The document summarizes a presentation on patent and trade secret protection strategies for nanotechnology given at the 2007 NAPP Annual Meeting. It discusses the basic requirements and advantages/disadvantages of patents and trade secrets. It also outlines regulatory considerations from agencies like the EPA, FDA, and those governing exports. The presentation provides an overview of strategic issues around intellectual property exploitation, protection of confidential information, licensing, and the nanotechnology patent landscape.
This document discusses the importance of considering people in business continuity planning. It notes that people may react differently during real emergencies compared to practice drills. Effective planning needs to account for staff's personal and family needs, security concerns, transportation to alternate worksites, payroll needs, and emotional well-being after crises. The key message is that business continuity depends upon addressing people's needs, not just technology issues.
The document lists the top patentees for 2008, with David Hall ranked first having been granted 52 patents from Novatek International. Ronald Crockett is ranked second with 21 patents from Novatek International, and Jeff Jepson is ranked third with 19 patents also from Novatek International. The document provides lists of patents for each top patentee.
Speaker: Peter Pekos, Dalton Pharma Services. Part of the MaRS Best Practices Series.This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies
More information: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/ind-05132008.html
Michael Swit -- Perspectives on the Future of Generic BiologicsMichael Swit
Presentation reviews legal, regulatory and marketplace challenges to implementing an abbreviated pathway for "generic biologics" in the United States.
Unifuse is a manufacturer of molded plastic products using a patented vibrational molding process. They produce durable containers and equipment for material handling, food service, healthcare, and custom applications. Unifuse touts the benefits of their process which includes low tooling costs, ability to modify designs easily, and production of large, complex parts. Their products are used across multiple industries for applications like transporting goods, storing food and medical waste, and protecting valuable components.
The course covers the following topics:
* General Intro to IP Rights
* Patenting Timeline and Costs
* The Patent Description
* Approaches to Claim Drafting
Part of the MaRS Best Practices Event Series. For more information, please visit: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/patents-05072009.html
The document discusses entrepreneurship and the challenges of developing new technologies, referring to the example of Rimon Therapeutics. It describes Rimon's focus on developing novel polymer-based medical devices called "Theramers" for applications like wound healing. The document outlines Rimon's business strategy, pipeline of Theramer products in development, clinical trial results, and upcoming milestones.
The document provides an overview of Good Manufacturing Practices (GMPs) for a company venturing into FDA-regulated materials. It discusses key GMP regulations from the FDA code including requirements for organization and personnel, facilities, equipment, components, production controls, packaging, holding and distribution, labs, records and reports. The goal of GMPs is to ensure quality, safety, purity and efficacy of pharmaceutical products through strict procedures and adequate training.
This document discusses the importance of considering people in business continuity planning. It notes that people may react differently during real emergencies compared to practice drills. Effective planning needs to account for staff's personal and family needs, security concerns, transportation to alternate worksites, payroll needs, and emotional well-being after crises. The key message is that business continuity depends upon addressing people's needs, not just technology issues.
The document lists the top patentees for 2008, with David Hall ranked first having been granted 52 patents from Novatek International. Ronald Crockett is ranked second with 21 patents from Novatek International, and Jeff Jepson is ranked third with 19 patents also from Novatek International. The document provides lists of patents for each top patentee.
Speaker: Peter Pekos, Dalton Pharma Services. Part of the MaRS Best Practices Series.This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies
More information: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/ind-05132008.html
Michael Swit -- Perspectives on the Future of Generic BiologicsMichael Swit
Presentation reviews legal, regulatory and marketplace challenges to implementing an abbreviated pathway for "generic biologics" in the United States.
Unifuse is a manufacturer of molded plastic products using a patented vibrational molding process. They produce durable containers and equipment for material handling, food service, healthcare, and custom applications. Unifuse touts the benefits of their process which includes low tooling costs, ability to modify designs easily, and production of large, complex parts. Their products are used across multiple industries for applications like transporting goods, storing food and medical waste, and protecting valuable components.
The course covers the following topics:
* General Intro to IP Rights
* Patenting Timeline and Costs
* The Patent Description
* Approaches to Claim Drafting
Part of the MaRS Best Practices Event Series. For more information, please visit: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/patents-05072009.html
The document discusses entrepreneurship and the challenges of developing new technologies, referring to the example of Rimon Therapeutics. It describes Rimon's focus on developing novel polymer-based medical devices called "Theramers" for applications like wound healing. The document outlines Rimon's business strategy, pipeline of Theramer products in development, clinical trial results, and upcoming milestones.
