II Patent:
a. Definition :- An exclusive right given to the innovator by the government for certain period to protect his innovation from others.
[or]
It is defined as a monopoly right given for an invention by the government to the inventor for certain period.
Under united states law, four types of patents issued.
1. Utility patents 2. Design patents 3. Plant patents 4. Provisional Patents:
1. Utility patents:- These patents covers processes, machines, manufacture or composition of matter and new and useful improvements.
Process: Method of treating cancer, use of a known chemical agent which was not known to have herbicidal properties. Method of nondestructive testing of composite materials .
Machines: A device to detect estrus in cow, A particle board blender, An electronic animal hoof force detection system.
Manufacture: Mutated proteins & Monoclonal Anybodies
Composition of matter: A physical utility where the substance itself is the important element , a new chemical compound, veterinary antibodies pure form of naturally occurring substance .
Improvements:- Improvement of above paten table matter if it is distinct.
2. Design patents :- US law provides for design patent protection for the appearance or ornamental design of a article. The form of a design patent is 14 years.
3. Plant patents;- Plant utility patent protection & available for biotechnology, processes, genes, seeds, plant parts, cultivates and hybrids. Plant protection is available under the plant patent act for a sexually reproduced plants only Ex: Apricot trees, cheery trees bent grass seed.
4. Provisional patents:- Provisional, can provide up to twelve months to further develop the invention, determine marketability acquire funding or capital, seek licensing or manufacturing. There are four 4 types of paragraphs in ANDA submission:1.Paragraph I: This is for applying fresh patent, there shouldn’t be any same patent.2. Paragraph II: This is to do and follow the existing patent up to its expiring.3. Paragraph III : This is the procedure to enter into the market” after expiring of patent
4. Paragraph IV: This is the procedure of challenging and showing that ‘The existing patent is non-infringing and invalidated.’
Intellectual property rights:- (IPR):- Responsibilities:-
Preparation of Dossier:-
Introduction, molecular formula, molecular structure, CAS number and chemical name.
Patent status, patent details & patent expiry.
Synthetic pathway:
Patent evaluation, literature collection.
Patent challenging paragraph IV
Infringing: - If the process is said to be infringing then it matching with that of prior act.
Non infringing: - If the process is said to be non infringing if it does not matching with prior act.
Prior act:- The information which is already disclosed or available.
Bio equivalence:- In all aspects strength and stability to be equivalent to that of innovator product. IPA: Indian patent act.
Patent: “A patent is a set of legal rights, that allows the inventor of a novel new or other wise useful invention to prevent others from making selling or even using the invention”
Intellectual properties :- Patents, Trademarks, copyrights, trade secrets, designs are forms of intellectual properties.
You have right to other intellectual prosperities without getting it registered with office or authority of government.
Patent has to be registered with patent office in order to on title you for protection. Importance of generics market.
Objective :
· Drug approval process for generics in us
· Role of us FDA in approving generics products
Hatch- waxman Act :
· Enacted by US Government in 1984.
· Legislated in response to growing concern over price of Drug spiraling out of control
· Gives rewards / incentives to generics companies who successfully challenge innovator patents
Introduction of TRIPS Agreement :
Trips : Trade related aspects of intellectual property rights
SALIENT FEATURES :
· First pronounced in year 1995
· Most of the countries are rignatovies to TRIPS
· Main objective is to bring in the system of uniform patent protection throughout the world.
· Sets certain minimum standards of patens legislation to be followed by all members countries.
· Most important condition required by TRIPS is “introduction product patent “
Patent law in India :
· Product patents
· Exclusive marketing Rights product patents
· Whether TRIPS regime will lead to increase in prices Drugs
· Patenting of traditional knowledge bases of indigenous need.
Aspects of FDA process:
In case of generic approval for new chemical entities innovator gets a minimum period of 5 years of exclusivity.
Term of protection given to inventor is 20 years standard from date of filing.
Minimum requirements for patent ability:- In order to grant a patent, paten office requires your application to fulfill 2 criteria’s, namely :
1. Novelty 2. Utility 3. Obviousness.
1. Novelty: Invention claiming must be new should not described by any publication before date of filling of application in patent office.
