Other related webinars
Are Genes Patentable in the United States? (A Re...
Friday, 26th August, 2011
Time : 02:00 PM | 11:00 AM
GLP Regulations – A Simplified Overview for Ac...
Friday, 2nd December, 2011
Time : 02:00 PM | 11:00 AM
Understanding FDA Guidance on GLP for Nonclinica...
Thursday, 22nd December, 2011
Time : 02:00 PM EST | 11:00 AM PST
FDA and EMA successful development and approvals...
Friday, 22nd June, 2012
Time : 02:00 PM EST | 11:00 AM PST
Strategic insights into European (CHMP/EMA) and ...
Monday, 3rd December, 2012
Time : 02:00 PM EST | 11:00 AM PST
FDA Approvals and Insights: Understanding US-FDA...
Friday, 1st March, 2013
Time : 02:00 PM IST | 09:30 AM CET
Effective Responses to FDA Warning Letters on Qu...
Friday, 15th August, 2014
Time : 01:00 PM | 10:00 AM
FDA’s view of Purchasing Controls, regulatory ...
Friday, 3rd October, 2014
Time : 01:00 PM EST | 10:00 AM PST
A review of the FDA’s oversight, regulatory re...
Friday, 16th January, 2015
Time : 01:00 PM EST | 10:00 AM PST
Preparing for and Managing EU Notified Bodies Au...
Thursday, 28th January, 2016
Time : 01:00 PM EDT | 10:00 AM PDT
Biopharmaceutical Method Transfer – Using a Qu...
Friday, 20th May, 2016
Time : 01:00 PM EDT | 10:00 AM PDT
Quality systems for Analytical Instrumentation a...
Friday, 24th June, 2016
Time : 01:00 PM EDT | 10:00 AM PDT
Effective Investigation of Deviations & Putting ...
Friday, 2nd September, 2016
Time : 04:00 PM IST | 11:30 AM BST
NO More Written Procedure (Standard Operating Pr...
Friday, 14th October, 2016
Time : 01:00 PM EDT | 10:00 AM PDT
Best Practices in Supplier Management: Evaluatio...
Friday, 20th January, 2017
Time : 10:00 AM EST | 04:00 PM BST
Using Quality Indicators for Successful FDA QSR ...
Friday, 10th February, 2017
Time : 04:00 PM IST | 11:30 AM BST
Effective Management Reviews for FDA and Managem...
Friday, 21st April, 2017
Time : 01:00 PM EDT | 10:00 AM PDT
FDA Internal Audits - An Important Tool for Avoi...
Friday, 30th June, 2017
Time : 04:00 PM IST | 11:30 AM BST
FDA Regulatory Rules for Supply Chain and Manufa...
Friday, 4th August, 2017
Time : 11:00 AM EDT | 08:00 AM PDT
FDA - Training Modules
Friday, 28th September, 2018
Time : Set the Time | Set the Time
FDA Quality Systems Inspection Technique (QSIT) ...
Friday, 26th October, 2018
Time : 01:00 PM EDT | 10:00 AM PST
Key Element of Quality Management System Complia...
Friday, 30th August, 2019
Time : 04:00 PM IST | 11:30 AM BST
A CAPA Primer - Elements of a CAPA Program
Friday, 28th February, 2020
Time : 01:00 PM EST | 10:00 AM PST
How To Respond To FDA 483s
Wednesday, 2nd March, 2022
Time : 01:00 PM EST | 10:00 AM PST
FDA Expectations from Supplier Management for GM...
Friday, 22nd April, 2022
Time : 01:00 PM EDT | 10:00 AM PDT
The clinical, regulatory and business challenges...
Friday, 19th August, 2022
Time : 01:00 PM EST | 10:30 AM PST
The FDA CGMP and Data Integrity in Pharmaceutica...
Friday, 7th April, 2023
Time : 01:00 PM EST | 10:30 AM PST
FDA PMA Submissions - Contents, Process, Pitfall...
Friday, 21st April, 2023
Time : 01:00 PM IST | 10:00 AM PST
Complaint Handling in Compliance with FDA and IS...
Friday, 26th May, 2023
Time : 01:00 PM EST | 10:00 AM PST
Recorded Webinar
Are Genes Patentable in the United States? (A Review of Court Decisions from Chakrabarty to Myriad)
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
In Diamond v. Chakrabarty, 447 U.S. 303 (1980), the United States Supreme Court held that “a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility,” was eligible for patenting under US patent laws. Technological advances have made patenting of biological products and methods both more possible and necessary. The line drawn by Chakrabarty between between products of nature and human-made inventions, the relevant distinction for purposes of determining novelty under US patent laws, has often been difficult to locate in the biological arena, even with a “magic microscope.”
On July 29, the US Court of Appeals for Federal Circuit issued its long anticipated decision in Association for Molecular Pathology v. USPTO (Myriad), a case about patents relating to breast cancer genes, known as BRCA I and II. The majority opinion held "isolated DNA" and cDNA to be patent eligible subject matter. A concurring and dissenting opinion offered different views that may lay groundwork for further review, either by the Federal Circuit en banc or by the Supreme Court.
On June 20, the Supreme Court granted review in Prometheus v. Mayo, a case concerned with certain diagnostic method claims of a kind similar to some claims at issue in Myriad. The Prometheus case, decided in light of the Supremes Court’s decision in Bilski v. Kappos, 130 S.Ct. 3218 (2010), also raises questions of patent eligibility under US law that may affect the outcome of Myriad and other future cases that involve patents covering biologic products and methods.
This webinar will review of these and other recent cases in some detail. It will attempt to distill principles that may help to guide future business decision making, patent prosecution and technology transfers. It will discuss the potential effects of Myriad in future patent litigation, especially under newly fashioned litigation procedures created in the Biologics Price Competition and Innovation Act of 2009. And, it will attempt to address the ultimate question raised in cases from Chakrabarty to Myriad: whether an individual can obtain patent rights to a gene, especially a human gene, or, still more simply, are gene genes patentable in the United States?
Who should attend
This webinar will provide valuable assistance to :
- Patent Attorney / Patent Agents / Patent Consultants / IPR Professionals
- Pharmaceutical companies or financial or investment institutions, or service providers as CROs, CMOs concerned with Biologics/Biotechnology/ Biogenerics, Biopharmaceuticals/ Biotherapeutics
- Head/VP/Director, Senior Managers of Commercial Affairs, Business Development, Marketing & Sales, Commercial Affairs, Legal Affairs Pricing and Reimbursement, Health Economics, Intellectual Property, Pharmacovigilance, Clinical Immunology
- Head/VP/Director, Senior Managers of R&D Biotechnology Clinical/Nonclinical/Pharmaceutical
- VP / Director of Product Development, or QA
- VP / Director of Business Development
- Director Regulatory Affairs or Clinical Operations
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
- QA Manager
- Clinical Quality Assurance
- Research and Development
- Clinical Serv
Content Disclaimer
Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.