[Ip-health] Patent Linkage, TPP and the First Generic Exclusivity

Heesob Nam hurips at gmail.com
Mon Feb 9 10:21:26 PST 2015

Apologies for the cross-posting.

The wikileaked 2013 IP Chapter contains this provision:

Article QQ.E.17:1(d) when a Party delays the grant of marketing
approval consistent with subparagraph 5(b)(i), provide an effective
reward, consistent with the provisions of this Agreement, for the
successful challenge of the validity or applicability of the patent.
[FN 116: A Party may comply with paragraph 5(d) by providing a period
of marketing exclusivity in appropriate circumstances to the first
such other person or persons to challenge a patent.]

But in the wikileaked 2014 text, such a provision is removed.

Was this because negotiators believed that the generic exclusivity is
bad for generic competition? Or the U.S. dropped this provision for
the full benefit of brand drug manufacturers?

I'm curious about the position of public health activists on the
generic exclusivity. Do you see that the generic exclusivity is
necessary when importing the patent-approval linkage provisions as
proposed by the U.S. in TPP or FTAs because it encourages patent
challenges by generic industries and therefore is good for generic
competition? Then why haven't Canada, Mexico, Australia, and Singapore
introduced the generic exclusivity? Also China, the sole country
implementing the patent linkage without FTA with the U.S., does not
allow the generic exclusivity for successful patent challengers.

I have many reasons why the generic exclusivity is bad:

- Subsequent generic entry is delayed;
- Pay-for-delay settlement between a patentee and the first challenger
is encouraged;
- Granting unfair and ridiculous benefit to patentee as the patentee
can duopoly market even when its patent is found invalid;
- Excessive reward for the first challenger (there is no such
incentive in other industries, but we have seen for several hundreds
years a plenty of patent challenges. And we don't call non-challenging
competitors "free riders".); and
- Nonsense as the successful patent challenge has nothing to do with
intellectual creation.


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