Pharmaceutical Development:Pharmaceutical Development:
Protecting Innovation vs. Promoting PublicProtecting Innovation vs....
InnovationInnovation
 How do we optimally integrate drugHow do we optimally integrate drug
development and public health?...
Background: PatentsBackground: Patents
 Make drug development profitable byMake drug development profitable by
secure mar...
 Proper subject matterProper subject matter
 UtilityUtility
 NoveltyNovelty
 Non-obviousnessNon-obviousness
 Patent d...
Background: PatentsBackground: Patents
 Quid pro quoQuid pro quo
– Make details of invention public, but secureMake detai...
0
5,000
10,000
15,000
20,000
25,000
30,000
1975-1979 1980-1984 1985-1989 1990-1994 1995-1999
Source: National Bureau of Ec...
Policy problemPolicy problem
 Patent lifePatent life ≠ Drug development≠ Drug development
– Invention of new molecules oc...
Policy problemPolicy problem
 Patent lifePatent life ≠ Drug development≠ Drug development
– Historically, FDA required fu...
Solution: Hatch-Waxman ActSolution: Hatch-Waxman Act
 1984 Drug Price Competition and Patent Term1984 Drug Price Competit...
Effects of Hatch-WaxmanEffects of Hatch-Waxman
 SuccessSuccess
– Remarkable number of important new drugsRemarkable numbe...
Persistent ProblemsPersistent Problems
 Since Hatch-Waxman, balance betweenSince Hatch-Waxman, balance between
incentives...
Abuse of available incentivesAbuse of available incentives
 1. Inappropriate patents1. Inappropriate patents
– Patents gr...
Drug patentDrug patent
Patents: ExamplesPatents: Examples
Patents: ExamplesPatents: Examples
Patents: ExamplesPatents: Examples
Abuse of available incentivesAbuse of available incentives
 Result: 90% of all drug patent applications areResult: 90% of...
Abuse of available incentivesAbuse of available incentives
 2. Patents not reward true discoverers2. Patents not reward t...
Abuse of available incentivesAbuse of available incentives
 3. Evergreening/“Life Cycle Management”3. Evergreening/“Life ...
Prilosec/Nexium
 Omeprazole (Prilosec)
– Original patents expire Apr 2001
– Patents on pill coating protect until 2007?
–...
2001 2002 2003 2004
$120M
$100M
$80M
$60M
$40M
$20M
Actual spending on omeprazole
Projected spending on omeprazole
No IP e...
Prilosec/Nexium
 Policy implications
– Medicaid programs facing rising costs
– One area where cost savings can be achieve...
Abuse of available incentivesAbuse of available incentives
 4. Manipulation of Hatch-Waxman4. Manipulation of Hatch-Waxma...
Abuse of available incentivesAbuse of available incentives
 Reform effortsReform efforts
– Patent reformPatent reform
» S...
Misaligned incentivesMisaligned incentives
 Some important public health issues fallSome important public health issues f...
Orphan Drug ActOrphan Drug Act
 ““Orphan condition”: <200,000 peopleOrphan condition”: <200,000 people
 Incentives:Incen...
Orphan Drug ActOrphan Drug Act
 Great success …Great success …
– 325 approvals since 1983 for rare diseases and enzyme325...
Pediatric Exclusivity ExtensionPediatric Exclusivity Extension
 6 mos of market exclusivity if conduct clinical6 mos of m...
AntibioticsAntibiotics
““The pipeline of newThe pipeline of new
antibiotics is drying up.antibiotics is drying up.
Major p...
AntibioticsAntibiotics
 Perceived inadequacies of current system forPerceived inadequacies of current system for
antibiot...
Spellberg B, Powers JH, Brass EP, Miller LG,
Edwards Jr. JE. CID 2004;38:1279-86.
Powers JH. Clin. Microbiology &
Infectio...
New therapiesNew therapies
Talbot, et al., CID 2006; 42:657–68.
Acinetobacter baumanniiAcinetobacter baumannii Tigecycline...
Wildcard Patent ExtensionsWildcard Patent Extensions
 New class of antibiotic with specific targetedNew class of antibiot...
Permanent PatentsPermanent Patents
 ““Patent terms for antibiotics should bePatent terms for antibiotics should be
extrem...
Exclusivity-based solutionsExclusivity-based solutions
 ProblemsProblems
– Using patents as a lever involves substantial ...
