This document provides an overview of patents, intellectual property, and the patent application process. It defines a patent and explains that it gives the owner legal rights to exclude others from making, using, selling, or importing an invention for a limited time (usually 20 years). It outlines the conditions an invention must meet to be patentable, including novelty, non-obviousness, and usefulness. It also describes essential elements of a patent like claims, descriptions, drawings, and fees. Guidelines are provided for conducting patent searches and properly documenting research in a laboratory notebook to support patent applications.
Documentation of technology Transfer .pptxParthRana47
This document outlines the various protocols and reports required for technology transfer between pharmaceutical companies. It discusses confidentiality agreements, licensing, research and development reports, technology transfer plans, process validation protocols, equipment and facility qualification protocols, cleaning validation protocols, and analytical methods transfer protocols. The goal of technology transfer is to ensure that manufacturing capabilities, methods, and intellectual property are effectively transferred between parties in a controlled and documented manner.
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
Distribution records document the transfer of drug products from manufacturers to distributors and must include information such as product name and strength, manufacturer, lot number, quantity shipped, and recipient. They allow defective products to be recalled and ensure accountability. Records should contain sections for product information, transaction details, distribution information, and recipient information according to WHO guidelines. An example distribution record format was also presented.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.
This document summarizes the Hatch-Waxman Act, which established the modern system for regulating generic drugs in the US. The Act aims to make generic drugs more accessible by streamlining the approval process for generics while also providing incentives to brand name drug companies. It allows generics to challenge drug patents and grants exclusivity periods to first generic applicants and brand name drugs for new chemical entities. The Orange Book lists approved drug products and related patent information.
The document discusses the abbreviated new drug application (ANDA) regulatory approval process for generic drugs in the United States. It describes the key steps and reviewing bodies involved, including filing review by the Regulatory Support Branch, coordination of reviews by bioequivalence, chemistry, and labeling teams, and final approval. The primary goal of the ANDA process is to determine if the generic drug is bioequivalent to the reference listed drug while ensuring safety and manufacturing quality standards are met.
1) When filing an ANDA application, an applicant must provide information on any patents listed for the reference drug in the Orange Book.
2) In its application, a generic applicant must submit one of four certifications regarding the patents: that there are no patents (Paragraph I); any patents have expired (Paragraph II); any patents will expire on a specific date (Paragraph III); or the generic product does not infringe on or the patents are invalid (Paragraph IV).
3) A Paragraph I or II certification allows immediate approval, while a Paragraph III approval is effective after patent expiration. A Paragraph IV certification requires notifying the innovator and may allow early generic entry.
Documentation of technology Transfer .pptxParthRana47
This document outlines the various protocols and reports required for technology transfer between pharmaceutical companies. It discusses confidentiality agreements, licensing, research and development reports, technology transfer plans, process validation protocols, equipment and facility qualification protocols, cleaning validation protocols, and analytical methods transfer protocols. The goal of technology transfer is to ensure that manufacturing capabilities, methods, and intellectual property are effectively transferred between parties in a controlled and documented manner.
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
Distribution records document the transfer of drug products from manufacturers to distributors and must include information such as product name and strength, manufacturer, lot number, quantity shipped, and recipient. They allow defective products to be recalled and ensure accountability. Records should contain sections for product information, transaction details, distribution information, and recipient information according to WHO guidelines. An example distribution record format was also presented.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.
This document summarizes the Hatch-Waxman Act, which established the modern system for regulating generic drugs in the US. The Act aims to make generic drugs more accessible by streamlining the approval process for generics while also providing incentives to brand name drug companies. It allows generics to challenge drug patents and grants exclusivity periods to first generic applicants and brand name drugs for new chemical entities. The Orange Book lists approved drug products and related patent information.
The document discusses the abbreviated new drug application (ANDA) regulatory approval process for generic drugs in the United States. It describes the key steps and reviewing bodies involved, including filing review by the Regulatory Support Branch, coordination of reviews by bioequivalence, chemistry, and labeling teams, and final approval. The primary goal of the ANDA process is to determine if the generic drug is bioequivalent to the reference listed drug while ensuring safety and manufacturing quality standards are met.
1) When filing an ANDA application, an applicant must provide information on any patents listed for the reference drug in the Orange Book.
2) In its application, a generic applicant must submit one of four certifications regarding the patents: that there are no patents (Paragraph I); any patents have expired (Paragraph II); any patents will expire on a specific date (Paragraph III); or the generic product does not infringe on or the patents are invalid (Paragraph IV).
3) A Paragraph I or II certification allows immediate approval, while a Paragraph III approval is effective after patent expiration. A Paragraph IV certification requires notifying the innovator and may allow early generic entry.
Technology transfer from R & D to production in pharmaceutical industrySagar Dhadwad
The document discusses technology transfer in the pharmaceutical industry. It defines technology transfer as the process of transferring manufacturing knowledge from research and development sites to production sites. The key steps in the technology transfer process are developing the technology in R&D, pilot plant studies, transferring technology from R&D to production, optimization and production, documentation, and approval. Successful technology transfer requires effective communication and teamwork between the sending and receiving sites.
