Beecham Group Plc v Lek D.d Ljubljana, Pharmaceutical & Chemical Company
[1996] APO 36
•31 July 1996
official notice
decision of a delegate of the commissioner of patents
Application : No. 525089 in the name of BEECHAM GROUP PLC
Title: PHARMACEUTICAL COMPOSITIONS
Action: Request under section 104 for leave to amend an application for extension of term.
Application for extension of term of the patent and opposition thereto.
Decision: Issued .
Abstract :
It appears that the Patents Act 1990 does not explicitly give the Commissioner a general discretion when considering amendments.
The application for the extension of term should be given a purposive construction.
The amendment to the application for the extension of term does not result in the application relating to new substances. The amendment is allowable.
Leave to amend granted.The amendment does not materially alter the meaning or scope of the document and must be allowed immediately.
The application for the extension of term includes substances which do not fall within the scope of the claims of the specification. The patentee given the opportunity to amend under section 104.
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent No. 525089 by Beecham Group Plc. An application for an extension of term of the Patent, and opposition thereto by Lek d.d. Ljubljana, Pharmaceutical & Chemical company, and a request under section 104 for leave to amend the application for extension of term.
background
Patent No 525089 was applied for on 6 October 1978 (as application 40506/78), and was sealed on 18 March 1983. On 7 September 1993 the patentee applied for an extension of term of the patent under section 70 of the Patents Act 1990, and provided a set of proposed claims. On 23 December 1993 the patentee filed a Marketing Approval Certificate (MAC) in respect of the pharmaceutical substance, Augmentin. The application was advertised for opposition purposes under Section 74 on 17 February 1994.
On 16 May 1994 a notice of opposition to the extension of term of 525089 was filed by Lek d.d. Ljubljana (Lek). Statements of grounds and particulars and evidence in support were served on the patent attorneys for the patentee on 11 August 1994. On 1 September 1994 the patentee filed a request under Section 104 to amend the application for extension of term. With respect to this request the Commissioner advised the parties by letter dated 28 September 1994:
“1. If the amendment sought materially alters the meaning or scope of the application, the Commissioner must (if satisfied the amendment is allowable) advertise it for opposition purposes [reg 10.5(2)(b)]. Otherwise he must allow the amendment - subject to the opponent being heard on whether the amendment materially alters the meaning or scope of the application.
2. An amendment of the application which has the effect of changing the substances for which extension is sought must be made (subject to the operation of s.223) before the end of the 15th year of the patent. Furthermore, an extension of time under s.223 for making a s.70 application is limited to a maximum of 3 months [s.223(5)]. The 15th year of the patent expired on 6 October 1993. Consequently, if the amendment presently sought is found to materially alter the meaning or scope of the application for an extension of term, that amendment cannot be allowed. See, for example, Merck v Virbac & others 26 IPR 70 (1992) AIPC 90-952.
3. It is thus apparent that a significant part of the opposition may critically depend on the issues of whether the amendment sought materially alters the meaning or scope of the application for extension of term.
4. Unless the opponent concedes that the amendment does not materially alter the meaning or scope of the application for extension of term, the Commissioner proposes to make the following direction:
a. The parties to complete their evidence by the respective due dates; and
b. the matter of whether the amendment materially alters the meaning or scope of the request for an extension of term, be heard as part of the opposition to the extension of term.”
Following further correspondence both parties agreed that the amendment matter be dealt with at the hearing of the Section 74 opposition.
On 23 December 1994 the patentee requested a determination by the Commissioner of whether or not the grounds of lack of novelty, lack of inventive step, manner of manufacture and lack of utility could be raised in an opposition under section 74. In a decision dated 30 May 1995 the Deputy Commissioner of Patents found that these grounds were not available for consideration in the opposition (31 IPR 587, (1995) AIPC 91-190).
A hearing to determine both the request to amend the application for the extension of term and the opposition to the extension of term of the patent was held in Canberra on 30 April 1996. Mr Bruce Caine of Counsel appeared at the hearing on behalf of the patentee instructed by Mr John Slattery, patent attorney of Davies Collison Cave, Melbourne. Mr John Terry, patent attorney of Griffith Hack & Co, Sydney, appeared for the opponent.
