The document provides information about an upcoming presentation on Good Clinical Practice (GCP). It includes:
1) Details about the presenter including his background and experience in clinical research.
2) The learning objectives of the presentation which are to define GCP, differentiate GCP requirements from recommendations, and identify circumstances where industry best practices go beyond FDA requirements.
3) An introduction stating the presentation was developed to correct common myths and errors heard about GCP throughout the presenter's career.
The document provides an overview of Good Clinical Practice (GCP) guidelines. It discusses:
1) How GCP standards were developed to ensure clinical trials are conducted ethically and that trial data is accurate. This includes guidelines from the Declaration of Helsinki, International Conference on Harmonization, and US regulations.
2) The key documents that define GCP responsibilities, including ICH E6, FDA regulations around informed consent and monitoring, and the Common Rule for research involving human subjects.
3) How GCP guidelines continue to evolve with new standards from organizations like the FDA, WHO and revisions to founding documents like the Declaration of Helsinki. Compliance with GCP is important for researchers, sponsors and IRBs conducting
Conducting Studies to the International Gold Standard: Going Beyond What the ...Paul Below
The document discusses the differences between the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) and the U.S. Food and Drug Administration (FDA) regulations for clinical trials. The ICH guidelines aim to harmonize standards across countries in order to streamline drug development. Key differences highlighted in the document include additional informed consent requirements, documentation standards, and record retention timelines under the ICH guidelines compared to FDA regulations. Adhering to the international gold standard of the ICH GCP guidelines can facilitate global drug development and approval processes.
The document provides an overview of Good Clinical Practice (GCP) training, including:
1. A refresher on the key events that led to the development of GCP guidelines like the Nuremberg Code and Declaration of Helsinki in response to unethical medical experiments and drug issues.
2. An overview of the regulatory framework for clinical trials in Europe and the UK, including EU directives and UK laws that implement GCP principles.
3. A discussion of what guidelines and regulations are applicable for the conduct of clinical trials today, including ICH E6 and EU Clinical Trials and GCP directives.
The document summarizes new rules and regulations around clinical trials and compensation in India put forth in 2019. Key changes include:
1) Tightened timelines for reporting serious adverse events like death - sponsors and investigators must report within 14 days, ethics committees within 30 days.
2) An expert committee may review injury cases and make recommendations to the licensing authority within 60 days.
3) The licensing authority must make a decision on compensation within 90 days for injuries or death, down from 150 days previously.
4) Formulas are provided to calculate compensation amounts based on factors like age, disability level, and hospitalization duration.
This document discusses biowaste management in India. It begins by outlining the relevant legislation passed in 1986 and 1998 that makes occupiers of institutions responsible for properly handling and disposing of biomedical waste without harming human health or the environment. It then defines different types of biomedical waste, including infectious waste. The document goes on to list sources of biomedical waste such as hospitals, labs, and homes providing healthcare. It describes approved methods of disposal including incineration, autoclaving, microwaving, and secured landfilling and outlines characteristics of waste suitable for each method. The presentation concludes by classifying biomedical waste into four color-coded categories.
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
The document provides information about an upcoming presentation on Good Clinical Practice (GCP). It includes:
1) Details about the presenter including his background and experience in clinical research.
2) The learning objectives of the presentation which are to define GCP, differentiate GCP requirements from recommendations, and identify circumstances where industry best practices go beyond FDA requirements.
3) An introduction stating the presentation was developed to correct common myths and errors heard about GCP throughout the presenter's career.
The document provides an overview of Good Clinical Practice (GCP) guidelines. It discusses:
1) How GCP standards were developed to ensure clinical trials are conducted ethically and that trial data is accurate. This includes guidelines from the Declaration of Helsinki, International Conference on Harmonization, and US regulations.
2) The key documents that define GCP responsibilities, including ICH E6, FDA regulations around informed consent and monitoring, and the Common Rule for research involving human subjects.
3) How GCP guidelines continue to evolve with new standards from organizations like the FDA, WHO and revisions to founding documents like the Declaration of Helsinki. Compliance with GCP is important for researchers, sponsors and IRBs conducting
Conducting Studies to the International Gold Standard: Going Beyond What the ...Paul Below
The document discusses the differences between the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) and the U.S. Food and Drug Administration (FDA) regulations for clinical trials. The ICH guidelines aim to harmonize standards across countries in order to streamline drug development. Key differences highlighted in the document include additional informed consent requirements, documentation standards, and record retention timelines under the ICH guidelines compared to FDA regulations. Adhering to the international gold standard of the ICH GCP guidelines can facilitate global drug development and approval processes.
The document provides an overview of Good Clinical Practice (GCP) training, including:
1. A refresher on the key events that led to the development of GCP guidelines like the Nuremberg Code and Declaration of Helsinki in response to unethical medical experiments and drug issues.
2. An overview of the regulatory framework for clinical trials in Europe and the UK, including EU directives and UK laws that implement GCP principles.
3. A discussion of what guidelines and regulations are applicable for the conduct of clinical trials today, including ICH E6 and EU Clinical Trials and GCP directives.
The document summarizes new rules and regulations around clinical trials and compensation in India put forth in 2019. Key changes include:
1) Tightened timelines for reporting serious adverse events like death - sponsors and investigators must report within 14 days, ethics committees within 30 days.
2) An expert committee may review injury cases and make recommendations to the licensing authority within 60 days.
3) The licensing authority must make a decision on compensation within 90 days for injuries or death, down from 150 days previously.
4) Formulas are provided to calculate compensation amounts based on factors like age, disability level, and hospitalization duration.
This document discusses biowaste management in India. It begins by outlining the relevant legislation passed in 1986 and 1998 that makes occupiers of institutions responsible for properly handling and disposing of biomedical waste without harming human health or the environment. It then defines different types of biomedical waste, including infectious waste. The document goes on to list sources of biomedical waste such as hospitals, labs, and homes providing healthcare. It describes approved methods of disposal including incineration, autoclaving, microwaving, and secured landfilling and outlines characteristics of waste suitable for each method. The presentation concludes by classifying biomedical waste into four color-coded categories.
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
This document describes the giant puppets Pep and Flora who visit the school for festivals and holidays. Pep and Flora enjoy dressing up for celebrations like Carnival where they dress as the school colors. They help make the festivals more fun for the students. The document discusses their costumes for Carnival and how they lead a parade before returning tired to the school.
