Patent Protection and Bypass Continuation Applications: Evaluating Benefits and Risks, Navigating Priority

For over 25 years, Ms. Mueller has provided strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology, and chemistry sectors. She brings in-depth knowledge and extensive experience to her work, advising clients on the global patent protection, freedom to operate, and validity of blockbuster drugs they aim to produce and distribute. With a background in chemistry and biology, she provides advice on the full spectrum of global intellectual property portfolio management, including patent prosecution, opposition, and other post-grant proceedings, and diverse regulatory matters. Since 2001, she has worked closely with in-house legal departments of global pharmaceutical firms regarding their patent development and enforcement strategies. In this partnership, Ms. Mueller provides training to new in-house counsel. She meets with scientists and other business development to anticipate and resolve a wide array of problems, including navigation of FDA approval. A thought leader on pharmaceutical and biopharmaceutical patent law, Ms. Mueller frequently speaks to legal and industry groups and publishes widely.

Dr. Landau is a seasoned Patent attorney with 18+ years of legal experience and doctoral level training in environmental/industrial microbiology. As a Shareholder in the Firm’s Intellectual Property Group, he focuses his practice on patent drafting, patent prosecution, managing international patent portfolios, providing legal analysis and opinions, and brand protection and enforcement. Dedicated to intellectual property law and the advancement of biological science, he is active in the biotechnology industry, serving as a board member of BIO Alabama, former Chair of the AIPLA Biotechnology Committee, and an Adjunct Professor of Law at Cumberland School of Law.

Ms. Simmons’s practice includes strategic and business-oriented intellectual property counseling, patent preparation and prosecution, diligence, and opinions of counsel in the areas of pharmaceuticals and chemistry. She has particular experience with the preparation and prosecution of US and foreign patents involving small molecules including molecular glues, enantiomers/diastereomers, isotopologues, polymorphs, and prodrugs, for use as immunotherapies, antibiotics, cannabinoid receptor agonists, and anti-cancer drugs. Ms. Simmons also has significant experience with secondary patenting strategies to manage life cycle and maximize brand exclusivity, including method of use, process, solid form, formulation, and combination therapy patents, and patents involving assays and devices for use within the pharmaceutical industry.