The document provides an overview of Good Manufacturing Practices (GMPs) for a company venturing into FDA-regulated materials. It discusses key GMP regulations from the FDA code including requirements for organization and personnel, facilities, equipment, components, production controls, packaging, holding and distribution, labs, records and reports. The goal of GMPs is to ensure quality, safety, purity and efficacy of pharmaceutical products through strict procedures and adequate training.
Elevated Skin Temperature Screening - How to Get Back to Work Safely with FLIRTranscat
-A History of EST (Elevated Skin Temperature) Solutions
-How to get the best measurements
-Best correlation to core body temperature
-Variance with core body temperatures
-FLIR's EST screening mode
-FLIR's EST screening solutions
An international panel comprised of members of AQSIQ (China), INMETRO (Brazil), Health Canada and CPSC (U.S.) used this presentation to discuss the regulatory structure and suggestions for businesses.
The document discusses intellectual property rights (IPR) and access to medicines in Thailand. It describes Thailand's patent laws and three cases where consumer movements fought for more affordable access to drugs. The cases involved revoking a patent for the drug ddI, opposing a patent application for the drug combination AZT+3TC, and issuing compulsory licenses for the drugs efavirenz, lopinavir/ritonavir, and clopidogrel. The document argues that compulsory licenses do not significantly impact patent holders' existing commercial markets and examines the price reductions that resulted from license issuances and negotiations.
This report provides an analysis of the product pipeline of AnaZyme, LLC, a diagnostic assay company focused on developing assays to detect biomarkers for the onset and progression of shock. The report details AnaZyme's three main pipeline products: a breath-based assay to detect volatile compounds for shock; a blood-based assay to detect specific enzymes; and a blood-based assay to detect the absence of specific compounds. All assays can be run on commercially available laboratory instruments. The report provides profiles of each pipeline product along with their status, descriptions, applications, and patent details. It aims to help readers understand AnaZyme's portfolio and competitive landscape to support business and market strategies.
Overview of CPSC, Health Canada, and Profeco cooperation, legislation, joint recalls, and including a case study of stroller regulatory requirements in all 3 jurisdictions.
Slide Show Export Compliance - Propertyguest66dc5f
This document provides an overview of export compliance requirements for US companies. It discusses the roles of the Departments of State and Commerce in regulating exports, defines key terms like defense articles and foreign persons, and outlines responsibilities for technical staff, licensing administrators, and empowered officials. It also covers processes for classifying, labeling and shipping exports according to ITAR or Commerce controls. The presentation warns that penalties for noncompliance can include heavy fines, loss of security clearances, and imprisonment, as recent cases involving large defense contractors demonstrate. Overall, the document stresses the legal necessity of following all US export laws and an organization's own compliance policies.
This presentation is an introduction to computer vision and our product Intra, which makes it easy to implement this for your business. Our company website provides more information https://centillien.com
BioEntrepreneurship: Intellectual Property: What Do Investors Look For?MaRS Discovery District
Strong patent protection is essential for a start-up biotechnology company and can be a valuable company asset. However, it is also expensive, with costs ranging from tens to hundreds of thousands of dollars over time. This session will focus on how to get the most out of your patent dollars.
This session presentation is available in audio format here: http://www.marsdd.com/bioent/dec4
Economic Aspects & Enforcement of IP_Dr Mandar Kodgule_19th Dec 2013_WKMandar Kodgule
This document contains an agenda and presentation slides about economic aspects and enforcement of intellectual property in the pharmaceutical industry. The presentation covers topics such as innovation trends in pharma, the role of acquisitions on IP, changing business models, IP licensing trends, and legal challenges in IP enforcement in both the US and EU. It also discusses litigation facts regarding patent lawsuits in the US pharmaceutical industry and provides an overview of the Indian scenario regarding patents.