Question 6 What have you learnt about technologies from the preliminary task ...bremangi
The document discusses what was learned about technologies from creating a film product. It describes learning how to use editing software like Final Cut Pro on Mac computers after losing an editor colleague. Filming was challenging due to camera battery issues requiring two days of shooting. Editing required constant guidance since the author was inexperienced. Scary clown scenes received positive feedback due to correct cinematography and mise-en-scene techniques. Feedback noted the ending felt rushed and could have been improved with a stronger cliffhanger.
This document contains a list of various accounting and business documents and reports including purchase invoices, balance sheets, ledgers, vouchers, registers, summaries, requests and more. The list covers documents related to products, purchases, sales, customers, suppliers, bank accounts, payments, expenses, employees, taxes and other financial aspects of the business. Comparative reports are also included to analyze data over time.
The document outlines potential risks and hazards from filming activities and measures to control risks. It identifies who may be at risk from issues like equipment falling or theft. Control measures are suggested like securely attaching cameras and filming in less crowded areas. Most risks are rated as low probability but high consequence issues like cars hitting film crews are identified. The document concludes with emergency contact numbers for assistance.
Raj is an 18-year-old male hip hop/R&B artist who enjoys partying and taking influence from artists like Post Malone, Jeremih, and Drake. The group chose to use Raj's real name to make him seem like a real person and close the gap between artist and audience. They will film a music video for Post Malone's "Too Young" showing a younger version of Raj enjoying life with no responsibilities and the present version reminiscing. The target audience is 16-25 year olds as the group can relate to them and not have to censor content. They will promote Raj through social media like Instagram, creating a music video and digipak to gain recognition.
Digital Pathology streamlines tissue diagnostics and helps protect patient sa...Roche Tissue Diagnostics
RZ Tienen Hospital became one of the first hospitals in Belgium, and one of the first in Europe, to implement and integrate digital pathology into daily operations. They have transformed their AP lab and are now able to manage caseloads remotely, facility MDT oncology meetings and enhance collaboration with colleagues. The benefits of digital pathology have been well recognized and RZ Tienen expects continued growth in this area.
1. The document provides an overview of intellectual property strategies for diagnostics, including a brief review of patent basics, the scope of patent protection for diagnostics, common types of claims, considerations for support and examination procedures, and enforcement and exploitation of patents.
2. Key topics covered include what can be patented in diagnostics, such as inventions, selection patents, subject matter restrictions, medical methods, higher life forms and biotechnological inventions. Common claim types for diagnostics like products, methods, machines and uses are described through examples.
3. Support for patent applications requires meeting criteria like novelty, inventiveness, utility and enablement, with enablement ensuring sufficient disclosure to support the claim scope without undue experiment
Ethics and the Law: The Case of Myriad Genetics, Ethics in Patenting and Eth...Kirby Drake
This document discusses the case of Myriad Genetics and the controversy surrounding human gene patents. It provides background on gene patents and Myriad's patents on the BRCA1 and BRCA2 genes. The Association for Molecular Pathology sued Myriad, arguing the patents were invalid as products of nature. The court agreed the composition claims were directed to unpatentable natural phenomena, though it did not rule on constitutional questions. The document examines the conflicting ethical issues around gene patenting and licensing practices, and possible policy solutions like compulsory licensing or research exemptions.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed by the World Medical Association. It has undergone several revisions since its adoption in 1964 to address developments in research ethics. While not legally binding, it is considered an important document for guiding ethical medical research. The US FDA abandoned following the Declaration in favor of other guidelines, sparking debate around its continued relevance and whether differing international standards could result in ethical hypocrisy.
This document discusses the case of Myriad Genetics and the ethics around patenting human genes. It summarizes that Myriad Genetics holds patents on the BRCA1 and BRCA2 genes linked to breast cancer and faces criticism for aggressively enforcing these patents. The document also summarizes a key lawsuit where a court invalidated Myriad's gene patents, finding that isolated DNA is not patentable subject matter. The document discusses ongoing debates around the ethics, impacts on research and healthcare, and potential policy solutions regarding human gene patents.
Obtaining patentable claims after Prometheus and MyriadMaryBreenSmith
The Supreme Court cases significantly changed what is patentable subject-matter in the U.S. But how broadly has the scope of patentable subject matter been narrowed by these decisions? Presentation analyzes major claim types in diagnostics and gene-type patents and whether they remain patentable under this new case law.
An analysis of how the U.S. Supreme Court’s recent decision in Bilski v. Kappos will impact the patent-eligibility of medical diagnostic and treatment methods, and offering practical insights and best practices on how to defend or challenge medical method patents.
This document describes the giant puppets Pep and Flora who visit the school for festivals and holidays. Pep and Flora enjoy dressing up for celebrations like Carnival where they dress as the school colors. They help make the festivals more fun for the students. The document discusses their costumes for Carnival and how they lead a parade before returning tired to the school.
Question 6 What have you learnt about technologies from the preliminary task ...bremangi
The document discusses what was learned about technologies from creating a film product. It describes learning how to use editing software like Final Cut Pro on Mac computers after losing an editor colleague. Filming was challenging due to camera battery issues requiring two days of shooting. Editing required constant guidance since the author was inexperienced. Scary clown scenes received positive feedback due to correct cinematography and mise-en-scene techniques. Feedback noted the ending felt rushed and could have been improved with a stronger cliffhanger.
This document contains a list of various accounting and business documents and reports including purchase invoices, balance sheets, ledgers, vouchers, registers, summaries, requests and more. The list covers documents related to products, purchases, sales, customers, suppliers, bank accounts, payments, expenses, employees, taxes and other financial aspects of the business. Comparative reports are also included to analyze data over time.
The document outlines potential risks and hazards from filming activities and measures to control risks. It identifies who may be at risk from issues like equipment falling or theft. Control measures are suggested like securely attaching cameras and filming in less crowded areas. Most risks are rated as low probability but high consequence issues like cars hitting film crews are identified. The document concludes with emergency contact numbers for assistance.
Raj is an 18-year-old male hip hop/R&B artist who enjoys partying and taking influence from artists like Post Malone, Jeremih, and Drake. The group chose to use Raj's real name to make him seem like a real person and close the gap between artist and audience. They will film a music video for Post Malone's "Too Young" showing a younger version of Raj enjoying life with no responsibilities and the present version reminiscing. The target audience is 16-25 year olds as the group can relate to them and not have to censor content. They will promote Raj through social media like Instagram, creating a music video and digipak to gain recognition.
