Should a New Technology Change the Patent System?

linuxizer writes "Congress seems poised to turn an effort to create a pathway for generic biotech drugs, such as Remicade, into the exact opposite. Instead of the 5-year protection that traditional pharmaceuticals get, or the 0-year protection that the FTC recommends, the bill offers 12-year exclusivity with renewability for minor changes. The issue is highly charged, with activists waging a campaign to change the bill. Yet it also raises interesting questions for other technologies. To what extent do the traditional contours of patent law need to change in response to new technologies with a different set of market realities (biotech drugs are 22 times more expensive on average, and development costs for generics will be substantially higher) and in what direction? Need every new technological category get its own patent rules, and how do those rules get decided?"

Comments

People with the Money Call the Shots

[eldavojohn]

Apparently the author of the summary is unfamiliar with lobbying so here goes the simplest explanation I can think of for it.

Need every new technological category get its own patent rules, and how do those rules get decided?

Depends on the leaders of that category. The people with the most money will give tiny amounts of that money to the lawmakers. Then a bill is introduced and these weird rules probably get tagged onto some bill that has a much more important focus (like health care or one of the various wars we are engaged in). Since all the lawmakers received money from the the people with money, nobody objects.

Here's one of many examples in which a bill titled "Affordable Health Choices Act" gets tiny peppering of patent law attached to it like this (which is in regards to the category 'interchangeable biological products'):

... (i) a final court decision on all patents in suit in an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or

(ii) the dismissal with or without prejudice of an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; ...

What's worse is that no voter immediately cares. Everyone cares more about things that directly affect them--like their health or their kin dying on some god forsaken soil. The immediate threat of these lobbyists is not only unseen but no one is held accountable down the line. You have to get someone not too politically savvy to be the poster child/target for this stuff if it's a whole bill you're introducing -- like Sonny Bono on copyright extension. Oh and there's another neat little thing in American politics where if you vote for that bill and then something like this gets added and you vote against the bill, your opponents label you as a "flip flopper", "waffler" or "indecisive."

Now, I paint a picture where opposition to lobbyists never arises because no one makes it a serious issue. But there are a few examples of this working positively. Example is the generic drug manufacturers do actually have some money and realize they are getting the short end of the stick so you have these lobbying wars occasionally. The really ironic thing is that name brand drugs are more expensive for the consumer. But often the consumer is on a health plan where they pay a small percentage or a copay on their drugs. If it is a copay and the consumer buys the $100/dose Calvin Klein drugs instead of the $1/dose Walmart drugs, someone (like your health care provider) is paying a lot more. Now, imagine what kind of state our health care would be in when there can't be any generic drugs for 12 years? Won't matter if you're a copay or a percentage, you'll be taking that $100/dose because it's your health and you can't exactly put a price on your health.

Re:People with the Money Call the Shots

[dkleinsc]

Reminds me of a great moment by Dr House: When he explains to his audience that Vogler's new drug will work really well, because the old drug worked really well, and nothing significant has changed, just minor changes in order to keep the patent protection.

Re:People with the Money Call the Shots

[Thykka]

This is exactly the reason democracy fails. People need to realize, that governments aren't in no way necessary or even beneficial for healthy societies. In a world without such authorities, the success of companies would be measured solely by their ability to provide the best service to their customers. Without artificial restrictions, such as patents or copyrights, there'd never be an opportunity for a company not to try to improve their services. A popular argument against removing patent and copyright laws is that a company has to invest significant amounts of time and money in inventing new products (such as medicine in this article's context) and that the patent would allow them to make profit out of their investment. I believe, that if a certain product really requires years of exclusive research it also isn't possible for competing companies to copy in a timeframe that wouldn't allow for the original inventor to gain reasonable profit. Nevertheless, if another company is able to provide better selling service regarding another company's invention, why not allow it? After all, we should be concerned about mankind's collective well-being and not the profit of select companies.

Re:People with the Money Call the Shots

[corbettw]

Without the FDA, the research time on these drugs would be cut from 22 years to less than one. Of course, then you'd have every charlatan out there peddling his snake oil as the latest and greatest cancer cure. And without any research to back up their claims, no one would be able to judge whether or not those claims were true until after trying the drug. And if you're going to insist that companies spend billions of dollars proving their products work, then you have to also protect them and their ability to turn a profit on those products or else no one else will ever develop any.

There's a reason why the majority of drug research is done in the US: we don't force drug companies to give away their products for free. Oh, and incidentally, one of the reasons drugs cost so much here is because other countries do put price controls in place, so we end up carrying the burden for those slackers. Too bad Congress doesn't enact an export tariff on prescription drugs, we'd make enough off that to pay for healthcare.

What needs to change

[Targon]

To encourage invention or innovation, the system MUST go back to the original reason for patent protection in the first place. The idea is that new ideas should be protected so the patent "owner" can develop said idea and turn it into a product. If there is no ability or intention to DIRECTLY make a product to take advantage of the protection, then the protection should be removed.

This means that patent trolls would all go away, since none of them have any intention to make a product based on the patents they own. It is one thing for a company like AMD or Intel to file a patent and make use of their inventions, and another for someone sitting in an office to buy a patent just so they can file lawsuits against anyone who makes a product that might infringe on the patent in question.

So, for all of these companies that file patent related lawsuits, they SHOULD be looked at to see if they have taken even a few steps towards making a product. If there has been no effort made to create a working product based on the technology, they should be fined for filing a lawsuit in the first place.

Re:Recoup period

[RiotingPacifist]

yeah its not like FTC know anything about trade! (did you even read their argument.)

Do you have any idea how long it takes to get drugs approved for use by the public? drugs (like software) can't simply be copied and resold, if you develop a new drug you have a good 3/4 years of no competition while a competitor gets reverse engineers it and gets approval for his version, after that you have the fact that your drugs are tried and tested and you've been producing it for 3/4 years. Patents are useful in many sectors, but medicine is even less one of them than software (especially when you consider the human cost).

IF the drug approval process was faster AND it was easy to reverse engineer drugs THEN patents are needed in medicine (probably 5 years), but until then the drug company's can shove the any proposal up their respective asses!

The answer is so EASY...

[Karem Lore]

The solution to the never ending patent rubbish that is coming out is:

1) All R&D needs to be logged (in terms of cost).
2) All patents are protected and valid until the net profit of selling any item has reached the level of costs, or 1 year if no progress on the the patent has been made to monetize anything.
3) After R&D costs are covered, the patent becomes public knowledge and usable in any capacity by anyone.
4) Any litigation from a patent holder can only be back tracked 1 year prior to the declaration of accusation. No, oh you've been abusing my patent since 1985, cough up Billions please...

This will help innovation of new products based on older patents by opening them up as soon as they become viable.
This will stop people sitting on patents (trolls).

You may ask about well, if on the day the patent opens some foreign firm floods the market in cheap XYZ drug...Well, no...Because said company may not develop until the patent has been released...Thus, the lawyers will be happy because they can still litigate companies who abuse this rule, patent holders will have a lead time to get profits, future innovators can innovate still and the whole world will advance much much quicker...

And no, I have not thought through everything and I am sure there are some holes in this that a eagle-eyed slashdotter will notice...but it could be a good starting point.