Posts Tagged: "ANDA litigation"

The debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices.

On November 5, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Celgene Corp. v. Mylan Pharmaceuticals Inc. affirming a ruling of the District of Delaware, which dismissed a Hatch-Waxman lawsuit against related Mylan entities for either improper venue or failure to state a claim upon which relief could be granted. In issuing the decision, the Federal Circuit found that Mylan’s submission of a notice letter to Celgene regarding Mylan’s paragraph IV certification to the U.S. Food and Drug Administration (FDA) stating that Mylan’s generic version of the multiple myeloma treatment Pomalyst would not infringe Celgene’s patents was not itself an act of infringement for purposes of the patent venue statute.

Last week, we explained our 2021 findings for the best firms involved in inter partes review proceedings. Today, based on the second annual ANDA Litigation Intelligence Report, which evaluates all stakeholders in Hatch-Waxman cases, we will focus on some of the best law firms involved in these complex cases, and their ranking based on their performance and activity. The study covered a four-year period, from July 1, 2017, through June 30, 2021, where we identified a total of 1,179 ANDA cases, 1,471 ANDA attorneys, including 289 local counsels, and 243 law firms. More than 90% of all cases were filed in New Jersey and Delaware, which made some attorneys and law firms in those states very busy during this period.