Digital Pathology streamlines tissue diagnostics and helps protect patient sa...Roche Tissue Diagnostics
RZ Tienen Hospital became one of the first hospitals in Belgium, and one of the first in Europe, to implement and integrate digital pathology into daily operations. They have transformed their AP lab and are now able to manage caseloads remotely, facility MDT oncology meetings and enhance collaboration with colleagues. The benefits of digital pathology have been well recognized and RZ Tienen expects continued growth in this area.
1. The document provides an overview of intellectual property strategies for diagnostics, including a brief review of patent basics, the scope of patent protection for diagnostics, common types of claims, considerations for support and examination procedures, and enforcement and exploitation of patents.
2. Key topics covered include what can be patented in diagnostics, such as inventions, selection patents, subject matter restrictions, medical methods, higher life forms and biotechnological inventions. Common claim types for diagnostics like products, methods, machines and uses are described through examples.
3. Support for patent applications requires meeting criteria like novelty, inventiveness, utility and enablement, with enablement ensuring sufficient disclosure to support the claim scope without undue experiment
Ethics and the Law: The Case of Myriad Genetics, Ethics in Patenting and Eth...Kirby Drake
This document discusses the case of Myriad Genetics and the controversy surrounding human gene patents. It provides background on gene patents and Myriad's patents on the BRCA1 and BRCA2 genes. The Association for Molecular Pathology sued Myriad, arguing the patents were invalid as products of nature. The court agreed the composition claims were directed to unpatentable natural phenomena, though it did not rule on constitutional questions. The document examines the conflicting ethical issues around gene patenting and licensing practices, and possible policy solutions like compulsory licensing or research exemptions.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed by the World Medical Association. It has undergone several revisions since its adoption in 1964 to address developments in research ethics. While not legally binding, it is considered an important document for guiding ethical medical research. The US FDA abandoned following the Declaration in favor of other guidelines, sparking debate around its continued relevance and whether differing international standards could result in ethical hypocrisy.
This document discusses the case of Myriad Genetics and the ethics around patenting human genes. It summarizes that Myriad Genetics holds patents on the BRCA1 and BRCA2 genes linked to breast cancer and faces criticism for aggressively enforcing these patents. The document also summarizes a key lawsuit where a court invalidated Myriad's gene patents, finding that isolated DNA is not patentable subject matter. The document discusses ongoing debates around the ethics, impacts on research and healthcare, and potential policy solutions regarding human gene patents.
Obtaining patentable claims after Prometheus and MyriadMaryBreenSmith
The Supreme Court cases significantly changed what is patentable subject-matter in the U.S. But how broadly has the scope of patentable subject matter been narrowed by these decisions? Presentation analyzes major claim types in diagnostics and gene-type patents and whether they remain patentable under this new case law.
An analysis of how the U.S. Supreme Court’s recent decision in Bilski v. Kappos will impact the patent-eligibility of medical diagnostic and treatment methods, and offering practical insights and best practices on how to defend or challenge medical method patents.
Clinical trials are an important but risky process for developing new drugs and medicines. In India, clinical trials are regulated by the Drugs and Cosmetics Act of 1940 and its amendments. However, the regulatory framework is still weak with instances of non-compliance, such as trials being conducted without proper protocols or registration. Several Supreme Court rulings have aimed to strengthen protections for clinical trial participants in India by requiring innovation, safety, and benefit for India to be established before approving trials. Nonetheless, problems persist due to the large financial interests involved and more regulatory reforms are still needed.
Good clinical practices (GCP) are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. GCP provides protection for trial subjects, enhances the quality and integrity of trial data, and helps ensure that trial results are credible and reported appropriately. The seminar discussed the history and development of GCP, from the Nuremberg Code to the ICH guidelines, with the goal of establishing consistent standards that are acceptable globally.
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
The document provides an overview of ICH-GCP (Good Clinical Practice) guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The summary discusses the key sections and principles of ICH-GCP, which aim to protect trial subjects and ensure valid clinical trial data. It outlines the historical background and development of GCP standards from the Nuremberg Code to the ICH-GCP guidelines of 1996. The document reviews responsibilities of ethics committees, sponsors, investigators, clinical trial protocols, and informed consent processes.
This document provides an overview of biotechnology and recent patent law cases affecting patent eligibility of biotechnology inventions. It begins with primers on biotechnology topics like DNA, proteins, and therapeutic products. It then discusses why strong patent protection is essential for biotechnology given the lengthy and expensive research and development process. The document reviews various biotechnology patent claims and recent Supreme Court cases that have impacted patent eligibility of diagnostic methods, natural correlations, and processes applying natural relationships. It concludes with a discussion of personalized medicine and precision diagnostics representing future areas for biotechnology.
The document presents information on the Declaration of Helsinki (DoH), including its history, development, scope, and basic ethical principles for medical research involving human subjects. It notes that the DoH is a cornerstone document developed by the World Medical Association that has undergone several revisions since 1964 to update principles for ethical human research. The summary provides an overview of the key topics covered in the document.
An expert at HGF Limited presented on developing effective patent strategies for personalized medical devices in Europe and the US. The presentation covered:
1) Considerations for patenting personalized medical devices in Europe, including allowable claim types and restrictions on methods of treatment.
2) A hypothetical case study of a company developing a customized implantable medical device, and strategies for patenting it in Europe and the US.
3) Lessons learned from litigation involving Conformis, a pioneer in personalized orthopedic implants, highlighting the complexities of prosecuting patents for such technologies.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
The document provides an overview of good clinical practices (GCP) and the historical standards that contributed to its development. It discusses key milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report that established ethical and quality standards for clinical research involving human subjects. The document also outlines the four phases of clinical trials and principles of GCP like prior approval, informed consent, and quality assurance. It notes that GCP provides an international quality standard to ensure the rights, safety, and well-being of clinical trial participants.
The Declaration of Helsinki is a set of ethical principles for human subject research developed by the World Medical Association. It has undergone several revisions since its adoption in 1964. While some argue it is outdated and newer guidelines exist, others believe the Declaration remains highly relevant as it provides strong ethical protections for research subjects and upholds principles of respect for persons. It remains a morally binding document for physicians in conducting ethical clinical trials.
This document discusses patenting aspects of traditional knowledge and natural products, using the cases of turmeric and neem. It defines traditional knowledge and intellectual property rights, explaining that patents provide legal protection for inventions. It then describes the patenting process and requirements, such as an invention being novel, non-obvious, and useful. The document outlines what can and cannot be patented for natural products. It provides examples of patented formulations, new uses of herbal constituents, and isolation or modification of natural compounds. The case studies detail how India challenged and had a turmeric wound-healing patent revoked for lack of novelty, as well as a neem patent dispute.