The application for extension of term
The original application applying for an extension of term states as follows:
“We, Beecham Group plc ... apply for an extension of Patent No. 525089 in respect of the following pharmaceutical substances:
1. A pharmaceutical composition suitable for oral administration comprising ampicillin trihydrate and potassium clavulanate, being a pharmaceutical substance contained in the product AUGMENTIN.
2. The pharmaceutical substance is in substance disclosed in the complete specification of that patent and in substance fall within the scope of the claim or claims of that complete specification.
3. We have requested the issue of a marketing approval certificate in respect of the pharmaceutical composition comprising ampicillin trihydrate and potassium clavulanate, being a pharmaceutical substance contained in the product AUGMENTIN.”
the proposed claims
The proposed claims accompanying the application defined a composition comprising amoxycillin trihydrate together with potassium clavulanate. There are eight proposed claims of which claim 1 is the only independent claim:
“1. A dry unit-dose pharmaceutical composition suitable for oral administration which composition comprises 20 mg to 1500 mg of amoxycillin trihydrate, 20 mg to 500 mg of potassium clavulanate and a pharmaceutically acceptable carrier with the proviso that the weight ratio of amoxycillin trihydrate to potassium clavulanate is 6:1 to 1:1.”
The marketing approval certificate
The MAC states that a delegate of the Secretary to the Department of Health, Housing and Community Services, gave a MAC under section 72 of the Patents Act 1990 to Beecham Group plc in respect of the following pharmaceutical substance:
“Tablets or powders for suspension suitable for oral administration which comprise pharmaceutically suitable excipients and amoxycillin trihydrate and potassium clavulanate in the following amounts, expressed as amounts of amoxycillin and clavulanic acid, respectively:
500mg and 125mg, or 250mg and 125mg, or 125mg and 31.25mg, or 250mg and 62.5mg.The proprietary name of the products containing the substance is Augmentin.”
statement of grounds of opposition
The notice of opposition states:
“(a) That the application for the extension of term of the patent, the Marketing Approval Certificate, or the proposed claim or claims, is/are not in accordance with the Act;
(b) The proposed claim or claims, claim matter other than the pharmaceutical substance or substances to which the application relates.”
The statement of particulars asserted that there were a number of deficiencies in the application, in particular it stated that the substance Augmentin, and the substances disclosed and claimed in the patent specification, relates to a composition comprising amoxycillin rather than ampicillin as stated in the application.
The request to amend
In a request dated 1 September 1994 the patentee requested that the application for extension of term be amended as follows:
“Correct the word “ampicillin” in paragraphs 1 and 3 of the Application to read “amoxycillin”, as set out in the substitute application for extension of term enclosed herewith
Our reason for making this request is as follows:
An inadvertent error or mistake occurred during preparation of the Application dated September 7, 1993 in referring to the product AUGMENTIN as containing “ampicillin” trihydrate, instead of “amoxycillin” trihydrate. This error mistake (sic) is evident from the entry for AUGMENTIN in MIMS Annual 1992, Australian Edition (a copy of which is enclosed), and from the fact that the “proposed claims” which accompanied the application dated September 7, 1993 correctly defined a pharmaceutical composition comprising “amoxycillin” trihydrate and potassium clavulanate (see also the text of patent Specification No. 525089, as a whole).”
evidence
Evidence in support
The evidence in support comprised a declaration from Mr Graham A.R. Carnie. It relates to the novelty of the proposed claims and therefore has no bearing on the current matter.
Evidence in answer
The evidence in answer comprised a declaration and several exhibits from Mr John Michael Slattery in which he makes the following points:
Mr Slattery is a registered Patent Attorney, and a member of the firm Davies Collinson Cave. He is acting on behalf of the patentee in this matter.
On September 3, 1993, his firm received an urgent inquiry by facsimile from the Corporate Patent Department headed “Australian Patent 525089 - Augmentin Oral Formulation”, pointing out that this patent relates to potassium clavulanate/amoxycillin trihydrate compositions and to “oral formulations of Augmentin”, seeking guidance as to whether an extension of term of the patent was possible. A copy of this letter was annexed to the declaration.
Following advice and receipt of instructions, Mr Slattery arranged for the preparation and filing of a Section 70 Application and a set of proposed claims. Mr Slattery also forwarded a request for the issue of a MAC in respect of the product Augmentin.
