Merck Patent GmbH v Virbac (Australia) Pty Limited, Pitman-Moore Australia Limited, and Ancare Distributors Limited

[1992] APO 70

official notice

decision of a delegate of the commissioner of patents

Patent: No. 485552 in the name of MERCK PATENT GmbH

Title             : 2-ACYL-4-OXO-PYRAZINO-ISOQUINOLINES

Action: Application under section 70 (Patents Act 1990) for extension of the term of the patent in respect of the substance Praziquantel, and oppositions thereto by 1. VIRBAC (AUSTRALIA) PTY LIMITED,

2. PITMAN-MOORE AUSTRALIA LIMITED, and

3. ANCARE DISTRIBUTORS LIMITED.

Decision: Issued            .  An extension of term is granted for a pharmaceutical substance per se. The fact that a pharmaceutical substance has a use additional to human use is not relevant to whether an extension of term ought to be granted.

Claim 34 (insofar as it refers to a compound mixed with animal feed or feed concentrate), and claim 35 (insofar as it refers to example 60 which illustrates veterinary use only) are not directed to a pharmaceutical substance.

The claims must not claim matter other than the pharmaceutical substance or substances to which the application relates. "Relates" fundamentally refers to the specific substance or substances identified in the s70 application, but it is appropriate to have regard to how a person skilled in the art would interpret the identification of those substances in the specification. Proposed claims which include salts of Praziquantel claim matter other than the pharmaceutical substance or substances to which the application relates.

Patentee allowed 60 days to amend the proposed claims, under s.75(3).

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 485552  by MERCK PATENT GmbH, an application under section 90 (Patents Act 1952) for extension of the term of the standard patent, and oppositions thereto by VIRBAC (AUSTRALIA) PTY LIMITED, PITMAN-MOORE AUSTRALIA LIMITED, and ANCARE DISTRIBUTORS LIMITED.

background

Patent no. 485552 was applied for on 16 December 1974 as application no. 76438/74. The application was advertised accepted on 11 August 1977; there was no opposition to the grant of a patent, and the application was sealed on 25 November 1977.

The 16th year of the term of the patent expired on 16 December 1990. On 7 February 1990 the patentee applied under section 90 (Patents Act 1952) for the extension of the term of the patent; although this date was after the end of the 15th year of the patent, it was within the time provided by subsection 11(1) of the Patents Amendment Act 1989 (which provides certain transitional provisions.)

On 7 May 1990 the patentee requested an amendment of the application; that amendment was allowed on 1 June 1990.

On 4 March 1991 the patentee filed a Marketing Approval Certificate and proposed claims. The application was advertised for opposition in the Official Journal of Patents of 26 April 1991 (that is, before the commencement of the Patents Act 1990.)

On 26 July 1991 notices of opposition were filed by Virbac (Australia) Pty Limited, Pitman-Moore Australia Limited, and Ancare Distributors Limited. I note peripherally that I understand the opponents to be associated with veterinary medicine.

After some correspondence between the parties and the Office concerning the transitional provisions of the Patents Act 1990, each of the opponents filed their evidence in support together with an application under s223 to extend the time for serving that evidence. The patentee served its evidence in answer on 30 June 1992.

On 26 May 1992, the patentee filed a revised set of proposed claims, restricted to 5 only of the previously proposed claims.

The matter was heard in Sydney on 4 November 1992. The patentee was represented by Dr Annabelle Bennett of counsel, instructed by Mr G Gordon (patent attorney of Davies Collison Cave, Sydney); the opponents were represented by  Mr David Yates of counsel, instructed by Mr J O'Connor (patent attorney of Spruson & Ferguson, Sydney).

Although the request for extension of term was made under section 90 (Patents Act 1952), the matter is to be determined as a request under section 70 (Patents Act 1990) by reason of section 235(1); at the hearing, the parties concurred.

submissions

Although the evidence filed by the opponents raised a number of issues, at the hearing the only issue argued by the opponents related to the scope of the terms "pharmaceutical substance" and "therapeutic use". Specifically, the opponents contend that the provisions of the Act permit the grant of an extension of term of a patent only if the proposed claims are restricted in some manner to the use of the pharmaceutical substance in humans.

