Patent Timeline
Step 7
Step 5
Step 3
Step 1
Step 6
Step 8
Step 2
Step 4
Timeline of R&D
Preclinical Development
Some introductory text here
Subtitle
Target Identification
Phase 1 Trials
Plan
Subtitle
Phase 2 Trials
Target Validation
Subtitle
Structure
Phase 3 Trials
Lead Identification
Subtitle
Design
Regulatory Approval
Lead Optimization
Subtitle
Communicate
Target Identification
Plan
Timeline of R&D
Target Validation
Structure
Some introductory text here
Lead Identification
Design
Lead Optimization
Communicate
Preclinical Development
Subtitle
Timeline of R&D cont.
Phase 1 Trials
Subtitle
Phase 2 Trials
Some continued text here
Subtitle
Phase 3 Trials
Subtitle
Regulatory Approval
Subtitle
Lead Optimization
Top compounds are selected from the Lead Optimization step. The goal of this step is to improve the selected compounds chemically to make them more specific for the target or to bind more tightly. Small structural modifications can significantly affect properties of drug candidates such as absorption and water solubility.
Example Lipitor
Work is still being done to make the molecule for Atorvastatin Calcium more absorbable, which means the dosage would be reduced for the same effect. This is also the step where patent counsel looks to see if anyone else has patents on the leads that were identified.
Lead Optimization
Top compounds are selected from the Lead Optimization step. The goal of this step is to improve the selected compounds chemically to make them more specific for the target or to bind more tightly. Small structural modifications can significantly affect properties of drug candidates such as absorption and water solubility.
Example Lipitor
Work is still being done to make the molecule for Atorvastatin Calcium more absorbable, which means the dosage would be reduced for the same effect. This is also the step where patent counsel looks to see if anyone else has patents on the leads that were identified.
Patents
Patents are issued by the USPTO after a thorough and lengthy review of the invention and application. Patents are not immediate and are expensive to obtain and maintain. This timeline demonstrates a simplified version of steps in the patent application process
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Phase 1 Trials
This is the first foray into humans. A small sample of healthy volunteers is selected to make sure the drug is safe. Highly toxic drugs such as chemotherapy drugs may go directly to patients. Phase 1 Trials can take 1-2 years and can cost millions. To introduce the drug in multiple markets, such as pediatric and adult, one must do these studies in both markets.
More targeted drug development strategies such as late-stage oncology products allow for skipping this step. Healthy individuals cannot be made subject to highly toxic oncology treatments and these are tested directly in patients.
Lead Identification
Once a target has been identified, we need a chemical (small molecule) or biologic (large molecule) that binds to the target. Using large chemical libraries and high throughput screening technologies, compound leads are identified. This step may take an additional year.
Open Innovation is a major strategy used by pharmaceutical companies. AstraZeneca has a program where they welcome proposals from scientists that have identified and validated targets. If the proposal is accepted, scientists can access the company's screening library to identify leads.
Example Lipitor
Atorvastatin Calcium (Lipitor) was identified as the chemical that binds to the (HMG-CoA) reductase enzyme in the cholesterol pathway.
Target Identification
Disease can be a result of one or more pathways or processes in our bodies gone wrong. To treat this disease, a drug must intervene and correct or modify the pathway or process. Hence, the very first step of drug discovery is to find out what went wrong. The Target Identification step leads to finding new targets, normally proteins, that when inhibited, lead to reversing of the disease. As one can imagine, there are thousands of pathways in the body, so identifying the exact pathway and target takes 3-4 years. In recent years, more and more partnerships with universities have led to early discovery steps for Target Identification that are performed in university research labs.
Example Lipitor
Example: LipitorThe blockbuster drug Lipitor, used to reduce cholesterol, targets an enzyme that is part of the cholesterol producing pathway in the liver.
Preclinical Development
This is where you test whether your optimized lead compound is safe and effective in the petri dish (in vitro) and animal (in vivo) models. This may take a year or two.
If good results are found at this stage, drugs may be out-licensed from companies if they don't fit a company's portfolio strategy or in-licensed for further development from other companies or academic institutions.
