official notice

decision of a delegate of the commissioner of patents

Patent	:	No. 510809 in the name of Astra Lakemedel Aktiebolag

Title	:	Method for Combating Virus Infections

Action	:	Extension of the term of a patent under section 70, and objections by a delegate of the Commissioner.

Decision	:	Issued             .  

Abstract			:	-	an extension of term is only available for substances per se, and not for methods involving the use of substances;

-	proposed claims can only be founded on claims to substances; they cannot be founded upon method or process type claims in the specification;

-	the proposed claims do not claim a pharmaceutical substance which in substance falls within the scope of the claim or claims of the complete specification;

-	the proposed claims, in so far as they do not contain the disclaimer of claim 1 of the patent, relate to the new use of a known substance and are directed to a method using the substance; and

-	unclear whether the Marketing Approval Certificate has been given in respect of a pharmaceutical substance which can validly form the subject of the present request for an extension of term of the patent.

Patentee given an opportunity to submit a further statement of proposed claims, amend the application, and provide clarification with respect to the Marketing approval Certificate. 

patents act 1990

decision of a delegate of the commissioner of patents

Re:	Patent No. 510809 in the name of Astra Lakemedel Aktiebolag, and an application for an extension of term of the patent.
background
Patent 510809 was applied for on 27 June 1977 (as application 26505/77), and was granted on 29 January 1981. On 19 June 1992, the patentee applied for an extension of term of the patent, and provided a set of proposed claims.

Pursuant to correspondence between the patentee and the Commissioner, the applicant:

-	provided amended applications for an extension of term, on 5 Nov. 1992 and 18 March 1993; and

-	provided proposed claims on 5 Nov. 1992, 18 March 1993, 28 April 1993, 6 Dec. 1993, 12 April 1994 (the day before the hearing), and 18 April 1994. [This last set of proposed claims differs from that considered at the hearing only by the deletion of the first claim.] 

A Marketing Approval Certificate was filed on 18 March 1993. Significantly, the Marketing Approval Certificate is for the marketing of a product CONTAINING the substance trisodium phosphonoformate, without specifying the nature of the product containing the substance.

The application was advertised pursuant to s.74, on 29 July 1993, with certain objections to the application by the Commissioner's delegate remaining unresolved. No oppositions were filed.

A hearing was held on 13 April 1994, to deal with the unresolved objections to the application. The patentee was represented by Mr. M Royal (patent attorney of Phillips Ormonde & Fitzpatrick, Melbourne).
The Patent
The patent relates to a method for combating virus infections. The specification states:

"... we have found that phosphonoformic acid of the structural formula

and physiologically acceptable salts thereof, selectively inhibits certain viral functions which are essential for the replication of the virus."

The patent concludes with 42 claims. Claim 1 is:

"1.	A pharmaceutical preparation suitable for combating virus infections in animals including man, comprising as active ingredient an effective amount of the compound of the formula:

or a physiologically acceptable salt thereof, in admixture with a carrier which is physically acceptable to animals including man and is other than water or an organic solvent or a mixture of water and an organic solvent or an emulsified aliphatic hydrocarbon oil or any other form of carrier conventionally used for the preparation of plant growth regulating formulations."

Claims 2 to 16 are dependant upon claim 1.

Claim 17 is for a method for the selective treatment of virus infections, using either phosphonoformic acid, a salt thereof, or the preparation of any one of claims 1 to 16.

Claims 18 to 38 are method claims dependant upon claim 17.

Claim 39 is:

"39.	The use of phosphonoformic acid or a physiologically acceptable salt thereof for inhibiting the replication of virus in animals and man."

Claims 40 to 42 are in similar terms to claim 39, but directed specifically to the influenza virus (claim 40), herpes (41), and the growth of virus-transformed cells (42).

Examination History
The application was examined in 1981. A summary of significant matters arising from that examination is as follows.

Claim 1 as lodged was directed to a pharmaceutical preparation involving phosphonoformic acid 'in association with a pharmaceutically acceptable carrier'. The examiner objected to this claim as including phosphonoformic acid in common organic solvents and water, and cited patent 492534.

