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
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
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
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
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
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
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
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
||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
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.