Demo Day presentation at theClubhou.se in Augusta, GA for Startup Day Across America with presentations from seven Augusta Startup Companies created at theClubhou.se and Georgia Regents University, including Blackbox.email, Camellix, Sumo Bot League, E3 Embedded Systems, Dylanpickups, txtcam, Humble Finance, and Sand Hill Endeavors. Attendees included Congressman John Barrow and multiple Venture Capital investors.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
FDA Trends in Medical Device ComplianceMichael Swit
Presentation to the Joint American Bar Association (ABA)/Medical Device Manufacturers Association (MDMA) Conference, on December 11, 2014, in Washington, D.C.. Slides focus on:
• Major Initiatives –
– Inspection Realignment
– Reporting of Corrections Guidance
• FDA Inspections –Key Observations in Device Inspections
• Marketing & Social Media –
– Intended Use Creep --Aegerion
– Space Limitation Guidance
• HHS Exclusion for FDA Violations –the Curious Case of the Purdue Pharma Executives
Patent infringement searches are conducted to ensure no other individual or organization is using, making, or selling a patented invention without authorization. The search process involves breaking down the technical features of the patent claim and any potentially infringing products, then comparing them to determine if there is infringement. If infringement is found, the patent owner can take legal action or pursue licensing opportunities.
The document provides an overview of the U.S. Consumer Product Safety Commission (CPSC). It discusses that the CPSC is an independent federal agency established in 1973 that is responsible for protecting the public from unreasonable risks of injury from consumer products. The CPSC works to reduce an estimated 34,500 deaths and 36 million injuries annually associated with consumer products through regulation and enforcement, recalls, education, and monitoring of voluntary standards. It summarizes the CPSC's laws, regulations, testing and certification requirements, market surveillance, data collection and analysis, and international cooperation to promote product safety.
AFPT Opportunities of Entrepreneurship in Food ProcessingSuyog Khose
This document discusses opportunities for entrepreneurship in the food processing sector in India. It notes that India has a large and diverse production base for foods like fruits, vegetables, milk, eggs, meat, fish and grains. The food processing sector currently makes up only about 2% of total production. The document outlines several sub-sectors within food processing that show potential for growth, such as processed, frozen and organic foods. It also highlights India's policy support for food entrepreneurs through programs like mega food parks, cold chain infrastructure development, and fiscal incentives like tax deductions and import duty reductions. Overall, the food retail industry is poised for significant expansion in India, creating opportunities for entrepreneurs across the food supply chain.
This document discusses the risks of seafood-borne illnesses from biogenic amines like histamine and proposes Senz-It's solution of real-time quantitative detection of these amines in seafood products. It notes that only 2% of seafood is tested by US authorities and outlines the health effects of histamine poisoning. Senz-It pitches its in-house product for simple, disposable testing and becoming a priority council member for input into product design and custom opportunities.
The document discusses 3D printing terminology and processes. It begins by explaining that 3D printing, additive manufacturing, direct digital manufacturing, and rapid prototyping are interchangeable terms. It then describes the six main industrial 3D printing processes according to the International ASTM standards organization. The document goes on to discuss how 3D printing is different from traditional manufacturing in that it democratizes the process and moves it away from centralized control. It concludes by examining potential reactions from industries at risk from 3D printing disruption and considerations for intellectual property strategies related to 3D printing.
The document is a user manual for ThermTec's Hunt Series thermal clip-on device. It provides instructions on safely using the device, including not pointing it at intense heat sources. It also details features like the 12μm thermal imaging detector, 1024x768 resolution OLED display, and IP67 protection rating. The manual covers device components, menu operation, recording and sharing capabilities, and maintenance guidelines.
An Eye On Google, Executive Summary PresentationKetzirah Lesser
Executive summary presentation I developed for the RTCRM whitepaper of the same name written by Sara Weiner, Croom Lawrence, and Carlen Lea Lesser that provides guidance for digital marketing after the 14 simultaneous warning letters the FDA issued in April 2009 to pharmaceutical companies in regards to their Google Ads. The impact of these warning letters goes far beyond PPC ads, and ideas on how to deal with this new regulation are outlined in the presentation and more deeply in the whitepaper (http://www.rtcrm.com/whitepapers).
A patented, active, consumer operable display shipper which will create substantial savings for your brand versus current 3 tiered Halloween candy packaging while making the package fun and usable for Mom and kids.
