CIRD210170 - Patent Box: qualifying companies: qualifying IP rights: other rights to which Part 8A applies

The scope of the Patent Box extends to rights similar to patents which relate to human and veterinary medicines, plant breeding and plant varieties.

Supplementary protection certificates

Supplementary protection certificates (‘SPC’) are issued under Regulations (EC) 469/2009 and 1610/96 relating to medicinal and plant protection products respectively. This will also include any paediatric use extension: Article 36 of Regulation (EC) 1901/2006 extends the duration of an SPC issued under Regulation 426/2009 in respect of paediatric use medicinal products for six months. Therefore where this is the case, the company would continue to hold the SPC issued under Regulation 469/200 for an additional six months and hence continue to hold an IP right to which the Patent Box applies for that period.

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Plant breeders and plant variety rights

Plant breeders’ rights are granted in accordance with Part 1 of the Plant Variety Act 1977.

Community Plant Variety rights are granted under Council Regulation (EC) No 2100/94.

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Medicinal and veterinary products with marketing authorisations and marketing or data protection

Companies granted marketing authorisation, for example medicinal products for human use under Regulation (EC) 726/2004 or Directive 2001/83/EC and who benefit from marketing protection by virtue of Article 14.11 of Regulation (EC) 726/2004 and Article 10.1 of Directive 2001/83/EC respectively, will be treated as if they hold a right to which the Patent Box applies for the period of the marketing or data protection. This is ten years, extended by a further year in certain circumstances.

Companies granted marketing authorisation which benefits from one year of data exclusivity under Article 10.5 of Directive 2001/83/EC, or an in-force one year prohibition on referring to the results of test or trials in relation to the product imposed by Article 74a of that directive, will be treated as if they hold a right to which the Patent Box applies for those one year periods.

As set out in Article 38 of Regulation (EC) 1901/2006, paediatric use medicinal products are also granted marketing authorisations under Regulation (EC) 726/2004 or Directive 2001/83/EC. Therefore companies will also be treated as holding a right to which the Patent Box applies during the periods of marketing protection for such paediatric use medicinal products.

Medicinal products designated as orphan medicinal products under Regulation (EC) 141/2000 benefit from a period of marketing exclusivity by virtue of Article 8.1 of Regulation (EC) 141/2000. Where this is the case, a company will also be treated as holding a right to which the Patent Box applies for the ten year period of the marketing exclusivity. This period is extended to twelve years if the orphan medicinal product is also a paediatric use medicinal product that meets the requirements set out in Article 37 of Regulation (EC) 1901/2006. Therefore where this is the case, the company would continue to benefit from marketing exclusivity under Regulation 141/2000 for an additional two years and hence continue to hold an IP right to which the Patent Box applies for that period.

As for medicinal products for human use, where a company is granted a marketing authorisation in respect of a veterinary medicinal product that benefits from marketing protection under Article 13.1 of Directive 2001/82/EC, it will be treated as if it holds a right to which the Patent Box applies for the period of the marketing protection, i.e. ten years, extended by a further three years in certain circumstances. Where veterinary medicinal products are authorised in accordance with Regulation (EC) 726/2004, they also benefit from the provision of marketing protection under Article 13.1 of Directive 2001/82/EC and therefore will also be treated as if they hold a right to which the Patent Box applies for the marketing protection period referred to above.

As the Veterinary Medicines Regulations 2011 implement Directive 2001/82/EC, where a marketing protection or prohibition under Paragraph 11 or 12 of Schedule 1 to those Regulations is in force, it will also be treated as if it holds a right to which the Patent Box applies for the period of the marketing protection/prohibition.

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Plant Protection Products with Data Protection Benefits

Similarly, plant protection products which benefit from a period of data protection under Article 59 of Regulation 1107/2009 will also be treated as holding a right to which the Patent Box applies for the period of ten to thirteen, or thirteen to fifteen, years as set out in that Article. However, a company will not be treated as holding a right to which this Patent Box applies if the only data protection afforded under Article 59 is in respect of a study that was necessary for the renewal or review of an authorisation.