Sunday, May 20, 2007

Generics and the FTA, and Pfizer's small victory

The Hankyoreh  (the Hani, locally) that picked up on something I have been saying to foreigners here for a long time. The KORUS FTA talk about Korea's proposed "positive list" system for the National Health Insurance Service to choose which drugs reimburse is actually an intellectual property issue. Actually the Hani does not cover it explicitly, but gets pretty close. Korean IP and regulatory law does not adequately protect drug patents.
The patent laws make it easy for companies to get around. You patent a specific treatment for the drug, not the drug itself. This makes it easy for a Korean firm to produce a generic version, and claim it's for a different condition. Further the effect could be interpreted by a number of government agencies as so narrow to accommodate such generics.
In addition Korea does not provide what is called "data exclusivity" for drug trials. That is to say the millions a drug firm will spend on drug trials are not the exclusive property of that firm. Meaning the generic maker can cite the affectivity of the sponsored drug trails in order do gain KFDA approval.
To add insult to injury, the KFDA requires that domestic tests be submitted. So if you spend millions to test the drug in Europe, you have to do it again in Korea according to the KFDA. So this invested data set is even more valuable for the company.
As you can expect, this amounted to a trade barrier for foreign drug firms. In many cases a generic could come out produced by a Korean firm. Add this to the fact that the National Health Insurance Service could add that cheaper generic to the positive list and not the proper rights holder, you have a situation where a huge market is shut out the company.
The recently concluded KORUS FTA was to deal with some these issues. The linked Hani article discusses how some companies are acting or reacting according to the changes. Also talked about in the news piece is the fact some companies are trying to use existing law to stop some of these shenanigans with varying success.
An interesting little final note is the Hani's mention of Anguk's production of a generic of Pfizer's Novasc. A couple months ago Seoul District Court ruled that Anguk's generic did violate Pfizer's patent on the drug. The court ruled that Anguk's version of Norvasc using a different type of saylatic salt had no noticeable differences from the stated effects in the patent (please excuse the chemical spellings if wrong). I do not know how broad or narrow the patent or ruling was, and this matter will likely end up in the Korean Supreme Court, but I thought it worth noting here. 


At May 21, 2007 2:18 PM, Anonymous Anonymous said...

"You patent a specific treatment for the drug, not the drug itself. This makes it easy for a Korean firm to produce a generic version, and claim it's for a different condition. "

This is complete nonsense.You obviously havent a clue what youre talking about. Drug mfrs patent the molecule, umpteen differnt salts, the process, the formulation, and the use etc etc.

If the generic claims it is for another condition then it wont get registered.

This is beyond ridiculous.

At May 21, 2007 2:39 PM, Blogger Dram Man said...

I agree its beyond ridiculous, welcome to the world of Korean Patent Law!

Basically, Korean Law considers any molecule as a naturally occurring substance, and therefore something you cannot patent. Accordingly in Korea a drug maker cannot generally " patent the molecule, umpteen different salts, [and] the formulation" as you say.

You are correct about the manufacturing techniques, however they must prove to be sufficiently novel. WIth that as well if the claims are drafted too specifically (as KIPO examiners are known to require) they can create many loopholes for generic makers.

This is not to say that Korea is a generics paradise. A generic would need to prove some therapeutic effect to gain approval by the KFDA and get distributed.


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