Dearth of crucial details has led to lack of clarity among Member States.
The law governing patent-term extensions in the EU is in theory harmonized. However, the legislation that seeks to create this harmonized position is surprisingly lacking in detail. This has resulted in divergent positions being taken by different EU Member States.
Even in some circumstances where a substantial consensus has arisen, there remains uncertainty about the legal validity of the position settled on. There are now nine cases pending before EU’s highest court, all seeking greater clarity as to the criteria for obtaining patent term extensions.
With the initial opinions in these cases starting to be published, there is hope that a more definite position will be reached. Nevertheless, detailed consideration is still required to devise an effective strategy for obtaining and maximizing patent term extensions in Europe.
Within the EU and Switzerland, patents for authorized medicinal products may be extended by a Supplementary Protection Certificate (SPC). This can extend the monopoly period by up to five years to compensate for the period of monopoly lost while seeking regulatory approval. It is thus similar to the U.S. patent term extension under Hatch-Waxman system. In Europe, though, an SPC can be obtained for biologics as well as small molecules and, in certain circumstances, medical devices.
Defining the Product
An SPC is granted based on both the award of a market authorization for a medicinal product and the existence of patents that protect that product. The product in this sense means solely the active ingredient(s) of the authorized drug.
However, it is this question of when a patent can be deemed to “protect” the active ingredients that has given rise to some of the greatest uncertainty. The national courts of some EU Member States have taken the view that if the unauthorized use of the active ingredient(s) would infringe the patent, then the patent protects those ingredients (“the infringement test”).
Most Member States, however, have rejected this test in favor of a stricter requirement that requires the patent, or indeed the claims of the patent, specifically cite the active ingredient(s). This can be problematic where, for example, the product is a combination product with multiple active ingredients, as it may well be the case that a patent covers only one of the active ingredients in the combination. In these circumstances, the product (e.g. a multidisease vaccine) will infringe the patent but not the SPC (i.e., not the patent once extended) if the stricter test is adopted.
This issue has been referred to the highest court in the EU, the Court of Justice of the European Union (CJEU). Although the court has yet to rule on this, the Advocate General (AG) has now issued her opinion; the CJEU tends to follow the AG’s opinion in about 80% of cases, and so this is a good guide as to what the court may decide.
In the AG’s opinion, the infringement test should not be used. For a patent to be eligible for patent term extension, the active ingredient(s) should form the subject matter of the patent, according to the rules governing the basic patents (i.e., the national laws of the Member States). Consequently, if the product comprises multiple active ingredients, those multiple actives should “form the subject matter of the basic patents.” What this will mean may, and probably will, vary between Member States but will mean that the combination of actives must have been envisaged in some way in the patent.
The AG also ruled, though, that where a marketing authorization has been granted for a particular combination of active ingredients, it is legitimate when applying for an SPC for a patent covering only one of those actives to then define the product for the purposes of the SPC as only that active which the patent covers.
Consequently, the AG has sought to provide a way for patentees to obtain patent term extensions for multiactive products when the patentees only have a patent relating to one of those actives. Assuming this decision is followed by the CJEU, it will provide a means for new applicants for SPCs to apply their patents for single or a subset of active ingredients to products comprising multiple active ingredients.
This will not help existing applicants, however, whose SPC applications did not define the product in a way that the AG has approved of but which was previously thought to have been potentially unacceptable. It may be possible for these existing applications to be amended, but this will depend upon national laws, again giving the potential for disharmony between the EU Member States. Further, the uncertainty and disharmony will remain, at least for the time being, when trying to decide whether a product forms the subject matter of the patent. It is possible that a number of pending cases may yet add more clarity to this though.
Prior Approval a Concern
The AG’s approval of a more flexible approach to defining the product could be open to manipulation by applicants seeking to obtain multiple extensions to their patents if it were not for the fact that a further requirement for obtaining an SPC is that the marketing authorization for the product must be the first authorization to place that product on the market as a medicinal product.
A series of decided cases have meant that this has been interpreted in a restricted manner so that if a previously authorized product is later approved for an entirely new indication or in combination with an excipient that, although not active itself nevertheless modifies the activity of the active, then this new authorization can still not be the basis of a new SPC.
The extension of this principle has now been referred to the CJEU in relation to a case with somewhat extreme facts. The product for which an SPC was applied for was a treatment for insomnia in humans, but the active had previously been authorized for improving reproductive performance in sheep. The marketing authorizations for the insomnia and sheep reproduction products were entirely separate, with the insomnia product requiring full clinical trials.
Further, there was no overlapping intellectual property. Consequently, the insomnia treatment seems to be exactly the sort of product for which the SPC regime is supposed to provide extended protection for. However, the logical extension of the current legal position would prevent an SPC being granted.
It will be interesting to see the way in which the CJEU rules on this while taking into account earlier cases. However, at least until that ruling, there will be uncertainty as to what constitutes a prior approval when considering SPC applications.
Further Areas of Uncertainty
There are more questions that remain unresolved with regard to how certain transitional provisions of the legislation should be applied as well as how the SPC regulations relate to new laws providing further extensions in return for conducting trials to test the efficacy of medicinal products for the pediatric population.
Divergence between when SPCs can be enforced has also arisen between Member States, with France deciding that an SPC covering an active was infringed by the sale of a product comprising that active in combination with a second active, while on the same facts Belgium ruled there was no infringement.
There is a complex and changing set of interrelated factors that impact how and when an SPC can be obtained. Given the value of these rights, it is important that the hurdles are given full consideration when devising a strategy to maximize both the likelihood of success in obtaining patent term extensions and the value of the rights thereby obtained.
Andrew Sharples ([email protected]), partner at EIP and head of its life sciences group, EIP Life, is a U.K. and European patent attorney and solicitor.