Pharmaceutical industries invest billions of dollars, Euros in these highly risky health care solutions, for this Intellectual property protection is essential. Innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company for the same drug substance.
A patent is a negative right that allows the patent holder to exclude others from making, using, selling, or importing the claimed invention in the country where the patent is granted. To obtain a patent, an invention must be novel, non-obvious, and adequately described in the patent application. There are various types of patent applications that can be filed, including provisional, utility, design, plant, and PCT applications. Requirements for patentability include novelty, non-obviousness, enablement, and best mode disclosure.
NEWS FLASH: //Check our latest course offering on Patent-Business-Strategy over at Udemy here: http://www.udemy.com/patent-business-strategy/ with a 50 per cent launch discount //
This a discussion on patent infringement for academic purpose. Please do NOT consider this legal advice.
[Some material has not been updated for recent changes, so use it at your own risk]
Disclaimer: This is not legal advice.
The document summarizes the process for obtaining a patent through the European Patent Office (EPO). The EPO is a single office located in Munich that serves 38 European countries. To file for a European patent, an applicant can file directly with no deadline, use the Paris Convention with a 12 month deadline, or file through the Patent Cooperation Treaty (PCT) with a 31 month deadline. The filing must include a request form, specification, inventor/applicant information, fees, and translations if needed. The EPO will examine the application for formalities before publishing it after 18 months. The applicant can then request examination, pay designation fees, and go through the examination and grant process.
This Presentation teaches on how to search patent using various patent database like Free patent database, Patent database of National Authority and Paid patent database. It also focus on general parts of the patent and why patenting is needed. This presentation was delivered to M.Pharm. student by Mr. Pratik Vora for supporting them in their dissertation topic search. Hope you may find it helpful to you, also.
Revocation , restoration of patent and compulsory licensesViraj Shinde
1. This document summarizes key aspects of patent law in India, including who can revoke a patent, grounds for revocation, compulsory licensing, and restoration of lapsed patents.
2. It discusses the first case of compulsory licensing in India, where Natco Pharma received a license for the cancer drug Nexavar, significantly lowering its price in India.
3. The document also outlines the required patent application forms under Indian law.
- Patent is a grant from the government that provides exclusive rights over an invention for a limited period of time, allowing the inventor to commercially benefit from the invention [1].
- The key requirements for patentability are that the invention must be novel, non-obvious, and industrially applicable [2].
- The patent process involves filing an application, examination by the patent office, potential pre-grant opposition, publication if granted, and the ability for post-grant opposition challenging the validity of the patent [3].
This document discusses compulsory licensing of patents in India. Compulsory licensing allows the government to grant a license to a third party to produce a patented product or use a patented process without the consent of the patent holder. The objectives are to reward patent holders while also making patented pharmaceutical products available to the public at affordable prices. Section 84 of the Indian Patent Act lays out the conditions for granting compulsory licenses, such as if the patented invention is not available to the public at a reasonable price. The first compulsory license granted in India was for the cancer drug Nexavar, allowing generic manufacturer Natco to sell a version at a much lower price than the branded version from Bayer.
The document discusses the Indian Patent Act of 1970 and the process for obtaining a patent in India. It provides background on intellectual property rights and patents. It then outlines the key stages of filing a patent application in India, including formality check, publication, request for examination, examination and issuance of an examination report, response from applicant, pre-grant opposition, and final grant of the patent. It also discusses different types of patent applications under Indian law such as provisional, ordinary, convention, and divisional applications.
A patent is a negative right that allows the patent holder to exclude others from making, using, selling, or importing the claimed invention in the country where the patent is granted. To obtain a patent, an invention must be novel, non-obvious, and adequately described in the patent application. There are various types of patent applications that can be filed, including provisional, utility, design, plant, and PCT applications. Requirements for patentability include novelty, non-obviousness, enablement, and best mode disclosure.
NEWS FLASH: //Check our latest course offering on Patent-Business-Strategy over at Udemy here: http://www.udemy.com/patent-business-strategy/ with a 50 per cent launch discount //
This a discussion on patent infringement for academic purpose. Please do NOT consider this legal advice.
[Some material has not been updated for recent changes, so use it at your own risk]
Disclaimer: This is not legal advice.
The document summarizes the process for obtaining a patent through the European Patent Office (EPO). The EPO is a single office located in Munich that serves 38 European countries. To file for a European patent, an applicant can file directly with no deadline, use the Paris Convention with a 12 month deadline, or file through the Patent Cooperation Treaty (PCT) with a 31 month deadline. The filing must include a request form, specification, inventor/applicant information, fees, and translations if needed. The EPO will examine the application for formalities before publishing it after 18 months. The applicant can then request examination, pay designation fees, and go through the examination and grant process.
This Presentation teaches on how to search patent using various patent database like Free patent database, Patent database of National Authority and Paid patent database. It also focus on general parts of the patent and why patenting is needed. This presentation was delivered to M.Pharm. student by Mr. Pratik Vora for supporting them in their dissertation topic search. Hope you may find it helpful to you, also.
Revocation , restoration of patent and compulsory licensesViraj Shinde
1. This document summarizes key aspects of patent law in India, including who can revoke a patent, grounds for revocation, compulsory licensing, and restoration of lapsed patents.
2. It discusses the first case of compulsory licensing in India, where Natco Pharma received a license for the cancer drug Nexavar, significantly lowering its price in India.
3. The document also outlines the required patent application forms under Indian law.
- Patent is a grant from the government that provides exclusive rights over an invention for a limited period of time, allowing the inventor to commercially benefit from the invention [1].
- The key requirements for patentability are that the invention must be novel, non-obvious, and industrially applicable [2].
- The patent process involves filing an application, examination by the patent office, potential pre-grant opposition, publication if granted, and the ability for post-grant opposition challenging the validity of the patent [3].
This document discusses compulsory licensing of patents in India. Compulsory licensing allows the government to grant a license to a third party to produce a patented product or use a patented process without the consent of the patent holder. The objectives are to reward patent holders while also making patented pharmaceutical products available to the public at affordable prices. Section 84 of the Indian Patent Act lays out the conditions for granting compulsory licenses, such as if the patented invention is not available to the public at a reasonable price. The first compulsory license granted in India was for the cancer drug Nexavar, allowing generic manufacturer Natco to sell a version at a much lower price than the branded version from Bayer.
The document discusses the Indian Patent Act of 1970 and the process for obtaining a patent in India. It provides background on intellectual property rights and patents. It then outlines the key stages of filing a patent application in India, including formality check, publication, request for examination, examination and issuance of an examination report, response from applicant, pre-grant opposition, and final grant of the patent. It also discusses different types of patent applications under Indian law such as provisional, ordinary, convention, and divisional applications.
The document outlines the procedure for filing a patent application in India. Key points include:
- Only inventors, assignees, or legal heirs of deceased inventors can apply for a patent.
- There are different types of patent applications including convention, international, divisional, and patent of addition applications.
- Applications must be filed in the prescribed form along with a provisional or complete specification and applicable fees.
- The specification must include a title, description, drawings or samples, method to perform the invention, scope, and abstract.
- Priority date rules depend on whether the application is a single filing or based on an earlier application.
Filing a Patent application is the first step towards protecting an invention. This presentation details in brief on how and where to file a patent application along with the other documentary and statutory requirements.
The document discusses various topics related to patent searching and drafting patent claims including:
1) The purposes of conducting patent searches such as avoiding infringement and monitoring competitors.
2) Resources for conducting patent searches such as online databases and tools from patent offices which provide time-efficient and cost-effective access to comprehensive international patent information.
3) Key considerations for drafting patent claims including writing broad and narrow claims to fully cover the invention while avoiding prior art and unnecessary limitations.
The presentation herein, on the US Patent Process, has been delivered by Mr. Nitin Nair at the National Law School of India University, Bangalore, for Senior Officials of the Ministry of MSME, Government of India. For more information about the presentation or the event, you may contact the Sinapse team at sinapse@bananaip.com.
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
Dr. amit gangwal ka pharmaceutical patent presentation
highly exhaustive and updated ppt on pharmaceutical patents, a must watch by all those concerned with the same.