Neglected DiseasesNeglected Diseases
 Tropical infections endemic in low-incomeTropical infections endemic in low-income
...
Priority Review VoucherPriority Review Voucher
 Food and Drug AdministrationFood and Drug Administration
Amendments Act o...
Priority Review VoucherPriority Review Voucher
 ProblemsProblems
– Incentives do not include implementation,Incentives do...
Misaligned IncentivesMisaligned Incentives
 Reform:Reform:
– Critically examine whether incentives areCritically examine ...
Proposed alternatives to patent-basedProposed alternatives to patent-based
incentive systemincentive system
 ““Regulatory...
ConclusionConclusion
 Patent system provides incentives, intellectualPatent system provides incentives, intellectual
prop...
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Kesselheim slides

  1. 1. Pharmaceutical Development:Pharmaceutical Development: Protecting Innovation vs. Promoting PublicProtecting Innovation vs. Promoting Public HealthHealth December 12, 2008 Aaron S. Kesselheim, M.D., J.D., M.P.H. Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital Harvard Medical School akesselheim@partners.org
  2. 2. InnovationInnovation  How do we optimally integrate drugHow do we optimally integrate drug development and public health?development and public health? – Ensure creation of important new drugsEnsure creation of important new drugs currently through incentives for investmentcurrently through incentives for investment – Ensure that access to such drugs is not undulyEnsure that access to such drugs is not unduly compromisedcompromised
  3. 3. Background: PatentsBackground: Patents  Make drug development profitable byMake drug development profitable by secure market exclusivity for new drugsecure market exclusivity for new drug – 20 years20 years  US Constitution, Art I, § 8, cl 8: “…US Constitution, Art I, § 8, cl 8: “… promote progress of science and the usefulpromote progress of science and the useful arts…”arts…”  Four basic criteria for patenting…Four basic criteria for patenting…
  4. 4.  Proper subject matterProper subject matter  UtilityUtility  NoveltyNovelty  Non-obviousnessNon-obviousness  Patent document requirements: WrittenPatent document requirements: Written description, enablement, best mode,description, enablement, best mode, definitenessdefiniteness Background: PatentsBackground: Patents
  5. 5. Background: PatentsBackground: Patents  Quid pro quoQuid pro quo – Make details of invention public, but secureMake details of invention public, but secure government protection against free ridersgovernment protection against free riders – Primary claim: Composition of matter coveringPrimary claim: Composition of matter covering the active ingredientthe active ingredient
  6. 6. 0 5,000 10,000 15,000 20,000 25,000 30,000 1975-1979 1980-1984 1985-1989 1990-1994 1995-1999 Source: National Bureau of Economic Research Number of New Drug-Related Patents Granted Background: Patents
  7. 7. Policy problemPolicy problem  Patent lifePatent life ≠ Drug development≠ Drug development – Invention of new molecules occurs early inInvention of new molecules occurs early in course of drug developmentcourse of drug development – Patent law requires filing of patent onPatent law requires filing of patent on composition at that timecomposition at that time » Publication, use can make ineligiblePublication, use can make ineligible – Preclinical studies, clinical trials, FDA reviewPreclinical studies, clinical trials, FDA review » 8-10 years between patent filing and approval – Once approved, can charge whatever marketOnce approved, can charge whatever market will bearwill bear
  8. 8. Policy problemPolicy problem  Patent lifePatent life ≠ Drug development≠ Drug development – Historically, FDA required full complement ofHistorically, FDA required full complement of tests (NDA) for companies seeking to markettests (NDA) for companies seeking to market identical copies of drugs whose patentidentical copies of drugs whose patent protection had expired (“generic drug”)protection had expired (“generic drug”) » By 1984, 150 brand-name drugs lacked genericBy 1984, 150 brand-name drugs lacked generic versions despite being off-patentversions despite being off-patent » Generics accounted for only 19% of allGenerics accounted for only 19% of all prescriptionsprescriptions – Result: de facto permanent market exclusivityResult: de facto permanent market exclusivity » Runs past end of patent termRuns past end of patent term
