to resort to the narrower inquiry which un-derlies a ’double patenting’ rejection").

Until now, the law has been clear that a patent thatis not obvious over the prior art based on a § 103 statu-tory obviousness analysis is afortiori not subject to re-jection for obviousness-type double patenting. SeeProcter & Gamble Co. v. Teva Pharms. USA, Inc., 566F.3d 989, 999 (Fed. Cir. 2009); In re White, 405 F.2d904, 906 (C.C.P.A. 1969); In re Jezl, 396 F.2d at 1013; Inre Land, 368 F.2d 866, 879 (C.C.P.A. 1966). Indeed, thedoctrine of obviousness-type double patenting was de-veloped in part to address the situation where patentsare not citable as reference against each other. See Inre Ornitz, 376 F.2d at 334.

The Federal Circuit has now thrown this frame-work into doubt. The decision below abandoned thenarrow double patenting inquiry in favor of a categori-cal rule rejecting the availability of a patent for "anyuse for a compound that is disclosed in the specificationof an earlier patent claiming the compound and is laterclaimed as a method of using that compound." Pet.App. lla-12a (emphasis added). No obviousness analy-sis is conducted under this bright-line rule, and nonewas conducted by the Federal Circuit in the case below.The result is a greatly expanded double patenting doc-trine that now threatens to invalidate a broad range ofpatents that would not be subject to rejection under astatutory obviousness inquiry.

18

The facts of this case illustrate the potential conflictbetween statutory obviousness and the newly ex-panded double patenting rule. Here, the claims of theearlier patent are prior art to the claims of the laterpatent. In a separate proceeding, the later patent wasfound to be non-obvious in view of the same earlierpatent under § 103 by a federal district court after atrial. See Pet. 14-15. Under longstanding precedent,that determination would generally preclude, afortiori,rejection based on a double patenting analysis. Butthat was not the case here under the Federal Circuit’snew categorical rule.

Thus, the new rule sets up the perverse result thata third party could obtain a patent to a non-obvious use(including the claimed anticancer therapy here), whilethe original holder of the compound patent could not.The Federal Circuit’s decision thus supplants the statu-tory obviousness inquiry as to the holder of the originalpatent. That makes little sense: either a novel and non-obvious development is patentable to all, or to none,and the result should not vary depending on patentownership. Subjecting the holder of the original com-pound patent to a different and more stringent pat-entability standard disincentivizes the very party usu-ally in the best position to investigate new uses for thecompound, to the detriment of patients in need of suchtherapies and the public health. See supra pp. 13-14.

This conflict with § 103 is particularly problematicbecause double patenting is a judicially crafted rule.Such rules may not impinge on congressionally enactedstatutes. See Northwest Airlines, Inc. v. TransportWorkers Union of Am., 451 U.S. 77, 95 (1981) ("federalcommon law is subject to the paramount authority ofCongress" (internal quotation marks omitted)). TheCourt should grant review to define careful limits on

19

double patenting doctrine to ensure the doctrine doesnot impinge on the statutory obviousness inquiry pre-scribed by the Patent Act.

B. The Decision Conflicts With This Court’sPrecedent And Settled Patent-law Principles

Review is also warranted because the decision be-low squarely conflicts with this Court’s own doublepatenting precedent. In Miller v. Eagle Mfg. Co., 151U.S. 186, 199 (1894), the Court explained in the doublepatenting context that "an inventor may make a newimprovement on his own invention of a patentablecharacter" and that in such cases "a later patent may begranted where the invention is clearly distinct from,and independent of, one previously patented." Milleralso makes clear that double patenting concerns what isclaimed by the patents at issue and that a prior pat-ent’s disclosures do not themselves pose a bar to a laterpatent on a distinct invention. As the Miller Courtstated, "where the second patent covers matter de-scribed in the prior patent, essentially distinct andseparable from the invention covered thereby andclaims made thereunder, its validity may be sus-tained." Id. at 198 (emphasis added).

