IN THE CANADIAN PATENT OFFICE
DECISION OF THE COMMISSIONER OF PATENTS
Patent application number 547,163, having been rejected under
Subsection 47(2) of the Patent Rules, the applicant asked that
the Final Action of the Examiner be reviewed. The rejection has
consequently been considered by the Patent Appeal Board and by
the Commissioner of Patents. The findings of the Board and the
ruling of the Commissioner are as follows:
Agent for Applicant
Cowling, Strathy & Henderson
160 Elgin Street, Suite 2600
Ottawa, Ontario
K1P 1C3
COMMISSIONER'S DECISION SUMMARY
C.D. 1201 ....Application No. 547,163 (J70;K20)
Per se claims for microbiologically produced antibiotics
The examiner rejected per se claims for novel antibiotics
produced by a microbiological process on the grounds that Section
39(1) of the Patent Act as it read at the time did not allow an
applicant to make such claims; process dependent claims being the
only type allowed. On the recommendation of the Board the
rejection of the per se claims was withdrawn by the Commissioner.
This decision deals with the Applicant's request that the
Commissioner of Patents review the Examiner's Final Action on
patent application number 547,163 (Class 195-89) which was filed
on September 17, 1987 for an invention entitled "GLYCOPEPTIDE
ANTIBIOTICS A82846 FROM NOCARDIA ORIENTALIS". The inventors are
Robert L. Hamill, James A. Mabe, David F. Mahoney, Walter M.
Nakatsukasa and Raymond C. Yao and the application was assigned
to Eli Lilly and Company. The Examiner in charge issued the Final
Action on December 2, 1991 refusing claims 5 to 1.2 and 16 to 18,
claims 1 to 4 and 13 to 15 being declared allowable. The
Applicant replied on June 2, 1993 requesting a review by the
Commissioner and an oral hearing before the Patent Appeal Board.
Consequently an oral hearing was held on August 10, 1994 at which
Mr. David Watson and Dr. John Rudolph of Cowling, Strathy &
Henderson represented the Applicant, Dr. Isaac Ho and Dr. Michael
Gillen represented the Patent Branch and the Board was comprised
of Mr. Peter Davies as chairman and Dr. Michael Howarth as
member.
The application is directed to novel glycopeptide antibiotics of
the vancomycin group. In particular it relates to antibiotic
A82846, to its individual components A82846A, A82846B and A82846C
and to their preparation by cultivation of novel strains of the
micro-organism Nocardia orientalis designated as NRRL 18098, NRRL
18099 and NRRL 18100 in a culture medium containing assimilable
sources of carbon, nitrogen and inorganic salts. Antibiotic
A82846 is structurally similar to vancomycin but is disclosed to
have improved in vitro and in vivo activity against Gram-positive
bacteria as well as improved pharmacokinetics resulting in a much
longer half-life than that of vancomycin.
The application contains claims 1 to 3 directed to processes for
producing the disclosed antibiotics, claim 4 directed to a
biologically purified culture of the disclosed Nocardia
orientalis strains, claims 5 to 7 and 13 to 15 directed to the
antibiotics claimed in process dependent manner, claim 8 directed
to the glycopeptide antibiotic which can be produced by
fermentation of Nocardia orientalis, claims 9 to 12 directed to
the disclosed antibiotics in per se form, claims 16 and 17
directed to compositions containing the novel antibiotics and
claim 18 directed to the use of the novel antibiotics as
antimicrobial agents. Claims 5, 8 and 9, which are typical of the
claims rejected, are as follows:
5. Antibiotic A82846, A82846A, A828468 or A82846C, or s
pharmaceutically acceptable salt thereof, whenever prepared by a process
according to claim 1, or by an obvious equivalent thereof.
8. The glycopeptide antibiotic which can be produced by submerged
aerobic fermentation of Nocardia orientalic NRRL 18098, NRRL 18099 or
NRRL 18100 in a culture medium containing assimitable sources of carbon,
nitrogen and inorganic salts.
