Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC (No 2)

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FEDERAL COURT OF AUSTRALIA

Ranbaxy Australia Pty Ltd v Warner-Lambert Company LLC (No 2)
[2006] FCA 1787

PATENTS - construction of patent - principles of construction - skilled addressee - composition of a team skilled in the relevant field of art - common general knowledge - patent not restricted to racemate

PATENTS - revocation of later patent – selection patent - whether patent obtained by false suggestion or misrepresentation - whether claimed invention is a patentable invention - whether claimed invention is a manner of manufacture within the meaning of Statute of Monopolies - whether claimed invention is useful  

Patents Act 1990 (Cth) ss 3, 18(1), 18(1)(a), 18(1)(c), 138(3)(b), 234, Sch 1
Patents Act 1952 (Cth) ss 100(1)(d), 100(1)(e), 100(1)(h)
Patents Act 1903 (Cth)

Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 applied
Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 applied
Décor Corp Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 applied
Fisher & Paykel Healthcare Pty Ltd v Avion Engineering Pty Ltd (1991) 22 IPR 1 cited
Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 67 IPR 230 cited
Pfizer Overseas Pharmaceuticals v Ely Lilly & Co (2005) 68 IPR 1 applied
Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 applied
PhotoCure ASA v Queen’s University at Kingston (2005) 216 ALR 41 applied
Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 221 ALR 373 applied
Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 applied
Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56 cited
Root Quality Pty Ltd v Root Control (2000) 49 IPR 225 approved
The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 cited
NSI Dental Pty Ltd v University of Melbourne (2006) 69 IPR 542 approved
Aktiebolaget Hassle v Alphapharm Pty Ltd (2002) 212 CLR 411 cited
Minnesota Mining & Manufacturing Co v Beiersdorf (Aust) Ltd (1980) 144 CLR 253 approved
W R Grace & Co v Asahi Kasei Kogyo Kabushiki Kaisha (1993) 25 IPR 481 approved
Asahi Kasei Kogyo Kabushiki Kaisha v W R Grace & Co (1991) 22 IPR 491 cited
NutraSweet Australia Pty Ltd v Ajinomoto Co Inc (2005) 67 IPR 381 cited
Ranbaxy (UK) Ltd v Warner-Lambert Company [2006] EWCA 876  considered
Houssein v Under Secretary, Department of Industrial Relations and Technology (NSW) (1982) 148 CLR 88 cited
Wentworth v NSW Bar Association (1992) 176 CLR 239 cited
Bristol-Myers Squibb Company v FH Faulding and Co Limited (2000) 97 FCR 524 explained
FAI Traders Insurance Co Ltd v Savoy Plaza Pty Ltd [1993] 2 VLR 437 cited
Pfizer Inc v Ranbaxy Laboratories Limited 457 F3d 1284 (2006) considered
Ranbaxy UK Limited v Warner-Lambert Company [2005] EWHC 2142 cited
Pfizer Inc v Ranbaxy Laboratories Ltd 405 FSupp2d 495 (D Del 2005)  cited
Pfizer Canada Inc v The Minister of Health [2006] FC 1471  cited
Commissioner of Patents…

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Details
Case
[2006] FCA 1787
Decision Date

CaseChat Overview and Summary

Ranbaxy Australia Pty Ltd brought an action against Warner-Lambert Co LLC alleging invalidity and unenforceability of Australian Letters Patent No 601981 (the "601 Patent") and Australian Letters Patent No 628198 (the "628 Patent"). Warner-Lambert counterclaimed alleging that Ranbaxy’s intended importation and sale of the Ranbaxy Product would infringe claim 6 of the 628 Patent. The court was required to determine the validity of the 601 Patent and the 628 Patent, as well as whether Ranbaxy’s product would infringe the 628 Patent. The court held that the 628 Patent was valid and that Ranbaxy’s product would infringe claim 6 of the 628 Patent. The court also held that the 601 Patent was invalid and revoked it. The court further restrained Ranbaxy from infringing claims 1 to 4 (inclusive), 8 and 9 of the 601 Patent. The court's reasoning was based on the evidence of the expert witnesses and the Agreed Technical Primer prepared by the parties. The court found that the 628 Patent was valid as it related to a new and useful invention, and that Ranbaxy’s product would infringe claim 6 of the 628 Patent as it contained atorvastatin calcium as its active ingredient. The court also found that the 601 Patent was invalid as it lacked novelty and was obvious in view of the prior art. The court revoked the 601 Patent and restrained Ranbaxy from infringing claims 1 to 4 (inclusive), 8 and 9 of that patent.

