<<–2/”>a >span style=”text-decoration: underline;”>Intellectual property:- is regarded as creation of mind in the form of patents for invention or copyright for literary and Art works in the form of Trademark and geography indicators.
copyright:- includes nobles, poems ,films, musical work, artistic work such as drawing, painting, Photograph structural
Trademark :– it is a distinctive sign which is identified with certain goods or Services as those produced by a specific person or Enterprises.The system has consumers identified and purchase a product or service because its nature is indicated by its unique trademark
Geographical indication:- it is an indicator used on goods that has a specific geographical Origins and posses qualities, reputation or character that attributes to that place of origin .The most common Government of India geographical indicator includes the name of the place of origin and name of goods. Geographical indicator may be used for all varieties of products with natural, agricultural and manufacturing. It may consist of geographical name or traditional designation used for the products which have a specific qualities and characters that areessentially due to Geographic Environment in which they are produced for example:- Kullu shawls of Himachal Pradesh, Darjeeling Tea, Mugha silk of Assam ,Kanchipuram silk of Tamilnadu and other GI’s
Patent:- it is an exclusive right granted for an invention which is a product for a process that provides in general a new way of doing something Oasis a new technological solution to a problem a patent provides protection for invention which is granted to unlimited period upto 20 years
National Pharmaceutical Pricing Authority(NPPA)
- It is under department of ministry of chemical and Fertilizers .It is interested with the task of fixation or revision of prices of pharmaceuticals products and enforcement of provisions of drug price control order and monitoring enforcement of prices and the drug price control order 2013.
- It authorises NPPA that in extraordinary circumstances if it considered necessary in Public Interest it can fix the price of any drugs for a period as it deams fit. So the new law allowed NPPA to fix prices cap of drugs and this class applied to both drugs which are a part of National list of essential medicines or even outside of it.
- In this context also looking into the ascent role that in the area of Public Health which is a social rights as government intervention become necessary especially when high prices makes medicine unaffordable and also put huge financial burden in terms of out of pocket expenditure, this measure was used recently by nppa to fix the prices of widely used expensive antidiabetic and Cardiac medicine even not listed under National list of essential medicines.
- National list of essential medicine is one of the key Health Care delivery system which includes acceptable and affordable quality medicines at all the levels of Health Care system.
- Realising this Government of India Ministry of Health and Family Welfare decided to have its own essential medicine list.
- To address the issue of changing disease ,privileges treatment modalities, introduction of new medicines and identification of therapeutic profile of some medicines, Ministry of Health and Family Welfare consider the need for updating the NLEM.
Primary purpose of NLEM is to promote the rational use of medicine, considering three important aspects:-
- cost
- safety
- efficiency
The central drugs standard control organisation is the national regulatory authority that evaluate the safety efficiency and quality of drugs in the country.
Generic drugs and their significance
- Generic drugs are identical to a brand name drugs in chemical composition ,doses,route of Administration,Bio availability, safety and efficiency.
- Although genetical drugs are chemically identical to their branded counterparts and frequently as effective as branded medicines ,but much cheaper and sold at substantially DISCOUNT from the price of branded name Drug. The Price of branded name Drug Company maybe 10 times higher than its generic counterpart.
- This is cost incurred on the Clinical Research done by the Original drug manufacturer and also the advertisement cost of the branded drugs and as the brand name Drug Company has already spent considerable time in research , so generic companies are not required to conduct any Clinical Research.
- Branded drugs are produced by only company granted patent whereas generic drugs are produce by many companies.
- The competition in generic drugs is also another reason for low cost of generic drugs .Generic drug are marketed after the expiry date of patent and other exclusive rights .
- Because of their low price generic drugs are often the only medicine that the poorest can access in particular life saving drugs ,anticancer drugs .
- So that generic drug is effective and safer as branded drugs
Novratis vs Union of India case
- Cognizant of patenting practice:- Parliament introduces a significant and important provision to prevent evergreening and granting of frivolous patent under section 3D of Indian Patent Act.
- Section 3D of Patent Act stated the protection of Indian Masses in the Indian patent law, it disallowed patenting of new forms of drugs with no substantive advancement, unless the new drug exhibit a significant enhancement in efficiency.
- Evergreening is the practice of pharmaceutical companies to obtain patent on frivolous or minor change to non-drug and thereby establish a monopoly over a drug.
- The Swiss pharmaceutical company is fighting for the patent of its anticancer drug GLIEVEC on the basis of increase bioavailability of the new drug in the cancer patient, but it lost its 7 year long battle as it could not with stand the test on the basis of enhanced Efficiency i.e. enhanced theraputical efficiency.
- So was rejected the patent even from The Supreme Court of India. It is the landmark judgement which will act as a deterance even for other multinational pharmaceutical companies not to involve in unfair practices of Evergreenery of patents.