9 Antibiotic A82846, having the following structural formula
<IMG>
wherein X is H or Cl and Y is Cl or H.
In the Final Action two objections to the claims were made:
firstly, the Examiner rejected process dependent product claims 5
to 7 for the use of the expression "or by an obvious equivalent
thereof" and secondly the Examiner rejected claims 8 to 12 and 16
to 18 for not being in the form required by Subsection 39.(1) of
the Patent Act.
In rejecting claims 5 to 7 the Examiner stated that:
Claims 5 to 7 are rejected as being indefinite and lacking support within the
disclosure. The term "obvious equivalent thereof" renders the scope of the
claim indefinite end must therefore be avoided. Further, Applicant provides
no support for any methods of producing the antibiotics of the instant
application, other than that defined in claim 1.
Both in its response to the Final Action and at the Hearing the
Applicant has submitted that it is entitled by law to include the
rejected expression in the claims and has referred to the
acceptance by the Patent Office of the use by applicants of the
term "obvious chemical equivalents" in chemical product by
process claims, which warding tracks the wording of Subsection
39.(1) of the Act [Patent Act R.S., 1985, c. P-4]. The subsection
at the time the application was filed and prior to its repeal
read as follows:
In the case of inventions relating to substances prepared or produced by
chemical processes and intended for food or medicine, the specification shall
not include claims for the substance itself, except when prepared or produced
by the methods or processes of manufacture, particularly and claimed
or by their obvious chemical equivalents.
The Applicant has adopted the words "obvious equivalents" rather
than "obvious chemical equivalents" as being more appropriate in
this case since the processes in question are microbiological
processes rather than chemical processes. In Applicant's
submission the claimed wording reflects the protection to which
the Applicant is entitled to as a matter of law. Thus, whilst the
repeal of the subsection with the 1987 amendments to the Patent
Act merely made it unnecessary to claim products intended for
food or medicine in process dependent form it is contended that
it did not take away the Applicant's rights to claim obvious
equivalents. In support of its submission the Applicant has
referred to two court decisions where the term "obvious chemical
equivalent" was present in the claims considered.
Firstly in the Exchequer Court decision in C.H. Boehringer Sohn
v. Bell-Craig Ltd. 39 C.P.R. 201, affirmed 41 C.P.R. 1 the Court,
in deciding whether claim 8 of the patent in question had been
infringed by the defendant, had to consider whether the
defendant's process was an obvious chemical equivalent of the
claimed process. In coming to its conclusion that the defendant's
process was not an obvious chemical equivalent of the process
described in the patent the Court however gave no indication that
the use of the term "by any obvious chemical equivalent" in the
claim was anything other than acceptable practice.
The second case referred to by the Applicant is the Exchequer
Court decision in Jules R. Gilbert Ltd, v Sandoz Patents Ltd. 64
C.P.R. 14; 8 C.P.R. (2d) 210. In this decision it was held that
claim 9, which claimed a therapeutically tolerable salt of 3-
methylmercapto-10-[-2'-(N-methyl-piperidyl-2'')-ethyl-1'-]-
phenothiazine whenever prepared by the process of claim 5 or by
any chemically equivalent process, was invalid because the
process of claim 5 had not been properly disclosed. In the
Supreme Court this finding was reversed and claim 9 was found to
be valid. In both of these decisions there was no indication that
the use of the term "chemically equivalent process" in claim 9
went to the root of the issue.
While these two court decisions show that reference to obvious
chemical equivalents was acceptable when the legislation
specifically referred to it the Board is not convinced that the
same can be said of the term "obvious equivalent" since there is
no reference to that term in the section that replaced former
Subsection 39.(1). It is the Board's opinion that if it had been
Parliament's intention that a patentee be allowed to claim the
obvious equivalents of a microbiological process it would have
included the term in the new subsection. The fact that the term
was not included can therefore be taken to mean that an applicant
cannot as a matter of course employ language in a claim to cover
obvious equivalents. The Board therefore considers that the
Applicant is not by law entitled to use the term "obvious
equivalent" in the claims.
