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Apotex Pty Ltd v Sanofi-Aventis

Apotex Pty Ltd v Sanofi-Aventis

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Case Copied 12 August 2008 76 min read

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FEDERAL COURT OF AUSTRALIA
Apotex Pty Ltd (formerly GenRx Pty Ltd) v Sanofi-Aventis [2008] FCA 1194
PATENTS – applications for revocation – validity – patent in suit claiming d-enantiomer (clopidogrel) of racemate, pharmaceutical compositions of d-enantiomer and process for preparation of each – where racemate the subject of prior art patents in Australia and overseas – available grounds for revocation where patent in suit granted under Patents Act 1952 (Cth) – whether d-enantiomer a novel invention in light of prior art patents – whether pharmaceutical compositions (salts) of d-enantiomer novel in light of prior art patents – whether process for preparation novel in light of prior art patents – whether patent in suit valid as a selection patent – whether obtaining d-enantiomer of racemate, preparing its pharmaceutical compositions (salts) and the process for preparation obvious so as to lack inventive step – relevance to consideration of inventive step of references to prior art patents in patent in suit – whether d-enantiomer valid as a manner of manufacture – whether patent in suit contained false suggestion or representation that was a material inducing factor leading to grant of patent in suit – whether d-enantiomer a useful invention – applications granted in part and dismissed in part
Patents Act 1952 (Cth), ss 40(1), 100, 100(1), Pt VII
Patents Act 1990 (Cth), ss 6, 7, 18(1), 75, 138, 138(3), 233, Ch 2 Pt 3, Ch 6 Pt 3, Ch 7
Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171 cited
Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411 discussed
Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559 discussed
Arrow Pharmaceuticals Ltd v Merck & Co Inc (2004) 213 ALR 182, (2004) 63 IPR 85 cited
Asahi Kasei Kogyo KK’s Application [1991] RPC 485 distinguished
Beecham Group Ltd’s (Amoxycillin) Application, Re [1980] RPC 261 cited
Biogen Inc v Medeva plc [1997] RPC 1, (1996) 36 IPR 438 discussed
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524 cited
CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 followed
C Van der Lely NV v Bamfords Ltd [1963] RPC 61 cited
Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 considered
EI Du Pont De Nemours & Co (Witsiepe’s) Application [1982] FSR 303 distinguished
F Hoffman-La Roche & Co AG v Commissioner of Patents (1971) 123 CLR 529 cited
Firebelt Pty Ltd v Brambles Australia Ltd (2002) 188 ALR 280, (2002) 76 ALJR 816 cited
Flour Oxidizing Co Ltd vCarr & Co Ltd (1908) 25 RPC 428 discussed
General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] RPC 457 followed
Graham Hart (1971) Pty Ltd v SW Hart & Co Pty Ltd (1978) 141 CLR 305 cited
Hill v Evans (1862) 1A IPR 1, (1862) 4 De GF & J 288, (1862) 31 LJ Ch 457, (1862) 6 LT 90, (1862) 45 ER 1195 applied

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2008] FCA 1194
Decision Date: 12 August 2008

CaseChat Overview and Summary

In the case of Apotex Pty Ltd v Sanofi-Aventis, the primary issue was the validity of a patent held by Sanofi-Aventis, which relates to the compound clopidogrel, an inhibitor of platelet aggregation used in the prevention of thrombus or clot formation. The defendants, Apotex and Spirit Pharmaceuticals, sought revocation of the patent on various grounds including lack of novelty, lack of inventive step, and inutility. The proceedings were heard together, with the same body of evidence used for both cases. The central dispute centred around the chemical properties and the specific claims made in the patent concerning the dextro-rotatory enantiomer of clopidogrel and the process for its preparation.

The court was required to determine whether the claims in the patent were valid and if there were any deficiencies such as lack of novelty or inventive step. The nature of the dispute involved complex organic chemistry and the stereochemistry of carbon compounds, specifically the chiral properties of the clopidogrel molecule. The court had to examine whether the claims regarding the optical activity and the efficacy of the compound were sufficiently novel and inventive, considering the prior art and the technical knowledge available at the time the patent was filed. Additionally, the court assessed whether the patent's claims were clear, precise, and supported by the evidence presented.