NC State Bbs 201 Intro To Biopharmaceutical Science April 3 2009stantolin
This document provides an overview of intellectual property presented by Stan Antolin of Smith Moore Leatherwood LLP. It discusses osteoarthritis and the protein aggrecanase, which is implicated in cartilage degradation. The document outlines strategies for stabilizing and producing aggrecanase to develop treatments for osteoarthritis. It also summarizes various forms of intellectual property including patents, trademarks, copyrights, and trade secrets that can protect ideas.
2009 AIChE Its A Flat World IP Assets In The Digital Agestantolin
The document discusses how intellectual property assets must be managed differently in the digital age. It notes the rise of cloud computing, software as a service, and how these trends impact intellectual property protection. The document suggests alternative means for protecting intellectual property when patents may not be applicable, such as trade secrets, copyrights, trademarks, contracts, and trade dress. It emphasizes that businesses must adapt to changing technologies and business models to safeguard their intellectual property assets in this new environment.
Elevated Skin Temperature Screening - How to Get Back to Work Safely with FLIRTranscat
-A History of EST (Elevated Skin Temperature) Solutions
-How to get the best measurements
-Best correlation to core body temperature
-Variance with core body temperatures
-FLIR's EST screening mode
-FLIR's EST screening solutions
An international panel comprised of members of AQSIQ (China), INMETRO (Brazil), Health Canada and CPSC (U.S.) used this presentation to discuss the regulatory structure and suggestions for businesses.
The document discusses intellectual property rights (IPR) and access to medicines in Thailand. It describes Thailand's patent laws and three cases where consumer movements fought for more affordable access to drugs. The cases involved revoking a patent for the drug ddI, opposing a patent application for the drug combination AZT+3TC, and issuing compulsory licenses for the drugs efavirenz, lopinavir/ritonavir, and clopidogrel. The document argues that compulsory licenses do not significantly impact patent holders' existing commercial markets and examines the price reductions that resulted from license issuances and negotiations.
This report provides an analysis of the product pipeline of AnaZyme, LLC, a diagnostic assay company focused on developing assays to detect biomarkers for the onset and progression of shock. The report details AnaZyme's three main pipeline products: a breath-based assay to detect volatile compounds for shock; a blood-based assay to detect specific enzymes; and a blood-based assay to detect the absence of specific compounds. All assays can be run on commercially available laboratory instruments. The report provides profiles of each pipeline product along with their status, descriptions, applications, and patent details. It aims to help readers understand AnaZyme's portfolio and competitive landscape to support business and market strategies.
Overview of CPSC, Health Canada, and Profeco cooperation, legislation, joint recalls, and including a case study of stroller regulatory requirements in all 3 jurisdictions.
Slide Show Export Compliance - Propertyguest66dc5f
This document provides an overview of export compliance requirements for US companies. It discusses the roles of the Departments of State and Commerce in regulating exports, defines key terms like defense articles and foreign persons, and outlines responsibilities for technical staff, licensing administrators, and empowered officials. It also covers processes for classifying, labeling and shipping exports according to ITAR or Commerce controls. The presentation warns that penalties for noncompliance can include heavy fines, loss of security clearances, and imprisonment, as recent cases involving large defense contractors demonstrate. Overall, the document stresses the legal necessity of following all US export laws and an organization's own compliance policies.
This presentation is an introduction to computer vision and our product Intra, which makes it easy to implement this for your business. Our company website provides more information https://centillien.com
BioEntrepreneurship: Intellectual Property: What Do Investors Look For?MaRS Discovery District
Strong patent protection is essential for a start-up biotechnology company and can be a valuable company asset. However, it is also expensive, with costs ranging from tens to hundreds of thousands of dollars over time. This session will focus on how to get the most out of your patent dollars.
This session presentation is available in audio format here: http://www.marsdd.com/bioent/dec4
Economic Aspects & Enforcement of IP_Dr Mandar Kodgule_19th Dec 2013_WKMandar Kodgule
This document contains an agenda and presentation slides about economic aspects and enforcement of intellectual property in the pharmaceutical industry. The presentation covers topics such as innovation trends in pharma, the role of acquisitions on IP, changing business models, IP licensing trends, and legal challenges in IP enforcement in both the US and EU. It also discusses litigation facts regarding patent lawsuits in the US pharmaceutical industry and provides an overview of the Indian scenario regarding patents.