It is therefore the Board's view that the term "or obvious
equivalents" must be considered on its own merits using the
general principles of claim construction. In this regard the
Board finds that the inclusion of the term "or obvious
equivalents" introduces an ambiguity into the claim. It cannot
be determined what these equivalents are and as stated by the
examiner, and not contradicted by the Applicant, the disclosure
does not provide any information as to what these obviously
equivalent processes might be. The Board therefore finds that
the term renders the claims indefinite and recommends that the
rejection of claims 5 to 7 be affirmed.
Turning now to the rejection of claims 8 to 12 and 16 to 18 for
non-compliance with the requirements of Subsection 39.(1) of the
Act the Examiner in her Final Action stated that:
Contrary to Applicant's arguments, applications that are governed by tire
provisions of subsection 39(1) of the Patent Act and that,were filed
October 1, 1989, the proclamation date of the Act to amend the Patent Act,
may not be issued containing product claims even after this subsection
ceased to have effect on November 19, 1991.
Section 27 of the Act to amend the Patent Act, which is a transitional suction,
specifies that applications filed before the coming into force of the amen
Patent Act "shall be dealt with and disposed of" according to the Patent Act as
it read immediately before October 1, 1989.
Since subsection 39(1) came into force upon Royal Assent on November 19,
1987, prohibiting the inclusion in the specification of claims to the naturally
occurring substances intended for food of medicine and prepared by, or
significantly derived from microbiological processes, this subsection as it now
reads was in effect when the amended Patent Act was proclaimed on October
1, 1989.
Consequently, all applications filed before October 1, 1989 are to be dealt with
and disposed of in accordance with the prohibition of subsection 39(1),
notwithstanding the expiry of this subsection on November 19, 1991.
Since Subsection 39.(1) deals with inventions which relate to
naturally occurring substances produced by microbiological
processes the remainder of the Final Action was concerned with
the question of whether or not the substances disclosed in the
application are in fact naturally occurring substances within the
meaning of the subsection. It is the Applicant's contention that
the disclosed antibiotics are not naturally occurring and
therefore not within the subsection. In its response to the Final
Action the Applicant submitted claims 19 to 26 which are directed
to pharmaceutically acceptable salts of the disclosed antibiotics
and asked that they be considered by the Commissioner. These
claims are said to be clearly directed to substances which cannot
be said to be naturally occurring since they are prepared by the
chemical reaction of the antibiotics with a suitable salt forming
reactant.
At the hearing in presenting the case for the allowability of
claims 8 to 12 and 16 to 18 Mr. Watson dealt with whether or not
the disclosed antibiotics are naturally occurring and also with
the interpretation of Subsection 39.(1) while Dr. Rudolph dealt
with the effect of the North American Free Trade Agreement
(NAFTA) on the interpretation of the subsection. After
considering the material filed in this case and the presentations
given at the hearing the Board has concluded that the Examiner's
position is based on a misinterpretation of the provisions found
in the statute, particularly in the transition clause.
An Act to amend the Patent Act and to provide for certain matters
in relation thereto [Chapter 33 (3rd Supp.) R.S. 1989] will
hereinafter be referred to as Bill C-22. Bill C-22, which was
given Royal Assent on November 19, 1987, made a number of changes
to the Patent Act, one of which was to what had been Subsection
39.(1). This subsection had required an applicant for a patent
relating to a substance produced by a chemical process and
intended for food and medicine to claim the substance in process
dependent form. The new subsection introduced in Bill C-22
however required an applicant for a patent relating only to a
naturally occurring substance which had been prepared by a
microbiological process and intended as a food or medicine to
claim the substance in process dependent form. The change was
clearly intended to increase the patent protection afforded to
the inventors of substances intended for food or medicine and
prepared by non-microbiological processes by allowing them to
claim the substances without any process limitations, i.e. in per
se form.
