Second generation patents in pharmaceutical innovation
The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks...
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| Médium: | E-kniha Kniha Publikácia |
| Jazyk: | English |
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Baden-Baden
Nomos
2014
Nomos Verlagsgesellschaft mbH & Co. KG Nomos Verlagsgesellschaft |
| Vydanie: | 1 |
| Edícia: | Munich Intellectual Property Law Center – MIPLC |
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| ISBN: | 3848708744, 9783848708741, 9783845250861, 3845250860 |
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| Abstract | The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks. This is one of the reasons the pharmaceutical industry depends greatly on patent protection. Despite the existing patent system, however, the number of new medications per year has decreased, especially during the last decade. In comparison, the number of second generation patents and products has been drastically increased. This industry is accused both of neglecting its real mission of providing new medications while generating second generation products, and of preventing the entry of generics. The dissertation reviewed whether the concerns are justified, and, if so, whether or how the patent system can improve the situation that confronts pharmaceutical companies and society. |
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| AbstractList | Die Entwicklung neuer Medikamente und deren Verbesserungen sind entscheidend, um deutliche Fortschritte in der Gesundheitsversorgung zu gewährleisten. Der Entwicklungsprozess ist lang und teuer, insbesondere der Aufwand,der betrieben werden muss,, um den hohen Regulierungsanforderungen gerecht zu werden. Im Gegensatz dazu verursacht die Nachahmung von Medikamenten vernachlässigbare Kosten und birgt deutlich weniger Risiken. Dies ist einer der Gründe, warum der Patentschutz für die die pharmazeutische Industrie von so großer Bedeutung ist. Trotz des bestehenden Patentsystems ist gerade während des letzten Jahrzehnts die Zahl der neuen Medikamente pro Jahr zurückgegangen. Im Vergleich dazu hat sich die Zahl der Patente und Produkte der zweiten Generation drastisch erhöht. Der Pharmaindustrie wird vorgeworfen, ihre ursprüngliche Aufgabe, die Entwicklung neuer Medikamente, zu vernachlässigen, indem sie Produkte der zweiten Generation erzeugt und die Einführung von Generika verhindert. Die Dissertation überprüft, ob diese Bedenken gerechtfertigt sind, und wenn ja, ob oder wie das Patentsystem den Konflikt zwischen Pharma-Unternehmen und der Gesellschaft im Hinblick auf eine bedarfsgerechte Arzneimittelversorgung lösen kann. The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks. This is one of the reasons the pharmaceutical industry depends greatly on patent protection. Despite the existing patent system, however, the number of new medications per year has decreased, especially during the last decade. In comparison, the number of second generation patents and products has been drastically increased. This
industry is accused both of neglecting its real mission of providing new medications while generating second generation products, and of preventing the entry of generics. The dissertation reviewed whether the concerns are justified, and, if so, whether or how the patent system can improve the situation that confronts pharmaceutical companies and society. Reihe Munich Intellectual Property Law Center - MIPLC - Band 19. The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks. This is one of the reasons the pharmaceutical industry depends greatly on patent protection. Despite the existing patent system, however, the number of new medications per year has decreased, especially during the last decade. In comparison, the number of second generation patents and products has been drastically increased. This industry is accused both of neglecting its real mission of providing new medications while generating second generation products, and of preventing the entry of generics. The dissertation reviewed whether the concerns are justified, and, if so, whether or how the patent system can improve the situation that confronts pharmaceutical companies and society. Die Entwicklung neuer Medikamente und deren Verbesserungen