Demo Day presentation at theClubhou.se in Augusta, GA for Startup Day Across America with presentations from seven Augusta Startup Companies created at theClubhou.se and Georgia Regents University, including Blackbox.email, Camellix, Sumo Bot League, E3 Embedded Systems, Dylanpickups, txtcam, Humble Finance, and Sand Hill Endeavors. Attendees included Congressman John Barrow and multiple Venture Capital investors.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
FDA Trends in Medical Device ComplianceMichael Swit
Presentation to the Joint American Bar Association (ABA)/Medical Device Manufacturers Association (MDMA) Conference, on December 11, 2014, in Washington, D.C.. Slides focus on:
• Major Initiatives –
– Inspection Realignment
– Reporting of Corrections Guidance
• FDA Inspections –Key Observations in Device Inspections
• Marketing & Social Media –
– Intended Use Creep --Aegerion
– Space Limitation Guidance
• HHS Exclusion for FDA Violations –the Curious Case of the Purdue Pharma Executives
Patent infringement searches are conducted to ensure no other individual or organization is using, making, or selling a patented invention without authorization. The search process involves breaking down the technical features of the patent claim and any potentially infringing products, then comparing them to determine if there is infringement. If infringement is found, the patent owner can take legal action or pursue licensing opportunities.
The document provides an overview of the U.S. Consumer Product Safety Commission (CPSC). It discusses that the CPSC is an independent federal agency established in 1973 that is responsible for protecting the public from unreasonable risks of injury from consumer products. The CPSC works to reduce an estimated 34,500 deaths and 36 million injuries annually associated with consumer products through regulation and enforcement, recalls, education, and monitoring of voluntary standards. It summarizes the CPSC's laws, regulations, testing and certification requirements, market surveillance, data collection and analysis, and international cooperation to promote product safety.
AFPT Opportunities of Entrepreneurship in Food ProcessingSuyog Khose
This document discusses opportunities for entrepreneurship in the food processing sector in India. It notes that India has a large and diverse production base for foods like fruits, vegetables, milk, eggs, meat, fish and grains. The food processing sector currently makes up only about 2% of total production. The document outlines several sub-sectors within food processing that show potential for growth, such as processed, frozen and organic foods. It also highlights India's policy support for food entrepreneurs through programs like mega food parks, cold chain infrastructure development, and fiscal incentives like tax deductions and import duty reductions. Overall, the food retail industry is poised for significant expansion in India, creating opportunities for entrepreneurs across the food supply chain.
This document discusses the risks of seafood-borne illnesses from biogenic amines like histamine and proposes Senz-It's solution of real-time quantitative detection of these amines in seafood products. It notes that only 2% of seafood is tested by US authorities and outlines the health effects of histamine poisoning. Senz-It pitches its in-house product for simple, disposable testing and becoming a priority council member for input into product design and custom opportunities.
The document discusses 3D printing terminology and processes. It begins by explaining that 3D printing, additive manufacturing, direct digital manufacturing, and rapid prototyping are interchangeable terms. It then describes the six main industrial 3D printing processes according to the International ASTM standards organization. The document goes on to discuss how 3D printing is different from traditional manufacturing in that it democratizes the process and moves it away from centralized control. It concludes by examining potential reactions from industries at risk from 3D printing disruption and considerations for intellectual property strategies related to 3D printing.
The document is a user manual for ThermTec's Hunt Series thermal clip-on device. It provides instructions on safely using the device, including not pointing it at intense heat sources. It also details features like the 12μm thermal imaging detector, 1024x768 resolution OLED display, and IP67 protection rating. The manual covers device components, menu operation, recording and sharing capabilities, and maintenance guidelines.
An Eye On Google, Executive Summary PresentationKetzirah Lesser
Executive summary presentation I developed for the RTCRM whitepaper of the same name written by Sara Weiner, Croom Lawrence, and Carlen Lea Lesser that provides guidance for digital marketing after the 14 simultaneous warning letters the FDA issued in April 2009 to pharmaceutical companies in regards to their Google Ads. The impact of these warning letters goes far beyond PPC ads, and ideas on how to deal with this new regulation are outlined in the presentation and more deeply in the whitepaper (http://www.rtcrm.com/whitepapers).
A patented, active, consumer operable display shipper which will create substantial savings for your brand versus current 3 tiered Halloween candy packaging while making the package fun and usable for Mom and kids.