Example Lipitor
Lipitor was tested in vivo in mice, rats, dogs, guinea pigs, miniature pigs and rabbits. Tests were done for its effect on cholesterol as well as safety on various systems of the body such as the central nervous system, cardiovascular system and gastrointestinal system. For in vitro studies, various studies were conducted in a line of human liver cells.
File PCT App.
One may file a PCT non-provisional application or a US non-provisional application.
Target Validation
Once a pathway has been identified and new targets have been identified, each of these needs to be validated to ensure that blocking them leads to the wanted result. The goal of this step is to demonstrate the function of the potential target in the disease. This may take an additional 1-2 years.
In recent years, more and more partnerships with universities had led to early discovery steps for Target Validation that are performed in university research labs.
Example Lipitor
The cholesterol pathway that Lipitor targets contains 10 enzymes. Of these, one was selected as a final target after validation.
Phase 2 Trials
This trial is done to demonstrate the efficacy of the drug. Usually a control group (placebo or current treatment) is compared with the treatment group. Hundreds of patients are enrolled. Sometimes these can be broken up into Phase 2a and Phase 2b trials where 2a is designed to determine the correct doing and 2b to determine the efficacy. At this stage, smaller pharmaceutical companies will partner with or be bought out by larger companies to assist with Phase 2 and Phase 3 trials, the most expensive parts of drug development.
Example Lipitor and Clinical Trials Phases
Lipitor was tested in 590 healthy males and females and various doses from 0mg (placebo) to 120mg of the drug were administered. Over Phase 2 and 3, 21 clinical studies with different endpoints and 3522 patients were completed for Lipitor. Studies ranged from 4 weeks to 52 weeks. Different populations were tested with different doses and combinations of the drug. One of the Phase 3 trials for Lipitor enrolled 3916 patients and lasted 54 weeks.
Regulatory Approvals
After all trials are completed, these are presented to the FDA. A panel reviews them and votes for approval of the drug or biologic. This could take up to a year but there are ways to fast-track it. Breakthrough drugs can go through accelerated approval processes. New strategies such as targeting orphan diseases and focusing on breakthrough oncology drugs leads to faster approval through various fast-track processes.
Target Identification
Disease can be a result of one or more pathways or processes in our bodies gone wrong. To treat this disease, a drug must intervene and correct or modify the pathway or process. Hence, the very first step of drug discovery is to find out what went wrong. The Target Identification step leads to finding new targets, normally proteins, that when inhibited, lead to reversing of the disease. As one can imagine, there are thousands of pathways in the body, so identifying the exact pathway and target takes 3-4 years. In recent years, more and more partnerships with universities have led to early discovery steps for Target Identification that are performed in university research labs.
Example Lipitor
Example: LipitorThe blockbuster drug Lipitor, used to reduce cholesterol, targets an enzyme that is part of the cholesterol producing pathway in the liver.
Lead Identification
Once a target has been identified, we need a chemical (small molecule) or biologic (large molecule) that binds to the target. Using large chemical libraries and high throughput screening technologies, compound leads are identified. This step may take an additional year.
Open Innovation is a major strategy used by pharmaceutical companies. AstraZeneca has a program where they welcome proposals from scientists that have identified and validated targets. If the proposal is accepted, scientists can access the company's screening library to identify leads.
Example Lipitor
Atorvastatin Calcium (Lipitor) was identified as the chemical that binds to the (HMG-CoA) reductase enzyme in the cholesterol pathway.
Novelty Search
The process starts with the conception of the idea and then doing a thorough search to make sure the process or molecule the company wishes to patent meets the three criteria for granting a patent: it is 1) novel 2) useful and 3) non-obvious. This starts at the lead identification/optimization step. Once a lead is identified, patent lawyers get to work to make sure that lead (or anything similar to it has not been patented before).
Regulatory Approvals
After all trials are completed, these are presented to the FDA. A panel reviews them and votes for approval of the drug or biologic. This could take up to a year but there are ways to fast-track it. Breakthrough drugs can go through accelerated approval processes. New strategies such as targeting orphan diseases and focusing on breakthrough oncology drugs leads to faster approval through various fast-track processes.