The Federal Circuit’s new rule is at odds with theclaims-based inquiry prescribed by Miller. In adoptinga categorical rule based on whether a use is disclosed inthe specification of a prior patent--without any consid-eration of the prior patent’s claims--the Federal Cir-cuit disregarded the teaching of Miller that only theclaims are relevant to a double patenting analysis.

The panel’s decision is, in fact, the culmination of aseries of recent Federal Circuit decisions that have dis-rupted established double patenting rules, and under-

20

mined the stability of patent law. It has consistentlybeen the law that double patenting analysis concernsonly a patent’s claims, not its disclosures. See GeneralFoods Corp. v. Studiengesellschaft Kohle mbH, 972F.2d 1272, 1277 (Fed. Cir. 1992) ("Double patenting isaltogether a matter of what is claimed."); In re Kaplan,789 F.2d 1574, 1579 (Fed. Cir. 1986) (in obviousness-type double patenting analysis "the patent disclosuremay not be used as prior art."); In re Vogel, 422 F.2d438, 441 (C.C.P.A. 1970) (same).

In two recent cases, however, the Federal Circuitexpanded the scope of the double patenting inquiry toencompass the specification, and not simply the claims,of the prior patent. See Pfizer, Inc. v. Teva Pharms.USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008); GenevaPharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373,1385 (Fed. Cir. 2003). In each case, the court of appealsrejected patents on a particular use of a compoundbased on the disclosure of the use in the specification ofthe compound patent. The Federal Circuit justified itsapproach on the ground that the relevant patent claimdid not "adequately disclose the patentable bounds ofthe invention" and that examination of the specificationwas therefore necessary to interpret the patent claims.Geneva, 349 F.3d at 1385. In focusing the double pat-enting inquiry on the specification, however, the Fed-eral Circuit departed from the limited claims-basedanalysis applied in prior cases.

But the categorical double-patenting rule an-nounced by the panel in this case represents yet a fur-ther significant departure from the claims-based analy-sis of Miller and prior decisions. The Federal Circuit’snew approach rejects the patentability of any use basedsolely on previous disclosure of the use in the prior pat-ent’s specification. That rule finds no support in Ge-

21

neva or Pfizer. Unlike those cases, examination of aprior patent’s disclosures under the new categoricalrule does not have any necessary connection to inter-preting the scope of the patent’s claims.

The novelty (and error) of this new categorical ap-proach was rightly recognized by the dissenters fromrehearing en banc in the Federal Circuit. In her dis-sent, Judge Newman, joined by Chief Judge Rader (theauthor of the opinion in Geneva) made clear that Ge-neva did not intend to upset the established rule that"the law of double patenting is concerned only withwhat is patented--that is what is claimed." Pet. App.135a. She further criticized the panel decision for mis-reading Geneva to apply to the circumstances of thiscase, and applying the double patenting rule wherethere could be no improper time-wise extension of thegemcitabine compound patent right by the patent ongemcitabine’s anticancer use, since upon expiration ofthe compound patent, all would be free to make, use orsell gemcitabine for any purpose other than the anti-cancer use. See id. at 139a-140a. This "change of law,"Judge Newman noted, would "negatively impact thepatentability of later-discovered uses" and "serves nopublic purpose in areas in which commercial develop-ment requires patent protection." Id. at 141a.

22

CONCLUSION

The petition for writgranted, and the judgmentshould be reversed.

of certiorari should beof the Federal Circuit

Respectfully submitted.

DAVID A. MANSPEIZER

WILMER CUTLER PICKERING

HALE AND DORR LLP

399 Park Ave.New York, NY 20006(212) 230-8800

DAVID W. OGDEN

Counsel of RecordDANIEL P. KEARNEY, JR.

WILMER CUTLER PICKERING

HALE AND DORR LLP

1875 Pennsylvania Ave., NWWashington, DC 20006(202) 663-6000david.ogden@wilmerhale.com

FEBRUARY 2011