Introduction
Supplementary protection certificates (SPCs) act as a token for pharmaceutical patents and plant protection products (e.g., insecticides and herbicides) to enjoy supplementary market protection in addition to the standard patent period of 20 years of protection from the date of patent filing. An additional five years of protection is possible on the expiry of the pharmaceutical patent if the patent holder has not enjoyed the protection of at least 15 years due to a delay in regulatory approval for commercial use [i]. In another sense, the minimum number of years of patent protection after regulatory approval, including SPCs, could be 15, where a maximum of 5 years can be granted using SPCs. Moreover, 6 months can be added along with the five years given by SPCs, if an agreed Paediatric Investigation Plan (PIP) is included (Article 36 of Regulation 1901/2006) in the clinical trial studies.
The delay in pharmaceutical product development is due to the involvement of various stages of pre-clinical and clinical studies to ensure the safety and efficacy of medicines before it enters the public market. This process takes an average of 10 years from the 20 years of patent protection, as these studies are normally conducted after the patent application [ii]. This loss of early years from patent protection is overcome using the SPCs.
Evolution of the SPCs in the E.U.
The publication made by the European Federation of Pharmaceutical Industry Associations in 1988 under the title ‘a memorandum on the necessity to restore the effective duration of patents for pharmaceutical products’ initiated the process for SPCs at the E.U level [iii]. The major agenda behind the formation of SPCs was to create uniformity and, thereby, competitiveness in the E.U. compared to the U.S. and Japan’s legal framework. In the U.S., the patent term extension came into effect through ‘the drug price competition and patent term restoration act’ of 1984 (Hatch-Waxman amendment). In Japan, a patent term extension system was enforced through the patent act revision in 1987, which made France and Italy adopt exclusive SPC regulations. Council Regulation (EEC) No 1768/92 of June 1992 regarding SPCs was adopted by the E.U to avoid the multiple standards for SPCs in the E.U and maintain uniformity. It was initially adopted by 9 member countries and later adopted by all the E.U member countries and European Economic Area (EEA) countries Norway and Iceland; currently, more than 20000 SPCs have been granted since 1993. The public health concerns limit the maximum protection to 15 years in the E.U. however, it is one year more than the protection given under the U.S. patent term restoration system, i.e., 5 years/14 years of effective protection. It would have been possibly introduced to increase the value of the E.U market.
Term = Date of 1st Market Authorization in the EEA – Filing date of patent – 5 years |
For example, the patent on dolutegravir, a drug used for treating Human immunodeficiency virus, was filed in 2006 (European Patent Office Application Number 06758843). This medicine got regulatory approval in 2014; hence the patent owner ViiV Healthcare gets only 12 years of market protection till 2026, which could be extended to 2029 by taking advantage of SPCs, and the company is actively trying for the same in many E.U member countries.
Unlike the European patent granted by the European patent organisation under the European patent convention, the SPCs can only be granted by individual member countries of the E.U. according to Regulation (EEC) No 469/2009. Moreover, the application can only be filed within 6 months after the market approval or after the grant of the basic patent (European or national patent by member countries), whichever is later.
The patent office can grant an SPC under Article 3 of the Regulation:
(a) a national or European patent should protect the medicine
(b) a marketing authorisation should have been granted for the medicine in question – either by the national regulatory authority or by the European Medicines Agency
(c) the authorised medicine should not have already been the subject of an SPC; and
(d) the marketing authorisation should be the first to place the medicine on the market.
If the patent or market approval is invalidated, the SPC stands cancelled. The scope of SPC is limited when compared with the patent, such that it covers only products or active ingredients. Moreover, the SPC is not given if the product is a mere new use or a new formulation of an already authorised product (However, the national courts and court of justice of the European Union (CJEU) have diverted from this position in several cases. One such case is the Neurim case [iv]. It has established the possibility of obtaining an SPC for a second medical use indication based on a second medical use patent.). The link of SPCs with market approval and limit of scope confirms the sui generis nature of the SPC.
SPCs have been decided differently in E.U member countries due to the hybrid nature of SPCs-depending on both basic patent and market approval [v]. The case of Truvada, a medicine for HIV treatment comprising a combination of active ingredients tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), is one such case. The patent on tenofovir expired in July 2017. However, the combination mentioned above was granted with SPC in many of the E.U member countries (including France, the United Kingdom (U.K.), Spain and Switzerland.), while others (the Netherlands, Italy and Greece) rejected the same. The major ground for rejecting SPCs was that the Truvada patent claimed only patent expired tenofovir specifically, not FTC, which is only a part of the combination-based product; moreover, it is against the regulation. The SPCs granted by France and Spain were rejected later due to opposition from generic industries. However, in the case of the U.K., the high court judge asked for clarification from the CJEU. In 2018, the CJEU ruled that in the case of SPCs concerning Truvada, the SPCs are used for evergreening of patent protection, contradicting the public health interests [vi]. The regulations do not prevent granting of SPC to a basic patent that claims an already authorised medicine without the permission of the marketing authorization holder. However, this can raise issues when the owner of the basic patent and the marketing authorizing holder differ [vii].
