In response to the efforts of Purdue Pharma to settle and resolve its litigation, I started a blog post considering the behavior of Purdue. Part I covered citizens petitions. Petitions filed with FDA provide insight into the story and establish that: (1) the risk of oxycodone addiction and abuse was well-known by the early 2000’s and (2) Purdue used the petition process in what may be considered an aggressive manner. While their petition responses and filed petitions try to establish concern for patient safety, the risk was well-known, and yet the company made several attempts to deflect these concerns and inhibit competition. The actions seem to defy the stated intent.

Part II – The Paragraph IV Cases

The ParagraphIV Market also provides insight into the behavior of Purdue. Having researched Paragraph IV cases for nearly 20 years, it is not a stretch by any means to state that this product has been the most litigated of all the products in the Paragraph IV Market.

After the original product was approved in the 1990’s, Purdue filed several PIV cases in New York starting in 2000. This turned out to be the first set of cases Purdue filed which, at the time, covered 9 PIV cases. Judge Stein in New York did not seem too impressed with the Purdue patents, going so far as to rule that these were unenforceable due to inequitable conduct.

There have only been a small handful of inequitable conduct rulings which is the legal way of saying, “the patent is a valid patent, but due to the bad behavior of the patent applicant (Purdue) in front of the US Patent and Trademark Office, Purdue cannot enforce them.” While Purdue was able to get the ruling overturned, you get a strong indication about what Judge Stein thought about the patents and the behavior of Purdue.

Purdue then removed this original product off the market, and FDA approved a reformulated version in April 2010. This action in effect, re-set the market where the new product would have no immediate generic competition, and Purdue filed another set of cases starting in 2010 to defend the additional patents. While it settled most cases, the same Judge Stein in New York ruled that several patents were invalid.

But this did not stop the PIV cases. Taking on an aggressive patent strategy, Purdue then obtained additional patents, forcing ANDA filers to certify against them which, in turn, enabled Purdue to file additional waves of PIV cases against them. With cases pending against them, ANDA filers are deterred from launching their products.

By 2016, Purdue began avoiding filing cases in New York. While I did not attend any of the hearings, you get the feeling that Judge Stein was getting tired of the Purdue PIV cases filed over the past 15 years. So, Purdue picked other places to file the newer cases like Delaware, likely to avoid Judge Stein. Some of these cases are still pending today.

Over the past 19 years, Purdue filed over 70 PIV cases, covering dozens of patents. While there is nothing wrong with filing a PIV case and defending patents, the pattern of behavior is a bit troubling. Contrary to most brand companies in the PIV Market, adverse rulings did not deter Purdue from filing for additional patents which proved to be as weak as the ones previously invalidated.

The PIV cases expose some additional truths which throw a great deal of doubt on their stated concern for patient safety and addiction and more of a concern for sheer profit: Purdue set the dubious benchmark of (1) filing PIV cases in terms of number; (2) replacing one product with another to set up multiple PIV cases and delayed generic entry; and (3) adding to its patent portfolio to set up additional PIV cases.

While some may applaud this “aggressive” strategy which is certainly “legal” in a sense, it is fair to say that no other brand company has gone to the lengths (and depths) of this behavior in the PIV Market. Coupled with the dangers of its product, the behavior is really nothing to applaud.

Part III covers what one company did in the market when faced with a similar dilemma — selling a wonder drug that has serious adverse risks.