As a result of his initial consideration of the opponent’s statement of particulars, he became aware for the first time that the application mistakenly referred to “ampicillin trihydrate” instead of “amoxycillin trihydrate” as being one of the components of the product Augmentin. On September 1, 1994 he prepared and filed a request under Section 104 of the Act to correct the application.
He states that he cannot ascertain exactly how or why the mistake occurred but confirms that at all times it was his intention and that of the patentee to apply for an extension of term for the substance containing amoxycillin trihydrate.
Mr Slattery states that he is informed and truly believes that a person skilled in the pharmaceutical field, on reading the reference in the Application to the product Augmentin would know and understand that the product contains amoxycillin trihydrate not ampicillin trihydrate.
Submissions
At the hearing Mr Caine made the following submissions for the patentee:
The purpose of the amendment is to rectify a clerical error or an obvious mistake to make the document clear.
The application itself correctly identifies Augmentin which the instructed reader would know would refer to Amoxycillin.
Sections 70 to 72 of the Patents Act require the application, the Marketing Approval Certificate (MAC) and the proposed claims to be considered together. The MAC and the proposed claims both correctly identify amoxycillin. In the light of these documents when considered together the rectification is obvious.
The declarant for the opponent did not put forward any evidence to suggest other than that he could readily rectify the error.
The purpose of the amendment is not to seek extension for a new substance.
Even without the proposed amendment the application for the extension of term should succeed.
Mr Terry for the opponent made the following submissions:
The proposed amendment would materially alter the scope and meaning of the document. Therefore it must be advertised for formal opposition (see Reg 10.5(2)(b)).
Applications for extensions of term cannot be amended out of time to specify substances or things which were not specified in the application as filed.
The present application is consistent on its face. If it is legitimate to refer to literature to interpret the word “AUGMENTIN”, the document is inconsistent and on the face of the document one does not know how to reconcile this inconsistency. It is not legitimate to look at other documents.
DECISION
Request to Amend
The amendment sought can properly be considered under section 104 as an amendment to “any other filed document”.
Clerical Error or Obvious Mistake
At the hearing I was directed to case law concerned with the allowability of amendments that involve the correction of obvious mistakes or clerical errors in patent specifications. These decisions are concerned with the application of section 102(3) of the Patents Act 1990 (or its equivalent in different legislation) in which certain amendments to complete specifications are allowable only if the amendment is for the purpose of correcting a clerical error or obvious mistake.
The reason for this restriction to amendments to patent specifications has been clearly set by the House of Lords in Holtite Limited v Jost (Great Britain) Limited ([1979] RPC 81): the purpose of the patent specification is to define the scope of the invention claimed so as to give public notice of the monopoly claimed. An amendment which enlarged the limits of the scope of the invention claimed would make actionable, ex post facto, what at the time when it was done the doer had no reason to suppose amounted to an infringement of the patentee’s rights. It is clear from decided cases that the specification must stand alone in that it should be possible for the instructed reader to determine the scope of the claims without recourse to other material.
These decided case have only limited relevance: the requirement to establish a clerical error or obvious mistake is not necessary in this case - the request for amendment to the application may be for any purpose including, but not limited to, the correction of a clerical error or obvious mistake. The allowability of the proposed amendment is not dependent upon the applicant establishing the presence of a clerical error or obvious mistake.
The Commissioner’s Discretion When Allowing an Amendment
At the hearing Mr Terry submitted that I should also consider the conduct of the applicant, in particular any undue delay, when considering the amendment. He referred me to Sly v United Development Corporation, 106 CLR 633. The Commissioner’s discretion when considering amendments was also considered by the High Court in Farbwerke Hoechst Meister Lucius and Bruning v. Commissioner of Patents 124 CLR 654 at page 663.
There is, however, a significant difference between the Acts under which these cases were decided and the Patents Act 1990. Sly, supra, was decided under the Patents Act 1903-1950. The relevant section of that Act, section 77, states that “... the Commissioner shall determine whether and subject to what conditions, if any, the amendments ought to be allowed ...”. Farbwerke Hoechst was decided under the Patents Act 1952 where the relevant section is in similar terms.