The impact of SPCs on the price of medicines is a hot topic for discussion, and significant studies have been torched to this aspect [viii]. The SPCs delay the entry of generic competitors to the market and block the price-decreasing process and competition for a further maximum of five years. In situations similar to the Truvada case, one can see a huge price difference for the same medicine with SPC and without SPC in different countries (Since July 2017, Truvada has been progressively available in generic forms in European countries without SPCs (e.g., the Netherlands and Greece) but not in others with SPCs in force (e.g., Switzerland)). It shows the impact of SPCs on access to medicine.
General procedure for filing SPC in E.U.
General steps for obtaining SPCs in the E.U include,
- Obtaining basic patent: A ‘basic patent’ (national patent from the European Economic Area (EEA) or European patent) is to be obtained for the product to be applied for SPC.
- Marketing authorisation: A prior marketing authorisation (M.A.) licence is to be obtained to ensure the product has entered the European market. The deadline for filing SPC is within six months from the date of the patent grant or first M.A. licence.
- Legal requirements by nations: In cases where the ‘basic patent’ is national, the requirements may differ. Moreover, the definition of ‘the product’ differs in different countries. Accordingly, prepare and file the SPC application in respective nations within EEA.
- Maintaining annuity payments: The SPCs are subjected to annuity payments which may differ from country to country. Hence the maintenance of annuity payments is important.
The average cost of filing an SPC in the E.U. as of September 2021 ranged from approximately €1,500 to €2,500. However, additional fees for examination and publication may also apply [ix].
The patent term extension in India
In India, the term of patent protection was for 14 years from the patent grant. After signing the TRIPS agreement, which mandated 20 years of minimum protection from the patent filing date, the Indian patent act of 1970 was also amended accordingly. However, there were various attempts to the extension of the patent term in India due to the delay in the grant of patents, which hindered the complete enjoyment of patent protection, and the Delhi high court appointed a committee after the case of Nitto Denko Corporation v UOI and Ors, 2013 to check the possibility of the same. The committee discouraged the proposal as it was unsuitable for the Indian economy and could affect the generic industry, competition and access to medicine [x]. Hence, the quarrel over the patent term extension in India was settled.
Conclusion
One major premise on which the early Council Regulation (EEC) No 1768/92 of SPCs was based on that “The period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research (Recital 4 Regulation 1768/92 Concerning the Creation of a Supplementary Protection Certificate For Medicinal Products [1992] OJ L182/1.).” However, research show that the SPCs are granted without any evidence showing the need of SPC “to cover the investment put into the research.” Instead, SPCs are granted, and monopoly is extended for blockbuster medicines such as Humira till 16 October 2018, which expired its patent in 2017 and earned more than 16 billion U.S. dollars in 2016 alone. This practice is to be relooked, and SPCs are to be granted for relevant products only. Moreover, the need to file SPC applications separately in EEA countries creates a procedural hurdle. However, this is expected to be sorted out soon after enforcing the unitary patent, proposed on 1 June 2023.
[i] Supplementary Protection Certificates in the European Union: Briefing Document, Medicines Law & Policy, June 2019
[ii] Copenhagen Economics, ‘study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe’, European Commission, May 2018 p.182
[iii] Proposal for a COUNCIL REGULATION (EEC) concerning the creation of a supplementary protection certificate for medicinal products, COMMISSION OF THE EUROPEAN COMMUNITIES, COM(90) 101 final – SYN 255 Brussels, 11 April 1990
[iv] Case C-130/11 Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents [2012] E.U.:C:2012:489
[v] Max Planck Institute for Innovation and Competition, ‘Study on the Legal Aspects of Supplementary Protection Certificates in the E.U.’ (European Commission, 2018) <https://ec.europa.eu/docsroom/documents/29524>.
[vi] Pascale Boulet, ‘CJEU Ruling on Truvada recalls “evergreening” goes against public health interests’ (Medicines Law & Policy, 10 September 2018) <https://medicineslawandpolicy.org/2018/09/cjeu-ruling-on-truvada-recallsevergreeninggoes-against-public-health-interests/>.
[vii] Eli Lilly & Co v Genentech, Inc [2019] EWHC 388 (Pat) <https://www.bailii.org/ew/cases/EWHC/Patents/2019/388.html>.
[viii] Yuanqiong Hu, Dimitri Eynikel, Pascale Boulet and Gaelle Krikorian, Supplementary Protection Certificates and Their Impact on Access to Medicines in Europe: Case Studies of Sofosbuvir, Trastuzumab and Imatinib, Published in 2020 by Third World Network, 131 Jalan Macalister, 10400 Penang, Malaysia (www.twn.my)
[ix] Output from ChatGPT, OpenAI to Muhammed Faris V, 08 March 2023. The output was generated in response to the prompt, ‘average cost of filing supplementary protection certificate in Europe’.
[x] Neeti Wilson, Speedy Patent Application Examination at the Indian Patent Office: Impact of Nitto Denko Corporation Case, Journal of Intellectual Property Rights, Vol 20, March 2015, pp 127-130.
Authored by Muhammed Faris V (Intern, BananaIP Counsels)
