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Reported covered position: Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)
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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.) Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics. Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Source: Senate LDA
Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDAcAAP-approved products under certain circumstances.)
Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.) Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products The ongoing PTO-FDA collaboration on drug pricing
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products. Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners. The ongoing PTO-FDA collaboration on drug pricing.
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products. Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners. The ongoing PTO-FDA collaboration on drug pricing.
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Proposals to allow the direct expensing on R&D expenditures, including the Hassan-Young bill, S.866, he American Innovation and Jobs Act.
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Issues related to biotechnology firms engaged in developing gene therapies, including: Successor legislation to the 117th Congress Guthrie-Schrader MVP Act (H.R. 7389) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Amendments to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies.
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA) discussed at the February 3rd hearing of the House Energy & Commerce Committee. Legislative discussed at the March 17th hearing of the House Energy & Commerce Committee as potential riders to the PDUFA bill, including: H.R. 6696, the Accelerating Access for Patients Act; H.R. 6963, the Accelerating Approval Integrity Act; H.R. 6000, the CURES 2.0 Act; H.R. 1730, the Speeding Therapy Access Today Act; H.R. 6888, the Helping Experts Accelerate Rare Treatments Act; Development of Value Based Agreement (VBA) legislation, including proposals under discussion by Rep. Schrader, Guthrie and Mullin. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Legislative proposals to reinstate direct expensing of R&D investment such as considered but not included in the year end Omnibus Appropriations bill, H.R.2167.
Legislative proposals contained in year end Omnibus Appropriations Bill (H.R. 2617) including certain unenacted PDUFA "riders" such as clinical trial diversity and the FDA accelerated approval program.(H.R. 6696 and H.R. 6963.) In addition, provisions in the omnibus bill related to the funding of newborn screening programs as well as the enactment of a National Academy of Medicine study of NBS. Continued work on Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA) discussed at the February 3rd hearing of the House Energy & Commerce Committee. Legislative discussed at the March 17th hearing of the House Energy & Commerce Committee as potential riders to the PDUFA bill, including: H.R. 6696, the Accelerating Access for Patients Act; H.R. 6963, the Accelerating Approval Integrity Act; H.R. 6000, the CURES 2.0 Act; H.R. 1730, the Speeding Therapy Access Today Act; H.R. 6888, the Helping Experts Accelerate Rare Treatments Act; Development of Value Based Agreement (VBA) legislation, including proposals under discussion by Rep. Schrader, Guthrie and Mullin. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Legislative proposals contained in year end Omnibus Appropriations Bill (H.R. 2617) including certain unenacted PDUFA "riders" such as clinical trial diversity and the FDA accelerated approval program.(H.R. 6696 and H.R. 6963.) In addition, provisions in the omnibus bill related to the funding of newborn screening programs as well as the enactment of a National Academy of Medicine study of NBS. Continued work on Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA) discussed at the February 3rd hearing of the House Energy & Commerce Committee. Legislative discussed at the March 17th hearing of the House Energy & Commerce Committee as potential riders to the PDUFA bill, including: H.R. 6696, the Accelerating Access for Patients Act; H.R. 6963, the Accelerating Approval Integrity Act; H.R. 6000, the CURES 2.0 Act; H.R. 1730, the Speeding Therapy Access Today Act; H.R. 6888, the Helping Experts Accelerate Rare Treatments Act; Development of Value Based Agreement (VBA) legislation, including proposals under discussion by Rep. Schrader, Guthrie and Mullin. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA) discussed at the February 3rd hearing of the House Energy & Commerce Committee. Legislative discussed at the March 17th hearing of the House Energy & Commerce Committee as potential riders to the PDUFA bill, including: H.R. 6696, the Accelerating Access for Patients Act; H.R. 6963, the Accelerating Approval Integrity Act; H.R. 6000, the CURES 2.0 Act; H.R. 1730, the Speeding Therapy Access Today Act; H.R. 6888, the Helping Experts Accelerate Rare Treatments Act; Development of Value Based Agreement (VBA) legislation, including proposals under discussion by Rep. Schrader, Guthrie and Mullin. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA) discussed at the February 3rd hearing of the House Energy & Commerce Committee. Legislative discussed at the March 17th hearing of the House Energy & Commerce Committee as potential riders to the PDUFA bill, including: H.R. 6696, the Accelerating Access for Patients Act; H.R. 6963, the Accelerating Approval Integrity Act; H.R. 6000, the CURES 2.0 Act; H.R. 1730, the Speeding Therapy Access Today Act; H.R. 6888, the Helping Experts Accelerate Rare Treatments Act; Development of Value Based Agreement (VBA) legislation, including proposals under discussion by Rep. Schrader, Guthrie and Mullin. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Legislative proposals contained in year end Omnibus Appropriations Bill (H.R. 2617) including certain unenacted PDUFA "riders" such as clinical trial diversity and the FDA accelerated approval program.(H.R. 6696 and H.R. 6963.) In addition, provisions in the omnibus bill related to the funding of newborn screening programs as well as the enactment of a National Academy of Medicine study of NBS. Continued work on Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.
