PatentlyO writes on obviousness in Allergan v Sandoz (Fed. Cir. 2013) (see here). The relevant claim is:
A composition comprising about 0.2% timolol by weight and about 0.5% brimonidine by weight as the sole active agents, in a single composition.
The District Court found this to be nonobvious. On appeal the Federal Circuit reversed this finding. Timolol and brimonidine were sold at the claimed concentrations and a prior art reference taught serial administration of the two substances. The District Court focused on unpredictability and reasonable expectation of success and the factors the FDA took into account for approval decisions. The Federal Circuit disagreed with this emphasis.
However a claim which referred to administration twice a day was found to be nonobvious by the Federal Circuit (over administering three times a day) based on the fact there was no loss in efficacy. However there was a dissenting opinion where Judge Dyk felt this was a newly-discovered property of an obvious method.
I found this interesting because it shows the interplay between the prior art, reasonable expectation of success and resultant properties is complex, making obviousness (inventive step) difficult to predict.
This article consists of observations on Life Sci VC’s recent article (see here) on the way that the Venture Capital firm Atlas invest in biotech.
Life Sci VC sets out certain principles that guide how they invest in early stage biotech companies. This article focusses on the fifth principle, using a seed-led model and funding real innovation. It is striking that Life Sci VC focuses on innovation without elucidating in detail what that really means. Instead a description is given of innovation unlocking new areas of biology and providing new modalities and approaches. Life Sci VC is the most informative and sophisticated blogger I have seen on the subject of biotech investing, and so his writing represents the cutting edge of ‘biotech investment theory’ as it were. That means most people in the biotech sector are no appreciative of the need to find real innovation in the companies they invest in.
Life Sci VC’s comments are consistent with my own experience as a patent attorney where little real analysis occurs in choosing the technology to invest in. Of course, research companies will have graphs showing projected sales figures of whatever they are developing, but it rarely gets more sophisticated than that. What we lack is a clear view of where the true breakthrough points of biotech are, i.e. an understanding of which areas need to be stepped into to provide radical new ways of doing things. Once that’s known it needs to filter down to tech transfer departments and the those who form startups.