Carl A. Morales, Ph.D.

212-430-2602
cmorales@fenwick.com
Partner
Intellectual Property

Carl A.
Morales, Ph.D.

Carl A.
Morales, Ph.D.

Carl A.
Morales, Ph.D.

Partner
Intellectual Property
Industries

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).

Prior to joining Fenwick, Carl was a partner in a leading international law firm. He previously also represented pharmaceutical clients in patent infringement litigation, particularly matters arising under the Hatch-Waxman Act.

Read more

  • 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)

  • 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)

  • “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 U.S. Patent Term,” China Pharma IP Summit 2019, October 2019 (Speaker)
  • “Counteracting the flux of patent eligibility,” Managing Intellectual Property U.S. 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)

  • “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 U.S. Patent Term,” China Pharma IP Summit 2019, October 2019 (Speaker)
  • “Counteracting the flux of patent eligibility,” Managing Intellectual Property U.S. 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)

Recognition Recognition Recognition

Recognition Recognition Recognition

Recognition
LMG Life Sciences

2022

Named a Leading Life Sciences Lawyer by LMG Life Sciences for Patent Prosecution and Patent Strategy & Management

The Legal 500

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)

IAM Patent 1000

2020 - 2024

Recognized by IAM Patent 1000 for Prosecution in New York 2020 - 2023 and for Transactions in New York in 2022 - 2023

LMG Life Sciences

2021

Named Patent Strategy Attorney of the Year – New York by the LMG Life Sciences Americas Awards

Recognition
LMG Life Sciences

2022

Named a Leading Life Sciences Lawyer by LMG Life Sciences for Patent Prosecution and Patent Strategy & Management

The Legal 500

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)

IAM Patent 1000

2020 - 2024

Recognized by IAM Patent 1000 for Prosecution in New York 2020 - 2023 and for Transactions in New York in 2022 - 2023

LMG Life Sciences

2021

Named Patent Strategy Attorney of the Year – New York by the LMG Life Sciences Americas Awards