The document discusses the drafting of a patent specification. It explains that an applicant must file a specification describing the invention to receive patent rights. The specification can be a provisional or complete specification. A provisional specification broadly discloses the invention to secure priority date, while a complete specification discloses all details clearly to enable practice of the invention and must include claims. The complete specification format includes the title, technical field, background, objectives, description, drawings, claims, and abstract.
The document provides an overview of patent law in India, including:
1) A patent grants an inventor exclusive rights to an invention that is novel, useful, and non-obvious.
2) India's patent law has evolved since the 1850s through several Acts, with the current Patents Act coming into force in 1970.
3) The Act provides for patents on both products and processes, with a term of 20 years, and includes pre- and post-grant opposition provisions.
Trade Secrets: Presentation on Trade Secret Protection in India - BananaIPBananaIP Counsels
This document discusses trade secret protection in India. It begins by defining trade secrets as confidential business or technical information with competitive advantage and potential for revenue generation. Trade secrets must be not readily ascertainable, acquired through proper means, and subject to reasonable security efforts. The document outlines how trade secrets can be acquired and protected, including through confidentiality agreements and identification of confidential information. It also discusses enforcement of trade secret protection through statutes, contracts, arbitration, and court decisions in India which have addressed issues like proving damages and explicitly defining confidential information.
The document discusses several international patent systems for obtaining patent protection in multiple countries. It describes the Paris Convention which established the principles of equal treatment of citizens across member states and union priority rights allowing applicants to extend protection to other member states. The Patent Cooperation Treaty allows filing a single international patent application and receiving an international search report and preliminary examination, postponing the decision to pursue patents in individual countries for 30 months. The European Patent Convention provides a single place of filing, granting, and protection equivalent to national patents across member states if patented in one.
A patentee is a person to whom a grant is made or privilege secured by patent the patentee assigned the patent to his employer.
According to Patent Law, the patentee enjoys exclusive rights by which the patentee possess, use, benefit from and dispose of the patent, and no entity or individual may, without the authorization of the patentee, exploit the patent, that is, make, use, offer to sell, sell or import the patented product, or use the patented process, or use, offer to sell, sell or import the product directly obtained by the patented process, for production or business purposes.
Patent: A presentation on "Patent Drafting" by Ms. Vinita Radhakrishnan - Ban...BananaIP Counsels
Patent: A presentation on "Patent Drafting" by Ms. Vinita Radhakrishnan - BananaIP
BananaIP Counsels, formerly Brain League IP Services, founded in 2004 at the Indian Institute of Management (IIM) Bangalore’s incubation center (NSRCEL), is recognized as an IP/Patent trailblazer in India. The firm’s mission is to help clients maximize business value from their Intellectual Property (IP)/Patents, and gain competitive advantage in the market place. In its evolution from Brain League, BananaIP carries forward the firm’s core values – Merger of Technology,Management and Law, Swift Adaptation to changes in competitive environment, and business driven approach to Intellectual Property (IP)/Patent Services.
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
This document provides an overview of patent law from an Indian perspective. It defines what a patent is, outlines the key benefits and requirements for obtaining a patent in India, and describes the patent application and granting process. The document also discusses what can and cannot be patented, infringement issues, and how patents can provide strategic advantages for companies.
International Patenting: Paris Convention, Patent Cooperation Treaty, and Pat...Patterson Thuente IP
India's place in the patent world.
International patenting basics.
Patent Cooperation Treaty (PCT) overview.
Patent Prosecution Highway (PPH) benefits.
The document discusses intellectual property rights and patenting processes. It provides information on different types of intellectual property including patents, designs, trademarks, and copyrights. It describes the patent application process in India, including requirements for filing a patent application, contents of a patent application, and the patent granting procedure. Key requirements for patentability discussed are that an invention must be new, non-obvious, and capable of industrial application.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
This document provides an overview of the case of Natco Pharma Ltd. vs Bayer regarding the granting of the first ever compulsory license for a pharmaceutical patent in India. It discusses the key considerations and timeline of the case, including Natco's application for a compulsory license to produce the cancer drug Nexavar at an affordable price after Bayer refused to provide a voluntary license or lower the price. The document summarizes the Indian Patent Act provisions for compulsory licensing and the IPAB verdict upholding the license grant with a slightly increased royalty rate for Natco. It also outlines some of the effects on access to medicines and potential solutions.
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.
The document discusses regulations around natural health products in Canada. The Natural Health Products Regulations came into force on January 1, 2004 and apply to all natural health products. A review of the regulations was launched within the first three to five years of implementation to address any challenges. Natural health products must be licensed and manufacturers must hold site licenses to ensure safety standards are met.
Data exclusivity laws grant originator pharmaceutical companies exclusive rights to clinical trial and other registration data submitted to drug regulators for a period of time. This prevents generic companies from relying on the originator's data to gain marketing approval for generic versions. While intended to reward innovation, data exclusivity can delay competition and affordable generic drug access. The TRIPS agreement requires protection of undisclosed drug data, but does not mandate data exclusivity. Less restrictive alternatives that still comply with TRIPS, such as data protection only, are preferable from a public health perspective.
The Drug Price Competition and Patent Term Restoration Act of 1984: The Basi...Michael Swit
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, September 2009 at Teva Parenterals, with a focus on the key basic provisions of the 1984 Hatch-Waxman Act
The document outlines the procedure for filing a patent application in India. Key points include:
- Only inventors, assignees, or legal heirs of deceased inventors can apply for a patent.
- There are different types of patent applications including convention, international, divisional, and patent of addition applications.
- Applications must be filed in the prescribed form along with a provisional or complete specification and applicable fees.
- The specification must include a title, description, drawings or samples, method to perform the invention, scope, and abstract.
- Priority date rules depend on whether the application is a single filing or based on an earlier application.
Filing a Patent application is the first step towards protecting an invention. This presentation details in brief on how and where to file a patent application along with the other documentary and statutory requirements.
The document discusses various topics related to patent searching and drafting patent claims including:
1) The purposes of conducting patent searches such as avoiding infringement and monitoring competitors.
2) Resources for conducting patent searches such as online databases and tools from patent offices which provide time-efficient and cost-effective access to comprehensive international patent information.
3) Key considerations for drafting patent claims including writing broad and narrow claims to fully cover the invention while avoiding prior art and unnecessary limitations.
The presentation herein, on the US Patent Process, has been delivered by Mr. Nitin Nair at the National Law School of India University, Bangalore, for Senior Officials of the Ministry of MSME, Government of India. For more information about the presentation or the event, you may contact the Sinapse team at sinapse@bananaip.com.
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
Dr. amit gangwal ka pharmaceutical patent presentation
highly exhaustive and updated ppt on pharmaceutical patents, a must watch by all those concerned with the same.
The document discusses the drafting of a patent specification. It explains that an applicant must file a specification describing the invention to receive patent rights. The specification can be a provisional or complete specification. A provisional specification broadly discloses the invention to secure priority date, while a complete specification discloses all details clearly to enable practice of the invention and must include claims. The complete specification format includes the title, technical field, background, objectives, description, drawings, claims, and abstract.
The document provides an overview of patent law in India, including:
1) A patent grants an inventor exclusive rights to an invention that is novel, useful, and non-obvious.
2) India's patent law has evolved since the 1850s through several Acts, with the current Patents Act coming into force in 1970.
3) The Act provides for patents on both products and processes, with a term of 20 years, and includes pre- and post-grant opposition provisions.
Trade Secrets: Presentation on Trade Secret Protection in India - BananaIPBananaIP Counsels
This document discusses trade secret protection in India. It begins by defining trade secrets as confidential business or technical information with competitive advantage and potential for revenue generation. Trade secrets must be not readily ascertainable, acquired through proper means, and subject to reasonable security efforts. The document outlines how trade secrets can be acquired and protected, including through confidentiality agreements and identification of confidential information. It also discusses enforcement of trade secret protection through statutes, contracts, arbitration, and court decisions in India which have addressed issues like proving damages and explicitly defining confidential information.
The document discusses several international patent systems for obtaining patent protection in multiple countries. It describes the Paris Convention which established the principles of equal treatment of citizens across member states and union priority rights allowing applicants to extend protection to other member states. The Patent Cooperation Treaty allows filing a single international patent application and receiving an international search report and preliminary examination, postponing the decision to pursue patents in individual countries for 30 months. The European Patent Convention provides a single place of filing, granting, and protection equivalent to national patents across member states if patented in one.