  9. 9. Solution: Hatch-Waxman ActSolution: Hatch-Waxman Act  1984 Drug Price Competition and Patent Term1984 Drug Price Competition and Patent Term Restoration ActRestoration Act – To promote access, uplift generic drug mfrs:To promote access, uplift generic drug mfrs: » ““ANDA” for generic drug mfrs showing bioequivalenceANDA” for generic drug mfrs showing bioequivalence » 6-month generic exclusivity incentive for first company to6-month generic exclusivity incentive for first company to challenge patentchallenge patent – To provide incentives, assist brand-name mfrs:To provide incentives, assist brand-name mfrs: » 5 yrs of data exclusivity for new products5 yrs of data exclusivity for new products » 2.5 year window for resolution of patent challenge2.5 year window for resolution of patent challenge » FDA review time added back to patent life (maxFDA review time added back to patent life (max 14 yrs14 yrs))
  10. 10. Effects of Hatch-WaxmanEffects of Hatch-Waxman  SuccessSuccess – Remarkable number of important new drugsRemarkable number of important new drugs approved in 1980s and 1990sapproved in 1980s and 1990s » Cardiovascular disease, cancer, GI disease,Cardiovascular disease, cancer, GI disease, psychiatric disorderspsychiatric disorders – Low costs of generic drugs allow cost-savingLow costs of generic drugs allow cost-saving and promote patient adherenceand promote patient adherence » Beginning at conclusion of market exclusivityBeginning at conclusion of market exclusivity » Now 65% of prescriptions are for generic drugsNow 65% of prescriptions are for generic drugs
  11. 11. Persistent ProblemsPersistent Problems  Since Hatch-Waxman, balance betweenSince Hatch-Waxman, balance between incentives for drug development and publicincentives for drug development and public health goals continues to plaguehealth goals continues to plague pharmaceutical marketpharmaceutical market  In particular, two categories of problemsIn particular, two categories of problems have emerged:have emerged: – Problem #1: Abuse of available incentivesProblem #1: Abuse of available incentives – Problem #2: Incentives misaligned with publicProblem #2: Incentives misaligned with public health goalshealth goals
  12. 12. Abuse of available incentivesAbuse of available incentives  1. Inappropriate patents1. Inappropriate patents – Patents granted for pharmaceutical productsPatents granted for pharmaceutical products that don’t meet statutory requirementsthat don’t meet statutory requirements – USPTO is a regulatory body with importantUSPTO is a regulatory body with important limitationslimitations » 2006: 332,000 applicants; 4,000 examiners2006: 332,000 applicants; 4,000 examiners » In the pharmaceutical compound area, timeIn the pharmaceutical compound area, time allocated for complete examination of an applicationallocated for complete examination of an application is 18 hours for an upper-level examiner, and 21is 18 hours for an upper-level examiner, and 21 hours for a mid-level examinerhours for a mid-level examiner » Do not seek outside expertise, may not even beDo not seek outside expertise, may not even be allowed to search Internetallowed to search Internet
  13. 13. Drug patentDrug patent
  14. 14. Patents: ExamplesPatents: Examples
  15. 15. Patents: ExamplesPatents: Examples
  16. 16. Patents: ExamplesPatents: Examples
  17. 17. Abuse of available incentivesAbuse of available incentives  Result: 90% of all drug patent applications areResult: 90% of all drug patent applications are eventually approvedeventually approved – Patent feesPatent fees  Overturning bad patents takes time, effort,Overturning bad patents takes time, effort, resourcesresources
  18. 18. Abuse of available incentivesAbuse of available incentives  2. Patents not reward true discoverers2. Patents not reward true discoverers – Early basic science critical to drug development, butEarly basic science critical to drug development, but may not meet statutory req’ts for “patent”may not meet statutory req’ts for “patent” – Example:Example: RochesterRochester casecase » 1990s: Researchers at Univ of Rochester isolate COX-21990s: Researchers at Univ of Rochester isolate COX-2 receptor, apply for patent on “method of inhibiting”receptor, apply for patent on “method of inhibiting” » Pharmacia/Pfizer develop Vioxx and Celebrex ($5BPharmacia/Pfizer develop Vioxx and Celebrex ($5B market), claim Rochester’s patent invalidmarket), claim Rochester’s patent invalid » Circuit Court upholds – did not take critical step ofCircuit Court upholds – did not take critical step of isolating a compound, akin to “alchemists”isolating a compound, akin to “alchemists” Source: Kesselheim & Avorn, University-based science and biotechnology research: defining the boundaries of intellectual property. JAMA 2005;293:850-854.
