East Sunshine Billion Grade Hypoglycemic Drug "linagliptin" Convicted of Patent Infringement

 

7Month27On the same day, the State Intellectual Property Office made the first national administrative ruling on major patent infringement disputes since the implementation of the Administrative Adjudication Measures for Major Patent Infringement Disputes:

Ordered the petitioned Guangdong dongyangguang pharmaceutical co., ltd. to immediately withdraw the net of the accused infringing preparation linagliptin tablets from the online drug procurement platform; At the same time, the petitioned parties Guangdong dongyang pharmaceutical co., ltd. and Yichang dongyang changjiang pharmaceutical co., ltd. were ordered to immediately stop manufacturing, selling and promising to sell the infringing claimant Boehringer Ingelheim pharmaceutical company (Boehringer Ingelheim Pharma GmbH & Co. KG, hereinafter referred to as: Boehringer Ingelheim) invention patent (patent number:ZL201510299950.3) of products.

Case1Case No.: Guo Zhi Bao Ce Zi[2021]1No.

1. Cause of action

The claimant, Boehringer Ingelheim, filed a request for an administrative ruling on a major patent infringement dispute with Guangdong East Sunshine Pharmaceutical Co., Ltd. (hereinafter referred to as "East Sunshine"). The request relates to an invention named“8-[3-Amino-Piperidine-1-Base]-Xanthine compound, preparation method thereof and use thereof as pharmaceutical preparation”The invention patent (patent number:ZL201510299950.3）。

2. Trial process

2021Year11Month5The State Intellectual Property Office accepted the application;

2021Year12Month10On the same day, East Sunshine made a request for invalidation (4W1134081) Apply to suspend the trial of the case;

2021Year12Month15The case was suspended;

2022Year5Month16Day, due to the withdrawal of East Sunshine invalid request, the case resumed trial;

2022Year5Month18On the same day, East Sunshine once again filed an application for suspension of the trial (in the case of invalid request4W114187For reasons), after the collegial group discussion, do not agree;

2022Year6Month22Japan, this case and another related case (case number: Guo Zhibao word[2021] 2No.) for oral hearings;

2022Year6Month24On the same day, the collegiate group organized the parties to conduct on-site display and verification of the relevant physical evidence;

The case has now been closed.

3.Request Matters

(1) Order the requested person to immediately stop manufacturing, selling or promising to sell the products that infringe the patent rights involved in the case throughout the country.

(2) The requested person shall be ordered to immediately withdraw the application for listing of lixagliptin tablets from the drug procurement platforms that have applied for listing (including but not limited to Shanghai, Fujian, Shandong, Guangdong, Jiangxi, Hainan, Gansu, Shaanxi, Henan and other places).

4.Reason for award

The collegial panel held that the claimant was the patentee of the patent involved, the patent involved was legal and valid, and his legal rights should be protected by law.

5.Award

The (I) ordered the respondent Guangdong Dongyang Sunshine Pharmaceutical Co., Ltd. to immediately stop manufacturing, selling and promising to sell the invention patent right of Boehringer Ingelheim Pharmaceutical Co.(Patent Number: ZL201510299950.3)of products.

The (II) ordered the petitioned Guangdong Dongyang Sunshine Pharmaceutical Co., Ltd. to immediately withdraw from the drug procurement platform that has been linked to the Internet.TingThe hanging net of the piece.

 

Case2Case No.: Guo Zhi Bao Ce Zi[2021]2No:

1.Cause of action

The claimant, Boehringer Ingelheim, filed a request for administrative ruling on major patent infringement disputes with Yichang East Sunshine Yangtze River Pharmaceutical Co., Ltd. (hereinafter referred to as "East Sunshine"). The request relates to an invention named“8-[3-Amino-Piperidine-1-Base]-Xanthine compound, preparation method thereof and use thereof as pharmaceutical preparation”The invention patent (patent number:ZL201510299950.3）。

2.Trial process

2021Year11Month5The State Intellectual Property Office accepted the application;

2021Year11Month29On the 2nd, Dongyang applied to suspend the trial of the case on the grounds of the request for invalidation. As Dongyang failed to submit the notice of acceptance of the request for invalidation, the collegial panel decided not to suspend the trial;

2021Year12Month10On the same day, East Sunshine once again applied to suspend the trial of the case on the grounds of the request for invalidation and submitted a notice of acceptance of the request for invalidation;

2021Year12Month15The case was suspended;

2022Year5Month16Day, due to the withdrawal of East Sunshine invalid request, the case resumed trial;

2022Year5Month18On the same day, East Sunshine once again filed an application for suspension of the trial (in the case of invalid request4W114187As a result), the case will not be suspended again by the collegial group;

2022Year6Month22Japan, this case and another related case (case number: Guo Zhibao word[2021]1No.) for oral hearings;

2022Year6Month24On the same day, the collegiate group organized the parties to conduct on-site display and verification of the relevant physical evidence;

The case has now been closed.

