Bayer Pharma AG v Pharma Dynamics (Pty) Ltd

• Jurisdiction: South Africa
• Judge: Pretorius J
• Judgment Date: 14 March 2013
• Docket Number: 2004/4083
• Court: Commissioner of Patents
• Hearing Date: 15 October 2012
• Citation: 2013 JDR 0506 (CP)

Pretorius J

[1]

This action concerns the validity and alleged infringement of SA patent 2004/2083, with priority date 31 August 1999 brought under the provisions of section 65 of the Patents Act, 57 of 1978.

[2]

On 4 March 2011 Pharma Dynamics, the respondent, obtained approval from the Medicines Control Council ("MMC") to sell a contraceptive product for women called Ruby. This product is the generic equivalent of the Yasmin product sold by the plaintiffs which is covered by the 2004 patent. Pharma Dynamics is the local distributor of generic pharmaceuticals.

[3]

The first plaintiff is the proprietor of South African patent 2004/4083 (the "2004 patent").

[4]

The second plaintiff is a licensee of the 2004 patent and enjoys locus standi in terms of section 65 (5) of the Act.

[5]

The court will refer to the two plaintiffs as Bayer.

[6]

It is common cause that Yasmin and Ruby contain identical amounts of the two active pharmaceutical ingredients referred to in the claim of the 2004 patent viz., drospirenone ("DSP") and ethinylestradiol ("EE").

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[7]

The priority date of the 2004 patent is 31 August 1999. The plaintiffs sell two oral contraceptives which fall within the scope of the 2004 patent.

[8]

The patent is for an invention titled "Pharmaceutical combination of ethinylestradiol and drosperinone for use as a contraceptive."

[9]

An application for an interim interdict was launched against the defendants and was granted on 14 November 2011, which is still in place pending the outcome of the present action. Bayer, the applicants, sought relief based on the 2004 patent, prohibiting Pharma Dynamics from selling and distributing Ruby. An application to amend the 2004 patent was launched simultaneously with the interim interdict and granted on 14 November 2011. The elect of the amendment was that all of the claims of the 2004 patent were deleted, except claim 1. The amendment to the 2004 patent was not appealed and remains final. Thus the sale and distribution of Ruby was prohibited, pending the institution of this action.

[10]

Bayer alleges that the sale of the Ruby product by the defendant will infringe claim 1 of the 2004 patent. The applicant seeks a final order, for delivery of and enquiry into damages and costs.

[11]

Pharma Dynamics instituted a counterclaim for an order revoking the patent on the basis that the patent is invalid for lack of

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novelty, and for lack of an inventive step (obviousness). The other two grounds were not argued and is not dealt with by the commissioner,

Infringement

[12]

The onus is on the plaintiffs to prove infringement of the claim of the patent. The onus is on the defendant to prove the invalidity of the patent. Rules 39 (13) and (14) of the High Court Rules apply.

[13]

Section 45 (1) of the Act provides:

"The effect of a patent shall be to grant to the patentee in the Republic, subject to the provisions of this Act, for the duration of the patent, the right to exclude other persons from making, using, exercising, disposing or offering to dispose of, or importing the invention, so that he or she shall have and enjoy the whole profit and advantage accruing by reason of the invention."

[14]

It is the object of the claims to define the monopoly to which the patentee lays claim. The lodging date of the 2004 patent of 25 May 2004 was antedated to 31 August 2000.

[15]

The claim in the 2002 patent reads:

'A pharmaceutical composition comprising; as a first active agent drospirenone In an amount corresponding to a daily

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dosage, on administration of the composition, of from about 2 mg to 4 mg, and as a second active agent, ethinylestradiol in an amount corresponding to a daily dosage of from about 0,01 mg to 0.05 mg, together with one or more pharmaceutically acceptable carriers or excipients, wherein said drospirenone is in micronized form." (Court's emphasis)

[16]

and in the 2004 patent reads:

"A pharmaceutical composition comprising;

As a first active agent drospirenone in an amount corresponding to a daily dosage., on administration of the composition, of from about 2 mg to 4 mg, and as a second agent ethinylestradiol in an amount corresponding to a daily dosage of from about 0.01 mg to 0,05 mg, together with one or pharmaceutically acceptable carriers or excipients, wherein at least 70% of said drospirenone is dissolved from said composition within 30 minutes, as determined by USP XXIII Paddle Method II using water at 37°C as the dissolution media and 50 rpm as the stirring rate." (Court's emphasis)

[17]

The claim of a patent has to define clearly the monopoly claimed. The patent specification performs a different function, although the claim must be read as part of the whole document,

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However, the language of the claim is the part which sets out the boundaries of the patent.

