If India wants to break patents in order to make drugs available to low income citizens that's one thing (in this case Gilead was already offering a cheap generic), to say the patent on Sovaldi is not innovative is a bit ridiulous.
"India believes that the patent standards are so low that companies can get patents for inventions very easily," Amin said in an interview. The patent office's examiner ruled Gilead's patent claim "lacks novelty and inventive step," as Bloomberg News noted, and also doesn't demonstrate it's significantly more effective than already known compounds. Amin explains that the controller general's decision holds that "there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for."
But Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug." Gilead didn't offer comment on Wednesday.
So it's not like the drug maker was necessarily whacked by some rogue judge issuing a weird decision out of the blue. It may very well be that Gilead was taking a known risk at the hands of the Indian patent system.
Does Sovaldi satisfy India's standards for novelty? I don't know. I've had a patent application struck down over novelty, so I know it's not a happy day when it happens.
But it is not the activity (which describes, essentially, most research) being patented, it is the result of that activity. If the search space is very large, that is actually an indication of the non-obviousness of a solution that works in practice. Drug discovery certainly meets that criteria.
This could be a case of a bad decision in India, of course, but it also could be one where the patent examiners in US and Europe were more lenient than they should of been.
(Disclaimer: I helped work on equipment designed to assist in this kind of chemical searching).