[Ip-health] Who is responsible for damages resulting from the governmental price cut by generic entry?

Heesob Nam hurips at gmail.com
Thu Oct 10 02:04:08 PDT 2019

The validity of Zyprexa (Olanzapine) patent was disputed in many
jurisdictions. In Canada, it was invalidated by the Supreme Court
applying the promise utility doctrine, invoking a NAFTA ISDS dispute.

In Germany and Australia, the first instance courts found the patent
invalid, both were reversed by upper courts. See,
and http://www.chinaipmagazine.com/en/journal-show.asp?id=659

Interestingly, the China IP Magazine reports that when the German 1st
court rendered the invalidation decision, several generics entered the
market. Lilly tried to stop this but failed in the first place, which
was again reversed by the Higher Court. Then, I guess that Lilly might
seek a damage compensation against the generic companies. But I can't
see any report still.



IV. Infringement Proceedings
As a consequence of the revocation of the Olanzapine patent in the
first instance, a considerable number of generic manufacturers
immediately launched generic medicaments containing olanzapine in
Germany. Lilly reacted aggressively and requested provisional
injunctions against the generics offering and selling olanzapine.
While all of these requests for provisional injunctions were rejected
by the first-instance courts (Regional Courts of Düsseldorf and
Hamburg), Lilly had spectacular success before the Higher Regional
Court of Düsseldorf. This Court allowed Lilly’s appeal and issued
preliminary injunctions against some of the generic manufacturers,
arguing that it was not bound by the Federal Patent Court’s decision
which it designated as “evidently wrong”.


On Wed, 14 Aug 2019 at 20:11, Heesob Nam <hurips at gmail.com> wrote:
> I'm looking for those who join a written submission to the Korean
> Supreme Court. I believe if the Supreme Court upholds the Patent Court
> decision explained below, no generics will enter until all of the
> patent matters are completely cleared by the highest court.
> We have two conflicting court decisions.
> Last year (8 February 2018), the Korean Patent Court held that the
> generic company was liable for all of the lost profit of Lilly Korea
> (an exclusive licensee of a patent on Olanzapine of Eli Lilly). The
> lost profit, according to the Patent Court, includes the loss caused
> by the price cut that the government carried out under the National
> Heath Insurance system when generic products entered into the market
> after a court decision invalidating the Olanzapine patent.
> Later the invalidation decision was reversed by the Supreme Court, and
> the Lilly Korea brought a suit against two generic companies: Hanmi
> Pharmaceutical, and Myung-In Pharmaceuticals.
> In Myung-In case, the Patent Court ruled in favor of Lilly Korea and
> found that generic was liable for damages resulting from a price cut
> of patented medicine (according to the National Health Insurance
> system, the government may cut the patented drug price by 20% when
> generic enters). This is the case, according to the Patent Court, even
> when the generic company trusts a court decision finding a patent
> invalid (in this case the decision was rendered by the same court, the
> Patent Court).
> Yet, in Hanmi case, the Seoul High Court found no liability of lost
> profit due to the price cut which was carried out by the government
> according to regulations.
> Now both cases are pending in the Supreme Court and PhRMA already
> filed a written submission to the Court arguing that the ruling of the
> Patent Court should be upheld.
> Please contact me if you are interested in my planned written submission.
> Best,
> --
> Heesob Nam, PhD
> Representative, Knowledge Commune
> Director, Commons Foundation
> T: +82 (0)2 796 1839
> M: +82 (0)10 3925 2797
> hurips at gmail.com, heesobnam at commons.foundation

Heesob Nam, PhD

Representative, Knowledge Commune
Director, Commons Foundation
T: +82 (0)2 796 1839
M: +82 (0)10 3925 2797
hurips at gmail.com, heesobnam at commons.foundation

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