in the high court of south africa (south eastern cape ... in the high court of south africa (south...

Download IN THE HIGH COURT OF SOUTH AFRICA (SOUTH EASTERN CAPE ... IN THE HIGH COURT OF SOUTH AFRICA (SOUTH EASTERN

Post on 16-Oct-2019

0 views

Category:

Documents

0 download

Embed Size (px)

TRANSCRIPT

  • IN THE HIGH COURT OF SOUTH AFRICA

    (SOUTH EASTERN CAPE LOCAL DIVISION)          CASE NO: 1481/2007

    In the matter between: 

    B BRAUN MEDICAL (PTY) LIMITED                         

    APPLICANT

    and

    FRESENUS KABI SOUTH AFRICA (PTY) LTD                 RESPONDENT

    JUDGMENT

    DAMBUZA J:

    1. In this matter, the applicant seeks an interim interdict, on an urgent basis, 

    restraining the respondent from distributing certain documents and from 

    otherwise   spreading   offending   information   about   a   medical   product 

  • marketed   and   sold   by   the   applicant   known   as   Venofundin   which   is 

    apparently similar medical product known as Voluven marketed and sold 

    by the respondent.  

    2. There   is   also  an   application,   brought   by   the   respondent,   for   leave   to 

    supplement its answering affidavit.  

    3. The applicant, a wholly owned subsidiary of  B Braun Melsungen AG, a 

    private German Company, and the respondent, a South African Company, 

    are   competing   pharmaceutical   companies   which   operate   within   the 

    country and internationally.  The medical products in question are a colloid 

    plasma volume substitute that is used during surgical operations and in 

    emergency units of hospitals and clinics.   Venofundin is a potato based 

    product   also   known   as   hydroxyethl   starch   (HES)   130/0.42/6:1   whilst 

    Voluven   is  maize  or  waxy­corn  derivative  alternatively   known  as  HES 

    130/0.4/9:1.   The respondent’s Voluven product has been used in South 

    Africa   since   2002   and   internationally   since   1999.     The   applicant’s 

    Venofundin is relatively new, having been registered in South Africa on 2 

    March 2007 and launched at the end of March 2007.

    4. The facts giving rise to this application are largely common cause.  On 22 

    May 2007 representatives of both parties attended a seminar held at 1 

    Military Hospital in Pretoria. Various other competitors in the same market 

    2

  • as   the   parties   also   attended   the   seminar   and  presented   their   volume 

    replacement   therapy  products   to  senior  members  of   the  military.    The 

    respondent’s   national   sales   manager,  Marlize   Haarde  made   a 

    presentation in respect of the respondent’s Voluven and Armin Junkuhn, 

    a   divisional   manager   in   the   employ   of   the   applicant,   made   a 

    representation in respect of Venofundin.  In the course of her presentation 

    Haarde  referred to  the applicant’s Venofundin, stating, amongst others, 

    that:

    4.1   Doses of up to 33ml/kg of Venofundin are associated with hyperbilirubinaemia 

    (excessive concentration of bilirubin (a bile pigment) in the blood) ;

    4.4 Venofundin  is contra–indicated  for  liver  failure  in  its European package  insert 

    whereas in South Africa it is not;

    4.2 The potato based HES product   is  registered for a dosage of  33ml/kg,  with a 

    maximum  daily   dosage   of   40ml/kg   in   acute   cases   and   there   is   no   data   for 

    administration of higher doses thereof ; and 

    4.3 The potato­derived HES has a greater effect on (blood) coagulation than waxy­

    corn derived .

    5. These   statements   appear   in   a   36   page   document   prepared   by   the 

    respondent   titled  “VOLUVEN   Colloids   Overview”  (the   respondent’s 

    pamphlet or Annexure “E” to the founding papers).   This document was 

    distributed   by  Haarde  at   the   seminar.   In   this   document   Volume 

    3

  • Replacement Therapy is discussed and a comparison is drawn between 

    Voluven and Venofundin. In the comparison it is also stated that:

    A the Amylopectin/Amylase content of the products is 95/5 for Voluven and 

    80/20 for Venofundin;

    B Unlike with Voluven, there is no information available on  the safety  of 

    Venofundin use in paediatrics; and

    C Unlike   with   Voluven   there   is   no   information   available   in   respect   of 

    Venofundin   regarding   tissue   storage,   renal   function,   toxicology   and 

    compatibility with other drugs.

