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Preparing a Nanotech Strategy

Preparing a Nanotech Strategy






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    Preparing a Nanotech Strategy Preparing a Nanotech Strategy Presentation Transcript

    • NAPP® 2007 Annual Meeting “2007 Patent Practice Update” July 17, 2007 Preparing a Nanotech Strategy © 2007 Stanislav Antolin Used by NAPP with permission. www.smithmoorelaw.com
    • • 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
    • Basic requirements for patentability: • Statutory subject matter • Useful • New (novel) • Non-Obvious www.smithmoorelaw.com
    • • 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
    • 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
    • Examples of trade secrets: • Customer lists • Formulas • Manufacturing processes • Marketing/business strategies www.smithmoorelaw.com
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • www.smithmoorelaw.com
    • Other Considerations • Regulatory Arena • Product Liability • Entity structure • IP Exploitation www.smithmoorelaw.com
    • Regulatory Arena www.smithmoorelaw.com
    • 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
    • Environment => EPA Source: U.S. Environmental Protection Agency Nanotechnology White Paper www.smithmoorelaw.com
    • Health => NIOSH Source: Progress Toward Safe Nanotechnology in the Workplace, A Report from the NIOSH Nanotechnology Research Center www.smithmoorelaw.com
    • Health => NIOSH Source: Progress Toward Safe Nanotechnology in the Workplace, A Report from the NIOSH Nanotechnology Research Center www.smithmoorelaw.com
    • 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
    • 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
    • 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
    • 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
    • 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) www.smithmoorelaw.com
    • 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) www.smithmoorelaw.com
    • 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) www.smithmoorelaw.com
    • 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 www.smithmoorelaw.com
    • 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? www.smithmoorelaw.com
    • 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 www.smithmoorelaw.com
    • Entity structure • Sole proprietorship . . . and another thing! • Partnership Which state(s)? • Corporation – Limited Liability Company – C corporation – S corporation www.smithmoorelaw.com
    • IP Exploitation => Patents www.smithmoorelaw.com
    • • 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 www.smithmoorelaw.com
    • 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 www.smithmoorelaw.com
    • IP Exploitation => Patents • Disruptive Technology vs. Complementary Technology • Commercialize – Licensing – Mergers & Acquisitions – Sales – Litigation www.smithmoorelaw.com
    • Protection of know-how • Parties involved: – Employees – R&D-partners – Subcontractors – Clients • Non Disclosure Agreements • Implementation of efficient security measures www.smithmoorelaw.com
    • 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!!! www.smithmoorelaw.com
    • NAPP® 2007 Preparing a Nanotech Strategy July 17, 2007 THANK YOU Stan Antolin Smith Moore LLP 300 North Greene Street Suite 1400 Greensboro, NC 27401 336.378.5516 (voice) 336.433.7591 (direct fax) © 2007 Stanislav Antolin Used by NAPP with permission. www.smithmoorelaw.com
    • 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 www.smithmoorelaw.com