sind entscheidend, um deutliche Fortschritte in der Gesundheitsversorgung zu gewährleisten. Der Entwicklungsprozess ist lang und teuer, insbesondere der Aufwand,der betrieben werden muss,, um den hohen Regulierungsanforderungen gerecht zu werden. Im Gegensatz dazu verursacht die Nachahmung von Medikamenten vernachlässigbare Kosten und birgt deutlich weniger Risiken. Dies ist einer der Gründe, warum der Patentschutz für die die pharmazeutische Industrie von so großer Bedeutung ist. Trotz des bestehenden Patentsystems ist gerade während des letzten Jahrzehnts die Zahl der neuen Medikamente pro Jahr zurückgegangen. Im Vergleich dazu hat sich die Zahl der Patente und Produkte der zweiten Generation drastisch erhöht. Der Pharmaindustrie wird vorgeworfen, ihre ursprüngliche Aufgabe, die Entwicklung neuer Medikamente, zu vernachlässigen, indem sie Produkte der zweiten Generation erzeugt und die Einführung von Generika verhindert. Die Dissertation überprüft, ob diese Bedenken gerechtfertigt sind, und wenn ja, ob oder wie das Patentsystem den Konflikt zwischen Pharma-Unternehmen und der Gesellschaft im Hinblick auf eine bedarfsgerechte Arzneimittelversorgung lösen kann. Die Entwicklung neuer Medikamente und deren Verbesserungen sind entscheidend, um deutliche Fortschritte in der Gesundheitsversorgung zu gewährleisten. Der Entwicklungsprozess ist lang und teuer, insbesondere der Aufwand,der betrieben werden muss,, um den hohen Regulierungsanforderungen gerecht zu werden.Im Gegensatz dazu verursacht die Nachahmung von Medikamenten vernachlässigbare Kosten und birgt deutlich weniger Risiken. Dies ist einer der Gründe, warum der Patenschutz für die die pharmazeutische Industrie von so großer Bedeutung ist.Trotz des bestehenden Patentsystems ist gerade während des letzten Jahrzehnts die Zahl der neuen Medikamente pro Jahr zurückgegangen. Im Vergleich dazu hat sich die Zahl der Patente und Produkte der zweiten Generation drastisch erhöht.Der Pharmaindustrie wird vorgeworfen, ihre ursprüngliche Aufgabe, die Entwicklung neuer Medikamente, zu vernachlässigen, indem sie Produkte der zweiten Generation erzeugt und die Einführung von Generika verhindert. Die Dissertation überprüft, ob diese Bedenken gerechtfertigt sind, und wenn ja, ob oder wie das Patentsystem den Konflikt zwischen Pharma-Unternehmen und der Gesellschaft im Hinblick auf eine bedarfsgerechte Arzneimittelversorgung lösen kann |
| Author | Ahn, Hyewon |
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| Notes | Includes bibliographical references (p. 333-354) MODID-ff01a8158bb:Nomos |
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| Snippet | The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and... Die Entwicklung neuer Medikamente und deren Verbesserungen sind entscheidend, um deutliche Fortschritte in der Gesundheitsversorgung zu gewährleisten. Der... |
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| SubjectTerms | Book Industry Communication Commercial Drug development Drug development. fast (OCoLC)fst00898670 Drugs -- Law and legislation Drugs -- Law and legislation. fast (OCoLC)fst00898830 Drugs -- Patents Drugs. fast (OCoLC)fst00898761 Economic aspects Gewerblicher Rechtsschutz K1-7720 Law Markenrecht Patent laws and legislation Patent laws and legislation. fast (OCoLC)fst01054823 Patents. fast (OCoLC)fst01423842 Pharmaceutical industry Pharmaceutical policy Technological innovations Urheberrecht / Gewerblicher Rechtsschutz und Medienrecht |
| TableOfContents | b) Other selection inventions -- 2. Selection inventions from the era of penicillin to the 21th century -- a) Early medications and the novelty requirement -- b) "Made available to the public" for the first time -- 3. Analysis and conclusion -- C. Proposals on the breadth of patents -- 1. Arguments on the breadth of patents -- a) Arguments for a broader patent scope -- b) Arguments against a broader patent scope -- c) Arguments on patent scope with consideration of other relevant factors -- Value dependent -- Situation dependent -- 2. Interim conclusion -- 3. Solutions to the overlapping scope with species selection invention -- a) Voluntary licensing agreements -- b) Non-voluntary licenses -- (1) Compulsory licenses -- (2) Case law relevant to compulsory licenses -- In the United States: eBay