In response, the attorney for the applicant argued that the inventive step in 492534 was the discovery that plant growth can be regulated by application to the plants of certain carbomoylphosphates; that the inventive step in the present invention is the discovery that phosphonoformic acid inhibits certain viral functions which are essential for viral reproduction; and the citation does not deal with the problem on which the present invention is based.

The examiner agreed with the attorney about the 'inventive step' of the present application, but maintained the objection to the claims directed to the substance. In response, the claims as accepted were filed, with the following comment:

"This explicit form of definition and disclaimer, so it is submitted, distinguishes from the disclosures in the cited specification ...."

It is thus quite clear that the present form of claim 1, with the disclaimer, arose as a result of a pertinent citation. It is also apparent that, in the absence of the disclaimer, the invention relates to a new use of a known substance.
Proposed Claims
The statement of proposed claims filed on 18 April 1994 contains 8 claims. Claim 1 is in the following terms:

"1.	A pharmaceutical preparation including as the pharmaceutically active substance phosphonoformic acid or a physiologically acceptable salt thereof when used for inhibiting the replication of virus in man."

Claims 2 to 8 are independent claims of identical form, differing only in whether or not the trisodium salt is specified, and the type of virus being inhibited.

I observe that the form of claiming in the proposed claims is quite different to that of the patent. The patent has no claim of the form 'X when used'; on the other hand, the proposed claims have no claims of the form of claim 1 of the patent (whether or not with the disclaimer) - nor do they include claims to a method of treatment per se, nor claims of the form "The use of X to treat ...". The reason for this is apparently provided by the following statement in correspondence from the attorney dated 2 Dec 1993:

"In the present situation [the form of the claims] is necessary to avoid an objection of prior use because the active ingredient was previously known as a plant growth regulator. The patentee was the first to appreciate the utility of this substance in the treatment of virus (in particular the Aids Virus). Thus, the patentee is not able to lay claim to the active ingredient as such but is entitled to lay claim to the active ingredient when it is used in the treatment for which the patentee has found it to be useful."

This also supports the view that the invention relates to the new use of a known substance.

When the application was advertised pursuant to s.74, there were unresolved issues raised by the delegate of the Commissioner in relation to the proposed claims. These are:

a.	the marketing approval certificate does not indicate the nature of the product in which the substance is approved for marketing. Given the extensive disclaimer in claim 1 of the patent, it is not apparent that the marketing approval is given in respect of a substance the subject of the patent.

b.	the claims to the substance "when used" are disguised method claims, and are not appropriate claims for the grant of an extension of term.

Point (a) was not argued at the hearing, as the proposed claims were amended shortly before the hearing to delete a claim of the form of claim 1 of the patent.
Submissions
At the hearing, Mr Royal argued that each proposed claim was clearly directed to a substance. He also argued that an extension of term under section 70 was not restricted to substances per se, but could be granted for method-type claims. Finally, he argued that the proposed claims fell within the scope of claims 39 to 42.
Statutory Requirements
Subsection 70(1) of the Act provides:

"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."

and subsection 75(2) provides:

	"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."
Decision
Are Claims to 'X when Used' Method claims? 
During the consideration of the proposed claims, there was some debate about the status of a claim of the form "substance X when used". At the hearing Mr Royal submitted that the proposed claims were claims to the substance, and not to a method using the substance.

A claim of the form "X when used ..." is a compound form of claim. The nominal subject of the claim is a 'thing'; and that thing is qualified by way of steps of a method. That is, the claim is part object, part method. Normally there is prima facie no objection to a claim which includes both method steps and definition of objects - indeed many method claims will, in addition to the definition of steps in a process, include reference to product features. However, in the present case the delegate of the Commissioner objected to the proposed claims on the basis that they are in fact disguised method claims, and therefore do not provide a basis for an extension of term of the patent.

Mr Royal argued that as a matter of plain grammatical construction, a claim of the form "X when used" has as its subject "X", and is therefore a product claim - and not a method type claim. While I might accept this proposition in vacuo, it is well established that claims cannot be properly construed in isolation from the overall context of the specification - which, in-so-far as the proposed claims relate to a substance with no restrictions on the carrier, is directed to the new use of a known substance. 

