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Positioning your intellectual property as a strategic and important business asset
William E. Hunter, PrincipalDecember 2017
Types of Intellectual Property
• Trademark – An indication of source for goods or servicesCannot be merely descriptive of the goods or services
• Copyright – Protects against copying an original work of authorship
Need not register it, but doing so provides advantages
• Trade Secret – Info kept confidential to gain commercial advantage
Must define it and keep it secret
• Patent – Limited monopoly granted in exchange for public disclosure
Provides the right to stop others from using your invention
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Trademarks
• A trademark can be any word, name, symbol, device, or combination thereof (including sounds and colors) used to identify and signify a source and quality of a product or service
• Fanciful versus suggestive versus merely descriptive marks; note that trade dress protection is also available (e.g., product packaging)
• Federal registration provides benefits (e.g., evidence of ownership, potential to be “incontestable” after five years, nationwide notice, …)
• Must actually use the mark to avoid abandonment/cancellation risks• Can last forever, but must actively enforce rights (e.g., by use of
worldwide watch service or employee monitoring of the Internet)• Subject to fair use: descriptive terms can still be used in their
descriptive sense, and competitor can use mark to identify your product
• Real long term value for the business, e.g., represents good will and thus can add to margins, assists in advertising new products, etc.
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Copyrights
• Copyright protects “original works of authorship,” including graphic, artistic, literary, dramatic, musical, and certain other intellectual works; examples include photographs, illustrations, and software.
• Must be original; facts are not protectable• Must not be functional; e.g., clothing designs are typically
considered functional and thus not copyrightable• Function/Expression issues - not all of the software is functional:
(1) the best protection is against literal copying of source code;(2) courts use the “abstraction-filtration-comparison” test – basic idea is to abstract the elements of a computer program at different levels, filter out unprotectable elements, and compare what’s left;(3) can also protect the visual elements generated by the software –for the most important products, submit copyright registrations for the source code and screenshots
• Note that there are options to deposit only representative code with the Copyright Office, potentially allowing parallel copyright and
trade secret protection
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Copyrights (continued)
• Copyright protection arises automatically from the moment a work is first “fixed in a tangible medium of expression”, but you should register the copyright to enhance your ability to enforce your rights
• Work prepared by employee within scope of employment or work specially ordered in writing in which the parties agree that it is a “work made for hire” is authored and owned by the hiring party
• Copyrightable work created by an independent contractor without a written “work made for hire” agreement is owned by the contractor (MUST GET AN ASSIGNMENT)
• Copyright term is life of author + 70 years, or in case of “work made for hire”, shorter of 95 years from publication or 120 years from creation
• Copyright protects the expression of an idea, but not the idea itself• The copyright owner has the exclusive right to: reproduce the work;
distribute copies of the work to the public; prepare derivative worksbased upon the work; perform the work publicly; and display the work publicly. Thus, if you don’t own the copyright or have a license to it, contact Legal before doing any of these
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Trade Secrets
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Where do Trade Secrets fit into an IP strategy?• Critical during design phase of products; be sure to have non-
disclosure agreement (NDA) in place with any outside collaborator• As a supplement to copyright and patent protection, subject to patent
disclosure requirements• As an alternative to copyright and patent protection in appropriate
circumstances; note that a trade secret can potentially last forever
• Any secret/confidential information, which provides the Company with a competitive advantage
• The information need not be innovative or patentable• Examples include technical and business information, source code,
processes, contact lists, negative information regarding prototypes
What are Trade Secrets?
Trade Secrets (continued)
• Know & Identify what is a trade secret• Restrict Access to only employees who need to know the
information• Treat the information as a secret by controlling access to the
information with security and log-in credentials• Mark documents with potential trade secret information as
CONFIDENTIAL & PROPRIETARY• Periodically remind employees of their duty of confidentiality
and monitor compliance• Use written confidentiality agreement that allocates and
assigns IP between parties when partnering with a third party• Disclose the least amount of information necessary when
working with vendors, suppliers, contractors, partners or other third parties, even when a non-disclosure agreement is in place.
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Patents• U.S. Constitution, Article I, Section 8 – “promote the progress of
science and useful arts”
• Personal Property – A patent can be bought, sold, licensed, etc.
