Fay Sharpe members have worked closely with pharmaceutical clients in a variety of areas within in the pharmaceutical industry including: Hatch-Waxman patent and regulatory exclusivity strategy; pharmaceutical patent litigation; freedom to operate and patentability opinion work; patent and trademark preparation and prosecution; pharmaceutical lifecycle management; Paragraph IV Abbreviated New Drug Application (ANDA) and 505b2 New Drug Application (505b2 NDA) filing and launch strategies, FDA Orange Book exclusivity and forfeiture analysis, FDA Citizen Petition counsel, biosimilar and over-the-counter product filing and launch strategy, State Boards of Pharmacy and Medicine licensing, and FDA/DEA compliance consultation. Firm members also have IP and regulatory experience in the dynamic and ever-changing Medical Marijuana/Cannabis Industry space.
Pharmaceutical Patent Opinions, Counseling and Hatch-Waxman Litigation
Fay Sharpe works closely with clients to determine offensive and defensive patent strategies. Issues we routinely addresses include: freedom to operate, invalidity, patent infringement, unenforceability, licensing, and Inter Parties Review. We have counseled generic and brand pharmaceutical companies on competitive portfolio analysis and possible design-around/PIV solutions, and advised on broader IP and Hatch-Waxman patent and regulatory exclusivity strategies. Over the years, firm members have managed litigation counsel from an in-house perspective and been directly involved in patent litigation from an outside counsel perspective. With this combined experience, we are in a unique position to advise creative business solutions to complex patent and related FDA Orange Book regulatory exclusivity issues.
Pharmaceutical Patent Application Preparation and Prosecution
We provide patent application drafting and prosecution services designed to efficiently prepare patent applications with broad patent scope and ultimately obtain timely issued patents. We have experience drafting patent applications that will avoid common setbacks when subsequently filing the application in foreign countries and has a network of foreign associates that can assist with filing applications throughout the world.
FDA Regulatory and Medical Marijuana
We provide counsel to clients on many areas in the pharmaceutical, medical marijuana (also known as medical cannabis) and medical device FDA and State Board regulatory space. In particular, we provide strategic advice regarding FDA new product filing through launch strategy, along with guidance related to various State Board of Pharmacy rules and regulations as relates to pharmaceutical products and medical marijuana.
FDA Drug, Medical Marijuana, and Medical Device Counseling
We counsel clients on many areas in the pharmaceutical space including: Hatch-Waxman patent and regulatory exclusivity analysis, pharmaceutical lifecycle management, Paragraph IV Abbreviated New Drug Application (ANDA) and 505b2 New Drug Application (505b2 NDA) filing and launch strategies, FDA Orange Book exclusivity and forfeiture analysis, FDA Citizen Petition counsel, biosimilar and over-the-counter (OTC) product filing and launch strategy, managing post-market issues, medical marijuana licensing, and DEA license consultation. Fay Sharpe also has provided strategic advice to medical device companies regarding 510(k)/Premarket Notification (PMN) submissions to the FDA.
State Boards of Pharmacy and Medical Marijuana
We advise drug manufacturers, wholesalers, and individual pharmacies and pharmacists related to various State Board of Pharmacy licensing rules and regulations. We have successfully represented clients at State Board of Pharmacy hearings and have had licenses reinstated by putting together comprehensive corrective action plans. We also provide guidance related to State Medical Boards and State Veterinary Boards.
Fay Sharpe leverages its vast pharmaceutical and State Board of Pharmacy experience along with medical marijuana expertise to provide the counseling necessary to navigate this emerging medical marijuana/cannabis industry. We can assist with license application preparation, compliance with ever-changing regulations, preparation for inspections and responses to alleged violations, and provide other strategic counseling related to the medical marijuana/cannabis industry.
DISCLAIMER: Marijuana is an illegal Class I drug pursuant to the United States Federal law. All activities related to marijuana are currently illegal under the federal law of the United States. Potential consequences for violations of federal marijuana law include civil penalties and criminal penalties up to and including imprisonment.