The Patents Act 1990 does not seem to explicitly give the Commissioner a broad discretion to decide whether the amendment ought to be allowed. Under the current Act, for proposed amendments of this type (to “any other filed document”) the Commissioner must report on whether if made, the proposed amendments would not “otherwise be allowable under the Act or these Regulations” (subregulation 10.2). If the Commissioner is reasonably satisfied that a proposed amendment is not allowable then he or she must refuse the request for leave to amend (subregulation 10.4). If the report under subregulation 10.2 is not adverse the Commissioner must grant leave to amend (paragraph 10.5(1)(a)).
This would seem to have the effect that the grounds of refusing an amendment are restricted to those as set out in the Act and Regulations. There is apparently no general discretion to consider the public interest or the conduct of the Patentee when determining whether an amendment is allowable.
Although it is not clear that I have the discretion to consider the conduct of the patentee when deciding whether the amendment is allowable, I do not have to decide the point because I do not believe that I could refuse the amendment on the grounds of undue delay in any event. Mr Terry submitted that the patentee had left the application until the eleventh hour and that if they had prepared the documents earlier they could have checked them I note that the original application was filed within the time allowed by the legislation and so cannot have caused any delay. It is clear from the evidence that the attorney for the applicant first became aware of the error when the statement of grounds was served on 11 August 1994 and the request for amendment was filed 1 September 1994. I do not think that the period of approximately three weeks amounts to undue delay.
Criteria for Allowability
I have concluded above that the only ground for not allowing this amendment is that it would “not be otherwise allowable under the Act or these Regulations” . The appropriate test is therefore that if the proposed amendment offends under another section of the Act the amendment will not be allowable.
The only test of allowability of an amendment to an application for an extension of term of which I am aware is as set out in Merck Patent GmbH v Virbac (Australia) Pty Ltd (1992) 26 IPR 70: if the amendment has the effect that it includes a new substance then it amounts to a new application and must satisfy the time for filing as specified in the Act.
If the proposed amendment to the section 70 application in the present case is such that it includes substances that were not specified in the section 70 application as filed, then this amendment could be considered to amount simply to a new section 70 application for those extra substances. This new application would have an effective filing date of the date of the amendment, and as this is outside the time specified in section 70(1) an extension of time of almost eleven months would be required. An extension of more than three months for this purpose is expressly excluded by section 223(5) (presumably to protect the public interest so that an interested party can know with certainty for which substances the extension of term is sought). Thus, if this request has the effect of a new section 70 application directed to different substances it would be contrary to the Act and could not be allowed. (It should be noted that although section 223(5) was repealed by the Patents (World Trade Organization Amendments) Act 1994 it still applies to this application for the reasons set out by the Deputy Commissioner in Re Application by Bristol-Myers Company 33 IPR 487.)
In order to determine whether the proposed amendment has the effect that it includes a new substance I have first to construe the section 70 application as filed.
On its face, the original application applies for an extension of term in respect of “a pharmaceutical composition suitable for oral administration comprising ampicillin trihydrate and potassium clavulanate, being a pharmaceutical substance contained in the product AUGMENTIN”. Thus it defines the substance in terms of both the chemical names of the components and also by the trade name of the product containing the substance. A reader would need to understand both parts of the definition to construe the document. If the reader was familiar with and understood the term “Augmentin” (as submitted by Mr Caine) then they would recognise that there was an ambiguity on the face of the document.
On the other hand, if the reader was not familiar and did not understand the term “Augmentin” then they would use a dictionary or standard reference work to determine the meaning of this word in order to fully construe the document. A standard work in the field of pharmaceuticals, and one referred to by both the patentee and opponent, is “MIMS Annual”. An extract from the MIMS Annual 1992 edition is included in the statement of particulars filed by the opponent. It describes AUGMENTIN as “a combination product containing the semisynthetic antibiotic amoxycillin and the beta-lactamase inhibitor, potassium clavulanate (the potassium salt of clavulanic acid)”. Another standard reference work, The Merck Index, Tenth Edition, 1983, also describes Augmentin as a combination of the potassium salt of clavulanic acid with amoxicillin trihydrate. From this information the reader who did not immediately understand the term would also recognise that there was a conflict on the face of the document.
The practice of the Patent Office has been to try to determine the purpose of the document if there is doubt about its meaning, see for example Abacus Engineering Ltd v John Cananzi Hydropneumatics [1984] APOR 3. Purposive construction of a document has been approved by the courts in a number of cases such as R v Commissioner of Patents; Ex parte Weiss (1939) 61 CLR 240 and Kaiser Aluminium & Chemical Corp v Reynolds Metal Co (1969) 120 CLR 136.