A patentee is a person to whom a grant is made or privilege secured by patent the patentee assigned the patent to his employer.
According to Patent Law, the patentee enjoys exclusive rights by which the patentee possess, use, benefit from and dispose of the patent, and no entity or individual may, without the authorization of the patentee, exploit the patent, that is, make, use, offer to sell, sell or import the patented product, or use the patented process, or use, offer to sell, sell or import the product directly obtained by the patented process, for production or business purposes.
Patent: A presentation on "Patent Drafting" by Ms. Vinita Radhakrishnan - Ban...BananaIP Counsels
Patent: A presentation on "Patent Drafting" by Ms. Vinita Radhakrishnan - BananaIP
BananaIP Counsels, formerly Brain League IP Services, founded in 2004 at the Indian Institute of Management (IIM) Bangalore’s incubation center (NSRCEL), is recognized as an IP/Patent trailblazer in India. The firm’s mission is to help clients maximize business value from their Intellectual Property (IP)/Patents, and gain competitive advantage in the market place. In its evolution from Brain League, BananaIP carries forward the firm’s core values – Merger of Technology,Management and Law, Swift Adaptation to changes in competitive environment, and business driven approach to Intellectual Property (IP)/Patent Services.
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
This document provides an overview of patent law from an Indian perspective. It defines what a patent is, outlines the key benefits and requirements for obtaining a patent in India, and describes the patent application and granting process. The document also discusses what can and cannot be patented, infringement issues, and how patents can provide strategic advantages for companies.
International Patenting: Paris Convention, Patent Cooperation Treaty, and Pat...Patterson Thuente IP
India's place in the patent world.
International patenting basics.
Patent Cooperation Treaty (PCT) overview.
Patent Prosecution Highway (PPH) benefits.
The document discusses intellectual property rights and patenting processes. It provides information on different types of intellectual property including patents, designs, trademarks, and copyrights. It describes the patent application process in India, including requirements for filing a patent application, contents of a patent application, and the patent granting procedure. Key requirements for patentability discussed are that an invention must be new, non-obvious, and capable of industrial application.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
This document provides an overview of the case of Natco Pharma Ltd. vs Bayer regarding the granting of the first ever compulsory license for a pharmaceutical patent in India. It discusses the key considerations and timeline of the case, including Natco's application for a compulsory license to produce the cancer drug Nexavar at an affordable price after Bayer refused to provide a voluntary license or lower the price. The document summarizes the Indian Patent Act provisions for compulsory licensing and the IPAB verdict upholding the license grant with a slightly increased royalty rate for Natco. It also outlines some of the effects on access to medicines and potential solutions.
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.
The document discusses regulations around natural health products in Canada. The Natural Health Products Regulations came into force on January 1, 2004 and apply to all natural health products. A review of the regulations was launched within the first three to five years of implementation to address any challenges. Natural health products must be licensed and manufacturers must hold site licenses to ensure safety standards are met.
Data exclusivity laws grant originator pharmaceutical companies exclusive rights to clinical trial and other registration data submitted to drug regulators for a period of time. This prevents generic companies from relying on the originator's data to gain marketing approval for generic versions. While intended to reward innovation, data exclusivity can delay competition and affordable generic drug access. The TRIPS agreement requires protection of undisclosed drug data, but does not mandate data exclusivity. Less restrictive alternatives that still comply with TRIPS, such as data protection only, are preferable from a public health perspective.
The Drug Price Competition and Patent Term Restoration Act of 1984: The Basi...Michael Swit
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, September 2009 at Teva Parenterals, with a focus on the key basic provisions of the 1984 Hatch-Waxman Act
The document provides information on how a product is developed, including literature searches, sources for information on innovators and patents, and criteria for procuring active pharmaceutical ingredients (APIs). It discusses preformulation studies including stress testing APIs under various conditions like heat, humidity, acids, bases and metals. The document also covers topics like therapeutic equivalence codes, national drug codes, drug master files, exclusivity, and types of patents listed in the Orange Book.
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.
Hatch- waxman act (The drug price competition and patent term restoration act...Mohit Kumar
The Drug Price Competition and Patent Term Restoration Act , informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
Lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
This document discusses various types of non-patent market exclusivities that provide legal protection from generic competition for pharmaceutical companies. It describes five types of exclusivities in the US including orphan drug exclusivity which provides 7 years of protection, new chemical entity exclusivity with 5 years, new clinical study exclusivity for 3 years, pediatric exclusivity which extends existing protections by 6 months, and 180 days of exclusivity for being the first generic applicant to challenge a patent. The document also discusses exclusivity regimes in Europe including supplementary protection certificates and India's framework which does not guarantee data exclusivity.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
Intellectual Property Considerations During Nonclinical Drug DevelopmentMaryBreenSmith
Presentation provides a brief overview of regulatory and patent market exclusivities for new drugs. Presentation also covers the types of intellectual property typically arising out of preclinical studies.
SUI GENERIS PROTECTION FOR PHARMACEUTICALS AND ITS IMPACT ON GENERIC COMPANIESRitwik Parikh
This document discusses data and market exclusivity protections for pharmaceuticals in the European Union and United States. It provides background on the lengthy and costly drug development and approval process, and how data exclusivity helps incentivize pharmaceutical innovation by protecting clinical trial data and providing a period of market exclusivity. The EU generally provides 8 years of data exclusivity plus 2 additional years of market exclusivity, which can be extended to 11 years if a new therapeutic indication is approved. The US system is also described but to a lesser extent. The document examines how these exclusivity periods impact generic drug companies.
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.
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.
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval to begin human clinical trials of an experimental drug. An IND application includes preclinical animal data, clinical trial protocols, and information about manufacturing. The FDA has 30 days to review an IND for safety before trials may begin. Clinical holds may be placed on applications that pose unreasonable risks or are missing required information. Notifications are provided to sponsors regarding review outcomes and any deficiencies that must be addressed.
A) Study in detail about Para - IV filing. B) Case studies for Para - IV Filing.Aakashdeep Raval
This document discusses paragraph IV (P-IV) filings under the Hatch-Waxman Act. It provides details on:
1) P-IV filings allow generic drug companies to file an Abbreviated New Drug Application (ANDA) to challenge a patent before it expires.
2) If the original drug company sues for patent infringement within 45 days, approval is automatically stayed for 30 months.
3) The first generic company to file a successful P-IV challenge receives 180 days of market exclusivity prior to other generics entering.
This document provides an overview of the Hatch-Waxman Act and its amendments, which established an abbreviated approval pathway for generic drugs (ANDA) and encourages generic drug competition. It discusses key aspects like patent term extensions, exclusivity periods for innovator drugs, the process for generic drug companies to file an ANDA including certifying patent status, triggering potential patent litigation, and the first-filer 180 day marketing exclusivity period. The Act aims to balance incentives for innovation with accelerating access to affordable generic drugs.
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.
This document provides an overview of the drug approval processes in the United States, Europe, and India. In the US, drugs must undergo investigational new drug application and new drug application processes with the FDA, including clinical trials and demonstrating safety and efficacy. Europe has a centralized process through the EMA for certain drugs and mutual recognition or national processes for others. India requires new drugs to conduct clinical trials and submit a new drug application to the DCGI to prove safety and effectiveness in the Indian population. While requirements vary between regions, the overall goals are to safeguard public health by ensuring pharmaceutical quality, safety and efficacy.
In this humorous and data-heavy session, join us in a joyous celebration of life honoring the long list of SEO tactics and concepts we lost this year. Remember fondly the beautiful time you shared with defunct ideas like link building, keyword cannibalization, search volume as a value indicator, and even our most cherished of friends: the funnel. Make peace with their loss as you embrace a new paradigm for organic content: Pillar-Based Marketing. Along the way, discover that the results that old SEO and all its trappings brought you weren’t really very good at all, actually.
