Drug Patent Extension System in the United States

In 1984, the U.S. Congress passed the Food, Drug and Cosmetic Act, an important amendment to the Food Drug and Cosmetics Act, abbreviated as FDCA, Drug Price Competition and Patent Term Recovery Act. Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act. The extension of the patent period for drugs is clearly stipulated in the bill.

The conditions for the extension of the patent period of the 1.1 drug patent can be extended, including product patents and method patents. A method patent is a method patent or a preparation method patent.

The extension of the patent protection period of a drug must meet the following conditions:

The patent has not expired.

A patent term extension has never been granted before.

The drug has been registered and approved by the FDA prior to marketing and is approved by the FDA for the first time for sale, use, or production under the preparation method patent.

A statement that the product has undergone a mandatory FDA review period before being marketed for use.

A patent extension application must be submitted to the USPTO within 60 days of FDA approval for marketing, even if the drug is not yet ready for marketing.

The applicant for a patent extension for a drug must be the holder of the patent on the USPTO record and participate in the mandatory review of the drug's registration.

1.2 The duration of drug patent period extension The duration of drug patent period extension is limited by the following two aspects:

(1) The extension period shall not exceed 5 years.

(2) The remaining basic patent term plus extension period after FDA approval of the drug product shall not exceed 14 years. For example, an approved drug can obtain a 5-year patent extension as required, but it has a 10-year basic patent period remaining at the time of approval for marketing, and the drug can only obtain a 4-year patent extension.

The basis for determining the drug patent extension period under this limited condition is the FDA's mandatory review period Regulatory Re- view Period for drug registration. The mandatory review period usually consists of two parts, the trial phase and the approval phase. The trial phase refers to the clinical trial phase from the approval of the research new drug application (Investigational New Drug Application, INDA, also known as "clinical research application") to the new drug application New Drug Application, referred to as NDA. The time interval between the first submission approval phase is the time interval between the receipt of the NDA and its approval by the FDA. The FDA will review its records and consult with experts to confirm the duration of the trial and approval phases of the application. If at any stage there is a delay in time due to the applicant's failure to exercise undue diligence, that stage shall be deducted from that delay. Once the mandatory review period is determined, FDA will notify the USPTO and the applicant to copy to the FDA Document Summary Management Office at the same time.

Dockets Man- agement Branch and published in the Federal Register Federal Regis- ter magazine. The Federal Registration will indicate the name of the applicant, the trade name and generic name of the product, the patent number, the determined mandatory review period, including the length of the trial stage and the approval stage, and the due diligence decision at each stage.

Objection Handling in Extension of Patent Period of 1.3 Drugs Anyone can file a due diligence complaint with FDA within 180 d after the announcement of the decision on the mandatory review period due to diligence petition complaint is aimed at changing FDA's decision to reduce the extension of the patent period due to the applicant's failure to exercise due diligence. At the same time, anyone can request the FDA to hold an informal hearing within 60 days after the FDA publishes the due diligence decision, that is, due diligence hearing due diligence hearing.

FDA considers a mandatory review period to be final if:

(1)180 d period expires without due due due appeal.

(2) Objections to the timely submission of the mandatory review period are resolved through a due diligence appeal or due diligence hearing.

The procedure for the extension of the patent period of the 1.4 drug and the division of responsibilities in the approval The procedure for the extension of the patent period of the drug is:

(1) The applicant shall submit an application for patent extension to the USPTO within 60 days after receiving the FDA approval letter.

(2)USPTO sends the application to FDA within 60 days of receipt of the application

(3) Responsible for calculating the mandatory review period and notifying the USPTO of the calculation results.

(4)FDA publishes the results of the mandatory review period and conducts due diligence appeals and due diligence hearings.

(5) The USPTO reviews the patent extension application and determines the final patent extension period.

A notable feature of the U.S. drug patent extension system is the connection and division of responsibilities between the USPTO and the FDA. FDA's primary responsibility is to assist the USPTO in examining the eligibility for patent term extensions for the proposed drug, to provide information on the legal approval period for the product, to calculate the mandatory review period, and to be responsible for subsequent due diligence proceedings and due diligence hearings. The USPTO is responsible for receiving applications for patent extension of drugs and has the final determination of the patent extension period. The FDA aligns with the USPTO in all matters concerning patent interpretation and validity.

Restrictions on the right to extend the patent period of 1.5 drugs Only patents approved by FDA for drugs, methods of use of drugs or methods of preparation of drugs can obtain patent period extension. Each patent can only obtain one patent period extension even if there are multiple drugs approved by FDA under the patent. Each drug approved by FDA can only have one patent for patent period extension even if the drug enjoys multiple patents such as the first patent. Is the second patent of the drug patent is the use method or preparation method patent.

Why is there no drug patent extension system in China?

my country does not have a system to extend the patent protection period. Although at the beginning of reform and opening up, my country, as a developing country, has a relatively backward economic and technological level. my country's protection of innovative drugs is relatively weak, and the overall per capita income is relatively low. Protection, the price of medicines is relatively high, which is bound to increase the economic burden of the country and patients. However, since the beginning of the 21st century, people's living standards have been improved a lot, especially after 2005, with China's continuous attention to science and technology, the level of science and technology and the ability of independent innovation have been improved a lot. Objectively, it is required to give more development space to China's pharmaceutical enterprises, and more institutional support for independent innovation is needed in the system. Therefore, there are also many scholars calling for China to establish and improve the drug patent extension system, but the actual system implementation and implementation, there is still a long way to go.

　　http://www.docin.com/p-778323706.html