Janssen-Ortho Inc. and Daiichi
Pharmaceutical Co., Ltd..v. Novopharm Limited
Federal Court (Hughes J.)
T-2175-04 October 17, 2006
2006 FC 1234 online
Anticipation and Obviousness
[98]
Section 2 of the Patent Act, supra, defines an invention in terms of
that which is Ònew and usefulÓ. The Supreme Court of Canada has reminded us
that Òinventive ingenuityÓ has also been an essential requirement for a valid
patent. (Commissioner of Patents v. Farbwerke Hoechst A/G, [1964] S.C.R. 49 at 51).
[99]
The Supreme Court of Canada has recently said
that to be valid, a claimed invention must be new, that is, not previously
disclosed, whether or not it was inventive; it must be useful; and it must
possess inventive ingenuity. (Biolyse Pharma Corp. v. Bristol-Myers Squibb Co., [2005] 1 S.C.R. 533 at para. 1,
2005 SCC 26). The patent monopoly should be purchased with the hard coinage of
new, ingenious, useful and unobvious disclosure (Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153 at para. 37,
2002 SCC 77). The requirement that a patent claim which is ÒnovelÓ has
sometimes been considered by the courts in terms of its antithesis was the
claimed invention ÒanticipatedÓ. Similarly, the requirement of inventive
ingenuity has sometimes been considered by the courts as being of its
antithesis ÒobviousnessÓ.
[100]
As the Federal Court
of Appeal stated in Imperial Tobacco Ltd. v. Rothmans Benson & Hedges Inc. (1993), 47 C.P.R. (3d) 188 at 198,
[1993] F.C.J. No. 135 (QL), anticipation and obviousness are both questions of
fact but each must be approached differently. Anticipation means that your claimed invention, whether or
not it was inventive, was already known to the public, thus cannot be the
subject of a monopoly subsequently given to any one person. Obviousness means that while the claimed
invention may not have been presumably known, it is nonetheless not something
that a person can monopolize since it is something that a person skilled in the
art would have been expected to come up with in any event.
[106]
The House of Lords in
Synthon v. SmithKline
Beecham PLCÕs Patent,
[2005] UKHL 59 para. 19 (Lexis), [2006] 1 All. E.R. 685, [2006] RPC 10 has put
the matter succinctly: there are two requirements for anticipation,
enablement and disclosure.
[107]
The Defendant argues
that the phrases Òpurely by mechanical skillÓ and Òproduce the claimed
invention without the exercise of any inventive skillÓ mean that if an ordinary
person skilled in the art could bring to bear on the publication the understanding
of the day and routine techniques of the day, from which the invention as
claimed would result, there is anticipation. This is not the correct
interpretation of the test for anticipation as set out by the Supreme Court of
Canada.
[108]
The Supreme Court
test requires that the ÒflagÓ be planted at the point of the claimed invention
and that the direction as to how to arrive at that point must be so clear such
that an ordinary person skilled in the art would in every case, without possibility
of error, be led to that point. No such flag is planted and no such direction
is given in either the Õ840 patent or the Daiichi publication. There is no
anticipation of what is claimed in claim 4 of the Patent.
Obviousness
[109]
Inventive ingenuity
is not defined in the Patent Act. Obviousness has only been defined recently in the
post-October 1, 1996 version of the Patent Act, section 28.3 (1993, c. 15, s.33)
as being Òsubject matter that would not have been obvious [at the relevant
date] to a person skilled in the artÉ having regard to information disclosed É
in such a manner that [it] became available to the public.Ó This definition is not different from
the law as it was generally understood previously.
[111]
The classic test for
obviousness as established by the Federal Court of Appeal is that of Beloit
Canada Ltd. v. Valmet
OY (1986), 8
C.P.R. (3d) 289 at 294 [Beloit]:
The classical touchstone for obviousness is the technician
skilled in the art but having no scintilla of inventiveness or imagination; a
paragon of deduction and dexterity, wholly devoid of intuition; a triumph of
the left hemisphere over the right. The question to be asked is whether this
mythical creature (the man in the Clapham omnibus of patent law) would, in the
light of the state of the art and of common general knowledge as at the claimed
date of invention, have come directly and without difficulty to the solution
taught by the patent. It is a very difficult test to satisfy.
[112]
This definition comes
perilously close to that for anticipation as set out by the Supreme Court of
Canada if it is to be interpreted that the person skilled in the art has Òno
scintilla of inventiveness or imaginationÓ and that being led Òdirectly and
without difficultyÓ to Òthe solution taught by the patentÓ means that there
must be only one way so as to inevitably arrive at the invention and that the
Òinvention taughtÕ is different from the claim as properly construed. There
would be no point in considering obviousness if it is, in effect, little
different than a consideration of anticipation.