Legislative proposals contained in year end Omnibus Appropriations Bill (H.R. 2617) including certain unenacted PDUFA "riders" such as clinical trial diversity and the FDA accelerated approval program.(H.R. 6696 and H.R. 6963.) In addition, provisions in the omnibus bill related to the funding of newborn screening programs as well as the enactment of a National Academy of Medicine study of NBS. Continued work on Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Interagency Patent Coordination and Improvement Act of 2022
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Interagency Patent Coordination and Improvement Act of 2022
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Interagency Patent Coordination and Improvement Act of 2022
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.) Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.) Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Preserve Access to Affordable Generics and Biosimilars Act
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products. Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners. The ongoing PTO-FDA collaboration on drug pricing.
Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.) Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products. Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners. The ongoing PTO-FDA collaboration on drug pricing.
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics. Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.) Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDAcAAP-approved products under certain circumstances.)
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics. Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products The ongoing PTO-FDA collaboration on drug pricing
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Issues related to biotechnology firms engaged in developing gene therapies, including: Successor legislation to the 117th Congress Guthrie-Schrader MVP Act (H.R. 7389) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Amendments to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies.
Proposals to allow the direct expensing on R&D expenditures, including the Hassan-Young bill, S.866, he American Innovation and Jobs Act.
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics. Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products The ongoing PTO-FDA collaboration on drug pricing
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Legislative proposals contained in year end Omnibus Appropriations Bill (H.R. 2617) including certain unenacted PDUFA "riders" such as clinical trial diversity and the FDA accelerated approval program.(H.R. 6696 and H.R. 6963.) In addition, provisions in the omnibus bill related to the funding of newborn screening programs as well as the enactment of a National Academy of Medicine study of NBS. Continued work on Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Legislative proposals to reinstate direct expensing of R&D investment such as considered but not included in the year end Omnibus Appropriations bill, H.R.2167.
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization, including proposals to expand the waiver beyond vaccines to therapeutics and diagnostic products. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization, including proposals to expand the waiver beyond vaccines to therapeutics and diagnostic products. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA),S.4348 and H.R. 7667, including "rider"amendments such as those pertaining to the FDA accelerated approval pathway (H.R. 6696 and H.R. 6963. Development of Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA) discussed at the February 3rd hearing of the House Energy & Commerce Committee. Legislative discussed at the March 17th hearing of the House Energy & Commerce Committee as potential riders to the PDUFA bill, including: H.R. 6696, the Accelerating Access for Patients Act; H.R. 6963, the Accelerating Approval Integrity Act; H.R. 6000, the CURES 2.0 Act; H.R. 1730, the Speeding Therapy Access Today Act; H.R. 6888, the Helping Experts Accelerate Rare Treatments Act; Development of Value Based Agreement (VBA) legislation, including proposals under discussion by Rep. Schrader, Guthrie and Mullin. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.) Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
Proposed Covid-19 IP waiver under consideration by the U.S. Congress, Biden Administration and World Trade Administration. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.) Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement. Planned trade related activities for new Administration and 117th Congress.
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issues related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. This includes responding to the CMS regulatory proposal with respect to value based agreements and providing feedback on how this proposed rule affects legislation on VBAs pending in the Senate and being planned in the House. Activities included responding to Interim Final Rule known as the "Most Favored Nation" reimbursement system for certain Part B drugs. Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee. In addition, working to achieve the reauthorization of the soon-expiring Pediatric Priority Review Voucher legislation. Identify issues and allies with respect to the upcoming FDA User Fee reauthorization legislation (PDUFA VII) and the under development CURES 2.0 legislative initiative. Identified issues relevant to possible participation in NIH-FDA-FNIH Bespoke Gene Therapy Consortium.
