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How India's Patent Office Destroyed Gilead's Global Game Plan

businessweek.com

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Re: How India's Patent Office Destroyed Gilead's Global Game Plan

#5

Post by pkaye »

girishso wrote: post #4
pkaye wrote: post #3

Can people in now go to India on medical tourism and get the treatment much cheaper?

Not only that, I think Indian pharmas can market the drug as generic in USA too. I am not really an expert in legal stuff though.

I feel if companies want to operate globally then consumers so be able operate globally.

Re: How India's Patent Office Destroyed Gilead's Global Game Plan

#6

Post by alricb »

Here's the decision (pdf): http://freepdfhosting.com/985d1c013c.pdf

It relies on section 3(d) of the The Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005) [1]:

> What are not inventions. —The following are not inventions within the meaning of this Act,— (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation. — For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

This is the same section that was opposed to Novartis in 2013 [2]

1: http://www.wipo.int/wipolex/en/text.jsp?file_id=295102

2: http://articles.economictimes.indiatimes.com/2013-04-01/news...

Re: How India's Patent Office Destroyed Gilead's Global Game Plan

#9

Post by chdir »

refurb wrote: post #7

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.

The article explains it better instead of simply saying it's not innovative. It's worth reading these 2 paragraphs:

"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.

Re: How India's Patent Office Destroyed Gilead's Global Game Plan

#10

Post by alricb »

alricb wrote: post #6

Here's the decision (pdf): http://freepdfhosting.com/985d1c013c.pdf It relies on section 3(d) of the The Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005) [1]: > What are not inventions. —The following are not inventions within the meaning of this Act,— (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mer…

Gilead argued that 1) its compound is not a mere "new form" of a substance known in the prior art, and 2) even if it were, it differs significantly since it is less toxic and more active than other similar compounds.

But the Patent Office says that "efficacy" here means therapeutic efficacy, and it would need to be proven by a clinical trial.

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