This document summarizes a presentation on intellectual property rights and public health with a focus on TRIPS and access to medicines. It discusses:
1. The nature of the pharmaceutical industry, markets, and role of IP protection. Key points include high R&D costs, price controls, and innovation issues.
2. An overview of TRIPS including origins, provisions on patents, compulsory licensing, and public health flexibilities. It examines India's implementation of Section 3(d) and compulsory licensing.
3. Recent Indian cases including Novartis v. India on patentability criteria under Section 3(d), and Bayer v. India on the country's first compulsory license granted for unreasonable prices
The document discusses Good Clinical Practices (GCP) as defined by the International Conference on Harmonization (ICH). It provides an overview of the history and guidelines of GCP, from the Nuremberg Code to the Declaration of Helsinki to the formation of the ICH. The key principles of GCP according to the ICH are described, including protecting trial subjects, obtaining informed consent, and ensuring proper documentation and storage of trial information. The areas addressed by the GCP guidelines are outlined, such as the responsibilities of ethics committees, investigators, and sponsors.
Similar to Methods of Medical Treatment Claims Issues in Canada US and Europe (20)
This document discusses brands, trademarks, and advertising. It begins by defining what a brand is, noting that a brand comprises a product or service, packaging, name/logo, promotion, and appeals to customers physically, aesthetically, rationally, and emotionally. It then defines what a trademark is, explaining that it distinguishes one company's goods/services from another's. The document recommends conducting trademark searches to identify potential issues and minimize risks. It also explains why trademarks should be registered, providing exclusive rights and prima facie evidence of ownership. The document concludes by discussing proper trademark use and marking.
Le gestion de crise : considérations juridiques et pratiques pour traverser l...This account is closed
Au cours de ce programme de formation préparé spécifiquement pour les conseillers juridiques en entreprise, nous vous présenterons une série d’outils visant à vous équiper pour affronter la tempête, peu importe quand et comment elle se présente.
This presentation includes information about legal project management fundamentals, creating a framework for legal project management (define, plan, monitor and manage, review and improve), ethics and the law, conflicts from outside counsel and the general counsel.
This document discusses financing models for nuclear power projects and the risks involved. It describes three models for government engagement: complete engagement where governments own projects and absorb risks; complete disengagement where private actors must take on risks; and a middle road where governments hedge some risks. Two US projects using the middle road of rate increases are proceeding, while others failed. The UK uses contracts that hedge electricity prices but not completion risks, requiring massive contingent equity funds. For new projects, sponsors may need to pass completion risks down the supply chain.
Canadian Procurement/Construction Delivery Methods
Various procurement/construction delivery methods exist to provide alternatives as to how risks and responsibilities are allocated for a project and how key factors such as time and price are addressed.
Traditional Delivery Method:
Design-Bid-Build
- Stipulated Price
- Cost Plus
- Unit Price
Contemporary Delivery Methods:
- Construction Management (not-at-risk / at-risk)
- Design-Build
- P3’s
This document summarizes the key intellectual property rights affected by the Trans-Pacific Partnership (TPP) agreement, including patents, trademarks, copyright, industrial designs, and geographical indications. It outlines the TPP provisions relating to patentable subject matter, patent term extensions, data protection, biologics, trademark registration requirements, well-known marks, copyright duration, and industrial design harmonization. The TPP signatories recognize different approaches to geographical indication protection and enforcement measures include criminal sanctions for IP infringement and border measures.
In this presentation, Gowlings partner Parul Armitage will look at current trends in life sciences licensing and collaborations.
Topics to be explored include:
Financial terms
Valuations
The continuing saga of the patent cliff
“More payer pressure, more commercialization risk”
Licensing as a commercialization strategy
Academic to industry licensing
The Cloud Computing Contract Playbook - Contracting for Cloud Services, Sept. 30This account is closed
The document discusses key considerations for contracting cloud services. It notes that cloud contracts replace on-premises infrastructure agreements and outlines important clauses like data security, service level agreements, auditing rights, and ensuring access to data if the provider exits. The document also recommends due diligence on provider security practices and insurance to cover risks from outages or breaches at third-party providers. Overall it provides guidance on structuring contracts to maintain control over data and set clear performance standards when transitioning IT services to cloud models.
It’s widely known that foreign companies looking to acquire strong targets are drawn to Canada’s vast resource sector. But there’s also plenty of M&A activity — and opportunity — across many other Canadian industries, such as technology, life sciences, media and communications, manufacturing and retail.
In this one-hour webinar, experts from Gowlings will share their insights on the Canadian M&A legal regime, and offer tips on how to navigate the complexities of the market and successfully acquire a Canadian company. Topics include:
- Building your acquisition model and determining the most appropriate structure for a Canadian company acquisition
- Determining the applicable tax rules and assessing the potential tax advantages
- An overview of competition law and the Investment Canada Act — due diligence, thresholds and the review process
PLSAs, SEPs and PAEs: The Antitrust/IP Acronyms You Should Know and UnderstandThis account is closed
In this presentation from June 2015, Davit Akman and a panel of other antitrust experts provide an overview of recent regulatory and jurisprudential developments in the U.S., Europe and Canada, and their impact on antitrust counselling and risk assessment.
Key topics discussed include:
• Patent litigation settlement agreements (PLSAs)
• Standard setting and conduct involving standard essential patents (SEPs)
• Conduct involving patent assertion entities (PAEs)
Your company’s people, products, profits and politics have a direct impact on its bottom line.
In this seminar presentation aimed at in-house counsel, HR and other business leaders, you’ll learn from legal and industry insiders on how to master these four key pillars ― and succeed in today’s competitive manufacturing market.
This document summarizes a presentation on navigating social media in the workplace. It discusses how social media has become integrated into daily life and work. While it provides opportunities as a business tool, it also poses risks if not properly managed, such as lost productivity, privacy issues, and legal liabilities. The presentation provides guidance for developing social media policies and educating employees on appropriate social media use and their obligations regarding loyalty, confidentiality and off-duty conduct. It also reviews case law establishing that employers can discipline employees for inappropriate social media use that damages the employer or violates policies.
This document summarizes five key employment law cases from 2015:
1. McConaghie v. Systemgroup Consulting Inc. found an employer discriminated against a female employee by holding a "Men's Day" event that excluded her. The employer was ordered to pay damages.
2. Wilson v. Atomic Energy established that without cause dismissals under the Canada Labour Code are not automatically unjust, allowing some flexibility for employers.
3. Thompson v. Cardel Homes was found to be a constructive dismissal when the employer asked an employee not to return to work before the end of their fixed term contract.
