Rob Taver IP Presentation

1. Intellectual Property Protection
Robert Traver

2. Question:
1. What is the best way to protect the design of a website?
a. trademark protection
b. patent protection
c. copyright protection
d. keep it a secret

3. Question:
2. Big Pharma buys your startup, which has developed
therapeutic antibodies. What is Big Pharma purchasing?
a. your patent portfolio
b. your trademark/tradename for the therapeutic
antibody
c. your employee contracts
d. your lab animals/animal models

4. Question:
3. You identify Italy as a large potential market for your
new therapeutic antibodies. How do you obtain patent
protection for your invention in Italy?
a. file a provisional application in Italy
b. file a PCT application in Italy
c. file a patent application in Italy claiming priority
to your US patent
d. file a European patent application

5. Question:
4. Company Z develops a new method of medical
treatment using your therapeutic antibodies. How do
you increase sales of your antibodies using this new
method of treatment?
a. do nothing
b. advertise the new use/treatment and/or inform
doctors of the new use for those antibodies
c. file a patent application for the new use
d. license patent rights from company Z

6. Intellectual Property

7. Intellectual Property: why?
Attracting investment/investors
Protecting your investment/employees/investors
Building value in your business

8. Patents in Biotech

9.  Patents – a negative right that allows you to stop others from
practicing your invention
confidentiality, liability, export control, invoicing, financial
reporting, structure of collaboration, application submission,
peer review processes, working with non-profit, foundation and
industry awards, employment issues, materials transfer and
ownership, expectations and milestones, reporting to federal
agencies, institutional mission vs. corporate mission, parallel
work, fee for service work, follow-on research, FDA approval
Patents – why not sufficient?

10. 2013 PhRMA White Sheet: Average cost to develop a drug (including cost of failures):
Early 2000s = $1.2 billion
Late 1990s = $800 million
Mid 1980s = $320 million
1970s = $140 million
2013: A new Forbes magazine analysis calculates that it now costs $5 billion to develop a new drug --
expenses that are borne by the private sector.
(http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-
the-future-of-medicine/print/)
AbbVie deal to buy Pharmacyclics and its Imbruvica medication (2015)
AbbVie Inc. paid $21 billion for part-ownership in Pharmacyclics, which has developed
Imbruvica (treatment for blood cancers) - hasn’t earned more than $1 billion in sales yet.
Economists predict that Imbruvica will eventually earn $6 billion per year.
Patents – why necessary?

12. Facebook filed at least 1 patent application today
Oracle filed about 3
Google filed about 5
Microsoft and Apple filed more than 8 each
IBM filed nearly 30 patent applications just today.
These are the recent averages per workday

13. Patents - what is patentable?
 Utility Patents cover:
• Machines
• Articles of manufacture
• Methods (processes)
• Compositions of matter (chemicals, cell lines, isolated DNA)
• Improvements to any of the above.
 Design Patents cover the appearance of useful objects.
They do not cover the function or construction of the
object.
 Plant Patents cover certain plants.

14. Patents: what’s not patentable
 Purely mental processes
 Mathematical algorithms or formulas (that is, just a formula without a real-
world effect - a formula or algorithm may be claimed as part of a method, so
long as there is an effect on the real world)
 Arrangements of printed matter (Printed matter may be part of a patentable
invention, but if the "invention" is just words, use copyright)
 Naturally occurring things (unaltered - these are not "inventions”=isolated
DNA)
 Scientific principles (a device or method which operates based on a new
scientific principle can be patented, but the underlying principle cannot)
 Inventions solely useful in making atomic weapons
 Human beings
 Abstract Ideas, and computer implementation of these ideas

15. 1. disclosing invention to the public (publications, posters,
presentations)
2. public use
3. selling
4. offering for sale
Most foreign countries require that no public disclosure take
place before filing. It is possible to file a foreign application from a
U.S. application. However to do so, the U.S. application must be
filed before any public disclosure or sale.
How to lose your patent rights

16. conception prov. Filing non-Prov
(priority document) (US, foreign,
both, multiples)
Patent Timeline
Reduction to practice
Less than or = 12 months

17. Moving, Selling, Renting Rights
MTA (material transfer agreement)
NDA/CDA (nondisclosure/confidentiality agreement)
License – exclusive or nonexclusive
Sublicense
Assignment

18. Sale of entire right, title and interest
transfer of ownership is permanent and irrevocable
lump sum payment vs. royalty stream
Transfers risks of reduced royalties in the event of technical
failure, market failure, regulatory failure, and competing products,
to the assignee.
Tax consequences
Standing: Right to Sue for Infringement
Right to Sue for Past Infringement
Joint Ownership: each party has an equal and undivided
interest in the invention
Assignment

19. Grants exploitation rights over a patent
Contract not to sue for otherwise prohibited activities
Joint ownership
Exclusive or Nonexclusive
Performance obligations that parties must comply with
Revocable=Failure to comply with those obligations
may lead to the termination of the license
Patent License

20. Scope of patent rights: Grant clause
Field licenses
Sublicensing rights
Reservations
Best Efforts
Definitions
Royalties
Cross Licenses
Subsidiaries, Affiliates
Territory
Improvements
Reporting and Accounting
Inflation and Deflation
Regulatory Requirements
Infringement
More favorable licensees
Indemnification
Liability
Prosecution of applications
Choice of Law
Marking
Term and Termination
Settlement/Arbitration
Attorney and Government Fees
License Terms

21. Antitrust
Patent Misuse
Bruelle rule
Aircraft, Laptops, Biotechnology
Patent Pooling

22. Generally: a term of 20 years from the date of filing
PTO delays: 14 months for the first office action,
4 months for a subsequent action, and
4 months between payment of an issuance fee and
the grant of a patent.
The original patent application process must be
completed within 3 years of actual filing If these time
constraints are not met, the patent receives a day-for-
day extension of the patent term
Patent term extension – PTO delays

23. A patent does not provide the owner with an affirmative right to
market or sell the invention
Biotech products are subject to marketing approval by the FDA
The Drug Price Competition and Patent Term Restoration Act of
1984 (the “Hatch-Waxman” Act) gives term extensions of
pharmaceutical patents to reflect regulatory delays encountered
in obtaining FDA permission to market the drug.
The term extension is equal to the time between the effective
date of the investigational new drug application (NDA) and its
submission, plus the entire time lost during FDA approval of the
NDA. However, the entire patent term extension may not exceed
5 years.
Patent term extension – FDA delays

24. Patent Infringement-Direct
Anyone who makes, uses, or sells the patented
invention is a direct infringer.
1st: the claims are analyzed by studying all of the
relevant patent documents.
2nd: the claims must "read on" the accused device or
process.

25. Patent Infringement-Indirect
If a person actively encourages another to
make, use, or sell the invention, the person
may be liable for indirect infringement.

26. Patents and secrets
How to patent an invention but keep the important parts secret:
 Don’t! The price of the so-called "patent monopoly" is that you must
tell the world how to practice your invention = how to make and use
 If you are manufacturing your invention yourself, and its operation
depends on something difficult to reverse engineer, you might want
to protect it by a trade secret rather than a patent.

27. Trade Secret: what
business information that is:
 Valuable
 Secret
 Subject of reasonable efforts to maintain secrecy

28. Trade Secret
The disadvantage of Trade Secret protection: once
your trade secret is no longer a secret, you have no
protection.
You also run the risk that someone else may later get
a patent on your secret process, and will file suit to
stop you from practicing the method.

29. Patent Protection (vs. Trade Secret)
• Advantages
• easier to enforce
• can’t be lost inadvertently
• greater recognized value
• can protect disclosed
inventions
• can protect more than what
is reduced to practice
• Disadvantages
• limited term
• cost
• must disclose invention

