When an ANDA filer settles its PIV case with the brand company, they expect to have certainty as to how the parties proceed from there. In fact, the settlement should bring at least some certainty as to launch date into the PIV Market. But one recent case suggests that maybe how the settlement plays out … Continue reading →
My last Blog Post covered when lawyers behave so badly they wear out the presiding judge, this Post covers another lawyer topic that was included in the mix of the same case involving Belbuca®(buprenorphine) Buccal Film. Due to my personal professional standards, and the fact that the Court never ruled on whether the lawyer was … Continue reading →
While a judges decide cases, it is really the lawyers who run it – their pace and interactions with the court. Sometimes, lawyers can frustrate judges to their wit’s end. The case seemed so normal until… A PIV case started in September 2018 over Belbuca®(buprenorphine) Buccal Film and three of its patents. Innocent enough, it … Continue reading →
As mentioned in my last Blog Post, 2025 revealed something about the market for aBLA’s and in turn the PIV Market. The First Decade of the aBLA Appearing in 2013-2014, FDA began to process the Abbreviated Biologics License Application (aBLA) to allow a “generic” manufacturer to produce, manufacture, and market a biosimilar. Of course, a … Continue reading →
The PIV Market in 2025 revealed two interesting developments, actually three, but more on that later. More ANDA’s filed Of course, we count PIV lawsuits and can count the number of ANDA’s filed included in them. 2025 saw a 25% increase in the number of ANDA’s filed. Out of 272 cases filed, there were 209 … Continue reading →
The 2025 filing year for Inter Partes Reviews finished September 30, 2025. The data suggest that Proceedings for Inter Partes Reviews may have arrived in their proper place. Back in 2012… When the Inter Partes Review process began in 2012, the idea was to provide tech companies with a quick, simple process to invalidate patents … Continue reading →
In May 2025, the Trump Administration issued an Executive Order to establish the policy of returning pharmaceutical manufacturing to the United States. What impact might these have on both brand and generic manufacturers? Return of Manufacturing On May 5, 2025, the Trump Administration issued an Executive Order which seeks to encourage pharmaceutical manufacturers to increase … Continue reading →
On May 12, 2025, the Trump Administration issued an Executive Order regarding Favored Nation Pricing. What are its potential impacts to the U.S. pharmaceutical market? Favored Nation Pricing The Executive Order seeks to reduce the price Americans pay for prescription drugs primarily in two ways. The first method is to level the pricing that the … Continue reading →
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 … Continue reading →
As we move into 2025, some notable topics have surfaced. Steady State in the PIV Market? The number of ANDA’s filed associated with a PIV case has remained steady over the past 5 years. In 2024, there were 167 of them filed, down from 173 in 2023. Since 2020, there have been between 167-179 ANDA’s … Continue reading →
