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05 December 2017
The Supreme Court recently rendered a landmark judgment on second medical use claims – more specifically, Swiss-type claims – which have been the subject of significant legal uncertainty throughout Europe.(1) The Supreme Court determined that indirect infringement of Swiss-type claims is possible and provided standards for direct and indirect infringement.
Merck owned a patent concerning the use of ribavirin for the manufacture of a pharmaceutical composition for treating a specific sub-group (Genotype 1) of Hepatitis C (HCV) patients suffering with chronic hepatitis (ie, a Swiss-type claim). The patent protection for the first medical use of ribavirin (ie, simply put for the larger group of HCV patients) had expired. Since the first medical use was no longer protected, Teva marketed a generic version of ribavirin which contained a carve out (ie, skinny label) concerning its use for the sub-group of HCV patients in relation to which Merck's patent was still in force.
Merck claimed that Teva had infringed its patent right. However, The Hague District Court and The Hague Court of Appeal reasoned that Teva's carve out was sufficient to remain outside the scope of protection afforded to Merck's Swiss-type claim.
In 1984 the European Patent Office approved Swiss-type medical use claims as a way of providing protection to new medical uses of known drugs. Swiss-type claims were formulated as follows: "use of X in the manufacture of a medicament for treating Y". They were used to circumvent the requirement of novelty (as the substance is known) and the prohibition on patenting a method of treatment. However, a change in EU patent law in 2007 (by way of the European Patent Convention (EPC) 2000) prohibited Swiss-type claims, although it alternatively allowed second medical use claims in a less convoluted manner (ie, "substance X for use in treatment of Y").(2)
Although the use of Swiss-type claims is now prohibited, previously obtained patents concerning Swiss-type claims still exist, as they were not retroactively affected by the change in law.
The following kinds of Swiss-type patent exist:
In the Netherlands and throughout Europe, the courts have judged the issue of second medical use patents and more specifically Swiss-type claims differently. This uncertainty is caused by:
The Court of Appeal found the aforementioned distinction (ie, a classic second medical use indication versus a sub-group indication) to be of great importance. It held that compared with a classic second medical use indication, in the case of a sub-group indication, a situation could arise in which the product is used for a sub-group that is part of the larger group in which the substance has already been applied. Compared with a second-medical use patent, this would not necessarily mean that someone other than the patent owner could reap the benefits of the patented invention.
According to the Court of Appeal, in order to profit from a sub-group indication patent, a substance must have been used specifically for that sub-group. Consequently, according to the court, the scope of protection of a sub-group indication patent is limited to situations in which a third party specifically indicates that the substance is meant for the sub-group. The court held that if it is not indicated that the substance is meant for the sub-group's use, no indirect or direct patent infringement can occur, regardless of whether pharmacists or doctors prescribe, sell or deliver the product for the patented use to the sub-group further down the supply chain.
However, the Supreme Court held that under the EPC framework, there is no room for an abstract, categorical distinction between the two types of second medical use indication, as made by the Court of Appeal.
Instead, the Supreme Court provided the following standard for direct infringement of Swiss-type claims, which applies to both classic second medical use indications and sub-group indications:
"A producer or trader only directly infringes a Swiss type claim patent if he foresees or should foresee that the generic drug produced or offered by him will consciously be used for the treatment on which the patent reads. For that it is required that the average man skilled in the art will, on the basis of the Summary of Product Characteristics (SmPC) or label, or other circumstances of the case, assume that the drug is (also) intended or suitable for that treatment. The producer or trader will then have to take all effective measures that can reasonably be requested from him, to avoid that his product will be provided for the patented second medical indication. Only having a carve out in the SmPC and label of the generic drug – like in the case at hand- is generally not sufficient to exclude direct infringement." (Paragraph 3.4.4.)
Article 73 of the Patent Act 1995 defines 'indirect patent infringement' as follows:
"The patentee may institute the claims at his disposal for enforcing his patent against any person who… supplies or delivers in or for his business, means relating to an essential part of the invention to others than those who by virtue of Articles… are authorised to work the patented invention… if that person knows, or if that it is evident considering the circumstances, that those means are suitable and intended for that application."