30. Example: IFNAN
2014: positions 39,739,154/5 of chromosome 19:
wt: GGGGGG-CCTT-CTG
HCV-clearer: GGGGGG-CC G-CTG

31. Example: IFNAN
Molecular Diagnostics Are in a Rut. The Industry Needs the FDA
Luke Timmerman 2/17/14:
Some of the more exciting ideas in biotech are coming up in molecular diagnostics. A
number of tests have potential to cut down on overtreatment, reduce waste in
healthcare, and give physicians clever new ideas on how to help patients. But this
industry, which accounts for less than 2 percent of healthcare spending, is stuck in
neutral. If it’s ever going to grow into a bigger business that delivers lots of valuable
information about health, the molecular diagnostics industry needs a tough, science-
minded, credible regulator to say with confidence what’s real, what’s clinically
meaningful, and what’s BS.
The Food and Drug Administration will take new steps to enforce regulations against
certain kinds of diagnostic tests, including some used for personalized medicine, to
which it previously took a laissez-faire attitude.
The announcement was made in a speech by Margaret Hamburg, the FDA
Commissioner, at the annual meeting of the American Society of Clinical Oncology
(ASCO), 2013.

32. Example: IFNAN
• Supreme Court's rulings in:
• Mayo Collaborative Services v. Prometheus Labs (2012)
• Ass'n for Molecular Pathology v. Myriad Genetic (2013)
• In Prometheus, the Court held that claims directed to a method of administering a
drug weren't patent-eligible because they covered products or laws of nature
• In Myriad the Court found that claims for isolated DNA aren't patent-eligible but claims
for complementary DNA (cDNA) were because they weren't naturally occurring
• March 4, 2014, PTO issues patent examination guidelines prompted by these
decisions, indicating that examiners will now be asked to consider whether the claim
recites or involves a judicial exception to patent eligibility—laws of nature/natural
principles, natural phenomena and/or natural products—and, if it does, whether the
claim as a whole recites something “significantly different” than the judicial exceptions.
• The PTO said that the effects of the Myriad ruling will not be limited to clams for
isolated DNA and will extend to bacteria, peptides, proteins, primers and organic
compounds.

33. Example: IFNAN
2015: the double mutation produces a novel mRNA transcript
-> a novel protein with frame shift starting at aa22
- related to IFNλ3

34. Example: IFNAN
2016: now named IFNλ4 and shown to have unique interferon
activity and useful in the treatment of cancer, infection and
autoimmunity
A new Forbes magazine analysis calculates that it now costs $5 billion to
develop a new drug -- expenses that are borne by the private sector.
(http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-
of-inventing-new-drugs-is-shaping-the-future-of-medicine/print/)

35. Example: iTriage
A phone app that provides health information and
links to health care providers and health plans:
consumers get information about:
Symptoms, conditions, medications, medical
procedures, providers, facilities, links or phone
numbers for additional information

36. Example: iTriage
Computer-Aided Selection Method Fails Patent-Eligibility
In SmartGene v. Advanced Biological Labs (Jan. 24, 2014)
at stake: two patents directed to methods, systems and computer programs that
guide the selection of a treatment regimen for a patient with a known disease or
medical condition.
the Federal Circuit held that a patent claiming the use of a computer to
implement routine mental information-comparison and rule-application
processes to select a treatment for a patient fails patent-eligibility because the
claims are directed to an abstract idea.
Those seeking to patent computer-aided diagnostic and therapeutic methods,
useful in personalized medicine, must identify and claim “something more” than
the use of conventional technologies
Alice Corp. v. CLS Bank International, June 2014- Supreme Court decides
computer-implemented inventions are not patentable subject matter.

37. Example: iTriage
Go without patent protection?
Marketing a new product (introducing it to the consumer and
getting it adopted = “creating a market”) costs time and money.
But as soon as you are successful, knock-offs and counterfeits
will instantaneously pop up:
copyrights
trademarks
design patents
trade secrets
data privacy and security
work for hire
employment contracts
HIPPA compliance

38. QUESTIONS?

39. Copyright: what?
• Literary works (books, magazine articles, instruction manuals, etc.)
• Computer programs and other software (including Web Pages). This
includes graphics and icons and the like, which may also be "graphic works".
• Musical works (including lyrics, if any)
• Dramatic works (stage plays, screenplays, speeches)
• Pantomime and Choreographic works
• Works of Art: Pictorial works (paintings, photographs, murals), graphic works
(maps, architectural plans, advertisements, posters, etchings), sculptures,
etc.
• Motion pictures, TV shows, and other audiovisual works
• Sound recordings (including the recording itself and the music being
performed)
• Computer Code
• Architectural Works (buildings)