The delegate of the Commissioner referred to the decision in Wellcome Foundation Ltd v Commissioner of Patents 30 ALR 510 at 516 as authority for treating the presently proposed claims as disguised method claims. Mr Royal sought to distinguish that decision on the basis that the parts relied upon were obiter, and was otherwise not relevant. 

In the Wellcome decision, the court was asked (inter alia) the following question:

"6. Whether or not a claim defined in terms of unit dosage which is unsuitable for previously known uses of a known substance but is suitable for a new non-obvious use of that substance defines sufficiently a patentable invention within the meaning of s.40 of the Patents Act 1952."

The following is the entire obiter dicta of the full bench of the High Court in the Wellcome decision:

"In connection with Question 6 the appellant further submits that it is entitled to a monopoly of the substance when used in the process, viz the method of administration of the dosage, and that this court should remit the case to the Deputy Commissioner with a direction to this effect. According to the appellant, when an invention consists of a process it is possible to claim a monopoly in the product of the process.

"We have an initial difficulty with question 6. The claims the subject of the appeal are not accurately described as claims defined in terms of a unit dosage. Claims 11 and 12, which refer to unit dosage, are basically claims to a container, as described in claim 1, having a relationship with the unit dosage described in the two claims. Question 6, as the appellant concedes, raises a question which does not arise from any of the claims as they have been expressed. For this reason we are unwilling to answer it.

"However, as the appellant's submission is a development of other arguments which have been canvassed, it merits some consideration. The principle invoked by the appellant which is said to entitle the inventor of a process to a monopoly in the product is subject to limitations: see Mullard Radio Valve Co Ltd v British Belmont Radio Ltd (1938) RPC 1; Interlego AG v Toltoys Pty Ltd (1973) CLR 461 at 480; Olin Corporation v Super Cartridge Co Pty Ltd (1971) 14 ALR 149; 51 ALJR 525 at 537. For the present purposes there is no need to discuss the precise scope and extent of these limitation. It is sufficient to say that the principle has no application here. What the applicant seeks is a monopoly in an old substance limited to its use in the process which is the subject of claims 17 to 28. It is one thing to say that the inventor of a process is entitled to a monopoly, albeit limited, in the product of that process. It is quite another and different thing to say that the inventor of a process is entitled to a monopoly in a substance which is used merely as an ingredient in that process. In the latter case the invention claimed makes no contribution to the manufacture of the substance. At best, it takes advantage of properties in the substance hitherto unknown or unsuspected.

"A further answer to the applicant's submission is that there is no distinction between the claim to the process and the claim to the substance when the substance claim is limited to its use in the process. So much appears from the judgement of Parker J in Adhesive Dry Mounting Ltd v Trapp & Co (1910) 27 RPC 341 at 353, upon which the appellant, mistakenly in our view, placed reliance. There the first claim in the patent specification was a process claim. The second claim was either a claim to a pellicle or to the use of the pellicle in the process described in the first claim. Parker J observed that, if the second claim was a claim to the use of the pellicle in the process, it added nothing to the first claim for it was already included in that claim. Later, his Lordship said (also at 353): 'The idea of using an old material for an entirely new purpose, not being analogous to purposes for which it has theretofor been used, may be good subject matter, but such idea, however ingenious, can hardly justify a claim to the material itself.'"

The first observation that I make is that the Wellcome decision involved an invention which was the new use of a known substance. I therefore consider its context to be relevant to the present case where the proposed claims do not delimit the carrier in the manner of claim 1 of the patent, and are similarly related to the new use of a known substance.

Secondly, although clearly obiter, the matters discussed by the full bench of the High Court are directly relevant to the interpretation of the present claims. Indeed, the first sentence in the obiter refers to 'a monopoly of the substance when used in the process' - that is, is expressed using the key words of the claim construction now being considered. And although obiter, it is necessarily persuasive when considering similar situations.

Thirdly, it seems to me that in the Wellcome decision the High Court was saying that where the invention relates to the new use of a known substance, the inventor is not entitled to claim the substance (it being merely the ingredient in the process); furthermore, a claim to such a substance which is characterised by its use in a process is not distinguished from a claim to the process.

