Generics makers challenging more patents

INICIO/Informes | Posted 05/12/2014 post-comment0 Post your comment

In recent years generics makers are becoming bolder and challenging more patents on originator drugs. In fact, litigation regarding patents on pharmaceuticals is on the rise, particularly when it comes to newer drugs.

Patent 1 V13E17

According to a report from legal analysis firm Lex Machina, patent challenges have been rising since 2009. The report finds that 2013 was a record year for abbreviated new drug application (ANDA) law suits and 2014 looks like it is following suit, see Figure 1. In 2013, a total of 5,793 patent cases were filed in the US, compared to a total of 3,564 patent cases filed between January and September 2014.

Figure 1: ANDA patent cases filed per year

figure1 GW1970G

ANDA: abbreviated new drug application.

Purdue Pharma’s pain relief medication Oxycontin (oxycodone) has had the largest number of ANDA litigation cases. While testosterone and metformin hydrochloride were the leading ingredients when it came to patent enforcement.

The down side for originator manufacturers is that it also takes longer for a company to gain approval for their drug after their patent has been filed, rising from 3.9 years in 2009 to 4.9 years in 2014.

The report also found that originator companies were likely to face patent attacks on their products from generics much earlier than previously. Currently, the drug patents facing litigation are still fairly new – only five years old on average – compared to an average of 10 years in 2010.

Related article
MSF launches online ‘Patent Opposition Database’

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro PharmaCommunications International. All Rights Reserved.

Source: Lex Machina

comment icon Comments (0)
Post your comment
Related content
PD biomarkers for biosimilar development and approval
Biomarker select V21K26
INICIO/Informes Posted 26/11/2021
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010