INTELLECTUAL PROPERTY BASICS

Tools for Technology Management David Poticha University of Colorado Technology Transfer Office (TTO)
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INTELLECTUAL property is more than just a great thought

WHY IS I.P. IMPORTANT?

protects important assets from theft, exploitation or abuse identifies contributions by the Company or inventor to the field secures monetary compensation for the Company (and sometimes the inventor) Sometimes all a company has to leverage is its IP

FOUR FORMS OF INTELLECTUAL PROPERTY

Patent - gives the right to exclude others from making, using, or selling your invention Trademark - identifies a unique source of goods (Pfizer) or services (Grease Monkey) with a protected name, symbol or combination Copyright - protects the copying of original works of print or art (book, movie, painting) Trade Secret - protection by virtue of secrecy (Cokes secret formula)

Trade Secret
Definition: A trade secret can be any information that derives independent economic value from not being generally known or readily ascertainable. Among the things that can be trade secrets are a formula, pattern, compilation, program, device, method, technique, or process.

Uniform Trade Secrets Act (UTSA)

Protects trade secrets if disclosed or is ascertained by improper means. So how can I discover a trade secret legally?
Independent invention Reverse engineering Obtaining a license Public observation

Trade Secrets Factors

the extent to which the information is known outside the business the extent to which it is known to those inside the business, i.e., by the employees the precautions taken by the holder of the trade secret to guard the secrecy of the information the savings effected and the value to the holder in having the information as against competitors the amount of effort or money expended in obtaining and developing the information the amount of time and expense it would take for others to acquire and duplicate the information.
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Trade Secrets and Other IP

Trademarks and Trade Secrets are mutually exclusive by the very nature of a TM Copyrighted material can also included redacted trade secret material Patents, prior to publication, can be a trade secret, but once public, they too are mutually exclusive
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Loss of Rights
Losing the rights of Trade Secret protection is very simple, the information becomes public (whether by choice, accident or malice)

Copyrights
Implemented by various acts including the Copyright Act of 1976 and the DMCA. Protect literary, dramatic, musical, artistic, and computer works. Prevent others from displaying, reproducing, adapting, performing, or publishing copyrighted works.
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Copyright
Copyright protection originates in the Constitution
Article 1, Section 8 gives Congress the power to promote the progress of Science and the Useful Arts by securing for limited times to Authors and Inventors the exclusive right to their respective writings and drawings.

Purposes
Limited monopoly provides incentives to create
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What is Protectable?
Original work of authorship Independent creation Some amount of creativity Fixed in a tangible medium of expression Physical record Examples: Protectable: literary works, a/v works, computer programs NOT Protectable: titles, slogans, ideas, processes (use Trademark or Patent instead)
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Rights
Exclusive rights to (or authorize others to)
Reproduce a work Prepare a derivative work Distribute copies Publicly perform or display a work

Violation of one of the exclusive rights is the basis for infringement.

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Related Laws Benefiting Copyright Holders

Sonny Bono Copyright Term Extension Act (CTEA) Extended duration of copyright protection by 20 years Individual = Life of author + 70 years Corporation = 95 to 120 years Digital Millennium Copyright Act (DMCA) Anti-circumvention protections The EU passed a similar law in 2004
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Notice: Is it Necessary?
Technically, legally, no.
However, it is HIGHLY recommended.

Best practices:
Notice should be placed on the work with the date being the date of first publication
For example, a work published today would say Copyright (c) 2006 The Regents of The University of Colorado

For computer programs, the copyright notice should appear on the first screen that is displayed when the program is executed.

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Registration: Is it Necessary?
No. Copyright registration is not required for protection. HOWEVER, it is required to sue for infringement! Also, registering the copyright within three months of publication of the work affords certain statutory damages.

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Registration: Three Requirements

Fill out a form. Pay a fee. Deposit a copy of the work with the Copyright Office
What if my work also contains a trade secret?
This depends on the work and how much of it is trade secret. While the Copyright Office prefers that source code be deposited; sometimes object code can be deposited depending on the length of the program.
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Copyright Infringement
Must be taken from the copyrighted source, not from an independent source. Must not have been created independently. Must be substantially similar to the copyrighted work Must have had access to the copyrighted work.

