Read the drug patent link system!

The drug patent link system is a new system of the drug patent protection system

Pharmaceuticals are an important product closely related to public health and social welfare, and one of the areas of concentration of intellectual property conflicts

There are some similarities in the institutional frameworks of different countries, but there are also differences, and the treatment of chemical drugs and biological drugs is different

Generally speaking, in addition to the drug patent link system, the drug patent protection system also includes the Orange Book system, patent protection period extension, experimental data protection and other supporting systems.

Interpretation of the drug patent link system

The implementation of the new "Patent Law" in October 2020 and the "Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes (Trial)" in July 2021 has created a new legal regulatory environment for new drug transactions .

The purpose of establishing the drug patent link system is to confirm the validity of the original innovative drug patent during the marketing approval of the generic drug, and/or whether the technical solution of the related generic drug falls within the protection scope of the original innovative drug patent, so as to solve the problem before the generic drug is listed.

Article 6 of the Administrative Adjudication Measures for the Early Resolution Mechanism of Drug Patent Disputes formulated and issued by the State Intellectual Property Office stipulates that when an applicant for a chemical generic drug submits an application for a drug marketing authorization, it shall compare the patent information published on the patent information registration platform of the original drug listed in China information, making a statement for each relevant drug patent of the generic drug

Figure 1: Source of patent declaration for four types of drugs: public information, collated by China Pharmaceutical Industry Information Center

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 from the date when the national drug evaluation agency publishes the application for drug marketing authorization.

Figure 2: Schematic diagram of the administrative implementation process of the patent link system Source: public information, collated by China Pharmaceutical Industry Information Center

The practice of domestic pharmaceutical companies to the drug patent link system

Since the drug patent link system kicked off in early July 2021, a variety of drugs have been challenged in Category 4.

Among them, the category 4.

At present, the patentee or interested party can still file a lawsuit or request an administrative ruling on the six patent claims

Aidosaban

Edoxaban is a new anticoagulant drug developed by Daiichi Sankyo that can directly act on coagulation factor Xa

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 including urinary incontinence, urgency and frequency.

daptomycin

The original research of daptomycin was Eli Lilly, and Eli Lilly authorized the development rights of daptomycin to Cubist Pharmaceutical, and then Cubist was acquired by Merck &
Co.
In 2003, daptomycin for injection was approved for marketing in the United States for the treatment of complex skin and skin and soft tissue infections caused by bacteria such as Staphylococcus aureus; in 2006, the FDA approved daptomycin for injection for use in adult and pediatric patients.
Staphylococcus aureus blood infection
.
Approved indications in China are similar to those in the United States
.

everolimus

Everolimus is an oral selective mTOR inhibitor that binds to the intracellular protein FKBP12, thereby inhibiting the activity of mTOR
.
Everolimus tablets were launched in the European Union in 2003, approved in the United States in 2009, and entered China in 2013, where they were approved for the treatment of renal malignancies and astrocytoma; they have now been approved for marketing in more than 120 countries around the world , 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 hepatocellular carcinoma (HCC) patients who had previously received sorafenib therapy.
It was the first approved second-line treatment for HCC in China.
new medicine
.
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
.

Summarize

Since the opening of the drug patent link system in early July 2021, a number of domestic pharmaceutical companies have entered the bureau and launched patent challenges for original research drugs
.
It is foreseeable that more domestic pharmaceutical companies will launch patent challenges in the future
.

For original pharmaceutical companies, it is very important to formulate strategies to deal with patent challenges in advance, including timely registration of relevant patents on the patent information registration platform for marketed drugs, and real-time tracking of generic drug patent claims after patent registration is completed
.

For generic drug companies, it is very important to have a comprehensive understanding of the core patented technology and expiration time of blockbuster drugs, track global R&D progress, take patent breakthroughs and patent evasion methods to circumvent patent disputes, and gain a leading generic drug market position in potential therapeutic areas.
The key is of great significance to the sustainable development of enterprises and the improvement of comprehensive competitiveness
.