NEWS

Reflection on Patent Layout from Patent Cliff

Release time:

2023-06-09 14:50

 

The profit of the pharmaceutical industry mainly depends on patent protection, especially the star-rated blockbuster drugs. The original research and development pharmaceutical companies form a patent family through multiple patent applications, making these drugs have a monopoly position in the market for a long time. However, patents have their timeliness, and as the term of these patents expires, the original R & D pharmaceutical companies will be subject to competition from generic pharmaceutical companies, resulting in a sharp decline in sales and profits from the protection of these patents, a phenomenon known as the "patent cliff."(patent cliff) 」.

 

For example, Eli Lilly(Eli Lilly) The star antidepressant "Thousand Worries Solution (Cymbalta®) "At its peak, annual sales can reach $5 billion.[1]However, with the solution of thousands of worries.Since December 2013, patent exclusivity has been lost in various countries, leading to the immediate entry of several generic competitors. At Lilly's Fourth Quarter 2014 Report[2]pointed out that,December 2013 C ymbalta®and March 2014 Evista®The loss of U.S. patent exclusivity led to a 9% drop in global sales. In addition, according to the Ministry of Health and Welfare of Taiwan, China[3], thousands of worriesunit drug price of 60 mg, which remained at 51 between 2003-2013NT$above the price, but sinceFall to 47.3 in 2013NT$, fall as high7%, and has since fallen all the way to 25.5NT$It can be seen that the patent cliff has a crucial impact on the profitability of the pharmaceutical industry.

 

Due to the timeliness of patents, all patents will not be able to avoid the expiration of one day, but from the perspective of patent layout, applicants may try to continue the patent protection effect of key technologies through different application strategies. For example, when researchers find a novel compound with novel uses, they can give priority to the compound as the application category of the first patent alone, and then try to use the novel use as the application category of the second patent. Such a layout avoids the dilemma of applying for both categories at the same time and expiring at the same time. Since then, as the research and development work progresses, the applicant can continue to apply for the third and fourth patents through new derivatives, new compound crystals, or new drug dosage forms, etc., but it should be noted that the subsequent application should still have the patent requirements, especially the examination committee may challenge whether the subsequent application has its progress.

 

total andIn other words,InDrugsEarly formulation of developmentThe maximum patent layout is critical, and through the patent layout, when key patents expire, the original R & D pharmaceutical still has other patents as protection.Extend product life cycleIt can also interfere with the competition of other generic pharmaceutical companies, effectively reducing the possible impact of patent cliffs..