Merck Sharpe Dohme Group and Another v Cipla Agrimed (Pty) Ltd

• Jurisdiction: South Africa

Merck Sharpe Dohme Group and Another v Cipla Agrimed (Pty) Ltd
2016 (3) SA 22 (SCA)

2016 (3) SA p22

Citation	2016 (3) SA 22 (SCA)
Case No	20282/2014; [2015] ZASCA 175
Court	Supreme Court of Appeal
Judge	Ponnan JA, Theron JA, Wallis JA, Petse JA and Willis JA
Heard	November 10, 2015
Judgment	November 27, 2015
Counsel	L Bowman SC (with G Marriott) for the appellants.; CE Puckrin SC (with M Seale and H Worthington) for the respondent.

Flynote : Sleutelwoorde D

E Intellectual property — Patent — Revocation — Lack of novelty — Requirements of disclosure and enablement — Patents Act 57 of 1978, s 61(1)(c) read with s 25(1).

F Intellectual property — Patent — Selection patent — Proper approach to.

Headnote : Kopnota

The appellants were the joint patentees of South African Patent 98/10975 (patent 98). In terms of an order of the Commissioner of Patents, patent 98 had been revoked at the instance of the respondent, Cipla Agrimed (Pty) Ltd, on the ground that it was invalid for lack of novelty in terms of s 61(1)(c) read with s 25(1) of the Patents Act 57 of 1978. G In reaching this conclusion the court a quo had found that the claims of patent 98 had been anticipated by the disclosure of a prior art document, namely an earlier patent with specification 92/7457 (patent 92). Broadly speaking, patent 92 disclosed the invention of a therapeutic agent for use against parasites in animals. The invention comprised a particular injectable formulation, made up of certain ingredients, in particular for the purposes H of this matter, a 'hydrophobic carrier'. Patent 98 (as per claim 1 of such patent) was described as a 'long standing injectable formulation' comprising certain ingredients, including, too, a hydrophobic carrier. In this case, however, the patent claim also set out the exact ingredients making up such hydrophobic carrier. The question to be decided was whether the particular combination of hydrophobic carriers set out in patent 98 had been disclosed I in the 92 patent, such that patent 92 could be said to anticipate patent 98. The legal question was phrased thus, 'whether or not, and the extent to which, a generalised description in a prior art document discloses and enables a specific matter falling within that broad description for the purpose of anticipation' (para [1]). In addressing this issue, the Supreme Court of Appeal analysed the requirements for anticipation, namely prior J disclosure, and enablement, and, in doing so, endorsed the approach

2016 (3) SA p23

adopted in the United Kingdom. Another issue arising out of the facts was A the correct approach to the so-called 'selection patent', ie a patent of a specific compound or subclass of a broader or more generalised class. Once again, the court, in arriving at its conclusions, endorsed the approach adopted in the United Kingdom.

Held

To meet the requirement of prior disclosure, disclosure in the prior art of B subject-matter of the later patent had to be such that the subject-matter described was capable of being performed, and, if performed, would result in the later patent being infringed. The requirement of enablement provided that the prior disclosure had to enable a skilled person to make or obtain the subject-matter described in the later patent. If something C remained to be ascertained that was necessary for the useful application of the discovery as contained in the later patent, there was sufficient room for another valid patent. Anticipation therefore required that the prior publication had to contain clear and unmistakable directions to do what the patentee claimed to have invented. (Paragraphs [5], [7] and [22] at 28A – F, 29C – D and 35C – D.)

As to the correct approach to a 'selection patent', such patents were to be treated D in accordance with the general approach to patent validity. The disclosure in a prior art document of a generalised class did not necessarily result in a disclosure of each and every member of such class. What one had to look for in the prior art for the purposes of anticipation was an 'individualised description' of the later claimed compound or class of compounds. (Paragraphs [9] and [10] at 30E and 30F – G.) E

As opposed to the later patent 98, patent 92, while providing possible examples, taught only that a hydrophobic carrier had to be added to the formulation; no significance was placed on the choice of the carrier. Further, there was no suggestion that any of the examples so provided had any utility or advantage over other hydrophobic carriers or combination of carriers. By contrast, the F 98 patent provided for the selection of particular carriers, and taught the significant advantages that arose from using such carriers. (Paragraphs [18] and [19] at 33I – 34D.)

As per the undisputed expert evidence, a skilled person armed only with the 92 patent could not, without a significant amount of ingenuity and G experimentation, arrive at the specific combination of hydrophobic carriers disclosed in the patent in suit, as well as the significant technical advantage which those specific combinations represented over the disclosure of the 92 patent. (Paragraphs [21], [23] and [25] at 34H – I, 35H – 36A and 36D – E.)

