Drafting eligible biotech and immunotherapy claims

The very recent US Supreme Court and Court of Appeals for Federal Circuit (CAFC) cases have dramatically changed the standard of patent eligibility. Several groundbreaking innovations were thus determined to be patent ineligible. The patent ineligibility would impact on the innovation s of the field...

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Main Author: Shyh-Jen Wang
Format: Article
Language:English
Published: Taylor & Francis Group 2019-11-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
Online Access:http://dx.doi.org/10.1080/21645515.2019.1608746
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author Shyh-Jen Wang
author_facet Shyh-Jen Wang
author_sort Shyh-Jen Wang
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description The very recent US Supreme Court and Court of Appeals for Federal Circuit (CAFC) cases have dramatically changed the standard of patent eligibility. Several groundbreaking innovations were thus determined to be patent ineligible. The patent ineligibility would impact on the innovation s of the field of biomarkers, diagnostic methods and personalize cancer immunotherapy. To solve the thorny problem of eligibility, this study retrospectively analyzes all CAFC related cases and presents a flow chart determining patent eligibility based on the courts’ decisions. Our analysis indicates the best way to avoid eligible rejection or invalidation is that an invention cannot fall within the categories of natural law, natural phenomenon or abstract idea. Thus, claiming non-natural cDNA, involving a step to grow a transformed cell or adding a means clause in a method claim would be some possible solutions. Moreover, based on the flow chart, even though a claim with substantive limitation but not well-understood, routine or conventional activities would be patent eligible; no one has successfully made the argument in the CAFC so far. We believe that this flow chart can serve as a set of guidelines for determining patent eligibility.
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spelling doaj.art-6e8428a4c9474f6a818e050b79576f7a2023-09-22T08:45:31ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2019-11-0115112706271210.1080/21645515.2019.16087461608746Drafting eligible biotech and immunotherapy claimsShyh-Jen Wang0Taipei Veterans General Hospital; Institute of Hospital and Health Care Administration, National Yang-Ming UniversityThe very recent US Supreme Court and Court of Appeals for Federal Circuit (CAFC) cases have dramatically changed the standard of patent eligibility. Several groundbreaking innovations were thus determined to be patent ineligible. The patent ineligibility would impact on the innovation s of the field of biomarkers, diagnostic methods and personalize cancer immunotherapy. To solve the thorny problem of eligibility, this study retrospectively analyzes all CAFC related cases and presents a flow chart determining patent eligibility based on the courts’ decisions. Our analysis indicates the best way to avoid eligible rejection or invalidation is that an invention cannot fall within the categories of natural law, natural phenomenon or abstract idea. Thus, claiming non-natural cDNA, involving a step to grow a transformed cell or adding a means clause in a method claim would be some possible solutions. Moreover, based on the flow chart, even though a claim with substantive limitation but not well-understood, routine or conventional activities would be patent eligible; no one has successfully made the argument in the CAFC so far. We believe that this flow chart can serve as a set of guidelines for determining patent eligibility.http://dx.doi.org/10.1080/21645515.2019.1608746patent eligiblebiotechimmunotherapycafc
spellingShingle Shyh-Jen Wang
Drafting eligible biotech and immunotherapy claims
Human Vaccines & Immunotherapeutics
patent eligible
biotech
immunotherapy
cafc
title Drafting eligible biotech and immunotherapy claims
title_full Drafting eligible biotech and immunotherapy claims
title_fullStr Drafting eligible biotech and immunotherapy claims
title_full_unstemmed Drafting eligible biotech and immunotherapy claims
title_short Drafting eligible biotech and immunotherapy claims
title_sort drafting eligible biotech and immunotherapy claims
topic patent eligible
biotech
immunotherapy
cafc
url http://dx.doi.org/10.1080/21645515.2019.1608746
work_keys_str_mv AT shyhjenwang draftingeligiblebiotechandimmunotherapyclaims