Clause 14 of Bill C-22 which detailed the new subsection reads as
follows:
14. Subsection 39(1) of the said Act is repealed and the following substituted
therefor:
"39. (1) In the case of inventions relating to naturally
occurring substances prepared or produced by, or significantly
derived from, microbiological processes and intended for food or
medicine, the specification shall not include claims for the
resulting food or medicine itself, except when prepared or
produced by or significantly derived from the methods a
processes of manufacture particularly described and claimed.
(1.1) Subsection (1) ceases to have effect four years after
the coming into force of that subsection."
The Board agrees with the Examiner that Subsection 39.(1) came
into force on November 19, 1987 when Bill C-22 was given Royal
Assent and ceased to have effect according to the provisions of
Subsection 39.(1.1) on November 19, 1991. However the Board
disagrees with the Examiner's interpretation of transition clause
28 of Bill C-22. Clause 28 is as follows:
28. Applications for patents filed before the coming into force of the provisions
of this Act referred to in subsection 33(1) shall be dealt with and disposed of
in accordance with the Patent Act as it read immediately before the coming
into force of those provisions.
The Examiner in her Final Action has taken the position that the
Act in general was proclaimed on October 1, 1989 and that
transitional clause 28 somehow modifies the application of
Subsection 39.(1) of the Patent Act to pending applications. The
Examiner contends that Section 28 states that any application
filed before the coming into force date October 1, 1989 must be
dealt with in accordance with the Act as it read immediately
before that date. Since it is accepted that new Subsection 39.(1)
was in force on October 1, 1989 it is argued that all
applications pending at that date must be dealt with under that
subsection, notwithstanding the provisions of Subsection
39.(1.1). In other words any applications filed before October 1,
1989 relating to naturally occurring substances prepared by
microbiological processes should not be allowed with anything but
process dependent product claims. The expiry of the subsection in
November 19, 1991 is said not to apply to applications filed
before October 1, 1989.
In the Board's opinion this interpretation of the amended Patent
Act is based on an apparent misinterpretation of transitional
Clause 28. Transitional Clause 28 sets out how applications for
patents are to be treated during the changeover from the old to
the new legislation. However a reading of the section
demonstrates that the section is concerned only with certain
parts of Bill C-22, namely the provisions referred to in
Subsection 33(1) of the Bill which appears in Bill C-22 under the
heading "Coming Into Force". Transitional Clause 33 is as
follows:
33. (1) The definition of "priority date") in section 2 of the Patent Act, as
enacted by subsection 1(2) of this Act, sections 2, 5, 7 to 13 and 16 to 25 and
subsection 27(1) of this Act, or any of those sections or subsections, shall
come into force on a day or days to be fixed by proclamation.
(2) Sections 39.1 to 39.25 of the Patent Act, as enacted by section 15
of this Act, or any of those sections, subsections 27(2) and (3) of this Act or
either of those subsections, and section 31 of this Act shall come into force on
a day/or days to be fixed by proclamation.
The effect of these coming into force provisions was to divide
the legislation into three principal parts with each part having
a separate coming into force date. The first part relates to
those sections of Bill C-22 which are not mentioned in
Subsections 33(1) and (2) and which therefore came into force
upon Royal Assent on November 19, 1987. Since this first part
included Clause 14 of Bill C-22 relating to the changes under
consideration new Subsections 39.(1) and (1.1) clearly came into
force on November 19, 1987. The second part is described in
Subsection 33(2) of the coming into force provisions and relates
to the compulsory licensing provisions of Sections 39.1 to 39.25
as enacted under Clause 15 of Bill C-22. These provisions came
into force by royal proclamation on December 7, 1987. The third
part of Bill C-22 as described in Subsection 33(1) of the coming
into force provisions came into force by royal proclamation on
October 1, 1989. In the Board's opinion these three parts of Bill
C-22 were explicitly designed to operate independently of each
other to provide for full flexibility in the implementation of
the differing provisions of Bill C-22.