In this respectful and life-affirming service—erm, session—join Ryan Brock (Chief Solution Officer at DemandJump and author of Pillar-Based Marketing: A Data-Driven Methodology for SEO and Content that Actually Works) and leave with:
• Clear and compelling evidence that most legacy SEO metrics and tactics have slim to no impact on SEO outcomes
• A major mindset shift that eliminates most of the metrics and tactics associated with SEO in favor of a single metric that defines and drives organic ranking success
• Practical, step-by-step methodology for choosing SEO pillar topics and publishing content quickly that ranks fast
The digital marketing industry is changing faster than ever and those who don’t adapt with the times are losing market share. Where should marketers be focusing their efforts? What strategies are the experts seeing get the best results? Get up-to-speed with the latest industry insights, trends and predictions for the future in this panel discussion with some leading digital marketing experts.
We’ve entered a new era in digital. Search and AI are colliding, in more ways than one. And they all have major implications for marketers.
• SEOs now use AI to optimize content.
• Google now uses AI to generate answers.
• Users are skipping search completely. They can now use AI to get answers. So AI has changed everything …or maybe not. Our audience hasn’t changed. Their information needs haven’t changed. Their perception of quality hasn’t changed. In reality, the most important things haven’t changed at all. In this session, you’ll learn the impact of AI. And you’ll learn ways that AI can make us better at the classic challenges: getting discovered, connecting through content and staying top of mind with the people who matter most. We’ll use timely tools to rebuild timeless foundations. We’ll do better basics, but with the most advanced techniques. Andy will share a set of frameworks, prompts and techniques for better digital basics, using the latest tools of today. And in the end, Andy will consider - in a brief glimpse - what might be the biggest change of all, and how to expand your footprint in the new digital landscape.
Key Takeaways:
How to use AI to optimize your content
How to find topics that algorithms love
How to get AI to mention your content and your brand
The digital marketing industry is changing faster than ever and those who don’t adapt with the times are losing market share. Where should marketers be focusing their efforts? What strategies are the experts seeing get the best results? Get up-to-speed with the latest industry insights, trends and predictions for the future in this panel discussion with some leading digital marketing experts.
Breaking Silos To Break Bank: Shattering The Divide Between Search And SocialNavah Hopkins
At Mozcon 2024 I shared this deck on bridging the divide between search and social. We began by acknowledging that search-first marketers are used to different rules of engagement than social marketers. We also looked at how both channels treat creative, audiences, bidding/budgeting, and AI. We finished by going through how they can win together including UTM audits, harvesting comments from both to inform creative, and allowing for non-login forums to be part of your marketing strategy.
I themed this deck using Baldur's Gate 3 characters: Gale as Search and Astarion as Social
Did you know that while 50% of content on the internet is in English, English only makes up 26% of the world’s spoken language? And yet 87% of customers won’t buy from an English only website.
Uncover the immense potential of communicating with customers in their own language and learn how translation holds the key to unlocking global growth. Join Smartling CEO, Bryan Murphy, as he reveals how translation software can streamline the translation process and seamlessly integrate into your martech stack for optimal efficiency. And that's not all – he’ll also share some inspiring success stories and practical tips that will turbocharge your multilingual marketing efforts!
Key takeaways:
1. The growth potential of reaching customers in their native language
2. Tips to streamline translation with software and integrations to your tech stack
3. Success stories from companies that have increased lead generation, doubled revenue, and more with translation
In the face of the news of Google beginning to remove cookies from Chrome (30m users at the time of writing), there’s no longer time for marketers to throw their hands up and say “I didn’t know” or “They won’t go through with it”. Reality check - it has already begun - the time to take action is now. The good news is that there are solutions available and ready for adoption… but for many the race to catch up to the modern internet risks being a messy, confusing scramble to get back to "normal"
In the digital age, businesses are inundated with tools promising to streamline operations, enhance creativity, and boost productivity. Yet, the true key to digital transformation lies not in the accumulation of tools but in strategically integrating the right AI solutions to revolutionize workflows. Join Jordache, an experienced entrepreneur, tech strategist and AI consultant, as he explores essential AI tools across three critical categories—Ideation, Creation, and Operations—that can reshape the way your business creates, operates, and scales.This talk will guide you through the practicalities of selecting and effectively using AI tools that go beyond the basics of today’s popular tools like ChatGPT, Claude, Gemini, Midjourney, or Dall-E. For each category of tools, Jordache will address three crucial questions: What is each tool? Why is each one valuable to you as a business leader? How can you start using it in your workflow? This approach will not only clarify the role of these tools but also highlight their strategic value, making it perfect for business leaders ready to make informed decisions about integrating AI into their workflows.
Key Takeaways:
>> Strategic Selection and Integration: Understand how to select AI tools that align with your business goals and how to conceptually integrate them into your workflows to enhance efficiency and innovation.
>> Understanding AI Tool Categories: Gain a deeper understanding of how AI tools can be leveraged in the areas of ideation, creation, and operation—transforming each aspect of your business.
>> Practical Starting Points: Learn how you can start using these tools in your business with practical tips on initial steps and integration ideas.
>> Future-Proofing Your Business: Discover how staying informed about and utilizing the latest AI tools and strategies can keep your business competitive in a rapidly evolving digital landscape.
As 2023 proved, the next few years may be shaped by market volatility and artificial intelligence services such as OpenAI's ChatGPT and Perplexity.ai. Your brand will increasingly compete for attention with Google, Apple, OpenAI, and Amazon, and customers will expect a hyper-relevant and individualized experience from every business at any moment. New state-legislated data privacy laws and several FTC rules may challenge marketers to deliver contextually relevant customer experiences, much less reach unknown prospective buyers. Are you ready?Let's discuss the critical need for data governance and applied AI for your business rather than relying on public AI models. As AI permeates society and all industries, learn how to be future-ready, compliant, and confidentlyscaling growth.
Key Takeaways:
Primary Learning Objective
1: Grasp when artificial general intelligence (""AGI"") will arrive, and how your brand can navigate the consequences. Primary Learning Objective
2: Gain an accurate analysis of the continuously developing customer journey and business intelligence. Primary Learning Objective
3: Grow revenue at lower costs with more efficient marketing and business operations.
Mastering Local SEO for Service Businesses in the AI Era is tailored specifically for local service providers like plumbers, dentists, and others seeking to dominate their local search landscape. This session delves into leveraging AI advancements to enhance your online visibility and search rankings through the Content Factory model, designed for creating high-impact, SEO-driven content. Discover the Dollar-a-Day advertising strategy, a cost-effective approach to boost your local SEO efforts and attract more customers with minimal investment. Gain practical insights on optimizing your online presence to meet the specific needs of local service seekers, ensuring your business not only appears but stands out in local searches. This concise, action-oriented workshop is your roadmap to navigating the complexities of digital marketing in the AI age, driving more leads, conversions, and ultimately, success for your local service business.
Key Takeaways:
Embrace AI for Local SEO: Learn to harness the power of AI technologies to optimize your website and content for local search. Understand the pivotal role AI plays in analyzing search trends and consumer behavior, enabling you to tailor your SEO strategies to meet the specific demands of your target local audience. Leverage the Content Factory Model: Discover the step-by-step process of creating SEO-optimized content at scale. This approach ensures a steady stream of high-quality content that engages local customers and boosts your search rankings. Get an action guide on implementing this model, complete with templates and scheduling strategies to maintain a consistent online presence. Maximize ROI with Dollar-a-Day Advertising: Dive into the cost-effective Dollar-a-Day advertising strategy that amplifies your visibility in local searches without breaking the bank. Learn how to strategically allocate your budget across platforms to target potential local customers effectively. The session includes an action guide on setting up, monitoring, and optimizing your ad campaigns to ensure maximum impact with minimal investment.
Can you kickstart content marketing when you have a small team or even a team of one? Why yes, you can! Dennis Shiao, founder of marketing agency Attention Retention will detail how to draw insights from subject matter experts (SMEs) and turn them into articles, bylines, blog posts, social media posts and more. He’ll also share tips on content licensing and how to establish a webinar program. Attend this session to learn how to make an impact with content marketing even when you have a small team and limited resources.
Key Takeaways:
- You don't need a large team to start a content marketing program
- A webinar program yields a "one-to-many" approach to content creation
- Use partnerships and licensing to create new content assets
Unlock the secrets to enhancing your digital presence with our masterclass on mastering online visibility. Learn actionable strategies to boost your brand, optimize your social media, and leverage SEO. Transform your online footprint into a powerful tool for growth and engagement.
