Matrix tablets and scope of protection: a reader asks

One of our readers has a problem for which no information or case law could be found.  The SPC Blog wonders whether any of our other readers might be able to offer some information -- or at least their opinions -- for which our reader would be most grateful.  The problem runs like this:

"The basic patent concerned covers in claim 1 an oral formulation which releases the active ingredient in a specific amount, which may exist in specific embodiments (a) to (g).  (a) is a matrix tablet not specifying the excipients, while (b) to (g) are other forms such as a coated tablet, a pulsatile dosage form etc.

The SPC is based on a matrix tablet. The title reads: "Pharmaceutical formulations comprising (the active ingredient) X"

As far as reported in textbooks and commentaries, the scope of protection of an SPC is that of the basic patent, but restricted to the specific authorized product. This means that, if the basic patent claims a generally defined formula, the SPC is restricted to the specific active ingredient which is present in the authorized product. If the patent claims a use, then the scope of the SPC is restricted to this use of the authorized product. If the patent claims a process for obtaining the active ingredient, the SPC is restricted to the process for obtaining the active ingredient present in the authorized product.

My questions now are:

1: Is the scope of protection of the SPC restricted to the embodiment (a), that is, to a matrix tablet, and are the other embodiments (b) to (g) not covered by the SPC any more?

Or, even more narrowly:

2. Is the scope of protection SPC even restricted to the specific excipients used in the authorized products, and can other excipients be used without infringing the SPC literally? (Equivalency would have to be considered separately)".

If you have any bright ideas or comments, do let us know!

Belgian SPC Case

Last November, the Brussels Court of First Instance handed down a decision on the scope of protection conferred by SPCs. The case relates to a vinorelbine tartrate SPC and whether or not the scope of protection conferred by an SPC extends to the use of an active ingredient as such before it is transformed into a medicinal product.

In the case, the defendant,

O is a company that manufactures vinorelbine ditartrate in Belgium in its raw form for export purposes. The substance produced was sold to a company in the United States, which used it to manufacture and market a medicinal product whose therapeutic indication was identical to that for the drug produced by the exclusive licensee of the vinorelbine ditartrate patent, F.

The patent owner, C, and the exclusive licensee, F, pleaded

on the basis of the legislative history to Regulation 1768/92, that the terms “for any use of the product as a medicinal product ” are solely aimed at excluding from the scope of protection of the SPC such uses as do not fall within the pharmaceutical field. These terms therefore have to be construed in their broad sense as covering any use covered by the marketing authorization where what is ultimately concerned is the manufacture of a medicinal product.

The court followed this argument: the protection conferred by article 4 covers not only any use in a medicinal product (finished product), but also any use of the product covered by the patent (active ingredient) where that is destined for use as a medicinal product. The court briefly stated the reasons for its decision as being that the patented product is essential to manufacture of the medicinal product.

O also argued that the words “use of the product as a medicinal product” necessarily mean that the patented product (active ingredient) must be used as a medicinal product in the territory of Belgium for there to be an infringement, because the scope of the Belgian SPC is limited to that territory. According to that interpretation, there is no infringement in Belgium when all one does is manufacture the active ingredient and export it to the United States where it is transformed into a medicinal product.

C and F argued to the contrary that it is sufficient for there to be infringement that O should have manufactured the active ingredient in Belgium, even if for export purposes. In support of this interpretation, they made reference a contrario to EC Regulation 816/2006 which states that manufacture of an active ingredient protected by an SPC in state A with the sole aim of exporting it to state B with public health problems must be accorded a compulsory license. According to them, this regulation confirms that the patent-holder’s consent is necessary for any manufacture of the active ingredient, even if it is manufactured only for export purposes.

After stating very succinct reasoning on this point as well, the court followed the latter interpretation. It pointed out that the manufacture and offering for sale of a product protected by intellectual property rights are regarded as illicit acts and concluded that, for there to be infringement, it is sufficient for a protected product to be manufactured and sold in Belgium and be used in the manufacture of the medicinal product.

Thanks to Fernand de Visscher and Benjamin Docquir at Simont Braun for providing this information. Note: the decision is not yet published.