[113]
A determination of
obviousness on a principled and objective basis requires that the Court take
into consideration a number of factors. These factors may vary in number and
importance dependant upon the circumstances of the case. The Court is not a
scientific body, thus it must take the facts of the case, the opinions of the
experts and the circumstances as presented into consideration and come up with
a weighed decision (Molnlycke AB v. Procter & Gamble Ltd., [1992] FSR 549 (Ch.) (Lexis),
[1994] RPC 49 (Ch.) at 442 ff). The factors to be considered as of the date of
the invention which can be considered as December 1985, include:
1. What is the
invention as claimed? The claim or claims at issue, as construed by the Court
is what are at issue. The ÒinventionÓ as generally expressed in the patent or
by the inventors is not the issue, it is the claim as properly construed.
2. Who is the person
skilled in the art to whom the patent is addressed? To that extent the
uninventive and unimaginative person postulated in the Beloit quotation has
been supplanted by the Supreme Court of Canada in Whirlpool at para.74. The
Court said that while such a person is deemed to be uninventive as part of his
future personality he or she is thought to be reasonably diligent in keeping up
with advances in the field to which the patent relates. The common knowledge of
skilled workers undergoes continuous evolution and growth.
3. What body of knowledge
and information would the ordinary person skilled in the art be expected to have,
or to be reasonably able to obtain, as of the date of the alleged invention?
Not all knowledge is found in print form, much is simply commonly known and
passed from person to person. Just as one might learn to cook at motherÕs
elbow, it is not all in the recipe book. Similarly, not all knowledge
that has been written down, perhaps fleetingly, becomes part of the knowledge
that an ordinary person skilled in the art is expected to know or find.
4. What is the climate in
the relevant field at the time the alleged invention was made? The general
state of the art includes not only knowledge and information but also
attitudes, trends, prejudices and expectations.
5. What motivation existed
at the time the alleged invention was made to solve a recognized problem? There
may have been a general motivation such that everybody in the particular area
was looking for a solution. The more unique and personal the motivation was,
apart from any general motivation, the more one might be expected to be
inventive. If motivation came from an outside source, and common place thought
and techniques can come up with a solution, the less one is expected to have
exercised inventive ingenuity. The United States Supreme Court is expected to
consider the issue of motivation shortly in KSR International Co. v. Teleflex Inc., U.S. No. 04-1350 review granted
6/26/06, scheduled to be heard November 28, 2006.
6. What effort and time
was involved? Were the efforts randomized or focused? In this regard phrases
such as Òworth a tryÓ and Òdirectly and without difficultyÓ and Òroutine
testingÓ have been used by the courts. It is not useful to use such phrases as
they tend to work their way into expressions of law or statements of expert
witnesses. Sachs L.J. deprecated the coining of such phrases in General Tire
& Rubber Company
v. Firestone Tyre & Rubber Company Limited, [1972] R.P.C. 195 at pages
211-12. The length of time and expense involved in the efforts are not, in
themselves, useful considerations as an invention may be the result of a lucky
hit, or be simply the uninventive application of routine, of time consuming and
expensive techniques.
Of
secondary importance are factors arising after the time that the alleged
invention is made since, after all, the Court is to be concerned with
Òinventive ingenuityÓ exercised at the time of making the invention. These
secondary factors include:
7. Commercial
success. Was the subject of the invention quickly and anxiously received by
relevant consumers? This may reflect a fact that many persons were motivated to
fill the commercial market. This may also reflect things other than inventive
ingenuity such as marketing skills, market power and features other than the
invention.
8. Subsequently recognized
advantages. The inventors may have perceived only certain advantages, yet later
those inventors or others may determine that other, previously unrecognized
advantages lay in the alleged invention. This factor is of limited usefulness
in considering inventive ingenuity as of the date of the invention. The
recognition of later advantages, if unexpected, may themselves be the subject
of a patent. To the extent that the United States Courts in cases such as Re
Zenitz 33 F. 2d
924 have placed weight upon subsequently discovered advantages that is not the
law here. Little, if any, weight should be put on this factor.
9. Meritorious
awards, if in fact directed to the alleged invention may be recognition that
the appropriate community of persons skilled in the art believed that activity
to be something of merit.
The most
dangerous of all the factors and one to be avoided or applied only with the
greatest of care is:
10.
Hindsight.
It is far too easy to see how the alleged invention could have been arrived at,
even easily, once it has been done. As some cases say, simplicity does not
negate invention. However, if the number of decisions to be made in arriving at
the solution were few, and commonplace, hindsight may merely confirm that no
inventive ingenuity was required so as to arrive at the solution. If the
points for decision were many and choices abundant, there may be inventiveness
in making the proper decisions and choices.
...