The document provides an overview of stability testing during product development. It discusses the importance of stability testing to ensure product quality and safety over the shelf life. Various methods of stability testing are described, including real-time, accelerated, and retained sample testing. Guidelines for stability testing from ICH, WHO, and other agencies are also covered. The document outlines the key aspects of a stability testing protocol, including batches, containers, storage conditions, sampling plan, test parameters, and acceptance criteria. It provides details on conducting, recording, and presenting stability testing data.
A platform is a group of technologies that are used as a base
or infrastructure upon which other applications, technologies
or processes are developed for the end-user.
“a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacturing of different products ” An array of multi-disciplinary technologies covering major aspects of the drug discovery and development processes have been established in Institute of Biotechnology and Pharmaceutical Research (IBPR)
- Generic drugs are comparable to brand name drugs in dosage, quality, and intended use but are cheaper. They contain the same active ingredients as original formulations.
- The generic drug development process involves concept development, system-level design, detail design, testing and refinement, production ramp-up, and product launch. It aims to develop affordable drugs that balance public health needs.
- Generic drugs are available after patents or marketing rights expire on brand name drugs. They maintain quality at affordable prices for critical diseases.
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
The Hatch Waxman Act established provisions to balance the interests of branded and generic drug manufacturers as well as consumers. It created the Abbreviated New Drug Application (ANDA) process to streamline generic approval. It also provides incentives like exclusivity periods and a 30 month stay on generic approval to encourage drug development while facilitating generic competition through the ANDA pathway. The Act aims to reduce drug costs over time through increased generic competition.
The document discusses validation of pharmaceutical processes. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. There are several types of validation including process validation to ensure consistency in manufacturing, cleaning validation to minimize contamination, equipment validation to ensure equipment works correctly, and validation of analytical methods to establish test method performance. Proper documentation is essential for validation including a validation master plan, protocols, reports and standard operating procedures.
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.GvDurgamani
This document provides information about technology transfer in the pharmaceutical industry. It defines technology transfer as the logical procedure that controls the transfer of any process along with documentation and expertise between development and manufacturing sites. The WHO guidelines for technology transfer provide a flexible framework to guide the transfer process with a focus on quality. The scope of the WHO guidelines includes guidance for transferring manufacturing processes of APIs, packaging, and all dosage forms. Reasons for technology transfer include a lack of manufacturing capacity, resources, or marketing capabilities.
Pharmaceutical Licecnsing authorites of indiaAtul Bhombe
Central Drug Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It regulates the import of drugs, approves new drugs and clinical trials. CDSCO works with six zonal offices, seven sub-zonal offices, and thirteen port/airport offices. The Drug Controller General of India, who is responsible for new drug, medical device, and clinical trial approvals, advises CDSCO. At the state level, State Licensing Authorities regulate and control the licensing of drug manufacturing, distribution, and sale within the state.
Technology Transfer Related Documents.pptxAfroj Shaikh
SlideShare Description: Technology Transfer Related Documents
Welcome to SlideShare's collection of technology transfer related documents in the field of pharmacy. This presentation focuses on the essential documentation needed for successful technology transfer in pharmaceutical manufacturing, emphasizing its role in ensuring quality, safety, and regulatory compliance.
Technology transfer plays a crucial role in the dynamic and ever-evolving field of pharmacy. It facilitates the smooth transfer of knowledge, processes, and technologies from research and development to commercial production. To ensure a seamless transition, a well-defined set of documents is required to capture critical information, procedures, and controls.
This SlideShare presentation explores the key documents involved in technology transfer within the pharmaceutical industry. The technology transfer protocol is discussed first, highlighting its purpose, contents, and significance. Acting as a roadmap, this protocol outlines the transfer scope, stakeholder responsibilities, timelines, and acceptance criteria, promoting effective communication and collaboration between the sending and receiving units.
The importance of comprehensive process descriptions is also emphasized. These documents detail the manufacturing process, equipment specifications, critical parameters, and in-process controls. They serve as a guide for the receiving unit to replicate the process accurately, ensuring consistent product quality and performance.
Validation and qualification protocols are addressed as well, highlighting their role in verifying that equipment, processes, and systems are suitable for their intended use. These protocols are crucial for meeting regulatory requirements and mitigating risks associated with the transfer.
Analytical method transfer documents are discussed next, encompassing the procedures for transferring and validating analytical methods used to assess the quality attributes of pharmaceutical products. Robust analytical methods are essential to ensure accurate and reliable test results throughout the product lifecycle.
The presentation also covers documentation related to training, risk assessments, change control, and deviation management. These documents help establish a robust quality management system, ensuring adherence to regulatory standards and facilitating continuous improvement.
Whether you're involved in technology transfer, quality assurance, or regulatory affairs, this SlideShare is a valuable resource for understanding the essential documents involved in successful technology transfer within the pharmaceutical industry. By leveraging these documents effectively, you can ensure a seamless transfer process, maintain product quality, and uphold patient safety.
Explore our SlideShare and gain the knowledge necessary to navigate the intricacies of technology transfer in pharmacy. Stay updated with the latest best practices and regulatory guidelines.