• Limited Monopoly – A patent expires after a fixed time period
• The Exchange – Full disclosure must be provided for the monopoly
• Government Agency – Patents are examined by Federal Employees of the US Patent & Trademark Office - www.USPTO.gov
• Subject – Process, Machine, Manufacture, or Composition of Matter
• Patentability – The innovation must be new, useful, & non-obvious
• Timing – File a patent application before any disclosure or use of the invention, subject to filing grace period(s) (none in most countries; 1 year in the U.S., but limited to information actually published)
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Patents (continued)
• Provisional – Never examined, published or issued; 12 months
• Design – Shows and claims innovative ornamental feature
• Utility – Describes and claims innovative functional featureContinuation – Same specification and general invention, and
same priority date, but new claim languageDivisional – Same specification and same priority date, but claims
different invention described in specificationContinuation-in-part – New disclosure added; priority depends on
when claimed subject matter was first disclosed
• Patent Cooperation Treaty (PCT) – A single application that servesas a patent filing for the US and many othercountries around the world; a notable exception isTaiwan
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Design Patents versus Utility Patents?• A design patent protects the innovative ornamental features of a product
as shown in the drawings, whereas a utility patent protects innovative functional features of a system, apparatus, method, composition of matter, etc., as recited in the claims
• Design patent term is 15 years from issue versus 20 years from U.S. filing
• Design patents are less expensive to prepare and have no maintenance fees, and can generally be obtained quickly (12-15 months from filing)
• Design applications are not published, foreign priority is only 6 months for design patent applications
• A design application cannot claim priority to a provisional application
• Design patent infringement is based on the ordinary user and validity is based on the ordinary designer, whereas utility patents depend on a “person of ordinary skill in the art”
• Damages include disgorgement for infringing products (scope is in flux)10
Why bother getting patents?
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• Patents show that R&D spending is actually generating real innovation
• Patents provide the right to sue in US Federal Court, which can providevalue to a company irrespective of how the business does
• Benefits of a patent portfolio:- Increased company valuation by investors- Revenue generation through royalty payments- Exclude competitors from best products or most efficient processes- Increase competitors’ risk and uncertainty- Bargaining chips to exchange with other companies to use their
intellectual property- Potentially gain entry
to domestic or foreignmarkets that wouldotherwise be unavailable
Importance of Intellectual Property (IP)
• World Intellectual Property Indicators - 2017: Worldwide patent application filings increased 8.3% in 2016 over 2015, for a total of 3.1 million applications filed; #1 – China; #2 – U.S.; #3 – Japan; #4 – Korea; #5 – European Patent Office. Worldwide trademark application filings increased 16.4% in 2016 over 2015, for an estimated total of 7 million applications in 9.77 million classes.
• World Intellectual Property Report 2017: World Intellectual Property Organization (WIPO) estimates that ‘intangible capital’ (branding, design and technology) accounts for more than a third of the value of manufactured products sold around the world, twice the value ascribed to tangible capital (buildings and machinery).
• In order to thrive (locally or globally) a business should identify and protect its Intellectual Property.
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Some Notable IP Developments in 2017
• Patent: Battles over “Alicide” continue – Inventors & Small Business Owners File Amicus Briefs Requesting Clarification re 35 USC 101
• Trade Secret: Lawsuits in Federal Courts begin to define the scope of the new civil cause of action for misappropriation provided by the Defend Trade Secrets Act (DTSA) – see e.g., Surviving Motion to Dismiss DTSA Suit
• Copyright: The U.S. Supreme Courts creates a new test for conceptual separability in Star Athletica, LLC v Varsity Brands, Inc.(feature is perceivable as 2D or 3D work of art that is separable from the useful article and, if separated, would qualify as a protectable pictorial, graphic or sculptural work) and, in China, Lego wins first Chinese legal case against imitators after “a Beijing court ruled that Lego's name and logo are well-known trademarks in China, giving the company stronger legal footing for pursuing copyright cases.”
• Trademark: Win-Win Protection of Your Trademarks – Budweiser uses a "town crier" & Netflix uses Stranger Things geek-out to police + reinforce their brands; also Velcro Industries B.V. does a Silly Video in attempt to head off genericide of Velcro® .
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Questions?
Protecting Your IP From Infringement with Effective Patent Prosecution and Counsel
Crystal Culhane, Ph.D.
Protecting your IP
• Strategically protect and extend the commercial life of products
• Start early• Integral part of product life cycle management
• Pharmaceuticals• Patents• Patent and regulatory exclusivities• FDA regulatory procedures• OTC strategy• Original product replacement• Litigation
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Patents – What kind?
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Provisional applications• What is a provisional application?