2. Utility: Composition /compound/formulation is applied for, & must have been shown to animal test.
Obviousness:
3. Efficacy in human being does not need to prove.
Patents listed in orange book can not be challenged by generic company up to 5 to 6 years of market exclusivity. If innovator files an NDA for a different chemical entity which is related to originally approve Drug, then the innovator will be awarded 3 years of marketing exclusivity.
II b
1.) Abbreviated New Drug Application: It is a formal application to market a new generic drug in USA.
ANDA: one the patent life of a successful drug inventor has expired, other companies are allowed to manufacture and cell generic versions of they till need FDA’s specific approval for these generic products, for which they submit on ANDA.
Abbreviated in the sense that there is no requirement to include clinical data to support safety or efficacy that has already demonstrated by drug inventor.
However the ANDA must demonstrate the bio equivalence of the proposed generic product to the innovator drug.
2. NDA: New Drug Application: - Formal application to market a new drug in USA.
INDA: - Investigational new drug application: Document submitted to FDA prior to commence clinical trials.
ANDA can only be filed by generic company in the last year of market inclusively, of the innovator.
II C
Definitions:
Process suitability:- The established capacity of the manufacturing process to produce effective and reproducibility of results consistently.
Accelerated testing: Studies designated to increase the rate of chemical degradation or physical change of an active drug substance or drug product by using storage conditions as a part of the formal definitive storage programme
Rejected material: Any material of item that has been determined to be unacceptable for the specified use.
Theoretical yield: The quantity that would be produced at any appropriate phase of manufacture processing or packing of a drug product based upon the quantity of components to be used, in the absence of any loss or error in actual production.
Actual yield: The quantity that is actually proceed at any appropriate phase of manufacture processing or packing of a drug product .
Percentage of theoretical yield: The ratio of actual yield to the theoretical yield .
Cross contamination:- An undesired introduction of one or more materials .
Shelf life or expiration dating period:- The time interval that a drug product is expected to remain within the approved shelf life specification provided that is stored under the conditions defined on the label.
In process testing: Testing performed during production to monitor & to adjust the process to ensure that the drug substance or intermediate conforms to its specifications.
Recovery:- The appropriate processing of materials to make them for further use.
Impurity: - Any component of a drug substance which is not the chemical entity defined as a new drug substance. OR Impurity is a foreign particle (material) which is present along with desired product.
Impurity profile:- A description o identified & unidentified impurities present in a new drug substance.
Potential impurity:- An impurity that theoretically can arise during manufacture or storage.
Extraneous impurities:- An impurity arising from any source extraneous in the manufacturing process, due to conformation.
Active pharmaceutical ingredients:- (API) : A substance produced by chemical synthesis, formation recovery from natural materials that is used as drug component labeled.
Pharmaceutical:- It is defined as a mixture of binding agents preservatives, micro cellulose coatings, execipients, packing material & other ingredients which cures side effects.
Starting material:- USFDA has defined as it is incorporated into the new drug substance as an important structure element, as it is commercially available.
Intermediate:- A material produced during the step of the synthesis of a new drug substance that undergoes further chemical transformation before it becomes a new drug substance.
Reagents:- A substance other than starting material, intermediate or solvent that is used in the manufacture of new drug substance.
Solvent: An in organic liquid used as a vehicle for the preparation solutions & suspensions in the synthesis of a new drug substance.
Pharmacopoeia:- It is the book containing a list of medicinal drugs and directions for the use.
Ligand:- An agent with a strong affinity to a metal ion.
Protocol:- It is the clear procedure & clear picture of experimental observations.
COD: Chemical oxygen demand:- The amount of oxygen needed to decompose a chemical in air.
Known impurity:_ structural conformation has been achieved.
Unknown impurity:- Structural conformation has not been achieved.
Infringing: - It the process is said to be infringing, than it is matching with prior art’s (prior art: Information which is already available/.disclosed
Non infringing:- If the process is said to be non-infringing if it doesn’t matches with that of the information which is already disclosed/ Available (prir art).
