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). FDA-approved drug products on which Carl has worked include 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.

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 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 in IP diligence for its $155M acquisition of royalty interest in the drug product seltorexant from Minerva Neuroscience
  • Royalty Pharma in its $575M acquisition of the residual royalty interest in Vertex Pharmaceuticals, Inc.’s cystic fibrosis treatments owned by the Cystic Fibrosis Foundation
  • Royalty Pharma in its $650M royalty purchase agreement with PTC Therapeutics, Inc. to acquire a portion of PTC’s royalty interest in Risdiplam
  • Royalty Pharma in its $255M acquisition from Agios Pharmaceuticals, Inc., of sales-based royalty rights on worldwide net sales of Bristol Myers Squibb’s IDHIFA® (enasidenib)
  • Royalty Pharma in its $220M acquisition of AiCuris Anti-infective Cures GmbH’s partial royalty interest in Prevymis™ (letermovir)
  • Royalty Pharma in its $94M acquisition of Massachusetts General Hospital’s royalty interest in Entyvio (vedolizumab)
  • Royalty Pharma in its $330M acquisition of Eisai Co., Ltd.’s royalties on sales of Epizyme Inc.’s soon-to-be-FDA-approved drug tazemetostat
  • Royalty Pharma in its $100M equity investment (with options to invest up to an additional $100M) in Epizyme Inc.
  • Royalty Pharma in its $827M acquisition of Ligand Pharmaceuticals’ royalties on sales of Promacta

* Includes experience from a prior firm

  • 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 in IP diligence for its $155M acquisition of royalty interest in the drug product seltorexant from Minerva Neuroscience
  • Royalty Pharma in its $575M acquisition of the residual royalty interest in Vertex Pharmaceuticals, Inc.’s cystic fibrosis treatments owned by the Cystic Fibrosis Foundation
  • Royalty Pharma in its $650M royalty purchase agreement with PTC Therapeutics, Inc. to acquire a portion of PTC’s royalty interest in Risdiplam
  • Royalty Pharma in its $255M acquisition from Agios Pharmaceuticals, Inc., of sales-based royalty rights on worldwide net sales of Bristol Myers Squibb’s IDHIFA® (enasidenib)
  • Royalty Pharma in its $220M acquisition of AiCuris Anti-infective Cures GmbH’s partial royalty interest in Prevymis™ (letermovir)
  • Royalty Pharma in its $94M acquisition of Massachusetts General Hospital’s royalty interest in Entyvio (vedolizumab)
  • Royalty Pharma in its $330M acquisition of Eisai Co., Ltd.’s royalties on sales of Epizyme Inc.’s soon-to-be-FDA-approved drug tazemetostat
  • Royalty Pharma in its $100M equity investment (with options to invest up to an additional $100M) in Epizyme Inc.
  • Royalty Pharma in its $827M acquisition of Ligand Pharmaceuticals’ royalties on sales of Promacta

* Includes experience from a prior firm

  • "'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)

  • "'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 - 2023

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 - 2023

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

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