Analysis of Supplementary Protection Certificate (SPC) and Certificate of Supplementary Protection (CSP) Manufacturing Waivers and Their Impact on Pharmaceutical Industry

Mayur Kardile, Archna Roy, Manthan Janodia

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Supplementary Protection Certificate (SPC) is a type of Intellectual Property Right which extends the patent term and is applicable to approved specific pharmaceutical and plant protection products in European Union (EU). On 01 July 2019, Regulation (EU) 2019/933 of 20 May 2019 concerning SPC came into force. It is also referred as “the SPC manufacturing waiver” Regulation and was published in the Official Journal of the EU on 11 June 2019. Similarly, Canada also introduced Certificate of Supplementary Protection (CSP) Regulations on 21 September 2017. It is governed by provisions in the Canadian Patent Act and the CSP Regulations. These developments would have impact on global pharmaceutical industry including United States of America (US). US being the largest pharmaceutical market, policy making in US has direct and indirect impact on global pharmaceutical industry. Thus, it is important to study SPC or CSP manufacturing waiver in light of the developments in the USA. On 30 October 2019, United States Food and Drug Administration (USFDA) released a report on Drug Shortages. Apart from identifying root causes for drug shortages, the Report also recommended enduring solutions to maintain or enhance the quality of medicines and manufacturing facilities.This research work compares EU and Canadian SPC/CSP manufacturing waiver developments with each other. In-depth analysis of the impact of these SPC/CSP manufacturing waivers on competition amongst pharmaceutical companies, economic impact on patients and pharmaceutical companies, swifter access to generic medicines, rise of new generic companies has been carried out. The impact of suggestion from USFDA to create a rating system for manufacturing facilities in light of these SPC/CSP manufacturing waiver is also studied. It was observed that there are few important differences between these manufacturing waivers of EU and Canada. These waivers would have an impact on the manufacturing facilities of pharmaceutical product. It could change the manufacturing clusters like China and India, which exists today and would increase the competition amongst the pharmaceutical manufactures.It is likely to help reduce the cost of generic medicines especially in USA and EU region.

Original languageEnglish
Pages (from-to)37-54
Number of pages18
JournalNTUT Journal of Intellectual Property Law and Management
Issue number2
Publication statusPublished - 2020

All Science Journal Classification (ASJC) codes

  • Business and International Management
  • Strategy and Management
  • Law


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