The German Federal Patent Court requested that the Court of Justice of the European Union (the Court) provide a ruling as to whether a Supplementary Protection Certificate (SPC) may be granted if it would not result in a “positive” term, because marketing authorization (APM) for a drug had been obtained within five years of the filing of the corresponding patent application. The question was referred in the context of the availability of a six-month extension to an SPC under Article 36 of European Council Regulation 1901/2006 (the Paediatric Regulation). The Court’s Advocate General concluded1 that the six-month exclusivity extension conferred by the Paediatric Regulation was not predicated on the APM being obtained at least five years after the filing of the patent application covering the drug. The Advocate General also concluded that an SPC could indeed have a “negative” period from which the starting date of the extension would be determined.
In Europe the SPC regime is intended to encourage innovation in the pharmaceutical industry. It can often take many years for a new drug to obtain APM, thereby shortening the period of exclusivity provided by a patent and potentially discouraging companies from continuing to invest in research and development. Therefore, implementation in the early 1990s of European Council Regulation 1768/92 (SPC Regulation) meant that businesses were able to apply for an SPC to extend the period of protection for a patented medicinal product to compensate for delays in commercializing the product arising from the need to obtain APM. An SPC is a national right and separate applications must be made in each European territory.
In most countries, the term of a patent is generally 20 years from the date on which the application for the patent is filed. The SPC has a duration equal to the period between:
- the date of filing of the application for the patent upon which the SPC is based; and
- the date of the first authorization to place the product on the market in the Community, minus 5 years. SPCs take effect at the end of the term of the patent and have a maximum duration of 5 years.
The total combined period of market exclusivity provided by the basic patent and the SPC cannot normally exceed 15 years. To further encourage investment in drugs of benefit to the paediatric population, which can take even longer to come to market with their APM, the EU enacted the Paediatric Regulation, which enables companies to obtain an additional six months of protection with the SPC. The maximum combined protection would therefore be 15.5 years.
If, however, a patent was applied for on 1 January 2000, for example, and APM was granted on 1 September 2004, the SPC would effectively have a term of minus four months. Prior to the Paediatric Regulation, there was no point in applying for an SPC with a negative term; as that Regulation affords an additional six months of SPC duration, however, pharmaceutical companies have been keen to exploit the extra protection it provides – in the above case, two months of unfettered supply to customers. Given that the market for a particular drug can be worth hundreds of millions of Euros annually, this apparently short period is nevertheless significant.
In the case prompting the referral to the Court, Merck Sharp & Dohme Corp., formerly known as Merck & Co., filed a patent application for a drug in July 2002. It obtained the APM in March 2007 and applied for an SPC in September 2007, but this was rejected by the German Patent and Trade Mark Office (DPMA) in July 2008 as such an SPC – which would have a negative term – could not be granted.
Merck appealed the decision to the German Federal Patent Court on the basis that it was implementing a paediatric investigation for the drug and should, accordingly, benefit from the six-month extension to its exclusivity period under the Paediatric Regulation. As this would be an extension to the duration of the SPC, Merck argued that it should be granted an SPC even if it were for a zero or negative period. Merck further argued that the six-month extension should run from either March or July 2022; that is, either 15 years from the date on which APM was obtained for the drug or from the date on which the patent would expire, respectively.
The German Federal Patent Court requested a ruling from the Court as to whether, following the adoption of the Paediatric Regulation, it could issue an SPC of either zero or negative duration. It noted that the applicable Regulations did not explicitly provide for such an SPC and that Merck had, nonetheless, obtained one in several other EU Member States (including the UK and the Netherlands).
The Advocate General considered whether the grant of an SPC of positive duration was a prerequisite to the additional six-month exclusivity extension under the Paediatric Regulation.
Advocate General’s Opinion
It is in this context that the Advocate General, an advisor to the Court, considered whether the grant of an SPC of positive duration was a prerequisite to the additional six-month exclusivity extension under the Paediatric Regulation.
