Pharma Dynamics (Proprietary) Limited v Bayer Pharma AG and Another (468/2013) [2014] ZASCA 123; [2014] 4 All SA 302 (SCA); 2014 BIP 69 (SCA) (19 September 2014)

Pharma Dynamics (Proprietary) Limited v Bayer Pharma AG and Another (468/2013) [2014] ZASCA 123; [2014] 4 All SA 302 (SCA); 2014 BIP 69 (SCA) (19 September 2014)

The court held that claim 1 of the 2004 patent is not limited to DSP provided in micronised form or sprayed onto inert carrier particles, but covers any method achieving the specified dissolution rate. The Ruby product meets this criterion and thus infringes the patent. The inventive step lies in the unexpected finding that DSP, though acid labile and poorly soluble, can be administered in rapidly dissolving form without an enteric coating and still achieve good bioavailability, which was not obvious to a skilled formulator at the priority date. The 2004 patent is a valid divisional patent under section 37 of the Patents Act, with claims broader than the parent but not extending beyond...

Citation
[2014] ZASCA 123
Parties
Appellant: Pharma Dynamics (Proprietary) Limited; Respondent: Bayer Pharma AG (formerly Bayer Schering Pharma AG); Respondent: Bayer (Proprietary) Limited
Court
Supreme Court of Appeal
Jurisdiction
South Africa
Judgment Date
19 September 2014
Case Number
468/2013
Procedural Posture
Civil Appeal / Appeal From the Court of the Commissioner of Patents
Outcome
Appeal dismissed with costs, including the costs of two counsel.
Judges
Brand, Cachalia, Wallis, Mbha, Mathopo
Legal Topics
Patent Infringement, Inventive Step, Divisional Patent, Novelty, Pharmaceutical Patents
Intellectual Property Patent Infringement Inventive Step Divisional Patent Novelty Pharmaceutical Patents

Case Brief

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Parties

Pharma Dynamics (Proprietary) Limited

Appellant

Bayer Pharma AG (formerly Bayer Schering Pharma AG)

Respondent

Bayer (Proprietary) Limited

Respondent

Procedural Posture

Civil Appeal / Appeal From the Court of the Commissioner of Patents

Legal Issues

  1. 1 Does Pharma Dynamics' Ruby product infringe claim 1 of Bayer's 2004 patent?
  2. 2 Does the 2004 patent involve an inventive step as required by section 25(1) of the Patents Act?
  3. 3 Is the 2004 patent a valid divisional patent under section 37 of the Patents Act, or does it lack novelty in light of the parent patent's disclosures?

Ratio Decidendi

The court held that claim 1 of the 2004 patent is not limited to DSP provided in micronised form or sprayed onto inert carrier particles, but covers any method achieving the specified dissolution rate. The Ruby product meets this criterion and thus infringes the patent. The inventive step lies in the unexpected finding that DSP, though acid labile and poorly soluble, can be administered in rapidly dissolving form without an enteric coating and still achieve good bioavailability, which was not obvious to a skilled formulator at the priority date. The 2004 patent is a valid divisional patent under section 37 of the Patents Act, with claims broader than the parent but not extending beyond...

Court Disposition

Appeal dismissed with costs, including the costs of two counsel.

Orders

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