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]
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.
FDA trials are only required to compete against a placebo. A drug is accepted if it is safe and more effective than a placebo in a double-blind clinical trial. That's it.
So they have no data to show with, unless they went above and beyond to get it. (Which should teach them a lesson about testing their drugs.)
You don't have to have head-to-head data to claim your drug is superior to existing therapies. Yes, head-to-head data is the best way to show it, but if you have two separate trials, each comparing to a placebo, you can draw conclusions about relative efficacy. It's not perfect, but in the case of Gilead, their drug blows away anything else currently on the market.
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...