Date: 13/11/2002
Source: Deputy Ministry of Trade and Industry
Title: Hendricks: Introduction of the Patents Amendment Bill, NCOP
INTRODUCTION OF THE PATENTS AMENDMENT BILL BY THE DEPUTY MINISTER OF TRADE AND INDUSTRY, MS L HENDRICKS, NCOP, 13 November 2002
Madam Chairperson, honourable members, the second amendment that I present you today are the amendments proposed to the Patents Act. These amendments are largely technical, however, there is one major substantive amendment proposed.
I will first present the technical amendments and then the substantive amendments. The proposed technical amendments relate primarily to clarifying sections of the Act that are inconsistent or unclear, they are:
* Section 32 and 61 require amendments to bring the wording of the Act in line with that of Article 29(1) of the TRIPS Agreement
* It is proposed that various clauses under Section 43 be amended with the insertion of the words "national phase of an international application." This will clarify the relationship that South African patent registrations have with the process of international applications
* There are changes proposed to several sections to ensure the consistent use of language. Some sections refer to the disposal of a patent, whereas others refer to the sale of a patented article
* Certain sections require amendment as they refer to section of the Act, which was amendment in 1997 and through the amendments they now refer to the correct section of the Act.
The second area that I referred to earlier is the substantive change to the Act. This relates to section 69A of the Act on the introduction of "early working of a patent". The purpose of this amendment is primarily to facilitate access to cheaper medication and also to promote our local pharmaceutical industry.
As the Patents Act currently stands, no one may conduct research into or develop an alternative to a product with an active patent. Also, products may not be approved by the relevant authority, such as the Medicines Control Council (MCC), before the patent expires. So, for example, when a particular medicine has an active patent, no generic substitute may be developed in South Africa until the patent expires. Furthermore, no drug may be registered or approved during this period. This has the effect of extending the term of the patent by the period that it takes to register a new drug or a generic substitute. It furthermore greatly disadvantages our domestic industry, as many foreign firms do not have to wait for the expiry of the patents in their own countries and therefore can conduct research and develop the products. Once the patent expires in South Africa, they can register the substitute with the MCC and import their product as soon as it is approved. Our local industry, however, can only begin to research and develop an alternative product when the patent has expired, as they cannot obtain access to the specification of the medicines. They are therefore placed at a disadvantage in comparison to international producers of generic medicines.
The amendment seeks to allow research and development, as well as registration of products, to be allowed during the term of the patent, as long as it is for non-commercial use. Similar provisions are applied in international jurisdictions, such as the USA, Canada, Australia, the EU, India and Israel. In some countries these provisions have been coupled with the extension of patents for the period that approval takes, or the exclusivity of data for a particular period of time. These amendments do not propose similar provisions, as data exclusivity should be dealt with by the relevant approval authority, such as the MCC. More work is required to determine whether patent term extension is required. However, our initial assessment was that it was not necessary. The dti will engage further with industry and the MCC in this regard.
In conclusion, therefore, these amendments proposed are in line with international practice and the TRIPS Agreement. Further they seek to facilitate access to cheaper medicines on the one hand and to promote our local pharmaceutical industry on the other.
Issued by the Office of the Deputy Minister of Trade and Industry
Source: Deputy Ministry of Trade and Industry
Title: Hendricks: Introduction of the Patents Amendment Bill, NCOP
INTRODUCTION OF THE PATENTS AMENDMENT BILL BY THE DEPUTY MINISTER OF TRADE AND INDUSTRY, MS L HENDRICKS, NCOP, 13 November 2002
Madam Chairperson, honourable members, the second amendment that I present you today are the amendments proposed to the Patents Act. These amendments are largely technical, however, there is one major substantive amendment proposed.
I will first present the technical amendments and then the substantive amendments. The proposed technical amendments relate primarily to clarifying sections of the Act that are inconsistent or unclear, they are:
* Section 32 and 61 require amendments to bring the wording of the Act in line with that of Article 29(1) of the TRIPS Agreement
* It is proposed that various clauses under Section 43 be amended with the insertion of the words "national phase of an international application." This will clarify the relationship that South African patent registrations have with the process of international applications
* There are changes proposed to several sections to ensure the consistent use of language. Some sections refer to the disposal of a patent, whereas others refer to the sale of a patented article
* Certain sections require amendment as they refer to section of the Act, which was amendment in 1997 and through the amendments they now refer to the correct section of the Act.
The second area that I referred to earlier is the substantive change to the Act. This relates to section 69A of the Act on the introduction of "early working of a patent". The purpose of this amendment is primarily to facilitate access to cheaper medication and also to promote our local pharmaceutical industry.
As the Patents Act currently stands, no one may conduct research into or develop an alternative to a product with an active patent. Also, products may not be approved by the relevant authority, such as the Medicines Control Council (MCC), before the patent expires. So, for example, when a particular medicine has an active patent, no generic substitute may be developed in South Africa until the patent expires. Furthermore, no drug may be registered or approved during this period. This has the effect of extending the term of the patent by the period that it takes to register a new drug or a generic substitute. It furthermore greatly disadvantages our domestic industry, as many foreign firms do not have to wait for the expiry of the patents in their own countries and therefore can conduct research and develop the products. Once the patent expires in South Africa, they can register the substitute with the MCC and import their product as soon as it is approved. Our local industry, however, can only begin to research and develop an alternative product when the patent has expired, as they cannot obtain access to the specification of the medicines. They are therefore placed at a disadvantage in comparison to international producers of generic medicines.
The amendment seeks to allow research and development, as well as registration of products, to be allowed during the term of the patent, as long as it is for non-commercial use. Similar provisions are applied in international jurisdictions, such as the USA, Canada, Australia, the EU, India and Israel. In some countries these provisions have been coupled with the extension of patents for the period that approval takes, or the exclusivity of data for a particular period of time. These amendments do not propose similar provisions, as data exclusivity should be dealt with by the relevant approval authority, such as the MCC. More work is required to determine whether patent term extension is required. However, our initial assessment was that it was not necessary. The dti will engage further with industry and the MCC in this regard.
In conclusion, therefore, these amendments proposed are in line with international practice and the TRIPS Agreement. Further they seek to facilitate access to cheaper medicines on the one hand and to promote our local pharmaceutical industry on the other.
Issued by the Office of the Deputy Minister of Trade and Industry
Advertisement
EMAIL THIS ARTICLE SAVE THIS ARTICLE FEEDBACK
To subscribe email subscriptions@creamermedia.co.za or click here
To advertise email advertising@creamermedia.co.za or click here
