Unified Patent Court / Five things you need to know about litigation in the pharma / biotech area

Five things you need to know about litigation in the pharma / biotech area

1.  Efficient pan-European protection and injunctions
The UPC and the Unitary Patent offer the patentee efficiency benefits on both the portfolio management and enforcement front. The single Unitary Patent provides protection across European member states, without the costly requirements of acquiring separate national patents for all those states. Other significant benefits are apparent on the enforcement front. For the participating member states, the UPC has international jurisdiction for both the new Unitary Patent as well as traditional European patents (if not opted-out, see below). A court decision granting an injunction will automatically apply in all participating member states, bringing an end to the current practice of parallel litigation in Europe and its associated complexity and costs. (See also: Relief and evidence).

2. Central clear-the-way proceedings for generics
The international scope of the decisions of the UPC provides generics manufacturers with an efficient tool to clear the way for an intended launch of a generic pharmaceutical. Rather than having to challenge the patents at issue in all relevant jurisdictions, the generic can simply start a pre-emptive validity attack at the Central Division. Invalidation at this level will open the market in all participating member states. Both Unitary and traditional European patents are at risk, due to the transnational effect of a decision of the UPC. To avoid this vulnerability, the patentee should opt-out (part of) his portfolio of existing and future traditional European patents. For Unitary Patents, that will not be an option.

3. Traditional European patents can be kept out of the scope of the UPC by opting-out
For the pharmaceutical patentee, the benefits of streamlined enforcement are likely to eclipsed by the risk of central invalidation. Not applying for unitary effect of new European patent applications is insufficient to avoid this risk, as the UPC also has international jurisdiction over traditional European patent and can invalidate the bundle of national rights in a single blow. During the transitional period, this risk may be averted by opting out traditional European patents from the jurisdiction of the UPC. In the pharmaceutical industry, where a limited number of patents protect a high value market, opting-out should be seriously considered.

There are various options for strategic patent portfolio management under the new system, such as keeping traditional European patents out of the scope of the UPC, and opting them back in when necessary. It is also possible to build hybrid portfolios, consisting of some traditional European patents that are in and some that are outside of the jurisdiction of the UPC. 

4. Evidence gathering tools
The rules of procedure of the UPC incorporate the procedural practices of various European jurisdictions. Whilst there is no discovery or disclosure, it does provide various other tools for gathering and preserving evidence. These goes beyond the options currently available under the national laws of certain jurisdictions, and opens up possibilities in fields classically fraught with evidentiary problems such as - most notably - process claims and biosimilars cases.

5. Supplementary Protection Certificates
Supplementary Protection Certificates (SPCs) offer an additional term of protection during what is often the most profitable phase in the lifecycle of pharmaceuticals: the final years of maturity. Unfortunately, there is still an area of uncertainty around SPCs for Unitary Patents. It is at present unlikely that there will be a Unitary SPC. It appears that SPCs will remain national rights that may be granted on the basis of a Unitary Patent. To make this possible, amendments are needed to the SPC Regulation. For the patentee, such a mechanism would take away an important benefit of the unitary character, in that it will remain necessary to maintain a bundle of national rights. The uncertainties surrounding this valuable right, and the lack of true unitary character, may well be an additional consideration for opting out (part of) the patent portfolio.