This document discusses the Roche Products v. Bolar Pharmaceutical case and the subsequent establishment of the "Bolar exception" in various countries' patent laws. In the Roche case, the court ruled that Bolar's experiments using Roche's patented drug to obtain regulatory approval for its generic version constituted patent infringement. However, Congress then passed a law allowing generic drugmakers to use patented inventions for regulatory approval purposes before patents expire, known as the "Bolar exception." Section 107A of India's Patents Act includes a similar Bolar exception, allowing use of patented inventions solely for regulatory approval without the patent owner's consent.
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
This document provides guidelines for scale-up and post-approval changes (SUPAC) as outlined by the FDA. It discusses SUPAC documents, levels of changes, and recommendations for changes to components and composition, manufacturing site, batch size, and manufacturing process and equipment. The guidelines provide recommendations for submitting documentation to the FDA for level 1, 2, and 3 changes to ensure quality and performance of drug products after approval. It notes some limitations of the SUPAC guidelines, including that they have not been updated since 1995/1997 and do not cover all potential changes.
An ANDA contains data submitted to the FDA to review and approve a generic drug product. Once approved, a generic manufacturer can produce and market a safe, low-cost alternative to the innovator drug. All approved drugs are listed in the Orange Book. ANDAs have four types of submissions: Paragraph I for drugs with no listed patents allowing immediate approval; Paragraph II for off-patent drugs; Paragraph III where generics agree not to market until patents expire; and Paragraph IV for generics believing patents are invalid allowing earlier market entry. The examples show drugs with Paragraph III certifications and their patent expiration dates.
Online Patent Registration | Patent Application Process in Indiaregistrationwala
Get complete detail about patent registration in India with Registrationwala. Here patent professional and experts are available for your guidance. So, if you are looking for consultation to patent registration, Registrationwala is here for your help.
Patents and intellectual property patent disclosure.gidla vinay
This document provides an overview of the patent disclosure process. It discusses the different types of intellectual property including patents, trademarks, trade secrets, and copyrights. It then describes the steps to prepare a patent disclosure, including formulating a strategy, studying prior art, outlining claims, writing the specification, refining claims, and pursuing the application. Guidelines are provided for each step, with examples of patents and claims. The purpose is to educate about effectively obtaining patent protection for new inventions.
Technology transfer from R & D to production in pharmaceutical industrySagar Dhadwad
The document discusses technology transfer in the pharmaceutical industry. It defines technology transfer as the process of transferring manufacturing knowledge from research and development sites to production sites. The key steps in the technology transfer process are developing the technology in R&D, pilot plant studies, transferring technology from R&D to production, optimization and production, documentation, and approval. Successful technology transfer requires effective communication and teamwork between the sending and receiving sites.
The document provides an overview of stability testing during product development. It discusses the importance of stability testing to ensure product quality and safety over the shelf life. Various methods of stability testing are described, including real-time, accelerated, and retained sample testing. Guidelines for stability testing from ICH, WHO, and other agencies are also covered. The document outlines the key aspects of a stability testing protocol, including batches, containers, storage conditions, sampling plan, test parameters, and acceptance criteria. It provides details on conducting, recording, and presenting stability testing data.
A platform is a group of technologies that are used as a base
or infrastructure upon which other applications, technologies
or processes are developed for the end-user.
“a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacturing of different products ” An array of multi-disciplinary technologies covering major aspects of the drug discovery and development processes have been established in Institute of Biotechnology and Pharmaceutical Research (IBPR)
- Generic drugs are comparable to brand name drugs in dosage, quality, and intended use but are cheaper. They contain the same active ingredients as original formulations.
- The generic drug development process involves concept development, system-level design, detail design, testing and refinement, production ramp-up, and product launch. It aims to develop affordable drugs that balance public health needs.
- Generic drugs are available after patents or marketing rights expire on brand name drugs. They maintain quality at affordable prices for critical diseases.
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
The Hatch Waxman Act established provisions to balance the interests of branded and generic drug manufacturers as well as consumers. It created the Abbreviated New Drug Application (ANDA) process to streamline generic approval. It also provides incentives like exclusivity periods and a 30 month stay on generic approval to encourage drug development while facilitating generic competition through the ANDA pathway. The Act aims to reduce drug costs over time through increased generic competition.
The document discusses validation of pharmaceutical processes. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. There are several types of validation including process validation to ensure consistency in manufacturing, cleaning validation to minimize contamination, equipment validation to ensure equipment works correctly, and validation of analytical methods to establish test method performance. Proper documentation is essential for validation including a validation master plan, protocols, reports and standard operating procedures.
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.GvDurgamani
This document provides information about technology transfer in the pharmaceutical industry. It defines technology transfer as the logical procedure that controls the transfer of any process along with documentation and expertise between development and manufacturing sites. The WHO guidelines for technology transfer provide a flexible framework to guide the transfer process with a focus on quality. The scope of the WHO guidelines includes guidance for transferring manufacturing processes of APIs, packaging, and all dosage forms. Reasons for technology transfer include a lack of manufacturing capacity, resources, or marketing capabilities.
Pharmaceutical Licecnsing authorites of indiaAtul Bhombe
Central Drug Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It regulates the import of drugs, approves new drugs and clinical trials. CDSCO works with six zonal offices, seven sub-zonal offices, and thirteen port/airport offices. The Drug Controller General of India, who is responsible for new drug, medical device, and clinical trial approvals, advises CDSCO. At the state level, State Licensing Authorities regulate and control the licensing of drug manufacturing, distribution, and sale within the state.
