Supplementary Protection Certificates for Medicinal Products: Where are We Now and What Challenges Lay Ahead?

Miles, John C.

doi:10.4155/ppa.12.31

Cited by 3 publications

(8 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Supplementary Protection Certificates (SPCs) are one of the most important IP rights available for medicines in the EU and other territories in the European 31 Area (EEA) . This is because they provide additional monopoly protection beyond the term of the basic patent, for medicinal products that require regulatory approval before they can be sold.…”

Section: Resultsmentioning

confidence: 99%

“…SPCs for both human and veterinary products are governed by EU Regulation No 469/2009 . The operative legislation of SPCs is the European Union's Medicinal Products Regulation 1768/92 . The conditions for obtaining an SPC for a product are: the product is protected by a basic patent in force; a valid authorization to place the product on the market as a medicinal product has been granted in respect of the territory in question in accordance with the relevant EU directives; the product has not already been the subject of an SPC; the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product.…”

Section: Resultsmentioning

confidence: 99%

“…Is a single‐enantiomer medicinal product developed by application of the chiral‐switch strategy, protected by a basic patent and granted a valid marketing authorization to place it on the market, entitled to an SPC? The issue of SPCs for enantiomers has recently been analyzed in depth . Other issues of SPC eligibility of a combination of active ingredients of a medicinal product are not discussed here.…”

Section: Resultsmentioning

confidence: 99%

“…Interestingly, the Court brought out the argument that there may be enantiomer–enantiomer interactions when the racemate is administered . However, at present, there is no uniform position as to whether it is possible to obtain an SPC to an enantiomer when the racemate has been the subject of an earlier authorization in the territory . In the case of Vimovo, the relevant question here is whether the authorization to place omeprazole on the market and the grant of an SPC for omeprazole are considered an authorization to place esomeprazole on the market.…”

Section: Resultsmentioning

confidence: 99%

“…Supplementary Protection Certificates (SPCs) are one of the most important IP rights available for medicines in the EU and other territories in the European 31 Area (EEA). 46,47 This is because they provide additional monopoly protection beyond the term of the basic patent, for medicinal products that require regulatory approval before they can be sold. The SPC extends the protection conferred by that patent for an additional maximum period of 5.5 years so that the holder will have the benefit of a maximum period of 15 years of exclusivity from the first marketing authorization of the medicinal product concerned in the European Union, including the life of the patent.…”

Section: Spc Exclusivity For Vimovo An Esomeprazole-related Medicinamentioning

confidence: 99%

See 4 more Smart Citations

Single Enantiomer Versus Racemate: Chiral Distinction in the Proton Pump Inhibitors Omeprazole and Esomeprazole

2014

View full text Add to dashboard Cite

Chiral distinction in the proton pump inhibitor drugs omeprazole and in its chiral-switch esomeprazole magnesium was studied employing the Density Functional Theory (DFT) method. At B3LYP/6-311G(d,p), the 6-methoxy∙∙∙6-methoxy and 5-methoxy∙∙∙5-methoxy homochiral and heterochiral dimers were calculated. The chiral distinction free energies (ΔΔG(298,(RS-SS))) between the cyclic C2-(S,S)- and Ci-(R,S)-dimers with two intermolecular hydrogen bonds are 3.8, 1.9 (with BSSE counterpoise correction), and -6.9 (with D3 dispersion and BSSE counterpoise corrections) kJ/mol. Adding water as an implicit solvent (polarized continuum model [PCM] model) resulted in a chiral distinction energy of -3.3 kJ/mol, indicating a reversal of the order of the relative stabilities of C2-(S,S)- and Ci-(R,S)-dimers. The chiral distinction free energies between the corresponding (less stable) C1-dimers with one intermolecular hydrogen bond are -9.3, -5.8 (with BSSE CC), 17.6 (D3 + BSSE CC), and -3.2 (H2O) kJ/mol. The results highlight the contention that omeprazole is not just a superposition of its enantiomer constituents. They are consistent with the pharmacological evidence of enantiomer-enantiomer interactions in omeprazole versus esomeprazole and the differences between the drugs omeprazole and esomeprazole magnesium and support the lodged application for regulatory supplementary protection certificate (SPC) exclusivity for the esomeprazole-related combination drug Vimovo.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Spc Exclusivity For Vimovo An Esomeprazole-related Medicinamentioning

confidence: 99%

See 3 more Smart Citations

Single Enantiomer Versus Racemate: Chiral Distinction in the Proton Pump Inhibitors Omeprazole and Esomeprazole