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy. Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues. Followed up with the AAG for Antitrust and Antitrust Division staff on issues related to the anti-competitive effects of current U.S. case law and PTO administrative actions related to subject matter patentability. Assisted Senior Vice President and Chief Patent Counsel in her participation on joint DOJ(ATR)-PTO Workshop on Competition Issues in the Life Sciences
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries. Analyzed and planned response to an Executive Order restricting immigration of highly-qualified non-U.S. citizen scientists and clinical trial patients.
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries. Analyzed and planned response to an Executive Order restricting immigration of highly-qualified non-U.S. citizen scientists and clinical trial patients.
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issued related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee.
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules.
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy.
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules.
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals.
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights.
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing.
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Issues related to gene therapy
Issues related to gene therapy
Legislative proposals to reinstate direct expensing of R&D investment such as included in the draft Senate version of the Build Back Better legislation and in some versions of the "U.S.- China" competitiveness legislation. Potential inclusion of the R&D expensing provision in any appropriation vehicles.
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA),S.4348 and H.R. 7667, including "rider"amendments such as those pertaining to the FDA accelerated approval pathway (H.R. 6696 and H.R. 6963. Development of Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22. Newborn Screening Act reauthorization legislation: H.R. 482 and S.350. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Legislative proposals to reinstate direct expensing of R&D investment such as included in the draft Senate version of the Build Back Better legislation and in some versions of the "U.S.- China" competitiveness legislation.
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Legislative proposals to reinstate direct expensing of R&D investment such as included in the draft Senate version of the Build Back Better legislation.
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Development of Value Based Agreement (VBA) legislation. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill. Advocated in favor of a VBA amendment offered during the House E&C markup of the BBB bill. Participated in strategy sessions related to confirmation hearing for the Commissioner of Food and Drugs nominee.
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Proposed Covid-19 IP waiver under consideration by the U.S. Congress, Biden Administration and World Trade Administration. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Proposed Covid-19 IP waiver under consideration by the U.S. Congress, Biden Administration and World Trade Administration. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Proposed Covid-19 IP waiver under consideration by the U.S. Congress, Biden Administration and World Trade Administration. Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy. Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues. Followed up with the AAG for Antitrust and Antitrust Division staff on issues related to the anti-competitive effects of current U.S. case law and PTO administrative actions related to subject matter patentability. Assisted Senior Vice President and Chief Patent Counsel in her participation on joint DOJ(ATR)-PTO Workshop on Competition Issues in the Life Sciences. Participated in meetings of the Section 101 Workgroup and Senate staff in preparation for discussion of legislative response to certain patent issues related to Section 101.
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries. Analyzed and planned response to an Executive Order restricting immigration of highly-qualified non-U.S. citizen scientists and clinical trial patients.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issues related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. This includes responding to the CMS regulatory proposal with respect to value based agreements and providing feedback on how this proposed rule affects legislation on VBAs pending in the Senate and being planned in the House. Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee. In addition, working to achieve the reauthorization of the soon-expiring Pediatric Priority Review Voucher legislation. Identify issues and allies with respect to the upcoming FDA User Fee reauthorization legislation (PDUFA VII) and the under development CURES 2.0 legislative initiative. Identified issues relevant to possible participation in NIH-FDA-FNIH Bespoke Gene Therapy Consortium.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issued related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. This includes responding to the CMS regulatory proposal with respect to value based agreements and providing feedback on how this proposed rule affects legislation on VBAs pending in the Senate and being planned in the House. Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee. In addition, working to achieve the reauthorization of the soon-expiring Pediatric Priority Review Voucher legislation. Identify issues and allies with respect to the upcoming FDA User Fee reauthorization legislation (PDUFA VII) and the under development CURES 2.0 legislative initiative.
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy. Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues. Followed up with the AAG for Antitrust and Antitrust Division staff on issues related to the anti-competitive effects of current U.S. case law and PTO administrative actions related to subject matter patentability.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy. Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues.
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE