Thanks for the heads up from Aaron Wininger of Schwegman Lundberg & Woessner, the first drug patent linkage decision has been decided by the Beijing IP Court (see announcement). There does not seem to be news from the competing CNIPA of the CNIPA's drug patent linkage decision, although the CNIPA has accepted a lot more cases than the Beijing IP Court (12 for CNIPA, 1 for Beijign IP Court).

mp.weixin.qq.com/s/-9SocP2TLE20Xw7me3OxNw

Further details of the above announcement are as below. As reported previously (see my post https://www.linkedin.com/feed/update/urn:li:activity:6859816088893583360?commentUrn=urn%3Ali%3Acomment%3A%28activity%3A6859816088893583360%2C6864391360473104385%29), the details of the case is as below:

  • The drug at issue is Eldecalcitol of the Japanese company Chugai Pharmaceutical Co., Ltd. (under the brand Edirol) for treating osteoporosis.
  • The generic supplier is Wenzhou Haihe Pharmaceutical Industry (Haihe).
  • The patent at issue is CN ZL2005800098777.6 ('777).

The Beijing IP Court found that the generic drug of Haihe does not fall within the scope of '777 literally or by equivalence, for which claim 1 specifies the following:

  1. The degradation of the active ingredient ((5Z,7E)-(1R,2R,3R)-2-(3-hydroxypropoxy)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol) into specific degradation products (6E-(1R,2R,3R)-2-(3-hydroxypropoxy)-9,10-secocholesta-5(10),6,8(9)-triene-1,3,25-triol and/or (5E,7E)-(1R,2R,3R)-2-(3-hydroxypropoxy)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol) is suppressed.
  2. After being stored for 12 months at room temperature and shading, the amount of the degradation product is 1% or less.

With the above, it may not be that difficult for the generic of Haihe to get around claim 1 of '777. For example, this could be achieved by showing that the degradation product of the generic is significantly more than 1% after being stored for 12 months at room temperature and shading.

The announcement also mentioned that the patentee Chugai is going to appeal the decision.

The acceptance of the complaint by the Beijing IP Court was announced by the Court in November 2021, while the decision was made in April 2022, i.e. in about 5 months and therefore seemingly within the 9-months window stipulated by the NMPA/CNIPA drug patent linkage regulations. However, if the appeal was filed, it may not be easy for Chugai to obtain a favorable appeal decision (if at all possible, which I am skeptical) within this 9-months window for Chugai to enjoy the patent linkage protection (which is to delay the drug marketing approval process of Haihe at NMPA).

It is worth noting that the Beijing IP Court's announcement specifically stated "allowing Chinese people to have good and cheap drugs". This may reflect the attitude of the Chinese government and the courts of the purpose of the Chinese drug patent linkage system, which does not seem to be too encouraging to original drug developers.

Seems I have to update my CN Orange Book User Guide......

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