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Defenses to Copyright Infringement

Fair Use
Educational uses Parody Literary criticism Satire Other uses protected by the First Amendment

Typically courts look at whether money exchanged hands in the use of the work!

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TRADEMARKS What is a Trademark?

A word, name, symbol, or device Used to identify the source of a good or service Can be used to identify the seller and/or the product (Coke vs. Viagra)

Brands make you feel good (or bad)

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Adopting a New Brand and Evaluating Existing Brands

Distinctiveness

Availability

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Distinctive Marks Are Best

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Trademark Infringement
Likelihood of confusion (Dreamworks vs. Dreamwerks) Marks need not be identical to conflict Nature of products, buyers, channels are key Highly subjective, factual inquiry

Why is Registration Important?

Can reserve rights
Secure financing/investor confidence Provides greater rights in litigation

In most countries, is the only source of trademark rights

Discourages others from taking a similar name

Prevents distributor extortion

Protects Internet domain names Keeps counterfeit products out of U.S.
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Policing Tips
Educate employees about the need to police Identify a point-person Notify counsel promptly Be sure of your rights before making a challenge Be consistent in your policing

Proper Use of Trademarks

E.g. Xerox used to say When you use Xerox the way you use aspirin, we get a headache. Be careful how you use your marks, and how you represent the marks of competitors

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Proper Use of Trademarks

Make them stand out Use and symbols Identify them as your marks Use them to modify generic terms
Never use as nouns Never plural or make possessive Never use as verbs

Trademarks That Became Generic

YO-YO CELLOPHANE ESCALATOR THERMOS 386 ASPIRIN (generic) vs. TYLENOL (still protected)

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Patents (a great idea)

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PATENTS
the three different kinds of patents are utility, design and plant patent only confers the right to exclude others; no right to practice your own invention remedies include injunction and damages (often measured by reasonable royalty) treble damages for willful infringement (which is hard to prove)
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Patent Requirements

In order to obtain a patent, the invention must: Be unique (novel) Be useful (utility) Be non-obvious Be disclosed Be described so others can make it (enablement) These requirements are established through the patent application process.
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PATENTABILITY
claims (see examples) determine scope statutory subject matter (under U.S. Code) includes machines, articles of manufacture, compositions of matter, processes (including new uses)
Human beings (organs?), raw DNA sequences, natural objects or organisms are excluded excluded subject matter also includes printed matter (subject of copyright) and pure algorithms
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Sample Claims We claim

(1) A compound of the formula X. (2) A pharmaceutical formulation for a compound of the formula X. (3) A method of using compounds of the formula X to treat diseases 1, 2 10. (4) A method of treating disease 2 comprising the steps (a), (b) and (c)
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UTILITY (35 U.S.C. 101)

just need some practical utility (e.g., entertainment) specific exclusions for products of nature, perpetual motion machines (absent a working model, this is not per se excluded from patentability), and those inventions that are contrary to public policy (i.e. biological weapons delivery systems) usually a trivial requirement, but new biotech examination guidelines may revive this rejection (especially in light of cloning and EST controversies, In re Fisher just decided)
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BARS TO NOVELTY (102)

patented, published, known or used by others before your invention was made in public use, on sale, or published more than 1 year before your filing date described in a patent by another with a filing date earlier than your invention date (possible secret art) invented by another abandoned by inventor, or invented but failure to show diligence from conception to filing many of these may go away with upcoming amendment to the patent laws
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NONOBVIOUSNESS (103)
obviousness means that the invention is different from the prior art, but the differences are so trivial as to be obvious to one of ordinary skill in the art
The bucket and spout analogy

requirements are (a) a teaching of each element in the prior art; (b) a motivation to modify the prior art to arrive at the invention; and (c) a likelihood of success in making and using the invention
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Incremental Improvements are not necessarily obvious

