Saturday, September 23, 2017

Japanese generic company works on strategic lawsuit with a recently acquired US company to develop the US market

A Japanese generic company, Sawai Pharmaceutical Co. is planning to actively work on lawsuits in the US in cooperation with its US subsidiary, Upsher-Smith Laboratories Inc., the Nikkan Kogyo Shimbun (the Daily Industrial News) reported on August 25. Sawai acquired Upsher-Smith for $1,050 million on May 31 this year. 

According to the article, Sawai will conduct invalidity search for patents which protect original drugs and of which remaining patent term is long until expired, to submit paragraph IV certifications. By invalidating patents for original drugs, Sawai expects to expand sales of its generic drugs. Sawai has a plan to release one or two generic drugs per year in the US, starting from early 2020's, through this kind of activities.

Sawai obtained ANDA (Abbreviated New Drug Application) approval for Pitavastatin Tablets in February this year. It is said that this is the first ANDA approval based on a paragraph IV for Japanese generic manufacturers. It seems that Sawai doesn't want to wait for expiration of patents, but rather wants to actively  invalidate patents for original drugs. IP service companies who excel in patent invalidity search may become good partners for Sawai.

The Japanese government concerns about the growth of medical expenses in recent years. In 2016, the amount of total national medical expenses amounted to JPY 41.28 trillion, which includes drug dispensing cost JPY 7.49 trillion. The government is promoting the use of generics to reduce medical expenses and announced a plan to make penetration rate of generics increase to 80% by September in 2020 (cf. 69.8% in December 2016). 

If Sawai goes well, other Japanese generic companies may follow the same approach as Sawai. I personally don't want to see many patents for original drugs invalidated, though.

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