• Great Britain
  • Germany
  • France
  • China
  • Souht Korea

SPCs & Regulatory

SPCs and regulatory data exclusivity are valuable rights that can extend a product’s lifecycle. It is vitally important to understand the interplay between these important and often complex rights.

With agrochemical, pharmaceutical and biotech patent attorney specialists, and lawyers with prior in-house experience, we are uniquely placed to advise you on all aspects of SPCs and regulatory issues.

 

SPCs and regulatory data exclusivity are valuable rights that can extend a product’s lifecycle. It is vitally important to understand the interplay between these important and often complex rights.

With agrochemical, pharmaceutical and biotech patent attorney specialists, and lawyers with prior in-house experience, we are uniquely placed to advise you on all aspects of SPCs and regulatory issues.

SPCs are available for medicinal or plant protection products in all European Union states as well as the UK and Switzerland. Once granted, they provide an additional monopoly right coming into force on expiry of the patent upon which the SPC is based. As there is no centralised process for filing SPCs, they must be filed nationally on a country-by-country basis. Our team’s experience in developing filing plans and prosecuting SPC applications allows us to provide the strategic advice necessary to successfully secure SPC protection.

We also have significant expertise in analysing the scope of competitor SPCs and contesting their validity (determined on country-by country basis) and we provide advice regarding generic products being brought to market.

As European IP specialists we are also uniquely positioned to advise on the developing legal framework resulting from the UK’s departure from the European Union (Brexit).

In contrast to patents and SPCs, which provide monopoly rights in relation to ownership of intellectual property, data exclusivity is a reward for the effort made by pharmaceutical and agrochemical companies to submit test data to regulatory authorities demonstrating the efficacy, safety and quality of new products. Data exclusivity is a right that is available in addition and irrespective of the patent status of the product.

Our team provides practical, commercially aware advice to companies navigating the complex world of both SPC’s and regulatory data exclusivity.

 

  • Post Brexit – UK supplementary protection certificates update

  • Sufficiency – from transgenic mice to a chocolate teapot

  • Canada amends its SPC Regulations following Brexit

  • Evolution of SPC Law in Europe

  • Kymab prevails as the UK Supreme Court affirms the requirement for sufficient disclosure

  • The EU’s SPC Manufacturing Waiver comes into Force on 1 July 2019

  • Supplementary Protection Certificate Update

  • CJEU clarifies the scope of the ‘Specific Mechanisms’ in case C-681/16 Pfizer v Orifarm

  • Supplementary Protection Certificate Update – November 2018