The court concluded that claim 1 of the patent was invalid due to lack of novelty, as the invention had already been disclosed in prior art. Consequently, claims 10 and 11 were also found to be invalid as they depended on claim 1. Furthermore, claims 6–9 were deemed invalid on the grounds of lack of inventive step. The court found no merit in the other grounds of invalidity presented by the defendants, such as inutility and false suggestion or misrepresentation. The proceedings were adjourned to allow the parties to consider and potentially agree on the orders to be made, including any costs, and to ensure that no critical issues had been overlooked.

The final orders of the court were to stand the proceedings over to a time to be fixed, pending further agreement or argument on the specific orders to be made, including any orders regarding costs. The court also encouraged the parties to review the reasons given to ensure no necessary issues had been overlooked.

Orders

Orders of the court

The proceeding stand over to a time to be fixed.

Note:

Background

Background to the litigation

Each of Apotex Pty Ltd (Apotex) and Spirit Pharmaceuticals Pty Ltd (Spirit) seeks revocation of the patent in suit on the grounds of lack of novelty, lack of inventive step, not being a manner of manufacture, inutility and false suggestion or misrepresentation. Both proceedings were heard together, on the same body of evidence, and one set of reasons will be given. Chemical background The title of the invention in the specification is:“Dextro-rotatory enantiomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-acetate, a process for its preparation and the pharmaceutical compositions containing it.” The compound the subject of claim 1 of the patent in suit has the international non-proprietary name clopidogrel. After obtaining regulatory approval, a product was launched by Sanofi-Aventis in 1998 under the name Plavix, the active ingredient of which is the bisulfate salt of clopidogrel. It has been very successful commercially. It inhibits platelet aggregation at the site of blood vessel damage and so inhibits thrombus or clot formation. It is admitted that the applicant Apotex intends to make and sell compositions, the active ingredient of which is clopidogrel bisulfate and, so, would be in breach of claims 1, 3, 10 and 11 of the patent in suit. The invention relates to organic chemistry, which is concerned with the study of carbon compounds and, in particular, with the stereochemistry of carbon compounds respecting the three dimensional structure of their molecules. Isomers are compounds whose molecules consist of the same number and kind of atoms but differ in their structure or arrangement. Material that rotates the plane of polarised light is said to be optically active. The means of identifying compounds which have that property is by shining the plane of polarised light through a sample of the compound dissolved in an appropriate solvent then measuring the extent of the rotation. If the compound displays optical activity, this indicates that the chemical structure of the molecule is non-superimposable on its mirror image. That property is called “chirality” and the molecule is described as “chiral”. An organic compound is said to have a chiral centre if it includes a carbon atom bonded to four different substituents. If the structure of a molecule is non-superimposable on its mirror image, the mirror image must be a different molecule. In each case of optical activity of a pure compound there are two, and only two, isomers called enantiomers, which differ in structure such that the arrangements of their atoms in space are non-superimposable mirror images of each other. Enantiomers have identical physical and chemical properties except in two important respects: they rotate the plane of polarised light in opposite directions, though in equal amounts; and they interact in different ways with other chiral compounds, including reacting with them at different rates. The isomer which rotates the plane of polarised light to the left (counter clockwise) is called the levo isomer, or levo-rotatory or L-enantiomer, and is designated (-), while the one that rotates the plane of polarised light to the right (clockwise) is called the dextro isomer, or dextro-rotatory or D- enantiomer, and is designated (+).

Evidence

Evidence Before The Court

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Decision

Reasons for decision

GYLES J

Here, there is no suggestion that any of the process claims do not work in that sense and there is no suggestion that the compounds claimed do not usefully inhibit platelet aggregation. Indeed, it has not been contended that the compounds claimed are not better in that respect than the racemate. I do not see that the claims that the properties were “unexpected” or “surprising” have anything to do with that concept. The decision of Young J in Ranbaxy [2006] FCA 1787, 71 IPR 46 must have been based upon the view that the specification there was construed as promising a particular level of result. The correctness of the decision on this point was left open in the Full Court (Ranbaxy [2008] FCAFC 82 at [142]–[144]).Conclusion Claim 1 is invalid on the ground of lack of novelty. Claims 10 and 11 as presently framed fall with it. Claims 6–9 inclusive are invalid on the ground of lack of inventive step. All other grounds of invalidity are dismissed. The proceeding will stand over for a limited period for orders to be made, either by agreement or after argument, including orders for costs. The parties should also consider whether any necessary issue has been overlooked in these reasons.

Ratio Decidendi

Legal Principle Established

Established by: GYLES J

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