In the present case I believe that I have to look at the purpose of the application having regard to any relevant surrounding facts when construing the document. The purpose of the section 70 application is to identify the pharmaceutical substance in respect of which the patentee has requested the issue of a MAC, which substance must be in substance disclosed and fall within the scope of the claims of the complete specification. The patentee may apply for an extension of term in respect of this substance and any other pharmaceutical substances which are in substance disclosed and which fall within the scope of the claims of the complete specification.
This document is then to be considered together with the MAC and the proposed claim or claims. It is important to note that the extension of term is granted in relation to the proposed claim or claims and not in relation to the substances specified in the application. The application is used merely as a request.
As the proposed claims were filed at the same time as the application it seems reasonable to have placed a considerable weight on them when construing the application, especially as the application does not in itself define the legal monopoly sought. The relevant question is then how the informed reader would have reasonably resolved the ambiguity in the application in the context of the proposed claims, the patent specification on file and their knowledge of the product “Augmentin”.
Having regard to all the circumstances of the case I think that the most reasonable construction would be one that assumed that the purpose of the application was actually to request an extension of term for the substance contained in the product “Augmentin”, which substance is both disclosed by the complete specification and within the scope of the proposed claims. Such a construction would involve the conclusion that the word “ampicillin” was used erroneously in the application.
This conclusion means that when properly construed the application for the extension of term even before amendment was in respect of the substances containing amoxycillin and not ampicillin. Thus the proposed amendment does not result in the application being directed to different substances.
I therefore find that the amendment is allowable and find it appropriate to grant leave to amend
Advertisement of the Request
If the amendment materially alters the meaning or scope of the document then according to regulation 10.5(2) the amendment has to be advertised for opposition purposes.
The amendment may appear, prima facie, to change both the meaning and scope of the application. I have found, however, that upon proper construction, the meaning and scope of the document is unchanged by the amendment. As the amendment does not materially alter the meaning or scope of the document it must be allowed immediately (subregulation 10.6).
application for extension of term
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.
The application for extension states that the substance for which the extension is sought is a pharmaceutical composition suitable for oral administration comprising ampicillin trihydrate and potassium clavulanate, being a pharmaceutical substance contained in the product Augmentin. I have construed this as referring to amoxycillin instead of ampicillin.
Claim 1 of the patent is the only independent claim and is identical to proposed claim 1. This claim has the following features which are not included in the description of the substance of the application:
The composition is a dry unit-dose composition.
The amounts and weight ratios of the components are defined.
A pharmaceutically acceptable carrier is present.
Thus the application may also include suspensions that are not in a dry form, a mixture of active ingredients without a carrier and amounts and weight ranges outside the ranges specified in the claims. As such substances of the application are not within the scope of the claims of 525089 the application is not in accordance with section 70 of the Act.
The opponent also submitted that the proposed claim or claims claim matter other than the pharmaceutical substance or substances to which the application for extension of term relates because the original application erroneously names ampicillin. I have already found that using a purposive construction the application is in fact consistent with the proposed claims in this regard.
conclusion
I grant leave to amend the application for the extension of term according to section 104 request filed on 1 September 1994. I find further that this amendment does not materially alter the meaning or scope of the application and allow the amendment on the date of this decision.
I find that the application for the extension of term includes substances which do not fall within the scope of the claims of the specification and is therefore not in accordance with the Act. It seems possible that the application can be amended under section 104 to limit it to substances which do fall within the scope of these claims. I allow the patentee one month from the date of this decision to file such amendments consistent with this decision. If suitable amendments are not filed within this time the application for the extension of term will be refused.
costs
In matters before the Commissioner costs usually follow the event. In this case I upheld one of the grounds of opposition to the application for the extension of term of the patent. Although the patentee was successful in the section 104 matter I have found that this has had no material effect on the application for the extension of term. On balance I consider it appropriate that I award costs against the applicant, Beecham Group plc.
Vivienne Thom
Delegate of the Commissioner of Patents
Patent attorneys for the patentee: Davies Collison Cave, Melbourne
Patent attorneys for the opponent: Griffith Hack & Co, Sydney
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