1.Technical barriers to auto injector

The parts of an auto injector are generally less than 20, and the structure is relatively simple, so breaking through the original auto injector patent is the core barrier of the industry. In addition, due to the early appearance of injector, there are currently more than 40,000 insulin pen patents accumulated worldwide, of which more than 1,500 are core pen structure patents, and most of them are registered by some international companies. As of 2022, YPS, the world’s largest OEM manufacturer, has 2,162 patents worldwide. Overseas pharmaceutical companies including Eli Lilly, Novo Nordisk, Sanofi and other companies have not only accumulated a large number of injection pen-related patents for product strategy considerations, but also developed auto injector pens for their own drugs to achieve cost-effective sales.

At present, China’s auto injector pens face the following pain points:

· The patent density is high and the breakthrough difficulty is high; Because the structure is relatively simple, and the simpler the structure, the fewer options there are in terms of solutions; And international companies started research and development very early and have already laid out basic feasible solution patents, so it is extremely difficult to break through the patents.

· Patent study requires high time costs, requires large investment in special R&D equipment, and takes a long time;

· As customers’ drug development, clinical trials, approval and marketing progress, there is a risk that progress may not be as expected.

At present, if Chinese drug and medicine manufacturers need auto injector pens, there are two options:

Option 1, cooperate with auto injector manufacturers with independent intellectual property rights.

For example, choose to cooperate with YPS; but its high-end, cost-effective products are often used by giants, leaving few auto injector options for biopharmaceutical manufacturers, and this situation has led to a reduction in the cost-effectiveness of pharmaceutical drugs.

Option 2, choose to cooperate with domestic auto injector manufacturer. 

Under such conditions, the quality of the auto injector pen product itself may not be effectively guaranteed; even if pharmaceutical companies use domestically made subcutaneous injection, they can only promote them in China and underdeveloped regions where the awareness of intellectual property protection is not strong, and cannot promote them in developed markets in Europe and the United States with higher consumption capacity.

However, both of the above solutions will further restrict the development of enterprises. Moreover, each manufacturer’s auto injector can only be used with its own manufacturer’s insulin pen cartridge. In order to make the adjusted insulin dose injection more accurate, control the patient’s blood sugar level, avoid serious consequences of blood sugar disorders in the future, and ultimately improve the patient’s quality of life, long-term mixed use of different injection pens should be avoided. Therefore, in terms of patent breakthroughs, Chinese companies still need more time to polish.