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.
Worked with innovator drug companies to develop strategies for approval of new drug applications (NDAs), including those filed as 505(b)(2) NDAs and biologics license applications (BLAs) (including biosimilar products filed as 351(k) applications. The approval strategies included developing clinical strategies, pre-investigational new drug applications (INDs) and pre-NDA/pre-BLA FDA meetings.*
Worked with companies to develop strategies for approval of combination drug/device and combination drug products, including clinical programs, for example, an artificial pancreas incorporating marketed glucose monitors and insulin pumps and smartphone applications and algorithms, in view of FDA’s mobile medical application and information technology guidance.*
Worked with innovator and generic companies to address and evaluate FDA’s filing, complete response and other regulatory correspondence/compliance letters.*
Reviewed food and dietary ingredient structure/function-type claims, including recommending or developing clinical trials for adding new claims.*
Reviewed formulations (ingredients) for FDA compliance and proposed labeling for new cosmetic products, including making recommended labeling changes to avoid regulatory actions such as potential-drug-versus-cosmetic claims.*
Reviewed proposed new tobacco products to determine whether they qualified as substantially equivalent or as new or modified-risk products.*
Provided regulatory litigation support for patent infringement litigations, including reviewing status of product approvals and regulatory requirements (including guidance documents), developing expert reports and litigation documents for stays and other actions, and otherwise integrating the patent litigation and regulatory strategies.*
Represented a global pharmaceutical company in a patent litigation in the District Court of Delaware regarding an injectable drug product. Client obtained a favorable settlement.*
Advised Par Pharmaceutical Inc. regarding a method to sort data for complex compositions, including biologics without the need for a reference standard (US Patent No. 7,246,020: System and Method for Sorting Data).out the need for a reference standard (US Patent No. 7,246,020: System and Method for Sorting Data).*
Member, Federal and State Legislative, CLE, and Non-Resident Community Committees, New York State Bar Association
Member, Cannabis-Derived Cannabis Committee, Food and Drug Law Institute (FDLI), Washington, D.C.
Adjunct Professor, Katz School of Science and Health (Yeshiva University), Biotechnology Management and Entrepreneurship (BME) (course: Intellectual Property, Regulation, and Compliance for Biotechnology)
Guest Lecturer, AU Washington College of Law, “Intellectual Property and FDA Exclusivity: Considerations for Vaccines”
Guest Lecturer, Georgetown Law School (Health Law LLM courses: Health Law and Regulation, Legal and Regulatory Framework for Drugs and other Medical Products, Clinical Trials & FDA Enforcement Authorities, Medical Marijuana Laws and Global Drug Law and Regulations)
Guest Lecturer, American Law Washington College of Law, Health Law and Policy Summer Institute on “Generic Drugs, Biosimilars, and the Intersection of Intellectual Property and the Drug Approval”
Guest Lecture, University of Maryland Mtech Biotechnology Research and Education Program, “Entrepreneurship for Life Sciences: Lessons in Start-Ups for Life Sciences Innovation”
Life Sciences/Healthcare Judge and Start-Up Mentor, MassChallenge (worldwide startup accelerator based in Boston, Massachusetts)
Advisory Board Member, Rare Disease Report
Editorial Board Member, FDAnews
Member, Advisory Board of Global Bioethics Initiative
Former Member, Board of Trustees, The Harbor School (pre-K to 2nd grade school in Bethesda, Maryland) (2016-2020)
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