NC State Bbs 201 Intro To Biopharmaceutical Science April 3 2009stantolin
This document provides an overview of intellectual property presented by Stan Antolin of Smith Moore Leatherwood LLP. It discusses osteoarthritis and the protein aggrecanase, which is implicated in cartilage degradation. The document outlines strategies for stabilizing and producing aggrecanase to develop treatments for osteoarthritis. It also summarizes various forms of intellectual property including patents, trademarks, copyrights, and trade secrets that can protect ideas.
2009 AIChE Its A Flat World IP Assets In The Digital Agestantolin
The document discusses how intellectual property assets must be managed differently in the digital age. It notes the rise of cloud computing, software as a service, and how these trends impact intellectual property protection. The document suggests alternative means for protecting intellectual property when patents may not be applicable, such as trade secrets, copyrights, trademarks, contracts, and trade dress. It emphasizes that businesses must adapt to changing technologies and business models to safeguard their intellectual property assets in this new environment.
This document provides an overview of inventorship issues in U.S. patent law. It discusses that the applicant for a patent must be the inventor, and that U.S. law requires having the correct inventors listed. It covers topics like conception, joint inventorship, derivation, identifying inventors, correcting inventorship, and standing. The document is intended to help practitioners properly determine inventorship when prosecuting patent applications.
The document discusses types of examiner interviews in patent prosecution, including planned and unexpected interviews. It provides tips for determining whether an interview should be in-person or telephonic, preparing for interviews, conducting interviews, and following up after interviews. The goal of interviews is to advance prosecution by clarifying issues, defining allowable subject matter, agreeing on claim language, or developing a work plan to resolve outstanding issues. Interviews require preparation, courtesy, and building a constructive relationship with the examiner.
The document summarizes changes to the Patent Cooperation Treaty (PCT) rules and procedures presented at a 2006 conference for intellectual property paralegals. Key points include: the 2004 introduction of a new PCT search and examination system; 2006 rule changes regarding electronic publication and designation exclusions; and 2007 rule changes incorporating priority restoration and obvious mistake corrections in line with the Patent Law Treaty. The document also provides statistics on PCT filings, applicants, International Searching Authorities, and timeliness.
This document summarizes a presentation on navigating regulatory and development pathways for Abbreviated New Drug Applications (ANDAs) and 505(b)(2) New Drug Applications (NDAs) given by patent attorneys Stan Antolin and Walter Boyd. The presentation covers patents, patent infringement, the Hatch-Waxman Act, ANDAs, 505(b)(2) NDAs, and strategies for avoiding patent infringement. It also includes diagrams of typical patent and drug development cycles.
2. • A patent is a legally-recognized temporary
monopoly which the government grants in
exchange for complete disclosure by the inventor
of how to make and use the invention.
www.smithmoorelaw.com
3. Basic requirements for patentability:
• Statutory subject matter
• Useful
• New (novel)
• Non-Obvious
www.smithmoorelaw.com
4. • A trade secret is something which confers a
business advantage, is not generally known, and
that the owner takes steps to maintain as a secret.
www.smithmoorelaw.com
5. Basic requirements for trade secret
protection (under UTSA)
• Information must not be generally known or readily
ascertainable by proper means
• Must have “independent economic value” due to
its secrecy
• Trade secret holder must use “reasonable
measures under the circumstances” to protect the
secrecy of the information
www.smithmoorelaw.com
7. Advantages of Patents:
• Patents deter competitors who might be tempted to copy
• Potential revenue stream from licensing
• Patenting avoids the need to maintain complete security for
inventions
• Potential large damage awards for infringement
• Provide an asset to attract investment and measure value
of company
• May be used to exclude imports
• Injunction—to keep competitors out of a particular market or
technology
www.smithmoorelaw.com
8. Disadvantages of Patents
• Nanotechnology is a new technology
• Expensive
• All information in a patent application becomes public
knowledge once the patent application is published (as