The patentee submitted that, providing the substance had a pharmaceutical use, it was entitled to the extension of term of the patent in respect of that substance per se, unfettered by any limitations on use.

Documentation

The following are relevant extracts from the documentation filed by the patentee in respect of its application for an extension of term.

The application

We, Merck .... apply for an extension of Patent No. 485552 (Application No. 76438/74) in respect of the following pharmaceutical substance(s):

Praziquantel

2-(Cyclohexylcarbonyl)-1,2,3,6,7-11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one.

Note; Praziquantel is monograph No. 7609 in the
"Merck Index", 10th Edition

[Note: the portion in italics was added by amendment referred to above.]

The Marketing Approval Certificate

I, a delegate of the Secretary to the Department of Community Services and Health, give a marketing approval certificate under section 92 of the Patents Act 1952 to:

MERCK PATENT GESELLSCHAFT MIT BESCHRANKTER HAFTUNG

in respect of an application for a marketing approval certificate made on 26th Day of November 1990 in respect of the following pharmaceutical substance:

PRAZIQUANTEL which is described in the attached schedule dated 26 Day of February 1991

and I certify:

(a)that the substance is a pharmaceutical substance as defined in section 6 of the Act; and

(b)that I, BREWSTER CHARLES EARNFAUNCE ASHLEY, on 19 November 1990 approved the marketing of a product containing the substance in Australia

dated 26 Day of February 1991.

SCHEDULE TO MARKETING APPROVAL CERTIFICATE FOR PRAZIQUANTEL DATED 26 DAY OF FEBRUARY 1991

THE STRUCTURAL FORMULA OF THE SUBSTANCE IS:

THE FULL CHEMICAL NAME OF THE SUBSTANCE IS:

2-(Cyclohexylcarbonyl)-1,2,3,6,7-11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one.

THE PROPRIETARY NAME OF THE SUBSTANCE IS BILTRICIDE

THE GENERIC NAME OF THE SUBSTANCE IS PRAZIQUANTEL

The proposed claims (as restricted by the patentee on 26 May 1992)

1. Compounds of the general formula:

wherein R is cyclohexyl, and the physiologically compatible salts, the quaternary ammonium salts and the optical antipodes thereof.

8.2-Cyclohexyl-carbonyl-4-oxo-1,2,3,6,7-11b-hexahydro-4H-pyrazino [2,1-a] isoquinoline.

33.Compounds of the general formula shown in claim 1, said compounds substantially as herein described with reference to any one of examples 1, 6, 10, 11, 12 or 49.

34.An anthelmintic composition, comprising an effective dose of at least one compound according to any one of claims 1, 8, or 33 in admixture with a solid, liquid or semiliquid pharmaceutical diluent or carrier or in admixture with an animal feed or feed concentrate.

35.An anthelmintic composition, substantially as herein described with reference to any one of Examples 53 to 60.

Relevant statutory provisions

This application is the first opposition to the extension of the term of a patent requested under the provisions first introduced by the Patents Amendment Act 1989. The relevant statutory provisions in the Patents Act 1990 (which are essentially the same as those in the Patents Amendment Act 1989) are as follows:

Application for extension of term of patent relating to a pharmaceutical substance

70. (1) Where:

(a)a pharmaceutical substance is in substance disclosed in the complete specification of a standard patent and in substance falls within the scope of the claim or claims of that complete specification; and

(b)the patentee has requested the issue of a marketing approval certificate in respect of that substance;

the patentee may, by notice in writing in the approved form given to the Commissioner not later than 12 months before the end of the term of the patent, apply for an extension of the term of the patent in respect of that substance and any other pharmaceutical substance which is in substance disclosed in the specification and in substance falls within the scope of the claim or claims of the specification.

