Beecham Group Plc v Lek D.d. Ljubljana, Pharmaceutical & Chemical Company

[1995] APO 31

official notice

decision of a dePUTY commissioner of patents

Application        :    No. 525089 in the name of Beecham Group plc

Title:   

Action:    Application for an extension of term of the Patent, and Opposition thereto by Lek d.d. Ljubljana, Pharmaceutical & Chemical Company

Decision:    Issued            . 

A claim in a specification is a vehicle for defining the invention. The requirements of a claim are essentially set out in s.40.

The requirement that an invention be novel, have an inventive step, be a manner of new manufacture, and have utility, are requirements of an invention in order for it to be a patentable invention. They are not requirements of a claim per se, but of the invention as expressed by the vehicle of the claim.

The reference in s.74 to 'the proposed claim or claims' being 'in accordance with this Act' does not bring into a s.74 opposition the grounds of novelty, inventive step, manner of new manufacture, or utility.

patents act 1990

decision of a dePUTY commissioner of patents

Re:525089 in the name of Beecham Group plc, an application for an extension of term of the Patent, and Opposition thereto by Lek d.d. Ljubljana, Pharmaceutical & Chemical Company

background

This matter concerns a preliminary point regarding the scope of opposition under s.74 to an application for an extension of term of a patent under s.70 of the Patents Act 1990.

The patentee of 525089 applied for an extension of term of that patent. The term of the patent expired on 6 October 1994. As this date is before 1 July 1995, the patent is not entitled to a 20 year term by reason of the operation of the Patents (World Trade Organization Amendments) Act 1994; and s.70, repealed by that Act, remains in force for this patent - see s.7 of that Act

The application for an extension of term was opposed on 16 May 1994. The statement of grounds and particulars includes allegations of lack of novelty, lack of inventive step, manner of manufacture, and lack of utility [which for convenience, and having regard to how the matter was argued, I will hereafter refer to as novelty (etc)]. Evidence in support of these grounds has been served.

The patentee requested a determination of whether or not those grounds can be raised in an opposition under s.74, and consequential directions. They observed that if it was possible to challenge the patent on these grounds, their evidence is likely to be extensive, and may take considerable time to collect. The opponent agreed to a hearing.

The hearing in the matter was held in Sydney on 15 May 1995. The patentee was represented by Mr B. Cain of counsel instructed by Davies Collison & Cave. The opponent was represented by Dr. A Bennett of counsel, instructed by Griffith Hack & Co. At the hearing, agreement was reached between the parties regarding a direction that the time for serving evidence in answer should be three months from the date of this decision.

the issue

The issue to be determined is the scope of the phrase in s.74(a) setting out the first of two grounds of opposition - viz:

"that the application for the extension, the marketing approval certificate, or the proposed claim or claims, is or are not in accordance with this Act;"

The opponent argues that the requirement of the claims being "in accordance with this Act" is a requirement that inter alia the proposed claims define a novel non-obvious invention, are directed to a manner of new manufacture, and define an invention which has utility.

The patentee argues that the Act makes a clear distinction between the requirements for claims, and those for inventions. S.40 sets out the principle requirements for claims; the requirements of novelty, non-obviousness, manner of new manufacture, and utility, are requirements of an invention - not of a claim. On this basis s.74(a) does not bring these requirements into a s.74 opposition.

discussion

The key issue in this matter is the statutory relationship between inventions and claims. The starting point is to consider the requirements the Act places on the claims. The dictionary to the Act defines "claim" in the following terms:

"claim" means:

(a)when used as a noun in relation to a patent-a claim (including a dependent claim) of the specification relating to the complete application on which the patent was granted; and

(b)when used as a noun otherwise than in relation to a patent-a claim (including a dependent claim) of a complete specification; and

(c)when used as a verb-to claim in a claim (including a dependent claim) of a complete specification;

which definition does not provide any particular assistance in the present matter. I then turn to s.40 of the Act, which inter alia sets out requirements of claims. The principle requirements there set out are that a claim:

-must DEFINE an invention [s.40(2)(b)] - contrast with claims of the form "My invention works better than others'", which are submitted by inexperienced applicants;

-must be clear [s.40(3)];

-must be succinct [s.40(3)];

-must be fairly based on the description [s.40(3)]; and

-must relate to only one invention [s.40(4)].

I note that these requirements can all be assessed on the basis of the specification in isolation; no knowledge of the prior art base is required.

It is then appropriate to consider how the Act deals with the issues of novelty (etc). A scan through the Act gives the following examples:

s18in specifying what is a patentable invention, refers to an invention "so far as claimed in any claim";

s23in referring to invalidity by certain publications, refers to an invention "so far as the invention is claimed in any claim";

s25in dealing with patents of addition and possible anticipation by the parent, refers to "the invention, so far as claimed";

s59 and 138, dealing with oppositions and revocation, refer to a patentable invention - ie s.18, which refers to an invention "so far as claimed in any claim".

There are two common themes. Firstly, the Act refers to the novelty (etc) of 'the invention' - not of the claim per se; and makes a distinction between 'invention', and 'patentable invention'. Secondly, the claims only appear in the context of identifying the relevant invention - that is, the invention 'so far as claimed ...'. Nowhere in the Act can I find any reference or suggestion that the claim per se must be novel (etc), or the like.

It thus seems to me that the claims are no more than a vehicle for defining the "invention". The vehicle must comply with certain statutory requirements (essentially those of s.40). The requirements for novelty (etc) are not requirements of that vehicle per se - they are requirements of "the invention" in so far as it is expressed by the vehicle. It follows that a requirement that a claim must comply with the requirements of the Act is quite different from a requirement that an invention "so far as claimed" must comply with the requirements of the Act.