Thus transitional Clause 28 by referring only to those provisions
of the Act referred to in Subsection 33(1) specifically excluded
Clause 14 from consideration. In other words Clause 28 does not
require that the provisions of Subsection 39.(1) be applied to
pending applications filed before October 1, 1989 as contended by
the Examiner. In the Board's view the most reasonable
interpretation of the transitional sections of Bill C-22 is that
Subsection 39.(1) came into force on Royal Assent on November 19,
1987 and according to Subsection 39.(1.1) ceased to have effect
four years later on November 19, 1991. The coming into force date
of October 1, 1989 of other sections of Bill C-22 therefore has
no influence on the operation of the provisions of Section 39.
The effect of this is that any application relating to naturally
occurring substances prepared by microbiological processes and
pending on November 19, 1991 was allowed to contain claims to the
substances without any process limitations whatsoever regardless
of its filing date and to issue with those claims.
This same conclusion can be drawn from the clear and ordinary
meaning of the language employed in Clause 28 of Bill C-22.
Clause 28 stipulates that applications filed before October 1,
1989 are to be dealt with and disposed of in accordance with the
Patent Act as it read immediately before October 1, 1989.
Immediately before October 1, 1989 both subsection 39.(1) and
39.(1.1) were included in the Act viz. subsection 39.(1) which
introduced the prohibition on claiming in the microbiological
area and subsection 39.(1.1) the repeal of subsection 39.(1). It
follows that applications/filed before October 1, 1989 must be
dealt with and disposed of taking into account the repeal that
came into effect on November 19, 1991.
It is therefore the Board's opinion that subsection 39.(1) came
into force on November 19, 1987 and continued in force until the
provisions of subsection 39.(1.1) became operative four years
later, i.e. on November 19, 1991. From the period November 19,
1987 until November 19, 1991 no patent would be allowed to issue
containing claims to a naturally occurring substance intended for
food or medicine and prepared by a microbiological process unless
the substance was claimed in process dependent fashion. After
November 19, 1991 Section 39 ceased to have effect so that any
patent issuing after that date was allowed to contain claims to
naturally occurring substances with no process limitations. In
other words inventions relating to naturally occurring substances
intended for food or medicine and prepared by microbiological
processes were to be treated no differently than substances
intended for food or medicine and prepared by chemical processes
or indeed from substances intended for entirely different uses
such as pesticides, insecticides, lubricants. etc.
Since it has been decided that the Applicant is entitled to per
se claims for the antibiotics disclosed in its application on the
grounds that Subsection 39 of the Act/clearly ceased to have
effect on November 19, 1991 the Board has not found it necessary
to consider the other submissions made by the Applicant, such as
whether or not the disclosed antibiotics are naturally occurring,
whether or not the subsection discriminates against certain
applicants and what the possible effect of the recent NAFTA
legislation on the subsection might be. Nor has the Board found
it necessary to consider claims 19 to 26 which were submitted by
the Applicant in its response to the Final Action. The Board
therefore recommends that the rejection of claims 8 to 12 and 16
to 18 be withdrawn.
In conclusion the Board recommends that the rejection of claims 5
to 7 be affirmed but that the rejection of claims 8 to 12 and 16
to 18 be withdrawn.
P.J. Davies M. Howarth
Chairman Member
Patent Appeal Board Patent Appeal Board
I concur with the findings and the recommendation of the Board.
Accordingly, I withdraw the rejection of claims 8 to 12 and 16 to
18 and uphold the rejection of claims 5 to 7. Consequently I
refuse to grant a patent containing claims 5 to 7. Under the
provisions of Section 41 of the Patent Act the Applicant has six
months within which to appeal this decision to the Federal Court
of Canada.
M. Leesti
Commissioner of Patents
Dated at Hull, Quebec
this 13h day of January 1995