3.Request Matters

(1) Order the requested person to immediately stop manufacturing, selling or promising to sell the products that infringe the patent rights involved in the case throughout the country.

(2) The requested person shall be ordered to immediately withdraw the application for listing of lixagliptin tablets from the drug procurement platforms that have applied for listing (including but not limited to Shanghai, Fujian, Shandong, Guangdong, Jiangxi, Hainan, Gansu, Shaanxi, Henan and other places).

4.Reason for award

The collegial panel held that the claimant was the patentee of the patent involved, the patent involved was legal and valid, and his legal rights should be protected by law.

5.Award

Order the Requested Party Yichang East Sunshine Yangtze River Pharmaceutical Co., Ltd. to immediately stop manufacturing, selling and promising to sell the invention patent of Boehringer Ingelheim Pharmaceutical Company(Patent Number: ZL201510299950.3)of products.

 

The main focus of the dispute between the two cases

1.On whether the case needs to be suspended

For the first time, the respondent applied to suspend the trial of the case with the request for invalidation. The collegiate group suspended the trial of the case according to the application of the respondent. After resuming the trial, the respondent applied for suspension again. The collegiate group held that the same applicant for invalidation in the case had already made one request for invalidation, and the patent right of the invention was still valid after the trial of the invalidation procedure, taking into account the fairness and efficiency of the award, it was decided not to suspend the case.

2.Regarding whether the accused infringing product falls into the scope of protection of the patent involved

To determine whether the technical scheme of the accused infringing product falls within the scope of protection of the patent right, all the technical features recorded in the claims claimed by the right holder shall be examined. If the alleged infringing product contains the same or equivalent technical features as all the technical features recorded in the claims, it shall be deemed to fall within the scope of protection of the patent right.

In this case, linagliptin is a specific compound, and the collegial panel believes that: for a specific compound, as long as the parent nucleus of the specific compound and each substituent on the parent nucleus fall into one of the selected elements listed in the claim protection formula at the same time, it can be considered that the specific compound falls within the protection scope of the general formula.

3.Regarding whether the requested person has committed the act of manufacturing, selling, promising to sell the alleged infringing product

Regarding manufacturing and sales: the alleged infringing products in this case have been purchased in Shanghai and other medical institutions, and the outer packaging and instructions of the alleged infringing products that have been sold clearly record that the holder of the drug marketing license and the manufacturer are Guangdong Dongyang Sunshine Company (case1of the requested person), and Yichang East Sunshine Yangtze River Pharmaceutical Co., Ltd. (case2ofThe requested person) is an affiliated company, therefore, the requested person in both cases has carried out the act of manufacturing and selling the alleged infringing product without the permission of the patentee.

About the promised sales behavior: the linagliptin tablets of the requested person have been approved by the State Drug Administration for marketing, and have been qualified to be sold in the market, and the accused infringing products have been announced, published or listed on the relevant official websites of Shanghai, Guangdong and other provinces (regions and cities), in Fujian, Shandong and other provinces (autonomous regions, municipalities) on the relevant official website was at least public hanging network. The requested person has a clear intention to sell the accused infringing products to medical institutions in the province (region, city) where the drug centralized procurement platform is located, and has even implemented sales in Shanghai and other places. Accordingly, the requested person in both cases committed the act of promising to sell the alleged infringing product.

Regarding whether the act of drug listing is an infringement exception: Item (V) of Article 75 of the Patent Law of the People's Republic of China stipulates that in order to provide information required for administrative examination and approval, manufacture, use, or import patented drugs or patented medical devices, And those who manufacture or import patented drugs or patented medical devices specifically for them shall not be regarded as infringement of patent rights. However, the related acts of drug listing do not belong to the infringement exception stipulated in Item (V) of Article 75 of the Patent Law of the People's Republic of China.