Arachnova: The Patent Problem with Re-Indication Strategies
Dynogen and Arachnova both independently thought up a new indication for an unapproved but soon-to-genericize Mitsubishi anti-depressant. They both filed use patents, then both licensed the same preclinical data from Mitsubishi. Suddenly revealed to each other, they're now arguing over who owns the IP--a sobering message for the increasing number of companies pursuing re-indication strategies.
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Two recent examples of the difficulties of drug repurposing: Bionaut's ability to find new indications was not sufficient to get a foot in pharma's door without novelty to create barriers to entry to deter fast followers. Sention couldn't generate data fast enough on its L-amphetamine in improving cognitive impairment to counter amphetamine's bad image. (Its second program, even armed with pharma-vetted, baggage-less NCEs in-licensed from Merck, emerged too late to save the company.)
Discovery research is an ever more difficult investment to justify, so companies are placing greater emphasis on mining discoveries that have already been made but whose real value remains unexploited. Big Pharma, in part inhibited by habit and current infrastructure, has not moved aggressively in the new direction-but the jumpstart model now dominates small-company strategies and will increasingly translate into the rest of the industry.
A handful of European biotechnology companies is embracing development shortcuts that were once the exclusive provenance of specialty pharmaceutical firms. Shedding traditional biotech start-up discovery models, these firms aim to identify, reformulate and incrementally improve existing products. The hope is that low risk needn't be low reward; in the process these so-called reprofilers of existing therapies may indeed spark an increase in industry productivity. The trick, observers say, is finding and getting their hands on the right products.