The IPKat posted a nice summary of the Tercica Inc v Avecia Ltd et al. case involving summary judgment motions on the validity of a patent having Swiss-type claims. The action concerned two applications for summary judgment in linked proceedings. In the first, Tercica, a licensee under a Genentech patent for a growth hormone, sued Avecia and Insmed for infringement; in the second, Avecia and Insmed sought revocation of that patent. The patent had a Swiss claim, its essential inventive content being a new use for a known drug.

Tercica’s suit in the UK alleged that by making, using, and selling the SomatoKine(R) product in the United Kingdom for the treatment of Growth Hormone Insensitivity Syndrome (GHIS), Avecia and Insmed infringe a European (UK) patent under which Tercica holds an exclusive license from Genentech. SomatoKine(R) is a complex of insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). Tercica licensed world-wide rights to develop, manufacture and commercialize rhIGF-1 and IGF-1/IGFBP-3 from Genentech.

The High Court of Justice (Chancery Division Patent Court) in London dismissed both sides’ applications for summary judgments. The Court also ordered Insmed and Avecia to pay Tercica’s and Genentech’s legal fees saying:

“What I was asked to consider (among other things) was a concept which Jacob J has called the “artificial construct of a Swiss form claim” (see Merck & Co Inc’s Patents [2003] FSR 498 at para 80), and in particular what is meant by “new use” where part of that new use involves a particular method of administration, and the interface with the method of treatment point. One of the questions which might arise is: just how far can the artificiality be pushed before reality forces its way in? These are not subjects which are particularly happily determined on applications for summary judgment, even when those applications are argued as well and as fully as the one before me was.”

Basically, if a chemical composition or a method of manufacture or use, is already known, then it is not patentable. The therapeutic use of that substance cannot be patented either. This is because that use is a method of treatment of a human or animal body by surgery, therapy or diagnosis which is practiced on that human or animal body and methods of treatment are regarded in Europe as not being capable of industrial application and are consequently not patentable.

However, if an invention relates to a substance or composition which is to be used in a method of treatment of a human or animal body by surgery, therapy or diagnosis practiced on that human or animal body then, even if that substance is known, that knowledge does not prevent the compound from being regarded as new, if the use of that substance or composition in any such method does not form part of the state of the art. In other words, it is possible to patent a known chemical compound as a pharmaceutical provided that it has not been previously known to have any pharmaceutical activity.

This is what is known as the Swiss Claim, adopted by the EPO and the Swiss Patent Office, which has a basic format along the lines of:

“Use of compound X in the manufacture of a medicament for the treatment of disorder Y”.

In the UK, the view is that merely indicating that something is “for” or “suitable for” a new purpose will not give novelty to subject matter which is already known but allowed the Swiss form of claim to be granted in order to achieve conformity with EPO practice.

The Swiss claim is a claim to a manufacturing process and not merely to the taking of the active ingredient and converting it into a special medicament. However, the distinguishing feature of the claim is the use to which that medicament is then put. That new medical use must be entirely new and cannot just be a modification of an existing treatment or a better method for treating the disease, for which the drug is already known to have an effect.

It will be interesting to see how the case law on Swiss claims evolves in both the UK and the EPO.

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