Chemical Engineering April 2019 - 56

MedCo more than one year before
patent filing. The district court disagreed,
determining that the transaction
between MedCo and Ben
Venue was not a commercial offer
for sale of the claimed invention because
MedCo retained title to the
product and the three batches were
supplied for experimental purposes
rather than commercial profit. On
appeal, the Federal Circuit affirmed.
While Ben Venue's claims were not
invalidated in this instance, this
case may have turned out differently
if the court had determined,
for example, that the batches were
supplied for commercial profit. This
risk to the claims could have been
avoided by filing a U.S. patent application
before batches of the product
were supplied.
A sale does not need to actually
occur for an offer of sale more than
one year before patent filing to present
a possible problem for U.S. patent
rights. For example, in 2016, the
Federal Circuit considered whether
a fax with price, delivery, and payment
terms could be used to invalidate
U.S. patent claims owned by
Merck & Cie even though a sale did
not take place [14]. A Merck manager
had sent a fax in 1998 to Weider
Nutrition International relating to
the sale of a crystalline calcium salt
of tetrahydrofolic acid. About one
and half years later, Merck filed a
patent application. A patent issued,
and Merck sued Watson Laboratories,
Inc. in the District of Delaware
for infringement. During litigation,
Watson Laboratories argued
that the patent claims were invalid
based on an offer for sale more than
one year before patent filing. The
district court disagreed, finding that
there was no legally binding sale of
the claimed invention because the
agreement had not been reduced
to writing and signed by both parties.
On appeal, the Federal Circuit
reversed, holding that the fax was
an offer for sale that could invalidate
the patent claims even though a
sale never occurred, because both
parties understood it to be an offer
for sale of the claimed invention.
A sale more than one year before
patent filing only presents a
possible problem if the invention
is ready for patenting at the time
of the sale. Whether an invention
56
is ready for patenting depends on
the facts of the case and does not
necessarily require a working prototype.
For example, in 1988, the
U.S. Supreme Court considered
whether an inventor's commercial
offer for sale could be used to invalidate
U.S. patent claims related
to computer chip sockets [15].
The inventor had offered to sell
his computer chip socket in commercial
quantities to Texas Instruments
in 1981. Although he had
not yet made a working prototype,
he showed sketches of the design
concepts to Texas Instruments in
relation to the offer for sale. One
year and eleven days after confirmation
by Texas Instruments, the
inventor filed a U.S. patent application.
A patent issued, and the
inventor subsequently sued Wells
Electronics, Inc. in the Northern
District of Texas for infringement.
During litigation, Wells Electronics
argued that the patent claims were
invalid based on the offer for sale
more than one year before patent
filing. The district court decided
that some of the patent claims
were invalid. On appeal, the Federal
Circuit reversed, holding that
all the patent claims were invalid
based on an offer for sale of the
claimed invention more than one
year before patent filing. It reasoned
that even though the inventor
did not have a working prototype
at the time he offered his
product for sale, the invention was
substantially complete. On appeal,
the U.S. Supreme Court affirmed.
Learning from these cautionary
tales, scientists should consider filing
a U.S. patent application within
one year of offering their invention
for sale, or before offering it for sale
at all if they are considering global
patent protection.
Closing thoughts
Placing an invention into the public
domain more than one year before
filing a U.S. patent application may
present a possible problem for U.S.
patent rights. Scientists should thus
think twice before disclosing their
inventions when seeking grants,
submitting abstracts, presenting,
publishing, and communicating
with others, particularly if they have
not yet filed a U.S. patent application.
As reflected in cautionary
tales of other inventors, the circumstances
and timing of the disclosure
may determine whether a scientist
inadvertently forfeits their U.S. patent
rights.
■
Edited by Dorothy Lozowski
References
1. Oxford Nanopore Technologies Ltd. v. University of Washington,
IPR2014-00512, Paper 12 (P.T.A.B. Sept. 15, 2014).
2. Ex Parte Brimm & Gailey, 1963 WL 8018 (B.P.A.I. Oct.
29, 1963).
3. Norian Corp. v. Stryker Corp., 363 F.3d 1321 (Fed. Cir.
2004).
4. Cordis Corp. v. Boston Scientific Corp., 561 F.3d 1319
(Fed. Cir. 2009).
5. Nichols Institute Diagnostics, Inc. v. Scantibodies Clinical
Laboratory, Inc., 195 Fed. App'x 947 (Fed. Cir. 2006).
6. Massachusetts Institute of Technology v. AB Fortia, 774
F.2d 1104 (Fed. Cir. 1985).
7. Regents of the University of California v. Howmedica, Inc.,
530 F. Supp. 846 (D.N.J. 1981).
8. In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 2004).
9. Oxford Nanopore Technologies Ltd. v. University of Washington,
IPR2014-00513, 2016 WL 853080 (P.T.A.B.
Feb. 26, 2016).
10. Invitrogen Corp. v. Biocrest Manufacturing, 424 F.3d
1374 (Fed. Cir. 2005).
11. Jursich v. J.I. Case Co., 350 F. Supp. 1125 (N.D. Ill.
1972).
12. National Research Dev. Corp. v. Varian Associates, Inc.,
17 F.3d 1444 (Fed. Cir. 1994).
13. Medicines Co. v. Hospira, Inc., 827 F.3d 1363 (Fed.
Cir. 2016) (en banc).
14. Merck & Cie v. Watson Laboratories, Inc., 822 F.3d
1347 (Fed. Cir. 2016)
15. Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (1988).
Authors
Shana K. Cyr, Ph.D., is a partner
and patent attorney at Finnegan,
Henderson, Farabow, Garrett &
Dunner, LLP (11955 Freedom
Drive,
Reston,
Phone:
Virginia 20190;
shana.cyr@finnegan.com).
571-203-2434; Email:
She
represents clients in complex patent
litigations, contentious proceedings
before the U.S. Patent
and Trademark Office (USPTO), and appeals related to
pharmaceuticals, biologics, combination products, diagnostics,
and medical devices. She also counsels clients
on issues arising under patent and U.S. Food and Drug
Administration (FDA) law. Cyr employs her strong technical
knowledge to specialize in working with experts
and inventors in the chemical and pharmaceutical arts.
James M. Eaton, Ph.D., is a patent
attorney at Finnegan, Henderson,
Farabow, Garrett & Dunner,
LLP (11955 Freedom Drive, Reston,
Virginia 20190; Phone: 571203-2414;
Email: james.eaton@
finnegan.com), who focuses his
practice on patent litigation, prosecution,
and strategic counseling in
the pharmaceutical, biotechnology,
and chemical areas. Eaton prosecutes patent applications
and prepares patentability opinions and freedom-tooperate
analyses.
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