On 24 February 2006, the US CAFC handed
down its decision in SmithKline v Apotex.
essence, SmithKline v Apotex provides generic pharmaceutical companies with
another avenue of attack when seeking to invalidate later-filed process
patents in the USA. However, as discussed below, it is unlikely
that this case will change the practice of filing (or litigating) such
patents as there appear to be several clear grounds to distinguish it.
claims to paroxetine in tablet form in SmithKline’s ‘944 patent
were invalidated by the District Court by summary judgment in light of the
earlier broad product claims to paroxetine in tablet form in
SmithKline’s ‘723 patent.
A key point was that the later, product-by-process claims were to the
same product. The CAFC affirmed the
District Court’s ruling.
had attempted to argue before the CAFC that the products claimed in each
patent were not the same. However,
argument was precluded on appeal as this point wasn’t raised in the
obviously left wondering who would have prevailed if SmithKline had been
allowed to argue the ‘different product’ point.
case is unlikely to act as a deterrent to filing such patents, as there are a
number of avenues left open to distinguish (and possibly overrule) this
case. The obvious ones being to firstly argue that the product of the
later patent is different and secondly to argue that novelty requires disclosure
of each and every claim element. The
process-elements being further limitations and therefore novelty-conferring.
side for patentees is that inherent in the Court’s decision is the
finding that product-by-process claims are not limited by the process
elements. Thus, if they can chart the
now-more-difficult waters of validity, then, in the US, the patent confers a much
broader monopoly than in other countries.
case is appealed, then it is quite likely that it will be reversed since, as
pointed out in the dissenting opinion by Judge Newman, the basic rules of
novelty seem to have been ignored.