Paragraph Four Explained




Indeed, most, if not all, generic companies have made the Paragraph IV certification a routine part of doing business. Since 2000, many companies have entered the PIV Market, and there has been a steady uptick in PIV cases (per ParagraphFour.com research). For example, in:

2005 -- 77 PIV cases were filed

2010 -- 234 cases were filed and 

2015 -- 402 cases were filed

The PIV certification has arguably become the most viable pathway for an ANDA filer to reach the generic market. Without filing a PIV certification, an ANDA filer can find itself reaching the market long after the product's price has eroded too low to ensure any reasonable profit.

Size of Brand is No Barrier and When PIV Certifications are Filed is Often Unpredictable

As mentioned in the prior section, the Barr victory in the blockbuster Prozac(r)(fluoxetine) case was an important starting point for the Emerging Trend. However, the size of the brand is not the only factor in determining whether it will receive a PIV challenge. In fact, brands of all levels of sales have received PIV certifications over the years.

Moreover, when a brand receives a PIV certification can be unpredictable as well. Since 2000, some brands have received a PIV certification within months of approval but at other times it may be years before it receives its first PIV certification. The only exception to this general observation is for NCE products which have certain rules around when they can first receive a PIV certification (four years after approval). Since about 2012, many of these "NCE-1" products have received multiple ANDA filers at year four.

However, while intuition might suggest that: (1) nearly every brand receives a PIV certification; (2) there are always many (4+) ANDA PIV filers per product; and (3) there are always many (4+) ANDA filers at time of generic launch, the data do not support these assertions. In fact, in research compiled for ParagraphFour.com subscribers, the data often show the opposite.

Inter Partes Reviews, Petitions, and PIV Cases

In many instances, there are correlations between pending PIV cases and citizens petitions filed with the FDA as well as PIV cases and petitions filed for Inter Partes Review with the USPTO. (The IPR Process began in 2011 and enables a different way to challenge a patent.) However, citizens petitions rarely affect a PIV case and the IPR proceedings often run in parallel with PIV cases. A recent US Supreme Court case (to be decided in 2018) may put an end to the IPR process.


The Paragraph Four Report® is a registered trademark of Parry Ashford Inc. • © Parry Ashford Inc. 2018