[18]

In Aktiebolaget Hässle and another v Triomed (Pty) Ltd 2003 (1) SA 156 (SCA) at paragraph 8 Nugent JA held:

"While the enquiry into infringement requires the allegedly infringing article or process to be compared against the language of the claim, it appears from that dictum, and has subsequently been repeated by this Court, that the language of the claim must be construed purposively, so as to extract from it the essence, or the essential elements, of the invention.

[19]

For as pointed out by Lord Diplock in Catnic Components Ltd and Another v Hill and Smith Ltd [1982] RPC 163 (HL) in a passage that was approved and adopted by this Court in the cases I referred to,

'...A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee

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to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked,"' (Court's emphasis)

and further

"While the claim must be construed to ascertain the intention of the inventor as conveyed by the language he has used (Gentiruco AG v Firestone SA (Pty) Ltd 1972 (1) SA 589 (A) at 614B - C) what is sought by a purposive construction is to establish what were intended to be the essential elements, or the essence, of the invention, which is not to be found by viewing each word in isolation but rather by viewing them in the context of the invention as a whole." (Court's emphasis)

Experts:

[20]

Both parties called expert witnesses. I am totally aware of the fact that expert witnesses are not called to give an opinion of whether they consider that an infringement had taken place or that an invention is bad for want of novelty or obviousness. The court has to make that decision and can only rely on the experts' evidence to place the court in a position as an "addressee".

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[21]

The parties agreed that the claim of the patent may be divided into the following integers:

"(A)

A pharmaceutical composition comprising:

(B)

as a first active drospirenone in an amount corresponding to a daily dosage, on administration of the composition, of from about 2mg to 4mg;

(C)

as a second active agent ethinylestradiol in an amount corresponding to a daily dosage of from about 0.01 mg to 0.05 mg;

(D)

together with one or more pharmaceutically acceptable carriers or excipients, and

(E)

wherein at least 70% of said drospirenone is dissolved from said composition within 30 minutes, as determined by USP XXII Paddle Method II using water at 37°C as the dissolution media and 50 rpm as the stirring rate."

[22]

Should the Ruby product include integers A — E of the claim of the patent, the Ruby product will infringe the patent.

[23]

The only dispute which the court has to consider is whether integer E causes Ruby to fall within the scope of claim 1 of the 2004 patent and thereby infringes the claim as it is common cause that integers A — D are present in both Ruby and the plaintiffs' product.

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[24]

The court has to decide whether the defendant's contention that claim 1 is limited to DSP in micronized form or possibly, dissolved in a solvent, and sprayed onto the surface of inert carrier particles is correct, whilst the plaintiffs argue that the claim is not limited.

[25]

The plaintiffs argue that it is irrelevant what the dissolution rate is for the court to determine the infringement.

[26]

The defendant is requesting the court to find that a limitation exists as propounded by Dr Rue. If claim 1 in the 2002 patent is compared with claim 1 in the 2004 patent it is clear that claim 1 of the 2002 patent is limited to micronized DSP, whereas this limitation was not expressly included in claim 1 of the 2004 patent.

[27]

In Gentiruco AG v Firestone SA (Pty) Ltd 1972 (1) SA 589 (A) at 646 H Trollip JA found:

"Again it is emphasised: the opinions of the expert witnesses that a document does or does not anticipate a claim of the patent in suit must be disregarded, for that is for the Court to decide."

[28]

The role of the expert witness is to instruct the court in the art of the science at the time to enable the court to understand the claim and to make an informed decision. The court should be able to be in the

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position of an "addressee". This would be a person who is skilled in the...