Key Takeaways:
1. Effective techniques to increase your brand's visibility across various online platforms.
2. Strategies for optimizing social media profiles and content to maximize reach and engagement.
3. Insights into leveraging SEO best practices to improve search engine rankings and drive organic traffic.
Build marketing products across the customer journey to grow your business and build a relationship with your customer. For example you can build graders, calculators, quizzes, recommendations, chatbots or AR apps. Things like Hubspot's free marketing grader, Moz's site analyzer, VenturePact's mobile app cost calculator, new york times's dialect quiz, Ikea's AR app, L'Oreal's AR app and Nike's fitness apps. All of these examples are free tools that help drive engagement with your brand, build an audience and generate leads for your core business by adding value to a customer during a micro-moment.
Key Takeaways:
Learn how to use specific GPTs to help you Learn how to build your own marketing tools
Generate marketing ideas for your business How to think through and use AI in marketing
How AI changes the marketing game
How to Use AI to Write a High-Quality Article that Ranksminatamang0021
In the world of content creation, many AI bloggers have drifted away from their original vision, resulting in low-quality articles that search engines overlook. Don't let that happen to you! Join us to discover how to leverage AI tools effectively to craft high-quality content that not only captures your audience's attention but also ranks well on search engines.
Disclaimer: Some of the prompts mentioned here are the examples of Matt Diggity. Please use it as reference and make your own custom prompts.
The Strategic Impact of Storytelling in the Age of AI
In the grand tapestry of marketing, where algorithms analyze data and artificial intelligence predicts trends, one essential thread remains constant — the timeless art of storytelling. As we stand on the precipice of a new era driven by AI, join me in unraveling the narrative alchemy that transforms brands from mere entities into captivating tales that resonate across the digital landscape. In this exploration, we will discover how, in the face of advancing technology, the human touch of a well-crafted story becomes not just a marketing tool but the very essence that breathes life into brands and forges lasting connections with our audience.
We will explore the transformative journey of American Bath Group as they transitioned from a traditional monolithic CMS to a dynamic, composable martech framework using Kontent.ai. Discover the strategic decisions, challenges, and key benefits realized through adopting a headless CMS approach. Learn how composable business models empower marketers with flexibility, speed, and integration capabilities, ultimately enhancing digital experiences and operational efficiency. This session is essential for marketers looking to understand the practical impacts and advantages of composable technology in today's digital landscape. Join us to gain valuable insights and actionable takeaways from a real-world implementation that redefines the boundaries of marketing technology.
What’s “In” and “Out” for ABM in 2024: Plays That Help You Grow and Ones to L...Demandbase
Delve into essential ABM ‘plays' that propel success while identifying and leaving behind tactics that no longer yield results. Led by ABM Experts, Jon Barcellos, Head of Solutions at Postal and Tom Keefe, Principal GTM Expert at Demandbase.
2. For the pharmaceutical industry to invest the billions of dollars, Euros, yen, etc. in these
highly risky health care solutions, Intellectual property protection is essential. However,
patent and trademark protections are not the entire story.
An innovator company enjoys a period of "data exclusivity" during which their pre-
clinical and clinical trials data may not be referenced in the regulatory filings of
another company(typically a generic company) for the same drug substance.
The rationale for granting data and market exclusivity is to compensate the innovator
company for the investment it has put in to developing the new medicinal product and to
generating the data required to obtain a marketing authorisation. It was designed to
promote a balance between new drug innovation and generic drug competition.
Regulatory approval for medicinal products requires applicants to provide information
about the efficacy and safety of their product to regulatory authorities. The first applicant
for approval of a new medicinal product must provide a substantial body of data relating
to the product (including the results of pre-clinical tests and clinical trials).
2
WHAT IS DATA EXCLUSIVITY
3. 3
The regulatory regime permits generic companies, who subsequently wish to gain their own
approval for the same drug substance, to rely on information filed by the innovator company that
made the first application. In order to be able to benefit from the data provided by the innovator in
their regulatory filings for that medicinal product - the "reference medicinal product" - a generic
company must show that their product has the same qualitative and quantitative composition as that
product and that it is bioequivalent.
The Agreement on Trade-Related Intellectual Property Rights (the “TRIPs Agreement”/ also known
as Doha Declaration) specifically recognizes the “protection of undisclosed information” as being a
category of Intellectual property subject to protection.
Article 39.3 of the TRIPs Agreement provides that:
“Members, when requiring, as a condition of approving the marketing of
pharmaceutical or of agricultural chemical entities, the submission of undisclosed
test or other data, the origination of which involves a considerable effort, shall
protect such data against unfair commercial use.
In addition, Members shall protect such data against disclosure, except where
necessary to protect the public, or unless steps are taken to ensure that the data are
protected against unfair commercial use.”
4. 4
The Intellectual property right reference in Article 39.3 is commonly referred to as
“data exclusivity” in the U. S. and “data protection” or “regulatory data protection” in the
European Union.
SECTION 7 : PROTECTION OF UNDISCLOSED INFORMATION (TRIPS)
Article 39
1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention
(1967), Members shall protect undisclosed information in accordance with paragraph 2 below and data submitted to governments or
governmental agencies in accordance with paragraph 3 below.
2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to,
acquired by, or used by others without their consent in a manner contrary to honest commercial practices* so long as such
information :
is secret in the sense that it is not, as a body or in the precise configuration of its components, generally known among or readily
accessible to persons within the circles that normally deal with the kind of information in question ;
has commercial value because it is secret ; and
has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it
secret.
3. Members, when requiring, as a condition of approving the marketing of a pharmaceutical or of agricultural or chemical products
which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable
effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except
when necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
5. 5
In short article 39.3 requires countries to protect undisclosed registration data, against disclosure and
unfair commercial use.
The data exclusivity (DE) is independent of IP laws
DE determines the length of time during which;
the generic/biosimilar application cannot cross-refer to the originators’ data and
the regulatory authorities cannot rely on originator’s data to approve a generic/biosimilar
version of relevant originator product
DE period becomes Market Exclusivity (ME) when;
There is no patent or when weak patents are invalidated
Country has no patent law
DE exclusivity period goes beyond patent/SPC expiry
Exclusivity is granted upon approval of a drug product if the statutory requirements are met. The length
of time that FDA grants new drug
exclusivity depends on the type of exclusivity. Note that exclusivity is not added to the patent life.
6. 6
"Market exclusivity" refers to the period in which the recipient of the first regulatory
approval for a product is granted an exclusive right to market the product.
“Data exclusivity” refers to the period in which certain information that has been
provided to a regulatory authority for the purposes of obtaining regulatory approval,
remains confidential, or cannot be relied upon by the regulatory authority or a third party
in order to obtain regulatory approval of a follow-on product.
The data protected by data exclusivity regimes typically include the results of extensive
and costly clinical trials. As such, data exclusivity can effectively block or significantly
delay the launch of equivalent competitor products during the data exclusivity period,
even in the absence of patent protection.
Data exclusivity is separate from other forms of intellectual property protection, such as
the protection provided by patents. In some instances, the period of data exclusivity may
extend beyond the term of any patent which protects the same product.
7. 7
Normally, the DE application must be submitted within 18 months from the date the product is first
registered or granted market authorization in the country of origin, or any other country, and is
referred to as the ‘access window.’
For pharmaceutical products with a new indication, the DE period of three years is calculated from
the date the additional indication is approved in any country. Application for DE must be made
within 12 months from the date the second indication is approved.
8. 8
US EXCLUSIVITIES
In the US, “exclusivity” provided by the Food and Drug Administration (FDA) generally refers to
market exclusivity only, but may also have the effect of providing a period of data exclusivity.
On September 24, 1984 the President signed into law the Drug Price Competition and Patent Term
Restoration Act of 1984 (Hatch/Waxman Amendments).
Title 1 of the Hatch/Waxman Amendments amended the Federal Food, Drug, and Cosmetic Act (the
Act) to expand the universe of drugs for which FDA would accept ANDAs.