Inc. v. MercExchange, L.L.C. -- In Germany: Orange Book Standard case -- c) Reverse doctrine of equivalents -- d) Conclusion -- D. Proposals on the length of patents -- 1. Arguments on the length of patents -- 2. Proposals on the length of patents -- a) Proposal on the length of basic patents -- (1) Introduction -- (2) Proposed term of basic patents -- (3) The basis of the proposal -- (4) Expected effects -- b) Proposal on the patent term extension of second generation patents -- E. Proposals on the patentability requirements -- 1. Introduction: Technology specific patentability standards -- 2. Proposals on the novelty requirement -- a) Arguments on the novelty requirement -- b) Proposal on the novelty requirement of species selection invention -- (1) Meaning of something "made available to the public" in the pharmaceutical industry -- (2) A patent as a double-edged sword to NMEs -- (3) Statutory exceptions to the novelty requirement and considerations thereof -- (4) Proposed novelty requirement for NMEs Cover -- I. INTRODUCTION -- A. Overview -- B. Outline of the dissertation -- C. Scope of the dissertation -- II. PHARMACEUTICAL INVENTIONS, INNOVATIONS & -- PRODUCTS -- A. Cumulative nature of inventions -- 1. Basic and second generation inventions -- a) Improvement inventions -- b) Selection inventions -- B. Inventions and innovations in pharmaceutical field -- 1. Inventions and patents in pharmaceutical field -- a) Product invention and the absolute character of its protection -- b) Hierarchy of pharmaceutical patents -- 2. Innovations in pharmaceutical field -- a) Invention v. innovation -- b) NMEs as the core of pharmaceutical innovation -- C. Second generation inventions and patents in pharmaceuticals -- 1. Product inventions and patents -- a) Species selection inventions -- Markush type claim -- A species claim -- b) Optical isomers -- c) Crystalline forms -- d) Metabolites and prodrugs -- e) Esters and salts -- f) Dosage forms -- g) Combinations of active ingredients -- 2. Use inventions -- a) New Use/New method of treatment -- b) Dosage regime -- 3. Process inventions -- a) Process -- b) Intermediates -- D. Pharmaceutical products in the market -- 1. New medical entities, new molecular entities -- 2. Similar or equivalent "me-too" products -- 3. Second generation products -- 4. Generic drugs -- E. Summary -- III. SPECIFICITIES IN PHARMACEUTICALS AND RECENT DEVELOPMENTS -- A. Innovating and inventing in pharmaceutical industry -- 1. Specificities in the drug development process -- a) Highly regulated industry -- b) R& -- D - a costly and lengthy road to a medicine -- c) Uncertainties in post-invention development -- (1) Scientific uncertainty: Unpredictability of substances -- (2) Regulatory and market uncertainties -- d) Information rich chemicals -- 2. Specificities in the market for pharmaceuticals 2. Examination of inventive step -- In the EPO -- In the United Kingdom -- In Germany -- In the United States -- In Korea -- 3. Inventive step requirement for selection inventions -- a) Species selection invention -- In the EPO -- In Germany -- In the United Kingdom -- In the United States -- In Korea -- b) Optical isomers -- In the EPO -- In Germany -- In the United Kingdom -- In the United States -- In Korea -- c) Crystalline forms -- In the EPO -- In the United Kingdom -- In Germany -- In the United States -- In Korea -- d) Metabolites -- 4. Analysis and conclusion -- C. Disclosure requirement -- 1. Written description requirement -- 2. Enablement requirement -- a) Enablement requirement -- b) Enablement requirements in the patent law -- (1) Enablement as a requirement for anticipation -- (2) Basic similarity of the two enablement requirements -- (3) Differences between the two enablement requirements -- 3. Disclosure requirement of selection inventions -- a) Species selection invention -- b) Optical isomers -- c) Crystalline forms -- D. Conclusion -- V. IMPLICATIONS OF THE PATENTABILITY REQUIREMENTS ON INNOVATION AND COMPETITION IN THE PHARMACEUTICAL INDUSTRY -- A. Concerns about lowered patentability -- 1. General concerns about lowered patentability -- a) Superfluous second generation patents -- b) Increased patent exclusivities and amplified uncertainties thereof -- c) Encouraged waste of resources -- d) Hindrance of pharmaceutical