McDermott Will & Schulte, a global law firm

Emily Jane Cook serves as counsel to clients in the healthcare sector from start-ups to established market leaders on a wide range of critical regulatory matters to ensure compliant business operations. Her guidance allows these organizations to prospectively and retrospectively manage the risks associated with operating in a high-complexity and highly-regulated sector.

A national authority on the 340B drug pricing program, Emily also helps clients across the country navigate a wide range of complex federal and state healthcare regulations. Her counsel encompasses issues such as navigating federal and state fraud and abuse laws, development of innovative models for healthcare delivery, Medicare provider-based and co-location rules, pharmacy laws and licensure, graduate medical education, and federally qualified health centers. This depth of knowledge across many regulatory issues allows her to provide her clients with comprehensive legal advice and guidance, which allows them to fully evaluate risks in their business and clinical operations. She works closely with colleagues in McDermott’s diverse practice areas to deliver fully realized solutions for her clients.

Emily’s deep insights into US healthcare regulation stem from her previous tenure at the US Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA). For more than five years, she worked with providers and across government agencies to address regulatory barriers to healthcare delivery. She advised senior HHS leadership on Medicare and Medicaid regulation and reimbursement issues affecting rural communities and providers, and served as senior policy advisor to the National Advisory Committee on Rural Health and Human Services.

Emily is an active member of the American Health Law Association, where she most recently served as the Chair of their Medicare and Medicaid Institute. She is also a member of the firm’s Health/White Collar cross-practice group.

Jason Leonard advises clients on complex life sciences patent litigation. During his 14 years of practice, he has counseled numerous pharmaceutical companies in developing effective patent litigation strategies for a wide array of pharmaceutical products. He leads and directs patent litigations involving small molecule drugs and peptides, including cancer therapies, oral contraceptives, steroids, antifungal agents, anticholinergics, β3-agonists and pharmacologic stress agents. Jason has successfully defended patents covering new chemical compounds, as well as complex inventions covering formulations, polymorphs, and methods of treatment. Clients frequently rely on him to address difficult infringement issues, particularly when design-around defenses have been asserted and extensive infringement proofs must be presented at trial.

Jason’s legal experience spans all stages of patent litigation, including pre-suit investigations, multiple-defendant litigations and appeals to the Federal Circuit. In developing trial strategies, Jason uses his passion for science and mastery of pharmaceutical chemistry to simplify the intricacies of drug discovery and development into concise and compelling narratives for trial.

Prior to attending law school, Jason spent six years as a pharmaceutical chemist at an innovator pharmaceutical company where he specialized in analytical and solid-state chemistry. As part of his work, Jason’s research resulted in more than a dozen patents and patent applications, including patents covering the cholesterol medication atorvastatin. His industry experience has become indispensable to clients as they frequently request his thorough analysis of the technology as part of the trial strategy.

While his practice focuses on leading and advising on patent litigation, Jason has also been involved in due diligence and licensing matters, including arbitrations concerning patent licenses. He has also been involved in inter-partes review (IPR) and interference practice at the US Patent and Trademark Office.

Jason is also active in the areas of diversity and inclusion in the practice of law. He currently serves his community of New Rochelle, New York where he was appointed to the LGBTQ Advisory Committee to the City Council.

Read Jason’s full biography in Japanese.

Simon Roberts focuses his practice on patent litigation in the life sciences and biotechnology sectors. He has nearly 30 years of experience practicing law in both the US and Europe. Simon leverages his background in chemistry to translate complex technical issues into relatable terms for clients.

Simon has in-depth experience and knowledge in Hatch-Waxman related litigations involving small molecules as well as other pharma-related patent matters including those involving large molecule pharmaceuticals. With a proven track record in high-stakes litigation matters, Simon represents clients before the federal courts as well as the United States Patent and Trademark Office (USPTO) in contested proceedings including IPRs and PGRs.

Notably, Simon orchestrated the first successful supplemental examination request to be filed with the USPTO that included disclosures unrelated to prior art leading to the significant strengthening of a patent portfolio protecting one of the world's most successful branded pharmaceutical products. He also has the rare distinction of being permitted to present oral argument before the Patent Reexamination Board (PRB) of China's Intellectual Property Office (SIPO) in Beijing, resulting in the PRB upholding the patentability of the patent covering an active ingredient in the world's best-selling HIV medications. All of Simon’s litigations to date have resulted in successful outcomes for his clients, despite many involving secondary patents that involved both disputed validity and infringement contentions.

Read Simon’s full biography in Japanese.