Legal & Regulatory > South Africa > Patents & Trademarks

The ins and outs of patents and trademarks in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.

1. What are the basic requirements to obtain patent and trademark protection?

Patents and Trademarks form part of Intellectual property in terms of South African law, where Intellectual Property is defined as: “a generic term used to refer collectively to a variety of diverse intangible products such as inventions and patents, trademarks and brand names, industrial designs, copyright, plant breeders’ rights, performances, trade secrets and know-how etc.”

The Patents Act 57 of 1978 and Patent Regulations provide the legal framework within which patent protection can be obtained.

Protection of TrademarkTrademarks are provided under the Trademarks Act No 104 of 1993.

PATENT PROTECTION

A South African Patent Application is not subjected to substantive examination; the Registrar merely examines the application for compliance with the formal requirements of the Act and if he is satisfied, the application will proceed to acceptance and grant.

For an application for a patent to be granted certain requirements must be met in terms of the Patents Act.

One being that an application for a patent in respect of an invention may be made by the inventor or by any other person acquiring from him the right to apply or by both such inventor and such other person.

There are some difficulties in obtaining protection for industrial property rights in any number of countries in the world as a result of the diversity in national laws, and the increasing need to file patent applications in every country in which protection is desired almost simultaneously to avoid a novelty destroying event, created an urgent need for the harmonisation of industrial property laws.

The Paris Convention and the Patent Cooperation Treaty (PCT) also apply and both have been accepted by South Africa and entered into force. The PCT is complementary to the Paris Convention. Benefits of the PCT include the effective harmonisation of the filing, searching and examination of patent applications.

It is possible to seek patent protection simultaneously in a number of countries by filing a single international application. It is also possible, in addition to last mentioned, for the international application to be subjected to international search and examination, providing the opportunity for critical evaluation and assessment of the application.

Since South Africa has acceded to the PCT, it is possible for South African Nationals to proceed by way of PCT international and PCT national phase applications. The Patents Act regulates applications filed under PCT in Chapter VA.

It is possible for an international application to be designated to South Africa, subject to provisions of Chapter VA, the application shall be deemed to be an application for a patent lodged at the South African patent office to act as receiving, designated and elected office as set out in Section 43C of the Act.

The National phase entry deadline in South Africa is 31 months from the earliest filing date, with allowance for the deadline to be extended for a further three months. This can only be done through a request to the Registrar. Should the applicant fail to enter the national phase within the prescribed deadline, it will result in the application being deemed abandoned for the purposes of the Act.

Regulation 22 of the Patent Act provides the information regarding the prescribed manner in which a provisional patent application must be made. Payment of the prescribed fee and provisional specification (as set out in  Section 30(1)) of the Act, must accompany this application.

Form P1 is the application form which must be used when the applications are made and must be accompanied by the following documents:

1. Form P1, in duplicate, one copy of which shall be returned to the applicant as proof of lodging;
2. Form P2 in duplicate;
3. A declaration and power of attorney on Form P3;
4. Where the applicant has acquired a right to apply from the inventor, an assignment or other proof, to the satisfaction of the registrar, of the right of the applicant to apply;
5. A single copy of a provisional specification on Form P6 or two copies of a complete specification on Form P7;
6. Drawings, in the prescribed manner, if drawings are necessary to exemplify the invention; and
7. An abstract on Form P8, in duplicate, if the application is accompanied by a complete specification.

In addition to the above requirements for an application with a provisional specification, an application accompanied by a complete specification must be accompanied by two copies of a complete specification (as required in terms of regulation 22(1) (e)), which must commence on the prescribed form and be signed by an agent.

TRADEMARK PROTECTION

The current Trademarks Act 194 of 1993 provides for the registration of trademarks, certification trademarks and collective trademarks.

Registration of a Trademark is required in terms of Section 16 of the  Act. Regulation 11 provides details on the application for registration of a Trademark.