4. Paquette v. Quadraspec Inc. determined that termination pay must include
John, an employee of Talk2Me Inc., began experiencing migraines in 2014 that caused frequent absences and reduced productivity. After various attempts to accommodate John through modified duties and arrangements, it was discovered that John had a brain tumor requiring surgery and lengthy rehabilitation. John was provided disability benefits but was eventually told he may no longer qualify. Talk2Me must now determine how to reasonably accommodate John upon his return to work or termination of benefits, considering its legal obligations and undue hardship factors.
This document discusses enforceable termination provisions in employment agreements. It emphasizes that termination language must comply with employment standards legislation and outlines key cases that highlight the importance of carefully drafting provisions. Specifically, provisions must refer to benefits during notice periods and not potentially provide less than legally required compensation. Overall, the document recommends using employment agreements with saving clauses and reviewing them regularly to balance protecting business interests with employees' legal rights.
Adani Group's Active Interest In Increasing Its Presence in the Cement Manufa...Adani case
Time and again, the business group has taken up new business ventures, each of which has allowed it to expand its horizons further and reach new heights. Even amidst the Adani CBI Investigation, the firm has always focused on improving its cement business.
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The Steadfast and Reliable Bull: Taurus Zodiac Signmy Pandit
Explore the steadfast and reliable nature of the Taurus Zodiac Sign. Discover the personality traits, key dates, and horoscope insights that define the determined and practical Taurus, and learn how their grounded nature makes them the anchor of the zodiac.
AI Transformation Playbook: Thinking AI-First for Your BusinessArijit Dutta
I dive into how businesses can stay competitive by integrating AI into their core processes. From identifying the right approach to building collaborative teams and recognizing common pitfalls, this guide has got you covered. AI transformation is a journey, and this playbook is here to help you navigate it successfully.
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Enhancing Adoption of AI in Agri-food: IntroductionCor Verdouw
Introduction to the Panel on: Pathways and Challenges: AI-Driven Technology in Agri-Food, AI4Food, University of Guelph
“Enhancing Adoption of AI in Agri-food: a Path Forward”, 18 June 2024
Cover Story - China's Investment Leader - Dr. Alyce SUmsthrill
In World Expo 2010 Shanghai – the most visited Expo in the World History
https://www.britannica.com/event/Expo-Shanghai-2010
China’s official organizer of the Expo, CCPIT (China Council for the Promotion of International Trade https://en.ccpit.org/) has chosen Dr. Alyce Su as the Cover Person with Cover Story, in the Expo’s official magazine distributed throughout the Expo, showcasing China’s New Generation of Leaders to the World.
Tired of chasing down expiring contracts and drowning in paperwork? Mastering contract management can significantly enhance your business efficiency and productivity. This guide unveils expert secrets to streamline your contract management process. Learn how to save time, minimize risk, and achieve effortless contract management.
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Kirill Klip GEM Royalty TNR Gold Copper Presentation
Methods of Medical Treatment Claims Issues in Canada US and Europe
1. Methods of Medical
Treatment Claims: Issues
in Canada, US and Europe
Konrad Sechley and Scott Foster
November 27, 2012
2. Presenters
Scott Foster
Associate – Vancouver
604-891-2294
scott.foster@gowlings.com
Konrad Sechley
Principle, Patent Agent – Vancouver
604-443-7610
konrad.sechley@gowlings.com
2
4. Overview
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
4
5. Canada – Patent Eligible Subject Matter
• Section 2 of the Patent Act provides for the definition
of invention as follows:
“any new and useful art, process, machine, manufacture
or composition of matter, or any new and useful
improvement in any art, process, machine, manufacture
or composition of matter”
5
6. Agenda
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
6
7. Canada - Medical Treatment
It is trite law in Canada that methods of medical treatment
do not constitute patent eligible subject matter.
Public policy - to prevent a medical professional from being
barred from practicing a beneficial treatment that may be
based on their skill and judgment
7
8. Canada - Medical Treatment (cont.)
Tennessee Eastman Company et al. v. Commissioner
of Patents, SCC [1974]
• The patent included claims for a method for the surgical
bonding of body tissue using an ester of cyanoacrylic acid
• Section 41 Patent Act applied and restricted patents relating
to substances prepared by chemical processes and
intended for medicine
• The method of surgical treatment was found not to be
patent eligible because such subject matter does not fall
within the definition of "process" or "art”
8
9. Canada - Medical Treatment (cont.)
Imperial Chemical Industries Ltd. v. Canada
(Commissioner of Patents), FCA (1986)
• The invention claimed a method of cleaning dental plaque from teeth
by applying an aqueous composition
• It resulted in a cosmetic benefit and also the treatment of dental
caries
• The application was rejected as being a treatment of the human body
and not patent eligible as a result of Tennessee Eastman
• Held:
• Court confirmed that all methods of medical treatment are not a "process"
under section 2 of the Patent Act
• Although treatment of cavities is cosmetic, it also has a medical function
(treatment of caries)
9
10. Canada - Medical Treatment (cont.)
• Since Tennessee Eastman, the Canadian Patent
Office has rejected claims that are phrased as:
• methods of medical treatment involving therapeutic
treatment, and
• methods of surgical treatment in which the method
step requires actions by a surgeon or other medical
professional.
10
11. Canada - Medical Treatment (cont.)
Re Senentek (1997) 77 C.P.R. (3d) 21
• A method of treating skin cells to reduce the effects of aging
• Patent Appeal Board allowed the claims because aging is a
natural condition of the human body and not a disease
• The method should not be considered a method of medical
treatment since no pathological condition is remedied
Re General Hospital Corp. (1996) 74 C.P.R. (3d) 544
• Claims were directed to a method of preventing pregnancy
• Patent Appeal Board allowed the claims because pregnancy is a
natural condition, not a disease
11
12. Europe – Medical Treatment
European Patent Convention 1973 and 2000:
• Methods of medical treatment are not patent eligible in Europe
• EPC 1973
• Inventions, to be patent eligible, must be ‘susceptible of industrial
application’
• Art 52(4) provided a fiction that medical methods are not
susceptible of industrial application
• EPC2000
• Art 53(c) excludes medical methods per se from patent eligibility
• In both cases, exclusion does not extend to products for use
in such methods
12
13. Europe – Medical Treatment (cont.)
“treatment”
• Claims directed to solely cosmetic effects have been found
allowable.