- India is leading producer of generic drugs in the world which is not only important for Poor patients in India, but also act as a lifeline of patent in the developing world especially in poor’s part of Africa to provide cheaper drugs including anticancer drug and life saving drugs
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Introduction to Drugs and Patenting
A drug is a substance that can be used to diagnose, cure, treat, or prevent a disease. Drugs can be classified into different types based on their chemical structure, mechanism of action, and therapeutic use.
Patents are legal rights that give inventors exclusive control over their inventions for a limited period of time. Patents are intended to encourage innovation by providing inventors with an incentive to invest in the research and development of new products and technologies.
Types of Drugs
There are many different types of drugs, each with its own unique properties and uses. Some common types of drugs include:
- Antibiotics: Drugs that kill or inhibit the Growth of bacteria.
- Antidepressants: Drugs that are used to treat depression.
- Antihistamines: Drugs that are used to treat allergies.
- Antipsychotics: Drugs that are used to treat schizophrenia and other mental disorders.
- Antivirals: Drugs that are used to treat viral infections.
- Cardiovascular drugs: Drugs that are used to treat heart disease.
- Cholesterol-lowering drugs: Drugs that are used to lower cholesterol levels.
- Diabetes drugs: Drugs that are used to treat diabetes.
- Diuretics: Drugs that are used to increase urine output.
- Epilepsy drugs: Drugs that are used to treat epilepsy.
- Painkillers: Drugs that are used to relieve pain.
- Steroids: Drugs that are used to treat a variety of conditions, including inflammation, allergies, and asthma.
Patenting of Drugs
Drugs can be patented in the same way as any other invention. To obtain a patent, an inventor must file a patent application with the appropriate government agency. The application must include a description of the invention, drawings of the invention, and a claim that defines the scope of the invention.
If the patent application is approved, the inventor will be granted a patent that gives them exclusive rights to make, use, sell, and import the invention for a period of 20 years.
The Drug Development Process
The drug development process is a long and complex process that can take many years and millions of dollars to complete. The process begins with the identification of a potential drug target. Once a target has been identified, scientists must then design and synthesize a molecule that will interact with the target in a desired way.
If a promising molecule is identified, it must then be tested in preclinical studies to assess its safety and efficacy. Preclinical studies are typically conducted in animals. If the molecule is found to be safe and effective in preclinical studies, it can then be tested in human clinical trials.
Clinical trials are conducted in three phases. Phase I trials are small studies that are conducted to assess the safety of the drug in humans. Phase II trials are larger studies that are conducted to assess the efficacy of the drug. Phase III trials are large-scale studies that are conducted to confirm the safety and efficacy of the drug.
If a drug is found to be safe and effective in clinical trials, it can then be submitted to the Food and Drug Administration (FDA) for approval. The FDA has a rigorous approval process that can take several years to complete. If the FDA approves the drug, it can then be marketed to the public.
The Economics of Drug Patenting
The economics of drug patenting are complex and controversial. On the one hand, patents provide incentives for companies to invest in the research and development of new drugs. On the other hand, patents can lead to higher prices for drugs, which can make them inaccessible to some people.
The debate over the economics of drug patenting is likely to continue for many years to come.
The Impact of Drug Patenting on Human Health
The impact of drug patenting on human health is a complex issue. On the one hand, patents can lead to higher prices for drugs, which can make them inaccessible to some people. On the other hand, patents can also lead to the development of new drugs that save lives.
The overall impact of drug patenting on human health is likely to vary depending on a number of factors, including the specific drug, the country in which it is marketed, and the economic status of the people who need it.
The Future of Drug Patenting
The future of drug patenting is uncertain. The debate over the economics of drug patenting is likely to continue for many years to come. It is also possible that new technologies, such as gene editing, will make it possible to develop new drugs more quickly and cheaply. This could lead to a decrease in the importance of drug patents.
Overall, the future of drug patenting is likely to be shaped by a number of factors, including the ongoing debate over the economics of drug patenting, the development of new technologies, and the changing needs of patients.
Drugs and Their Patenting
-
What is a drug patent?
A drug patent is a legal right granted to an inventor for a new drug or a new use for an existing drug. The patent gives the inventor the exclusive right to make, use, and sell the drug for a period of 20 years from the date of filing the patent application. -
What are the benefits of drug patents?
The benefits of drug patents include:- Encouraging innovation by giving inventors the incentive to invest in the research and development of new drugs.
- Protecting public health by ensuring that new drugs are available to patients.
- Promoting competition by allowing other companies to make generic versions of patented drugs once the patent expires.
-
What are the challenges of drug patents?
The challenges of drug patents include:- The high cost of developing new drugs, which can make it difficult for small companies to enter the market.
- The length of the patent term, which can give drug companies a monopoly on a drug for a long period of time.
- The abuse of the patent system by companies that file for patents on minor changes to existing drugs.
Human Health
-
What is human health?
Human health is a state of complete physical, mental, and social well-being. It is not merely the absence of disease or infirmity. -
What are the determinants of human health?
The determinants of human health are the factors that influence a person’s health status. These factors include:- Biological factors, such as age, sex, and genetic makeup.
- Environmental factors, such as air quality, water quality, and exposure to toxins.