(2) - (5) ... .

Opposition to extension

74.The Minister, the Secretary to the Department of Community Services and Health or a person interested may, within the prescribed period and in accordance with the regulations, oppose the grant of an extension of the term of a patent on either one or both of the following grounds, but on no other ground:

(a)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;

(b)that the proposed claim or claims claim matter other than the pharmaceutical substance or substances to which the application relates.

Determination of application for extension

75. (1) The Commissioner may determine an application for an extension of the term of a patent even though the term of the patent has expired.

(2)Where the time for opposing the grant of an extension of the term of a patent has expired, the Commissioner must, if satisfied that:

(a)the application for the extension, the marketing approval certificate and the proposed claim or claims are in accordance with this Act; and

(b)the proposed claim or claims do not claim matter other than the pharmaceutical substance or substances to which the application relates;

grant an extension of the term of the patent for a period of 4 years in relation to the proposed claim or claims, but if not so satisfied, the Commissioner must, subject to subsection (3), refuse to grant an extension of the term of the patent.

(3)The patentee may, within such period as the Commissioner allows, amend the proposed claim or claims.

(4)If, after amendments are made under subsection (3), the Commissioner is satisfied as to the matters referred to in subsection (2), the Commissioner must grant an extension of the term of the patent for a period of 4 years in relation to the proposed claim or claims, but if the Commissioner is not so satisfied the Commissioner must refuse to grant an extension of the term of the patent.

(5), (6)

(7)Where relevant proceedings in relation to a patent are pending, the Commissioner must not determine an application for an extension of the term of the patent without the leave of the court.

Definitions in the Dictionary to the Act

"pharmaceutical substance" means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:

(a)a chemical interaction, or physico-chemical interaction, with a human physiological system; or

(b)action on an infectious agent, or on a toxin or other poison, in a human body;

but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing;

"therapeutic use" means use for the purpose of:

(a)preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

(b)influencing, inhibiting or modifying a physiological process in persons; or

(c)testing the susceptibility of persons to a disease or ailment;

Decision

Pursuant to section 75(2), before granting an extension of term, I must be satisfied that:

(a)the application for the extension, the marketing approval certificate and the proposed claim or claims are in accordance with this Act; and

(b)the proposed claim or claims do not claim matter other than the pharmaceutical substance or substances to which the application relates;

I note that:

-the application was made within the required time;

-the Marketing Approval Certificate was applied for on or before the date of making the application. I note the date specified on the Marketing Approval Certificate as the date of the application (being a date later than the date of the application) apparently reflects the way the Department of Community Services and Health processes such applications. In other respects the Marketing Approval Certificate is in accordance with the Act;

-the Marketing Approval Certificate and proposed claims were filed within the time prescribed;

-the parties agree that the substance praziquantel has a human use;

-the proposed claims are in substance disclosed in the specification and in substance fall within the scope of the claim or claims of the specification; and

-the patentee has provided (on 26 November 1992) a written statement to the effect that no relevant proceedings in relation to a patent are pending. That is, there is no bar under s75(7) to my determining this matter.

The fundamental issue of this opposition is whether the claims are in respect of a pharmaceutical substance as required by the Act; more particularly, whether the Act requires that the proposed claims must exclude uses of the substance other than in humans. In the present case, the evidence shows that Praziquantel is widely used in veterinary medicine.

In construing the requirements of section 70, I note:

-section 70(1), provides for the patentee to "apply for an extension of the term of the patent in respect of that substance", and not (for example) a method of treatment involving the substance;

-sections 74(b) and 75(2)(b), in referring to the requirements of the proposed claims, likewise refer to the substance per se;

-the dictionary definition of "pharmaceutical substance" refers to a substance FOR therapeutic use. The plain meaning is that the term refers to a substance per se. The qualification "FOR therapeutic use" adds a requirement that the substance must have a therapeutic use as defined - but does not restrict the substance to that particular use. (For example, where a substance has differing uses, the "substance for use X" is the same substance as the "substance for use Y"); and

-the dictionary definition of "pharmaceutical substance", in referring to its manner of application, states "whose application (or one of whose applications) involves...". The plain meaning is that, so long as one of its applications is consistent with the remainder of the definition of pharmaceutical substance, a substance is not excluded if it also has other applications; neither is it restricted to a particular manner of application.