Applying these considerations to the proposed claims, I observe that there is nothing in the specification or claims that suggests phosphonoformic acid in the form claimed is anything other than the ingredient in the process of the invention. The claims characterise the phosphonoformic acid by its use in a method of treatment. Following the Wellcome decision [and noting that (in the absence of the exclusions of claim 1 of the patent) the invention relates to a new use of a known substance] there is no distinction between the proposed claims and the method of treatment - that is, the proposed claims are to methods of treatment, not substances. 
Extension of Term for Methods
Mr Royal argued that section 70 permitted an extension of term to be granted for method-type claims - that a patent directed to the new use of a known substance could be granted an extension of term for that use, so long as the use was 'in respect of' that substance. 

To address this matter, it is necessary to consider the requirements of subsections 70(1) and 75(2) in some detail. Subsection 70(1) requires that:

a.	the pharmaceutical substance must be in substance disclosed in the complete specification;

b.	the pharmaceutical substance must in substance fall within the scope of the claim or claims of the complete specification;

c.	the patentee must have requested the issue of a marketing approval certificate in respect of that pharmaceutical substance; and

d.	the application is for an extension of the term of the patent in respect of that pharmaceutical substance (and in respect of certain other substances).

I observe here that this subsection refers solely to a 'pharmaceutical substance' - there is no explicit reference to (for example) methods of treatment using pharmaceutical substances.

Subsection 70(1) requires the pharmaceutical substance be both in substance disclosed in the specification, and in substance fall within the scope of the claim or claims of the complete specification. In the present case, there is no dispute that the pharmaceutical substance is in substance disclosed in the specification. But there is an issue relating to the requirement of 'in substance fall within the scope of the claim or claims of the complete specification' - as this requirement dictates which claims of the specification can be relied upon to support the extension.

The phrase 'in substance fall within the scope' has been the subject of judicial interpretation in the context of amendments. In The Distillers Co. Ld.'s Application, (1953) 70 RPC 221 at page 223 the test for 'in substance fall within the scope' was stated to be:

"would the amendment make anything an infringement which would not have been an infringement before the amendment?"

Section 70 requires the pharmaceutical substance to in substance fall within the scope of the claim(s) of the specification. Applying the Distillers test, I observe that a pharmaceutical substance would be an infringement of a claim to that substance per se; however a pharmaceutical substance would not be an infringement of a method claim using that pharmaceutical substance - to infringe a method claim, the steps of the method would also have to be performed. That is, a substance per se does not in substance fall within the scope of a method claim which uses that substance.

It follows that the pharmaceutical substance for which an extension of term can be applied for under section 70 must be a substance which is claimed as such. An extension cannot be sought for a substance relying on it being mentioned as an ingredient in a method claim or a process claim.

Consequently, an extension of term can only be founded in the present case on the substances that are claimed in claims 1 to 16 of the specification. Claims 17 to 42 do not provide any basis for an extension of term of the patent; these claims are to methods and uses, and go beyond a substance per se.

[I note here that Mr Royal conceded at the hearing that the basis for the present proposed claims is claims 39 to 42. That being so, the proposed claims do not meet the requirements of section 70.]

Although these considerations clearly identify which substances can be the subject of an extension of term, subsection 70(1) refers to an extension of term 'in respect of' those substances - a phrase which (considered in isolation) appears to admit an interpretation that an extension of term can be obtained for anything relating to that substance, such as a method using the substance.

However, subsection 75(2)(b) provides that the proposed claim or claims must not claim matter other than the pharmaceutical substance or substances to which the application relates. The plain meaning of this clause is that the proposed claims can only claim pharmaceutical substances per se; method-type claims are excluded as they would clearly claim matter other than the pharmaceutical substance - viz the steps of the method.  Consequently subsection 75(2)(b) requires that the proposed claims must claim substances per se. 

I found above that the presently proposed claims are to methods of treatment, not substances. Consequently the proposed claims do not comply with the requirements of section 70, as they are not directed to the substance per se.
In Substance within the Scope
Section 70 requires that the proposed claims must in substance fall within the scope of the claim or claims of the specification. 