Swiss-type claims are considered to be process claims (ie, concerning the manufacture of a medicament) and are therefore referred to as 'purpose limited process claims'. As such, it is possible to advocate that – according to a literal reading – such claims do not allow for indirect infringement. Along the lines of this reasoning, The Hague District Court ruled in Novartis v Sun(3) that there could be no indirect infringement as no preparation (manufacturing) occurred downstream after the generic producer had delivered the product.
However, the Supreme Court considered that indirect infringement is possible, holding as follows:
"Against the background of the reason behind accepting Swiss type claim patents, as well as in light of the possibility, introduced with the 2000 revision of the EPC, to use a product based substance or composition claim in order to protect a second medical indication, the reasonable protection of the patent holder prescribed by Art 1 of the Protocol justifies accepting that one can indirectly infringe a Swiss type claim in the same way it can be done on a claim according to Art 54 par 5 EPC." (Paragraph 3.6.3.)
"In case of a product based substance or composition claim, the use given to the product (drug) is an 'essential element of the invention' as referred to in art 73 DPA." (Paragraph 3.6.4.)
As such, the Supreme Court applied the following standard for indirect infringement of Swiss-type claims:
"The producer of a generic drug can indirectly infringe a Swiss type claim patent that reads on a second medical indication, which is the case if he offers or delivers the generic drug to people who have no license to apply the patented invention, while he knows, or it should be obvious to him given the circumstances of the case, that the drug is suitable for and will be used for the patented second medical indication." (Paragraph 3.6.4.)
According to the Supreme Court, it is irrelevant that, in doing so, a producer could infringe a patent both directly and indirectly.
The Supreme Court proceeded to clarify its earlier judgment in Senseo concerning the interpretation and identification of 'means relating to an essential part of the invention', as stipulated in Article 73 of the Patent Act.
The court did so by clarifying that not only elements of a claim or elements of the characterising part of a claim can constitute 'means relating to an essential element of an invention'. Such determination requires construction of the patent at hand and is strongly connected with a factual assessment. A solid definition of 'means relating to an essential element of an invention' cannot be found in national or international case law or literature. However, the Supreme Court concurred with German Federal Court of Justice case law from May 4 2004 which held that the 'means' should contribute to the "concept of the invention" (ie, "that on which the invention is based") and should contribute to realising the teachings of the patent. In making an assessment, the court should also take into account the ratio of indirect infringement in order to prohibit third parties from directly using the invention unlawfully through the supply of unpatented means.
The Supreme Court's judgment provides welcome clarification on Swiss-type claims with regard to the possibility of indirect infringement and the standards for direct and indirect infringement.
Notably, the Supreme Court – in relation to indirect infringement – appears to have remained silent on the possibility of a generic producer avoiding liability or infringement by taking all of the effective measures that could reasonably be requested of it. However, in its earlier decision in Novartis (concerning a classic Swiss-type claim), the Supreme Court found that the Court of Appeal had correctly assessed that insufficient measures had been taken in order to avoid indirect infringement.(4)
Hence, it appears that in cases of indirect infringement, a generic producer can avoid liability or infringement by taking all of the effective measures that could reasonably be requested of it. The Supreme Court may consider that the question of foreseeability will be influenced where such measures have been taken.
However, questions remain as to what constitutes foreseeability and what foreseeable measures a generic producer can reasonably be requested to take in order to avoid its product being used for the patented second medical indication. As this case has been referred back to the Court of Appeal, it will be interesting to see what measures are considered sufficient to prevent indirect infringement.
The measures required will depend on the exact circumstances of the case, but the following relevant circumstances and measures can be identified from existing case law:
For further information on this topic please contact Bram Woltering or Peter Claassen at AKD by telephone (+31 88 253 50 00) or email (firstname.lastname@example.org or email@example.com). The AKD website can be accessed at www.akd.nl.
(4) Supreme Court, April 14 2017, ECLI:NL:HR:2017:692 (Novartis v Sun). However, in this case, the Supreme Court did not, in essence, have to determine whether indirect infringement was possible in the first place.
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