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clatteringlippsBiotechnology

Dec 5, 2012 (4 years and 7 months ago)

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Biotechnology and
Pharmaceutical Patenting


Rodney L. Sparks, J.D., Ph.D.

S
enior Biotechnology Patent Counsel

University of Virginia Patent Foundation

rodney@uvapf.org

434
-
243
-
6103


Disclaimer


Please note that no legal advice is being
offered and no attorney
-
client
relationships will arise during this
presentation.

IP Rights are Provided for in the
Constitution


Article I, Section 8: “The
Congress shall have power to
…promote the progress of
science and useful arts, by
securing for limited times to
authors and inventors the
exclusive right to their
respective writings and
discoveries”


Policy Behind IP Rights


IP Law seeks to promote
creativity


The property rights granted
protect the creators’
opportunities to recoup their
investment and earn a profit,
and encourages them to
invest their time and efforts
in developing new products
and services

Four Types of

Intellectual Property


patents



copyrights


trademarks


trade secrets


Four Types of

Intellectual Property con’t.



Patents

cover compounds, machines, and processes


Give the right to exclude others from making, using,
offering for sale, selling, importing (they do not
necessarily allow you to practice your own patent!)



Copyrights

cover works of authorship reduced to a tangible
means of expression


Give exclusive rights to copy, distribute, perform,
display, make derivative works

Four Types of

Intellectual Property con’t.


Trademarks

indicate source of goods and services


prevent others from “passing off”



Trade Secrets

are legally protected secrets



misappropriation is unlawful, but reverse engineering
is fair game


Utility (useful)
: proposed or demonstrated use


Novelty
: not previously described in a publication


Non
-
obvious
: not suggested by combinations of
publications


Enablement
: one of “ordinary skill” in that field
can carry it out (lack of data)


Written Description
: you can only claim as much
as you actually invented (lack of data)


Best Mode
: at the time of filing

Patent requirements

An invention is not patentable unless it is
useful, novel, and non
-
obvious

What is Patentable?

What is Patentable?


Anything under the sun made by man”


New chemical compounds, e.g., drugs, pesticides


Methods of producing new compounds


Methods of diagnosing or treating diseases, including


biomarkers, delivery systems, and vaccines (no gene
therapy in humans)


New uses for old compounds


Purified natural materials, e.g., DNA, enzymes


New formulations or mixtures, e.g., alloys, shampoo


Transgenic animals or plants (excluding humans)


Devices (stents, machines, orthopedic devices, prosthetics,


etc., and novel and non
-
obvious modifications thereof)


Methods of performing a function by computer software


Methods of doing business


Methods of processing digital signals

WHAT IS
NOT

PATENTABLE?


Patent law provides for what is patentable
and for what is not patentable.


An invention is not patentable if it falls into
one of the following categories
:

perpetual
motion device; anti
-
gravity device;
abstract ideas or mental processes; laws
of nature or scientific principles; naturally
occurring substances; an invention
disclosed publicly more than 12 months
ago (includes sale, offer to sell, exhibit at
a trade show, publication); substituting
superior material for inferior material;
(cont).

WHAT IS NOT PATENTABLE? (con’t.)


a mere change in size, form, or shape;
literary, dramatic, musical, and artistic
works (these are subject to copyright
laws); data structures or programs per
se; mere mathematical algorithms;
nonfunctional descriptive material;
electromagnetic signals; human beings;
an invention that is inoperative; an
invention which can only be used for
illegal or immoral purposes (such as a
torture device); and an invention solely
useful in making atomic weapons.

WHAT IS NOT PATENTABLE? (con’t.)


Mere
discoveries

are not patentable


A discovery can be thought of as
something which adds to human
knowledge, but does so by observation.
Discoveries include such things as
identification of a new species of plant, a
new biochemical pathway, naturally
occurring substances, or laws of nature.


Once a discovery is made a modification
or new use of the discovery might be
patentable.

Correlation Between Patentability
and Commercial Value of an Invention


NONE
! (not quite true, but it makes my
point)


A patentable invention may have little or
no commercial value


An invention with a lot of commercial
value my have little chance of being
patented


Dilemma
-

Without the potential for
adequate patent protection, most
companies will not invest in a technology



Invention

Disclosure




Triage


Patent

Protection

???

Copyright 2003

UVA Patent Foundation

All Rights Reserved

Evaluation of New Invention Disclosures

To File or Not to File?

General Triage Factors to Consider
:

1. Preliminary Assessment of Patentability
(with an eye toward written description and
enablement issues due to too little data
and on novelty and obviousness issues
exposed in a prior art search)

2. Pre
-
market Analysis

3. Commercial Potential

From invention to patent


Bad things
-

Public disclosure before filing
-

results in lack of novelty (kills foreign rights;
starts one year clock for filing in the U.S.); also
possible obviousness issues


Presentations


Publications (remember abstracts, web)


Grant applications (once awarded
-

if federal)


In use


Good things
-

Inventors are diligent in filing
invention disclosures


Lab notebooks (identify inventors and dates)

Good Invention Disclosure
-

for a cheaper and better result


Invention has been fully completed and
many examples are in the invention
disclosure; make it easy for the licensing
associate and attorney to review it and to
be able to cut and paste necessary
portions of the disclosure in an efficient
manner

Good Invention Disclosure
-

for a cheaper and better result


Well organized
-

such as draft manuscript;
a grant proposal, but only if there are a
lot of preliminary data; (keep total
documents to a minimum if possible)


Editable (Word, etc.)


Keep cited references to a minimum

Bad Invention Disclosure
-

results in a more expensive and less
desirable result


Unorganized


Incomplete
-

missing sections such as materials
and methods; incomplete description of results or
figures; figures with no accompanying legend or
which are not described in the text of the
disclosure


Multiple unrelated documents (meeting abstract +
manuscript rough draft + grant proposal draft +
PowerPoint presentation =
piecemeal disclosure
)


Uneditable files (pdf, etc.)


A poster in PowerPoint


Invention
-

disclose to UVAPF (180/year)


Triage


File Provisional application
-

1 year (perform
inventorship determination if necessary;
remember
-

authorship is not the same as
inventorship)


File International/PCT application
-

1.5yr


Nationalization: file in US, other countries

then you wait 2
-
3 years


Prosecution, 1
-
2 years
-


Issued patent (maybe), 20 year term from
filing date (costs from
$50k to $750k
,
depending on the global scope)
-

Patents can
be challenged


The patenting process

Provisional Patent Applications


The current PTO filing fee is $110


With
in
-
house patent counsel

you can
draft and file many more provisional
patent applications than with outside law
firms where reasonable applications cost
from $2,500 to $12,000 in attorney’s
fees.


We file 150/year!

Conversion of a Provisional Patent
Application to a PCT Application


This decision requires more effort and is
tougher to make because the expenses
are much higher at this point (about $5k
just in government filing fees)


If a licensee has been found in the year
since the provisional has been filed or if
there is a good chance for a license
agreement, a PCT application is usually
filed.

How do universities use patents?


Universities patent and license the invention
(allowed by Bayh
-
Dole Act)


A
license

is a contract in which the patent
owner allows a company to make, use, offer
for sale, sell, and/or import the patented
article or use the patented method


In exchange, the “licensee” company pays
the patent owner royalties (usually a % of
sales) and other payments (e.g., up
-
front
fees, milestone fees)


Royalties on successful products can be
huge! (even more than a graduate student’s
stipend)

Ownership of IP
at UVA


Patents


UVA owns inventions by contract


Bayh
-
Dole Act (allows universities to
own federally funded research)


Co
-
ownership with other entities


MTAs, sponsored research agreements,
consulting can modify ownership

The UVA Patent
Foundation
-
(technology transfer)


Protection and licensing of UVA’s
inventions


Bayh Dole government reporting


Advice on intellectual property for UVA
(primarily for patents; some for
trademarks and copyrights)

UVA and the UVA Patent
Foundation Honor Inventors

2010 UVA Inventors of the Year

Tim Macdonald and Kevin Lynch

Some Familiar UVA Inventors

PATENT MYTHS

Myth #1
: An inventor needs to know how
an invention works


The inventor does not need to understand
how or why their invention works.


If an inventor discovers a new method of
curing cancer, it does not matter how the
method works, just that it works.

PATENT MYTHS


Myth #2
: An inventor needs a prototype


If the invention is such a simple device that
drawings and a description will allow one of
ordinary skill in the art to make or practice
the invention, that is all that is needed. In
fact, if the invention is simple enough,
actual reduction to practice may not be
necessary (forget about this for
biotechnology).

F
H
2
N
O
O
H
2
N
O
O
PATENT MYTHS

Myth #3
: An idea is patentable


Although an idea is not patentable, if that idea
has been formulated in such detail that it can be
so clearly described in the specification that one
of ordinary skill in the art could make or practice
the invention based on the details provided in
the specification, then it might be possible to get
a patent on the idea.


Few

technologies other than simple machines
or simple processes fall into this category.

PATENT MYTHS

Myth #3
: An idea is patentable (cont.)


For most technologies, such as
biotechnology, the standards of written
description and enablement are so high it is
difficult to get a patent even when there is
substantial data and actual reduction to
practice!

PATENT MYTHS

Myth #4
: The preferred or best way of
practicing an invention can be kept secret by
exclusion from a patent application


Patent law requires that the “best mode” of
practicing the invention be included in the
application, if a best mode is known. Failure
to comply can result in invalidation of a
patent. If secrets are to be kept, then they
must be protected as a trade secret and are
not allowed in patent law.

Rodney L. Sparks, J.D., Ph.D.


Senior Biotechnology Patent Counsel

University of Virginia Patent Foundation



434
-
243
-
6103

rodney@uvapf.org