Written by Mr. Tianxia Jia of Chofn IP

Edited by Mr. Hui Wang and Ms. Hui Liu of Chofn IP

As an important part of pharmaceutical patents, chemical medicine patents involve a wide range of applications in practice and have a great impact on public health issues, often attracting widespread attention.

According to statistics, Beijing IP court received a total of 251 chemical medicine related patent cases, of which 236 are administrative cases, 15 are civil cases. In the 236 administrative cases received, there are 158 re-examination cases, 78 invalidation cases. 10.6% of the cases were withdrawn among all the 142 cases closed. After an analysis, some unique characteristics of the cases involving chemical medicine patents are summarized as below:

1.About 70% of the cases involve foreign countries, China has become a must-win place for global pharmaceutical enterprises

Among the 251 chemical medicine related patent cases, 172 cases involve foreign parties, accounting for 68.5%.

In terms of nationality/region of these enterprises, major countries of medical innovation have been involved in patent litigation in China, especially the United States, accounting for 28.5%, followed by Switzerland for 18%, Japan for 17%, Germany for 13%, France for 6%. The distribution of foreign parties in these cases largely reflects the three regions of the world where pharmaceutical innovation is currently most vocal.

In terms of the foreign enterprises, many well-known pharmaceutical companies including Fairey, Novartis, Merck, Gilead, GSK and others have been involved in such litigations. This shows that China, as an important pharmaceutical market in the world, has become a "must-win place" for global pharmaceutical companies to lay out patents, allocate resources and compete in the market.

Of the 236 administrative cases involving chemical medicine patents, 215 cases involve pharmaceutical companies and research institutes, accounting for 91%. Various domestic and foreign pharmaceutical companies include Pfizer, Novartis, Mercer, Gilead and other well-known pharmaceutical enterprises, while research institutes include China Pharmaceutical University, Duke University, Peking University, etc.

2. Such cases are more related to serious diseases, chronic illnesses, which means that public health issues are concerned.

The concerning patents involved cover a wide range of sub-divided fields, including the treatment of cardiovascular, tumor, mental and pulmonary diseases, and chronic diseases. Among the concluded cases, 20.4% were related to cardiovascular diseases and 13.4% of oncological diseases. On the one hand, it shows that current pharmaceutical research is focused on the needs of doctors and patients, and follows the consumer trends in the pharmaceutical market. On the other hand, it also illustrates that the broad medicine market has promoted the research and development innovation of serious and chronic disease drug.

Challenging competitors' patents is one of the effective ways for pharmaceutical companies to develop their business, once successful, it is likely to have a decisive impact on the marketing and sales of their medicines. In the past five years, Beijing IP court have received 78 invalidation requests of chemical medicine patents, and the number is increasing year by year. After reviewing the cases, it was found that foreign parties were involved in 62% of these cases, and most of the invalidation were initiated by domestic pharmaceutical enterprises to challenge the patents of foreign pharmaceutical enterprises in China, such as the invalidation case of the patent of "Gronronium salt combination" owned by Novartis, the invalidation case of the patent of "treatment of gastrointestinal stromal tumor" owned by Novartis. This feature is consistent with the status of the mainly Chinese generics industry but there are also cases of domestic pharmaceutical companies' patents being challenged, indicating that the innovation capacity of Chinese pharmaceutical companies is gradually improving.

Suggestions for chemical medicine patent cases

After a systematic reviewing of patent cases involving chemical medicines, it was found that there are some common problems. So here are two suggestions provided as below.

1. Value the drafting of claims

In the case of pharmaceutical patents, particular attention needs to be paid to the writing of the Markusch claims. Markusch claims, which are often used in drafting chemical patents, are in principle considered as a technological solution rather than a collection of technological solutions, so such claims need to be written in such a way as to take full advantage of good dependent claims and to maximize the protection scope of the inventor's technological contribution through a layer-by-layer approach.

2. Fully disclose the technical solution

To the extent possible, it is necessary to document in the specification the relevant work done prior to the filing date (including the experimental data tested) in order to enable the practitioner to fully understand the technical contribution of the invention and to ensure that the applicant has access to the corresponding scope of rights.

Report on Trial of Chemical Drug Patent Cases by Beijing Intellectual Property Court (1)

Report on Trial of Chemical Drug Patent Cases by Beijing Intellectual Property Court (3)

Report on Trial of Chemical Drug Patent Cases by Beijing Intellectual Property Court (4)