Liz Coleman, Divisional Director at the Intellectual Property Office
Welcome to our new regular feature on IP issues in the life sciences. Our aim is to keep you up to date on key IP issues in the sector, identifying new developments or reflecting on recent activities.
While case law drives much of the discussion around developments in life sciences, our first piece will, instead, focus on three topical issues in which the IPO is directly involved: the export waiver for supplementary protection certificates (SPCs); the unitary patent and Unified Patent Court (UPC), and what might happen post-Brexit; and the processing of biotech/pharma searches on patent applications to the IPO.
After extensive debate on health care initiatives under the Dutch Presidency of the EU Council of Ministers, and a stakeholder consultation at European level, the EU Commission published their proposal for an SPC export waiver at the end of May. This would allow EU manufacturers to produce products for export under certain conditions without infringing the relevant SPC.
The proposal appears to have two objectives: first to mitigate competitive disadvantage for EU manufacturers in third countries where the product concerned is not protected; and second to facilitate earlier generic entry to the EU market. This last issue has been a long-standing concern of the EU Commission and was picked up in their pharmaceutical sector enquiry of 2009.
For the proposed system to meet either of these objectives it needs to be workable in practice. This is where national delegations have to take into account the needs of their own administrative processes as well as the requirements of stakeholders. The UK delegation has been participating in Council working groups under the Austrian Presidency to help bring this about. The Commission’s aim will be for the proposal to reach agreement in both the Council and the Parliament before EU elections in 2019.
Meanwhile, returning to a slightly longer-running project, the unitary patent and Unified Patent Court took a step further towards completion with the UK’s ratification on World IP Day, 26 April. This package will set up a single patent court covering multiple European states, with jurisdiction over European patents and the future Unitary Patent, which will be granted by the European Patent Office. The central division of the UPC, which will deal mainly with revocation cases, will be based in Paris with a section in Munich and one for life sciences in London. The UPC Appeal Court will be in Luxembourg.
For the system to come into force Germany’s ratification of the Unified Patent Court Agreement is needed. This is awaiting the outcome of a complaint before the German Federal Constitutional Court. Should that be resolved, the UPC implementation teams will be working during a provisional application phase of several months to make sure that all systems are in place for the Court to open for business. This phase will include the interviewing, recruitment and training of judges as well as the finalisation of the IT tools for the UPC and its users.
While the UPC is not an EU body, the underlying Agreement is based on contracting states being members of the EU. We expect that under the UK-EU withdrawal agreement, currently close to finalisation, the UK will be able to continue to participate in the UPC and the unitary patent system at least until the end of the implementation period set out in that agreement. The future after that will depend on the outcome of European negotiations, but the UK has made clear in the White Paper on the Future Relationship between the UK and the EU published on 12 July that we intend to explore staying in the system after we leave the EU. We will work with other contracting states to ensure that the UPC Agreement can continue on a firm legal basis.
Finally, the UK is one of the 38 states of the European Patent Organisation and regularly participates in meetings of the EPO Administrative Council. We are pleased that the Council agreed in its June meeting that the EPO and the UK could open negotiations on a bilateral cooperation agreement under which the EPO would carry out some searches in the biotech area, where the UK IPO is heavily loaded and currently not able to deliver the timeliness that we want for our customers. This agreement has now been signed and teams on both sides are working to make sure we have a seamless electronic document exchange system in place, meeting the necessary requirements of confidentiality before 18 month publication. Once this is in place, we will be able to start the bilateral cooperation and the first searches under this agreement are likely to be delivered in 2019.