alexa IP Checklist For Similar Biologics
ISSN: 1948-593X

Journal of Bioanalysis & Biomedicine
Open Access

Like us on:
OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Share This Page

Additional Info

Loading
Loading Please wait..
 

3rd International Conference and Exhibition on Biowaivers, Biologics & Biosimilars
October 27-29, 2014 Hyderabad International Convention Centre, Hyderabad, India

Mita Sheikh
ScientificTracks Abstracts: J Bioanal Biomed
DOI: 10.4172/1948-593X.S1.013
Abstract
Various blockbuster Biologics go off patent by 2020 creating a huge opportunity for the Biopharma Industry. To capitalize on this opportunity and improve access to such Biologics, innovators as well as generic companies are developing molecules called similar Biologics, more commonly referred to as ?Biosimilars?. Intellectual Property (?IP?) challenges faced by developers planning to launch Biosimilars in India and other jurisdictions are far more complex than those faced by their counterparts developing generic small molecules. Besides the molecule itself and its manufacturing process clones, promoters, vectors, plasmids, sequences, and downstream processes can also be separately patented. Therefore, an in-depth study of the IP landscape revolving around a specific product of interest has become a prerequisite. A well thought out IP strategy would go a long way in ensuring an encumbrance free and effective launch of biosimilar products. Creation of a stepwise IP checklist is a good start for devising and implementing a cost effective IP strategy. An effective stepwise IP checklist aligned to various steps of development and launch should include ? ? CDA; ? FTO - carried out at the final stages for the innovator product is required to be carried out early on in case of similar biologics; ? Study of Patent family, file wrappers; ? Claim scope; ? Litigations in jurisdictions of interest; ? R&D considerations ?assignments, lab notebooks, research material IP status e.g. of clones, plasmids, phages, etc. ? Due diligence of materials to be In-licensed; ? Patentability and creating own IP; ? Complimentary FTO
Biography
Mita Sheikh has Masters Degree in Plant Physiology from the I.Sc. Mumbai. She is a Patent Agent and Sr. Associate with the Life Sciences and Chemistry Department of Krishna & Saurastri Associates. She has been providing counseling for protection and management of patent estate in global geography for Life Sciences inventions. She has assisted clients with inventions relating to stem cells, recombinant proteins, vaccines, diagnostics, industrial biotechnology, etc. She has over fifteen years of experience in the field of intellectual property management and around six years of research experience from prominent pharmaceutical and biotechnology organizations of India.
image PDF   |   image HTML
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

[email protected]

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

[email protected]

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001 Extn: 9042

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords