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Patents / Biotechnology / US Biotechnology Practice |
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8.1 Direct Infringement In
order to be held as a direct infringer of a United States patent under 35 USC
§ 271(a), it is necessary during the life of the patent to have made, used,
offered to sell
[182]
or sold what is claimed in the patent within the United States or to have
imported the patented invention into the United States. Under this test one
can be liable for patent infringement even though one was unaware of the patent
or that the acts one is carrying out are tortious.
[183]
Furthermore it has long been the law that one does not have to sell the
product one produces to be an infringer of a patent, mere manufacture, at least
if for a commercial purpose will suffice. The possibility of suit against
someone offering a product for sale was added to the statute as part of the
Uruguay Round Amendments Act, taking effect on January 1, 1996. If the offer
for sale originates from the United States there may be an infringement even if
the physical embodiment never enters the United Sates as was the case in
Halmar Robicon Group v. Texas Instruments
[184]
where a letter making an offer for sale originated in Texas but the goods in
question were made in Japan and shipped direct to a customer in Canada. It
appears that the term “offer for sale” in this context may have a
broader meaning than is normal in contract law and may include acts that a
contract lawyer would find to be merely an invitation to make an offer.
[185]
It seems clear, however, that an uncompleted offer to donate an alleged
infringing article is not an infringement.
[186] Limited
use of an invention for non-commercial
experimental
purposes may, however, be permissible without being an infringement. To
succeed with such a defense, it is however, necessary that the use be of an
entirely non-commercial nature.
[187]
[182]
35 USC § 271(i) makes it clear that an offer for sale is only an infringement if
the sale itself will occur before the expiration of the term of the patent.
[183]
As stated by the Supreme Court in
Kewanee
Oil Co. v. Bicron Corp., 416 U.S. 470, 181 USPQ 673 (1974), patent protection "goes not only to copying
the subject matter, which is forbidden under the Copyright Act ... but also
forbids independent creation."
[184]
53 USPQ2d 1501 (W.D. Penn. 1999).
[185]
3D Systems Inc. v. Aarotech Laboratories Inc., 160
F.3d 1373, 48 USPQ2d 1773 (Fed. Cir. 1998) where a price quotation letter was
held to be an offer for sale for the purpose of determining patent
infringement. The issue was considered further in
Rotec
Industries v. Mitsubishi Corp., 55 USPQ2d 1001 where it was held that there was no evidence to prove that an
offer had been made so that the exact definition of what constituted an offer
was not fully decided. The case did, however, make it clear that for there to
be an infringing offer for sale, that which was offered had to be the whole
invention as claimed and not merely a part of it.
[186]
HollyAnne
Corp. v. TFT Inc. , 53 USPQ2d 1201 (Fed. Cir. 1999).
[187]
Roche Products Inc. v. Bolar Pharmaceutical Co., Inc., 221 USPQ 937
(Fed. Cir. 1984) held that the carrying out of experiments with a
view to filing an application with the FDA for approval to market a patented
drug did not fall within the experimental use exception, noting that the
experiments were "solely for business reasons and not for amusement, to satisfy
idle curiosity or for strictly philosophical inquiry". This decision led to
the enactment of 35 USC § 271(e) as part of the Drug Price Competition and Patent
Term Restoration Act of 1984. This is discussed below.
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© Copyright 2002 John Richards - Posted July 2002
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