Phase 3 Trials
This is the final and most expensive step – a large scale study, with hundreds to thousands of patients to confirm that the drug works in a large population. This could take several years with many follow-ups and costs in the hundreds of millions. As the pharmaceutical industry moves towards personalized medicine, these trials will become smaller and more targeted. With the FDA moving towards more real-world evidence, the size and cost of these trials could also go down.
Phase 3 Trials
This is the final and most expensive step – a large scale study, with hundreds to thousands of patients to confirm that the drug works in a large population. This could take several years with many follow-ups and costs in the hundreds of millions. As the pharmaceutical industry moves towards personalized medicine, these trials will become smaller and more targeted. With the FDA moving towards more real-world evidence, the size and cost of these trials could also go down.
Phase 1 Trials
This is the first foray into humans. A small sample of healthy volunteers is selected to make sure the drug is safe. Highly toxic drugs such as chemotherapy drugs may go directly to patients. Phase 1 Trials can take 1-2 years and can cost millions. To introduce the drug in multiple markets, such as pediatric and adult, one must do these studies in both markets.
More targeted drug development strategies such as late-stage oncology products allow for skipping this step. Healthy individuals cannot be made subject to highly toxic oncology treatments and these are tested directly in patients.
Target Validation
Once a pathway has been identified and new targets have been identified, each of these needs to be validated to ensure that blocking them leads to the wanted result. The goal of this step is to demonstrate the function of the potential target in the disease. This may take an additional 1-2 years.
In recent years, more and more partnerships with universities had led to early discovery steps for Target Validation that are performed in university research labs.
Example Lipitor
The cholesterol pathway that Lipitor targets contains 10 enzymes. Of these, one was selected as a final target after validation.
File NON-Provisional Utility Patent App. w/ USPTO
A non-provisional application is filed within 12 months. The applicant is required to identify and submit relevant publications and patents. If a patent is issued, the patent term is 20 years from the date of the filing of the non-provisional application.
Maintenance Fee Schedule
Once the patent is granted, maintenance fees must be paid to maintain the patent until it expires. Once the patent expires, other companies have the right to sell the same drug.
File Provisional Utility Patent App. w/ USPTO
There is an option to file a provisional application which gives the company 12 months to generate more data to support the utility and efficacy of the invention.
Preclinical Development
This is where you test whether your optimized lead compound is safe and effective in the petri dish (in vitro) and animal (in vivo) models. This may take a year or two.
If good results are found at this stage, drugs may be out-licensed from companies if they don't fit a company's portfolio strategy or in-licensed for further development from other companies or academic institutions.
Example Lipitor
Lipitor was tested in vivo in mice, rats, dogs, guinea pigs, miniature pigs and rabbits. Tests were done for its effect on cholesterol as well as safety on various systems of the body such as the central nervous system, cardiovascular system and gastrointestinal system. For in vitro studies, various studies were conducted in a line of human liver cells.
Phase 2 Trials
This trial is done to demonstrate the efficacy of the drug. Usually a control group (placebo or current treatment) is compared with the treatment group. Hundreds of patients are enrolled. Sometimes these can be broken up into Phase 2a and Phase 2b trials where 2a is designed to determine the correct doing and 2b to determine the efficacy. At this stage, smaller pharmaceutical companies will partner with or be bought out by larger companies to assist with Phase 2 and Phase 3 trials, the most expensive parts of drug development.
Example Lipitor and Clinical Trials Phases
Lipitor was tested in 590 healthy males and females and various doses from 0mg (placebo) to 120mg of the drug were administered. Over Phase 2 and 3, 21 clinical studies with different endpoints and 3522 patients were completed for Lipitor. Studies ranged from 4 weeks to 52 weeks. Different populations were tested with different doses and combinations of the drug. One of the Phase 3 trials for Lipitor enrolled 3916 patients and lasted 54 weeks.