•T144/83 – DU PONT / Appetite Suppressant
• A treatment causing a cosmetically beneficial loss of weight
of a person not suffering from obesity was not necessarily
beneficial to the health of that person, and consequently was
not considered to be a method for treatment barred from
patentability
•Therapy by “treatment relates to the treatment of a disease
in general or to a curative treatment in the narrow sense…”
13
14. US - Medical Treatment
• Method of treatment claims permitted in the US since 1954
• re Scherer (103 USPQ 107, 1954)
• 35 U.S.C. 271 - Infringement of patent.
• …whoever without authority makes, uses, offers to sell, or sells any patented
invention, within the United States… infringes the patent.
• 35 U.S.C. 281 - Remedy for infringement of patent.
• A patentee shall have remedy by civil action for infringement of his patent.
• 35 U.S.C. 287 (c) Limitation on damages...
• (1) With respect to a medical practitioner's performance of a medical activity
that constitutes an infringement under section 271(a) or (b) of this title, the
provisions of sections 281, 283, 284, and 285 of this title shall not apply against
the medical practitioner or against a related health care entity with respect to
such medical activity.
• (2) For the purposes of this subsection: (A) the term “medical activity” means the
performance of a medical or surgical procedure on a body, but shall not
include (i) the use of a patented machine, manufacture, or composition of matter in
violation of such patent, (ii) the practice of a patented use of a composition of
matter in violation of such patent, or (iii) the practice of a process in violation of a
biotechnology patent.
14
15. Agenda
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
15
16. Canada - Use
• “A method of treating condition Y by administering
compound X” is not patent eligible
• But can get around this issue by drafting use claims:
• “A use of compound X for treating condition Y” (Canadian Style)
• “A use of compound X in the preparation of a medicament for
treating condition Y” (Swiss style)
• “Compound X for use in the treatment of condition Y” (New
European Style)
16
17. Canada - New uses of old compounds
Shell Oil v. Canada (Commissioner of Patents) (1982), 67
C.P.R. (2d) 1 (SCC)
• Not a medical or surgical treatment
• Chemical compounds (new and old) mixed with an adjuvant discovered
to be useful as plant growth regulators
• Held that the invention lay in the application of an old compound to a new
use and patent eligible.
• The Court observed that the distinction between what is patent eligible is
based on whether the subject matter is related to professional skills on
the one hand or trade, industry, or commerce on the other.
17
18. Canada - New uses of old compounds (cont.)
Re Application for Patent of Wayne State University (1988)
22 C.P.R. (3d) 407 (PAB)
• The claims were directed to a new therapeutic method for reducing
metastasis and neoplastic growth in mammals
• The Patent Appeal Board extended the principle introduced by Shell Oil
and held that “use” claims could be a way to work around the prohibition
against methods of medical treatment
• A new medical use for an old compound is patent eligible
• Canadian patent office accepts claims directed to the use of
compositions, apparatuses, etc, in medical treatments provided there is
no active step of treatment directed (“administered” versus
“administration”)
18
19. Amazon case in Canada
• Amazon.com “one-click” decision
• One-year anniversary of the Federal Court of Appeal’s
Amazon.com decision on patentable subject matter
• April 2012 – CIPO published draft guidance on
patentable subject matter (with reference to diagnostic
methods and medical uses)
• November 2012 – The Commissioner recently
suggested that the guidelines will not be published
until 2013
19
20. Amazon case in Canada (cont.)
• Current issues - life sciences & law 2012/2013
• Authors wrote paper on draft guidelines
20
21. Recent decisions in Canada
• Teva v Pfizer (Viagra) SCC decision
• November 8, 2012, decision from Canada’s highest court
• Number of cascading claims
• Claim 1 covered 260 quintillion possible compounds used to treat
erectile dysfunction
• Claim 7 related to sildenafil for use in treating erectile dysfunction
21
22. Recent decisions in Canada (cont.)
• Teva v Pfizer (Viagra)
• According to the judgment, although Pfizer knew that sildenafil
was the effective compound, the specification did not identify
sildenafil as the one compound that was stated as being effective
in treating erectile dysfunction
• Held that this lack of information meant that Pfizer had failed to
disclose the invention sufficiently (section 27(3) Patent Act).
• According to the patent bargain theory, the patent was invalid
• Apotex v Pfizer Ireland Pharmaceuticals 2012 FC 1339:
• Granted summary judgment declaring same patent invalid
22
23. Europe - use claims
EPC1973
• A claim to a product must be novel and inventive to be patent eligible
• Requirements for novelty are set out in Art 54 – must “…not form part of
the state of the art”
• Art 54(5) provides a statutory exception for medicinal products to the
normal novelty rules.
• Even if such a product is itself not new, it is patent eligible for use in any
medical method provided ‘its use for any (medical treatment) method is not
comprised in the state of the art’.
• In G05/83 (EISAI) the Enlarged Board of Appeal of the EPO held that Art
54(5) enables the inventor of a first medical use to obtain purpose-limited
product protection for a known substance or composition
23
24. Europe - use claims (cont.)
EPC1973
• The exception in Art 54(5) did not apply to second and subsequent
medical uses (G05/83 (EISAI))
• In G05/83 (EISAI) for second and subsequent medical uses, the EPO
approved of Swiss form claims
• This claim was referred to as the “Swiss” claim, after the then-practice of
the Swiss Federal Intellectual Property Office
• Also known as a second medical use claim, this claim takes the form:
“compound X for use in the manufacture of a composition
for the treatment of disease Y”
• “compound X for use in the manufacture of a composition…” removes
the claim from the ambit of methods of treatment as it is directed to a
method of manufacture
• “… for the treatment of disease Y” describes the use of the composition
and provides the novelty of the claim
24
25. Europe - use claims (cont.)
EPC2000
• Came into force on December 13, 2007.
• Art 53(c) EPC2000 removes the fiction about industrial applicability. It
simply declares that patents may not be granted for medical methods.
• But even more significantly new Art 54(5) provides for novelty of second
and subsequent medical uses (codification of G05/83)
• A Enlarged Board of Appeal decision (G2/08) determined that Swiss
claims are no longer admissible in Europe under EPC2000.
• Instead, a method of treatment can be protected by a claim of the form
"Substance X for use in the treatment of condition Y by steps Z“.
25
26. US use claims
Use claim format generally not accepted in the US
MPEP 2173.05(q) “Use” Claims
• Attempts to claim a process without setting forth steps involved in the process
raises an issue of indefiniteness under 35 U.S.C. 112, 2nd para.
• “A process for using monoclonal antibodies of claim 4 to isolate and purify
human fibroblast interferon.”
• held to be indefinite as it recites a use without any active, positive steps delimiting
how this use is practiced. (Ex parteErlich, 3 USPQ2d 1011,1986).
