Pharmaceutical product liability systems: Regulatory models and Challenges

2018 ◽  
Vol 20 (1-4) ◽  
pp. 1-3
Author(s):  
M. Martin Casals ◽  
J. L. Valverde
Keyword(s):  
Product Liability ◽  
Pharmaceutical Product ◽  
Regulatory Models

scholarly journals Pharmaceutical Product Liability, Litigation Regimes and the Propensity to Patent: an Empirical Firm-level Investigation

2020 ◽  
Author(s):  
Mitja Kovac ◽  
Salvini Datta ◽  
Rok Spruk
Keyword(s):  
Legal Status ◽  
Patent Application ◽  
Product Liability ◽  
Pharmaceutical Product ◽  
European Patent ◽  
Firm Level ◽  
Patent Applications ◽  
A Minor ◽  
Second Category ◽  
The Empirical Analysis

<p>Our data on the legal status of patent applications is from European Patent Office's (EPO) PATSTAT database which contains bibliographic and legal status firm-level patent data from leading industrialized and developing countries for the period 1995-2015. Sixteen different forms of legal statues are broadly classified and systematized into four broad categories. The first category entails the patent applications sent to EPO. This category is used to code firm-level observations based on whether the patent application has been submitted to EPO. The second category comprises the pooled firm-level observations for which the patent application has been approved and official validated. This category comprises the firms for which a valid patent has been approved in a given year. The third category comprises the firms whose patent application has been rejected by EPO on various ground which exceed the scope of this paper. And fourth, the remaining forms of legal status were coded into miscellaneous category which amounts to a minor fraction of the whole set of applications and which are omitted from the empirical analysis.</p>

scholarly journals Carga de la prueba y estándar mínimo de la prueba por indicios en materia de responsabilidad por los daños ocasionados por un producto farmacéutico defectuoso (a propósito de la STJUE de 21 de junio de 2017) = Burden of proof and circumstantial evidence standard for pharmaceutical product liability: commentary to ECJ judgment of 21 june 2017

2017 ◽  
Vol 9 (2) ◽  
pp. 709
Author(s):  
Bárbara Sánchez López
Keyword(s):  
Burden Of Proof ◽  
Product Liability ◽  
Indirect Evidence ◽  
Causal Link ◽  
Pharmaceutical Product ◽  
The State ◽  
Circumstantial Evidence ◽  
Valid Method

Resumen: La Sentencia del TJUE de 21 de junio de 2017 (Sala 2ª), Sanofi Pasteur MSD SNC, C-621/15, aborda la compatibilidad de la llamada «prueba por indicios» con el art. 4 de la Directiva 85/374, sobre responsabilidad por los daños causados por productos defectuosos, en circunstancias en las que el estado de la ciencia no permite demostrar, pero tampoco excluir, la relación entre un producto farmacéutico y los daños. La sentencia examina las condiciones y los límites que debe reunir y respetar para constituirse en un método válido para levantar la carga de la prueba sobre el carácter defectuoso del producto, el daño causado y la relación de causalidad que el artículo 4 de la Directiva arroja sobre el perjudicado.Palabras clave: prueba por indicios, prueba indirecta, carga de la prueba, valoración probatoria judicial, standard probatorio, presunciones legales, responsabilidad por productos defectuosos.Abstract: The ECJ judgment of 21 June 2017 (Second Chamber), Sanofi Pasteur MSD SNC, C-621/15, addresses the compatibility of the so-called “evidence for presumptions or indications” with art. 4 of Directive 85/374 on liability for damage caused by defective products, in circumstances where the state of science does not allow to demonstrate, but does not exclude, the relation between a pharmaceutical product and the damage. The judgment examines the conditions and limits which it must comply with in order to constitute a valid method of lifting the burden of proof on the defectiveness of the product, the damage caused and the causal link which article 4 of the Directive imposes on the injured.Keywords: circumstantial evidence, indirect evidence, burden of proof, evidence standard, legal presumptions, product liability.

Pharmaceutical product liability in Spain

2018 ◽  
Vol 20 (1-4) ◽  
pp. 143-161
Author(s):  
Josep Solé Feliu
Keyword(s):  
Product Liability ◽  
Pharmaceutical Product

scholarly journals Pharmaceutical Product Liability, Litigation Regimes and the Propensity to Patent: an Empirical Firm-level Investigation

2020 ◽  
Author(s):  
Mitja Kovac ◽  
Salvini Datta ◽  
Rok Spruk
Keyword(s):  
Legal Status ◽  
Patent Application ◽  
Product Liability ◽  
Pharmaceutical Product ◽  
European Patent ◽  
Firm Level ◽  
Patent Applications ◽  
A Minor ◽  
Second Category ◽  
The Empirical Analysis

<p>Our data on the legal status of patent applications is from European Patent Office's (EPO) PATSTAT database which contains bibliographic and legal status firm-level patent data from leading industrialized and developing countries for the period 1995-2015. Sixteen different forms of legal statues are broadly classified and systematized into four broad categories. The first category entails the patent applications sent to EPO. This category is used to code firm-level observations based on whether the patent application has been submitted to EPO. The second category comprises the pooled firm-level observations for which the patent application has been approved and official validated. This category comprises the firms for which a valid patent has been approved in a given year. The third category comprises the firms whose patent application has been rejected by EPO on various ground which exceed the scope of this paper. And fourth, the remaining forms of legal status were coded into miscellaneous category which amounts to a minor fraction of the whole set of applications and which are omitted from the empirical analysis.</p>

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