№ files_lp_4_process_3_135733
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Analysis of a Federal Circuit case assessing the adequacy of written description for a patent claiming a specific dosage of dimethyl fumarate for treating multiple sclerosis, highlighting judicial interpretation of disclosed ranges versus specific endpoints.
Year:
2021
Region:
United States
Subject:
Patent law, pharmaceutical patents, multiple sclerosis treatment
Document type:
Legal case analysis
Court / institution:
Federal Circuit, U.S. District Court for the Northern District of West Virginia
Author:
Dennis Crouch
Key parties:
Biogen Int’l GMBH, Mylan Pharma Inc.
Patent number:
US 8,399,514
Drug involved:
Dimethyl fumarate (DMF)
Legal issue:
Written description requirement
Date of decision:
November 30, 2021
Judges involved:
Judge Keeley, Judge Reyna, Judge Hughes, Judge O’Malley
Relevant prior art:
Original 2007 provisional application
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Context description:
This document provides email templates and guidelines for communicating with end users about upcoming changes related to Duo Security’s Trusted Endpoints enforcement and Duo Mobile app requirements.
Source of adaptation:
Code of Practice for the Housing and Care of Laboratory Mice, Rats, Guinea Pigs and Rabbits, Agriculture Victoria
Institution:
Griffith University
Committee:
Animal Ethics Committee (AEC)
Facility:
Biosciences Resources Facility
Document type:
Monitoring scoresheets and clinical welfare assessment forms
Purpose:
Submission with AEC application and annual reports
Retention requirement:
Records kept for 7 years after project completion
Scope:
Laboratory mice, rats, guinea pigs and rabbits
Includes:
Daily Monitoring Scoresheet; Clinical Welfare Scoresheet (Example 2 and 3); Post-Surgery Scoresheet
Reference cited:
Morton, D.B. (1997) A scheme for the recognition and assessment of adverse effects in animals. In Developments in animal and veterinary sciences, 27. Animal Alternatives, Welfare and Ethics. Elsevier Science B.V.
Contact details:
Animal Ethics Coordinator [email protected]
Note:
; Biosciences Resources Facility Manager telephone 5552 8308; Animal Ethics Coordinator telephone 3735 6648
Year:
2023
Region / City:
Manchester, UK
Subject:
Maternity Care, Health Research
Document Type:
Research Protocol
Institution:
University of Manchester
Author:
Professor Alexander Heazell
Target Audience:
Researchers, NHS Staff, Policy Advisors
Period of Validity:
November 2023 - May 2025
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2021
Region / City:
N/A
Theme:
Clinical outcomes, Radiographic analysis
Document Type:
Research table
Author:
Banger, Bell, Blyth, Çabuk, Clement, Cool, FuJun, Gilmour, Hansen, Katherine, Kayani, Lonner, Maritan, Motesharei, Park, St Mart, Tan, Thilak, Wong, Wu, Yin
Target Audience:
Researchers, Medical professionals
Period of validity:
N/A
Approval Date:
N/A
Date of changes:
N/A
Note:
Year
Note:
Year
Contextual description:
Template for a Memorandum of Understanding between an operating agency and a state Medicaid agency, detailing provisions for administrative claiming.
Year:
2020
Region / City:
Northern Ireland
Topic:
Agricultural business registration
Document Type:
Application form
Issuing Authority:
Department of Agriculture, Environment and Rural Affairs (DAERA)
Author:
Department of Agriculture, Environment and Rural Affairs (DAERA)
Target Audience:
Individuals or entities registering a small-scale farm business without claiming grants or subsidies
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Topic:
Refund, Rectification
Document Type:
Guidelines
Organ / Institution:
Protean CRA
Target Audience:
Subscribers of eNPS
Contextual description:
Guidelines for subscribers on how to submit documents to request refunds or rectification of erroneous transactions made through the eNPS portal/D-remit Mode.
Year:
2023
Region / City:
United Kingdom
Topic:
Police Misconduct
Document Type:
Guidelines
Organization / Institution:
Metropolitan Police, MOPAC
Author:
Not specified
Target Audience:
Legally Qualified Chairs of Police Misconduct Panels
Period of Validity:
Ongoing
Approval Date:
August 2023
Date of Last Changes:
Not specified
Year:
2020
Region / City:
Massachusetts
Subject:
Medicaid, Health Services, Education
Document Type:
Guide
Institution / Organization:
MassHealth
Author:
Not specified
Target Audience:
Local Education Agencies (LEAs), LEA staff, Health directors, Special education directors, Student services directors
Period of Validity:
Ongoing
Approval Date:
July 1, 2020
Date of Updates:
August 2020
Form Number:
MED-97
Issuing Authority:
Office of the Principal Director of Audit (Steel), Ranchi
Document Type:
Application Form
Subject:
Refund of Medical Expenses
Applicable To:
Central Government Servants and their families
Scope:
Medical attendance and hospital treatment
Sections:
Medical Attendance; Hospital Treatment; Declaration; For Official Use Only
Required Attachments:
Essentiality Certificate; Cash Memos; Hospital Receipts; Medical Certificates
Declaration:
To be signed in full by the Government Servant
Administrative Use:
Scrutiny and sanction by Audit Officer and Deputy Director
Requirement:
Separate form for each patient
Document Number:
20-P-018
Date:
November 25, 2019
Subject:
Claiming Exemption from Federal Taxation W-4 Changes for 2020
Effective Date:
Immediately
Issuing Office:
Office of the Chief Financial Officer
OCFO Contact:
Carmen Waters
Contact Phone:
(785) 296-7059
Contact Email:
[email protected]
Related Forms:
IRS Form W-4 (2020), Form K-4, Form 8233
System Referenced:
SHARP
Process Referenced:
KPAY320
Legislative Reference:
Tax Cuts and Jobs Act of 2018
Target Implementation Date:
December 30, 2019
Paper Submission Deadline:
January 3, 2020, 6:00 p.m.
Calendar Year:
2020
Region:
Kansas
Document Type:
Informational Circular
Agency:
Social Security Administration (SSA)
Form Number:
SSA-3881-BK
OMB Control Number:
0960-0499
Regulatory Citation:
20 CFR 416.912(a)
Document Type:
Addendum to Supporting Statement
Subject:
Revision of Privacy Act Statement and Information Collection Updates
Related Information Collection:
Questionnaire for Children Claiming SSI Benefits
Date of Last OMB Approval:
12/28/2021
Terms of Clearance:
Additional description of collection, burden adjustment, clarification of electronic submission capability
Systems Referenced:
Electronic Disability Collect System (EDCS)
Policy Reference:
M-22-10 (including Psychological Costs and Learning Costs)
Proposed Changes:
Update to Privacy Act Statement; expanded description of information collection; inclusion of future submittable PDF plans
Issuing Office:
Office of the General Counsel, SSA
Year:
Not specified
Region / City:
Not specified
Subject:
Insurance claim
Document type:
Claim Mandate Form
Organization:
TTK Health Care TPA Pvt. Ltd / The Insurance Company
Author:
Not specified
Target audience:
Insured individuals
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Financial Year:
2023–24 (ending on March 31, 2024)
Document Type:
Tax Residency and DTAA Benefit Declaration
Subject:
Claim of tax treaty benefits under India-[COUNTRY OF RESIDENCE] DTAA
Related Agreement:
Agreement for Avoidance of Double Taxation and Prevention of Fiscal Evasion between India and [COUNTRY OF RESIDENCE]
Issuing Party:
[NAME OF SHAREHOLDER]
Addressee:
_______________________ Limited
Jurisdiction:
India and [COUNTRY OF RESIDENCE]
Purpose:
Determination of applicable withholding tax on dividend income
Shareholding Details:
Beneficial ownership of [NO OF SHARES] shares and related dividend income
Tax Status Confirmation:
No taxable presence, fixed base, or permanent establishment in India during FY 2023–24
Execution:
Authorized Signatory of [NAME OF SHAREHOLDER]
Date:
DD/MM/YYYY
Year:
2022
Region / City:
Alabama, USA
Topic:
Tax Credits and Charitable Donations
Document Type:
Instructional Guide
Organization:
Alabama Department of Revenue
Author:
Maynard Cooper & Gale LLP
Target Audience:
Pass-through entity owners and potential donors
Effective Period:
Ongoing
Date of Publication:
November 2, 2022
Reference:
Final Regulations Relating to Business Expense Deductions and State Tax Credits for Donations to Charitable Organizations (T.D. 9907, Aug. 11, 2020)
Diet name:
Grapefruit diet
Subject:
Rapid weight loss diet instructions
Document type:
Informal diet instruction text
Claimed weight loss:
10 pounds
Claimed duration:
10 days
Primary food:
Grapefruit
Other foods mentioned:
Lamb chops, steaks, pork, chicken, other meats
Diet restriction:
Absence of carbohydrates
Warning:
Grapefruit consumption may be dangerous when combined with prescription medication
Disclaimer:
Diet stated as unproven and described as not working
Tone:
Humorous and ironic
Intended context:
Preparation for short-term events such as weddings or spring break
Year:
2023
Region / city:
Not specified
Topic:
Tax deductions for home-based businesses
Document type:
Guide
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Home-based business owners
Period of validity:
Ongoing
Approval date:
Not specified
Date of changes:
Not specified