40. Copyright – what not?
 Functional elements: You could register a copyright for the description of a machine – use
patent protection.
 Titles, names, short phrases and slogans: cannot be protected by copyright. These might be
protected by trademark.
 Blank Printed forms: are not protectable by copyright. The arrangement of written matter,
instructions, graphics, etc., might be, however.
 Designs of useful objects: Design patent is the proper form of protection.
 Ideas, themes, subjects: are not protectable - only the expression of ideas.
 Scenes a faire: Elements of a story which are dictated by the requirements of a setting.
 Facts
 Recipes: But collections of recipes with notes and descriptions (i.e. a cookbook) are protectable
 US Government Publications: so you can copy them

41. Copyright: how
• Register the copyright:
• Send the registration form with the fee and appropriate sample of the work to the Copyright Office in
Washington, D.C.
 E-filing: In 2008, the Copyright Office implemented a new e-filing system called eCO (Electronic Copyright
Office). This system allows on-line registration of claims to copyright, and there is a discount in the filing
fee for filing through eCO rather than on paper. For more information, and access to eCo, see:
www.copyright.gov/eco.index.html
• Give the proper notice: The copyright notice consists of the "c-in-a-circle" symbol (©) or the word
"copyright" (or both), the year (normally, the year of creation or publication), and the name of the copyright
owner. If the work has been revised over a period of time, you can list more than one year. For example:
© Copyright 2002-2014 Sheridan Ross, PC
• Put the copyright notice someplace noticeable:
• Computer programs, put it on the opening screen and on any physical media (CDROM, packaging, etc.).
• Graphic and pictorial works, the lower right-hand corner is traditional.
• Audiovisual works usually have the copyright notice in the opening and closing credits.
• Web pages: put a copyright notice on index page and, if you want to be extra careful, at the bottom of
each subsidiary page.

42. Copyright: what right?
 Copying or reproducing your work directly
 Making new works based on your work ("derivative
works")
 Selling or distributing copies of your work
 Performing or displaying your work publicly
 Building based on copyrighted plans (e.g.
architectural drawings)
 Using (running), copying, selling the same computer
code

43. Copyrights – who?
 The "author" of a work owns the copyright initially. The "author" may
be the actual person who created the work.
 The owner may be the author’s employer if the work is "made for
hire." Under some circumstances, the person who contracts with
another to create a work is the "author" under the "made for hire"
doctrine.

44. Copyright: how long?
 The copyright will last for the author's life, plus
70 years.
 For works made for hire, the term is 95 years
from publication, or 120 years from creation,
whichever expires first.

45. Copyrights: someone else’s
 If the work was created after 1977, assume it is covered by copyright.
 Fair Use:
 1) The purpose and character of the use (is the use commercial or nonprofit
educational? Is it one of the listed uses? How much have you changed or
adapted the work?)
 2) The nature of the copyrighted work (is the work worth protecting?)
 3) The amount and substantiality of the portion used in relation to the copyrighted
work as a whole (use only so much of the copyrighted work as is necessary and
reasonable to accomplish your purpose); and
 4) The effect of the use on the potential market for, or value of, the copyrighted
work (i.e. will your use replace the copyrighted work in the marketplace? Will it
reduce the market for derivative works?)
See: fairuse.stanford.edu/Copyright_and_Fair_Use_Overview/chapter9/9-a.html

46. Copyright: Penalties
 Injunction, preventing you from selling your work.
 Impounding and destruction of infringing articles
 Money Damages: the copyright owner may be awarded either:
• the owner's actual damages (her lost profits) plus your profits; or
• statutory damages of not less than $750 or more than $30,000 for all infringements involved
in the action, with respect to any one work. This may be increased up to $150,000 per work, if
the court finds that the infringement was "willful.” Statutory damages may be awarded
whether or not the copyright owner has sustained any monetary loss at all, and whether or not
you have made any profits or sold any copies. Statutory damages are what the recording
industry relies on in lawsuits against those who illegally share music files over the internet.
 Court Costs and Attorney's Fees
 Criminal Penalties
• Imprisonment for up to 5 years (10 years for a second offense)
• Fines as set forth in Title 18 of the US code
• Fines of up to $2,500 are also available under for Fraudulent Copyright Notices, Fraudulent
Removal or Alteration of a Copyright Notice and False Representations in applying for a
copyright registration.
 There is a three-year statute of limitations for civil copyright infringement actions, and a five-year
statute of limitations for criminal copyright infringement.