Technology Transfer Related Documents.pptxAfroj Shaikh
SlideShare Description: Technology Transfer Related Documents
Welcome to SlideShare's collection of technology transfer related documents in the field of pharmacy. This presentation focuses on the essential documentation needed for successful technology transfer in pharmaceutical manufacturing, emphasizing its role in ensuring quality, safety, and regulatory compliance.
Technology transfer plays a crucial role in the dynamic and ever-evolving field of pharmacy. It facilitates the smooth transfer of knowledge, processes, and technologies from research and development to commercial production. To ensure a seamless transition, a well-defined set of documents is required to capture critical information, procedures, and controls.
This SlideShare presentation explores the key documents involved in technology transfer within the pharmaceutical industry. The technology transfer protocol is discussed first, highlighting its purpose, contents, and significance. Acting as a roadmap, this protocol outlines the transfer scope, stakeholder responsibilities, timelines, and acceptance criteria, promoting effective communication and collaboration between the sending and receiving units.
The importance of comprehensive process descriptions is also emphasized. These documents detail the manufacturing process, equipment specifications, critical parameters, and in-process controls. They serve as a guide for the receiving unit to replicate the process accurately, ensuring consistent product quality and performance.
Validation and qualification protocols are addressed as well, highlighting their role in verifying that equipment, processes, and systems are suitable for their intended use. These protocols are crucial for meeting regulatory requirements and mitigating risks associated with the transfer.
Analytical method transfer documents are discussed next, encompassing the procedures for transferring and validating analytical methods used to assess the quality attributes of pharmaceutical products. Robust analytical methods are essential to ensure accurate and reliable test results throughout the product lifecycle.
The presentation also covers documentation related to training, risk assessments, change control, and deviation management. These documents help establish a robust quality management system, ensuring adherence to regulatory standards and facilitating continuous improvement.
Whether you're involved in technology transfer, quality assurance, or regulatory affairs, this SlideShare is a valuable resource for understanding the essential documents involved in successful technology transfer within the pharmaceutical industry. By leveraging these documents effectively, you can ensure a seamless transfer process, maintain product quality, and uphold patient safety.
Explore our SlideShare and gain the knowledge necessary to navigate the intricacies of technology transfer in pharmacy. Stay updated with the latest best practices and regulatory guidelines.
This document discusses the Roche Products v. Bolar Pharmaceutical case and the subsequent establishment of the "Bolar exception" in various countries' patent laws. In the Roche case, the court ruled that Bolar's experiments using Roche's patented drug to obtain regulatory approval for its generic version constituted patent infringement. However, Congress then passed a law allowing generic drugmakers to use patented inventions for regulatory approval purposes before patents expire, known as the "Bolar exception." Section 107A of India's Patents Act includes a similar Bolar exception, allowing use of patented inventions solely for regulatory approval without the patent owner's consent.
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
This document provides guidelines for scale-up and post-approval changes (SUPAC) as outlined by the FDA. It discusses SUPAC documents, levels of changes, and recommendations for changes to components and composition, manufacturing site, batch size, and manufacturing process and equipment. The guidelines provide recommendations for submitting documentation to the FDA for level 1, 2, and 3 changes to ensure quality and performance of drug products after approval. It notes some limitations of the SUPAC guidelines, including that they have not been updated since 1995/1997 and do not cover all potential changes.
An ANDA contains data submitted to the FDA to review and approve a generic drug product. Once approved, a generic manufacturer can produce and market a safe, low-cost alternative to the innovator drug. All approved drugs are listed in the Orange Book. ANDAs have four types of submissions: Paragraph I for drugs with no listed patents allowing immediate approval; Paragraph II for off-patent drugs; Paragraph III where generics agree not to market until patents expire; and Paragraph IV for generics believing patents are invalid allowing earlier market entry. The examples show drugs with Paragraph III certifications and their patent expiration dates.
Online Patent Registration | Patent Application Process in Indiaregistrationwala
Get complete detail about patent registration in India with Registrationwala. Here patent professional and experts are available for your guidance. So, if you are looking for consultation to patent registration, Registrationwala is here for your help.
Patents and intellectual property patent disclosure.gidla vinay
This document provides an overview of the patent disclosure process. It discusses the different types of intellectual property including patents, trademarks, trade secrets, and copyrights. It then describes the steps to prepare a patent disclosure, including formulating a strategy, studying prior art, outlining claims, writing the specification, refining claims, and pursuing the application. Guidelines are provided for each step, with examples of patents and claims. The purpose is to educate about effectively obtaining patent protection for new inventions.
