Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more
The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more
This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more
The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...more
In FDA v. Wages and White Lion Investments LLC, the U.S. Supreme Court’s unanimous decision in favor of the Food and Drug Administration serves as a reminder of the deference still accorded to regulatory agencies post-Loper...more
The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more
A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe...more
AMGEN INC. v. HOSPIRA, INC. Before Moore, Bryson, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: Biological engineering activity that would otherwise constitute patent...more
On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more
Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval July 06, 2016 According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars....more
Addressing Sherman Act and Lanham Act claims arising out of an Abbreviated New Drug Application (ANDA), the US Court of Appeals for the Second Circuit upheld the district court’s dismissal of the plaintiffs’ Sherman Act claim...more
There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more
On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more