The Hatch/Waxman Amendments also provided for New Drug Product Exclusivity and are often
referred to as Hatch/Waxman exclusivity since Senator Hatch and Congressman Waxman sponsored
the amendments.
New Drug Product Exclusivity is provided by the Federal Food, Drug, and Cosmetic Act under
section 505(c)(3)(E) and 505(j)(5)(F).
If a product is approved in combination and if a product is approved as single entity (NCE) from that
combination then the exclusivity will be calculated from the approval date of combination of that
entity (called as Umbrella Exclusivity i.e. exclusivity applied under same drug combination for
individual entities). (this rule applies for calculating combination exclusivity in Europe as well)
9. 9
Exclusivity Period Notes
New Chemical
Entity
(NCE)
5 years Commences on the date of the NDA approval
prohibits the FDA from accepting for review during the period of exclusivity, any
ANDA or application under s 505(b)(2) for a drug containing the same active
moiety.
- 5 years if an ANDA or 505(b)(2) does not contain a paragraph IV certification to a
listed patent
- 4 years if an ANDA or 505(b)(2) is submitted containing a paragraph IV certification
to a listed patent
(Described in 21 CFR 314.108)
Orphan Drug
Exclusivity
(ODE)
7 years commences on the date of approval of the NDA or BLA.
(Covered under the Orphan Drug Act and 21 CFR 316.31)
Paediatric
Exclusivity
(PED)
6 months provided when the sponsor of a drug conducted and submitted paediatric studies
on the active moiety in response to a Written Request from the FDA
Paediatric exclusivity can attach to any of the NCE, ODE or “Other” exclusivity
periods
(Described in Section 505(A) of the FDA Modernization Act of 1997)
Exclusivities Table
10. 10
Exclusivity Period Notes
New Clinical
Investigation
(NCI)
3 years granted in respect of a pharmaceutical product for which regulatory approval
was obtained, where the FDA had previously provided regulatory approval of
another pharmaceutical product containing the same active moiety.
exclusivity period is granted by the FDA when an application or supplement
contains reports of new clinical investigations (other than bioavailability)
conducted or sponsored by the applicant.
(Described in 21 CFR 314.108)
First generic
exclusivity
180 days first company to submit an ANDA to the FDA has the exclusive right to
market the generic drug for 180 days.
exclusivity provisions provides an incentive of 180 market exclusivity for
the first generic applicant who challenges a listed patent.
The 180 day period of exclusivity commences on the day that the
commercial marketing of the first generic product begins, or from the date
that a court find a relevant patent invalid, unenforceable or not infringed
(whichever date is earliest).
11. 11
Exclusivity Period Notes
Competitive
Generic
Therapy
(CGT)
180
days
Granted when there is not more than one approved drug in the active section of the
Orange Book/ Inadequate generic competition
This may either be the reference listed drug (RLD) or a drug approved in an ANDA
referencing the same RLD as the drug for which designation as a CGT is sought
e.g. Sildenafil Citrate oral suspension (no OB listed patents and not more than 1 RLD listed
in Orange book)
(Described in FDA Reauthorization Act of 2017, or FDARA)
Generating
Antibiotic
Incentives
Now
(GAIN)
5 years On July 9, 2012, GAIN was signed into law as Title VIII of FDASIA to stimulate
development of new antibacterial and antifungal drugs
GAIN created incentives for sponsors to bring to market antibacterial and antifungal
drugs intended to treat serious or life-threatening infections.
GAIN provides for the designation by FDA of certain antimicrobial drugs as QIDPs
(QUALIFIED INFECTIOUS DISEASE PRODUCTS).
A QIDP is defined in GAIN as “an antibacterial or antifungal drug for human use
intended to treat serious or life-threatening infections, including those caused by ─
1. an antibacterial or antifungal resistant pathogen, including novel or emerging
infectious pathogens; or
2. qualifying pathogens listed by the Secretary under subsection (f) [of section 505E
of the Food, Drug, and Cosmetic Act (FD&C Act)].”
12. 12
Exclusivity Period Notes
Biologics
License
Application
(BLA) –
Reference
Product
Exclusivity
12 years period of time during which a biosimilar applicant (i.e. a sponsor submitting a
351(k) application) is not permitted to submit and the FDA is not permitted to
license a 351(k) application that refers to a reference product.
period of exclusivity extends from the date of first licensure of the reference
product
Approval of a 351(k) application may not be made by the FDA until 12 years
from the first licensure of the reference product (plus any additional 6 month
period for pediatric indication).
A 351(k) application may not be submitted to the FDA for review until 4 years
after the date of first licensure.
13. 13
EUROPE DATA EXCLUSIVITIES
For marketing authorisation applications made from November 2005 onwards, the
period of data exclusivity in Europe has been harmonised as 8 years from the date of first
authorisation in Europe.
For marketing authorisation applications made before November 2005, the period of
data exclusivity varies from EU member state to EU member state, and is either 6 years or
10 years.
For marketing authorisation applications made from November 2005 onwards, there is
an additional period of 2 years of "market exclusivity". This is the period of time during
which a generic company may not market an equivalent generic version of the originator's
pharmaceutical product (although their application for authorisation may be processed
during this period, such that they are in a position to market their product on the expiry of
this additional 2 year period).
14. 14
The rules determining exclusivity changed in 2005. Under the "old rules" data exclusivity
lasted either 6 or 10 years. The "new rules" follow an "8 + 2 + 1" year approach:
During the first 8 years from the grant of the innovator company's marketing
authorisation, data exclusivity applies.
After the 8 years have expired a generic company can make use of the pre-clinical and
clinical trial data of the originator in their regulatory applications, but still cannot
market their product.
After a period of 10 years from the grant of the innovator company's marketing authorisation,
the generic company can also market their product, unless the innovator product qualifies for a
further one year of exclusivity.
This additional 1 year may be obtained in a number of circumstances, such as where the
innovator company is granted a marketing authorisation for a significant new indication for
the relevant medicinal product. In such a situation the generic company can only market
their product after 11 years from the grant of the innovator company's marketing
authorisation.
15. 15
Regulatory evolution for DE in Europe,
1990’s
DE: 6 or 10 yrs
CAP: 10 yrs
2000
Orphans Market
exclusivity
Revision 2004-5
DE/ME
8+2/(+1)
2006
Paediatrics:
Supplementary Protection
certificate extension
10+2 yrs ME (orphans)
DE: 8 years (DE) + 2 years (ME) + 1 year (market protection if new indication is registered in first 8
years with significant benefits over existing therapies)
Generic launchGeneric application can be filed
Orphan Drug Exclusivity: 10 years
Exclusivities in Europe
Paediatric Exclusivity (PIP): 10 years + 2years (ME)
Supplementary protection certificate (SPC): Max 5 years
(provides additional monopoly to compensate the time to get a MA. SPC application need to be lodged within 6
months of the grant of MA. SPC enters into force after expiry of basic patent)
SPC extension for Paediatric trials: 6 months
16. 16
Examples for 8+2(+1) year market protection
Medicinal Product Therapeutic Indication Grounds for acceptance/ refusal
Torisel (temsirolimus)
(+ 1 year granted)
Treatment of adult patients with relapsed and/or
refractory mantle cell lymphoma (MCL)
(New target disease)
There is no approved treatments
for relapsed MCL in EU
Zytiga (Abiraterone)
(+ 1 year granted)
Tretament of men with mCRPC after failure of
androgen deprivation therapy
(different stages or severity of a disease)
There is no available treatment
options in EU for patients with
mCRPC who are asymptomatic or
mildly symptomatic
Isentress
(Raltegravir)
(+ 1 year refused)
ART-naïve patients Lack of proof of superior efficacy
results and safety profile
Prezista (darunavir)
(+ 1 year refused)
Co-administered with low dose ritonavir in
combination with other antiretroviral medicinal
products for the treatment of HIV-1 infection in
ARV treatment-naïve adults
Lack of proof of superior efficacy
and safety profile not significantly
better
17. 17
Centralised Process in Europe
The following states are currently members of the European Patent Organization: 31
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland,
France, United Kingdom, Greece, Croatia, Hungary, Ireland,, Italy,, Lithuania, Luxembourg, Latvia,
Malta, Netherlands,, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Iceland, Norway,
Liechtenstein
There are two ways of obtaining a marketing authorisation:
1. Centralised Procedure
2. National Authorisation Procedures
18. 18
Marketing authorisations granted under the "centralised procedure" allow the marketing-
authorisation holder to market the medicine and make it available to patients and healthcare
professionals throughout the EU on the basis of a single marketing authorisation.
