In 2022, 6 drugs have launched 4.1 category patent challenges!

The implementation of the new patent law in June 2021 and the drug patent linkage system in July have created a new legal and regulatory environment for new drug transactions.

Source: Website of China Listed Drug Patent Information Registration Platform

Given that four types of declarations can lead to patent invalidation and infringement lawsuits, they are worthy of attention

Source: GBISOURCE Drug Patent Radar

According to the regulations, if the patentee or interested party has any objection to the four types of patent declarations, he may file a lawsuit in the people's court or request an administrative ruling from the patent administration department of the State Council within 45 days

Source: GBISOURCE Drug Patent Radar

Among them, the 4.

Edoxaban is a new anticoagulant drug developed by Daiichi Sankyo

Albumin Paclitaxel

Abraxane, the original research product of paclitaxel for injection (albumin-bound), was developed by Abraxis BioScience and later acquired by Celgene.

Mirabellon

Mirabegron is a selective beta3-adrenoceptor agonist developed by Astellas for the treatment of overactive bladder (OAB) including urinary incontinence, urgency and frequency.

daptomycin

The original research of daptomycin was Eli Lilly , and Eli Lilly licensed the development rights of daptomycin to Cubist Pharmaceutical, and Cubist was acquired by Merck &

everolimus

Everolimus is an oral selective mTOR inhibitor that binds to the intracellular protein FKBP12, thereby inhibiting the activity of mTOR
.
Everolimus was first listed in the European Union in 2003, approved in the United States in 2009, and entered China in 2013, where it was approved for the treatment of renal malignant tumors and astrocytoma; it has now been approved in more than 120 countries around the world Listed, accumulated more than 70,000 cases using evidence-based
.

Regorafenib

Regorafenib, originally developed by Bayer , is an oral multi-kinase inhibitor that can inhibit tumor formation, tumor angiogenesis, distant metastasis and tumor immune escape
.
In December 2017, regorafenib was approved in China through the priority review process for the treatment of patients with hepatocellular carcinoma (HCC) who had previously received sorafenib therapy.
It was the first approved second-line treatment for HCC in China.
of new drugs
.
In 2018, Regorafenib entered the 2017 National Medical Insurance Catalogue, and the contract was successfully renewed in 2020
.
In addition to Sichuan Kelun Pharmaceutical Research Institute, in September 2021, Qilu Pharma launched a 4.
1 category patent statement for regorafenib tablets
.

In October last year, GBI invited Mr.
Chen Chi , Partner of Jones Day Law Firm Shanghai Office and Chairman of Baihua Association, and Mr.
Cheng Yongshun , Director of Beijing Pragmatic Intellectual Property Development Center, to interpret the "Compensation System for the Term of New Drug Patent Rights" and the "Drug Patent Linking System" .

.

Attorney Chen Chi, a partner at Jones Day, emphasized:

China's patent linkage system is more complicated than that of the United States, like a three-dimensional chessboard
.
Participants need complete and timely patent tracking information in order to know the enemy and fully realize the value of drug patents; avoid new drugs being broken by 4 types of challenges soon after registration, and falling off the patent cliff induced by centralized procurement
.