Intellectual Property Rights
The safeguarding of product trade secret, its formulations and other process parameters by law is usually covered by IPR. It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance in the field of biologics and biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR. The very name Biosimilars calls for the occurrence of Intellectual Property rights laws and by-laws. Hence this session is of utmost interest to the attorneys and law personnel. Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.
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Intellectual Property Rights Conference Speakers
Recommended Sessions
- BCS and IVIVC Based Biowaivers
- Biological Medicine
- Biopharmaceutical Informatics
- Biosimilars Approval to Biogenerics in Clinical Practice
- Biosimilars Development in Markets
- Biosimilars Market and Cost Analysis
- Biosimilars Research Pipeline
- Challenges in Biosimilars Pharmacovigilance
- Chemical and Analytical Strategies for Biosimilars
- Consequences of Brexit on Biosimilars
- Current Agency Expectations for Approval for Biosimilars
- Current Challenges in Developing Biosimilars
- Drug Delivery and Development
- Emerging Biosimilars in Therapeutics
- Formulation Strategies for Follow-on Biologics
- Globalization of Biosimilars
- Innovative Clinical Approach in Biosimilars
- Intellectual Property Rights
- Legal Issues and BPCI Act
- Monoclonal Antibody Biosimilars
- Regulatory Updates on Biosimilars
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