The area of Supplementary Protection Certificates (SPCs) is a special one, even for patent professionals. Those involved in this area are aware of both the difficulties and rewards connected with it.
Where are we today?
Swiss SPCs are detailed in our Patent Act which has been in force since May 1 1999. Its aim was to implement the corresponding EU regulation into Swiss law. As a result, the wording of the Swiss act follows the EU regulation, of course without recitals and adapted to the Swiss legal framework.
Today, almost 20 years later, it is surprising to see how differently both have developed. European SPCs are complemented by paediatric extensions, re-cast in codified version and significantly influenced by the ECJ from the outset. Swiss SPCs are safe from the ECJ's direct access, although the principle of autonomous alignment with EU law affects Swiss SPCs. Naturally, Swiss courts have decided many SPC cases and have therefore influenced the area.
Who can apply for an SPC? The patentee. There is no surprise there. The difficulties start when an applicant/owner wants to assign its SPC to another legal entity. This will not work in Switzerland. The patent office is extremely strict, and only allows basic patent and SPC transferred in toto.
On the other hand, the office is quite liberal when it comes to affiliated companies. According to the guidelines, affiliated companies are separate legal entities and thus not the same applicant when requesting an SPC based on the same marketing authorisation (MA), but different basic patents. Applicants who have more than one European patent to choose from may assign the Swiss parts to different legal entities prior to the filing of corresponding SPCs. As long as the basic principle of good faith is observed, this offers an opportunity for obtaining additional SPC protection.
This is a welcome opportunity for applicants, particularly in cases where it is hard to decide which basic patent to use, e.g. due to pending opposition procedures.
A long disputed question is how to ascertain whether a product is protected by a basic patent. Although the legal basis in the EU and CH is almost identical, case law goes in different – if not almost opposite – directions. The European Court of Justice chose the hard way. In its decisions Medeva et seq, it was clarified that the infringement test is not sufficient. This is in sharp contrast to the Swiss approach, where the infringement test is applied. This approach was confirmed in a recent decision by the Swiss Federal Patent Court. The SPC under dispute, as well as the Swiss marketing authorisation, relates to a combination of two active ingredients. The corresponding basic patent only specifies one of them, but also contains a claim to a pharmaceutical composition optionally comprising other active ingredients. The plaintiff took the position that Switzerland should adopt EU principles, as outlined in the ECJ case Medeva, thereby disqualifying the above basic patent as a suitable basis for a combination product. The patent court denied this request. Firstly, as Switzerland is not part of the common EU market, particularly when it comes to pharmaceuticals and secondly, as the ECJ line of decisions is hard to understand while the decision of the highest Swiss court in this respect is simple and clear. Accordingly, the infringement test is to be applied when assessing whether or not a patent covers the product as defined in an SPC request. No further requirements need to be met.
It should be noted that the infringement test not only applies in cases where the number of active ingredients differ between basic patent and SPC (as discussed above), but also applies with respect to claims where the active ingredient itself is not specified (e.g. defined by Markush-formulae or defined functionally).
Applying the infringement test to assess suitability of a basic patent, offers protection under Swiss SPCs, where no European SPC would be available. One may take the view that this favours originators, or even results in unjustified SPCs. At least it is a clear and comprehensible approach and provides legal certainty for both generics and originators.
Scope of protection
The question of whether an allegedly infringing product is within the scope of a Swiss SPC is of utmost importance to all stakeholders. In the context of preliminary measures the patent court had the opportunity to more precisely define the scope of a Swiss SPC. Accordingly, a three-step questionnaire is used. Firstly, does the infringing product fall in the product definition of the SPC? Secondly, is the infringing product a pharmaceutical approved prior to SPC expiry? Thirdly, does the infringing product fall within the scope of the basic patent? Of importance was the first question. In the case in dispute the generic version was a phosphate salt of the active ingredient, while the SPC under dispute specified the corresponding fumarate salt of the same active ingredient. As the generic version relied on the simplified approval mechanism before Swissmedic, it was clear that the salt form did not have an influence on the active ingredient. Correspondingly, both active ingredients are the same for the purposes of the SPC. It was out of the question that the generic product was a pharmaceutical approved prior to SPC expiry (second question) and it was covered by the basic patent (third question). The court emphasised that this decision was not based on discussing principles of equivalence of the basic patent but was based on defining the meaning of product as used in the context of the SPC.
We consider this a relevant decision for applicants of a Swiss SPC. The patent office is very strict when applying for an SPC. Typically, the active ingredient as defined in the MA is the only accepted definition of the product. Applicants are often concerned about the scope such definition confers, specifically regarding derivatives thereof (such as salts, esters) or stereoisomers thereof. The above decision now clarifies that an SPC defined by a specific active ingredient also covers pharmaceutically equivalent versions. Further, the decision confirms that the meaning of product is the same in the context of SPC applications and in the context of scope of SPCs.
Swiss SPCs may be invalidated based on essentially the same reasons as EU SPCs, particularly where conditions for obtaining an SPC were not met, or due to nullity, limitation or premature lapse of the basic patent. A recent decision confirmed that this enumeration is exhaustive. Other reasons, such as false reinstatement of rights are not valid ground for invalidating an SPC.
We consider this a welcome decision. It provides legal certainty to both originators and generics. It is consistent with patent law. As an immediate consequence of this decision, we recommend monitoring third party SPC grants that are relevant to your business, as the SPC grant date triggers the time limit to appeal. Appeals against the decision of the patent office are handled before the Federal Administrative Court. The grounds of appeal are more extensive compared to the grounds of nullity.
The Swiss parliament adopted amendments to the Swiss patent law, which are expected to come into force on January 1 2019. They will bring two major aspects to the Swiss SPC. The act now defines the term active ingredient for the purposes of an SPC and further implements an extension of term, provided paediatric studies are performed and made available to the public.
Definition of active ingredient
In an attempt to clarify the situation, the Swiss legislator decided to define the much-debated term active ingredient. The new patent act will comprise definitions of the term product (as already in place) and of the terms active ingredient and combination of active ingredients (newly implemented with no equivalent in the EU regulations). Accordingly, the active ingredient is a substance of chemical or biological origin belonging to the composition of a medicinal product which has a medicinal effect on the organism. A combination of active ingredients is a combination of several substances, all of which have a medicinal effect on the organism. Although we typically welcome the legislators' aim to provide clear and unambiguous laws, the present wording will raise a number of questions for the future.
A long disputed question is how to ascertain whether a product is protected by a basic patent
Does this definition have a retroactive effect? In a recent decision of the Patent Court, such a question was raised by one party, but explicitly left open in the decision.
A second, and more sophisticated question, will centre around the meaning of the definition provided. As a first example, what is the meaning of a substance of chemical or biological origin? What substance is excluded when including chemical or biological origin? Hopefully not biochemical origin. As a second example, what is a substance having a medicinal effect on the organism? One may argue that enzymes have no effect on the organism, as long as they are not activated. Most probably, it was not the legislators' intent to exclude enzymes from the definition of active ingredients. The same considerations apply to active ingredients supplied in the form of a pro-drug. It would be ridiculous to exclude pharmaceuticals supplied in the form of a pro-drug from the definition of active ingredient. Regarding combination products, it is quite clear that all of them have to qualify as active ingredients. This definition contains in itself the problems of the term active ingredient. For example, the ECJ considered a safener an active ingredient. The core argument the ECJ used was that an active ingredient may act directly or indirectly, both being encompassed by the wording of the regulation.
Little predictive skills are required to envisage litigation centred on these definitions.
Long awaited, and now in sight, are Swiss paediatric extensions. They will come as twins. Firstly, and in line with the EU, an existing SPC may be extended by six months. Secondly, and in addition to the EU, a basic patent may be extended by six months. This second option is only available if no SPC is in place. Extending patents is a welcome option, as there is no reason to reward SPC owners while patentees are ignored. There are many reasons why no SPC is in place but paediatric studies are made, therefore justifying paediatric extensions.
Both types of Swiss paediatric extensions (eSPC and pSPC) are available when case studies in agreement with a Paediatric Investigation Plan (PIP) are performed, the results thereof being made available to the public, and certain time limits are met. It is welcome that the PIP made under the EU regulations is accepted. There is no need for additional studies. A certification issued by Swissmedic that all studies agreed upon in the PIP were completed will suffice.
However, both types of paediatric extensions come with stumbling blocks, hidden in the various timelines to be met. The first one is to request paediatric extensions two years prior to expiry of the corresponding SPC or patent. This timeline is implemented for the sake of legal certainty. It may deprive applicants from obtaining paediatric extensions in cases where the PIP is accepted late. At least, this timeline is easy to monitor by patent practitioners.
The second timeline is much harder to monitor by patent practitioners, as it is typically outside the control of the patent department. The Swiss MA must be filed within six months after the corresponding EU MA was filed. This second time limit was implemented, as the Swiss legislator wanted to ensure that information on paediatrics is available in Switzerland with minimum delay. This time limit requires cooperation between the regulatory department and patent department. Accordingly, to benefit from the Swiss paediatric extension for a given product, the request for a Swiss MA of that product must be filed no later than six months after the first filing of the corresponding EU MA for the same product. This must be proved when requesting the eSPC or pSPC.
As already implied at the beginning, a consistent approach throughout Europe, the European Union and Switzerland, will lead to unexploited opportunities under Swiss Law.
At present, the selection of a suitable basic patent is governed by the principle of the infringement test and affiliated companies are not considered the same applicant. Further, the scope of protection conferred by a Swiss SPC is clearly defined and so are the reasons for nullity. Compared to the situation in Europe, this legal framework appears much more stable and predictable.
In the near future, paediatric extensions will be available. Be aware of the various timelines, and appreciate the additional option of extending not only SPCs but also basic patents.
||Siegfried Grimm obtained his PhD in chemistry from the RWTH Aachen, Germany. After this, he took up a position as a project leader in pharmaceutical development. He then worked as a patent attorney in the pharmaceutical industry. In 2005, he joined E Blum & Co and is now a partner of the firm.|
Siegfried predominantly advises clients in the fields of pharmacy, chemistry, material science, food processing and chemical engineering. He is highly experienced and has filed and prosecuted hundreds of cases to help start-ups, SMEs and multinational entities to secure and defend IP. For many years, he has been involved in SPC matters in Switzerland.