Biotechnology has led to the development of many of the most advanced therapies for cancer, infections, and Alzheimer’s Disease, and is at the forefront of renewable energy technologies. The combination of biotechnology and pharmaceuticals with diagnostics is the basis for the success of Personalized Medicine approaches, the future of medical treatment, including immunotherapy. As both an experienced scientist and IP attorney, Carla has worked closely with many academic scientists and companies in these fields and has more than 12 years of experience developing strong and diverse patent portfolios and counseling clients in IP matters.
Prior to joining the firm, Carla spent 12 years at Finnegan preparing and prosecuting patent applications before the U.S. and foreign patent offices and counseling clients on intellectual property strategies, due diligence acquisitions, freedom to operate, non-infringement, and validity opinions. Carla’s understanding of the critical scientific issues underlying each invention and its patentability comes, in large part, from the more than 13 years spent in academia, including her experience as a post-doctoral fellow at Harvard and a Principal Investigator on NIH-funded grants at the Maine Medical Center Research Institute.
Carla has published and lectured frequently on diagnostics and immunotherapy-related strategies and challenges.
Admitted:
- District of Columbia
- Maryland
- U.S. Patent and Trademark Office
Education:
- Catholic University of America, Columbus School of Law J.D., 2010
- George Washington University Ph.D., Biochemistry and Molecular Biology, 1999
- University of Porto, Portugal B.S., Biochemistry, 1993
Languages:
- French
- Portuguese
Professional Activities:
- American Intellectual Property Law Association
- Biotech Committee, 2010-Present
- Leader, Case Law Committee, 2017-
- Leader, Liaisons, 2017-
- Leader and Subchair, USPTO Relations, 2017-
- Leader and Subchair, Webinars, 2017-
- Biosimilars Subcommittee, 2013-Present
- Diagnostics and Gene Patenting Subcommittee, 2013-Present
- American Bar Association
- American Chemical Society
2018-Present Webinars and other Presentations:
- Biotechnology, Chemical and Pharmaceutical (BCP) Partnership Meeting Webinar, Washington DC, September 16, 2020:
- “Written Description for Antibodies”
- AIPLA Annual Meeting, Washington, D.C.; October 26, 2018
- Regulatory and IP Issues for Immunotherapies Including Car-T and Antibody Technologies (“Don’t Put The “Car-T” Before the Horse—IP And Regulatory Issues for Immunotherapies”)
- Obviousness of Immunotherapeutic Inventions in view of PTAB Decisions
- USPTO Biotechnology/Chemical/Pharmaceutical Customer Partnership; September 24, 2018
- Obviousness of Biologics: Identifying the Biggest Challenges
- AIPLA Webinar; September 19, 2018
- “Obviousness of Antibodies and other Biologics”
- Obviousness of Biologics Inventions: Strategies for Biologics Claims in the United States, Europe, and China; Strafford Publications; January 31, 2018
Selected Publications:
- The Immunotherapy Patent Landscape: Types of Patent Claims for Immunotherapeutic Inventions; August 10, 2017
- Amgen’s Sweet Spot Sends Praluent Out of the Market: Is the “Well Characterized Antigen” Doctrine Supported by Its Discovery?; January 2017
- Summary of FDA Clinical Pharmacology Guidance for Demonstrating Biosimilarity; January 4, 2017
- Federal Circuit Considers the “Newly Characterized Antibody” Test in Amgen v. Sanofi but Might Pass on a Ruling; June 2017
- “Agreeing to Disagree with the Supreme Court: Mayo Is Wrong, Would You Please Fix It?” Finnegan IP Update; December. 9, 2017
- “Structure or Function: Which Will Ultimately Have the Most Influence on Patent Eligibility of Biotech Inventions?” CIPA Journal; March 2015
- “What Was Everyone Waiting For? 2014 Interim Guidance on Patent Subject Matter Eligibility,” CIPA Journal; January 2015
- “Substantial Question of Patent Eligibility: The Claim as a Whole, The Function of the Product, The Conventionality of the Steps, What Else Can Be Questioned?” AIPLA Hot Biotech; October 6, 2014
- “A Call of Duty or an Overreaction? The 101 Guidance to the USPTO Examining Corps,” CIPA Journal; June 2014
- “In re Roslin: A Claim Drawn to “Exact Genetic Copies of Patent Ineligible Subject Matter” Is a Claim Drawn Itself to Patent Ineligible Subject Matter” AIPLA Biotech Buzz; May 8, 2014
- “The Old/New Test for Determining Patentability: Claims Must Be ‘Substantially Different’ from the Judicial Exceptions,” CIPA Journal; March 2014
- “New 35 USC 101 Guidance: ‘Significantly Different’ Is the Test for Determining Patent Eligibility of Claims Appearing to Be Drawn to Judicial Exceptions,” AIPLA Biotech Buzz; March 5, 2014
- “Mammalian Clones: Reduced to the Sum of Their Genetic Information for Determining Patent Eligibility,” AIPLA Biotech Buzz; February 5, 2014
- “Individuality Lost: Is Roslin’s Clone Innovation or Nothing but a Copy?” Lexology; February 3, 2014
- “It Took Myriad Years to Juxtapose Forethought with Ingenuity and Link BRCA Mutations to Breast Cancer: Will it Take Another Myriad to Settle Rights?” CIPA Journal; September 2012
- “A Hindsight-Averse Application of Lead Compound Case Law,” Law360; August 24, 2011
- “Lead Prior Art Methodology: Applying Lead Compound Case Law to Other Disciplines for Enhanced Objectivity,” Santa Clara Computer & High Technology Law Journal; February 2011
| Carla Mouta-Bellum can be reached via e-mail at: carla@arrigo.us Carla Mouta-Bellum can be contacted via her direct line at 202-316-3025 |