early as 18 months)
• Limited duration
• Not self-enforcing
• Limited coverage (technical information)
• No right to exclude for at least two (and possibly more)
years
• Only grants the right to exclude others
www.smithmoorelaw.com
9. Advantages of Trade Secrets
• Usually cheaper (no initial cost)
• Potentially unlimited duration provided secrecy is
maintained
• Information is not revealed to the public
• Broader coverage (non-technical information)
• Effective immediately
www.smithmoorelaw.com
10. Disadvantages of Trade Secrets
• Generally considered less valuable than patents—difficult to
value/license
• Potentially expensive to maintain—requires constant vigilance
• Protection is easily lost
• Competitors may develop information independently
• No exclusionary rights
• Difficult to discover loss
• Difficult to recover damages for misappropriation
• Based on state law
• May be blocked by patents from practicing your own trade secret
www.smithmoorelaw.com
11. Patent protection usually better choice
when:
• The technology of the invention is new
• The invention can be reverse-engineered easily
• The invention is likely to be developed by another
• There is a need to disseminate information about
the invention
• Potential to get broad claims and “pioneer” status
in a new technology
www.smithmoorelaw.com
12. Trade secret protection usually better
choice when:
• Invention has a short “shelf-life”
• The invention can easily be kept secret and
cannot be easily reverse-engineered
• Scope of claims would be unduly narrow
www.smithmoorelaw.com
13. Trade secret protection is the only
option when:
• The invention is not patentable
• The inventor does not have the money to seek
patent protection
www.smithmoorelaw.com
14. The Five Biggest Mistakes:
• Ignorance of statutory bars
• Withholding information from the patent/USPTO
• Cutting corners/doing things cheaply
• Emphasizing quantity over quality
• Failing to get assignments/agreements
www.smithmoorelaw.com
15. Whether patent or trade secret—
• Make privacy your TOP priority
• Monitor your competitors’ patents
• Make sensible decisions with respect to
intellectual property
www.smithmoorelaw.com
19. Regulatory Arena
• Environment => EPA (Environmental Protection Agency)
• Health => NIOSH (National Institute for Occupational Safety and Health)
• Safe Workplace => OSHA (Occupational Safety and Health Administration)
• Foods and Drugs => FDA (Food and Drug Administration)
• Consumer Product => CPSC (Consumer Product Safety Commission)
• Export => DOS, DOC, DHS, . . . Etc.
(State, Commerce, Homeland Security, . . . Etc. )
www.smithmoorelaw.com
20. Environment => EPA
Source: U.S. Environmental Protection Agency
Nanotechnology White Paper
www.smithmoorelaw.com
21. Health => NIOSH
Source: Progress Toward Safe Nanotechnology
in the Workplace, A Report from the NIOSH
Nanotechnology Research Center
www.smithmoorelaw.com
22. Health => NIOSH
Source: Progress Toward Safe Nanotechnology
in the Workplace, A Report from the NIOSH
Nanotechnology Research Center
www.smithmoorelaw.com
23. EHS Regulatory Arena
Environment => EPA
Health => NIOSH
Safe Workplace => OSHA
• Focus is “engineered, unbound nano particles”
• Worker safety and emissions are key areas of focus
• Positive potential impact of nanotech via environmental remediation (surface area
and unique absorption properties of nano materials
• General consumer not well versed in nanotech
• Depending on study, public perception of nanotech is very high in Asia, neutral
in the U.S. and in danger or already negative in Europe
• Governments, environmental organizations and industry working together on nano
EHS issues
• Regulation is not the biggest risk facing nanotech, a loss of public acceptance
is.” – Woodrow Wilson Center
www.smithmoorelaw.com
24. Foods and Drugs => FDA
regulated products
• Foods • Animal Feeds
• Pharmaceuticals
– All interstate domestic and
imported, including – Human
produce, fish, shellfish, – Animal
shell eggs, milk (not meat
– Tamper resistant packaging
or poultry)
• Medical devices
– Bottled water • Radiation emitting electronic
– Wine (<7% alcohol) products
• Vaccines
– Infant formula
• Blood products
• Food additives
• Tissues
– Colors
• Sterilants
– Food containers • Counter-terrorism products
• Cosmetics
• Dietary Supplements
www.smithmoorelaw.com
25. Foods and Drugs => FDA
regulates products on a product-by-
product basis
• Pre-market approval
– For products that require an FDA approval prior to introduction
to the market.
• Market clearance
– For products that are similar to products that were cleared to
market previously, or are prepared to approved specifications.
FDA review process for these products is more rapid than for
pre-market approval.