  19. 19. Abuse of available incentivesAbuse of available incentives  3. Evergreening/“Life Cycle Management”3. Evergreening/“Life Cycle Management” – Multiple (legitimate) patents covering the sameMultiple (legitimate) patents covering the same active ingredient, minor changes, or peripheralactive ingredient, minor changes, or peripheral features of the pillfeatures of the pill – Intended to perpetuate market exclusivityIntended to perpetuate market exclusivity – Example: Exploit “non-obvious” requirementExample: Exploit “non-obvious” requirement » Combination drugsCombination drugs » Use of drug (e.g. crushing and mixing inUse of drug (e.g. crushing and mixing in applesauce)applesauce) » Prilosec/NexiumPrilosec/Nexium
  20. 20. Prilosec/Nexium  Omeprazole (Prilosec) – Original patents expire Apr 2001 – Patents on pill coating protect until 2007? – Generic availability delay 21 months »Meanwhile, market s-isomer (Nexium) in 2001  No evidence of improved outcomes »Market over-the-counter version Source: Kesselheim AS, Fischer MA, Avorn J. The rise and fall of Natrecor for congestive heart failure: implications for drug policy. Health Affairs 2006;25:1095-1102.
  21. 21. 2001 2002 2003 2004 $120M $100M $80M $60M $40M $20M Actual spending on omeprazole Projected spending on omeprazole No IP extension = $609M Subst for Nexium = $1.2B Prilosec/Nexium Source: Kesselheim AS, Fischer MA, Avorn J. Extensions of intellectual property rights and delayed adoption of generic drugs: effects on Medicaid spending. Health Affairs 2006;25:1637-47.
  22. 22. Prilosec/Nexium  Policy implications – Medicaid programs facing rising costs – One area where cost savings can be achieved without affecting patient care
  23. 23. Abuse of available incentivesAbuse of available incentives  4. Manipulation of Hatch-Waxman4. Manipulation of Hatch-Waxman regulatory/legal systemregulatory/legal system – Multiple Orange Book listingsMultiple Orange Book listings – Collusive agreements between brand-name andCollusive agreements between brand-name and generic mfrsgeneric mfrs
  24. 24. Abuse of available incentivesAbuse of available incentives  Reform effortsReform efforts – Patent reformPatent reform » Supreme Court revamps “non-obvious” standard forSupreme Court revamps “non-obvious” standard for combination invention (combination invention (KSR v. TeleflexKSR v. Teleflex)) » Patent office reform (e.g. allow broaderPatent office reform (e.g. allow broader input/reexaminations of patents)input/reexaminations of patents) – Eminent domainEminent domain » Government takes over control ofGovernment takes over control of inappropriate/abusive patentsinappropriate/abusive patents – Better ways of determining multipleBetter ways of determining multiple contributions to a finished drug productcontributions to a finished drug product Source: Kesselheim AS and Avorn J. Biomedical patents and the public’s health: is there a role for eminent domain? JAMA 2006;295:434-437.
  25. 25. Misaligned incentivesMisaligned incentives  Some important public health issues fallSome important public health issues fall outside of patent incentive structureoutside of patent incentive structure – Orphan DiseasesOrphan Diseases – Pediatric PopulationsPediatric Populations – AntibioticsAntibiotics – Neglected DiseasesNeglected Diseases
  26. 26. Orphan Drug ActOrphan Drug Act  ““Orphan condition”: <200,000 peopleOrphan condition”: <200,000 people  Incentives:Incentives: – Federal funding of some grants and contracts toFederal funding of some grants and contracts to perform clinical trials of orphan productsperform clinical trials of orphan products – A tax credit of 50% of clinical testing costsA tax credit of 50% of clinical testing costs – Market exclusivity for orphan indication for 7Market exclusivity for orphan indication for 7 years from date of approvalyears from date of approval » Iron-clad, stronger than patentIron-clad, stronger than patent
  27. 27. Orphan Drug ActOrphan Drug Act  Great success …Great success … – 325 approvals since 1983 for rare diseases and enzyme325 approvals since 1983 for rare diseases and enzyme deficienciesdeficiencies  …… at a substantial costat a substantial cost – Annual spending on specialty pharmaceuticalsAnnual spending on specialty pharmaceuticals increases by more than >20% per yearincreases by more than >20% per year » Patients disproportionately bear costsPatients disproportionately bear costs » Harder to introduce genericHarder to introduce generic – Misuse?Misuse? » Vioxx approved as orphan for JRA in 2004Vioxx approved as orphan for JRA in 2004 » Epogen approved as orphan in anemia of CKDEpogen approved as orphan in anemia of CKD – Currently, ½ of all drugs produced by biotechCurrently, ½ of all drugs produced by biotech companies are orphanscompanies are orphans
