Dr. Reddy's Laboratories Ltd.
[2014] APO 47
•1 July 2014
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Dr. Reddy's Laboratories Ltd. [2014] APO 47
Patent Application: 2009314512
Title:Lenalidomide solvates and processes
Patent Applicant: Dr. Reddy's Laboratories Ltd.
Delegate: Dr S.D. Barker
Decision Date: 1 July 2014
Hearing Date: Submissions were due by 14 June 2014, but were not provided
Catchwords: PATENTS – re-examination of application following withdrawal of opposition – objection of lack of novelty – citation discloses preparation of hemihydrate of lenalinomide – no reasonable prospects of the applicant amending the specification – application refused
Representation: Patent applicant: Freehills Patent Attorneys
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2009314512
Title:Lenalidomide solvates and processes
Patent Applicant: Dr. Reddy's Laboratories Ltd.
Date of Decision: 1 July 2014
DECISION
I refuse to accept the request and specification.
REASONS FOR DECISION
Patent application number 2009314512 was filed as an application under the Patent Cooperation Treaty on 11 March 2009. The applicant is Dr. Reddy's Laboratories Ltd. (Dr Reddy's). The application was examined and accepted by the Commissioner, and subsequently opposed by Celgene Corporation (Celgene). Celgene withdrew the opposition on 12 November 2013. In the light of documents mentioned in the statement of grounds and particulars, the Commissioner decided to re-examine the application, and issued a report on 5 December 2013, and a subsequent report on 5 March 2014. Dr Reddy's did not respond to the second report, and the Commissioner decided to determine the re-examination on the basis of written submissions. Dr Reddy's did not provide any submissions.
The re-examination
The Examiner reported that claims 1 – 3, 5, 6 and 16 lack novelty in the light of WO 2009/114601 (D1). Dr Reddy's is also the applicant in relation to D1.
Clearly there are claims that the Examiner considers possess novelty, and a patent could be granted if the claims were amended to exclude the subject matter that lacks novelty. Dr Reddy's has not provided submissions disputing the objection, and has not proposed any amendment to attempt to overcome the objections.
In this situation, it appears that Dr Reddy's has lost interest in further prosecuting the application. Consequently, if I find that the objection is validly raised, there are no reasonable prospects of the objection being overcome. There would be no point in giving Dr Reddy's a further opportunity to amend, and I should proceed to refuse the application.
Status of the application
A continuation fee was due on 11 March 2014, but has not yet been paid. Pursuant to regulation 13.3(1A) if the fee is paid within 6 months of that date (and the additional fee is paid) then the time for payment of the fee is taken to be extended until the fee is paid. Consequently, this application has a status that is often referred to as in a "state of lapse". It is apparent from the decision in Miles v Commissioner [2013] FCA 1017, 306 ALR 349 that an application in a state of lapse can be refused.
The specification
The specification relates to the substance lenalidomide, which is an analogue of the thalidomide. The specification ends with 16 claims which are directed to the preparation of solvates of lenalidomide.
Construction of claim 1
Claim 1 is the independent claim. It reads:
A process for preparing a lenalidomide solvate, comprising:
a) reducing 3-(4-nitro-1-oxo-1,3-dihydroisoindol-2-yl) piperidine-2,6-dione of formula II,
with a catalyst in the presence of an acid to give an acid addition salt of lenalidomide of formula III
wherein HX is an acid; and
b) reacting the acid addition salt of lenalidomide of formula III with a base in the presence of a solvent to provide a lenalidomide solvate.
Novelty
It is a requirement of subsection 18(1) of the Patents Act (the Act) that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel in the light of the prior art. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim, or the information was contained in a specification that was published after the priority date of the claim and a claim to the relevant information would have a priority date earlier than the claim under consideration (this is known as a "whole of contents" citation).
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20], 137 CLR 228 at 235:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement"
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
WO 2009/114601
WO 2009/114601 (D1) was published on 17 September 2009 (which is after the priority date of the claim) but contains information having a priority date that is earlier than that of the present application. Consequently it is part of the prior art base as a "whole of contents" citation.
D1 discloses the preparation of lenalidomide. The preparation involves the reduction of the corresponding nitro compound of formula II. Example 4 shows the reduction of the nitro compound in water with methanesulfonic acid, using hydrogen gas and 10% palladium on carbon. The product is filtered and neutralised with sodium bicarbonate. A precipitate forms that is identified as "Form B of Lenalidomide". The steps of this process fall within claim 1. The only question is whether "Form B" is a solvate.
D1 only discusses "Form B" when referring to the prior art document WO 2005/023192. In that document, "Form B" is a crystalline hemihydrate. This is consistent with D1, where the product of Example 4 is crystallised from an aqueous solution. It seems clear that the product of Example 4 is a hemihydrate of lenalidomide, i.e. it is a solvate.
I am satisfied that the objection has been validly raised.
Conclusion
The objection of lack of novelty was validly raised, and there are no reasonable prospects of the objection being overcome. The application should be refused.
Dr S.D. Barker
Delegate of the Commissioner of Patents
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