47. Trademark – what?
A word or name: "Exxon" for petroleum products, "Century 21" for real estate services.
A phrase or slogan: "I'm lovin' it" for fast food (McDonalds), "Where do you want to go today?" for
software (Microsoft).
A way of presenting a word: the "stripey" IBM logo, or Walt Disney's signature on films.
A symbol or drawing ("logo"): The Rock of Gibraltar for Prudential Insurance, or the alligator on
Izod shirts.
A character: Mr. Peanut (Kraft)
A shape: the famous Coca-Cola bottle.
A distinctive building design: KFC's striped roof, McDonald's Golden Arches
Details of packaging ("Trade Dress"): The L'eggs egg for pantyhose; the red-and-white label on
Campbell's Soup cans.
In rare instances, other things, such as:
A sound: Tarzan’s yell
A spoken phrase: the Jolly Green Giant's “Ho Ho Ho"
A sequence of notes: the NBC chimes
A piece of music: the Lone Ranger “William Tell Overture” theme
A color: pink for Fiberglas® insulation; or a combination of colors: Green body and yellow
wheels, for John Deere tractors.
A fragrance: a floral scent

48. Trademark: how?
1) choose a mark: a distinctive mark that sets your product or service apart from others.
The "strength" of a mark – is judged on a scale:
Very Strong: coined terms (Xerox)
Strong: arbitrary (Apple)
Less Strong: suggestive (TopGolf)
Weak: descriptive (Best Pie)
Not a Mark generic (Escalator)
2) Do a search yourself
3) Have a search performed – the standard is "likelihood of confusion" = "is the
proposed mark so close to an existing mark that it is likely to confuse the intended
consumer as to the source of the goods?”
You may have registered your company with the Secretary of State, but that does not mean that you are clear to
use the name as a trademark. The state only reviews your proposed company name to make sure that it is
not identical with any other company name in the state, to be sure there is some small difference which would
allow them to distinguish your name from others for purposes of billing you for your corporate tax, or allowing
someone suing you to serve papers on the proper company.

49. Trademark: how to protect
1) use it in commerce
2) police the mark – looking for dilution
3) register your mark – then use the ® (otherwise use TM)
The registration becomes "constructive notice" of your ownership of the mark = once your mark is
registered on the Principal Register, anyone anywhere in the United States who starts to use
the mark is presumed to know about your previous use.
You may use the ® notice.
You may sue in Federal Court.
Your registration can be used in disputes over internet domain names to defeat a domain name
owner who does not have a registration.
Statutory damages and treble damages are available (in cases of "counterfeit" goods).
After five years of registration on the Principal Register, you can have the mark declared
"incontestable", which means that no one can later stop you from using it, even if you adopted
after they did.
Once on the Principal Register, you can file it with the US Customs and Border Protection
Agency, which can help in stopping importation of infringing goods.
4) enforce the mark - if you become aware that someone else is using your mark you must inform
them of your rights and demand that they stop

50. Trademarks: how long
 As long as you use them
 As long as you pay the renewal fees (and prove
continual use with filings every 8 years)

51. Trademarks: how to register
 Take this to a trademark attorney:
 The mark you want registered.
 Sharp image of the mark (if it involves drawings)
 Appropriate colors, if that’s intended
 Translation of the mark into English if it is in a foreign language
 Recording of sounds, scent samples of chemicals
 Registration numbers of similar marks
 The name and entity of the trademark owner.
 A detailed list of the goods or services on which the mark is (or will be) used.
 The date the mark was first used in connection with the goods/services, and the date the mark was
first used in interstate or international commerce ("intent to use" basis).
 If the application is based upon actual use, you will need to supply a "specimen" of the mark as
actually used on the goods or services.
 For goods, this means either actual labels, or photographs of the goods showing the mark
physically applied to the product - advertising material is not acceptable, unless it contains a
photograph of the goods showing the mark.
 For services, advertising material is acceptable, or business cards, program brochures, etc.