A Pharmaceutical and bio-pharmaceutical company’s biggest asset is its intellectual property, and it becomes very critical to keep track of own IPs and to monitor or check competitor activities on IP.
Intellectual property development, protection and identification are the few activities which play very important role for company’s success. To develop a new product, companies need to be sure that there are no existing patents for similar products. Following up on the outline of a patent to determine exactly what makes a given product unique, legally, we provide complete services to help in this stage of product life cycle.
• Who has most patents for a given therapeutic area?
• What are the current trends in patenting activity and understand what freedom to operate is?
• How can you monitor if anyone infringing your patent and what are the laws governing infringement?
• Determine trends in patenting among competitors?
We provide comprehensive patent analysis as part of our intellectual property services. This includes analysis of the technology of a given patent as well as the landscape - both legally and structurally of that patent and the current status of your competitors
How We Help?
• We provide you with complete intellectual property database for better understanding of IP scenario.
• We constantly look for new therapy area and new geographies for your current intellectual property to maximize probability of getting patent.
• IP Strategy: We develop patent strategy for pharmaceutical industries in chemical, process, formulation, and pharmacokinetic segment. IP Consulting involves the following dimensions:
1. Evaluation of Paragraph IV strategy of our client’s product
2. In-depth training for your department in IP strategy
3. Due diligence evaluation of products and companies
• FDA Consulting: FDA Consulting is comprised of following dimensions:
1. Development of strategy for the 505(b)(2)NDA and ANDA submission
2. FDA and ICH guidance interpretation
3. Assist regulatory filing for IND, ANDA and NDA
4. Assist your meeting with FDA (Pre-IND, end of Phase II, and Pre-NDA)
• Pharmaceutical IP Consulting: IP consulting in pharmaceutical segment is encompassed of the following:
1. High level strategy for pharmaceutical development of ANDA and NDA products
2. Pipeline selection for API and finished dosage form
3. Assist client’s present contractor to streamline your product development efforts
4. GMP evaluation of your development and manufacturing practice and facility
5. Market assessment of pipeline product for US, EU and other countries
• MRA Group enables our clients to check for any IP infringement to gain complete benefit of IP rights.
• We identify whether IP is unique or already used, in MRA Group IP database.