- Socioeconomic factors, such as income, Education, and social support.
- Behavioral factors, such as smoking, diet, and physical activity.
-
What are the key challenges to human health?
The key challenges to human health include:- Noncommunicable diseases, such as heart disease, stroke, cancer, and diabetes.
- Infectious diseases, such as HIV/AIDS, malaria, and tuberculosis.
- Injuries, such as road traffic injuries and violence.
- Mental health problems, such as depression and anxiety.
-
What are the key strategies for improving human health?
The key strategies for improving human health include:- Investing in primary health care.
- Promoting healthy lifestyles.
- Preventing disease.
- Treating disease.
- Caring for the sick and disabled.
For RAS/RTS Mains
-
What are the key issues in the field of drugs and their patenting?
The key issues in the field of drugs and their patenting include:- The high cost of developing new drugs.
- The length of the patent term.
- The abuse of the patent system.
- The impact of drug patents on access to medicines.
-
What are the key challenges in the field of human health?
The key challenges in the field of human health include:- Noncommunicable diseases.
- Infectious diseases.
Injuries.
Mental health problems.
-
What are the key strategies for improving human health?
The key strategies for improving human health include:- Investing in primary health care.
- Promoting healthy lifestyles.
- Preventing disease.
- Treating disease.
- Caring for the sick and disabled.
-
Which of the following is not a type of drug?
(A) Antibiotic
(B) Hormone
(C) Vitamin
(D) Vaccine -
Which of the following is not a function of drugs?
(A) To cure diseases
(B) To prevent diseases
(C) To treat symptoms
(D) To improve health -
Which of the following is not a side effect of drugs?
(A) Nausea
(B) Vomiting
(C) Diarrhea
(D) Weight gain -
Which of the following is not a way to prevent drug abuse?
(A) Talk to your doctor about the risks and benefits of taking drugs.
(B) Only take drugs that are prescribed by your doctor.
(C) Do not share needles or other drug-related equipment.
(D) Do not drink alcohol or use other drugs while taking prescription drugs. -
Which of the following is not a way to treat drug addiction?
(A) Detoxification
(B) Rehabilitation
(C) Inpatient treatment
(D) Outpatient treatment -
Which of the following is not a risk factor for drug abuse?
(A) Family history of drug abuse
(B) Peer pressure
(C) Mental health problems
(D) Stress -
Which of the following is not a sign of drug abuse?
(A) Changes in mood or behavior
(B) Changes in appearance
(C) Changes in social relationships
(D) Changes in school or work performance -
Which of the following is not a way to help someone who is struggling with drug abuse?
(A) Offer your support.
(B) Encourage them to seek professional help.
(C) Confront them about their drug use.
(D) Tell them you are worried about them. -
Which of the following is not a way to prevent the spread of HIV/AIDS?
(A) Use condoms during sex.
(B) Abstain from sex.
(C) Get tested for HIV regularly.
(D) Get vaccinated against HIV. -
Which of the following is not a way to treat HIV/AIDS?
(A) Antiretroviral therapy
(B) Antiviral drugs
(C) Immune system boosters
(D) Surgery -
Which of the following is not a symptom of HIV/AIDS?
(A) Fever
(B) Chills
(C) Night sweats
(D) Weight loss -
Which of the following is not a way to protect yourself from malaria?
(A) Use insect repellent.
(B) Sleep under a mosquito net.
(C) Take malaria pills.
(D) Wear long-sleeved shirts and pants. -
Which of the following is not a symptom of malaria?
(A) Fever
(B) Chills
(C) Headache
(D) Muscle aches -
Which of the following is not a way to treat malaria?
(A) Antimalarial drugs
(B) Intravenous fluids
(C) Oxygen therapy
(D) Surgery -
Which of the following is not a risk factor for tuberculosis?
(A) HIV/AIDS
(B) Malnutrition
(C) Crowded living conditions
(D) Smoking -
Which of the following is not a symptom of tuberculosis?
(A) Cough
(B) Fever
(C) Night sweats
(D) Weight loss -
Which of the following is not a way to prevent tuberculosis?
(A) Get vaccinated against tuberculosis.
(B) Take antibiotics if you have been exposed to tuberculosis.
(C) Avoid close contact with people who have tuberculosis.
(D) Get tested for tuberculosis regularly. -
Which of the following is not a way to treat tuberculosis?
(A) Antituberculosis drugs
(B) Intravenous fluids
(C) Oxygen therapy
(D) Surgery -
Which of the following is not a risk factor for heart disease?
(A) High blood pressure
(B) High cholesterol
(C) Smoking
(D) Obesity -
Which of the following is not a symptom of heart disease?
(A) Chest pain
(B) Shortness of breath
(C) Fatigue
(D) Swelling in the feet and ankles -
Which of the following is not a way to prevent heart disease?
(A) Eat a healthy diet.
(B) Exercise regularly.
(C) Maintain a healthy weight.
(D) Don’t smoke. -
Which of the following is not a way to treat heart