The Trans-Pacific Partnership (TPP) trade deal may have been signed by 12 nations, but one man stands in its way.

Key points: Orrin Hatch will not support deal until changes are made to patents

Orrin Hatch will not support deal until changes are made to patents Senator Hatch demands a 12-year data exclusivity, against Australia's proposed five years

Senator Hatch demands a 12-year data exclusivity, against Australia's proposed five years Says TPP would be difficult to secure while the Obama Administration was "lame duck"

With the rising tide of anti-trading sentiment within the United States, support from pro-traders has become crucial to ensure trading deals, such as the TPP, get passed.

One important pro-trader has been Senator Orrin Hatch, US Senate Finance Committee chairman, who has been holding out on passing the TPP through the US Congress — a make or break proposition for the international trade agreement.

President Barack Obama has been courting the Utah Senator, inviting him to the White House for one-on-one talks to try and gain his support.

But Senator Hatch said he would not budge until changes were made to medicines — especially biologics.

Senator Hatch holds a high-profile position among Republicans and was initially in favour of the trade agreement.

But near the end of 2015, when the TPP agreement was announced by the Obama Administration after nearly six years of negotiations, Mr Hatch criticised the TPP's intellectual property protections for a new class of drugs called biologics.

One of the major issues Senator Hatch said he had with the negotiations was Australia's demand for a five-year data exclusivity, which he said he could not agree with.

"Nobody in the pharmaceutical world, or in the biologics world, could agree with that," he said.

"And they know that if they agreed with something that stupid, that the next thing you know you'd [Australia] turn around and you'd do it to pharmaceuticals.

"I can't blame your [former] ambassador trying to do what he was doing, except for one thing, he knows it's not right and he knows that it would just dry up the business, they wouldn't have the funds to be able to continue."

Australia wants to 'steal US patents'

Senator Hatch accused Australia of wanting to steal the United States' patents, and said he could not blame them for trying.

"We cannot agree to something that would just destroy the biologics industry. In essence what the Australians are saying is 'let us steal your patents,'" he said.

"They want things to come off patent as quickly as they can.

"But there still has to be enough patent term to be able to recoup the approximately $2 billion and 15 years of effort that you have in biologics, and there's no way you can do that in five years."

What are biologics? Biologics are derived from less well-defined biosynthetic pathways

Biologics are derived from less well-defined biosynthetic pathways Use living cells or other materials derived from living organisms

Use living cells or other materials derived from living organisms More expensive to manufacture than small molecules (pharmaceutical agents)

In the negotiations Australia argued for a five-year patent deal and Senator Hatch said he would accept no less than 12.

"That is an agreement with no less than Ted Kennedy, who is as liberal as anyone ever sat in the United States Senate. He was up at the Cape when he sent me his proxy to vote for 12 years.

"So this is not some itty bitty out of the atmosphere pluck in, this is an absolute necessity if you're going to be in this world, if you're going to develop biologics and we have not only the opportunity for treatments, but we have the opportunity of serum for cures."

'Lame duck' period could sink pact

Senator Hatch said it would be difficult to get anywhere with the TPP while the Obama Administration was "lame duck".

Lame duck refers to the period between presidential and congressional elections, and a president is a lame duck after a successor has been elected.

"There's a real question whether the leadership will allow it during the lame duck, and if it isn't done in the lame duck then I think we're going to just start all over," he said.

"And that means negotiate these agreements… I think we're going to have to work on redoing that agreement if we can't get it done in this time.

"I'd like to do it, I think this is one area where the President is correct, except for the data exclusivity, and he's willing to compromise."

Senator Hatch said he had spoken with Mr Obama privately on the issue in the Oval Office and that Mr Obama "knows he has to add the data exclusivity years".

"I don't feel happy about being a thorn in their sides on this, because I would like to see this agreement go though," he said.

"But it's only in the last while that they have now started to talk in reasonable terms. I could see they just figured we'd cave in."