On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU.  The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023.  The Commission intends the new unitary SPC to encourage innovation and promote growth and jobs in the pharmaceutical industry, as well as incentivizing innovators to use the unitary patent system.  The proposal package also contains a draft recast of the basic SPC Regulation governing SPCs granted by national patent offices. 

For the purposes of this blog, we have focused on SPCs for medicinal products, although similar proposals apply with respect to plant protection SPCs.

Background to SPCs and Unitary Patents

The current SPC Regulation (EC) No 469/2009 (“SPC Regulation”) provides patent holders the ability to enjoy additional patent protection with respect to a medicinal product under an SPC for up to five years where there is a delay between the date of filing of the patent and the grant of the marketing authorization (“MA”).  An SPC takes effect at the end of the patent term and remains in force for the period between the date of patent filings and the date that the first MA for the medicinal product covered by such patent was granted, minus five years (and subject to a maximum duration of five years).  However, the period may also subject to a possible six-month extension under the Pediatric Regulation 1901/2006/EC upon the successful completion of an agreed pediatric investigation plan (currently only for non-orphan products).  Patent holders must lodge separate SPC applications with national patent offices in order to obtain SPC protection in each Member State where such protection is available.

The unitary patent is a single, uniform patent right that will have effect in all Member States participating in the unitary patent system, and the corresponding Unified Patent Court (“UPC”) will provide a forum for uniform patent litigation in participating countries.  25 of the 27 EU Member States have agreed to participate in the EU unitary patent scheme, although only 17 to date have signed and ratified the Unified Patent Court Agreement (which establishes the Unified Patent Court (“UPC”) as an international court).

Proposed Unitary SPCs and Combined Application Procedure

Unitary SPC rights will attach to the underlying unitary patent and will therefore take effect in the (currently) 17 Member States that will recognize unitary patents from June 1, 2023.  For medicinal products, unitary SPCs will only be available for products approved via the centralized procedure.  The European Union Intellectual Property Office (“EUIPO”) will be the body responsible for examining and issuing unitary SPCs.  Unitary SPC applicants who receive a negative opinion from the EUIPO will be able to appeal the decision before the Boards of Appeal of the EUIPO, with further appeals possible to the Court of Justice of the European Union.  The EUIPO will also handle third party opposition proceedings and will have jurisdiction to hear revocation actions.

In addition to the new unitary SPC, companies that satisfy the relevant SPC requirements will be able to file a “combined application” to obtain both a unitary SPC and a bundle of national SPCs for any Member States not included under the protection of the corresponding unitary patent.  Double protection by both a unitary SPC and a national SPC in any given Member State is prohibited.

The Commission’s accompanying factsheet states that the new system will provide estimated savings of €137,000 per applicant that receives five-year-long SPC protection in all 27 Member States.  Without a unitary SPC or combined application process, a unitary patent could only be extended through separate national SPC procedures, which can vary between Member States (increasing the administrative burden and costs for innovators).  The new Regulation intends for unitary SPCs to be able to be litigated before the body responsible under national law for the revocation of the corresponding basic patent.  Assuming that the Agreement on a Unified Patent Court (“UPCA”) is updated accordingly, infringements of unitary SPC rights may be handled by the new Unified Patent Court (provided that the Court has relevant jurisdiction over the underlying unitary patent).  

Proposed Updates to the SPC Regulation

Within the proposed recast of the SPC Regulation, the Commission has included some new explanatory language within the recitals of the previous SPC Regulation.  Some of these clarifications appear to specifically address the subject matter of previous EU case law relating to SPCs.  For example, the language in the proposed recitals confirms that an SPC cannot be granted to a patent holder on the basis of an MA held by a third party without such third party’s consent (so called “third party SPCs” or sometimes “hostile SPCs”).  In addition, there is new language regarding the acceptability of having multiple SPCs in connection with a single product, and new explanatory language regarding the SPC protections available for a given product and its therapeutically equivalent derivatives.  Aside from the changes to the Articles of the SPC Regulation, the changes to the recitals will likely impact the interpretation of SPC rights and eligibility requirements by national patent offices and courts in the future.

Conclusion

Overall, the new streamlined approach to obtaining EU-wide SPC protection will likely be welcomed by innovative pharmaceutical companies.  At the same time, generic companies are also likely to welcome the increased transparency that the unitary SPC and combined application procedures promise to bring.  It remains to be seen to what extent the proposed changes to the language of the basic SPC Regulation will affect the scope of rights available under SPCs (and how such rights will be interpreted by national patent offices and courts following such changes).

This blog is based on the wording of the EU’s proposal published on 27 April 2023.  This wording could significantly change during the legislative process.  Our Dublin, Brussels, Frankfurt and London teams will continue to monitor this legislation.  We will be hosting a webinar to discuss the impact of the these recent pharmaceutical legislation proposals on 9 May.  To sign up for the webinar please click here.

Photo of Marie Doyle-Rossi Marie Doyle-Rossi

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics…

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics, biologics, combination products, digital health and personalized medicine.

Marie provides strategic, policy and regulatory advice on biologics, orphans, human tissue and cells, market and data exclusivity, clinical trials, pricing and reimbursement, product life-cycle management, data privacy and compliance issues.

She has developed considerable expertise in GxP, including adverse event reporting, quality systems and manufacturing, supply chains and recalls. She regularly counsels clients on “Brexit” related issues from both a UK, EU and Irish perspective.

Marie also advises on, and performs regulatory due diligence for, corporate/commercial transactions including acquisitions, public offerings and clinical trial agreements.

She is associate co-chair of Covington’s Food, Drug, and Device Rapid Response team during the COVID-19 pandemic.

Photo of Roderick Dirkzwager Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a…

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products, medical devices and consumer products;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.