Orders

Orders of the court

1. Australian Letters Patent No 628198 be revoked.

2. The cross-respondent, Ranbaxy Australia Pty Ltd, whether by itself, its directors, officers, servants or agents or otherwise, be restrained during the term of Australian Letters Patent No 601981, and any extension of that term, from infringing claims 1 to 4 (inclusive), 8 and 9 of that patent by importing into Australia, or selling or supplying in Australia, any pharmaceutical product containing atorvastatin calcium as its active ingredient.

Background

Background to the litigation

By its amended defence and cross claim dated 17 May 2006, Warner-Lambert alleges that Ranbaxy’s intended importation and sale of the Ranbaxy Product will infringe claim 6 of the Enantiomer Patent.Background Chemistry Fundamental principles of stereochemistry lie at the heart of the technical terms that appear in the patents which are the subject of these proceedings. These principles require some explanation. The terminology, and the visual conventions that I have used in representing structural formulae, are the same as those appearing in the 981 Patent and the Enantiomer Patent. My summary of the relevant principles is based on the Agreed Technical Primer prepared by the parties and the evidence given by the expert witnesses in this case. Stereochemistry is the study of the three-dimensional structure of molecules, the smallest unit of a compound. Isomers are compounds that have the same chemical formula (that is, the same number and type of atoms) but differ in the connection or arrangement of atoms in the molecule. Isomers that differ in the way they are connected are known as ‘structural isomers’. This can be illustrated figuratively by an example that depicts structural isomers for C4H10, where ‘C’ denotes the element carbon, and ‘H’ the element hydrogen. Stereoisomers are another type of isomer. They are compounds with the same chemical formula but they differ in the precise arrangement of the atoms in space. The three-dimensional structure of molecules can be represented by structural formula in which a series of symbols are used to represent the orientation of the atoms in space: — (dash) refers to bonds in the plane of the page; (wedge) refers to bonds coming out of the plane of the page; and or ---- (broken lines/hashed lines) refer to bonds that go behind the plane of the page. When a carbon atom bonds with four non-identical atoms or groups of atoms it forms a tetrahedral shape and can be arranged three-dimensionally in two different ways. These three-dimensional arrangements are non-superimposable mirror images of each other, in the same way that a left hand and a right hand are non-superimposable mirror images. Any physical object that exists in left and right-handed forms, that is, whose mirror image is not identical with itself, is said to be ‘chiral’ (which derives from the Greek word for ‘hand’). Chirality and enantiomers Taking the example of a carbon atom bonded with four non-identical atoms or groups of atoms to form a tetrahedral shape, the carbon atom is said to be the chiral centre of the molecule. The mirror images of the chiral centre are not superimposable. Stereoisomers which are non-superimposable mirror images are called enantiomers. This is shown in Figure 2 below: Pairs of enantiomers have many of the same chemical and physical properties, such as identical melting points and the same solubilities and colours. However, they can be differentiated from one another based on the effect they have on the rotation of polarised light. When polarised light is passed through a solution containing only one enantiomer of a compound, the plane of polarised light is rotated either in a clockwise direction (right, denoted with a ‘(+)’ or ‘d-’) or in an anti-clockwise direction (left, denoted with a ‘(-)’ or ‘l-’). Because of their ability to rotate the plane of polarised light, enantiomers are said to be ‘optically active’. They are sometimes referred to as ‘optical isomers’.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

