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Friday, 17 October 2008

Levofloxacin SPC valid

Not every day does a case involving supplementary protection certificates come along. For the unitiated, supplementary protection certificates (or "SPCs" as they are lovingly called by their ardent admirers) are means by which patents for many pharmaceutical and plant protection patents can be extended for up to five years, to make up for the fact that so much marketing time is lost to patent owners when products made under those patents are rigorously tested for efficacy and side effects.

Right: SPC -- meet the Samurai Pizza Cats

For this reason SPCs aren't just issued willy-nilly -- they're not granted unless they are based on an actual product covered by the patent and for which a market authorisation has been granted. The Patents Court for England and Wales had an SPC case this week: Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and another [2008] EWHC 2413 (Pat), a ruling on Wednesday by Mr Justice Kitchin.

Daiichi owned a patent and a supplementary protection certificate for the (-) enantiomer of ofloxacin, a racemic compound. Ofloxacin belonged to the quinolone class of anti-microbial agents and its (-) enantiomer of ofloxacin was called levofloxacin. The patent itself, which claimed priority from three Japanese filings, was filed on 20 June 1986 and granted on 27 January 1993. UK marketing authorisations were granted in respect of levofloxacin on 6 June 1997.

On 23 October 1997 Daiichi applied for the SPC, identifying (i) the basic patent, (ii) levofloxacin as the product and (iii) the UK marketing authorisations in respect of levofloxacin as the first authorisations to place the product on the market. The SPC was granted on 13 July 1998. After the patent expired on 20 June 2006, the SPC came into force and was due to expire on 19 June 2011. Generics then applied for a declaration of invalidity of (or rectification of the register in respect of) the SPC and a declaration that certain claims of the patent were invalid.

According to Generics the SPC was invalid under Article 15 of Council Regulation 1768/92 on the creation of SPCs for medicinal products because the patent either should have been revoked or should have been limited so that levofloxacin would no longer be covered by its claims; also, Generics felt that Daiichi had already got its extension when it got an SPC for ofloxacin.

Kitchin J refused Generics’ application. In his view

• Since the various assaults on the now-expired patent would all have failed, the challenge to the SPC based upon Article 15 failed too.
• the earlier marketing authorisation for ofloxacin did not also cover levofloxacin.
The IPKat is aware of the immense value of the post-patent market for pharma products and recognizes how every day can yield precious rewards for the patent/SPC holder before its temporal monopoly is lost. That, he says, is why battles over SPCs, though not common, are so keenly fought. Adds Merpel, there are three interests to balance here: that of the investor in original products, that of the other manufacturers in the market and that of consumers. In general the system seems to achieve that balance in that all players are equally aggrieved by it. Originators feel that their protection remains inadequate in relation to the expense and risk of developing new products; competitors feel cheated by monopolies that stretch out beyond the natural life of the patent and consumers consider that long-term protection forces prices up.

What SPC really stands for .... here
For real enthusiasts of Supplementary Protection Certificates, here's The SPC Blog

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