Further, there was no individualised description in the 92 patent of the specific combinations of hydrophobic carriers of claim 1 of the 98 patent and the advantages which flowed from using them in combination. (Paragraph [25] at 36D – E.) H

In the circumstances, patent 92 could not be said to anticipate patent 98, and the revocation application should therefore have been dismissed with costs.

Cases Considered

Annotations I

Case Law

Southern Africa

B-M Group (Pty) Ltd v Beecham Group Ltd 1980 (4) SA 536 (A): referred to

Letraset Ltd v Helios Ltd 1972 (3) SA 245 (A): referred to J

2016 (3) SA p24

Monsanto Co v MDB Animal Health (Pty) Ltd (formerly MD Biologics CC) A 2001 (2) SA 887 (SCA) ([2001] ZASCA 4): referred to

Netlon Ltd and Another v Pacnet (Pty) Ltd 1977 (3) SA 840 (A): referred to

Standard Bank of SA v 3MFuture Africa (Pty) Ltd [2013] ZASCA 157 (SCA 47/2013): referred to

Sunsmart Products (Pty) Ltd v Flag and Flagpole Industries (Pty) Ltd t/a National Flags 2007 BIP 44 (SCA) ([2007] ZASCA 50): referred to.

B Australia

Eli Lilly & Co Ltd v Apotex Pty Ltd [2013] FCA 214: dicta in paras [272] and [273] applied.

Canada

Apotex Inc v Sanofi-Synthelabo Canada Inc C [2008] 3 SCR 265: referred to

Beloit Canada Ltd v Valmet OY (1986) 8 CPR (3d) 289 (FCA): referred to.

England

Dr Reddy's Laboratories (UK) Ltd v Eli Lilly and Company Ltd [2009] EWCA Civ 1362: dicta in paras [29] and [30] applied

General Tyre and Rubber Co v Firestone Tyre and Rubber Co Ltd D [1972] RPC 457: referred to

Hill v Evans (1862) 31 LJ(NS) 457: referred to

IG Farbenindustrie AG's Patents (1930) 47 RPC 289: referred to

Pope Appliance Corporation v Spanish River Pulp and Paper Mills Ltd [1929] AC 269: referred to

Synthon BV v SmithKline Beecham plc E [2005] UKHL 59 ([2006] 1 All ER 685): applied.

Case Information

L Bowman SC (with G Marriott) for the appellants.

CE Puckrin SC (with M Seale and H Worthington) for the respondent.

F An appeal from the Court of the Commissioner of Patents (Teffo J).

Order

1.

The appeal is upheld with costs, including the costs of two counsel.

2.

The order of the court below is replaced with the following:

'(a)

The application for revocation of South African Patent G No 1998/10975 is dismissed.

(b)

Each of the claims of South African Patent No 1998/10975 is certified as being valid in terms of s 74 of the Patents Act 57 of 1978.

(c)

Costs are awarded to the joint patentees, including the costs H of two counsel.'

Judgment

Ponnan JA (Theron JA, Wallis JA, Petse JA and Willis JA concurring):

'An old question and answer runs as follows: ''Where does a wise man hide a leaf? In a forest.'' It is, at least faintly, ridiculous to say that a I particular leaf has been made available to you by telling you that it is in Sherwood Forest. Once identified, you can of course see it. But if not identified you know only the generality: that Sherwood Forest has millions of leaves. The contention has no logical stopping place. . . .'

[1] That excerpt from Dr Reddy's Laboratories (UK) Ltd v Eli Lilly and Company Ltd J [2009] EWCA Civ 1362 paras 26 and 27 appears

2016 (3) SA p25

Ponnan JA (Theron JA, Wallis JA, Petse JA and Willis JA concurring)

particularly apt when considering the issue raised by this appeal, which A is whether or not, and the extent to which, a generalised description in a prior art document discloses and enables a specific matter falling within that broad description for the purpose of anticipation. The issue arises for determination in this context: The appellants, Merck Sharpe Dohme Corp and Merial LLC, the joint patentees of South African Patent B 98/10975, appeal against an order of the Commissioner of Patents (Teffo J) revoking their patent. The patent (the 98 patent) was revoked at the instance of the respondent, Cipla Agrimed (Pty) Ltd, on the basis that it was invalid for lack of novelty in terms of s 61(1)(c) read with s 25(1) of the Patents Act 57 of 1978 (the Act).

[2] A patent represents a quid pro quo (per Viscount Dunedin in the C UK Privy Council case of Pope Appliance Corporation v Spanish River Pulp and Paper Mills Ltd [1929] AC 269 at 281). The quid is the monopoly conferred upon the patentee for a number of years, and the quo is the new knowledge presented to the public, and which, after the expiry of the patent, will be available for general utilisation. D

'Hence the function of the claim is to inform prospective rivals of the limits of the field denied to them while the patent lasts; and the function of the body of the...