Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.
Brian’s regulatory experience includes all types of FDA-regulated products: drugs and biologics (including animal drugs and biologics), medical devices, cannabis, foods and dietary supplements, cosmetics and tobacco products. He is a key advisor to pharmaceutical and biologic clients in the premarket, regulatory review, and marketing, enforcement and lifecycle management phases of product development. Brian works alongside his clients on drug development strategies and patent strategies across a variety of areas, including:
Pre-Investigational new drug applications (INDs), new drug applications (NDAs), orphan /specialty drug designations, biologic license applications (BLAs) and abbreviated new drug applications (ANDAs)
505(b)(2) NDAs, including new indications, dosage forms or regiments, strengths or combination products
Risk evaluation and mitigation strategies (REMS), including some with elements to assure safe use (ETASU)
BLAs and biosimilars (351(k) applications)
Medical devices, including 510(k) clearances and premarket approval applications (PMAs), laboratory developed tests (LDTs), and combination drug/device products
Cannabis and cannabis-derived products including cannabidiol (CBD) products.
He is also an experienced litigator, representing clients in FDA and patent cases, including Hatch-Waxman Act cases and Biologics Price Competition and Innovation Act (BPCIA) cases. In particular, his patent law knowledge makes him an asset to drug and biotech companies, working alongside them to develop proactive strategies that protect their pioneering life sciences products from the earliest stages of development through approval, marketing and next-generation products, and wielding litigation when required.
Brian is also a strong partner in the boardroom, providing FDA and IP due diligence for deals and transactions in the life sciences space, supporting mergers and acquisitions and licensing for investors, private equity clients, and pharmaceutical and biotechnology companies. His combined experience across regulatory, IP, litigation and transactions in pharmaceuticals and biotechnology enables him to spot and mitigate issues that may negatively impact his clients’ investments and partnerships.
With more than 18 years of FDA and intellectual property law experience, including time spent in the Office of the Commissioner and the Center for Drug Evaluation at the FDA, and a degree in biochemistry, Brian’s background is uniquely tailored to the needs of life sciences innovators. He is also active in the promoting the biotechnology community and life sciences entrepreneurs in Maryland, Virginia, the District of Columbia and beyond.
Articles in the National Law Review database by Brian J. Malkin