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Transcript
Patent Timeline
Step 7
Step 5
Step 3
Step 1
Step 6
Step 8
Step 2
Step 4
Timeline of R&D
Preclinical Development
Some introductory text here
Subtitle
Target Identification
Phase 1 Trials
Plan
Subtitle
Phase 2 Trials
Target Validation
Subtitle
Structure
Phase 3 Trials
Lead Identification
Subtitle
Design
Regulatory Approval
Lead Optimization
Subtitle
Communicate
Target Identification
Plan
Timeline of R&D
Target Validation
Structure
Some introductory text here
Lead Identification
Design
Lead Optimization
Communicate
Preclinical Development
Subtitle
Timeline of R&D cont.
Phase 1 Trials
Subtitle
Phase 2 Trials
Some continued text here
Subtitle
Phase 3 Trials
Subtitle
Regulatory Approval
Subtitle
Lead Optimization
Top compounds are selected from the Lead Optimization step. The goal of this step is to improve the selected compounds chemically to make them more specific for the target or to bind more tightly. Small structural modifications can significantly affect properties of drug candidates such as absorption and water solubility.
Example Lipitor
Work is still being done to make the molecule for Atorvastatin Calcium more absorbable, which means the dosage would be reduced for the same effect. This is also the step where patent counsel looks to see if anyone else has patents on the leads that were identified.
Lead Optimization
Top compounds are selected from the Lead Optimization step. The goal of this step is to improve the selected compounds chemically to make them more specific for the target or to bind more tightly. Small structural modifications can significantly affect properties of drug candidates such as absorption and water solubility.
Example Lipitor
Work is still being done to make the molecule for Atorvastatin Calcium more absorbable, which means the dosage would be reduced for the same effect. This is also the step where patent counsel looks to see if anyone else has patents on the leads that were identified.
Patents
Patents are issued by the USPTO after a thorough and lengthy review of the invention and application. Patents are not immediate and are expensive to obtain and maintain. This timeline demonstrates a simplified version of steps in the patent application process
Got an idea?
Use this space to add awesome interactivity. Include text, images, videos, tables, PDFs... even interactive questions! Premium tip: Get information on how your audience interacts with your creation:
Phase 1 Trials
This is the first foray into humans. A small sample of healthy volunteers is selected to make sure the drug is safe. Highly toxic drugs such as chemotherapy drugs may go directly to patients. Phase 1 Trials can take 1-2 years and can cost millions. To introduce the drug in multiple markets, such as pediatric and adult, one must do these studies in both markets. More targeted drug development strategies such as late-stage oncology products allow for skipping this step. Healthy individuals cannot be made subject to highly toxic oncology treatments and these are tested directly in patients.
Lead Identification
Once a target has been identified, we need a chemical (small molecule) or biologic (large molecule) that binds to the target. Using large chemical libraries and high throughput screening technologies, compound leads are identified. This step may take an additional year. Open Innovation is a major strategy used by pharmaceutical companies. AstraZeneca has a program where they welcome proposals from scientists that have identified and validated targets. If the proposal is accepted, scientists can access the company's screening library to identify leads.
Example Lipitor
Atorvastatin Calcium (Lipitor) was identified as the chemical that binds to the (HMG-CoA) reductase enzyme in the cholesterol pathway.
Target Identification
Disease can be a result of one or more pathways or processes in our bodies gone wrong. To treat this disease, a drug must intervene and correct or modify the pathway or process. Hence, the very first step of drug discovery is to find out what went wrong. The Target Identification step leads to finding new targets, normally proteins, that when inhibited, lead to reversing of the disease. As one can imagine, there are thousands of pathways in the body, so identifying the exact pathway and target takes 3-4 years. In recent years, more and more partnerships with universities have led to early discovery steps for Target Identification that are performed in university research labs.
Example Lipitor
Example: LipitorThe blockbuster drug Lipitor, used to reduce cholesterol, targets an enzyme that is part of the cholesterol producing pathway in the liver.
Preclinical Development
This is where you test whether your optimized lead compound is safe and effective in the petri dish (in vitro) and animal (in vivo) models. This may take a year or two. If good results are found at this stage, drugs may be out-licensed from companies if they don't fit a company's portfolio strategy or in-licensed for further development from other companies or academic institutions.