IIC
Abbreviations:
1. GATT : General Agreement an Trade & Tariff.
2. SBOA : Summary Based on Approval
3. EMR : Exclusive market vights.
4. IPA : Indian patent act.
5. ETP : Effluent treatment plant.
6. BOD : Biological oxygen demand.
7. COD : Chemical oxygen demand
8. TDS : Total dissolved salts/solids.
9. COC : Certificate of compliance.
10. USFDA: United states food and drug administration.
11. ISO : International organization for standardization.
12. LOD : Limit of detection.
13. LOQ : Limit of Quantification.
14. MSDS : Material safety data sheets
15. PDE : Permitted daily exposure.
16. TDI : Tolerable daily intake
17. ADI : Acceptable daily intake
18. TOC : Total organic carbon analysis
19. USP : United states pharmacopoeia
20. ACS : American chemical society.
21. RM : Regulatory market (regulations are stringent)
22. LRM : Less Regulatory market.
II C
Definition:
Reference standard:- It is a substance prepared to use as the standard in assay, identification purity.
LOD: Limit of detection: The lowest concentration of a analyte in a sample that can be detected, but not necessarily quantiated under the stated experimental conditions.
LOD: Signal to noise ration 2 & 3 is acceptable, 2 to 3 times of LOD=LOQ.
LOQ: Limit of quantification:- The lowest concentration of analyte in a sample , that can be determined with acceptable precision accuracy under the stated experimental conditions. Signal to noise ration 10.1 is acceptable.
Bulk density: The amount of drug substance present in unit volume.
Total dissolved solids: (TDS) : The determination of total amount of organic / in organic solids dissolved in a solution of unit volume.
Hazard: Defined as the potential for harmful effects.
Reactivity: It is the tendency of a substance to undergo chemical reaction.
In compatibles:- These are the substances which are reactive with each other.
Flash point: It is the lowest temperature of a substance at and above, which it can produce a fire or explosion, if 1. Vapor concentration of the substance is with in flammability range 2. If an ignition source is available.
Threshold limit value (TLV):- It is the maximum concentration of a chemical in air to which a person can be exposed for a certain period.
Flammability range:- Range between lower exposure limit where it can produce fir or explosion .
Fire Extinguishers types:
Fire A solids -------------------------- Water, sand & CO2
Fire B liquids ------------------------- Foam & CO2
Fire C gas ------------------------- Dry chemical powder (DCP)
Fire D&E Electrical ----------------- DCP & CO2
ISO : International Organization for Standardization.
ISO : 9000 - Certification.
ISO : 9001 - Quality, design, & manufacturing\
ISO : 9002 - Manufacturing & Quality
ISO : 14001 - Environmental safety
IID
Medical terms related to symptoms:
1. Analgesia: Loss of sensitivity to pain
2. Anesthesia: Loss of feeling
3. Ashyxia: Suffocation
4. Bronchitis Coughing, difficult in breathing
5. Bruise: Discolored spot
6. Cancer Abnormal tissue growth.
7. Conjunctivitis: Inflamed and reddened eyes
8. Convulsions Violent body spasms
9. Depression Decrease in activity
10. Dermatitis Reddened skin.
11. Dizziness Feeling faint
12. Drocusiness Falling asleep
13. Edema Swelling
14. Fatigue Tiredness
15. Gastroenteritis Inflammation of the stomach & intestine.
16. Hallucination: Strongly experienced false perception which has compulsive sense of realty object of current.
17. Hematuvia Blood in the urine
18. Hemorrhage Bleeding
19. Inflammation Swelling, redness, warmth
20. Insomnia Inability to obtain normal sleep.
21. Jaundice Yellow discolovation of skin or eyes
22. Lacrimaiton Excessive eye tearing
23. Malnutrition Inadequate diet
24. Nausea Feeling of need to vomit.
25. Palpitations Forceful heart beat.
26. Paralysis loss of ability to move limbs
27. Seizure: Convulsion
28. Spasm Convulsive muscular contraction
29. Swelling Enlargement
30. Tremors Shaking, trembling
31. Vertigo Feeling of whirling motion
a. Definition :- An exclusive right given to the innovator by the government for certain period to protect his innovation from others.
