INTELLECTUAL PROPERTY Flashcards
Protecting valuable innovations and discoveries is crucial for the pharmaceutical industry.
INTELLECTUAL PROPERTY
Leveraging _____ rights can provide a competitive edge and ensure continued investment in research and development.
INTELLECTUAL PROPERTY
4 rights of intellectual property:
• PATENT
• TRADE SECRETS
• COPYRIGHT
• TRADEMARK
___ and ___ safeguard the product bame and formulation, ensuring exclusivity in the market.
TRADEMARKS AND PATENTS
Trademarks and Patents safeguard the product bame and formulation, ensuring exclusivity in the market.
BRAND PROTECTION
Trademark and Patents safeguard the product ___ and ____, ensuring exclusivity in the market.
NAME and FORMULATION
IP documentation support regulatory submissions and helps gain market access approvals.
REGULATORY APPROVALS
Exclusive rights allow companies to promote the product’s unique features and benefits to consumers.
MARKETING ADVANTAGES
Strategic IP planning extends product longevity and defends against generic competition.
LIFECYCLE MANAGEMENT
IPO
INTELLECTUAL PROPERTY OFFICE
It is a legal right granted by the government ti an inventor, providing them with exclusive rights to their innovation for a limited period of time.
PATENT
Patent is a legal right granted by the _____ ti an inventor, providing them with exclusive rights to their innovation for a limited period of time.
GOVERNMENT
It can provide wide range of inventions, including new products, processes, and compositions of matter, as long as they meet certain criteria.
PATENTS
To be patentable, an invention must be ___, ____ and have a _____.
NOVEL
NON-OBVIOUS
PRACTICAL APPLICATION or UTILITY
New drug molecules and compounds that demonstrate therapeutic utility and eligible for patent protection, provided they meet the requirements of novelty and non-obviousness.
PHARMACEUTICAL COMPOUNDS
Specialized medical devices and delivery systems developed for administering drugs and medications can also be patented as part of the pharmaceutical innovation.
PHARMACEUTICAL DEVICES
Innovative manufacturing processes and methods used to produce pharmaceutical products may be eligible for patent protection, especially if they enhance efficiency product quality.
PHARMACEUTICAL PROCESSES
Patentability:
• SUBJECT MATTER IS PATENTABLE
• USEFUL
• NEW/NOVEL
• NON-OBVIOUS
• ENABLEMENT
To be patentable, an invention must be new and not anticipated by prior art. The patents of evaluates novelty by comparing the claimed invention to everything publicly known before the filing.
NOVELTY
The invention must also be ____ to a person having ordinary skill in the art.
NON-OBVIOUSNESS
This ensures patents are not granted for trivial advances that would be naturally expected.
NON-OBVIOUSNESS
Inventions must have a specific substantial, and credible use to be eligible for patent protection. The disclosed invention must provide some identifiable and tangible benefit to society.
UTILITY
The patent application must be enable a person skilled in the art to make and use the invention with undue experimentation: the disclosure must provide enough detail for others to replicate the invention.
ENABLEMENT
Steps in Patent Application:
• INVENTION DISCLOSURE
• PRIOR ART SEARCH
• PATENT FILING
The first step is to document the novel invention and submit an invention disclosure to the company’s patent team.
INVENTION DISCLOSURE
A comprehensive search is conducted to ensure the invention is novel and non-obvious compared to existing patents and publications.
PRIOR ART SEARCH
Based on the patentability assessment, a patent application is drafted and filed with the relevant patent of…
PATENT FILING
Incentive for pharmaceutical companies to conduct pediatric clinical trials, extending market exclusivity by an additional 6 months.
PEDIATRIC EXCLUSIVITY
Encouraging the development of drugs for rare diseases affecting fewer than 200,000 patients in the US, providing tax credits and market exclusivity.
ORPHAN DRUG DESIGNATIONS
These programs aims to address critical gaps in treatment options for children and patients with rare, debilitating conditions.
UNMET MEDICAL NEEDS
Such as therapeutic proteins and monoclonal antibodies, are complex molecules derived from living cells.
BIOLOGICAL PRODUCTS
Are highly similar versions of these biologics, developed after the original patent expires
BIOSIMILARS
BIOSIMILAR ARE ALSO KNOWN AS GENERIC DRUGS
They must wait until key patents on a branded drug have expired before they can produce and market a generic version.
GENERIC DRUG
Generic drug manufacturer must wait until key patents on a branded drug have expired before they can produce and market a generic version.
PATENT EXPIRATION
Generic drug must undergo an approval process to demonstrate bio equivalence to the original brand product, meeting stringent regulatory standards.
REGULATORY APPROVAL
Have the same bioavailability.
BIOEQUIVALENCE
Generic manufacturers may license the right to produce a branded drug from the originator company, often under specific terms and conditions.
LICENSING AGREEMENTS
IP Considerations for Pharmaceutical Generic Drugs:
• PATENT EXPIRATION
• REGULATORY APPROVAL
• LICENSING AGREEMENTS
