Patents

    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rejection of the per se claims was withdrawn by the Commissioner.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