The opponents contend that parliament only intended to grant extensions of term for substances for human use; and that to the extent that a substance could be used in, for example, veterinary medicine, parliament did not intend to grant any extension of term. In support of this argument (and reliant upon sections 15AA and 15AB of the Acts Interpretation Act 1901) I was referred to a number of passages in Hansard (3 June 1988, and 2 May 1989) relating to the Patents Amendment Bill 1988.

I have carefully studied the various speeches and debates of parliament in respect of the Patents Amendment Bill 1988, as reported in Hansard. In my view (and noting the frequent references therein to "pharmaceuticals for human use"), there is no indication that there was any consideration given to situations where a substance had both human and veterinary application.

The only specific reference to this issue that I am aware of is in the Explanatory Memorandum to the Patents Amendment Bill 1989 (which takes account of amendments made by the House of Representatives to the 1988 Bill as introduced). Paragraph 8 of the Explanatory Memorandum relates to the definitions of pharmaceutical substance and therapeutic use. It states (and I quote in full):

The definitions of "pharmaceutical substance" and therapeutic use" have the effect that the new patent extension scheme will apply only to pharmaceuticals for human use. The scheme will be available for "therapeutic substances" in the terms of the Customs (Prohibited Imports) Regulations, with added limitations that:

only substances for use in relation to humans are included (those SOLELY for veterinary use would not be included);

only substances whose use involves a chemical or physico-chemical interaction with a human physiological system, or involves action on an infectious agent, or on a toxin or other poison, within a human body, are included (devices such as surgical ligatures are not included);

substances whose sole use is in in vitro diagnosis or testing are not included.

(My emphasis added.)

The inclusion of the word SOLELY as a qualifier of veterinary use is entirely redundant if the intention of the legislation is to exclude all substances which have a veterinary use. Rather, the inclusion of the word SOLELY makes it manifestly clear that the intention is to exclude substances whose only use is veterinary; those with both human and veterinary uses are clearly not intended to be excluded.

In addition to this extraneous material, at the hearing I hypothesized to Mr Yates that:

-perhaps most, if not all, pharmaceutical substances for use on humans may also have a veterinary use;

-the only way of distinguishing a substance by use would be by a method-type claim - which section 70 did not appear to admit;

-if, as a result of a pharmaceutical substance having a non-human use as well as a human use, an extension of term could not be granted in respect of the substance per se, extensions of term would (in a practical sense) be impossible to obtain; and

-parliament's intention to grant an extension of term for pharmaceutical substances is not put into effect by an interpretation that, in a practical sense, precludes the granting of any extensions of term.

In response, Mr Yates did not comment on whether or not section 70 excludes method-type claims. He asserted that it was not for him to indicate the type of claim that would be acceptable - rather the patentee has the onus of providing proposed claims consistent with the requirements of the Act. He suggested that the claims should be limited so as to allow for the exploitation of the substance for veterinary use; if the patentee cannot do this the Commissioner has no discretion but must refuse the application.

It is certainly true that the onus for proposing claims in accordance with the requirements of the Act lies with the patentee; and in this regard the patentee has proposed claims which, on the interpretation of the Act for which they argue, essentially meet the requirements of the Act.

On the other hand, on the interpretation of the Act for which the opponents argue I am unable to envisage a form of claim which would meet the requirements of the Act; and the opponents did not give any indication of the form of any claim that might meet those requirements. In these circumstances, and noting the intention of parliament to grant extensions of term of patents for pharmaceutical substances for human use, I do not consider the interpretation pressed by the opponents is consistent with parliament's intention - in which regard I note the requirements of s15AA of the Acts Interpretation Act 1901, which states:

15AA (1) In the interpretation of a provision of an Act, a construction that would promote the purpose or object underlying the Act (whether that purpose or object is expressly stated in the Act or not) shall be preferred to a construction that would not promote that purpose or object.

In conclusion, I am of the opinion that all the material available to assist in the interpretation of section 70 is consistent with the plain meaning of the provision - that is:

-extensions of term are granted for the substance per se, and

-the substance must have a human use as specified in Schedule 1; so long as it has such a use, the fact that the substance may have other uses is irrelevant to whether or not an extension of term can be granted for the substance per se.

On this basis, and with some exceptions which I detail below, I am satisfied that proposed claims define pharmaceutical substances within the meaning of the Act.

Other issues regarding pharmaceutical substances.

I do not consider that proposed claims 34 and 35 define a pharmaceutical substance within the meaning of the Act, insofar as claim 34 includes admixing the compound with an animal feed or feed concentrate, and claim 35 incorporates example 60 which relates solely to non-human use.

At the hearing, Dr Bennett argued that the most effective treatment for hydatids in humans was to treat animals - treating animals (particularly dogs) prevents the transmission of the disease to humans. In this context, she argued, the treatment of animals fell within paragraph (a) of the definition of therapeutic use, through preventing ... a disease ... in humans.

However attractive this argument might be, it overlooks the definition of a pharmaceutical substance. That definition specifies that the application of the substance involves either interaction with a human physiological system, or action in a human body. I do not consider a substance including animal feed as the major constituent can be said to be a pharmaceutical substance as defined in the Act; indeed the arguments put forward in support of claim 34 depend upon the clinical effect of the substance occurring in the animal rather than human body. Similarly, I do not consider an example of an invention that relates solely to non-human use can be illustrative of a pharmaceutical substance as defined in the Act.

Conformity of proposed claims to the s70 application

Section 75(2) of the Act provides:

(2)... the Commissioner must, if satisfied that:

(a)...; and

(b)the proposed claim or claims do not claim matter other than the pharmaceutical substance or substances to which the application relates;

grant an extension of the term of the patent for a period of 4 years in relation to the proposed claim or claims, but if not so satisfied, the Commissioner must, subject to subsection (3), refuse to grant an extension of the term of the patent.

At the hearing I expressed concern regarding whether the substances claimed in the proposed claims went beyond the substances specified in the application for an extension of term. Specifically, claim 1 includes the salts of the substance and its optical antipodes, and claim 34 includes the substance together with a carrier.

I note that this issue was not raised in the opposition by the opponents.

Subsequent to the hearing, the patentee filed material which, inter alia, referred me to the material cited in the Merck Index monograph [referred to in the application for extension of term]; and filed a request under section 104 to amend the s70 application for an extension of term [to add the words "and, mixtures or compounds thereof"]. For reasons which I will elaborate later, it is appropriate for me to consider the proposed claims in the context of the unamended s70 application.

Section 75(2) refers to 'the substance or substances to which the application relates'. The patentee argues that the word "relates" indicates there should be some imprecise linkage between what is claimed and the substances referred to in the application. I do not agree. I consider "relates" to fundamentally refer to the specific substance or substances identified in the s70 application. However I also consider it appropriate to have regard to how a person skilled in the art would interpret the identification of those substances in the specification.

In so far as the claims cover the substance with a pharmaceutical carrier, I note that the specification exemplifies Praziquantel with pharmaceutical carriers. Additionally, the Marketing Approval certificate refers to the proprietary name Biltricide, which the MIMS ANNUAL 1991 (provided as exhibit GHG-A1) states is a film-coated tablet. Furthermore I have no doubt that a person skilled in the art would recognise that pharmaceutical substances are usually incorporated in a carrier, and there is nothing in the specification that indicates that this is not the case with Praziquantel. I am therefore of the view that the application relates to Praziquantel together with known conventional pharmaceutical carriers.