One application leads to one evaluation leading to one authorisation valid in the 28 Member States
of the European Union as well as Iceland, Norway and Lichtenstein
Importantly it also results in a single set of product information for healthcare professionals and
patients in the all the European Union official languages.
Such authorisation is granted by the European Commission following the scientific assessment of
the application by the European Medicines Agency.
The centralised procedure is laid down in Regulation (EC) No 726/2004 compulsory for:
Products derived from biotechnology
Orphan medicinal products
Medicinal products for human use which contain an active substance authorised in the Union after
20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders
or diabetes.
19. 19
It can also apply to all medicinal products:
That contain an active substance not authorised before 20 May 2004,
Constituting a significant therapeutic scientific or technical innovation, or
For which an EU authorisation would be in the interest of patients.
Under the centralised procedure, a company may only obtain one marketing authorisation per
medicinal product.
However, in specific cases a company may apply for a duplicate marketing authorisation. Requests
to submit an application for a duplicate should be sent to the Commission.
The review process:
Companies wishing to market a medicinal product that is eligible for the centralised authorisation
procedure, submit their application directly to the European Medicines Agency (EMA). The EMA is
responsible for the validation and scientific evaluation of the application.
The EMA's Committee for Medicinal products for Human Use (CHMP) carries out a scientific
assessment of the application and give a recommendation on whether the medicine should be
authorised or not.
20. 20
A favourable opinion is accompanied by a draft summary of the product's characteristics, the package
leaflet, and the proposed text for the packaging.
The time limit for the evaluation procedure is 210 days, subject to extensions if additional
questions need to be addressed. Within 15 days of the adoption, the EMA will forward its opinion to
the European Commission to start the decision-making phase.
Authorisation:
Within 15 days a draft implementing decision is sent by the Commission to the Standing Committee
on Medicinal Products for Human Use, allowing for its scrutiny by EU countries.
They have 15 days to return their linguistic comments, and 22 days for substantial ones. Once a
favourable opinion is reached, the draft decision is adopted via an empowerment procedure.
The adoption of the decision should take place within 67 days of the opinion of the EMA.
The Commission's Secretariat-General then notifies the decision to the marketing authorisation holder.
The decision is subsequently published in the Union Register.
Marketing authorisations are initially valid for 5 years. Applications for renewal must be made to the
EMA at least six months before this five-year period expires.
21. 21
Type of Approvals
1. Standard: Comprehensive data is required to enable full evaluation
2. Conditional Approval:
Can be granted, when although comprehensive clinical data have not been supplied, and are unlikely
to be able to be provided (to be provided after approval)
Must fulfil scope for approval (orphan drugs, emergency threats, serious and life-threatening diseases)
These approvals are valid for a renewable 1 year period.
3. Exceptional Circumstances:
Medicines are approved where the applicant is unable to provide data on the efficacy and safety of the
medicine.
This is usually where the indication is so rare that the applicant cannot reasonably be expected to
provide comprehensive evidence or it is contrary to medical ethics to collect such information.
After Approval/Authorization:
The EMA monitors the safety of medicines for as long as they are on the market and if necessary takes
regulatory actions to protect public health in the EU.
22. Exclusivities in other countries
22
1. Australia
2. Canada
3. China
4. Hong Kong
5. India
6. Japan
7. Korea (South)
8. Malaysia
9. New Zealand
10. Russia
11. Saudi Arabia
12. Singapore
13. Thailand
14. Vietnam
23. AUSTRALIA
23
In Australia, the Therapeutic Goods Amendment Act 1998 established a 5 year data exclusivity
period for new products containing pharmaceutical actives approved after 17 April 1998.
The data exclusivity period begins on the date of marketing approval.
The Act provides data exclusivity in relation to therapeutic goods which contain a "new active
component". This is defined as a substance having a therapeutic effect.
The Explanatory Memorandum to the Act states that "substance" may include "a biological product or
compound".
Data exclusivity is only provided in relation to new active components which have never been
included in the Australian Register of Therapeutic Goods. Therefore, data exclusivity is not provided
for new uses/indications or new formulations of existing compounds.
Australia provides for patent term extensions of up to 5 years. To obtain an extension of the term
the first regulatory approval for goods that contain, or consist of the pharmaceutical substance(s)
which is “in substance disclosed” in the patent, and falls within the scope of at least one claim of the
granted patent, must have occurred more than 5 years after the filing date of the patent application.
An application for an extension of term must be made within 6 months after the latest of:
a) the date the patent was granted; b) the date of the first regulatory approval.
24. 24
CANADA
Data exclusivity is not legally defined term in Canadian law
DE is not a Canadian conception but was instead forced upon Canada in the course of trade
negotiations. The Food and Drugs Act is the enabling statute of the Food and Drug Regulations,
which contain Canada’s data exclusivity provisions.
The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug
Regulations. The register indicates the drugs that are eligible for data protection.
Under the October 5, 2006 data protection provisions, companies introducing a drug containing a
new chemical entity (i.e. an “innovative drug”) are entitled to an 8 year period of market
exclusivity.
In addition, a subsequent-entry manufacturer is prevented from filing a submission for a copy of that
innovative drug for the first 6 years of the eight-year period.
The data protection period may be extended a further 6 months if, within the first 5 years of the 8-
year period, the results of pediatric clinical trials, designed and conducted for the purpose of
increasing knowledge of the use of the drug in pediatric populations, are also submitted and found
acceptable.
There is also no market exclusivity for the first approved generic drug or biologic drug against
subsequent drugs.
25. 25
CHINA
Under Article 35 of the Implementing Regulations of the Drug Administration Law of 4 August
2002, China provides 6 years of data exclusivity as from the date of marketing approval.
Patent term extensions are not available in China.
The data exclusivity period is up to 6 years for innovative new drugs approved in China and up
to 12 years for innovative therapeutic biologics.
For innovative drugs that have been approved for marketing, a six-year data exclusivity period will
be granted. However, data exclusivity of 10 years will be granted if the innovative drug is for rare or
paediatric diseases.
For improved new drugs for rare or paediatric diseases, a three-year data exclusivity period will be
issued. Innovative and improved new drugs belong to Classes 1 and 2 respectively under the current
classification of new drugs.
26. 26
New Draft Policy in Chinese Government:
As per the new updates, Chinese national government extended the period of exclusivity on
pharmaceutical patents from 20 years up to 25 years.
The draft policy also proposed a 10-year data exclusivity period for therapeutically innovative
biologics.
In particular, the draft guideline limits the types of exclusivity-eligible data to those pre-clinical
and clinical trial data related to drug efficacy, and explicitly excludes data related to drug safety. In
addition, the following requirements must be met:
1. the data submitted to the agency as a part of the drug application are for the purpose of obtaining
a marketing authorization;
2. the data are not otherwise publicly disclosed prior to the drug application submission;
3. the data are independently developed without reliance on any experimental data by others or
published research results.
Data exclusivity will also be granted to a new drug which is first approved by other authorities and
later enters China within a certain period.
27. 27
According to the draft, corresponding data exclusivity will be granted for new drugs with an
application for marketing and data protection submitted in China within one year of being approved
in the United States, Japan and Europe.
If the application is submitted in China after the one-year period, any excess time will be deducted
from the corresponding data exclusivity.
Data exclusivity of one-and-a-half years will be granted if less than one-and-a-half years after
deduction.
Data exclusivity of one-and-a-half years will also be granted to the first generic drug launched under
a successful challenge to the patents.
28. 28
The exclusivity period may be reduced or revoked under any of the following scenarios:
a. When a drug application uses data from an international multicenter clinical trial in China and the
drug application filed in China is later than those outside of China, the exclusivity period is 1 to 5 years
depending on the delay. When the delay is more than six years, there is no data exclusivity.
b. If the drug application uses data from clinical trials conducted outside of China with no Chinese
patients, the data exclusivity period is 25 percent of the above.
c. If the drug application is supplemented with clinical trial data in China, the data exclusivity
period is 50 percent of the above.
d. The data exclusivity is revoked if a company fails to bring a drug to market within one year after
obtaining regulatory approval.