[or]
It is defined as a monopoly right given for an invention by the government to the inventor for certain period.
Under united states law, four types of patents issued.
1. Utility patents 2. Design patents 3. Plant patents 4. Provisional Patents:
1. Utility patents:- These patents covers processes, machines, manufacture or composition of matter and new and useful improvements.
Process: Method of treating cancer, use of a known chemical agent which was not known to have herbicidal properties. Method of nondestructive testing of composite materials .
Machines: A device to detect estrus in cow, A particle board blender, An electronic animal hoof force detection system.
Manufacture: Mutated proteins & Monoclonal Anybodies
Composition of matter: A physical utility where the substance itself is the important element , a new chemical compound, veterinary antibodies pure form of naturally occurring substance .
Improvements:- Improvement of above paten table matter if it is distinct.
2. Design patents :- US law provides for design patent protection for the appearance or ornamental design of a article. The form of a design patent is 14 years.
3. Plant patents;- Plant utility patent protection & available for biotechnology, processes, genes, seeds, plant parts, cultivates and hybrids. Plant protection is available under the plant patent act for a sexually reproduced plants only Ex: Apricot trees, cheery trees bent grass seed.
4. Provisional patents:- Provisional, can provide up to twelve months to further develop the invention, determine marketability acquire funding or capital, seek licensing or manufacturing. There are four 4 types of paragraphs in ANDA submission:1.Paragraph I: This is for applying fresh patent, there shouldn’t be any same patent.2. Paragraph II: This is to do and follow the existing patent up to its expiring.3. Paragraph III : This is the procedure to enter into the market” after expiring of patent
4. Paragraph IV: This is the procedure of challenging and showing that ‘The existing patent is non-infringing and invalidated.’
Intellectual property rights:- (IPR):- Responsibilities:-
Preparation of Dossier:-
Introduction, molecular formula, molecular structure, CAS number and chemical name.
Patent status, patent details & patent expiry.
Synthetic pathway:
Patent evaluation, literature collection.
Patent challenging paragraph IV
Infringing: - If the process is said to be infringing then it matching with that of prior act.
Non infringing: - If the process is said to be non infringing if it does not matching with prior act.
Prior act:- The information which is already disclosed or available.
Bio equivalence:- In all aspects strength and stability to be equivalent to that of innovator product. IPA: Indian patent act.
Patent: “A patent is a set of legal rights, that allows the inventor of a novel new or other wise useful invention to prevent others from making selling or even using the invention”
Intellectual properties :- Patents, Trademarks, copyrights, trade secrets, designs are forms of intellectual properties.
You have right to other intellectual prosperities without getting it registered with office or authority of government.
Patent has to be registered with patent office in order to on title you for protection. Importance of generics market.
Objective :
· Drug approval process for generics in us
· Role of us FDA in approving generics products
Hatch- waxman Act :
· Enacted by US Government in 1984.
· Legislated in response to growing concern over price of Drug spiraling out of control
· Gives rewards / incentives to generics companies who successfully challenge innovator patents
Introduction of TRIPS Agreement :
Trips : Trade related aspects of intellectual property rights
SALIENT FEATURES :
· First pronounced in year 1995
· Most of the countries are rignatovies to TRIPS
· Main objective is to bring in the system of uniform patent protection throughout the world.
· Sets certain minimum standards of patens legislation to be followed by all members countries.
· Most important condition required by TRIPS is “introduction product patent “
Patent law in India :
· Product patents
· Exclusive marketing Rights product patents
· Whether TRIPS regime will lead to increase in prices Drugs
· Patenting of traditional knowledge bases of indigenous need.
Aspects of FDA process:
In case of generic approval for new chemical entities innovator gets a minimum period of 5 years of exclusivity.
Term of protection given to inventor is 20 years standard from date of filing.
Minimum requirements for patent ability:- In order to grant a patent, paten office requires your application to fulfill 2 criteria’s, namely :
1. Novelty 2. Utility 3. Obviousness.
1. Novelty: Invention claiming must be new should not described by any publication before date of filling of application in patent office.
