IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
In a Hatch-Waxman case, the District of Delaware denied a motion for summary judgment seeking to apply the ANDA filing date as the date of the hypothetical negotiation used to calculate reasonable royalty damages. Instead,...more
Beginning on October 20, 2025, recently confirmed United States Patent and Trademark Office (USPTO) Director John A. Squires met with European Patent Office (EPO) Vice-President Steve Rowan and Japanese Patent Office (JPO)...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
Nature of the Case and Issue(s) Presented: Plaintiff American Regent, Inc. (“ARI”) sued multiple ANDA filers (including Sun, Cipla, RK Pharma, and Aspiro) under § 271(e)(2) of the Hatch Waxman Act, and moved for a preliminary...more
After more than six years of high-stakes litigation in multiple courts and regulatory fights at the Food and Drug Administration (FDA), generic versions of Novartis Pharmaceuticals Corp. (“Novartis”)’s Entresto® have entered...more
Nature of the Case and Issue(s) Presented: Novartis holds the NDA for Entresto, a drug used to treat heart failure, having the active ingredients sacubitril and valsartan. The ’918 patent is not an Orange Book-listed patent...more
Nature of the Case and Issue(s) Presented: Novo makes and sells Wegovy. Novo sued Mylan asserting patent infringement of five patents that are listed, or Novo intends to list, in FDA’s Orange Book. In its complaint, Novo...more
Nature of the Case and Issue(s) Presented: Tymlos is used to treat osteoporosis. The API in Tymlos, abaloparatide, is a synthetic analog of the first 34 amino acids of parathyroid hormone related protein (“PTHrP”). Early...more
Nature of the Case and Issue(s) Presented: Mallinckrodt’s (“MNK”) patents cover INOmax and its delivery system, DSIR Plus, which comprise products that administer inhaled nitric oxide gas (“iNO”) in a hospital setting to...more
Nature of the Case and Issue(s) Presented: Invega Sustenna® is a long-acting injectable antipsychotic medication indicated for the treatment of schizophrenia in adults. The ’906 patent addresses the problem of noncompliance...more
On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic companies that test and...more
The U.S. Food and Drug Administration (FDA) has introduced a new pilot program to prioritize Abbreviated New Drug Applications (ANDAs) for generic drugs that utilize U.S.-based manufacturing and testing. Announced on October...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
At a September 30, 2025, public meeting hosted by the U.S. Food and Drug Administration (FDA), industry stakeholders expressed strong support for the newly launched FDA PreCheck Program, while raising key questions about its...more
When a product or process does not literally infringe a patent’s claim language, the doctrine of equivalents (DOE) holds that a competitor’s product or process may still infringe if it is substantially equivalent to the...more
The Supreme Court may soon address a recent, pivotal case involving the use of “skinny labels” to avoid inducing infringement in pharmaceutical patent infringement cases. The outcome could clarify whether and how generic drug...more
In-house legal teams are encountering mounting pressure, especially as they balance cost control, risk mitigation and rising litigation of all types. For life sciences companies, the current environment raises the stakes as...more
On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence.”...more
On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination for refusing to approve a...more
The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more
Method-of-treatment (“MoT”) claims can be powerful tools for pharmaceutical companies seeking to extend market exclusivity for their products after the original composition-of-matter patents expire. However, the District of...more