Carl applies his scientific and legal training toward acquiring, protecting and managing patent rights for clients in the biotechnology, chemistry, pharmaceutical and medical device industries.
Carl has particular expertise in developing and prosecuting patent portfolios for FDA-approved or soon-to-be approved drug products, including for products involved or expected to be involved in litigation. He also devises and executes strategies to secure second and third generation patent coverage that extends pharmaceutical product exclusivity (e.g., formulation, dosing regimens and impurity profiles). Examples of FDA-approved drug products on which Carl has developed patent strategies include Krazati®, Beyfortus®, Imjudo®, Saphnelo®, Ibrance®, OxyContin®, Targiniq®, Fasenra™, Epanova®, Sitavig®, Oravig®, Bosulif®, Zetia® and Vytorin®.
Carl has prepared and prosecuted patent applications in the U.S. Patent and Trademark Office and numerous foreign patent offices. His practice also includes pre-litigation case assessments; preparing patentability, validity, infringement and enforcement opinions; and due diligence evaluations. He is experienced in post-grant patent proceedings when product-critical patents are at stake, such as reissues, reexaminations and European oppositions. Carl has also prepared numerous patent term adjustment petitions and patent term extension applications and conducted Orange Book listing investigations. Carl is a frequent speaker and author on developments in patents for life sciences companies. In addition to speaking engagements around the Untied States, he has recently co-authored “Emerging Legal Terrain: IP Risks from AI’s Role in Drug Discovery,” (May 2024) and “FTC Employs New Tactic in Effort Against Drug Makers Alleged to Have Improperly Listed Patents in the FDA’s Orange Book,” (November 2023).
Morales is revered as ‘thorough, knowledgeable, responsive and commercially oriented. He has a great bedside manner and is helpful as a partner to us on the matters we work on together.’”
IAM Patent 1000, 2024
Recognition Recognition Recognition
Recognition Recognition Recognition
2022
Named a Leading Life Sciences Lawyer by LMG Life Sciences for Patent Prosecution and Patent Strategy & Management
2020 - 2023
Recognized for Patents: Prosecution (including re-examination and post-grant proceedings) (2020-2023) and named a Next Generation Partner for Healthcare: Life Sciences (2023)
2020 - 2024
Recognized by IAM Patent 1000 for Prosecution in New York 2020 - 2024 and for Transactions in New York in 2022 - 2023
2021
Named Patent Strategy Attorney of the Year – New York by the LMG Life Sciences Americas Awards