2. Utility: Composition /compound/formulation is applied for, & must have been shown to animal test.
Obviousness:
3. Efficacy in human being does not need to prove.
Patents listed in orange book can not be challenged by generic company up to 5 to 6 years of market exclusivity. If innovator files an NDA for a different chemical entity which is related to originally approve Drug, then the innovator will be awarded 3 years of marketing exclusivity.
II b
1.) Abbreviated New Drug Application: It is a formal application to market a new generic drug in USA.
ANDA: one the patent life of a successful drug inventor has expired, other companies are allowed to manufacture and cell generic versions of they till need FDA’s specific approval for these generic products, for which they submit on ANDA.
Abbreviated in the sense that there is no requirement to include clinical data to support safety or efficacy that has already demonstrated by drug inventor.
However the ANDA must demonstrate the bio equivalence of the proposed generic product to the innovator drug.
2. NDA: New Drug Application: - Formal application to market a new drug in USA.
INDA: - Investigational new drug application: Document submitted to FDA prior to commence clinical trials.
ANDA can only be filed by generic company in the last year of market inclusively, of the innovator.
II C
Definitions:
Process suitability:- The established capacity of the manufacturing process to produce effective and reproducibility of results consistently.
Accelerated testing: Studies designated to increase the rate of chemical degradation or physical change of an active drug substance or drug product by using storage conditions as a part of the formal definitive storage programme
Rejected material: Any material of item that has been determined to be unacceptable for the specified use.
Theoretical yield: The quantity that would be produced at any appropriate phase of manufacture processing or packing of a drug product based upon the quantity of components to be used, in the absence of any loss or error in actual production.
Actual yield: The quantity that is actually proceed at any appropriate phase of manufacture processing or packing of a drug product .
Percentage of theoretical yield: The ratio of actual yield to the theoretical yield .
Cross contamination:- An undesired introduction of one or more materials .
Shelf life or expiration dating period:- The time interval that a drug product is expected to remain within the approved shelf life specification provided that is stored under the conditions defined on the label.
In process testing: Testing performed during production to monitor & to adjust the process to ensure that the drug substance or intermediate conforms to its specifications.
Recovery:- The appropriate processing of materials to make them for further use.
Impurity: - Any component of a drug substance which is not the chemical entity defined as a new drug substance. OR Impurity is a foreign particle (material) which is present along with desired product.
Impurity profile:- A description o identified & unidentified impurities present in a new drug substance.
Potential impurity:- An impurity that theoretically can arise during manufacture or storage.
Extraneous impurities:- An impurity arising from any source extraneous in the manufacturing process, due to conformation.
Active pharmaceutical ingredients:- (API) : A substance produced by chemical synthesis, formation recovery from natural materials that is used as drug component labeled.
Pharmaceutical:- It is defined as a mixture of binding agents preservatives, micro cellulose coatings, execipients, packing material & other ingredients which cures side effects.
Starting material:- USFDA has defined as it is incorporated into the new drug substance as an important structure element, as it is commercially available.
Intermediate:- A material produced during the step of the synthesis of a new drug substance that undergoes further chemical transformation before it becomes a new drug substance.
Reagents:- A substance other than starting material, intermediate or solvent that is used in the manufacture of new drug substance.
Solvent: An in organic liquid used as a vehicle for the preparation solutions & suspensions in the synthesis of a new drug substance.
Pharmacopoeia:- It is the book containing a list of medicinal drugs and directions for the use.
Ligand:- An agent with a strong affinity to a metal ion.
Protocol:- It is the clear procedure & clear picture of experimental observations.
COD: Chemical oxygen demand:- The amount of oxygen needed to decompose a chemical in air.
Known impurity:_ structural conformation has been achieved.
Unknown impurity:- Structural conformation has not been achieved.
Infringing: - It the process is said to be infringing, than it is matching with prior art’s (prior art: Information which is already available/.disclosed
Non infringing:- If the process is said to be non-infringing if it doesn’t matches with that of the information which is already disclosed/ Available (prir art).
