Lecture 1.5 (IP) Flashcards
What is the importance of IP protection?
Provide motivation for continuous R&D investment. Safeguard investment in innovative research.
What are the basic patent rights under IP protection?
Patents provide the patent owner with the legal means to prevent others from making, using or selling the new invention for a limited period of time.
Is a Patent a permit to put a product on the market?
No
What 2 main areas are IP rights divided into?
- copyright and its related right
-right of authors and art
works etc - Industry property –> to provide protection for new inventions, new technology
What type of patent application is filed for drugs?
Patent application of New Chemical Entity (NCE) and New Biological Entity (NBE)
The patents for newly discovered drug/medicine cover:
- patent of product (novel chemical/biological products)
- patent of production process
What is the significance of TRIPS? ( WTO’s Agreement on Trade – Related Aspects of Intellectual Property Rights)
Due to extent of protection and enforcement vary around the world, The TRIPS Agreement establishes agreed levels of protection that each government has to give to the IP of fellow WTO member
What is the full form of TRIPS?
Trade – Related Aspects of Intellectual Property Rights (TRIPS)
Which agreement by WTO ensures that IP protection is provided by different countries?
The WTO’s Agreement on Trade – Related Aspects of Intellectual Property Rights (TRIPS)
What does TRIPs agreement part 3 say?
- government have to enforce IP protection under their laws.
- Penalties be tough enough to deter violation.
- Procedure be not complicated or costly.
- Not to entail unreasonable time-limits or delays.
- Government to offer assistance to IP owners from Customs authorities to prevent imports of counterfeit and pirated goods
What is compulsory licensing according to WTO?
Compulsary licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner.
What is the purpose of ‘compulsory licensing’?
to allow drug access for poor countries by extending exemption on patent protection.
i.e. to enhance developing countries’ access to medicines
How are ‘essential medicines’ defined by WHO?
those drugs that satisfy the health care needs of the majority of the population, they should be therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford
What factors does the access of medicine depend on?
- Rational selection of use of medicine.
- Affordable prices and sustainable financing.
3.Reliable healthcare and efficient procurement systems (quality of healthcare system). - Government policy on import tariffs/taxes.
- Infrastructure of the countries.
What are the key strategies to increase access to medicine?
- Reduction of tax, tariffs, distribution mark-ups.
- Generic medicines and automatic generic substitution.
- Differential pricing: different price for different buyers. (developed vs developing)
- Compulsory licensing
- Donation from the industry / charitable organization
- Parallel imports?
What are the current challenges faced by the pharmaceutical industry?
- Patent expiry and Generic competition
- Pricing pressures from government
- Urgent need to develop innovative drugs quicker and enhance R&D productivity
- Public perception and Reputation Management
- Intellectual property protection against patent infringement
- Data security like patient information and clinical trial data against leakage and cyber attacks.
What are some opportunities for pharma companies?
- big markets like China, India, indonesia and Brazil with huge population and high sales growth potential.
- specialist markets e.g. cancer
- preventive drugs e.g. vaccines for special infections
- drugs for chronic diseases e.e ozempic for diabetes
- drugs for aging population
- novel antibiotics/antiviral drugs
- drugs for rare diseases - orphan drugs
What is one way to deal with expiry looms?
more innovative breakthroughs, second-generation version with improved safety and efficacy, new formulations.
How do big pharmas tackle pricing pressures from govt?
- Develop truly innovative drugs to obtain optimal price to secure reasonable return on investment.
- Innovation in marketing and sales management.
- More cost-conscious, focus on cost-saving in all aspects
State examples of a preventive drugs
Prevnar for prevention of lung infection.
Gardasil - HPV vaccine
State some examples of drugs associated with ageing population.
Humira for Arthritis (more effective, lesser side effects)
Eisai Leqembi for dementia / Alzheimer’ disease.
Name a recent novel and effective antibiotics/anitviral drug
Harvoni for Hep C
State an example in the pharma industry when the image of a pharma company was under public scrutiny.
J&J paid 2.3 Bln fine for off label and kickback in 2013 and others
-perception improved after covid-19 due to developing vaccines and drugs
How can pharmaceutical companies ensure good public image or positive reputation?
thru self – governing (marketing code) and being good corporate citizens (eg. drug donations to least developed countries).
What is the outlook of the biopharma industry?
- Immuno-Oncology and Immunology will continue to be the leading therapeutic areas
- Use of AI for new drug research and development
- Gene and Cell Therapy advances.
- Personalized medicine to become more common
- GLP-1 products will continue to be one of the most successful products
