💉NIH Proposes New Intellectual Property Policy for Cancer Research
The National Cancer Institute, an Institute of the National Institutes of Health, Department of Health and Human Services, Division of Cancer Prevention (DCP) is seeking comments on instituting a standard policy on Intellectual Property (IP) developed by certain funding recipients under NCI DCP funding agreements. This standard policy is entitled "The DIVISION OF CANCER PREVENTION INTELLECTUAL PROPERTY OPTION TO COLLABORATORS (IP Option)." The proposed policy, if finalized, shall apply to entities that conduct DCP-funded clinical studies under funding agreements which involve an NCI collaborator that provides its proprietary agent or technology for the DCP-supported studies where this IP Option is included as a term of applicable existing and future funding agreements.
Learn More🧬Requirements for Patent Applications with Nucleotide Sequence Disclosures
The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on the extension and revision of an existing information collection: 0651- 0024 (Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures). The purpose of this notice is to allow 60 days for public comments preceding submission of the information collection to the Office of Management and Budget (OMB).
Learn More🧬FDA Classifies Fluorescence Devices for Hematologic Malignancies
The Food and Drug Administration (FDA, the Agency, or we) is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More💊FDA Notice on ALTUVIIIO Patent Extension and Review Period
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALTUVIIIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💉Government-Owned Invention Licensing Opportunity in Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More💡Government-Owned Inventions Available for Licensing in Healthcare
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More💡Licensing Opportunities for Government-Owned Influenza Inventions
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More💊FDA's Patent Extension Review for ROLVEDON and Its Business Impact
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROLVEDON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💉Government-Owned Invention Licensing Notice for Norovirus Antibody
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More🌱Overview of Amendments to Genetically Engineered Organism Regulations
On December 2, 2024, a Federal court vacated the Animal and Plant Health Inspection Service (APHIS) final rule issued on May 18, 2020 (the May 2020 final rule) that revised APHIS' regulations governing the movement of certain genetically modified organisms and was issued under the authority of the Plant Protection Act. APHIS is therefore amending the CFR to conform the CFR to the Federal Court's vacatur of that rule. The Court's vacatur was effective December 2, 2024, and had the legal effect of vacating the May 2020 final rule in its entirety and restoring the legal effect of the pre-May 2020 regulations. These technical conforming amendments revise the CFR to reflect the court's vacatur of the May 2020 final rule.
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