In the life sciences industry, loss of patent term due to delays in obtaining regulatory approval can potentially cost companies millions of dollars. Those in the medical device industry have relied on provisions of the Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act," to recover patent term in the U.S. lost due to delays in regulatory approval. Recent European case law now allows for supplemental patent term for medical device patents in Europe.
In Europe, a Supplementary Protection Certificate (SPC) may extend the term of a patent for up to five years. Until recently, however, medical devices had not been eligible for such extensions, because only medicinal products with market authorization from either the European regulatory authority (EMEA) or the corresponding national authorities were eligible for such a patent term extension. However, recent developments in European case law have now extended the scope of SPCs to medical devices.
The procedure leading up to the grant of an SPC is codified in European Directive 469/2009/EC. In short, within six months of grant of a patent or issuance of market authorization, a patent owner can apply for an SPC. Even though the grant of SPCs is codified at the European level, the national patent offices are responsible for dealing with SPC applications. After an examination by the national patent offices, and if all the requirements have been met, the offices award and publish a certificate for the respective European countries. The SPC automatically takes effect after the lapse of the underlying patent, and the certificate is a property right that can-in many ways-be used like a patent. For example, an infringement action can be initiated by one holding an SPC, in the same way as for a patent. Additionally, an infringer must initiate a nullity action against the SPC in order to get the certificate revoked. Grounds of nullification can be either 1) failure to meet material requirements for obtaining an SPC, or 2) invalidity of the underlying patent.
According to Article 3b of SPC Directive 469/2009/EC, an SPC can only be granted if a valid authorization has been granted in accordance with Directive 2001/83/EC to place the product on the market specifically as a medicinal product. However, Directive 2001/83/EC is only applicable for medicinal products per se, i.e., classic pharmaceuticals. Since medical devices are authorized in Europe according to different directives, the patent office had previously refused SPC applications directed to medical devices.
This practice has now changed, at least in Germany and the Netherlands. The German Federal Patent Court (FPC) recently granted an SPC for an implantable device that contained an active pharmaceutical ingredient as an integral part of the device. In its decision, the FPC overruled the German Patent and Trademark Office (GPTO), which had rejected an SPC for a medical device including Yttrium90 glass microspheres. The GPTO reasoned that the SPC application contravened Article 3(b) of Directive 469/2009/EC, which makes reference solely to classic pharmaceuticals, not to medical devices. Yttrium90 glass microspheres had received marketing approval in accordance with Directive 90/385/EC, which governs the authorization of active implantable medical devices for use in radiotherapy. The FPC held that a lack of authorization under the Medicinal Products Directive 2001/83/EC should not be a bar for obtaining an SPC since the Yttrium90 glass microspheres are subject to the same level of regulatory scrutiny as pharmaceuticals. The FPC decision follows the previous decision of the Dutch Court, which also found that similarities between the level of testing required by the Medicinal Devices Directive and the Medicinal Products Directive allowed the product at issue to qualify for an SPC.
From a pragmatic point of view, the approach adopted by the FPC and the Dutch Court appears fair, in that there appears to be no justification for allowing an SPC on a medicinal product, which is subject to testing in accordance with the Medicinal Products Directive, but not for a product that has undergone similar rigorous testing but is instead classified as a medicinal device. However, the position adopted in the FPC decision is controversial, as the SPC regulation specifically states that an SPC should only be granted if the product has obtained an authorization under the Medicinal Products Directive. Therefore, it remains to be seen how other member states treat this issue. It is also possible that the issue will be resolved by a pending referral to the European Court of Justice (ECJ). In the corresponding British case, the English High Court has referred the case to the ECJ. It is expected that the ECJ will hand down its decision within two to three years.
Despite the legal uncertainties, those in the medical device field should file SPC applications for applicable products whenever possible. The timing window for filing an SPC is very tight-the SPC Directive only allows for an application for an SPC within six months of either the grant of the patent or the issuance of the market authorization, whichever occurs later. Those in the medical devices industry should consider seeking patent term restoration through an SPC in Europe in addition to applying for term restoration under Hatch-Waxman.