Bayer Pharma AG v Teva Pharmaceuticals (Pty) Ltd

• Jurisdiction: South Africa
• Judge: CJ Van der Westhuizen AJ
• Judgment Date: 14 December 2017
• Citation: 2018 JDR 0171 (GP)
• Docket Number: 2002/1668
• Court: Commissioner of Patents

Van der Westhuizen AJ:

[1]

The applicants apply for the grant of an interim interdict pending the final determination of an action instituted for a final interdict in respect of the alleged apprehension of infringement of the two patents, namely Patent No. 2002/1668 and 2004/4083. The application was launched on some urgency being alleged. Simultaneous with the launch of this application, the applicants issued an action for a final interdict in respect of the alleged apprehension of infringement of the patents.

[2]

The first applicant is the registered patentee of both patents and the second applicant is recorded as the registered licensee under both patents and joins as co-applicant in terms of the provisions of s 65(5) of the Patents Act, 57 of 1978 (the Act).

[3]

The first respondent is Teva Pharmaceuticals (Pty) Ltd and the second respondent is Medpro Pharmaceutica (Pty) Ltd. Both the respondents are generics companies active in the pharmaceutical sector in South Africa.

[4]

Patent no. 2002/1668 relates to an invention entitled "Pharmaceutical combination of ethinylestradiol and drospirenone for use as a contraceptive". The complete specification of this patent was lodged at the South African Patent Office on 27 February 2002 and claims priority from European Patent application no. 99202826.6 dated 31 August 1999 as well as US Patent application no. 60/240,953 also dated 31 August 1999. The patent is in force. This patent originated as a national phase entry into South Africa of International Patent Application no. PCT/IB00/01213 which was filed on 31 August 2000. On 26 May 2004, and prior to the grant of the patent, an amendment to the complete specification was applied for and the Registrar of Patents granted the amendment on 27 May 2004. The complete specification of the patent was accepted on 24 June 2004 and the publication of the acceptance occurred on 25 August 2004. The latter date is regarded as the date of grant of the patent. A further amendment to this patent

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was granted pursuant to a judgment of the Supreme Court of Appeal in Bayer Pharma Ag v Pharma Dynamics (Pty) Ltd 2014 BIP 87 (SCA). The patent is to expire on 31 August 2020.

[5]

Patent no. 2004/4083 relates to an invention entitled "Pharmaceutical combination of ethinylestradiol and drosperinone for use as a contraceptive". This patent is a so-called "divisional" patent of the 2002 patent, its "parent" patent. As such it has the same claim to a priority date as the 2002 patent. The claim of the 2004 patent relates to a different aspect of the invention claimed in the 2002 patent. The complete specification of the 2004 patent was lodged at the South African Patent Office on 25 May 2004 and is ante-dated to 31 August 2000, i.e. the filing date of the same PCT patent, International Patent Application no. PCT/IB00/01213. The complete specification of the 2004 patent was accepted on 30 November 2005 and publication of acceptance occurred on 22 February 2006. The 2004 patent was amended pursuant to a judgment of the Court of the Commissioner of Patents in the matter Bayer Schering Pharma AG et al v Pharma Dynamics (Pty) Ltd 2011 BIP 73 (CP). In the aforesaid matter, the court granted an interim interdict prohibiting Pharma Dynamics (Pty) Ltd from infringing the 2004 patent pending the outcome of a trial action. In both the trial action and the subsequent appeal to the Supreme Court of Appeal, the 2004 patent was held to be valid. [1]

[6]

The 2002 patent has only one claim following on the amendment granted by the Supreme Court of Appeal. The claim reads as follows:

"1. A pharmaceutical composition in an oral dosage form and in the form of a tablet, pill or a capsule comprising:

As a first active agent drospirenone in an amount corresponding to a daily dosage, on administration of the composition, of 3mg, and

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as second active agent, ethinylestradiol in an amount corresponding to a daily dosage of 0.015 mg to 0.03 mg, together with one or more pharmaceutically acceptable carriers or excipients, wherein said drospirenone is in micronized form and in a rapid dissolution form."

[7]

The 2004 patent contains also only one claim that reads:

"1. 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 4mg, and

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

together with one or more pharmaceutically acceptable carriers or excipients,

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

[8]

The Supreme Court of Appeal held that the inventive step of the 2004 patent "lies in the surprising, counter-intuitive finding that DSP, despite being both acid labile and poorly soluble, can be administered in a low dosage (of 2-4mg), having the rapid dissolution rate of claim 1 and yet give sufficiently good bioavailability in vivo to be effective."

[9]

I have recorded the foregoing extensively in view of the respondents' defences relating to the alleged invalidity of the two patents.

[10]

The respondents intend to launch two products within the South African market of female oral contraceptives before the aforementioned patents expire. These products are branded MAYA and YADE

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respectively. In this regard, the respondents obtained registration of the aforementioned two products with the Medicines Control Council (the MCC) under registration numbers 47/21.8.210024 and 47/21.8.2/0025 respectively.

[11]

The MAYA product comprises 21 active hormonal film-coated tablets, each containing 3,0 mg drospirenone and 0,03 mg ethinylestradiol, and 7 inactive tablets. It is gleaned from the package insert for the MAYA product that the absolute bioavailability of the drospirenone in MAYA is between 76% and 85% and the absolute bioavailability of the ethinylestradiol in MAYA is approximately 45%.

[12]

The YADE product comprises 24 active hormonal film-coated tablets, each containing 3,0 mg drospirenone and 0,02 mg ethinylestradiol, and 4 inactive tablets. No package insert in respect of YADE is available to the applicants. However, the applicants submit that given the similarities between MAYA and YADE, there is no doubt that the absolute bioavailability of the drospirenone in YADE is also between 76% and 85%. The applicants further submit that for the same reason the absolute bioavailability of the ethinylestradiol in YADE is also approximately 45%.

[13]

The applicants further submit that the registration for the MAYA product corresponds with the composition and dosage of the applicants' YASMIN product and that the registration for the YADE product corresponds with the composition and dosage of the applicants' YAZ product.

[14]

The respondents...