In December 2024, Pacira Pharma filed a PIV case in Illinois over its product
Exparel®(bupivacaine) Injectable Suspension. It raises some uncomfortable questions.

Bupivacaine and its new formulation Exparel

Bupivacaine has been on the US market for over 40 years (really longer). Pacira Pharma developed a new suspension formulation which FDA approved in 2011. We should always encourage innovation particularly when the product yields annual sales of over half a billion dollars which suggests it meets a real market need. Such a successful product attracts ANDA filers – also a good thing. Pacira filed a PIV case against ANDA filer Jiangsu/eVenus (and partner Fresenius Kabi) in New Jersey District Court.

Over the course of the past 3+ years, Pacira filed 5 more PIV cases in New Jersey after it listed a series of new patents in the Orange Book.

New Jersey District Court Declares Patent Invalid

In August 2024, the Court ruled in the lead case. Citing a prior Pacira patent as a reference, it found that the patent in question was a marginal improvement over the prior patent but that the difference was not significant enough to merit a new patent. As such, it concluded the patent was obvious and ruled in favor of the ANDA filer. This case is on appeal.

Time to Shop

Undeterred by this “setback,” Pacira filed a 6th case against the ANDA filer on December 3 over an additional patent the USPTO had issued the same day. However, instead of New Jersey where the prior 5 cases reside and where it already received an adverse decision, Pacira filed this Complaint in Chicago – a litigation strategy known as “forum shopping.” The ANDA filer countered a week later by filing its own case in New Jersey in an effort to return this 6th case back to New Jersey.

Is it really an innovation?

While there is nothing “illegal” about forum shopping, this filing raises some uncomfortable questions. Here, Pacira indeed re-formulated an old product for the better, but, as the Court ruled, it essentially relied on its own prior technology to get a patent issued. Several new “innovations” apparently have followed as Pacira has filed 5 subsequent PIV cases in an effort to “protect its intellectual property” which has the real effect of keeping its product’s monopoly status intact.

Pacira really has not done anything wrong in a sense (some may condone its strategy, in fact) but have its tactics abused the PIV process? Are these 5-6 later-issued patents really innovations? Should the court system encourage forum shopping after an adverse ruling? If an abuse of the process, should a Court or Congress step in to correct it for the future?

We should likely see how this plays out in 2025. It’s probable the Court of Appeals will affirm the finding of patent invalidity (but you never know), and we will see how the ANDA filer reacts in the market and in the court system.