With regard to the optical antipodes, I note that the s70 application makes no specific reference thereto. However, on page 62 the specification exemplifies optical antipodes of Praziquantel; furthermore, the structural formula of the substance is such as to indicate the likely existence of optical antipodes to a person skilled in the art. I am therefore of the view that the application, by its reference to Praziquantel, relates (inter alia) to the optical antipodes of Praziquantel.

On the other hand, I am not satisfied that the application relates to salts of Praziquantel. In coming to this view, I note:

i.the s70 request makes no specific reference to the salts of Praziquantel;

ii.although the specification refers generally to salts of the many substances referred to in the specification, there is nowhere any specific reference to salts of Praziquantel;

iii.the structural formula of Praziquantel shows an absence of groups (such as hydroxy or amine) for readily forming salts of the substance - that is, it is not readily apparent that the substance is one which can form salts;

iv.the material listed in the Merck Index monograph (referred to in the s70 application) does not apparently refer to any salts of Praziquantel; and

v.the patentee has not provided any material that establishes that a person skilled in the art would understand that the term Praziquantel would be understood to include the salts of the substance.

As a result, I am of the view that to the extent that the proposed claims (specifically claim 1, and consequentially the claims dependant thereupon) include salts of Praziquantel, the proposed claims claim matter other than the pharmaceutical substance or substances to which the application relates, and thus cannot be allowed.

The amendment of the s70 application

As I noted above, the patentee has (subsequent to the hearing) requested leave under section 104 to amend the s70 application to extend the term of the patent. The request adds the words:

"and, mixtures or compounds thereof"

to the statement of the substances for which the extension of term is sought.

The proposing of such an amendment at this late stage in the proceedings creates an undesirable complication in the determination of the extension of term - in that,

-if allowed, the amendment may change the nature of the whole s70 application;

-if the amendment alters the meaning or scope of the s70 application, the request to amend will have to be advertised for opposition purposes [regulation 10.5(2)(b)] - and over 3 months must elapse before the amendment can be allowed; and

-before allowing, or refusing to allow, the proposed amendment, all parties would have a right to be heard in the matter.

For these reasons, and to ensure that this opposition decision is not unnecessarily delayed, I have not considered the allowability of the request to amend at this time.

Nevertheless, I consider it appropriate to observe that, as presently advised:

-to the extent that I have determined that the claims are directed to substances to which the application relates, the amendment under section 104 would not appear to have any bearing on the outcome of this decision, and

-to the extent that the amended application would include substances to which the present application does not relate, the amendment may amount to a new s70 application for an extension of term for those extra substances. In the present case, section 11 of the Patents Amendment Act 1989 requires (in effect) that any such application must have been filed by 15 June 1990, a date long since past.

It is thus my view (as presently advised) that the request under section 104 is incapable of affecting my determination of this opposition.

conclusion

I have found that proposed claim 34, by reason of the reference to admixing the compound with an animal feed or feed concentrate, and claim 35 by its reference to example 60, do not define a pharmaceutical substance within the meaning of the Patents Act 1990.

I have also found that claim 1, by including salts of the substance, is claiming matter other than the pharmaceutical substance or substances to which the application relates.

Accordingly I allow the patentee 60 days from the date of this decision to amend [pursuant to s75(3)] the statement of proposed claims to overcome these defects.

Otherwise, I have found that the proposed claims define pharmaceutical substances within the meaning of the Act, and the application satisfies the requirements for granting an extension of term of the patent.

In respect of the proposed s104 amendment to the application for extension of term, the patentee is at liberty to pursue the amendment in the normal manner.

costs

In actions before the Commissioner, costs usually follow the event. In the present case, the opposition was in part successful, but not in respect of the main issue of the opposition. Accordingly I make no award of costs in the matter.

(D. HERALD)

Assistant Commissioner of Patents

Patent attorneys for the patentee   :  Davies Collison Cave, Sydney

Patent attorneys for the opponents  :  Spruson & Ferguson, Sydney