Written by | Cheng Long
On June 1 this year, China's newly amended Patent Law came into effect. Subsequently, the supporting Chinese version of the drug patent link system began to be implemented, the patent period compensation system is soliciting opinions, and the detailed rules for the specific implementation measures are expected to be introduced in the fourth quarter of this year.
The life of patents is directly related to how much economic value innovative products can create for the original pharmaceutical companies, especially under the current collection system, the relationship between patents and innovation returns is becoming closer.
"Timely and effective tracking, evaluation and layout of patents is particularly critical." Chen Chi, a partner at Jones Day Law Firm, said that in the current market environment, the patent strategy of innovative drugs will become an important lesson for enterprises.
To evaluate the patent situation of innovative drugs, it is necessary to challenge the three major areas of medicine, intellectual property rights and law at the same time. At present, GBI, a provider of medical information data, has launched a drug patent radar database to help users track the progress of drug patent registration and four types of challenges in real time by tracking this information, and then comprehensively evaluate the future innovation returns of drugs.
What is the Drug Patent Radar
According to the current centralized procurement system, for chemical drugs, it is basically to take the original research drugs plus generic drugs that have passed the consistency evaluation, as long as three can be included in the collection, that is, to meet the conditions of "1 (original research drugs) + 2 (generic drugs)".
For biological drugs, the inclusion of collection or collection is also at hand. According to the Opinions on Promoting the Normalization and Institutionalization of Centralized Drug Procurement issued by the General Office of the State Council at the beginning of the year, Guo Ban Fa [2021] No. 2, not only biosimilars with the same generic name will be included in the collection, but the targets and/or mechanisms are the same (similar clinical efficacy), and biological drugs with similar indications are likely to be combined to carry out centralized procurement in the future.
The term of patent protection determines how long an innovative drug can have a market exclusivity period after it is launched, and how long it will not be affected by the impact of collection. Especially after the implementation of the patent link system, the length of patent protection period for pharmaceutical products will face many uncertain factors.
On the one hand, the patent link system provides protection for the original drug, before the chemical drug is listed, the marketing license holder, patentee or interested party can file a lawsuit with the people's court or file a request for administrative ruling on the patent dispute of the drug, and there is a 9-month waiting period after filing the case, and the generic drug needs to be approved by the State Food and Drug Administration after the 9-month waiting period. On the other hand, the patent challenge mechanism provided by the system may also enable successful generic drug companies to obtain marketing approvals before the expiration of the patent, and the first generic drug that meets the conditions will also receive a 12-month exclusivity period.
The complex policy environment does require relevant practitioners to have a sharper "sense of smell". In the process of patent information analysis, the drug patent radar can track the drug patent declaration, the registration information and patent status of the original drug, and the progress of the declaration of generic drugs by realizing the search in Chinese and English and according to the marketing authorization holder, so as to be able to make a more specific and accurate judgment on the protection of the intellectual property rights of the original drug.
Lawyer Chen Chi also mentioned: "The drug patent radar provides the intellectual property index (π value) of the original drug. Π value comprehensively reflects the patent status of each new drug and predicts when the product may be affected by the collection. ”
"In simple terms, the π value starts from the time when the original drug is approved for listing, and ends at the time when the generic drug is listed, and predicts the potential of the future market exclusivity of innovative drugs around the patent link system and the patent term compensation system that will be implemented soon." Lawyer Chen further explained.
The impact of π value on the prospect of the original drug
With the continuous deepening of the reform of China's pharmaceutical system, the relevant legal system has gradually strengthened the protection of pharmaceutical intellectual property rights, and the development of pharmaceutical innovation has embarked on a fast track. Mr. Chen said: "In the new policy environment, the patent status of an innovative drug is crucial to its clinical development layout, the authorization transfer that may be involved, and the financing transaction of the related company. ”
For innovative pharmaceutical companies, the potential of product pipelines is the most important value for investors, especially those companies whose products have entered the clinical stage. Even if the company is already listed, the company is always with investors. How can companies demonstrate the potential of their products? How should investors evaluate the company's prospects? The π value of a company's products is an important reference for assessing the value it may create in the future.
"For example, when it comes to the licensing of an original drug developed in China, the licensee will definitely pay great attention to what patents the product can be registered on the Chinese drug patent information registration platform. Can the registration withstand the challenge? How long will the product ultimately be granted patent protection? These factors can affect the success rate of drug licensing negotiations and the final transaction price. Lawyer Chen said.
The company's IP team can use the π value to adjust the company's patent layout in a timely manner. If it is found that the product patent protection of a new drug is relatively weak, you can apply for other patents to strengthen protection, such as through dosage forms or indications to improve the π value.
In Mr. Chen's view, in the policy environment where China's patent link system has been implemented and the patent period compensation system will be implemented, the π value of the original research drug will become a reliable coordinate for the company to formulate patent strategies and layout, and contribute to improving the value return of innovative products.
Editor| Yao Jia layout | Zhang Yue
Issue 1440