CNIPA Issues First Patent Infringement Decision against Generic Drug Maker | Fieldfisher
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CNIPA Issues First Patent Infringement Decision against Generic Drug Maker

Defeng Song



The new Chinese patent law provides the China National Intellectual Property Administration (CNIPA) with jurisdiction to adjudicate patent infringement disputes upon request from rightsholders.

Previously, patent infringement disputes would be handled by local intellectual property offices ("IPOs") under CNIPA. CNIPA rarely heard patent infringement cases itself.

CNIPA's jurisdiction under the new legal regime is limited to patent infringement cases of 'national significance'. The cross-province nature of a dispute is one consideration in determining whether it is of 'national significance'. This factor was the subject of the case decided by the CNIPA earlier this month. The case was a consolidation of two related cases with the same patent in suit and substantially the same facts.

The dispute

The patent in suit is number CN201510299950.3, which seeks to protect linagliptin, a medication used to treat type 2 diabetes.

The claimant is Boehringer Ingelheim Pharma GmbH& Co, which is the patentee of the 950.3 patent. The first respondent is HEC (Guangdong), the holder of the marketing license of the generic linagliptin. The second respondent is HEC (Yichang), an affiliated company of HEC (Guangdong). The two respondents are collectively referred to as HEC.

The claimant claims that the two respondents infringe the 950.3 patent by manufacturing, selling and offering for sale generic linagliptin. The generic version of linagliptin had been approved for marketing by the National Medical Products Administration in July 2020. 

The generic linagliptin could be purchased in some hospitals at the time of the suit. The generic drug was also for sale online on many government-associated drug platforms from which hospitals could also purchase.

While the infringement case was pending with CNIPA, two invalidation proceedings were initiated with the Patent Reexamination Board of CNIPA against the patent in suit. HEC sought to stay the infringement proceedings twice pending the outcome of the invalidation proceedings. The infringement proceedings were stayed in response to HEC's first motion, but then resumed as the invalidation proceedings were withdrawn by HEC. Therefore one major issue of the case was whether the infringement proceedings should be stayed again pending the other invalidation proceedings in relation to the same patent. 

Adjudicators, whether they be judges in a court action or officers in an administration action, normally have broad discretion in deciding whether to stay infringement proceedings pending the outcome of parallel invalidation proceedings. Factors that are usually taken into account include: when the invalidation proceedings are initiated; whether the patent has been substantively examined at the prosecution stage before issue; and whether the validity of the patent has been officially evaluated before.

In the present case, even though the patent in suit had been maintained in the first invalidation proceedings, no decision was made on its validity since the invalidation proceedings were withdrawn by HEC.

However, CNIPA decided not to stay the infringement proceedings for a second time in order to resolve the dispute quickly.

Another issue is in relation to the alleged infringing activity of putting the generic drug for sale on the government's drug supply platform. CNIPA determined that offering for sale is infringing activity under Chinese patent law, and does not fall under the 'Bolar Exemption'. CNIPA considered that explicit intent to sell the infringing drugs had been demonstrated by putting them online, which met the definition of "offer for sale" under Chinese patent law.

As previously mentioned, the above activity is not eligible for the Bolar Exemption for various reasons: the Bolar Exemption under Chinese patent law only applies to the manufacturing, using and importing of patented drugs, rather than the offering for sale of the same (as in this case); and the Bolar Exemption applies to activities intended for seeking market approval which also does not apply in the present case. As mentioned earlier, the generic linagliptin had been approved for marketing before the lawsuit.

CNIPA therefore concluded that HEC (Guangdong), the holder of the generic drug marketing license, and HEC (Yichang), the actual manufacturer of the drug for HEC (Guangdong) were jointly liable for patent infringement by contractual arrangement.

There is no damage award in an administrative action. Damage claims can be either mediated in the administrative action or be raised by initiating a separate court action. Any dissatisfied party can appeal CNIPA’s decision to Beijing Intellectual Property Court against CNIPA. 

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