It is stipulated in the newly revised Patent Law in Article 42 Paragraph 3: "For the purpose of making up the time required for the assessment and approval of the marketing of a new drug, the patent administrative department of the State Council may, at the request of the patentee, provide patent term extension for an invention patent relating to the new drug approved for marketing in China. The extension may not exceed five years, and the total effective term of the patent after the new drug is approved for marketing shall not exceed 14 years.”

The United States, Japan, Europe and other countries and regions set up the drug patent term compensation system 20 to 30 years ago, in which the USA is the first country to establish the system. In 1984, Drug Price Competition and Patent Term Restoration Act, that is Hatch-Waxman Act, was adopted at the United States Congress, stipulating details on the patent term extension system which is listed in Patent Law in Article 156; in Japan, the patent term extension system was established in 1987 and revised and improved in 1999, it is generally regulated in Japan Patent Law in Article 67; in Europe, the EEC 1769/92 Act, that is EU SPC, was adopted and enacted at European Parliament in 1992, and officially came into effect in 1993.

The newly revised Patent Law in our country will come into effect on June 1, 2021, how to take effect depends on subsequent and more detailed method and system. In accordance with the statistical result of Frost&Sullivan, the worldwide famous market research company, from 2012 to 2016, the United States had been always the biggest drug consumption market, it is also the earliest country. There have been 2 million cases of patent having patent term adjustment.

Drugs and the corresponding US patents can be obtained from the US FDA Orange Book as of September 2020, involving 2,873 cases of patent, among the Chinese family of these patents, there are 296 cases of drug patents in total with valid legal status and before expiration by June 1, 2021. It is believed that the patentee of these patents may file a claim for the drug patent term compensation after June 1, 2021.

Rank patentees with 5 or more patents. MSD ranks first with 20 patents, which is much higher than other patentees; Novartis ranks second with 14 patents; AstraZeneca and Allei Biotech both rank third with 10 patents; the number of patents owned by other patentee is less than 10. According to their countries, 9 of the 13 patentees are from the United States, and the remaining four respectively come from Switzerland, UK, Japan and Germany.

In terms of patent drug application diseases that are most likely to file a claim for extension of drug patents, drug patent applicable to cancer with the number of 73 accounts for the most, which is much higher than other diseases; 28 drug patents applicable to neurological diseases rank second; 25 drug patents applicable to cardiovascular diseases rank third; patents applicable to skin diseases and AIDS are respectively 20 and 16; and the number of drug patents applicable to other diseases is less than 15.

Among the right holders who are most likely to file a claim for the extension of drug patents, Merck has much more drug types among the TOP5 patentee, which mainly are AIDS and hepatitis drugs; Novartis also owns many sorts of drugs leading by cancer ones; only three drugs are involved in AstraZeneca, of which TAGRISSO (generic name of the drug osimertinib mesylate) for the treatment of lung cancer is also the drug with the largest number of patents in a single drug layout, and all 7 patents protect compounds; ArrayBio involves only two drugs, both are cancer drugs, MEKTOVI (generic name Binimetinib) for treating melanoma ranks second in the number of patents in a single drug layout, 4 of the 6 patents protect compounds, one protects the use, and the other protects the compound, composition and use at the same time; Takeda also has many drugs, mainly are diabetes and gastric drugs.

From Sohu News

March 17, 2021