    6. In the founding affidavit Junkuhn states that on 17 April 2007 he received 

    an   enquiry   from  Carole   Lawrence  of   the  Life   Healthcare   Hospital 

    Groups in the country, requesting clarification on queries that she (Lewis) 

    had   received   concerning   Venofundin.   According   to   Lewis   there   were 

    insinuations that because Venofundin  is registered as a hetastarch this 

    could have clinical consequences, particularly regarding coagulation; that 

    because Venofundin contains a fair amount of phosphates it could have 

    more extensive side effects than Voluven; that contrary to the only article 

    used   in   the   applicant's   detail   aids,   written   by   Lehman  et   al,     a   few 

    published studies showed that Voluven has a greater plasma clearance 

    than Venofundin;  and  that  potato­derived  HES  has a greater  effect  on 

    coagulation   than corn­derived  HES.    Lewis  also enquired whether   the 

    4

  • applicant   had   a   safety   data   for   use  of   Venofundin   in   paediatrics   and 

    patients with compromised renal or hepatic function.

    7. The applicant received further queries from Entabeni Hospital in Durban, 

    expressing concern about  the amylopectin/amylase ratio for Venofundin 

    and Voluven being different; there being no data available for Venofundin 

    regarding   tissue   storage;   Venofundin   being   contra­indicated   for   liver 

    failure   in   the   European   package   insert   but   not   in   the   South   African 

    package insert; Venofundin dosages of up to 33 ml/kg being associated 

    with   hyperbilirubinaemia;   unavailability   of   toxicological   data   for 

    Venofundin;   and   unavailability   of   information   regarding   compatibility   of 

    Venofundin with other drugs.

    8. The applicant  contends  that   the only  conclusion  to  be  drawn  from  the 

    similarity   between   the   queries   raised   by  Lawrence  and  Entabeni 

    Hospital and the contents of the respondent’s pamphlet, Annexure “E” is 

    that   the   respondent’s   representatives   had   been   spreading   injurious 

    falsehoods  and  unsubstantiated   rumours  concerning  Venofundin.  Such 

    conduct on the part of the respondent, so argues the applicant, constitutes 

    unlawful  competition.  The applicant’s case  is  that   in  Annexure “E”,   the 

    respondent has made reference to articles written by medical experts on 

    the products, thus misleading the reader by giving an impression that the 

    5

  • statements   complained   of   are   supported   by   medical   evidence.    Mr 

    Mundell  submitted  on  behalf  of   the  applicant   that   the   respondent  has 

    undertaken   a   deliberate   extensive   campaign   of   falsely   maligning   the 

    applicant’s Venofundin product by suggesting that the product is unsafe 

    and has negative side effects which render Venofundin a less safe and a 

    less acceptable alternative when compared to Voluven whilst on the other 

    hand, claiming unwarranted accolades for Voluven. 

    9. The respondent denies that the statements in question are false and that 

    its   conduct   constitutes   unlawful   competition.   It   contends   that   the 

    statements find support in the studies and articles referred to in Annexure 

    “E” and in the package inserts of the products.

     10. Requirements for an interim interdict and unlawful competition

    It is trite that ordinarily an applicant seeking an interim interdict must prove 

    a prima facie right, a well­grounded apprehension of harm if the interim 

    interdict   is   not   granted  and   the  ultimate   relief   is   ultimately   granted,   a 

    balance of convenience in favour of the granting of the relief sought and 

    absence of an alternative remedy. See Steel and Engineering Industries 

    Federation and Others v National Union of Metal Workers of South 

    6

  • Africa  (2) 1993 (4) SA 196 (T) 199 G –

Recommended

View more >