[115]
Therefore, taking all
these factors into consideration, the claimed invention is one of the
enantiomers of Ofloxacin, a known compound, the S(-) enantiomer in a reasonably
pure form. The separation of racemic compounds into their enantiomers was
known, but was a matter of lesser significance in the medicinal chemical world
of the early to mid 1980Õs. Known techniques and devices for separation
of racemic compounds into their enantiomers could only produce minute
quantities of impure material, scarcely enough to interest anyone in
activity. Only Daiichi was motivated to pursue the matter. Once
pressed, it found ways, including a Gerster modification, to produce enough (-)
enantiomer to identify it as the S configuration and to determine that it
exceeded Ofloxacin as an antibiotic and was at least as good in respect of
toxicity; solubility was greater. With some marketing effort,
levofloxacin found a respectable place in the marketplace. Not the
greatest invention, not ÒeurekaÓ, but of sufficient Òinventive ingenuityÓ to
merit valid patent protection as set out in claim 4.
...
[122]
There is no
provision, in section 34(1) for sanctions if a patent fails to describe the
invention correctly, fully and, clearly. However, the Courts have said,
for instance, the Supreme Court of Canada in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of
Patents), [1989] 1
S.C.R. 1623 at 1637-38, [1989] S.C.J. No. 72 at para. 27 (QL) [Pioneer
Hi-Bred], that a
patent must disclose everything that is essential for the invention to function
properly. To be complete a patent must meet two conditions, first it must
describe the invention and define the way that it is produced or built, failing
which it is ambiguous. Secondly, the patent must define the nature of the
invention and how to put it into operation failing which the patent is invalid
for insufficiency.
...
[131]
The ÒoldÓ Patent Act,
section 55(1) provides that the patentee, Daiichi, and persons claiming under
the patentee, Janssen-Ortho, are entitled to all damages sustained by them by reason
of the infringement. Section 57 given the Court the power, in its
discretion to order an injunction and an account of profits. Normally an
order for delivery up or destruction of offending goods would follow an award
of an injunction. As part of the normal function of a superior court of
record, this Court may order pre and post judgment interest at rates and on
terms as it may determine, and costs.
[132] I have reviewed the consideration of remedies recently in Merck & Co. v. Apotex Inc., 2006 FC 524 at paras. 224-41 [Merck] and the Federal Court of Appeal has given its judgment in respect of that decision on October 10, 2006, 2006 FCA 324 revising to some extent the remedies given in that case. The award of profits is an equitable remedy, in Merck I disentitled successful plaintiffs from such an award because of certain conduct of that plaintiff. It is, however, necessary for a party seeking an equitable remedy, such as profits, to show some basis for the exercise of equity. Here the Plaintiffs have made no showing whatsoever. I have no reason, other than the PlaintiffsÕ success, for making such an award. Accordingly, I will not award the election of profits.
[133]
As to an injunction
that remedy normally follows a finding that a valid patent has been
infringed. While this action has gone on for a much lesser time than the Merck, supra, action, here only about two
years, it must be considered that this Court has in other proceedings refused
to prohibit the granting of an NOC to the Defendant so that the Defendant had
entered the market and commenced to sell its levofloxacin products. The
English Court of Appeal in Minnesota Mining & Manufacturing Co. v. Johnson & Johnson Ltd., [1976] RPC 671 at 676 et seq reviewed the importance of the
exercise of discretion in awarding a permanent injunction. Accordingly,
an injunction will be granted, but to take effect only after thirty days from
the date of issuing of these Reasons that is the period of time allowed for
filing an appeal. In that time the DefendantÕs may continue to sell or otherwise
dispose of its levofloxacin products already in its possession, custody or
control, but only in the normal course of business and provided that all monies
received in respect thereof are accounted for and held in a separate trust fund
to be paid to the Plaintiffs or as they may direct by December 31, 2006.
These monies are to be taken into consideration, by way of set off or
otherwise, when a final calculation as to damages is made.
[134]
With respect to
delivery up or destruction of levofloxacin products, the Defendant may elect to
destroy the product that it has on hand at the end of the thirty day period
referred to above, or to deliver up that remaining product to the Plaintiffs,
as they may direct. Delivery up should be made within the Greater Toronto
area where the Defendant carries on business. If delivery up is to be
made outside that area, the Plaintiffs should bear the cost.
[135]
Pre-judgment interest
is allowed in respect of any monetary award of damages. It should not be
compounded. The rate of such interest should be calculated separately for
each year since the infringing activity began at the average annual bank rate
established by the Bank of Canada as the minimum rate at which it makes short
term advances to the banks listed in Schedule I of the Bank Act, R.S.C. 1985, c. B-1.
[136]
Post-judgment
interest, not compounded, follows the establishment of the quantum of damages
at the rate of five percent (5%) established by the Interest Act, R.S.C 1985, c. I-15, s.4.