This document outlines the 10 step patent application and registration process in India. It begins with writing down details of the invention, including drawings and diagrams. It then involves checking if the invention is patentable subject matter under Indian law. Key steps include conducting a patentability search, deciding whether to file based on the results, drafting the application, publication, requesting examination, responding to objections raised during examination, clearing all objections, and ultimately receiving grant of the patent if all criteria are satisfied.
patent types of patent,utility patent,design patent,plant patent,expiry of patent,how to apply patent,filling form of patent,sample of patent advantages of patents to the patentee and society, patent history-india
Intellectual Property for Accountants. This deck is the launch presentation for the Nicholas Weston White Paper, “Definitive Guide to Intellectual Property for Accountants” (2015 Edition) held at William Buck in Melbourne on 25 November 2014. The presentation deck is not intended as a substitute for the White Paper which contains sections on Protecting intangible assets, Patents, Trade Marks, Domain Names, Registered Designs, Copyright, Licensing and royalty rates, Valuing IP rights, Tax implications and benefits (including Capital gains tax (CGT) and Income tax, Trade mark taxation, Tax deductions, Withholding taxes, GST treatment, the R&D Tax Incentive, Stamp Duty in each State and Territory), the Personal Properties Securities Act 2009 (PPSA), using the Freedom of Information Act 1982 (FOI) in the context of IP, Details Oppositions, Appeals and Injunctions, and has some handy ATO References. It also contains a Test of your IP awareness and a summary with Four things to remember about IP for Accountants.
The event was attended by Directors, Associates and Senior Managers from all William Buck divisions - Audit, Business Advisory, Tax, Corporate Advisory, Wealth Advisory.
The document provides guidelines for filing a patent application in Pakistan. It discusses that a patent grants exclusive rights to make, use and sell an invention for 20 years. It outlines the criteria for a patentable invention, including novelty, inventive step and industrial applicability. The registration process involves filing an application at the Patent Office of Pakistan, paying fees, and submitting a specification describing the invention. The application then undergoes examination and search to determine whether the claimed invention is patentable.
What is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problemWhat is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problemWhat is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a What is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problemWhat is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problem What is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problem What is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problem to a problemWhat is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problemWhat is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problemWhat is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problemWhat is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a What is a patent? A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problemWhat is a patent? A patent is an exclusive right granted for an in
It is focused to provide basic knowledge on prior art search for new intellectuals in the field of IPR. It includes Basic knowledge of Prior art, File wrapper analysis, not list preparation, and one of the important law of Prior Art.
MaRS Best Practices: IP Best Practices for Life Sciences Companies - Victoria...MaRS Discovery District
Discover why intellectual property is a critical asset to your company. Within the context of current economic uncertainty, this series covers cost-effective strategies for securing IP and patent rights to enhance the market value and competitive position of your life sciences or ICE company.
The document summarizes Abdul Waheed Salafi's seminar on intellectual property and patents. It discusses what a patent is, the conditions for obtaining a patent, the types of patents including utility, design and plant patents, and the Indian Patent Act. It provides examples of patentable and non-patentable inventions, and explains the patent application process and specifications.
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Guide for effectively utilizing patent information for business needsIntepat IP
Leverage to use the patent information available in WIPO and learn to know how effectively can be utilized.
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Novelty search USA & Canada | Patentability Search | InventionIPInvention ip
Explore the essential steps to master novelty and patentability searches for your invention with our comprehensive guide. Learn how to navigate the complexities of intellectual property, ensure uniqueness, and maximize the potential for patent approval. Dive into expert insights and practical tips to protect your innovative ideas effectively. Start your journey to securing your intellectual property today!
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1. Patent, Intellectual Property and
Regulatory Affairs.
Mr. Abdallah Abdalmalk
M.Pharm, 1st year IP
Dr. Rashime Mathew
Department of Industry Pharmacy
Karnataka College of Pharmacy
BANGALORE-540064, Karnataka, India
Cell no: 7899406897
E-mail: abdallahabdalmalk@gmail.com
1
2. Contents:
• Definition
• Need for patent
• Type of patent
• Condition to be satisfied by an invention to be patentable
• Introduction to patent search
• Parts of patents.
• Filling of patents.
• Essential element of patents.
• Guideline for preparation of laboratory note book.
• Non-obviousness of patents.
2
3. Definition:
• It can be defined as form of intellectual property category of property
that includes intangible creations of the human intellect, that gives it’s
owner legal right to exclude other from making, using selling and
importing and invention provided the invention for limited period of
year.
• i.e. up to 20 years.
3
4. Need for patent:
• Patent granted for an invention.
• Invention means product or process which is:
a. New (novel)
b. Involving intensive step (non-obvious)
c. Utility
• Capable of industrial application.
• To ensure the exclusive right over the invention.
• Stop other copying his invention and exploit it commercially.
• To stop other from using, selling, or working out his invention the invention must go for getting
patent.
• Benefit to R&D
• Stop inventioning the wheel.
• Know what is already patent.
4
5. • Rewards to inventor.
• Motivate/ stimulate inventive research.
• Encourages maximum disclosure to enable further research and
technology development.
• Transferring into public property after expiry of term or cessation of
patent.
• Encourage for improvement of technology.
5
6. Types of patent:
• Patent can be classified as:
1. Independent patent.
• Independent patent claims maybe three types:
A. Claim for thing.
B. Claim for method of making thing.
C. Claim for method of using thing.
2. Patent of an addition ( to some prior patent)
3. Term of patent addition.
• Second type of classification of patent:
A. Process of patent
B. Product patent.
6
9. Condition to be satisfied by an invention to be
patentable:
• Invention must satisfy the following condition to be patentable
A. Novelty (new)
B. Non-obviousness (intensive step)
C. Usefulness.
9
10. A. Novelty:
• An invention will be considered novel if it does not form of the global state of the art.