In his Opinion, the Advocate General explained that the German Federal Patent Court had referred to Regulation 469/2009, which entered into force later than July 2008 (i.e., after the date of the decision subject to the appeal). Accordingly, the relevant text was that of the SPC Regulation. The Advocate General noted that several EU Member States and the EU Commission had submitted comments to the Court which were opposed to the grant of a negative or zero duration SPC, arguing, among other things, that an SPC had to have a positive duration.
The Advocate General rejected the arguments, reasoning that:
Under the system arising from the SPC Regulation and the Paediatric Regulation, an SPC could be granted even if less than five years had elapsed between the patent application and the APM as:
- The issue of whether an SPC of a positive duration was a prerequisite to obtain the six-month extension period was not clearly dealt with by the SPC Regulation or the Paediatric Regulation. As a result, the answer must be found by analyzing the system and the objectives of the two Regulations;
- The duration of the SPC was not one of the conditions for the six-month extension under Articles 7 and 8 of the Paediatric Regulation;
- The duration of the SPC was mentioned in Article 13 of the SPC Regulation, i.e., after Article 10, which describes how an SPC is granted or an application rejected. It was, therefore, not a condition for obtaining an SPC;
- Article 36 of the Paediatric Regulation simply describes how the SPC and the six-month extension work together when both are granted; and
- An SPC with a negative duration was not originally envisaged, as the aim of the SPC was solely the extension of a patent's exclusivity period. With the Paediatric Regulation, the use of the SPC expanded.
The objectives of the SPC Regulation and the Paediatric Regulation clearly justify the granting of a SPC even if less than five years have elapsed between the patent application and the APM as:
- The SPC Regulation is intended to provide a monopoly of up to 15 years to the holder of a drug patent starting from the drug’s APM;
- The Paediatric Regulation compensated – with a six-month extension of the monopoly – for the extra costs and constraints borne by the holder of a drug patent in implementing a paediatric investigation plan for the drug; and
- The combined objectives of the regulations were to offer a maximum protection of 15 years and six months to the holder of a drug patent when the drug’s APM had been granted more than five years after the application for the patent.
The arguments of the opposing parties were contrary to the objectives of the two Regulations as:
- It would have been disproportionate either to grant or not to grant the six-month extension on the basis that it took approximately five years to obtain the APM; and
- The financial impact of obtaining the APM less than five years after the patent application could lead patent owners to delay the date at which they obtained their APM, contrary to the principle of public health protection, which requires a drug to be made available to patients as early as possible.
Although the referring German tribunal did not ask the Court to rule on it, the Advocate General gave his view as to the date on which the six-month “paediatric extension” to the SPC under the Paediatric Regulation should start. He stated that the maximum period of marketing exclusivity offered by the two Regulations should be 15 years and six months. On this basis, the extra six months is to be added to the negative term SPC (i.e., the commencement date of the extension is calculated by deducting from the expiry date of the patent the SPC term). In the Merck case, the SPC term was determined to be minus three months, 14 days, so that the addition of the paediatric extension would provide a protection period of two months and 16 days beyond the expiry date of the patent.
The Advocate General followed a purposive approach in his interpretation of how the Paediatric Regulation fits into the existing system of the SPC Regulation for both the availability of the extension and its starting date. He appears to have taken account of the importance of patent protection to the pharmaceutical industry and the need to encourage more investment in paediatric drugs, which were the original objectives of the Regulations. Of course, the suppliers of competing generic drugs will take a different view, as every extra day that they are restricted from entering the market is of detriment to their business. The beneficial effect of the Advocate General’s interpretation applies to all cases where the APM is obtained between four years and six months and five years after the filing of the corresponding patent application. It will be interesting to see whether the Court follows the Advocate General's Opinion – it does so more often than not. It has been speculated that the Court will go further and decide that the six-month SPC extension is to run from expiry of the patent. In any event, that the Court will, for the first time, have the opportunity to address the mismatched approach currently taken throughout the EU to additional protection under the Paediatric Regulation is to be welcomed