Dr Bennett argued that the requirement for novelty (etc) was available by way of s.40 of the Act. She argued that it was imported into s.40 by reason of the reference in s.40(2)(b) to the claim defining the invention (and the s.40(4) reference to the claims relating to one invention only) through the definition that an invention must be a manner of new manufacture - with (for example) novelty being required for a "new" manufacture. I do not agree. The dictionary defines invention as:

"invention" means any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention

Her proposition gives inadequate attention to the last clause of this definition - viz "and includes an alleged invention". That simple qualification makes manifestly clear that a mere reference to "invention" imports no assumptions as to whether or not an invention is a patentable invention - whether or not it is novel (etc). The references in s.40 to invention are equally references to alleged inventions, and by necessary implication references to inventions that are not novel (etc).

The significance of alleged invention is further illustrated by s.18(1), which sets out the requirements for a patentable invention - viz, "a patentable invention is an invention that ...". Thus, for example, an invention is not a patentable invention if the invention is not novel [s18(1)(b)]. This illustrates that the requirement of novelty is not inherent in the reference to 'an invention'; rather it is a requirement of a 'patentable invention'. See also Commissioner of Patents v Microcell Ltd., (1959) 102 CLR 232 at page 236 where Menzies J. discusses the identical definition of invention in the 1952 Act:

"... I regard the last words of the definition of "invention" (which have their origin in the Patent Design and Trade Marks Act 1883, sec 46) as intended to do no more than make clear that when an application is made it can proceed in accordance with the Act without the application having to establish as a pre-requisite to any step being taken that it is for an invention, i.e. a manner of new manufacture and that the Commissioner is not bound by the applicant's allegation  that his manner of manufacture is new any more than by the allegation that what is claimed is a manner of manufacture." 

I also observe that both s.59 and 138 include a specific requirement for compliance with s.40(2) and (3), in addition to the ground of 'patentable invention'. Also, s.18 (setting out what constitutes a patentable invention) makes no reference to the requirements of s.40. That is, the statute has been drafted on the basis that issues of novelty (etc) are distinct from those of s.40.

I therefore conclude that there is no basis to import into s.40(2)(b) or 40(4) a requirement that the claim must define a novel (etc) invention. [As an aside I note that the same issue arises with respect to s.102(2)(b)].

The opponent also argued that if s.74 was intended to refer solely to compliance with s.40, then s.74 could have easily referred to s.40 alone; the fact that s.74 does not explicitly refer to s.40 means that it must have broader application (and suggested that this meant that novelty (etc) was incorporated in s.74). I agree with this submission to the extent that s.74 by its wording must go beyond s.40. However I note that the reference to 'this Act' includes the Regulations (see the Dictionary to the Act), and schedule 3 of the Regulations sets out certain formality requirements for claims - see paras 5(4) and 8(3)(a) - which the Commissioner would expect to be complied with. I therefore see no reason to infer the presence of a requirement of novelty (etc) in s.74.

The opponent did not indicate any other specific section of the Act as giving cause to the interpretation that novelty (etc) is a requirement of claims per se, and I am not aware of any basis elsewhere in the Act. In my view the Act is drafted on the basis that the claims are no more than a vehicle to define an invention; and the requirements for that vehicle are essentially set out in s.40. In contrast, the requirements of novelty (etc) are requirements of the invention in order for it to be a patentable invention; most importantly, they are requirements of the invention as conveyed by the vehicle (claim), and not requirements of the vehicle per se.

Consequently, the reference in s.74 to the claims complying with the requirements of the Act does not bring into the opposition any requirement relating to novelty, inventive step, manner of new manufacture, or utility, of the invention.

Peripherally I would observe that this finding is consistent with the overall construction of the Act. Thus:

1. With the limited exception of re-examination, the provisions of the Act and Regulations enabling the Commissioner to determine the issues of novelty, inventive step, and manner of new manufacture procedurally all occur before the grant of the patent - which in the present case was some 12 years ago; and

1. The issue of utility of a patent is not elsewhere available for determination by the Commissioner.

Further, an extension of term is for a period of 4 years. An opposition process that would potentially last for the larger portion of that period seems incongruous. Additionally, if a patent has reached the end of its 16 year term without its validity being challenged, it would seem reasonable for the Commissioner to proceed on the assumption that the claims of that patent are novel (etc) [with a possible exception if the claims are plainly invalid]. The requirement of s.70(1) that the substances claimed must fall within the scope of the claims of the specification ensures a continuation of that presumption without requiring a new investigation of novelty (etc).

Finally, both parties addressed me at some length on E.I. DuPont v Cadbury Schweppes P/L 16 FCR 437. This is a decision under Part IX of the 1952 Act for an extension of term based on inadequate remuneration. I do not believe that this decision has any great relevance to the present case, due to the change in the legislation. However I do note its consistency with the proposition that in extension of term proceedings there is an operative presumption that the claims of the patent are valid unless they are plainly invalid.

Directions

Having regard to my findings, I make the following directions with regard to the conduct of the opposition to the extension of term of patent 525089.

1. Particulars which relate to whether the invention claimed in the proposed claims is prior published or not novel, does not involve an inventive step, is not a manner of manufacture, or lacks utility are not available for consideration in the opposition;

1. The period for serving evidence in answer will expire three months from the date of this decision.

Costs

In accordance with the general principle that costs follow the event, I award costs against the opponent Lek d.d. Ljubljana, Pharmaceutical & Chemical Company.

D Herald
Deputy Commissioner of Patents

Patent attorneys for the applicant  :  Davies Collison Cave, Melbourne

Patent attorneys for the opponent   :  Griffith Hack & Co., Sydney