Example Lipitor
Lipitor was tested in vivo in mice, rats, dogs, guinea pigs, miniature pigs and rabbits. Tests were done for its effect on cholesterol as well as safety on various systems of the body such as the central nervous system, cardiovascular system and gastrointestinal system. For in vitro studies, various studies were conducted in a line of human liver cells.
File PCT App.
One may file a PCT non-provisional application or a US non-provisional application.
Target Validation
Once a pathway has been identified and new targets have been identified, each of these needs to be validated to ensure that blocking them leads to the wanted result. The goal of this step is to demonstrate the function of the potential target in the disease. This may take an additional 1-2 years. In recent years, more and more partnerships with universities had led to early discovery steps for Target Validation that are performed in university research labs.
Example Lipitor
The cholesterol pathway that Lipitor targets contains 10 enzymes. Of these, one was selected as a final target after validation.
Phase 2 Trials
This trial is done to demonstrate the efficacy of the drug. Usually a control group (placebo or current treatment) is compared with the treatment group. Hundreds of patients are enrolled. Sometimes these can be broken up into Phase 2a and Phase 2b trials where 2a is designed to determine the correct doing and 2b to determine the efficacy. At this stage, smaller pharmaceutical companies will partner with or be bought out by larger companies to assist with Phase 2 and Phase 3 trials, the most expensive parts of drug development.
Example Lipitor and Clinical Trials Phases
Lipitor was tested in 590 healthy males and females and various doses from 0mg (placebo) to 120mg of the drug were administered. Over Phase 2 and 3, 21 clinical studies with different endpoints and 3522 patients were completed for Lipitor. Studies ranged from 4 weeks to 52 weeks. Different populations were tested with different doses and combinations of the drug. One of the Phase 3 trials for Lipitor enrolled 3916 patients and lasted 54 weeks.
Regulatory Approvals
After all trials are completed, these are presented to the FDA. A panel reviews them and votes for approval of the drug or biologic. This could take up to a year but there are ways to fast-track it. Breakthrough drugs can go through accelerated approval processes. New strategies such as targeting orphan diseases and focusing on breakthrough oncology drugs leads to faster approval through various fast-track processes.
Target Identification
Disease can be a result of one or more pathways or processes in our bodies gone wrong. To treat this disease, a drug must intervene and correct or modify the pathway or process. Hence, the very first step of drug discovery is to find out what went wrong. The Target Identification step leads to finding new targets, normally proteins, that when inhibited, lead to reversing of the disease. As one can imagine, there are thousands of pathways in the body, so identifying the exact pathway and target takes 3-4 years. In recent years, more and more partnerships with universities have led to early discovery steps for Target Identification that are performed in university research labs.
Example Lipitor
Example: LipitorThe blockbuster drug Lipitor, used to reduce cholesterol, targets an enzyme that is part of the cholesterol producing pathway in the liver.
Lead Identification
Once a target has been identified, we need a chemical (small molecule) or biologic (large molecule) that binds to the target. Using large chemical libraries and high throughput screening technologies, compound leads are identified. This step may take an additional year. Open Innovation is a major strategy used by pharmaceutical companies. AstraZeneca has a program where they welcome proposals from scientists that have identified and validated targets. If the proposal is accepted, scientists can access the company's screening library to identify leads.
Example Lipitor
Atorvastatin Calcium (Lipitor) was identified as the chemical that binds to the (HMG-CoA) reductase enzyme in the cholesterol pathway.
Novelty Search
The process starts with the conception of the idea and then doing a thorough search to make sure the process or molecule the company wishes to patent meets the three criteria for granting a patent: it is 1) novel 2) useful and 3) non-obvious. This starts at the lead identification/optimization step. Once a lead is identified, patent lawyers get to work to make sure that lead (or anything similar to it has not been patented before).
