Whanin·Myung In successfully evaded patent for Fycompa

Intellectual Property Trial and Appeal Board, crystal patent passive rights scope verification trial

Generic release possible after material patent expiration in October 2023

Fycompa

Myung In and Whanin succeeded in circumventing some of the patents of 'Fycompa (Perampanel anhydrous)', an epilepsy treatment.

 

The two companies will be able to launch generics as early as October 2023.

 

On the 21st, the Intellectual Property Trial and Appeal Board issued a trial decision for ``establishment of claim'' at the judgment on the passive scope of rights for crystal patent of Fycompa (October 14, 2026), which Myung In and Whanin claimed against Eisai.

 

As a result, the two companies met two of the three requirements for the early release of generics (first request for trial and trial decision for claim establishment).

 

One of the remaining requirements is 'application for approval for the first generic'.

 

For now, it is very likely that both companies will achieve this requirement at the same time.

 

The two companies are conducting bioequivalence tests for the generic for Fycompa.

 

Whanin has started bioequivalence tests in May of this year and Myung In in July.

 

Fycompa's PMS expires July 9, 2021.

 

Considering that it is possible to apply for an item permission after the expiration of the PMS, this means that about 9 months will be given.

 

It's time to end the bioequivalence test.

 

Assuming that the two companies apply for product license at the same time, the generic release is expected to be on or after October 14, 2023.

 

It is when Fycompa's material patent expires.

 

The two companies did not file a separate patent trial for material patents.

 

Fycompa is a new drug for epilepsy that was launched in Korea in February 2016.

 

In particular, it can be used as a monotherapy for adolescents 12 years of age or older with partial epilepsy seizures, and prescription performance is increasing.

 

According to UBIST, Fycompa's annual prescription amount increased more than three times in three years to ₩1.3 billion in 2016, ₩3 billion in 2017, ₩3.7 billion in 2018, and ₩4 billion in 2019.

 

Fycompa's prescription amount was worth ₩3.2 billion until September this year.