Assuming the proposed claims are properly claims to a pharmaceutical substance, I note that they do not include the disclaimer of various carriers as specified in claim 1 of the patent. That is, they do not fall within the scope of that claim, nor any claims dependant thereon.

Thus, even if it was argued that the proposed claims are founded on claims 1 to 16 of the specification, none of the proposed claims meet the requirements of section 70 as none of them fall within the scope of the claims of the specification.
Marketing Approval Certificate
Although the patentee has now proposed claims which do not include a claim of the form of claim 1 of the patent, it is appropriate (having regard to the history of the prosecution of this case and my findings above) that I make some comments on the objection by the delegate of the Commissioner that, given the extensive disclaimer in claim 1 of the patent, it is not apparent that the marketing approval is given in respect of a substance the subject of the patent.

As I have discussed above, an extension of term must be founded on claims directed to substances per se - and in the present case this means claims 1 to 16. The substance the subject of those claims is not phosphonoformic acid (or its sodium salt) per se, but phosphonoformic acid in combination with certain carriers. Consequently, before an extension of term can be granted, I must be satisfied that a Marketing Approval Certificate has been provided in respect of phosphonoformic acid in combination with one or more of those certain carriers.

The Marketing Approval Certificate filed gives approval for a product containing the substance Foscarnet Sodium (the trisodium salt of phosphonoformic acid), not that substance per se. The schedule to the certificate gives the chemical formula of that substance per se. It gives three corresponding full chemical names, none of which allude to carriers. It also lists the Generic name (Foscarnet Sodium), and the Proprietary name (Foscavir). In an attempt to ascertain the nature of carriers used with Foscarnet Sodium, I have referred to the Martindale Extra Pharmacopoeia (29th Edition), which states:

"Administration has been by continuous intravenous infusion and doses have ranged from about 50 to 160 µg per kg body-weight per minute."

which suggests that Foscarnet Sodium is typically used with water as a carrier - a carrier excluded by the terms of claim 1 of the patent.

Thus, although the Marketing Approval Certificate makes no mention of the type of product containing the Foscarnet Sodium - implying it could be in any carrier - I cannot conclude that marketing approval has necessarily been given for a pharmaceutical substance falling within the scope of the claims of the patent - that is, involving a carrier which is not disclaimed by claim 1 of the patent.

I am therefore not satisfied from the material before me that the Marketing Approval Certificate has been given in respect of a pharmaceutical substance which can validly form the subject of the present request for an extension of term of the patent.
The Application
The application for the extension of term originally filed by the applicant did not include the exclusions of claim 1 of the patent when identifying the substance. Following objection by the delegate of the Commissioner, the patentee filed an amended application; that application similarly did not include the exclusions of claim 1 of the patent. A further amended application was filed on 18 March 1993; this application in effect lists claim 1 of the patent, and eight paragraphs referring to a substance 'when used'. This application has not been objected to by a delegate of the Commissioner, but neither has it been allowed. I note that neither the original application, nor the two applications filed by way of amendment, are consistent with my findings that an extension of term is only available for substances per se and must be founded on claims to substances in the patent. Consequently, I also consider the application to be deficient.
conclusion
I have found:

-	an extension of term is only available for substances per se, and not for methods involving the use of substances;

-	proposed claims can only be founded on claims to substances; they cannot be founded upon method- or process- type claims in the specification;

-	the proposed claims do not claim a pharmaceutical substance which in substance falls within the scope of the claim or claims of the complete specification;

-	the proposed claims, in so far as they do not contain the disclaimer of claim 1 of the patent, relate to the new use of a known substance and are directed to a method using the substance; and

-	I am not satisfied that the Marketing Approval Certificate has been given in respect of a pharmaceutical substance which can validly form the subject of the present request for an extension of term of the patent.  

Consequently I give the patentee 60 days from the date of this decision to:

-	submit a further statement of proposed claims, 

-	to amend the application; and

-	provide clarification of whether or not the Marketing Approval Certificate has been given in respect of a pharmaceutical substance which can validly form the subject of the present request for an extension of term of the patent.

D. HERALD
Delegate of the Commissioner of Patents

Patent attorneys for the patentee   :  Phillips Ormonde & Fitzpatrick, Melbourne