We live in a world where everything seems to move at tremendous speed, especially when biotechnology is concerned. The top companies active in the pharmaceutical sector are not immune to the expiration of certain Intellectual Property (IP) protections and are always looking for ways to enjoy an additional period of exclusivity for their patents. That is why, to benefit from at least partial compensation for the delay in the commercial exploitation of their inventions, they file requests for supplementary protection certificates (SPCs) in Europe.
When it comes to applying for an SPC, there is no one-size-fits-all plan of action, but we at Dennemeyer present you with our five golden rules for handling these IP rights. Let us have a closer look.
1. Remember your marketing authorization
According to Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council, an SPC shall be granted if a "valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate." As such, there cannot be any request for an SPC without a prior marketing authorization (MA) license to affirm that the medicinal product's effects conform with its marketing. Whether the authorization is granted at a European or national level, it functions as proof that the basic patent has just entered the market and therefore justifies the extension of its effects.
What needs to be emphasized here is from what date the SPC application procedure can be initiated. In case C 471/14 (Seattle Genetics Inc.), the European Court of Justice (CJEU) ruled that "the holder of an SPC is entitled to market his product only from the date on which he is given notification of the decision granting the marketing authorisation in question, not from the date on which that decision was adopted." Since the deadline for filing an SPC application is six months from the notification date of the earliest MA, the clock starts ticking the moment an MA comes into effect. Decision C‑471/14 (Seattle Genetics Inc.) solely concerned Article 13 of the Regulation and only for cases of a European marketing authorization. However, most national patent offices also use this definition of the "day of grant" to calculate the six-month term for filing an SPC application based on national marketing authorizations and European marketing authorizations. Furthermore, the term for filing an SPC application is triggered by the first marketing authorization granted for the product. This means that this term can also be triggered by a marketing authorization granted for the same product to your competitor.
2. Always check national legal requirements
As we discussed in a previous blog post, Article 3(a) of the same European Parliament Regulation states that the product concerned must be protected by a basic patent in force. Therefore, since patents are territorial rights, the list of countries where extended protection is to be sought must be accurate and exhaustive. Hence, it is highly recommended to engage an IP service provider who can assist you with filing SPC requests in a coordinated and efficient manner. Needless to say, such a service provider will have all their IP legal requirements up to date and will be able to save you time and money throughout your SPC application. Moreover, the definition of "product" can differ in the respective member states. Therefore, a careful check of the national handling of this is critical.
3. Monitor and process annuity payments
In some cases, the filing of an SPC application is linked to the annuity payment. Official fees will vary significantly from one country to another, but tracking all deadlines and handling all payments need not be a burden. Neither is it necessary for procedural variances to interfere with a timely and successful SPC application. With professional support, the monitoring of annuities can be integrated into a single, comprehensive service package, as we shall see in the following rule.
4. Manage your portfolio with a professional IP management system
While it is always advisable to have a docketing system and to back up all your files electronically, this is especially true when SPCs are concerned. As dates, deadlines and data accumulate, an excellent option for you to stay on top of it all would be Dennemeyer's IP management software, Diams iQ. This software package - built from the ground up to be a company's one-stop-shop for managing their IP portfolio - allows the easy tracking and fulfilling of payment obligations while communicating directly with Dennemeyer's team of IP experts.
Additionally, you have the option to create various diary phases for your IP rights and seamlessly share IP information between your organization's teams.
5. Ask for advice from experts
Whether you are looking for a cost estimation or a trusted and confident expert to file an SPC application, you need someone who fully understands the product you wish to protect, the procedure to be followed and all the legal requirements of the jurisdictions involved. It is best to work with industry-leading professionals who will ensure that the entire process moves forward without any inconveniences or setbacks.
Our patent attorneys have years of expertise in the chemical, pharmaceutical and biotech sectors, and can bring their formidable knowledge and experience to bear in any IP matter. Find out what we can do to protect your returns on investment.
The authors contribute to this blog in their personal capacity. The views expressed are their own and do not necessarily represent the views of Dennemeyer IP Solutions, Dennemeyer & Associates, or Dennemeyer Consulting.