Fix The Patent Laws

Argentina introduces tougher standards for patentability. South Africa should follow suit.

Posted on | May 28, 2012 | No Comments

This month, Argentina joined the ranks of countries making it harder to get a patent for ‘inventions’ which offer little to no real improvement over existing drugs. The detailed guidelines, issued jointly by Argentina’s patents office and health department, can be found here.[1] The guidelines instruct patent examiners to reject (with some exceptions) new use, new form, and new formulation patents,[2] and specify a number of other frivolous changes to drugs which will no longer be acceptable.

Under TRIPS, countries are free to determine for themselves criteria of novelty, inventiveness and usefulness. Argentina’s move therefore, is completely allowed under international law. And they are not alone – the patent regime of the Andean Community countries (Peru, Bolivia, Colombia, Ecuador and Peru) rules out new use patents, and in India, patent applications which cannot demonstrate enhanced efficacy over existing drugs will be rejected.

But in South Africa today, the criteria for patentability are not high, and patent applications are not being checked for their inventive qualities. Our patents office operates rather as a registration office. This means that as long as an application meets administrative requirements, a patent will generally be granted unless someone opposes it (with legal opposition by the public in this country being difficult and costly). This has led to a situation where South Africa is granting far more patents than many comparable countries (see figure below).[3]

Our campaign is arguing that in respect of how patents are granted in South Africa, three things need to happen:

  1. patent laws must be tightened to require stricter standards of novelty and inventiveness;
  2. the patent office must start actually examining patent applications against these standards; and
  3. it must be made easier for third parties to oppose a patent, both before or after its grant.

South Africa should join Argentina and others in moving to a system which only rewards true innovation. We can do this by changing our laws to crack down on frivolous patenting. This will make way for more generics to enter to the market, and ultimately drive down prices.

Prepared by Katie Kirk.



[1] Adoption of Guidelines for Patentability Examination of Patent Applications Directed to Chemical and Pharmaceutical Inventions, Joint Resolution 118/2012, 546/2012 and 107/2012, available at

http://www.moellerip.com/index.php?PN=news_detail&FX=1&DX=139&EX=1

[2] A ‘new form’ patent is a patent granted on minor variations of existing chemical entities/active pharmaceutical ingredients (isomers, salts, polymorphs, etc). A ‘new use’ patent is a patent granted on a medicine that is found to be effective in treating a different disease than for what it is already registered and sold. A ‘new formulation’ patent is a patent that is granted for a new formulation of an already existing medicine (i.e. new dosages, new pill forms, new combinations).

[3] Note that the higher number of patents granted in India is widely attributable to the ‘mailbox’ provisions, or the backlog of patents for the 1995-2005 period, processed in 2005, when India began granting pharmaceutical patents for the first time. Table source: Correa C, IDRC report, Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing http://idl-bnc.idrc.ca/dspace/bitstream/10625/47912/1/IDL-47912.pdf

 

 

 

 

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  • About the Campaign

    fix the patent laws
    Fix the Patent Laws is a campaign co-founded by SECTION27, Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) in 2011. Since then, the coalition has grown to include 38 other organisations fighting together to push South Africa to amend its patent laws to prioritise public health. Through this blog we will highlight how amending South Africa’s Patents Act 57 of 1978 will reduce the cost of medicines, improving the health and saving the lives of millions of South Africans.

    The members of the Fix the Patent Laws Campaign are as follows: Treatment Action Campaign (TAC), Doctors Without Borders (MSF), SECTION27, the South African Non-Communicable Diseases Alliance (SANCD Alliance), DiabetesSA, EpilepsySA, Marie Stopes South Africa, Stop Stock Outs Project (SSP), South African Depression and Anxiety Group (SADAG), Cape Mental Health (CMH), the South African Federation of Mental Health (SAFMH), Schizophrenia and Bipolar Disorders Alliance (SABDA), as well as the following members of the Cancer Alliance and Advocates for Breast Cancer: Breast Course 4 Nurses, Breast Health Foundation, Cancer Association of South Africa (CANSA), Cancer Heroes, Can-Sir, CanSurvive, Care for Cancer Foundation, Childhood Cancer Foundation of South Africa (CHOC), Hospice Palliative Care Association (HPCA), Igazi Foundation, Look Good Feel Better, Love your Nuts, Lymphoedema Association of South Africa (LAOSA), Men’s Foundation, National Council Against Smoking, National Oncology Nursing Association of SA, Pancreatic Cancer Network of SA (PanCan), People Living With Cancer (PLWC), Pink Trees for Pauline, Pink Phoenix Cancer Foundation, Pocket Cancer Support, Project Flamingo, Rainbows and Smiles, Reach for Recovery, South African Oncology Social Work Forum (SAOSWF), The Pink Parasol Project, The Sunflower Fund, Vrede Foundation and Wings of Hope.

  • Read the TAC and MSF campaign pamphlet

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