• “The use of a high carbon austenitic iron alloy having a proportion of free
carbon as a vehicle brake part subject to stress by sliding friction.”
• improper definition of a process (Ex parteDunki, 153 USPQ 678, 1967)
• “The use of a sustained release therapeutic agent in the body of ephedrine
absorbed upon polystyrene sulfonic acid.”
• the claim was definite, but not a proper process claim under 35 U.S.C. 101:(Clinical
Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475,1966),
26
27. US use claims (cont.)
• MPEP 2173.05(q) “Use” Claims (cont)
A “USE” CLAIM SHOULD BE REJECTED UNDER
ALTERNATIVE GROUNDS BASED ON 35 U.S.C 101
AND 112
In view of the split of authority as discussed above, the
most appropriate course of action would be to reject a
“use” claim under alternative grounds based on 35
U.S.C. 101 and 112.
27
28. Agenda
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
28
29. Canada- diagnostic methods
Diagnosis and evaluation
• Generally speaking, not a method of medical treatment and
therefore patent eligible
In re Application for Patent of Goldenberg (1988), 22 C.P.R.
(3d) 159
• Application claimed a method of locating a tumour through the
administration of radio-labelled antibody substances to the body
• Examiner: claims were directed to a method that modified the metabolism
of the human body and that was equivalent to a method of medical
treatment.
• Commissioner: Rejected Examiner’s position that anything injected into a
human body will change its metabolism and is therefore a treatment of
the human body, whether or not the substance injected has a therapeutic
effect…
• Only methods of medical treatment in the strict sense excluded
29
30. Canada- diagnostic methods (cont.)
In re Application for Patent of Kevin McIntyre (1992), 53
C.P.R. (3d) 532
• Claims to a method of evaluating the mechanical condition of a heart:
•pulse signal, representative of arterial pulsation, was provided non-
invasively to the patient, the patient was then subjected to a heart
straining manoeuvre. The change in the pulse signal after the
manoeuvre relative to the pulse signal prior to the manoeuvre was
recorded
•PAB held that the method claimed has a commercial value as expected for
a diagnostic procedure and the application was allowed
30
31. Europe - diagnostic methods
EPC1973
• Excluded from patentability diagnostic methods practised on the
human or animal body (Art 52(4))
EPC2000
• Excludes from patentability diagnostic methods practised on the
human or animal body (Art 53(c))
31
32. Europe - diagnostic methods (cont.)
Decision G1/04 (Enlarged Board of Appeal)
•Narrowly interpreted exclusion for “diagnostic methods” and held
that a claimed diagnostic method is excluded from patentability only
if it includes all of the following steps:
I. Examination of the patient and collection of data;
II. Comparing the data with standard values;
III. Noting deviations from the standard values; and
IV. Making the diagnosis (i.e. the mental step that involves attributing
any deviation from standard values to a particular clinical
manifestation, enabling the choice of therapy to be determined),
•If any of the steps I-IV are absent from the claim, method is not
excluded from patent eligibility
•Thus, methods which lead to intermediate results but fall short of
providing a complete diagnosis are allowable such as:
“A method for obtaining blood pressure measurements (or other physical
quantities)…”
32
33. US - Diagnostic Methods
Recent challenges to method claims in the US:
Classen v Biogen (2006-1634, Aug 31, 2011; on remand from USSC)
• 3 patents: 6,638,739; 6,420,139; and 5,723,283;
Claim 1 from ‘739:
1. A method of immunizing a mammalian subject which comprises:
I. screening a plurality of immunization schedules . . . by
a. identifying [first and second patient populations that were
immunized with] . . . “infectious disease-causing organism associated
immunogens according to” . . . [first and second immunization schedules] and
b. comparing the effectiveness of said first and second screened
immunization schedules in protecting against or inducing a chronic
immune-mediated disorder …
II. immunizing said subject according to a subject immunization schedule . . . [with] . .
. lower risk . . .
• Claim 1 from ‘739 (and ‘139) included a final step of
immunizing
33
34. US - Diagnostic Methods: Classen (cont)
• Court concluded that the ‘739, ‘139 and ‘238 claims are
directed to “tangible specific application”
• The ‘739 (and ‘139) claim “includes the subsequent step of
immunization on an optimum schedule,”
• claims directed to a specific application and practical use of
the obtained knowledge;
• provided a step involving extra-solution activity; sufficient to
satisfy § 101.
• However - "methods that simply collect and compare data,
without applying the data in a step of the overall method,
may fail the § 101 filter”
• this was the problem with claim 1 from ‘238 which was
characterized as directed to “data gathering or insignificant
extra-solution activity”
34
35. US - Diagnostic Methods: Classen (cont)
• Claim 1 from ‘283:
• 1. A method of determining whether an immunization schedule affects the
incidence or severity of a chronic immune-mediated disorder in a treatment group
of mammals, relative to a control group of mammals, which comprises
immunizing mammals in the treatment group of mammals with one or more
doses of one or more immunogens, according to said immunization schedule, and
comparing the incidence, prevalence, frequency or severity of said chronic
immune-mediated disorder or the level of a marker of such a disorder, in the
treatment group, with that in the control group.
• characterized as “a method ‘determining whether an
immunization schedule affects the incidence or severity
of a chronic immune-mediated disorder’ by reviewing
information on whether an immunization schedule affects
the incidence or severity of a chronic immune mediated
disorder… but does not require using this information for
immunization purposes”
35
36. US - Diagnostic Methods: Mayo
Mayo V Prometheus (USSC, No 10-1150, March 20, 2012):
• 1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated
gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject…; and
(b) determining the level of 6-thioguanine in said subject…,
wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells
indicates a need to increase the amount of said drug subsequently administered to said
subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood
cells indicates a need to decrease the amount of said drug subsequently administered to
said subject.
• claim defined a natural relationship between metabolite concentration
in the blood and the probability that the metabolite will either be
therapeutically effective or harmful to the patient
• a claim must define more than a law of nature, must describe “an
application of a law of nature or mathematical formula to a known
structure of process” (citing Diehr 450 U. S. 175, 185 ,1981)
36
37. US - Diagnostic Methods: Perkinelmer
Perkinelmer v Intema (Appeal No 2011-1577, USFC Nov. 20, 1012):
• Diagnosing Down’s syndrome using known biomarkers
A method of determining whether a pregnant woman is at an increased risk of having a fetus with
Down’s syndrome, the method comprising the steps of:
measuring the level of at least one screening marker from a first trimester of pregnancy by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . .;
measuring the level of at least one second screening marker from a second trimester of pregnancy,
the at least one second screening marker from the second trimester of pregnancy being different from
the at least one first screening marker from the first trimester of pregnancy, by:
(i) assaying a sample . . .; and/or
(ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . .; and
determining the risk of Down’s syndrome by comparing the measured levels of both the at least one first
screening marker from the first trimester of pregnancy and the at least one second screening marker
from the second trimester of pregnancy with observed relative frequency distributions of marker levels
in Down’s syndrome pregnancies and in unaffected pregnancies.