YOUNG J
Another memorandum prepared by Warner-Lambert dated 1 June 1989 also reported a twofold increase in activity of the active enantiomer over the racemate:‘Animal Efficacy ConclusionsUnlike the racemic lactone (CI-971), PD 134298-38A [R-calcium salt] inhibited cholesterol synthesis in vivo in rats when gavaged as an aqueous suspension… The ED50 for inhibition was 0.89 mg/kg, which is identical to that for lovastatin. As expected, PD 134298-38A was twofold more potent than PD 124488-38A, the racemic calcium salt, which contains 50% inactive isomer.’ The 1 June 1989 report was signed by Dr Roth together with a Dr Roger Newton. Later internal memoranda of Warner-Lambert dated 28 September 1989 and 5 December 1989 make the same comparison with the racemic mixture – ie twofold more potent as expected. In Dr Scallen’s opinion, the in vivo assay is the most important form of testing of the two (in vivo and in vitro), and he considered it to be ‘the ultimate test’. In his affidavit at para 112, he attached particular importance to the results of the AICS tests that were reported in Warner-Lambert’s report of 31 May 1989 as:‘…this is the only data from Warner-Lambert, whether in vivo or in vitro, which involved two repeated paired, or head to head, experiments, in which the repeated experiment confirmed the first paired experiment. They are head to head in the sense that the racemate of atorvastatin calcium is going head to head (or is paired) against the R-trans enantiomer of atorvastatin calcium. Therefore this particular data has great scientific strength.’In cross-examination, he said that these two experiments provided results which are in excellent agreement, and none of the in vitro data provided numbers which were anywhere near as close. Further, it is the only example of two head-to-head experiments where one confirms the other: the data is therefore reliable and reproducible. Dr Watson also considered that these two head-to-head AICS tests were important data that should be taken into account before drawing conclusions as to the activity levels of potential new compounds. More generally, Dr Cunningham also considered it necessary to ‘have had regard to the totality of the data that was available in order to carry out a proper comparison’. He disagreed with Dr Roth’s evidence that in vivo assays are not used in SAR work by a medicinal chemist. These internal reports were put to Dr Roth during cross-examination. Dr Roth sought to distance himself from the conclusions contained in the 1 June 1989 report that he signed:‘Do I take it that although you signed that memorandum, you didn't agree with it?--- Sir, I wrote the chemistry part, Roger [Dr Newton] wrote the biology part. Basically what Roger - he has an interpretation of the in vivo data. However, without knowing the detailed pharmacokinetics of the compound, you really can’t draw this conclusion that it’s twofold more potent, but – so I would disagree with the conclusion. But frankly, it's not a significant conclusion to senior management. All they care about is: is the compound active? How does it compare with compactin?You were prepared nevertheless to sign a statement to the effect that a twofold increase was to be expected?--- I didn't sign in agreement to that statement necessarily. My name is on the front.But it has not only got your name, it has got - you actually signed it?--- I signed it. Again, it doesn't necessarily mean that I agreed with Roger's interpretation of the biology data.Would you agree that it reflects the general view of the correct interpretation of the biology data?--- It reflects Roger's interpretation.Did you raise any objection to the statement we have just been looking at, Dr Roth?--- To Dr Newton? I mean, here is your name on the document. It states a conclusion with which you say you disagree. Did you make your disagreement clear?--- I don't recall what discussions Roger and I had about the data, if any. His responsibility was the biology section, mine was the chemistry section. Frankly, whether it was twofold more active in the in vivo experiment and whether Roger expected that or not is really his opinion. I would not - again, unless you know the detailed pharmacokinetics, you don't know what you’re testing in an in vivo experiment. You don’t know whether absorption is the same, whether you are testing active metabolites, and so it’s really difficult to draw that conclusion unless you understand the pharmacokinetics of your compound, which we did not at that time. So Roger's conclusion there is inaccurate. Did we dispute it? Was it worth disputing about? I don't [know] that it was worth arguing about one way or another at the time.In any event, so far as you remember, you didn't dispute it at the time?--- I don't recall what conversations Roger and I had about the data.’

Ratio Decidendi

Legal Principle Established

Established by: YOUNG J

Full text does not contain this section.