Tag Archives: pharmaceuticals

Playing Your Cards Right: Arguments Against Obviousness Can Be Detrimental for Satisfying the Written Description Requirement

U.S. patent law establishes requirements that inventors and applicants must satisfy to obtain a patent, which include utility, recitation of patent eligible subject matter, novelty, nonobviousness, an adequate written description, enablement and the best mode of practicing the invention. Biogen International GmbH v. Mylan Pharmaceuticals, Inc. presents an example of tensions between the nonobviousness and written description requirements.

To read the full text of this Duane Morris Alert, please visit the firm website.

FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP

On January 30, 2020, the U.S. Food & Drug Administration (FDA) issued a new Manual of Policies & Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.

Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it “may grant an ANDA submission either a shorter review goal date or an expedited review” if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.

View the full Alert on the Duane Morris LLP website.

Much of Oklahoma’s $572 Million Opioid Case Likely to Be Replicated Elsewhere, But Unique Cause of Action May Not

On August 26, 2019, Cleveland County, Oklahoma, District Judge Thad Balkman delivered his highly anticipated ruling in the state of Oklahoma’s lawsuit against certain pharmaceutical companies responsible for manufacturing and marketing prescription opioid medications. Because the other pharmaceutical companies named in the state’s case settled with the Attorney General’s Office earlier this year, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals remained the primary subjects of the evidence at trial and the focus of the attention surrounding Judge Balkman’s then-forthcoming ruling.

As Judge Balkman stated in the published judgment, the defendants knowingly and misleadingly marketed their highly addictive prescription opioids, and by doing so caused harm for which the state could seek redress, as their “actions annoyed, injured, or endangered the comfort, repose, health or safety of Oklahomans.”

View the full Alert on the Duane Morris LLP website.

CDER’s New MAPP on Risk-Based Site Selection Model for Routine Inspections

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.

We invite you to read the full text of this Duane Morris Alert on the firm website.