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Patent Strategy in Pharmaceutical Industry: Are additional patents valuable?

Monica Donghi

Reihe: Munich Intellectual Property Law Center - MIPLC Studies

Band 20 2014

Treffer in den folgenden Teilen:

Generic Drugs Approval. S. 19-20

„… the centralized procedure is mandatory.22 Generic Drugs Approval. As far as generics are concerned …” „… exclusivity +1 for new indication] in a Member State or in the Community”. C. Generic Drugs Approval. 19 …”

New Drug Approval Regulations S. 18-19

„… completion of Phase I clinical trials.16 New Drug Approval Regulations The European system offers three …” „… products for which the centralized procedure is mandatory.22 Generic Drugs Approval. As far as generics are …” „… exclusivity +1 for new indication] in a Member State or in the Community”. C. Generic Drugs Approval. 19 …”

Introduction S. 13-15

„… directed towards new chemical and biological entities (drugs) and their development to bring forth new …” „… targets to be addressed by a drug to treat a given disease, but also much more is known about potential …” „… . Maloteaux, 5 Impact of genomics on drug discovery and clinical medicine, 93 QJM. Int. J. Med. 391, 394 (2000 …”

Titelei/Inhaltsverzeichnis S. 2-10

„… Generic Drugs Approval.C. 19 Case Studies-FactsIII. 21 TaxotereA. 21 General1. 21 Patent Portfolio2. 23 …” „… . 16 Pharmaceutical Industry – The Development of a New Drug. A. 16 New Drug Approval RegulationsB. 18 …” „… portfolio regarding two commercially successful drugs of significant importance for public health. The …”

General S. 21-23

„… course of developing a drug. This study will be conducted by highlighting the patent portfolio of two …” „… randomly selected successful drugs whose basic patent protection has been expired: Taxotere® and Xalatan …” „… disclosed in EP 0253738 A131 belonging to Rhone-Poulenc Santé and market approval in Europe was obtained …”

Use of Procedural Provisions S. 37-39

„… edge with respect to ease of application, this method of administering the drug to the eye would …” „… filled with the drug per se. It appears, that there existed a need to stabilise the packaged drug and …” „… application has been filed with respect to the packaging of a combination of the drugs timolol and latanoprost …”

Pharmaceutical Industry – The Development of a New Drug. S. 16-18

„… not being carried out before the completion of Phase I clinical trials.16 New Drug Approval …” „… Background Pharmaceutical Industry – The Development of a New Drug. The development of a new drug …” „… been bringing the current estimated average cost of researching and developing a new drug to about 1 …”

Patent Strategy and Innovation S. 66-69

„… percentage of children who need such drug is low (around 1%) it is duty of the health system to guarantee …” „… that a safe drug is available to them. The scope of paediatric extension is to give an incentive to …” „… companies to provide such drugs, therefore the ICA point of view cannot be shared and Pfizer’s use of …”

Innovation Tracks S. 45-62

„… Strategy: Commercial Value Further research to improve properties of a drug and to address unmet needs …” „… a blockbuster drug might present various problems also on the side of the originator. Such problems …” „… class (follow-on drugs) were launched in the U.S. with a price discount and the discount rate was on …”

Use of Procedural Provisions: Supplementary Protection Certificates (SPCs)/Patent Term Extension S. 27-30

„… research around docetaxel did not diminish the efforts in basic research to find new innovative drugs …” „… years in July 2007. Market approval for docetaxel in Europe was obtained only in November 1995,61 after …” „… more than eight years of research to determine safety and efficacy of the drug in various clinical …”

doi.org/10.5771/9783845251288

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Die Kinderarzneimittelverordnung der Europäischen Gemeinschaft

Caroline Buck

Reihe: Nomos Universitätsschriften - Recht

Band 596 2008

Treffer in den folgenden Teilen:

Federal Food & Drug and Cosmetic Act 1938 S. 58-61

„… Arzneibuch der USA gelistete Sub- 232 Hilts, Protecting America’s Health, xiv. 233 Peskoe, Drug-Approval …” „… industry, 53; Peskoe, Drug-Approval Before and After 1962, 51; Scoville, Anerkennung ausländischer Daten …” „… , 592 A. 2d 1176 (1991); Nielsen, Handbook of Federal Drug Law, 8. 243 Rosen, Generic Drug Approval Pre …”

Literaturverzeichnis S. 291-323

„… Right to Access Experimental Drugs Pending Final FDA Approval – Abigail Alliance v. von Eschenbach, 445 …” „… , Zulassungsvoraussetzungen). Beers, Donald O., Generic and Innovator Drugs, A Guide to FDA Approval Requirements, 5. Auflage …” „… New Drug Application, in: Guarino, Richard A., New Drug Approval Process, Accelerating Global …”

Patente und andere Schutzmaßnahmen für Arzneimittel S. 214-232

„… ; Fox/Bennett, History of Waxman-Hatch Act, 2; Guarino, ANDAs and SNDAs, 173; Rosen, Generic Drug Approval Pre …” „… Rosen, Generic Drug Approval Pre-1984, 103. 1192 Guarino, ANDAs and SNDAs, 173; Fox/Bennett, History of …” „… Patent Law, 13; Gross, Generic Approcal Process Post-1984, 108; Rosen, Generic Drug Approval Pre-1984 …”

