Mirror, mirror on the wall, what is the first marketing authorization for this enantiomer?

In the recently handed-down judgment of Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and another [2008] EWHC 2413 (Pat), Kitchin J has provided an insight on, among other things, how the UK courts deal with the issue of whether the marketing authorization for a racemic product counts as the first marketing authorization as required by Article 3(d) of the SPC Regulation.

In this case, Daiichi Pharmaceutical Co Ltd were the proprietors of European Patent (UK) No. 0206283 and supplementary protection certificate no. SPC/GB97/085. The patent related to the anti-microbial compound levofloxacin, which is the (-) enantiomer of a racemic compound called ofloxacin. The patent for levofloxacin was granted on 27 January 1993. The UK marketing authorization for ofloxacin was granted on 16 March 1990, whereas the marketing authorization for levofloxacin was granted on 6 June 1997.

Generics (UK) sought a declaration of invalidity of (or rectification of the register in respect of) the SPC based on the argument that the UK marketing authorization which were relied upon in support of the application of the SPC were not the first authorizations to place the product on the market as a medicinal product.

Kitchin J disagreed:

• ofloxacin was a recognized anti-microbial agent, known to comprise two enantiomers but, until the EP No. 0206283, the characteristics of the individual enantiomers were not yet known;


• ofloxacin was recognized to be the active ingredient of the medicinal product for which authorizations were sought and granted in 1990. The authorization was to place ofloxacin on the market and not levofloxacin and
  it was known that ofloxacin, levofloxacin and R(+) enantiomer have different properties.

It followed that an authorization to place ofloxacin on the market as a medicinal product cannot be considered as an authorization to place levofloxacin on the market as a medicinal product. Accordingly, the first marketing authorization of levofloxacin was in 1997 and the SPC does fulfill the requirements of Article 3(d) of the SPC Regulation.

Reading this case reminded The SPC Blog of the German Patent Court's rejection in the Fusilade case of the argument raised by the applicant that a racemate and an enantiomer should be considered as separate products for SPC application because they have separate marketing approval. The Court however held that an SPC for an individual enantiomer could potentially be granted if it were the subject of a patent in which it was specifically claimed.

The French Patent Office cooks up controversy

The SPC Blog has obtained information from a source in France about several ongoing cases before the Cour d'Appel de Paris regarding appeals to decisions by the Institut National de la Propriété Intellectuelle (INPI - the French Intellectual Property Office) rejecting SPC applications based on "the same previously market authorised product":

The French PTO appears to have taken a very unhelpful and certainly
"technically unaware" stance, and are applying the ECJ decisions of Yissum,
etc, with gusto.

In essence the cases revolve around the distinction between what was marketed
as essentially a sort of "primordial soup", for example, a mix of enzymes or
cell extract where one enzyme is predominant although others present in the soup
influence its activity (this is not the subject-matter of the cases involved),
and the later and subsequently patented isolation of one particular active
substance over all the others which was found to have an enhanced desired
pharmaceutical effect and was stabler in the absence of all the junk that
hindered it previously. Unfortunately, the name of the "primordal soup" product
as previously authorised for marketing happens to be the same as the specific
name of the isolated substance, and so the INPI has refused the SPC applications
on the grounds that it is the "same product".

It should be interesting to see what the French courts make of it providing
the cases go all the way to trial, especially since there are political
ramifications involved, i.e. one or more state run/owned/shared entities have a
financial stake in the matter.