The many patent cliffs seem to have emboldened generic drugmakers: Pharma patent litigation is on the rise, particularly when it comes to newer IP – 2014 was a record year for ANDA suits, according to a new report from Menlo Park legal analytics firm Lex Machina. This graphic says it all:
The Hatch-Waxman/ANDA Litigation Report analyzes 1,671 cases filed from 2009 through this past September (meaning despite showing incomplete data, 2014 really is emerging as a highly litigious year). The firm looked at 1,100 patents and 300 FDA applications. Here are some of the findings:
- Companies are likely to face IP attack from generics much earlier in the game. Currently, the drug patents facing litigation are still fairly new – they’re 5 years old on average – dropping from 10 years in 2010.
When Investment Rhymes with Canada
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- This means that despite the fact that they’ve got on average 15 years left on their patent – up from 8 years in 2009 – IP’s more vulnerable than ever.
- On the flip side, it takes longer for a company to get approval after their intellectual property has been filed, rising from 3.9 years in 2009 to 4.9 years in 2014
- Pain relief med Oxycontin has the largest number of ANDA litigation cases; testosterone and metformin hydrochloride were the leading ingredients when it came to patent enforcement. Here’s a descriptive world cloud showing the trade names under attack:
- It’s much harder to settle an ANDA patent case than a non-ANDA patent, but the former has double the likelihood of reaching judgment
- Most of the ANDA cases were filed in Delaware and New Jersey
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