Supplementary protection certificate extends the patent term by up to five and a half years – but who’s entitled?

For 25 years now, it has been possible in Finland to extend the term of a pharmaceutical or plant production patent by filing for a supplementary protection certificate, SPC. The patent term can be extended by a maximum of 5 years, up to 25 years altogether.

This option is available to compensate for the time lost by patent owners in the lengthy authorization procedure, which is required in order to obtain a marketing approval for a pharmaceutical or a plant protection product. Without the extension, owners could be left with a very short time to actually use their patented pharmaceutical or plant protection invention.

The patent owner is entitled to the maximum supplementary protection of five years if it takes 10 years to get a marketing approval for the product, counted from the filing date of the patent application. It’s also possible to request additional extension by six months, provided that the SPC relates to a medicinal product for children, and the product has been tested according to an approved test plan.

The world’s best-selling medicine was protected by an SPC

One example of an SPC-protected product is adalimumab, a biologic medicine and the active substance in a drug named Humira. Humira is used for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, psoriathic arthritis, psoriasis, Crohn’s disease and ulcerative colitis. In 2017, Humira’s sales in Finland were 44 million euros, making it Finland’s best-selling drug in euros. It was also the world’s best-selling drug in 2017, with sales exceeding 18.4 billion dollars.

In many of the EU countries, the term of Humira’s supplementary protection certificates came to an end in October 2018 (in Finland on 16 October 2018), clearing the way for competitors to enter the market. Without SPC protection in Europe, it has now been estimated that Humira’s sales will drop by 15% a year until 2020.

Who can apply for patent term extension?

The supplementary protection certificate is available for patent owners. Currently the Finnish Patent and Registration Office, PRH, receives around 60 to 70 SPC applications per year; for example, in 2018 the PRH had recorded 34 SPC filings by mid-October. The filers are mostly foreign pharmaceutical companies.

In 2015 the number of SPC applications filed within the EU was about 1 880. In 2006-2015 the top filers within the EU were Novartis (950 applications, 8.2%), MSD (4.7%), GSK (4.2%), Boehringer (3.7), Bayer Group and Janssen (2.8%) and Sanofi (2.7%). (Source: Alice de Pastors, Latest News on Medicinal Product SPCs in Europe, 29th Alice de Pastors’ SPC News, October 2016.)

The supplementary protection certificate is granted if the following conditions apply at the filing date of the application:

• the product is protected by a patent in force in Finland,
• the product has been approved to be marketed in Finland as a pharmaceutical or plant protection product (it has a marketing authorization); the certificate will be granted based on the first marketing authorization of the product,
• the product has not already been granted a certificate in Finland.

European Court of Justice gives preliminary rulings on SPCs

The SPC practice is guided by preliminary rulings. These rulings are issued by the European Court of Justice in response to questions presented to the Court on how to interpret the SPC regulations within the community.

As many drugs today are actually combinations of active ingredients, this is one of the questions frequently referred to the Court for a preliminary ruling. While certain basic principles have been established, some issues still remain open. In the most recent case (Truvada, C-121/17), the Court ruled that if a combination product is not expressly mentioned in the claims of the basic patent, the claims must necessarily and specifically relate to the combination in order for the owner to get an SPC. According to the ruling, a combination product must meet the following criteria to be protected by an SPC:

• the combination of active ingredients must necessarily fall under the invention covered by the patent, in the light of the description and drawings of the patent, and
• each of the active ingredients must be specifically identifiable in the light of all information disclosed by the patent.

The ruling seems to limit the possibilities to get an SPC for a combination product, unless the combination is expressly mentioned in the patent.

The PRH considers these preliminary rulings before granting the supplementary protection certificate.

Now the SPC manufacturing waiver is stirring up debate – what is it?

One of today’s hot topics is the ”SPC manufacturing waiver”, published by the European Commission on 28 May 2018. The waiver would permit producers of generic or biosimilar medicines to manufacture SPC-protected products in the EU, for instance in order to export the products to third countries where they are not protected by an SPC. We see this as reducing the intellectual property rights of SPC holders.

The proposed amendment to the SPC Regulation (EC) No 469/2009 could take effect midway through 2019. The current proposal would only apply to the SPCs granted after the amendment enters into force, so any SPCs granted before the amendment would be unaffected.

As a result, SPC applicants have started filing requests for expedited processing of their applications. The PRH has, however, responded by announcing that the process cannot be expedited on this basis, as this would apply to all pending applications. The applications will be processed in the order received, but in any case taken up at least two years before the basic patent expires.

Right now, the time it takes for the PRH to process new SPC applications is about 4 years. We would welcome more resources into the handling of these applications to reduce the longish time lag.

Papula-Nevinpat’s specialists can help your organization on all pharmaceutical patent matters – our expertise in chemistry and biotechnology is first-rate! We have represented our clients in several pharmaceutical disputes. We were also in charge of prosecuting the SPC application for Humira in Finland.