For orphan drugs and pediatric drugs, the data exclusivity periods are six years, regardless of the source
of the data and the timing of the drug application filing.
29. 29
China plans to increase market exclusivity term for pharmaceuticals based on improved pharmaceutical trial
data protection (August 26, 2018 article)
The proposed draft involves in a variety of protection terms for different conditions as shown in Table below.
Drugs/Products Conditions Protection Term
Innovative drugs Use the clinical trial data or Multi-regional Clinical
Trial (MRCT) data carried out in China to apply for
marketing domestically or apply for marketing
domestically and overseas simultaneously
6 years from the date of
approval for marketing in China
Innovative biological products for therapy 12 years from the date of
approval for marketing in China
Innovative drugs Use the Multi-regional Clinical Trial (MRCT) data
carried out in China to apply for marketing
domestically after first applying overseas
1 to 5 years from the date of
approval for marketing in China
Innovative biological products for therapy
Innovative drugs Only use the clinical trial data carried out overseas to
apply for marketing domestically
1.5 years from the date of
approval for marketing in China
Innovative biological products for therapy 3 years from the date of
approval for marketing in China
Innovative drugs Use the clinical trial data carried out overseas and
supplement clinical trial data on Chinese subjects to
apply for marketing domestically
3 years from the date of
approval for marketing in China
Innovative biological products for therapy 6 years from the date of
approval for marketing in China
Orphan drugs None 6 years from the date of the first
approval of the indication of a
newly-recognized disease in
China
Pediatric drugs
Generic drugs Invalidate relevant patents of original drugs
successfully
No official information yet
30. 30
INDIA
There are currently no provisions in India for obtaining an extension of term of a patent or for the
protection of data submitted to a regulatory authority.
HONG KONG
There are currently no provisions in Hong Kong for obtaining an extension of term of a patent or for
the protection of data submitted to a regulatory authority.
31. 31
JAPAN
There are no data or marketing exclusivity provisions for pharmaceutical products in Japan.
However, the effect of post market pharmacovigilance provisions is to ostensibly act as a data
exclusivity provision and prevent any generic from coming onto the market during the Post
Marketing Surveillance period.
Post Market Surveillance is a process whereby the Japanese regulatory authority (Pharmaceuticals
and Medical Devices Agency) re-examines the safety and efficacy of new chemical entities and
previously approved pharmaceuticals later approved for new indications.
The re-examination period lasts for between 4 to 10 years, during which time any data submitted to
the regulatory authority by the drug sponsor which relates to the safety of the drug cannot be
obtained by generic companies. It is not until after the conclusion of this period that a generic
company is able to commence marketing of their product.
The data exclusivity period varies from 4 years (for medicinal products with new indications,
formulations, dosages, or compositions with related prescriptions) to
6-8 years (for drugs containing a new chemical entity or medicinal composition, or requiring a new
route of administration) to
10 years (for orphan drugs or new drugs requiring pharmaco-epidemiological study).
32. 32
In Japan, patent term extensions of up to 5 years are available for pharmaceuticals and
agrochemicals.
An application for an extension of term must be filed within three months of the first regulatory
approval of the product. An early patent grant is also advantageous for maximising the term of the
extension because time lost in the regulatory process while the patent application is still pending does
not count towards the extension of term.
Notably, in Japan subsequent approval for the same active ingredient for a second indication may
serve as a basis for an additional extension.
The Japanese regulatory authority re-examines the safety and efficacy of new chemical entities and
drugs approved for new indications. The re-examination period lasts from 4 to 10 years during which
time data is protected.
33. 33
MALAYSIA
Malaysia grants a DE period for new pharmaceutical products for at least 5 years, while 3 years
protection is given if new indication, new formulation, or new method of administration is
approved for a previously approved pharmaceutical product.
In the case of a new biologic product, Malaysia currently does not provide DE for biologic product
but is taking the second option of a minimum standard of 5 years DE instead of 8 years to ensure
that less expensive biosimilar products reach the market more quickly.
34. 34
New Zealand implemented Article 39.3 of TRIPS via the Medicines Amendment Act 1994 (NZ),
effective as from 1 January 1995.
Generally, the protection period is 5 years. There is no data exclusivity period for data relating to
new uses/indications or formulations of old active ingredients.
Patent term extensions are not available in New Zealand.
NEW ZEALAND
35. 35
RUSSIA
The right of data exclusivity became effective on August 22, 2012, the official date of Russian
Federation accession to the WTO.
The concept was later introduced into the article 18 of Federal law № 61-FZ “On the Turnover of
Medicines”, a central law for pharmaceutical industry in Russia.
Russian Federal law № 429-FZ [December 22, 2014] – [Amendments to Federal law № 61-FZ on
“Circulation of Medicines”]
Effective from January 01, 2016, Data exclusivity was defined as follows:
It is not permitted to use for the commercial purposes the results of pre-clinical trials of medicinal
products and clinical trials of medicines, provided by the applicant for state registration of the
medicine without his consent for the period of 6 YEARS from the date of state registration of the
Reference Medicine in the Russian Federation.
Division of the 6 year term
[4 Year registration Exclusivity + 2 Year Market Exclusivity for generic drugs]
[ 3 year registration exclusivity + 3 year Market exclusivity for biosimilars]
Registration exclusivity is determined from the date of registration of a reference medicine
36. 36
SAUDI ARABIA
Under Saudi Arabian law, official authorities are required to protect the confidential commercial data
disclosed to them for a minimum period of 5 years from the date of obtaining the approval (Article 5,
Regulations for the Protection of Confidential Commercial Information).
(Case: Gilead Sciences was granted marketing approval by the SFDA in 2014 for its product Sofosbuvir. The SFDA
has subsequently granted marketing approval for generic versions of this product made by a Saudi and Egyptian
company within the 5-year data exclusivity window. This was the breach of Saudi data exclusivity regulations).
OMAN
In Oman, a person who has first obtained marketing approval for a new pharmaceutical or agricultural
chemical product in Oman can expect data disclosed to the governmental agency during the approval
process to not be relied for a period of at least:
5 years for pharmaceutical products and 10 years for agricultural chemical products.
It also provides protection for new clinical data that is required to be submitted as a condition of granting
marketing approval for a pharmaceutical product that includes a chemical entity that has been previously
approved for marketing.
The authorising body must not authorise another person to market the same or a similar product based on
the new clinical data submitted in support of the marketing approval, for at least 3 years from the date of
marketing approval in Oman.
37. 37
SINGAPORE
Singapore provides a 5 year data exclusivity period which commences on the date that
a product licence is granted.
The deadline for making an application for an extension of patent term is the later of six
months from the grant of the patent or six months from obtaining marketing approval for
the pharmaceutical product by Singapore’s Health Services Authority.
In order to be eligible to make an application, the time between filing for marketing
approval and the date marketing approval was obtained must be at least two years.
Of all the countries in Southeast Asia, only Singapore and Brunei provide for patent
term extensions, in each case of up to 5 years.
38. 38
SOUTH KOREA
South Korea provides patent term extensions of up to 5 years for pharmaceuticals and
agrochemicals. An application for an extension of term must be filed within three months of the first
regulatory approval of a product comprising a new chemical entity and within six months of the
expiry date of the patent.
South Korea provides a 5 year data exclusivity period for new chemical entities which commences
from the date on which a product licence is granted.
39. 39
THAILAND
Patent term extensions are not available in Thailand.
Thailand provides a 5 year protection period that ensures the data provided in respect of a new
drug application remains confidential.
VIETNAM
Patent term extensions are not available in Vietnam.
Vietnam provides a 5 year data exclusivity period which commences from the date on which a
product licence is granted.
For NCE: The period of exclusivity is:
4 years if an ANDA or s 505(b)(2) application contains a certification that any patent relevant to the pharmaceutical product is invalid or is not infringed by the generic product; or
5 years if an ANDA or s 505(b)(2) application does not contain a certification that any patent relevant to the pharmaceutical product is invalid or is not infringed by the generic product