2014

View full text Add to dashboard Cite

show abstract

Manufacturing for Export: A TRIPS-Consistent Pro-Competitive Exception

Correa

2023

MPI Studies on Intellectual Property and Competition Law

View full text Add to dashboard Cite

The paper discusses the flexibilization of the sui generis system of supplementary protection certificates (SPCs) under European law recently introduced to allow for the manufacturing, stockpiling and export of covered products. Against this background, it examines the viability under the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement) of an exception allowing for the manufacture and export of patent-protected products. It concludes that such an exception would promote competition and enhance access to medicines (including biologicals) for the general public while being consistent with Article 30 of the TRIPS Agreement if read in accordance with the principles of interpretation of customary international law.Ce document traite de la flexibilisation du système sui generis des certificats complémentaires de protection (CCP) en vertu de la législation européenne récemment introduite pour permettre la fabrication, le stockage et l'exportation de produits protégés. Dans ce contexte, il examine la viabilité, dans le cadre de l'Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (l'Accord sur les ADPIC), d'une exception autorisant la fabrication et l'exportation de produits protégés par un brevet. Elle conclut qu'une telle exception favoriserait la concurrence et améliorerait l'accès aux médicaments (y compris les produits biologiques) pour le grand public tout en étant compatible avec l'article 30 de l'accord sur les ADPIC s'il est lu conformément aux principes d'interprétation du droit international coutumier.El documento analiza la flexibilización del sistema sui generis de certificados complementarios de protección (CCP) en el marco de la legislación europea, introducido recientemente para permitir la fabricación, el almacenamiento y la exportación de productos cubiertos. En este contexto, se examina la viabilidad, en el marco del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (Acuerdo sobre los ADPIC), de una excepción que permita la fabricación y exportación de productos protegidos por patentes. Llega a la conclusión de que dicha excepción fomentaría la competencia y mejoraría el acceso a los medicamentos (incluidos los biológicos) para el público en general, al tiempo que sería coherente con el artículo 30 del Acuerdo sobre los ADPIC si se lee de acuerdo con los principios de interpretación del derecho internacional consuetudinario.

show abstract

Patent Term Extension in Japan: Challenges Still Lay Ahead Even After the 2011 Revision

Komatani¹

2012

Pharm. Pat. Analyst

View full text Add to dashboard Cite

Japan has a patent term extension (PTE) system similar to supplemental protection certificates in Europe and PTEs in the USA; however, the Japanese PTE system is different in many aspects. It is relatively known that it is not so difficult to obtain multiple PTEs, but as a matter of fact it can be challenging. Recently, the Supreme Court of Japan issued important decisions relating to multiple PTEs, followed by revision to the Japan Patent Office's Examination Guidelines. Further, calculation of an extended term is also an issue in obtaining a PTE in Japan, which is different from those of European supplemental protection certificates or US PTE systems. The Japanese court also held an important decision in this regard, particularly, how clinical trial outside Japan may be considered in the calculation of extended patent right. Additional recent court decisions issued in terms of PTE matter are introduced.

show abstract

Supplementary Protection Certificates for Medicinal Products: Where are We Now and What Challenges Lay Ahead?

Cited by 3 publications

References 2 publications

Single Enantiomer Versus Racemate: Chiral Distinction in the Proton Pump Inhibitors Omeprazole and Esomeprazole

Single Enantiomer Versus Racemate: Chiral Distinction in the Proton Pump Inhibitors Omeprazole and Esomeprazole

Manufacturing for Export: A TRIPS-Consistent Pro-Competitive Exception

Patent Term Extension in Japan: Challenges Still Lay Ahead Even After the 2011 Revision

Contact Info

Product

Resources

About