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SECONDARY CONSIDERATIONS
Even if all elements are found, prima facie obviousness can be overcome by secondary indicia of nonobviousness: commercial success long-felt need/failure of others unexpected advantages unexpected difficulties in achieving
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Enablement & Written Description (112, 1st )

a patent application must teach how to make and use the claimed invention (both by words and by example) it also must disclose the best mode for making and using the claimed invention often the major issue in biotech cases, especially for human therapies written description - new area of concern, particularly in biotech, requires virtual proof of having the invention in hand, a so called POSSESSION TEST. Can be quite literal and even more so in Europe

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KINDS OF APPLICATIONS
provisional - not examined; a placeholder non-prov. - examined and issues as patent divisional - contains claims to restricted inventions; same specification as parent continuation - same specification, different claims than were presented before continuation-in-part - contains some new material (rarely advisable) and prior application is prior art to the new matter reissues (by inventor) and reexaminations (by another or inventor, challenge to validity)
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THE APPLICATION PROCESS

Preparing the Application Filing the Application & Formal Documents Restriction Requirement Divisionals?? Office Action(s) Response(s) Advisory Action Appeal Allowance Issuance and Continuing Applications
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PATENT OWNERSHIP
inventors are the default/initial owners employers generally include assignment obligations as a condition of employment U.S. government rights (must be noted in application); note march in rights sponsored research agreements and materials transfer agreements can create contractual encumbrances

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Invention
Conception (the light bulb) Reduction to practice (RTP) Diligence from conception to RTP

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INVENTION
Two elements to any invention:
conception - an idea that is complete enough that the invention can be made by others; the light bulb paradigm reduction to practice - has the invention in fact been made/practiced? reduction to practice may be actual or constructive
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INVENTORSHIP
The threshold question in determining inventorship is who conceived the invention. Unless a person contributes to the conception of the invention, he is not an inventor ... [and] reduction to practice, per se, is irrelevant ....
However, while conception may be the key, reduction to practice may be very instructive.

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INVENTORSHIP
first determine what the invention is; focus on the claims and what is patentable examine both conception and reduction to practice (i.e., was conception complete?) who did what, under whos instruction, and at what time? you can have single, joint or co-inventors correction can be made at any time so long as there was no prior deceptive intent
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DOCUMENTATION
U.S. currently relies on a first to invent system (basis for interference practice; compare to opposition practice in other countries) need evidence of conception, reduction to practice, and diligence need corroboration by non-inventors invention disclosure is often used, but earlier information usually is needed

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If you do not document, someone can and likely will steal your invention!

Why Keep Records

For patent purposes it aids in writing the patent Establish a date of invention Not necessary to keep a lab notebook unless your invention is valuable and how do you know that in advance?
Usually never needed When needed, is desperately needed
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Conception
Idea of a complete and operative method or means to solve a problemin other words, the formation in the mind of the inventor(s) of the fully functional invention as it is to be practice in its final form.
1. In other words, you know what youve got, what youre doing and where youre headed.
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Reduction to Practice (RTP)

Actual (making the invention)
Building and testing invention

Constructive (a legal corollary to actual)

Accomplished by filing patent application, although with increased enablement standards in biotech cases this practice is much more difficult to satisfy enablement and written description standards.
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Diligence
Inventors must account for time lapses between conception and reduction to practice otherwise abandonment
Testing/Experimenting Researching Fine Tuning
there is no defined time period for abandonment
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PROOF = Lab Notebooks (or some co-signed evidence of date of invention)

The most common way to show invention is a notebook or journal But is not the only way
Submission of article or grant proposal Testimony

Purpose = a document to convince a judge or jury that you were the first to invent Key - must be acceptable as evidence (e.g. electronic notebooks, while useful, have not faced legal challenge)
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DUTY OF CANDOR