• Establishes an early filing date, but does not mature into an issued patent
• Why file a provisional?• Low filing fees• Fewer formal requirements• Not examined• Not made public if utility application not filed• Benefit of the filing date if perfected within one year
• Consider multiple provisionals• Research continues during the 12-month period• Invention is in a highly competitive field• Must file utility patent within one year from the first provisional filed
Patents – What kind?
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Provisional applications• Importance of adequate disclosure
• Can file anything (e.g., scientific paper), but…
• Adequate disclosure required in order to get the benefit of earlier filing date
• Include all subject matter/description for desired claim scope• Include both broad and specific descriptions, alternatives, and
variations• Claims not required, but can increase scope/coverage
• Inadequate disclosure could lead to problems• Prosecution – prevents issuance of claims with sufficient scope• Opposition/litigation – loss of claims in an issued patent• Due diligence – loss in value of the patent
Patents – What kind?
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Non-provisional applications
• Utility patent• Continuations and divisionals, design, plant
• Foreign patents• File within 12 months of filing the first provisional or
regular filing • Patent Cooperation Treaty (PCT)
• File single application which preserves the right to filed in most countries in the world within 30 or 31 months of the earliest filing date
Patents – What type of claims?
Pharmaceutical patents• Compound patents• Method of use patents• Formulation patents• Improvements
• New active drug combinations• New formulations• New dosage forms• New delivery systems• New indications• New dosing regimens
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Patents – When to file?
Stages in the life of a drug
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Stage Objective Time Frame
Discovery (preclinical) Identifying lead series (first), then lead compound; evaluating physical characteristics; determining activity/selectivity, PK profile, toxicity…
4 – 5 years
Phase I(~ 10-100 subjects)
Filing of IND; evaluate safety 1 – 1.5 years
Phase II (~ a few hundred subjects)
Evaluate efficacy / determine dosage 2 – 2.5 years
Phase III (~ several hundred or more)
Evaluate efficacy / long-term safety 3 – 3.5 years
NDA filing and FDA review Obtain FDA approval, launch on the market
1 – 1.5 years
Start to Finish… … 11–14 years
Patents – When to file?
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Stage Patents to file on Time Frame
Discovery (preclinical) Composition of matter – compound*, pharm. composition, method of treatment, method of making
*genus and/or species
4 – 5 years
Phase I(~ 10-100 subjects)
Salts and/or crystalline forms; possibly formulations
1 – 1.5 years
Phase II (~ a few hundred subjects)
Synthetic process; new methods of treatment; formulations; mode of delivery/dosage forms; combinations
2 – 2.5 years
Phase III (~ several hundred or more)
Synthetic process; new methods of treatment; formulations; mode of delivery/dosage forms; combinations; “patent-the-label”
3 – 3.5 years
NDA filing and FDA review “Patent-the-label” * *At least one claim recites features present on the label
1 – 1.5 years
Extending the life of patents
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Term adjustments and extensions
• Patent term adjustment (PTA)• Makes up for delays in prosecution caused by the PTO
• Patent term extension (PTE)• Makes up for time lost on a patent during drug registration
with FDA• Adds maximum of 5 years, but not longer than 14 years
from date of drug approval• Added to any PTA (35 U.S.C. § 156)
Extending the life of patents
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Patent and regulatory exclusivities• Patent exclusivity• Regulatory exclusivities
• Forms:• Marketing exclusivity• Data exclusivity
• Types:• New chemical entity (NCE) – 5 years• New condition of use/indication/formulation – 3 years• Orphan drug – 7 years• Pediatric – 6 months*• Qualified infectious disease products (QIDP) – 5 years*
Other procedures
• FDA regulatory procedures• Citizen petitions
• Orange Book listing and de-listing
• Authorized generics
• Original product replacement• Over-the-counter (OTC) strategy• Litigation
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Summary
• Multiple ways to protect your IP and discourage competitors from infringing throughout the life of the product
• If relying on a provisional application for an early priority date, adequate disclosure is essential
• Aim to obtain multiple patents to protect all aspects of your invention
• Original patents covering the specific invention• Patents covering improvements
• Strong patent portfolio will deter challenges and litigation• Take advantage of regulatory procedures and other
techniques that can offer additional protection12
WesternGeco LLC v. ION Geophysical Corp.: Patent Damages For Foreign Sales
December 14, 2017
Michael A. Amon
The Law
• 35 USC § 271—Patent Infringement
• § 271(f)(1) Whoever … supplies … in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.