Regulatory Approvals
After all trials are completed, these are presented to the FDA. A panel reviews them and votes for approval of the drug or biologic. This could take up to a year but there are ways to fast-track it. Breakthrough drugs can go through accelerated approval processes. New strategies such as targeting orphan diseases and focusing on breakthrough oncology drugs leads to faster approval through various fast-track processes.
Phase 3 Trials
This is the final and most expensive step – a large scale study, with hundreds to thousands of patients to confirm that the drug works in a large population. This could take several years with many follow-ups and costs in the hundreds of millions. As the pharmaceutical industry moves towards personalized medicine, these trials will become smaller and more targeted. With the FDA moving towards more real-world evidence, the size and cost of these trials could also go down.
Phase 3 Trials
This is the final and most expensive step – a large scale study, with hundreds to thousands of patients to confirm that the drug works in a large population. This could take several years with many follow-ups and costs in the hundreds of millions. As the pharmaceutical industry moves towards personalized medicine, these trials will become smaller and more targeted. With the FDA moving towards more real-world evidence, the size and cost of these trials could also go down.
Phase 1 Trials
This is the first foray into humans. A small sample of healthy volunteers is selected to make sure the drug is safe. Highly toxic drugs such as chemotherapy drugs may go directly to patients. Phase 1 Trials can take 1-2 years and can cost millions. To introduce the drug in multiple markets, such as pediatric and adult, one must do these studies in both markets. More targeted drug development strategies such as late-stage oncology products allow for skipping this step. Healthy individuals cannot be made subject to highly toxic oncology treatments and these are tested directly in patients.
Target Validation
Once a pathway has been identified and new targets have been identified, each of these needs to be validated to ensure that blocking them leads to the wanted result. The goal of this step is to demonstrate the function of the potential target in the disease. This may take an additional 1-2 years. In recent years, more and more partnerships with universities had led to early discovery steps for Target Validation that are performed in university research labs.
Example Lipitor
The cholesterol pathway that Lipitor targets contains 10 enzymes. Of these, one was selected as a final target after validation.
File NON-Provisional Utility Patent App. w/ USPTO
A non-provisional application is filed within 12 months. The applicant is required to identify and submit relevant publications and patents. If a patent is issued, the patent term is 20 years from the date of the filing of the non-provisional application.
Maintenance Fee Schedule
Once the patent is granted, maintenance fees must be paid to maintain the patent until it expires. Once the patent expires, other companies have the right to sell the same drug.
File Provisional Utility Patent App. w/ USPTO
There is an option to file a provisional application which gives the company 12 months to generate more data to support the utility and efficacy of the invention.
Preclinical Development
This is where you test whether your optimized lead compound is safe and effective in the petri dish (in vitro) and animal (in vivo) models. This may take a year or two. If good results are found at this stage, drugs may be out-licensed from companies if they don't fit a company's portfolio strategy or in-licensed for further development from other companies or academic institutions.
Example Lipitor
Lipitor was tested in vivo in mice, rats, dogs, guinea pigs, miniature pigs and rabbits. Tests were done for its effect on cholesterol as well as safety on various systems of the body such as the central nervous system, cardiovascular system and gastrointestinal system. For in vitro studies, various studies were conducted in a line of human liver cells.
Phase 2 Trials
This trial is done to demonstrate the efficacy of the drug. Usually a control group (placebo or current treatment) is compared with the treatment group. Hundreds of patients are enrolled. Sometimes these can be broken up into Phase 2a and Phase 2b trials where 2a is designed to determine the correct doing and 2b to determine the efficacy. At this stage, smaller pharmaceutical companies will partner with or be bought out by larger companies to assist with Phase 2 and Phase 3 trials, the most expensive parts of drug development.
Example Lipitor and Clinical Trials Phases
Lipitor was tested in 590 healthy males and females and various doses from 0mg (placebo) to 120mg of the drug were administered. Over Phase 2 and 3, 21 clinical studies with different endpoints and 3522 patients were completed for Lipitor. Studies ranged from 4 weeks to 52 weeks. Different populations were tested with different doses and combinations of the drug. One of the Phase 3 trials for Lipitor enrolled 3916 patients and lasted 54 weeks.