Federal Food and Drug Act 1906 S. 55-58

„… Peskoe, Drug-Approval Before and After 1962, 48; Nielsen, Handbook of Federal Drug Law, 4; Swann, History …” „… , Drug-Approval Before and After 1962, 49; Swann, History of Pharmaceutical Regulation, 17. 229 Cooper …” „… , Drug-Approval Before and After 1962, 50; Cooper, Introduction to Food and Drug Law, 3; Gordon, Admin. L. Rev …”

Maßnahmen zur Verkürzung der Verfahrensdauer S. 66-67

„… die Phasen der klinischen Prüfung komprimierte.290 1992 wurde dann mit dem Accelerated Drug Approval …” „… Generikazulassungen verzichtet, soweit der aktive Wirkstoff bei diesen Nachbauprodukten (auch Me-Too-Drugs („Ich Auch …” „… Kefauver-Harris-Drug-Amendment Act 1962 wird in den USA grundsätzlich jedes neue Arzneimittel nach erfolgreichem IND-Antrag im …”

Kefauver-Harris-Drug-Amendment Act S. 61-66

„… Regulation, 28; Peskoe, Drug-Approval Before and After 1962, 54; Greenberg, N.Y.U. J. Legis. & Pub. Pol’y …” „… , Science and pharmaceutical industry, 59; Peskoe, Drug-Approval Before and After 1962, 54; Salbu, Fla. L …” „… werden. V. Schwachstellen des FDCA 1938 Der FDCA 1938 optimierte den vorangegangenen Pure Food and Drug …”

Vergleich zur Arzneimittelzulassung in Europa S. 67

„… wurde dann mit dem Accelerated Drug Approval Program (ADAP) das Hauptverfahren für eine schnellere …” „… Vermarktung der Arzneimittel beschleunigt. Im gleichen Jahr wurde zusätzlich das Prescription Drug User Fee …” „… , 20. 293 Delamontagne, Accelerating New Product Approvals, 602. 294 Vgl. oben Teil 3, Kap. 4, C., II. …”

Anreiz der Pediatric Exclusivity S. 232-247

„… , Orphan Drugs, 66; Hoffman, Administrative Procedures of the FDA, 36; Peskoe, Drug-Approval Before and …” „… 232 c) Steuervergünstigungen Im Gegensatz zum europäischen Ansatz zur Regelung von Orphan Drugs …” „… werden in den USA neben der Marktexklusivität weitere bedeutende Anreize durch den Orphan Drug Act zur …”

doi.org/10.5771/9783845211893

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Wettbewerb und Regulierung in Medien, Politik und Märkten

Ralf Dewenter (Hrsg.), Justus Haucap (Hrsg.), Christiane Kehder (Hrsg.)

Reihe: Wettbewerb und Regulierung von Märkten und Unternehmen

Band 24 2013

Treffer in den folgenden Teilen:

Severin Frank, Wolfgang Kerber Patent Settlements in the Pharmaceutical Industry: An Antitrust Perspective S. 385-414

„… necessity of high investments by pharmaceutical companies to get approval for the marketing of a drug. Since …” „… certain proceedings necessary for an FDA approval of the respective drug without infringement of existing …” „… filed, this triggers an automatic 30-month stay with respect to the approval of the generic drug by the …”

doi.org/10.5771/9783845249469

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Gesundheits- und Sozialpolitik (G&S)

Alle Ausgaben: Gesundheits- und Sozialpolitik (G&S)

GuS Jahrgang 71 (2017) Heft 6 ISSN Online: 2942-3201

Treffer in den folgenden Teilen:

Antje Haas, Annette Zentner, Angela Schubert, Michael Ermisch Erstattung von Arzneimitteln mit unreifen Daten S. 16-22

„… . org/mediaroom/adaptive-pathways-why-arewe-cautious/?lang=de. Zugegriffen 17.10.2017 Banzi R, Gerardi C, Bertele‘ V, Garattini S (2015). Approvals of drugs …” „… . http://www.bukopharma.de/uploads/file/Pharma-Brief/Phbf2016_07.pdf. Zugegriffen 17.10.2017 Cattarin F (2016). When drug approval is quick, it should not …” „… / blog/when-drug-approval-is-quick-it-shouldnot-be-dirty/. Zugegriffen 17.10.2017 Collier R (2011). Bye, bye blockbusters, hello niche busters. CMAJ. 2011 …”

doi.org/10.5771/1611-5821-2017-6

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Zielerreichung internationaler Verträge

Armin Frey

2008

Treffer in den folgenden Teilen:

Anhang 2: Liste multilateraler Verträge bis Ende 2005 im Rahmen der Vereinten Nationen S. 302-340

„… Reciprocal Recognition of ApprovalsGranted on the Basis of These Prescriptions. Geneva, 20March 19581958151 …” „… theDistribution of Narcotic Drugs. Geneva, 13 July 1931 193139 Protocol of Signature. Geneva, 13 July 1931 …” „… Illicit Trafficin Dangerous Drugs. Geneva, 26 June 1936 193651 Protocol of Signature. Geneva, 26 June 1936 …”

doi.org/10.5771/9783845211626

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