• § 271(f)(1)(2) Whoever … supplies … in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringinguse, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.
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The Law
• 35 USC § 284—Patent Damages
• Upon a finding of infringement, “the court shall award the claimant damages adequate to compensate for the infringement, but in no event less than a reasonable royalty for the use made of the invention by the infringer ….”
• Reasonable royalty is the floor for damages
• It also allows for the patentee’s lost profits (if the patentee offers a competitive product)
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Overview of the Case• The Players:
• WesternGeco—Patentee that does not sell patented system; rather they build their system and then use that system to conduct marine surveys.
• ION—Accused infringer that makes parts for marine survey systems (DigiFin—used to control lateral or horizontal position of a “streamer” on survey ships). ION does not conduct or sell surveys.
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The Issues
• ION was found to infringe WesternGeco’s patents because it sold its DigiFin to customers outside the U.S. and those customers then used the DigiFin to conduct underwater surveys in international waters.
• WesternGeco got lost profits on 10 contracts they said they lost for surveys outside the U.S. Also got a reasonable royalty
• The Court of Appeal took the lost profits away as extraterritorial. WesternGeco was entitled to the reasonable royalty.
• The SCOTUS invited the Solicitor General to weigh-in on the lost profits issue.
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The Solicitor General’s View
The availability of foreign lost profits as damages for domestic acts of patent infringement is of significant importance for patent owners and infringers alike. The court of appeals reversed the jury’s award of lost profits as a matter of law. The court’s judgment, which applies nationwide as a result of the Federal Circuit’s exclusive appellate jurisdiction over cases arising under the patent laws, 28 U.S.C. 1295(a)(1), will systematically undercompensate patentees whenever an infringer’s domestic activity directly and foreseeably causes the patent owner to lose profits he otherwise would have earned for sales or services provided overseas.
WesternGeco, LLC v. Ion Geophysical Corp., Case. No. 16-1011, Solicitor General’s Amicus Br. at 18
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Questions?
Defending your IP through post-grants and litigation based upon recent decisions
December 14, 2017
Frank Albert, Ph.D.
America Invents Act
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• Created Inter Partes Review
Post Grant Petitions Instituted
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Post Grant Trial Outcomes
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Oil States – U.S. Supreme Court
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Oil States – U.S. Supreme Court
• (1) whether IPR violates Article III of the Constitution because it allows administrative judges rather than Article III judges to resolve controversies about the validity of issued patents
• (2) whether the Seventh Amendment requires the validity of issued patents to be resolved by a jury rather than an administrative agency
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Supreme Court Questions
• Justice Ginsberg
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Supreme Court Questions
• Justice Sotomayor
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Supreme Court Questions
• Justice Gorsuch
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Supreme Court Questions
• Justice Roberts
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Supreme Court Questions
• Justice Roberts
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Supreme Court Questions
• Justice Breyer
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Supreme Court Questions
• Justice Breyer
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The emerging role of science and technology in mass tort litigation
December 14, 2017
Roger Denning
Technology in Mass Tort Cases
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Typical Scorecard of Experts
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For Fresenius For PlaintiffsDr. Glenn Chertow Dr. Joseph AkarDr. Brian Duffy Dr. Julian AroestyStanley Frinak Dr. Bruce BarkalowDr. John Gennari Dr. Thomas BarocciJeff Gibbs Dr. Steven BorkanDr. Kamyar Kalantar-Zadeh Dr. Clark ColtonDr. Robert Kossmann Dr. Zayd EldadahDr. Herbert Lin Dr. Derek FineBen Lipps Dr. Michael FreemanDr. Frank Maddux Dr. Burt GertsmanDr. Peter McCullough Dr. David GoldfarbNorma Ofsthun Dr. Richard GoldsteinDr. Joseph Pulliam Dr. Nicholas JewellDr. Patrick Pun Dr. Jeffrey KrautDr. Arthur Rosenthal Dr. Joseph MilesDr. John Sargent Dr. Peggy PenceDr. Marc Shalek George SamarasDr. Sergio Waxman Dr. Arthur SchwartzbardDr. Lee Jen Wei Timothy UlatowskiDr. James Zazra Dr. Sushrut Waikar
Dr. Douglas ZipesDr. Andrew Zydney
Graphical Explanation of Important Principles
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Conventional Attacks on Expert Testimony
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Conventional Attacks on Expert Testimony
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Unconventional Attacks on Expert Testimony
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Unconventional Attacks on Expert Testimony
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