The Trans-Pacific Partnership

The Something Awful Forums > Discussion > Debate & Discussion > The Trans-Pacific Partnership

Are you in favor of the TPP?
	Yes
	No
	N/A without more data

WhiskeyJuvenile: Feb 15, 2002; by Nyc_Tattoo

Members of Congress shouldn't be involved in anything, because they're mostly Republicans

Process arguments are dumb

# ¿ Jun 14, 2015 04:07

Adbot: ADBOT LOVES YOU

# ¿ May 15, 2024 05:32

WhiskeyJuvenile: Feb 15, 2002; by Nyc_Tattoo

The "old patents" poo poo is just Hatch-Waxman, right?

# ¿ Jun 15, 2015 14:13

WhiskeyJuvenile: Feb 15, 2002; by Nyc_Tattoo

I don't understand reformulation issues

Why would this prevent generics of the now-lapsed original formulation?

# ¿ Jun 15, 2015 23:55

WhiskeyJuvenile: Feb 15, 2002; by Nyc_Tattoo

Obdicut posted:

We're stepping outside my area of knowledge but I think one of the main ways is that it means the data about the original formulation remains entirely proprietary property of the original company, so the generics companies are prevented from using that in the formulation--they have to start from scratch on the process, and the FDA approval is about process as well as final molecule. I may be wrong on this though.

That hasn't been the case for over 30 years, domestically, since the Hatch-Waxman Act.

quote:

Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. � 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA).

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal and in vitro) and clinical (human) trial data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

The trade-off was that under the old system, generic manufacturers couldn't start clinical trials until the patent expired, but if generics don't have to go through clinical trials while pioneers do, then the patent term is effectively lessened. Hatch-Waxman dictated a tradeoff where generics wouldn't have to bear the cost of repeating clinical trials, but the pioneer would still benefit from market exclusivity for the time of the trial.

quote:

In terms of patent term restoration, the bill provides that a pioneer drug can receive an extension term equal to one-half of the time of the investigational new drug (IND) period, which runs from the time human clinical trials begin to the time the NDA is submitted. In addition to getting credit for the IND period the complete period of NDA review is added as the second part of the extension. This is so long as half of the IND period plus the NDA review period is less than or equal to 5 years. Furthermore, the time after the drug has been approved and is on the market cannot exceed fourteen years.

# ¿ Jun 16, 2015 02:43

WhiskeyJuvenile: Feb 15, 2002; by Nyc_Tattoo

VitalSigns posted:

Really? The treaty has a grandfather clause that says "oh hey any patent violations you're already doing are totally cool and you don't have to pay any license fees"?

Well that's surprisingly generous.

Although it still doesn't change the fact that there's no profit in developing new drugs for people who can't afford to buy them.

They're not patent violations; the drugs at issue aren't patented at all in India, nor could they be at this point, so it is, in fact, only for prospective drugs

# ¿ Jun 19, 2015 16:53

WhiskeyJuvenile: Feb 15, 2002; by Nyc_Tattoo

MaxxBot posted:

I didn't elect Michael Froman and if his name was on a ballot there's no way I'd choose him to represent me in any capacity. It's of course not practical to elect every single government official and often the people you elect choose to appoint bad people.

So you're against the concept of representative democracy, thanks.

# ¿ Oct 6, 2015 22:18

WhiskeyJuvenile: Feb 15, 2002; by Nyc_Tattoo

The TPP is Cool and Good

# ¿ Oct 6, 2015 22:21

Adbot: ADBOT LOVES YOU

# ¿ May 15, 2024 05:32

WhiskeyJuvenile: Feb 15, 2002; by Nyc_Tattoo

mitztronic posted:

https://wikileaks.org/tpp-ip3/WikiLeaks-TPP-IP-Chapter/WikiLeaks-TPP-IP-Chapter-051015.pdf

I'm having a bit of difficulty understanding what this is saying in realspeak. A lot of sources (including EFF) are claiming this is saying that the TPP is going to allow private entities to enforce copyright violations (As opposed to the state [courts]). Others are saying this isnt true, and some people in comments are claiming that we are already at this point and there is private enforcement of copyrights going on.

I just read this; I have no clue what you're talking about.

# ¿ Oct 9, 2015 17:53

The Something Awful Forums > Discussion > Debate & Discussion > The Trans-Pacific Partnership