Medical, Pharmaceutical, Regulatory & FDA
Intellectual property is vital to the medical and pharmaceutical industries: it helps bring return on investment in expensive research and keeps imitators of your brand at bay. But few industries deal with subject matter and law as complex as the medical and pharmaceutical industries. Peacock Law has attorneys with the background necessary to bring true value to medical and pharmaceutical intellectual property. We also help clients handle the particularly complex regulatory environment medical and pharmaceutical products face.
Medical Devices & FDA Regulations
Medical devices range from low-tech tongue depressors (say “ah”) to highly complex pacemakers and surgical technologies. Given the complex regulatory environment and high-risk market medical innovations face, intellectual property is vital and helps to ensure a return on investment. Medical devices are most often protected by patent, trademarks and trade secret, or some combination of those approaches. Because medical devices are often used on (or inserted within) the human body, Food and Drug Administration (FDA) regulations apply. Obtaining valuable and valid patent claims and adhering to FDA regulations requires subject-matter expertise along with extensive knowledge of patent and regulatory law. As scientists and researchers, the attorneys at Peacock Law are uniquely qualified to provide guidance and advice concerning patents and FDA regulations for medical devices.
Generic drugs allow patients to obtain medications that are safe and effective at significantly lower prices than their name brand equivalents. Manufacturers who wish to introduce generic drugs to the market can do so through an Abbreviated New Drug Application (ANDA) filed under the Drug Price Competition and Patent Term Restoration Act (aka the Hatch-Waxman Act). Peacock Law advises clients on properly completing their ANDAs, as well as meeting Paragraph IV requirements, which require inclusion of an indication that one or more Orange Book patents for the name brand drug have either expired or have been ruled invalid – thereby assuring that the generic drug does not infringe on existing patent rights.