Without the TPP, any country can infringe US patents without fear of being persecuted. The US is no longer the leader on invention. Just look at their latest and greatest inventions - most are copied from Chinese or European inventions. Most inventors in the US are not born in America but leverage the strong patent laws in US for protection. Without the TPP, the might as well setup shops elsewhere in the word.
If TPP sooo good it would have been approved long ago n trump would endorsed it...n negotiations would not be held in secret.
http://mobile.abc.net.au/news/2015-12-18/trans-pacific-parternship-your-questions-answered/7037500
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Fact file: Your questions on the Trans-Pacific Partnership answered
The full text of the Trans-Pacific Partnership agreement was released by the Government on November 5, 2015 and we asked for your help in analysing it. We received many detailed submissions, on topics ranging from copyright to Swiss cheese.
Updated Mon Oct 10 16:30:08 EST 2016
You told us what you found interesting, what has been under-reported and those issues you feel need further explanation.
We then put the Australian political debate to one side, and sought the views of experts across the world.
Whether you are a farmer, businessman, activist or concerned citizen, ABC Fact Check has consulted experts about your TPP questions.
Check out the topics that you nominated below.
The basics
How and when it starts
Copyright laws
Illegal downloads
Medicines
Climate change
There has been concern that the TPP will require a change to Australian law that may increase the cost of pharmaceutical products.
The Government says that the TPP "will not require any changes to Australia's Pharmaceutical Benefits Scheme and will not increase the price of medicines for Australians".
Developers of new medicines usually obtain a patent that protects their rights in the drug for a certain period.
In Australia, it is usually 20 years but an extension of up to five years can be granted under some circumstances.
Given that a patent can be obtained early in the development process, in some cases the patent may be close to expiry by the time a medicine is approved for sale.
In addition to the patent system, in Australia drug companies are also granted a period of "data exclusivity" of five years from the date of approval for sale.
During this period, the trial data that the government used to approve the drug cannot be used by a generic manufacturer to justify the approval of its product.
Why does data exclusivity matter? According to Gary Cox, chairman of intellectual property law firm Wrays, a data exclusivity period "can theoretically prolong a manufacturer's monopoly beyond the life of the patent if the patent expires before the data exclusivity period" which could delay the introduction of cheaper generic medicines.
However, Mr Cox also notes that with a standard patent term of 20 years, it is "much more likely" that the data exclusivity period will expire before the patent does.
While the TPP provides a data exclusivity period of 5 years for standard pharmaceutical products (consistent with Australian law), the debate is centred around the treatment of "biologics" in the agreement.
A biologic is "a type of highly complex medicine created by biotechnology processes" and a generic version of a biologic medicine is called a "biosimilar".
In the United States, there is a 12-year data exclusivity period for biologics, which is a clear contrast to Australia's five-year period.
Fact Check understands that the United States pushed for the 12-year period to be adopted by all countries.
However, Article 18.52 in the final text instead provides for data exclusivity period for biologics of:
eight years or
five years if accompanied by "other measures" and recognition "that market circumstances also contribute to effective market protection".
Michael Caine, a patent attorney with Davies Collison Cave, tells Fact Check that:
"It is unlikely that Australia [has] to change the existing law. We already comply with the second option of five years plus other measures.
For 'other measures' the Government already compensates patent owners for delays in the drug approval process by extending the patent term when appropriate. This scheme for extending patent terms provides special extension opportunities limited to patents relating to biologics.
The time it takes for a biosimilar (generic) to be approved may also be taken into account when considering how long the market exclusivity period is in practice."
However, some commentators, such as Deborah Gleeson, a lecturer in public health at Latrobe University, suggest that "the legal language provides room for the United States to continue to pressure the other TPP countries" to keep biosimilars off the market for eight years.
Moving to an eight-year period would require a change in Australian law.
The Government says it does not need to make such a change to comply with the TPP.
Corporations suing governments
Setting precedents
Settling disputes
Protecting the public interest
Pressure from big business
Sugar and dairy
Can we get out of it?
Sources
Ministers' Statement, October 5, 2015
Department of Foreign Affairs and Trade, TPP text and associated documents
Copyright Act 1968 (Cth) s 93
Copyright Act 1968 (Cth) s 94
Therapeutic Goods Act 1989 (Cth), s 25A
Office of the United States Trade Representative, Overview of the Trans Pacific Partnership
Office of the United States Trade Representative, Investor-State Dispute Settlement
Luke Nottage & Leon Trakman, As Asia embraces the Trans-Pacific Partnership, ISDS opposition fluctuates, November 20, 2015
Luke Nottage & Leon Trakman, The Trans-Pacific Partnership FTA's investment chapter: What's next?, November 20, 2015
Pharmaceutical Research and Manufacturers of America, 12 Years of Data Protection in TPP
Joshua P. Meltzer, Hearing on the "Trans-Pacific Partnership environment chapter"
Remy Davison, Ratifying the TPP may be tough, but Australia needs it, October 7, 2015
National Australia Bank, Trans Pacific Partnership - highlights for agriculture
Andrew Hay, What the Trans-Pacific Partnership means for the agribusiness sector, October 15, 2015
Australian Sugar Industry Alliance, Australian sugar: TPP A story of contrasts, October 6, 2015
Australian Sugar Milling Council, Trans-Pacific Partnership: A net positive result, October 6, 2015
Sachet Singh and Sooraj Sharma, Investor-State Dispute Settlement Mechanism: The Quest for a Workable Roadmap, 2013
Dallas Buyers Club LLC & Anr v Iinet Limited & Ors, Federal Court judgment, August 14, 2015
Dallas Buyers Club LLC & Anr v Iinet Limited & Ors, Federal Court judgment, April 7, 2015
POSTED FRI DEC 18 06:55:34 EST 2015
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