• Post-market review
– For these products, market entry and distribution are at the
discretion of the manufacturer and FDA monitors the behavior
of these products. Regulatory action is taken if adverse
events occur.
www.smithmoorelaw.com
26. Foods and Drugs => FDA
regulated products expected to be
impacted by nanotechnology
• Drugs (new molecular entities (NMEs) or delivery
systems)
• Medical devices
• Biotechnology products
• Tissue engineering products
• Vaccines
• Cosmetics
• Combination products
www.smithmoorelaw.com
27. Foods and Drugs => FDA
currently approved
“nano-scale” therapeutics
• Gadolinium chelate for MRI imaging (Gd-DTPA
Dimeglumine)
• Iron oxide particles for MRI imaging (Feridex)
• Products using NanoCrystal technology (Rapamune,
Emend)
• Liposomes (Doxil, DaunoXome)
• Microemulsions (Cyclosporine)
• Albumin-bound nanoparticles (Abraxane)
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28. Foods and Drugs => FDA
currently approved
“nano-scale” devices
• Silver nanoparticles (anti-bacterial wound
dressing)
• Engineered Calcium Phospahate (NanOss TM,
duplicates microstructure, composition and
performance of human bone)
• Nanoparticle dental restorative (3M ESPE Filtek)
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29. Foods and Drugs => FDA
other currently approved
nanoparticle-containing products
• Cosmetics (containing lipid nanoparticles or
“nanosomes” used as delivery systems, for
controlled release of active ingredients; L’Oreal,
Estee Lauder)
• Sunscreens (containing titanium dioxide and zinc
oxide nanoparticles which make the product
appear transparent)
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30. Foods and Drugs => FDA
review Process for
Nanotechnology Drugs
• Existing pharmtox tests are probably adequate for
most nano-products
• For new nano-materials, new “tools” may be
needed
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31. Product Liability => Nano as Toxic Torts
• Asbestos, DDT, PCBs
• Some possible issues:
– Potential plaintiffs and defendants?
– Exposure to harmful substances or products?
– Causation/uncertainty questions?
– Latency between exposure to the substance and
manifestation of adverse impacts?
– Strict liability: design defect or failure to warn?
– Some possible indications from potential
• Defendants:
– A lack of transparency/CBI on safety evidence?
– Internal/public statement inconsistencies?
– Responsive to agency and public?
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32. Export => DOS, DOC, . . . etc.
• Department of State (DOS)
– 22 CFR 121.1
(a.k.a. ITAR: US Munitions List => “inherently military properties”)
• Department of Commerce (DOC)
– 15 CFR 774 Categories 0-9
(a.k.a. EAR: Commerce Control List => “dual use”)
• Violation => civil sanctions, criminal sanctions
(e.g., fines, jail time) can apply to the
individual
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33. Entity structure
• Sole proprietorship . . . and another thing!
• Partnership Which state(s)?
• Corporation
– Limited Liability
Company
– C corporation
– S corporation
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35. • Patent Cross-License
You
Claim A + B
C
Competitor
A Claims A + B + C
+C
+B
A
B
+
A
• Design Around
• Investigate Flaw
Customer wants B
A+B+C
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36. 2005 Nanotech Landscape
- Cross-citation
- Number of claims
to application areas
- White space
=> patenting room
- Entanglement
=> likely overlap
Source: Lux Research Inc.
Foley & Lardner LLP
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38. Protection of know-how
• Parties involved:
– Employees
– R&D-partners
– Subcontractors
– Clients
• Non Disclosure Agreements
• Implementation of efficient security measures
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39. Licensing
• Is it an option? Can you find a partner?
• Alternatives use it yourself or sell the invention &
patent
• Exclusive, sole or non-exclusive license
• Territory
• Proprietary vs. open licensing
• Licensing is the biggest business in the world!!!
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41. Smith Moore LLP
Office Locations
Charlotte, North Carolina Wilmington, North Carolina
Charlotte Plaza, Suite 110 300 N. 3rd, Suite 301
201 S. College Street Wilmington NC 28401
Charlotte NC 28244 910.251.7001
704.384.2600
Atlanta, Georgia
Greensboro, North Carolina One Atlantic Center, Suite 3700
300 N. Greene Street, Suite 1400 1201 West Peachtree Street
Greensboro NC 27401 Atlanta GA 30309
336.378.5200 404.962.1000
Raleigh, North Carolina www.smithmoorelaw.com
2800 Two Hannover Square
Raleigh NC 27601
919.755.8700
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