Hello lukkom-ga,
At the outset, I should emphasize the disclaimer at the bottom of this
page, which notes that answers and comments on Google Answers are
general information, and not intended to substitute for informed
professional legal advice. The information in this answer comes from
law-related web pages. If you need professional advice on
freedom-to-operate opinions, you should consult an attorney in your
area.
It appears that a "freedom-to-operate opinion" (sometimes abbreviated
as "FTO opinion") is not a term specific to medical devices, but
rather a term used by law firms and patent consultants with regard to
a variety of technologies, including medical devices. For example,
one law firm that does patent work for medical devices as well as
other technologies provides a single description for
freedom-to-operate opinions:
"Having a patent is not the same as having the freedom to make, use or
market a product. That is, one must have 'freedom-to-operate. ' We
assist clients in achieving their marketing objectives by analyzing
third-party patents to identify issues that inhibit
freedom-to-operate. We provide our analysis in the form of a written
opinion, which assists in defending against claims of patent
infringement. When necessary, we assist the client in identifying
strategies to obtain freedom-to-operate, such as product redesign and
licensing agreements."
"Practice Areas: Intellectual Property" [scroll to "Freedom-to-Operate
Opinions", near the bottom of the page]
Davis Wright Tremaine LLP
http://www.dwt.com/practc/int_prop/int_prop.htm.
A shorter but similar definition can be found on another web page:
Freedom-to-operate opinions “are not legal opinions, but common sense
analyses on infringement", which are provided "with regard to the
patents of your competitors, whether actively asserted against you or
not".
"Services Provided"
Patent Jungle
http://www.patentjungle.com/services.html
The only unusual aspect of this definition is that it comes from a
consultant firm, not a law firm. It seems that usually, though
apparently not always, a lawyer would be needed for a
freedom-to-operate opinion. This is implied by the following web
page, from a Cornell University initiative called "swiftt", which
notes that "swiftt itself does not provide legal opinions but legal
opinions can be provided through our partnership with patent
attorneys. Hence we can provide FTO opinion reports."
The swiftt page also gives a helpful explanation of freedom-to-operate
reviews and opinions. Among other things, it explains that "An FTO
review is designed to provide an organization with a clear
understanding of whether or not the organization can bring a
particular product (or component) into the stream of commerce.... It
is seldom, if ever, a definitive answer, but is rather a 'snapshot' of
the known IP and TP claims that are attached to some product and may
be provided as a legal opinion or as an analytical tool for product
development planning." The swifft page also notes that a
freedom-to-operate opinion might be done for "a single country or
worldwide". While this page relates specifically to biotechnology, it
might be worth reading to give you a sense of how freedom-to-operate
opinions are generated, used, or avoided.
"Freedom-to-Operate Reviews and Opinions"
The Strategic World Initiative for Technology Transfer
http://www.swiftt.cornell.edu/reviews.htm
As the swifft page suggests, it appears that a freedom-to-operate
opinion can be quite useful. One possible use is in litigation.
According to one article, "a freedom to operate opinion ... is a
critical factor in avoiding treble damages for intentional
infringement."
"Corporate Counsel’s Role In Commercializing New Products", by Mark
J. Gundersen and Frances Gauthier (September 2001)
Klett Rooney Lieber & Schorling, P.C.
http://www.klettrooney.com/newsroom/attorney_articles/KlettGUNDERSEN.pdf
Another article explains this issue in more detail:
"Investors may also want to consider obtaining opinions from counsel
when they or their portfolio companies become aware of potentially
problematic patents. If a company is found liable for 'willful' patent
infringement in a court action, it also may be liable for treble
damages. One manner of avoiding a finding of willful infringement is
to obtain a competent written opinion from counsel, often referred to
as a 'right-to-use' or a 'freedom to operate' opinion, which can be
relied upon at trial to demonstrate good faith and counter a demand
for treble damages. If a company or an investor is aware of a patent
that the company may be infringing (or is accused of infringing), it
is prudent to engage counsel and obtain an opinion that advises the
company whether it is free to operate in a given technology market.
The opinion may indicate either that the patent is not infringed or
that it is invalid. The opinion must be well reasoned and competent to
be relied upon in court. Oral opinions are usually insufficient."
"Protecting Venture Investments Against Patent Litigation", John J.
Egan & Ray Lupo (Dec 1, 2002)
Venture Economics: Venture Capital Journal
http://www.ventureeconomics.com/vcj/protected/1031550901664.html
Here are two more pages, like swifft relating to biotechnology but
also providing general information on freedom to operate opinions,
which you might find useful.
Unnamed Report
AgBiotechNet
http://www.agbiotechnet.com/reports/isaaa_briefs/Brief20.pdf
"Accessing Other People's Technology: Do Non-Profit Agencies Need It?
How to Obtain It", by Carol Nottenburg, Philip G. Pardey, and Brian D.
Wright (September 2001)
International Food Policy Research Institute
http://www.ifpri.org/divs/eptd/dp/papers/eptdp79.pdf
I hope that this information is helpful.
- justaskscott-ga
I used the following search terms, by themselves, in phrases, or in
combinations, on Google:
"freedom to operate"
fto
opinion
opinions
review
reviews
analysis
analyses
medical |
,
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