  28. 28. Pediatric Exclusivity ExtensionPediatric Exclusivity Extension  6 mos of market exclusivity if conduct clinical6 mos of market exclusivity if conduct clinical trials of products in pediatric populationstrials of products in pediatric populations  Success …Success … – 1/3 of drugs underwent labeling changes1/3 of drugs underwent labeling changes  …… at a costat a cost – Awarded regardless of outcome or utility of trialAwarded regardless of outcome or utility of trial » Many trials not publishedMany trials not published – Overcompensates blockbusters (and may under-Overcompensates blockbusters (and may under- compensate turkeys):compensate turkeys): » Cost of trials: $6 - $37MCost of trials: $6 - $37M » Return from 6 mos exclusivity: $-9M to $507MReturn from 6 mos exclusivity: $-9M to $507M Source: Li et al,Li et al, JAMAJAMA, 2007, 2007
  29. 29. AntibioticsAntibiotics ““The pipeline of newThe pipeline of new antibiotics is drying up.antibiotics is drying up. Major pharmaceuticalMajor pharmaceutical companies are losingcompanies are losing interest in the antibioticsinterest in the antibiotics market because these drugsmarket because these drugs are simply not as profitableare simply not as profitable as drugs that treat chronicas drugs that treat chronic (long-term) conditions and(long-term) conditions and lifestyle issues.”lifestyle issues.”
  30. 30. AntibioticsAntibiotics  Perceived inadequacies of current system forPerceived inadequacies of current system for antibiotic reimbursementantibiotic reimbursement – Short courses of therapy – blockbusters unlikelyShort courses of therapy – blockbusters unlikely – Resistance make “life-cycle management” less effectiveResistance make “life-cycle management” less effective – Public health efforts to limit prescribingPublic health efforts to limit prescribing
  31. 31. Spellberg B, Powers JH, Brass EP, Miller LG, Edwards Jr. JE. CID 2004;38:1279-86. Powers JH. Clin. Microbiology & Infection 2004;10(S4): 23-31. Is this really a problem?Is this really a problem?
  32. 32. New therapiesNew therapies Talbot, et al., CID 2006; 42:657–68. Acinetobacter baumanniiAcinetobacter baumannii TigecyclineTigecycline Aspergillus speciesAspergillus species Some therapies in development,Some therapies in development, but no substantive breakthroughbut no substantive breakthrough drugdrug ESBL–producingESBL–producing Enterobacteriaceae and KlebsiellaEnterobacteriaceae and Klebsiella speciesspecies TigecyclineTigecycline VREVRE Quinupristin-dalfopristin andQuinupristin-dalfopristin and linezolidlinezolid Pseudomonas aeruginosaPseudomonas aeruginosa Carbapenems onlyCarbapenems only Methicillin resistantMethicillin resistant Staphylococcus aureus (MRSA)Staphylococcus aureus (MRSA) Many drugs under developmentMany drugs under development
  33. 33. Wildcard Patent ExtensionsWildcard Patent Extensions  New class of antibiotic with specific targetedNew class of antibiotic with specific targeted indications, the company would be able to pickindications, the company would be able to pick any drug in its portfolio and add, for example,any drug in its portfolio and add, for example, between six months and two years of marketbetween six months and two years of market exclusivityexclusivity  ““It is potentially very attractive to establishedIt is potentially very attractive to established companies, but is politically challenging becausecompanies, but is politically challenging because the economic burden would be placed on patientsthe economic burden would be placed on patients or payers for different medicines, possibly inor payers for different medicines, possibly in another countries.” -- WHOanother countries.” -- WHO
  34. 34. Permanent PatentsPermanent Patents  ““Patent terms for antibiotics should bePatent terms for antibiotics should be extremely long … trying to encourageextremely long … trying to encourage pharmaceutical companies to stockpilepharmaceutical companies to stockpile drugs to deal with potential plagues.”drugs to deal with potential plagues.” Kades E. Northwestern Univ. L. Rev. 2005;99:611-675
  35. 35. Exclusivity-based solutionsExclusivity-based solutions  ProblemsProblems – Using patents as a lever involves substantial costsUsing patents as a lever involves substantial costs » For wildcard patents, public health implications in otherFor wildcard patents, public health implications in other marketsmarkets – No guarantee that market will respond as predictedNo guarantee that market will respond as predicted – Potential for abusePotential for abuse See: Outterson et al, Lancet Inf Dis, 2005