DUTY OF CANDOR
applicants must disclose all material/relevant information to Patent Office Information Disclosure Statement (IDS) violation is called inequitable conduct, but one needs to show materiality and intent (Purdue Pharma lost a series of patents to Oxycontin on this very issue) ongoing duty that continues until issuance if new art is discovered after issuance, the patentee or others may ask for reexam
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INTERNATIONAL PATENTS
major difference is that whoever is first to file gets the patent, not the person to invent first also, there is no one year grace period for the inventors own publications (except CA and JP) Paris Convention gives you one year to file abroad in all signatory countries Patent Cooperation Treaty (PCT) is a vehicle to maintain foreign rights for relatively minimal cost (few exceptions such as Taiwan exist) certain types of claims may not be available overseas (diagnostics and therapies on the human body, engineered plants & animals)
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TYPES of INFRINGEMENT
direct infringement: making, using, selling, importing or offering for sale an invention patented in the United States (271(a)) inducement to infringe: actively induces the infringement of a patent (271(b))

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TYPES of INFRINGEMENT
contributory infringement: offers for sale or sells a component that is known to be especially adapted to be used in infringement of a patent (271(c)) Importation infringement of product by process: product made anywhere in the world by a process patented in the United States (271(g)) cannot be imported to the U.S. literal infringement v. doctrine of equivalents
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WHATS NOT INFRINGEMENT

outside the scope of the claims 11th Amendment immunity (cannot sue govt) patenting or licensing performance of government contract used solely for FDA submission (see Hatch Waxman) research exemption, does it exist (common law)?

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Joint Ownership - Patents

May be two or more inventors
Does the person provide creative input to the invention?

Allows one inventor to grant or assign a license to a third party without the consent of the others. Creates collaboration problems. *** CU deals with joint inventors through contracts addressing the rights of the joint inventor in the patent (IIA)
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Joint Ownership Issues

Agenda Relationship
University - University University - Business

Goals and Priorities

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So what are the differences?

Patents protect the knowledge behind how to make an invention. Copyrights protect the work. Trademarks protect the name or image. Trade secrets protect anything secret. Patents expire within 20 years. Copyright expires within 70 years. Trademarks never expire. Trade secrets last until they become public.

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CU Policy on IP
Discoveries in which the University has an interest Assigns ownership of IP from inventors to the University Substantial Use of University Resources Addresses start-ups, consulting, distribution of revenues
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Valuation of IP
Detailed business analysis undertaken. Valuation done by licensing professionals. Contract written.

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Conduct market research.

Conduct a prior art search.

Is the invention commercially viable? Yes No Do we want to release rights? Yes

Follow procedure to release rights.

Is the invention patentable? No Yes

Get cost estimate from patent attorney to file a provisional application.

Prepare a Patent Justification and submit to case manager.

Approved?

Kimberly prepares engagement letter.

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Patent Justification Invention Provide a short summary explaining what the invention is.

Market Size
Provide a summary of the potential markets to commercialize this invention. Potential Commercial Licensees List of potential companies who might be interested in licensing this invention including start-up potential. Patent Issues/Prior Art Provide a summary of the closest prior art and how this invention can be distinguished. Potential Freedom to Operate Issues Provide a summary of any dominant patents that might make it difficult to commercialize the invention. Action Plan

Request to engage ATTORNEY to file a provisional application for costs not to exceed $X.
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 Inventorship

Other Considerations

Before a patent application is filed, it is important to determine who are the inventors of the invention.

Co-Ownership
If inventors are from different institutions, it may be necessary to execute an Inter-Institutional Agreement to determine who will control the patenting and commercialization of the invention.

Government Funding
Any government sponsorship should be included in the patent application.

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Pharmaceutical Strategies
Composition of Matter Patents (20 years from filing) Hatch Waxman (5 years exclusivity)
30 month (42) stays w/valid patents in Orange Book Pfizer v. Teva

Patent Term Extension (5/14 rule) Next Generation Patents: PK Patents, Formulation Patents, Metabolites, Enantiomers, Dosages, Dissolution Profiles, Methods of Use, New Indications
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Biological Materials at CU
Routinely licensed in and out. UBMTA
Agreed by many institutions

A License with a Limited Use

More later

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Software at CU
Model licenses
Exclusive Non-exclusive Source code Object code

May include third party elements May include open source software
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