• Information appearing in magazines, technical journals, books, newspaper etc.
• Oral description of the invention in a seminar/conference can also spoil novelty.
• Novelty is assed in global context.
• An invention will cease the to be novel if it has been disclosed in the public through
any type of publications any where in the world before filling a patent application in
respect of the invention.
• Therefore it’s advisable to fill patent application before publishing a paper if three is
a slight chance that the invention maybe patentable.
• Prior use of the invention in the country of interest before the filling data can also
destroy the novelty.
• Novelty determined through extensive literature and patent searches.
10
11. B. Non-obviousness (intensive step)l Ingenuity.
• A patent application involves an intensive step in the proposed invention is
not obvious to a person skilled in the art.
• Inventiveness cannot be decided on the material contained in unpublished
patents.
• The complexity or simplicity of an intensive step doesn’t have any bearing
on the grant of a patent.
• The reason is that it would depend on the interpretative skills of the inventor
and these skill will really be a function of knowledge in the subject area.
11
12. C. Usefulness:
• An invention must possess utility for the grant of patent.
• No valid patent can be granted for an invention devoid of utility.
• The patent specification should spell out various uses and manner of
practicing them, even if considered obvious.
• If you are claiming a process, you need not describe the use of the
compound produced thereby.
• Nevertheless it would be safer to do so, but if you claim a compound
without spelling out it’s utility, you maybe denied a patent.
12
14. Introduction to patent search:
• Patent search is search and analyze relevant patents in product development
step or prior to patent application process so that you can make sure the
patentability of your invention and get current technology information and
future trend of specific technology area.
• Also it helps you to avoid duplicate research and to invest your money to
safe market having no legal problems related to patent.
• Patent searches are very useful for serval purposes, not only organization
such as universities, but also for researchers.
• In order to performs a good and useful searches it is essential to understand
the structure of patent information, whatever from it can take ( full text or
bibliographies) as well as where and how to use the search tools available.
14
15. Appropriate time for conducting a patent search:
• It’s advisable to ascertain this position at a very early stage of developing later.
• Many a limes the search is conducted alter developing the invention and at the
time of preparing the patent specification.
• This is wrong one has to start doing the search from the time an invention is
conceived and through the development stage of the invention.
• Finally the details of the search already in hand will be helpful to make the
reference in patent specification by way of prior art.
• Such procedure will safe considerable amount of time and more important that
any later stage embracement by realizing that the invention has already been in
the prior art.
15
16. Conduction of patent search:
• The patents are classified under the national patent systems of every country
like( Indian patent classification system, US patent classification etc.).
• As well as under international patent classification system (IPC).
• The IPC classification system classifies the entire science and technology into
eight main heading, each heading further classified minutely into about 95000
subheading.
• There are available through various websites like USPTO website, website of
WIPO (world intellectual property organization).
16
17. Parts of patent:
I. Theme search: it provides the overview of patents related to your filed of
interest. These search are helpful to detect the recent trend of your technology
area and to establish your R&D direction.
II. Patentability search: it’s first step of patenting process a patentability search
surveys patents filled in each national intellectual property office to check
whether there exists inventions similar to yours.
III. Infringement search: its to check whether patents which can be infringed by
your products launched newly in a certain country exist or not in that country.
IV. Invalidity search: when you intend to make some claims of a particular patent
invalid, the invalid search can provide some prior at references that disclose
claims that are infringed by the subject disclosure.
V. Legal status search/ family patent: patent family search provides a list of
country in which a particular patent filled. Legal status gives the legal
progressing status of a particular patent.
17
19. Process of patent search:
Searching and reviewing
Reform search Search result and extracting data
Select key word
Make search queries
Clarify the purpose of search
Decide the extent of search
19
20. Where to search patent information:
20
Original published document (article, technical
study, patent, standard, market study…)
Database
Bibliographic reference
Summarized indexed
Search
Question?
Fig: Access to information.
21. Filling of patent:
• Patent filling can be defined as: process of submitting an application in patent
office requesting grant of patent to your invention.
• To protect the invention in different countries, then submit a patent
application in each of those countries.
• How to fill patent application:
Document can be filled in the patent office.
Through online ( e-filling).
www.indiaonline.gov.in/online
Can be submitted by hand.
21
22. Steps involved in the patent process in India:
• Check the patentability of the invention by performing a search for similar
technology.
• Drafting patent application (professional or complete).
• Provisional patent specification.
• Content of specification.
• Filling the patent application in India.
• Publication of patent application.
• Examination of patent application.
• Final decision on grant of patent
• renewal
22
23. General procedure for obtaining patent/ main
steps of patenting procedure:
• Filling patent application.
• Publication after 18 months.
• Pre grant opposition.
• Request for examination.
• Examination grant or refusal.
• Publication of grant of patent.
• Post grant opposition to grant of patent.
• Decision by controller.
23
24. Filling of patent application:
• A patent application shall be filled on along with professional or complete
specification, with the prescribed fee as given in first schedule as an appropriate office.
• Normal fee should be applicable for application contain up to 20 pages in specification
and up to 10 claims.
• If application exceeds 30pages or claims are more than 10 in number additional fee as
given in first schedule is payable.