• “Because the asserted claims recite an ineligible mental step and natural
law, and no aspect of the method converts these ineligible concepts into
patentable applications of those concepts, the claims cannot stand.”
37
38. US - Diagnostic Methods: Myriad
AMP v Myriad: (USCAFC, No 2010-1406, Aug 16, 2012 – under appeal)
• 15 claims from 7 patients challenged
Claim1 from 5,747,282:
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having
the amino acid sequence set forth in SEQ ID NO:2.
• “Mayo does not control the question of patent-eligibility of
such claims. They are claims to compositions of matter,
expressly authorized as suitable patent-eligible subject
matter in § 101…The isolated DNA molecules before us
are not found in nature. They are obtained in the laboratory
and man-made, the product of human ingenuity”
• Isolated DNA patentable – the act of cleaving covalent
bonds during isolation alters the chemical identity of DNA
38
39. US - Diagnostic Methods: Myriad (cont)
Claim 1 from 5,709,999 (emphasis noted in decision):
1. A method for detecting a germline alteration in a BRCA1 gene, said
alteration selected from the group consisting of the alterations set forth in
Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence
of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a
sequence of BRCA1 cDNA made from mRNA from said human sample with
the proviso that said germline alteration is not a deletion of 4 nucleotides
corresponding to base numbers 4184-4187 of SEQ ID NO:1.
• Methods claims compare patients sequence with isolated
sequence - law of nature/mental process, not patentable
• Claims do not apply the step of comparing two nucleotide
sequences in a process – “the step of comparing two
DNA sequences is the entire process that is claimed.”
39
40. US - Diagnostic Methods: Myriad (cont)
Claim 20 from 5,747,282 (emphasis noted in decision):
20. A method for screening potential cancer therapeutics which comprises:
growing a transformed eukaryotic host cell containing an altered BRCA1
gene causing cancer in the presence of a compound suspected of being a
cancer therapeutic, growing said transformed eukaryotic host cell in the
absence of said compound, determining the rate of growth of said host cell
in the presence of said compound and the rate of growth of said host cell in
the absence of said compound and comparing the growth rate of said host
cells, wherein a slower rate of growth of said host cell in the presence of
said compound is indicative of a cancer therapeutic.
• method for screening potential cancer therapeutics by
changes in cell growth rates of transformed cells are
patent-eligible: “a transformed cell, …is made by man, in
contrast to a natural material.”
40
41. Agenda
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
41
42. Canada - Dosage Regimes
• Dosing Regimes
• Generally speaking, medical use claims which include specific dosage
regimes are directed to methods of medical treatment and therefore
unpatentable.
• In Axcan Pharma Inc. v. Pharmascience Inc. (2006) FC 527, 50
C.P.R. (4th) 321
• Patent claimed a pharmaceutical composition for treatment of biliary
cirrhosis (PBC) that specified a particular dose (13-15mg/kg/day)
• The court compared a dosage unit and a dosage range and held that the
latter would be determined by a physician based on factors such as a
patient's weight
• The dosage range required a physician’s skill and judgment to select the
appropriate value based on information from the patient
• As the claim was directed to a dosage range, and as a dosage range is
not a vendible product, the patent was held to be invalid
42
43. Canada - Dosage Regimes (cont.)
Janssen Inc. v. Mylan Pharmaceuticals ULC, (2010) FC 1123
• The patent claimed an escalating dosage titration schedule for galantamine
in the treatment of Alzheimer’s disease.
• It was held that the claims at issue contained a dosage range that required
a physician’s skill and judgment to select the appropriate value based on
information from the patient – in this case the patient’s response to
treatment
• Held to be in the physicians area of expertise and therefore directed to
methods of medical treatment
43
44. Canada - Dosage Regimes (cont.)
In Re Allergan, Inc. Patent Application No. 2,300,723 (2009) 79
C.P.R. (4th) 161 PAB
• The PAB ruled that a claim reciting a dosage range of 50 to 300 units of
botulinum toxin for treating pain was a method of medical treatment
44
45. Canada - Dosage Units
Dosage Units
• If a claim specifies a dosage form the claim may not be a method of
medical treatment
• Should be directed to a vendible product having real economic value
Merck & Co. v. Pharmascience 2010 FC 510
• A claim to a 1 mg tablet taken as a daily dose was held to be patent
eligible subject matter on the basis that it is a “vendible product” and no skill
or judgment of a physician is required.
Merck & Co. Inc. v. Apotex, 2005 FC 755
• A claim directed to 70 mg of a particular drug on a once-weekly dosing
interval was also held to be patent eligible subject matter.
Based on these court decisions, a fixed amount of a drug administered on a
fixed schedule may not be considered a method of medical treatment and
therefore might constitute patentable subject matter
45
46. Europe - Dosage Regimes
• Enlarged Board of Appeal decision G2/08
• The claim at issue was directed to the use of a sustained-release
nicotinic acid in the treatment of abnormal levels of lipids in the blood
where the novel feature was providing the drug "once per day prior to
sleep"
• EBA held that a novel and inventive dosage regime is patent eligible,
even where that dosage regime is the only novel feature of a known drug
to treat a known illness
• Novelty can reside not only in a new dosage regime, but also in features
such as the class of patients to be treated or the method of administration
for a known disease
46
47. USA- Dosage Regimes
• Method claims reciting dosage regimes permitted if they
apply the outcome from a step of comparing, or a
determining step and describe:
• “an application of a law of nature or mathematical formula to a
known structure of process”
(Mayo v Prometheus; USSC, No 10-1150, March 20, 2012)
• a “tangible specific application”
(Classen v Biogen 2006-1634, Aug 31, 2011)
• and/or provides more than:
• “data gathering or insignificant extra-solution activity”
(Classen v Biogen 2006-1634, Aug 31, 2011)
47
48. Closing remarks
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
48
49. Thank You
Konrad Sechley Scott Foster
Tel: 604-443-7610 Tel: 604-891-2294
Email: konrad.sechley@gowlings.com Email: scott.foster@gowlings.com
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