CAFC creates another invalidity risk for US process patents

Copyright Friday, February 24, 2006 Duncan Bucknell Company

On 24 February 2006, the US CAFC handed down its decision in SmithKline v Apotex.

Take home

In 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.

Facts

The product-by-process 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.

SmithKline 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 appeal brief.

Comment

We are obviously left wondering who would have prevailed if SmithKline had been allowed to argue the ‘different product’ point.

This 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.

The flip 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.

If this 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.