24
25. Essential elements of patent:
1. Description
2. File No
3. Claims
4. Abstract
5. Drawings
6. Fees
7. Depositories
8. Disclosure
25
26. Description
• The description of the invention in the International Application must disclose the
invention in a manner sufficiently clear and complete for the invention to be
carried out by a person skilled in the art.
• The description first repeats the title of the invention. It then specifies the
technical field to which the invention relates. It indicates the so-called
“background art,” that is, the technical and, in particular, patent literature,
pertaining to that technical field, constituting the “prior art” or “state of the art”
or known technology for the newly filed application.
• It discloses the intention in a way which allows the technical problem and its
solution to be understood. It states the advantageous effects of the invention as
compared with the known technology. It briefly describes the figures in the
drawings. It sets forth the best mode contemplated by the applicant for carrying
out the invention and any other mode he wants to include. Finally, it indicates the
way in which the invention is capable of exploitation in industry. Explains the
inventive step and how it works.
26
27. Claims:
• Claims are the parts of a patent which define the boundaries of patent
protection. Patent claims are the legal basis for your patent protection.
They form a protective boundary line around your patent that lets
others know when they are infringing on your rights. The limits of this
line are defined by the words and phrasing of your claims.
• As the claims are key to receiving complete protection for your
invention, you may wish to seek professional help to ensure that they
are properly drafted. When writing this section you should consider
the scope, characteristics, and structure of the claims.
27
28. Scope:
• Each claim should have only one meaning which can be either broad or
narrow, but not both at the same time. In general a narrow claim specifies
more details than a broader claim. Having many claims, where each one
is a different scope allows you to have legal title to several aspects of
your invention.
28
29. Important characteristics
• Three criteria to take note of when drafting your claims are that they should clear, complete, and supported.
Every claim must be one sentence, as long or as short a sentence as required to be complete.
• Be Clear
Your claim must be clear so that you do not cause the reader to speculate about the claim. If you find yourself
using words such as "thin", "strong", "a major part", "such as", "when required", then you are probably not
being clear enough. These words force the reader to make a subjective judgment, not an objective
observation.
• Be Complete
Each claim should be complete, so that it covers the inventive feature and enough elements around it to put
the invention in the proper context.
• Be Supported
The claims have to be supported by the description. This means that all the characteristics of your invention
that form part of the claims must be fully explained in the description. In addition, any terms you use in the
claims must be either found in the description or clearly inferred from the description.
29
30. Abstract
• The abstract is intended to serve the purpose of technical information. The
treaty says clearly that it cannot be taken into account for any other purpose.
This means in particular that it cannot be used for the purpose of interpreting
the scope of the protection sought.
• The abstract consists of a concise summary of the disclosure of the Invention
as contained in the description, claims & drawing in within 50 to 150 words.
It must be drafted in a way, which Allow the clear understanding of the
technical problem, the general idea of the solution of that problem through
the invention, and the principal use of the invention.
30
31. • The abstract is the concise summary of the invention preferably within 150
words. It shall commence with the title of the invention, preferably within 15
words. It should be prepared in such a way that one can understand the
technical problem and solution with its usefulness. If necessary, most
relevant drawing should also be included in the abstract, particularly, in
mechanical type inventions.
• Each main feature mentioned in the abstract and illustrated by a drawing
should be indicated by reference numerals. In case of Chemical invention, it
should contain the Chemical Formula for understanding the invention.
However, it cannot be used for the purpose of interpreting the scope of
protection in legal proceeding.
31
32. drawing
• The drawings are only required where they are necessary for the
understanding of the invention. This will be the case for a mechanical
invention. It will not be the case when an invention cannot be drawn, as is the
case for a chemical product. Here again, the requirements are similar to those
of most patent Offices Drawings are preferred because it is typically easier to
show the novel, claimed Elements in solid lines and to show the non-
essential elements in dotted lines.
• However, photographs, both black and white and color, can be submitted as
informal drawings to obtain a filing date. Further, black and white
Photographs are now acceptable as formal drawings.
32
33. fees
• 1) There shall be paid in respect of the grant of patents and applications there for,
and in respect of other Matters in relation to the grant of patents under this Act,
such fees as may be prescribed by the Central Government.
• 2) Where a fee is payable in respect of the doing of an act by the Controller, the
Controller shall not do that act until the fee has been paid.
• 3) Where a fee is payable in respect of the filing of a document at the patent office,
the document shall be deemed not to have been filed at the office until the fee
has been paid.
• 4) Where a principal patent is granted later than two years from the date of filing of
the complete specification, the fees which have become due in the meantime may
be paid within a term of three months from the date of the recording of the
patent in the register.
• 5) International Application filing fees can be paid in the national currency and to
one Office, the Receiving Office. They may all be paid within one month after
filing.
33
34. Guideline for preparation of notebook:
• Laboratory notebooks should be provided to each researcher.
• Each notebook should have a number and be assigned to an individual
researcher, who is the only person who should enter data in the book. Only
one project should be entered in each notebook. Pages should not be removed
or replaced.
Signing for the book
The researcher should sign and date receipt of the book on the inside cover.
34
35. • Signing daily entries and witness signatures
a) Entries should be dated and signed by the researchers on the day the work is
conducted.
b) All entries require witness signatures on a weekly basis (signature to be
dated).
