Carl A. Morales PhD

A partner in Goodwin’s Life Sciences group and Intellectual Property practice, Carl Morales 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 complex patent portfolios for small molecule drug products, including for products involved or expected to be involved in patent litigation. He 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). Carl also routinely conducts due diligence on life science patent portfolios for a variety of transactions, including licensing deals, acquisitions, investments and royalty purchases.

Carl has prepared and prosecuted patent applications in the US Patent and Trademark Office and numerous foreign patent offices. His practice also includes pre-litigation case assessments as well as preparing patentability, validity, infringement and enforcement opinions. 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’s experience includes representing:

• Royalty Pharma and Pharmakon Advisors on IP diligence in their agreements to supply up to $375 million in funding to Geron Corporation*
• Royalty Pharma on IP diligence in its up to €128.8 million ($140 million) royalty monetization agreement with BRAIN Biotech AG*
• Royalty Pharma on IP diligence in its $150 million funding agreement with Ascendis Pharma, based on U.S. net sales of YORVIPATH*
• Royalty Pharma on IP diligence in its $905 million royalty acquisition agreement with Agios Pharmaceuticals*
• Royalty Pharma on IP diligence in its up to $575 million funding agreement with Cytokinetics*
• Royalty Pharma on IP diligence in its $525 million purchase of royalties for ImmuNext's frexalimab*
• Pharmakon Advisors on IP diligence in its $400 million non-dilutive loan agreement with Novocure*
• Pharmakon Advisors on IP diligence in its $200 million non-dilutive loan agreement with Tarsus Pharmaceuticals*
• Samsara BioCapital on IP diligence in its investment in Alumis’ $259 million Series C financing*
• Royalty Pharma on IP diligence regarding its up to $150 million R&D support agreement with Teva relating to Teva's olanzapine LAI (TEV-‘749)*
• Royalty Pharma on IP diligence regarding its up to $1.5 billion purchase of royalties for Roche’s Evrysdi, an orally administered survival motor neuron (SMN2) medication for the treatment of spinal muscular atrophy, from PTC Therapeutics*
• Royalty Pharma on IP diligence regarding its $150 million capped synthetic royalty funding agreement with Ascendis Pharma, based on U.S. net sales of Skytrofa® (lonapegsomatropin-tcgd)*
• Royalty Pharma on IP diligence regarding its acquisition of a synthetic royalty on U.S. net sales of Ferring’s Adstiladrin® (nadofaragene firadenovec-vncg) for up to $500 million*
• Pharmakon on IP diligence regarding a definitive senior secured loan agreement for Reata Pharmaceuticals for up to $275 million (in two parallel $137.5 million investments)*
• Pharmakon on IP diligence in its non-dilutive term loan financing for ImmunoGen for up to $175M*
• Royalty Pharma on IP diligence in its acquisition of an interest in Ionis' royalty in Biogen's SPINRAZA® (nusinersen) and Novartis' pelacarsen for up to $1.125B*
• Pharmakon on IP diligence in its $100M loan agreement with Immunocore*
• Royalty Pharma on IP diligence in its acquisition of a royalty interest in Amgen’s olpasiran from Arrowhead Pharmaceuticals totaling up to $410M*
• New Enterprise Associates on IP diligence related to Inversago Pharma’s $70M (USD) Series C financing*
• Pharmakon on IP diligence in its $350M strategic financing for Insmed*
• Royalty Pharma on IP diligence in its $425M funding agreements with Merck to co-fund the development of MK-8189*
• Marshall Wace on IP diligence of Elektrofi's $40M Series B financing*
• Royalty Pharma in its $450M investment in Cytokinetics Inc. based on the drug products aficamten and omecamtive mecarbil*
• Royalty Pharma on IP diligence in its $2.025B strategic funding partnership as part of MorphoSys' $1.7B acquisition of Constellation Pharmaceuticals*
• Royalty Pharma in its $342M acquisition of the royalty interest in the cabozantinib products Cabometyx and Cometriq from GlaxoSmithKline (GSK)*

*Denotes experience prior to joining Goodwin

Prior to joining Goodwin, Carl was an Intellectual Property partner at Fenwick & West LLP.

• LMG Life Sciences Americas Awards: Finalist for Patent Strategy Attorney of the Year – New York (2024)
• IAM Patent 1000: Recognized for Prosecution in New York (2020-2024) and Transactions in New York (2022-2024)
• LMG Life Sciences Americas Awards: Finalist for Patent Strategy Attorney of the Year – New York (2023)
• The Legal 500: Recognized for Patents: Prosecution (including re-examination and post-grant proceedings) (2020-2023) and named a Next Generation Partner for Healthcare: Life Sciences (2019-2021, 2023)
• LMG Life Sciences: Named a Leading Life Sciences Lawyer for Patent Prosecution and Patent Strategy & Management (2022)
• LMG Life Sciences Americas Awards: Named Patent Strategy Attorney of the Year – New York (2021)
• LMG Life Sciences: Named a US Rising Star – Intellectual Property (2020)

Carl is a frequent speaker and author on developments in patents for life sciences companies. He 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).

Carl’s speaking engagements include:

• “From Gilead to Cellect: A Comprehensive Analysis of Key Developments in ODP and Implications for PTA and PTE,” BIO Intellectual Property Counsels Committee Conference; New Orleans, LA, November 2023 (Speaker, panelist)
• “'Skinny Labeling,' Liability for Indirect Infringement,” BIO Intellectual Property Counsels Committee Conference, November 2022 (Speaker, panel moderator)
• “Original Sin: How Origination Credit Is a Barrier to Diversity Goals,” Office for Diversity & Inclusion of the New York City Bar Association, October 2020 (Speaker)
• “Keys to Maximizing US Patent Term,” China Pharma IP Summit 2019, October 2019 (Speaker)
• “Counteracting the flux of patent eligibility,” Managing Intellectual Property US Patent Forum 2019, April 2019 (Speaker, panel)
• “Identifying Patent Examiner Biases and Making Them Work Using Legal Analytics,” Legal Analytics and the Business of Law Summit, November 2014 (Speaker, panel)