  36. 36. Neglected DiseasesNeglected Diseases  Tropical infections endemic in low-incomeTropical infections endemic in low-income populations, usually in Africa or Asiapopulations, usually in Africa or Asia – WHO: >1 billion people suffer from aWHO: >1 billion people suffer from a neglected tropical diseaseneglected tropical disease – Kala-azar, Chagas’ disease, sleeping sickness…Kala-azar, Chagas’ disease, sleeping sickness… – 1975-1999: 1,393 new drugs were made1975-1999: 1,393 new drugs were made available to the public, but only 16 were meantavailable to the public, but only 16 were meant for neglected diseasesfor neglected diseases Source: Troullier et al,Source: Troullier et al, LancetLancet, 2002, 2002
  37. 37. Priority Review VoucherPriority Review Voucher  Food and Drug AdministrationFood and Drug Administration Amendments Act of 2007Amendments Act of 2007 – Require review of new product within 6 mosRequire review of new product within 6 mos – Awarded upon approval of NDA for drugAwarded upon approval of NDA for drug treating tropical diseasetreating tropical disease » Ineligible if active ingredient previously approvedIneligible if active ingredient previously approved – May transfer/sell to other companiesMay transfer/sell to other companies
  38. 38. Priority Review VoucherPriority Review Voucher  ProblemsProblems – Incentives do not include implementation,Incentives do not include implementation, “recycled” products, or adapting products to be“recycled” products, or adapting products to be useful in tropical climatesuseful in tropical climates – Lack of transparency in transfer dealsLack of transparency in transfer deals – Public health concern with speedy FDAPublic health concern with speedy FDA reviews for products without substantial healthreviews for products without substantial health interest involvedinterest involved Source: Kesselheim, NEJM, 2008
  39. 39. Misaligned IncentivesMisaligned Incentives  Reform:Reform: – Critically examine whether incentives areCritically examine whether incentives are needed, and if so, how muchneeded, and if so, how much – If additional incentives are needed, must includeIf additional incentives are needed, must include oversight to protect against abuse, ensure publicoversight to protect against abuse, ensure public benefitbenefit » Orphan Drugs: Ensure not pricing out of market, endOrphan Drugs: Ensure not pricing out of market, end exclusivity at certain pointexclusivity at certain point » Pediatric Trials: Condition of drug approval?Pediatric Trials: Condition of drug approval? » Antibiotics: Reward appropriate conservation andAntibiotics: Reward appropriate conservation and patient outcomespatient outcomes » Neglected diseases: Independent funds awardNeglected diseases: Independent funds award research, development, and then implementationresearch, development, and then implementation
  40. 40. Proposed alternatives to patent-basedProposed alternatives to patent-based incentive systemincentive system  ““Regulatory exclusivity”Regulatory exclusivity” – Starting for fixed period of time after FDAStarting for fixed period of time after FDA approval (e.g. biologics)approval (e.g. biologics) – Vary time based on importance of drug, origin ofVary time based on importance of drug, origin of IP, investment by sponsor, how they handle theIP, investment by sponsor, how they handle the post-approval periodpost-approval period  PrizesPrizes  Government investment/public fundsGovernment investment/public funds – Include fair return to underlying publicly-Include fair return to underlying publicly- funded sciencefunded science
  41. 41. ConclusionConclusion  Patent system provides incentives, intellectualPatent system provides incentives, intellectual property protection for drug developmentproperty protection for drug development  Not optimally designed to do that, leading toNot optimally designed to do that, leading to misuse and unresolved public health issuesmisuse and unresolved public health issues  In attempting to reform and find better balance,In attempting to reform and find better balance, keep in mind:keep in mind: – Reward important public health outcomes overReward important public health outcomes over intermediate stepsintermediate steps – Ensuring rewards accrue to proper inventorsEnsuring rewards accrue to proper inventors
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