innovation -- 2. Concerns about the novelty requirements -- a) Language dependent prior art disclosure problem -- b) Rendering inventive step requirement meaningless -- c) Potential concerns of "direct and unambiguous" disclosure requirement -- B. Implications considering the breadth of selection patents -- 1. Scope of the protection -- 2. Scope of selection patents -- a) Species selection patents b) Optical isomers -- In Europe -- In the United States -- c) Metabolite -- In the United Kingdom -- In Germany -- In the United States -- d) Polymorphs -- 3. Analysis and conclusion -- C. Implications considering the length of selection patents -- 1. Patent term and patent term extension -- a) In Europe -- b) In the United States -- c) In Korea -- 2. Patent term extension on selection patents -- a) Species selection patents -- b) Optical isomers -- In Germany -- In the United Kingdom -- In the United States -- c) Polymorphs -- d) Metabolite -- 3. Analysis and conclusion -- Lowered patentability requirements on second generation inventions and the SPC -- Patent term extension system and pharmaceutical innovation -- D. Implications on the competition in the pharmaceutical industry -- 1. Introduction -- 2. Quasi-obstacles of generics market entry -- a) Scope of second generation patents -- b) Length of second generation patents -- c) Delayed filing of second generation patent applications -- 3. Real obstacles to generics' market entry -- a) Automatic thirty-month stay and new list up in the Orange Book in the United States -- b) Pendency of patent applications: Uncertainty -- (1) Pendency of patent applications -- (2) Filing of divisional applications -- Divisional applications -- Arguable abuse of procedural possibility -- An attempt to adjust this phenomenon by the USPTO -- Rule 36 EPC -- c) Active movement of the market to new products -- Efforts to move the market to products covered by second generation patents -- Example of Nexium® -- Example of Clarinex® -- d) Along with very specific patents on the secondary products -- 4. Analysis and conclusion -- E. Summary and conclusion -- VI. PROPOSALS -- A. Introduction -- B. Nature of selection inventions -- 1. Different natures of selection inventions -- a) Species selection invention a) Imitation with negligible cost and much reduced risk -- b) Prescription based purchase: A disconnection between choosers and payers -- c) Information asymmetry and high loyalty to a medicine -- d) Pricing -- 3. Specificities of the patent protection for pharmaceuticals -- a) Patent protection for industrial technologies -- b) Patent protection in the pharmaceutical industry -- B. Challenges and overcoming efforts -- 1. Decreased R& -- D productivity -- 2. Dearth of new medical entities -- a) Significance of NMEs -- b) Decreased number of NMEs -- c) Potential reasons for the decrease -- (1) Decrease in solvable scientific problems -- (2) Stringent safety regulations -- (3) Problem of over-disclosure -- (4) Early and numerous abandonments of potential candidates -- 3. Patent cliffs of blockbuster medications -- 4. Frequent merger and acquisitions (M& -- As) and in-licensing -- 5. Drastic increase of second generation inventions -- a) Life cycle management or evergreening -- b) Drastic increase of this activity supported by the number of second generation patents -- C. Summary -- IV. STANDARDS OF PATENTABILITY FOR PHARMACEUTICAL SELECTION INVENTIONS -- A. Novelty and anticipation -- 1. Introduction -- 2. Examination of novelty -- 3. Inherent anticipation and enablement -- 4. Novelty of selection inventions -- a) Species selection inventions -- In the EPO -- In Germany -- In the United Kingdom -- In the United States -- In Korea -- b) Optical isomers -- In the EPO -- In Germany -- In the United Kingdom -- In the United States -- In Korea -- c) Crystalline forms -- In the EPO -- In Germany -- In the United Kingdom -- In the United States -- d) Metabolite -- In the United Kingdom -- In Germany -- In the United States -- 5. Analysis and conclusion -- B. Inventive step / Non-obviousness -- 1. Inventive step in patentability requirements (5) Appreciation of the Olanzapine decision and its expected results |
| Title | Second generation patents in pharmaceutical innovation |
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