Pharmaceutical research and development has the characteristics of high investment, high risk and long cycle. The newly revised Patent Law of People's Republic of China (PRC) came into effect on June, 2002 1,1,which introduced the compensation system for drug patents for the first time.
Compensation for pharmaceutical patents means that pharmaceutical patents can be protected within a certain period of time if they meet the legal conditions after the expiration of the protection period.
Article 42 of the Patent Law of People's Republic of China (PRC) stipulates that in order to compensate for the time occupied by the approval of new drug listing, the patent administration department of the State Council shall compensate the patentee for the patent term of the new drug invention patent that has obtained the listing license in China. The compensation period shall not exceed five years, and the total effective patent right period after the new drug is approved for marketing shall not exceed fourteen years.
Sun Piaoyang pointed out in the proposal that "in June 20021,the newly revised Patent Law of People's Republic of China (PRC) came into effect, and the compensation system for pharmaceutical patents was clearly established. However, according to the current implementation rules and the draft review guidelines, the provisions on the effectiveness of the compensation period are too narrow, which leads to the fact that although innovative drugs have the opportunity to obtain patent period compensation, their effect of preventing generic drugs or improved new drugs may be discounted. "
According to Sun Piaoyang's analysis, the newly added Article 85 sexies of the Detailed Rules for the Implementation of the Patent Law (Draft for Comment) has the following provisions: "During the compensation period of pharmaceutical patents, the scope of patent protection is limited to the new drugs approved by the drug supervision and administration department of the State Council, and limited to the indications approved by the new drugs. The patent right during the compensation period of drug patent is the same as the rights and obligations before the compensation period of drug patent. " The "approved indications" defined in this article cannot be accurately understood only through this article. Even if it is understood that all indications approved by the same marketing licensor are based on their innovative drugs, other entities may develop 2.4 new drugs (new indications) to circumvent the restriction of 1 new drug patent extension.
In August, 20021year, China National Intellectual Property Administration released the revised draft of Patent Examination Guide (draft for comments). Judging from the contents stipulated in the draft, the understanding of the above-mentioned "approved indications" seems to be narrower than the relevant provisions of the Detailed Rules for the Implementation of the Patent Law (Draft for Comment), and its true meaning may be "indications approved in the drug instructions on which the application for compensation for drug patent term is based", excluding any indications approved subsequently and those approved by others other than the licensor in the form of Class 2.4 new drugs.
According to the draft, 2.4 new drugs (new indications) can enjoy patent extension. But in reality, most of the 2.4 new drugs are declared by the developers of 1. 1 new drugs, and there are more and more indications. After being approved, they will not add any approval number, but only add some indications to the description of the same drug. Considering that China's licensing standards for the use of patents are strict, and many new indications are highly related to the approved indications, it is difficult to obtain new patents for use. Therefore, the original pharmaceutical companies did not apply for patent extension compensation for Class 2.4 new drugs.
Section 3.4 of Chapter 9 in Part V of the draft stipulates that the new drugs that can apply for term compensation do not include five drugs declared in China after overseas listing, but in fact, these new drugs listed overseas have also undergone complete clinical trials in China, and most of the patent periods have been consumed. It seems that this regulation is only unfavorable to foreign pharmaceutical companies. However, in recent years, domestic pharmaceutical companies have introduced a large number of excellent innovative drugs from abroad. The above provisions will cause domestic pharmaceutical companies to abandon imported projects because the remaining protection period is too short, the patents can not be compensated for the period, and the investment cost can not be recovered.
Sun Piaoyang pointed out that it takes a long time for anticancer drugs to be used in clinical trials, especially for some tumors with long survival time, and the dominant data of survival time need to be obtained by existing standard therapies, resulting in the total duration of clinical trials occupying most of the 20-year patent period. However, due to the current status of clinical treatment, the same drugs are used for the same tumors, but the time stages of drug use are different. For example, early, late, first-line, second-line and third-line drugs need to be declared and listed independently. After the new drug was approved for the first time, every clinical trial was regarded as a new indication, that is, a new class 2.4 new drug. Therefore, if the patentee extends the application for a compound patent at the time of initial listing, it can only cover the indications at that time, and adding 2.4 indications will require an extra extension, which will lead to many indications not being compensated within the corresponding period, which will easily make other subjects imitate those indications that have not been protected by extension to bypass the patent term compensation system, which will greatly hit the motivation of new drug research and development enterprises.
Based on the above situation, Sun Piaoyang made two specific suggestions to China National Intellectual Property Administration:
First, in the process of revising the Detailed Rules for the Implementation of the Patent Law and the Guide to Patent Examination, the above situation was fully considered, and imported new drugs that have undergone complete clinical trials in China were allowed to obtain patent term compensation.
Second, enhance the effectiveness of patent term compensation. At least for innovative drugs listed for the first time, when applying for a compound patent for time limit compensation, the effectiveness of time limit compensation should be able to cover all indications of the drug, not just the indications approved at the time of application.