IIC
Abbreviations:
1. GATT : General Agreement an Trade & Tariff.
2. SBOA : Summary Based on Approval
3. EMR : Exclusive market vights.
4. IPA : Indian patent act.
5. ETP : Effluent treatment plant.
6. BOD : Biological oxygen demand.
7. COD : Chemical oxygen demand
8. TDS : Total dissolved salts/solids.
9. COC : Certificate of compliance.
10. USFDA: United states food and drug administration.
11. ISO : International organization for standardization.
12. LOD : Limit of detection.
13. LOQ : Limit of Quantification.
14. MSDS : Material safety data sheets
15. PDE : Permitted daily exposure.
16. TDI : Tolerable daily intake
17. ADI : Acceptable daily intake
18. TOC : Total organic carbon analysis
19. USP : United states pharmacopoeia
20. ACS : American chemical society.
21. RM : Regulatory market (regulations are stringent)
22. LRM : Less Regulatory market.
II C
Definition:
Reference standard:- It is a substance prepared to use as the standard in assay, identification purity.
LOD: Limit of detection: The lowest concentration of a analyte in a sample that can be detected, but not necessarily quantiated under the stated experimental conditions.
LOD: Signal to noise ration 2 & 3 is acceptable, 2 to 3 times of LOD=LOQ.
LOQ: Limit of quantification:- The lowest concentration of analyte in a sample , that can be determined with acceptable precision accuracy under the stated experimental conditions. Signal to noise ration 10.1 is acceptable.
Bulk density: The amount of drug substance present in unit volume.
Total dissolved solids: (TDS) : The determination of total amount of organic / in organic solids dissolved in a solution of unit volume.
Hazard: Defined as the potential for harmful effects.
Reactivity: It is the tendency of a substance to undergo chemical reaction.
In compatibles:- These are the substances which are reactive with each other.
Flash point: It is the lowest temperature of a substance at and above, which it can produce a fire or explosion, if 1. Vapor concentration of the substance is with in flammability range 2. If an ignition source is available.
Threshold limit value (TLV):- It is the maximum concentration of a chemical in air to which a person can be exposed for a certain period.
Flammability range:- Range between lower exposure limit where it can produce fir or explosion .
Fire Extinguishers types:
Fire A solids -------------------------- Water, sand & CO2
Fire B liquids ------------------------- Foam & CO2
Fire C gas ------------------------- Dry chemical powder (DCP)
Fire D&E Electrical ----------------- DCP & CO2
ISO : International Organization for Standardization.
ISO : 9000 - Certification.
ISO : 9001 - Quality, design, & manufacturing\
ISO : 9002 - Manufacturing & Quality
ISO : 14001 - Environmental safety
IID
Medical terms related to symptoms:
1. Analgesia: Loss of sensitivity to pain
2. Anesthesia: Loss of feeling
3. Ashyxia: Suffocation
4. Bronchitis Coughing, difficult in breathing
5. Bruise: Discolored spot
6. Cancer Abnormal tissue growth.
7. Conjunctivitis: Inflamed and reddened eyes
8. Convulsions Violent body spasms
9. Depression Decrease in activity
10. Dermatitis Reddened skin.
11. Dizziness Feeling faint
12. Drocusiness Falling asleep
13. Edema Swelling
14. Fatigue Tiredness
15. Gastroenteritis Inflammation of the stomach & intestine.
16. Hallucination: Strongly experienced false perception which has compulsive sense of realty object of current.
17. Hematuvia Blood in the urine
18. Hemorrhage Bleeding
19. Inflammation Swelling, redness, warmth
20. Insomnia Inability to obtain normal sleep.
21. Jaundice Yellow discolovation of skin or eyes
22. Lacrimaiton Excessive eye tearing
23. Malnutrition Inadequate diet
24. Nausea Feeling of need to vomit.
25. Palpitations Forceful heart beat.
26. Paralysis loss of ability to move limbs
27. Seizure: Convulsion
28. Spasm Convulsive muscular contraction
29. Swelling Enlargement
30. Tremors Shaking, trembling
31. Vertigo Feeling of whirling motion
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