Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

By Bradley Graveline on October 14, 2016 Posted in FDA

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does not. The rule changes, if implemented, would have a significant impact on the potential liability of generic … Continue Reading

Forget About Vermont!: Congress Passes GMO “Labeling” Legislation

By Peter Reichertz on July 19, 2016 Posted in FDA

On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will preempt all state laws “relating to the labeling or disclosure of whether a food is bioengineered or was developed or produced … Continue Reading

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

By Jesse Salen on January 19, 2016 Posted in Biotechnology, FDA, Intellectual Property, Legislation

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious. … Continue Reading