The witness should understand the work but should not be directly involved in
the project so that he/she would not be deemed a co-inventor on any patent(s)
arising from the research.
35
36. • Recording data
a) Enter all research data directly into the laboratory notebook where possible.
b) Explain any unusual abbreviations.
c) Entries should be legible and understandable to a co-worker.
d) Entries must be in permanent black or blue ink to facilitate legibility,
photocopying, etc.
e) Leave at least a half-inch margin at the inside (bound) edge of each page, to
facilitate photocopying. Keep entries inside the printed margins of each page.
f) Do not erase or use correction fluid. Strike out errors with a single line through
the mistake so that it is still legible; enter the corrected word(s) or value(s) above
the error, indicating the reason for the correction. Initial and date all corrections.
g) Any unused pages or portions of pages must be closed out with a diagonal line
and dated with the researcher’s initials. Do not skip pages with the intention of
filling in data at a later date.
36
37. • Organising data
a) Only one project may be recorded in each book. Researchers should
maintain a current table of contents or running index within the book, including
date, experiment number, objective, subject and page number.
b) When a book is closed out, a cross-reference to the succeeding notebook
should be entered (e.g. Continued to notebook number).
• c) With each new book, the researcher should cross-reference the previous
notebook (e.g. Continued from notebook number).
d) For each new page, enter the title, project name/number and date.
e) Only one date should be used per page.
37
38. f) For patent purposes, records of new experiments should always be started on
anew page and dated at the onset of each experiment. The purpose/objective of
the experiment must be stated clearly.
g) If the experiment continues over more than one day, each entry must be dated
and continuation pages must be clearly annotated. For patent purposes, each page
should not contain entries for more than one day.
h) Only if absolutely necessary should new entries be added to previous pages,
when subsequent work of later date is already recorded on succeeding pages.
Backdating of these entries is strictly prohibited – the actual date of entry should
be used.
38
39. Organising ancillary documentation
a) Where possible, supporting data should be affixed to the notebook.
b) Attach inserts (folded graphs, raw data tables, or computer printouts) with
transparent tape, glue or staples.
Care should be taken that the tape does not cover data and that inserts are not affixed in
a manner that would hinder photocopying.
Sign and date the insert and notebook page (along the seam).
c) A form of binder, notebook, folder, or envelope must be used for organization
and traceability of ancillary documentation (raw data sheets and other supporting
documentation) that cannot feasibly be incorporated into bound notebooks, but are
needed as permanent records of specific experiments.
d) In all cases, ancillary documentation must be cross-referenced to the appropriate
notebook number and page and vice versa. Additional information, such as the project
name/number, study name, device used to collect data, date of collection, researcher’s
name, etc., should also be included where relevant.
e) Specify computer programs (not fully described in the study protocol or method)
used to perform calculations on raw data. Source codes are not necessary, but indicate
the nature of the calculations.
39
40. Records for patent purposes
• The importance of keeping careful, accurate records of laboratory work, to
prove inventor ship and to assist in preparing the patent specifications which,
by law, must describe the invention, cannot be over-emphasised.
• Dependence on memory or scanty notes for this purpose may result in an
invalid patent. Any record may serve as evidence to prove inventor ship, but
the laboratory notebook is the most important.
a) Describe methods in detail or by reference to an approved protocol,
standard operating procedure or method of the date of a previous notebook
entry at the beginning of the experiment.
40
41. • b) Keep entries factual when reporting an experiment. Note and record unusual or
interesting observations during an experiment separately, under a heading of
‘Observations’. Premature or hasty statements such as “an experiment was
unsuccessful” should be avoided. If recording an idea to be worked on later, be
full in your discussion; use general language, state equivalents, etc.
c) Keep entries up-to-date. Advance attention to planning the experiment will give a
clearer, more intelligible record.
d) Make the entries complete, so that one skilled in the art would be able to repeat
the work. The procedure should be clearly stated in words or by reference.
e) Record the findings regarding a compound’s/cell line/molecule/other reagents etc.
activity in the notebook at the end of each experiment. The result, clearly set
forth, should be supported with analytical data.
f) Do not describe an invention or name an inventor in the findings.
g) Enter a conception on a separate page in the notebook, or keep a conception
notebook.
4
42. Closing out notebooks
Notebooks that are not used for frequent reference should be returned to
the supervising senior researcher unless otherwise advised.
If a notebook is returned with unmarked pages, write ‘Notebook closed;
no further entries’, following the last recorded data. Date and sign the
page.
42
43. Non-obviousness of patent:
• The purpose of the intensive or non-obviousness requirement is to
avoid granting patent for invention which only follow from normal
product design and development to achieve proper balance between
the incentive provided by patent system, namely encouraging
innovation, and its social cost namely conferring temporary
monopolies the non-obviousness bar in thus a measure of what society
accepts as available discovery.
• Additional reason for non-obviousness requirement are providing
incentive for fundamental research rather than for incremental
improvement and minimizing the proliferation of an economically
insignificant patents that are expensive to search and to license.
43
44. THE END …
THANK YOU FOR YOUR TIME…
HOPE YOU ENJOYED THE PRESENTATION.
44