The mark must be: distinctive

• not be on the excluded list of marks as per Section 10 of the Trademarks Act;
• adhere to the requirements for

The procedure for registration of a Trademark in terms of Regulation 11 is as follows:

• An application for a trademark registration shall be made on Form TM1;
• The application shall be dated and signed by the applicant(s) or his/their duly authorised agent;
• The application shall be in triplicate and a separate and distinct applica tion is required for each class of goods or services and for each separate mark;
• If the application is made by a firm or partnership it may be signed in the name of or for and on behalf of the firm or partnership by any one or more members or partners thereof;

If the application is made by a body corporate it may be signed by any authorised person

It is further important to indicate whether the applicant claims convention priority under Section 63 of the Act in order for the Registrar to be aware of the type of application and which rules apply to the application being made.

2. What agencies or bodies regulate patents and trademarks?

Patents and Trademarks in South Africa are regulated by the Companies and Intellectual Property Commission.

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

PATENTS WHICH CAN BE PROTECTED

In terms of the Patents Act, Section 1 an “invention” is defined as one for which a patent may be granted under Section 25”.

In a very general manner certain positive requirements for patentability is set out such as:

• Any new invention which involves an inventive step and which is capable of being used or applied in trade or industry or

LIST OF EXCLUSIONS FROM PATENTABILITY

Section 25 provides specific indication on what shall not be deemed an invention for the purposes of this Act. Anything which consist of:

• A discovery;
• A scientific theory;
• A mathematical method;
• A literary, dramatic, musical or artistic work or any other aesthetic creation;
• A scheme, rule or method for performing a mental act, playing a game or doing business;
• A program for a computer;
• The presentation of

TRADEMARKS WHICH CAN BE PROTECTED

Certain Trademarks can be protected depending on whether or not they adhere to the requirement of distinctiveness.

To qualify for registration (and thus protection) under the Trademarks Act, a trademark must be capable of distinguishing the goods or services in relation to which it is used, or proposed to be used, from the same or similar goods or service.

l only fulfil this requirement if, at the date of application for registration it is inherently capable of distinguishing the goods or services in question or if, because of its prior use, it is capable of so distinguishing the goods or services. This test to determine whether or not the Trademark can be registered is a purely factual one

4. How can patents and trademarks be revoked?

A Trademark can be expunged, cancelled or removed in different circumstances – in all cases the term “expungement” will be used as a general term to describe each of the different scenarios.

Grounds for expungement of a Trademark include:

• Cancellation of a trademark upon request by the registered proprietor of the trademark;
• Removal of the trademark from the register if the original registration was a wrongly made entry or if it remains in the register wrongly or because of an error or defect in any entry in the register;
• A trademark can also be removed by any interested person who applies for the removal if the proprietor of the trademark, or any person permitted to use the trademark fails to comply with any condition entered in the register in relation to its registration;
• If the trademark has fallen into non-use – whether it appears that there is no bona fide intention to use it or if it can be shown that, there is no bona fide actual use of the trademark for a continuous period of five years or longer. This must be shown up to three months before the application is made;
• Removal from the register is also possible on the ground of failure to record an assignment in the case where the proprietor of the trade has  ceased to exist, a body (e.g. body corporate) has been dissolved, or if the proprietor was a natural person, where such person has died not less than two years prior to the application for removal;
• Removal of the register if (after due notice has been given to the proprietor of the trademark to affect the renewal, of the registration) the prescribed tim has expired and the renewal has still not been

Grounds for Revocation of a Patent include:

• Revocation can be achieved through an application in the prescribed manner on specific grounds only:
  • Where the Patentee is not a person entitled to apply for a patent;
  • Where the grant of the patent is in fraud of the rights of the applicant or of any person under or through whom he or she claims;
  • The invention concerned is not patentable under the requirements of the Patents Act;
  • The invention, as it was set out in the complete specification concerned cannot be performed or does not lead to results and advantages as set out in the complete specification;
  • The manner in which the invention is to be carried out by a person skilled to do so, is not fully described, ascertained and  illustrated or exemplified (where necessary) in the complete specification of the patent
  • Where claims of the complete specification of the invention are not clear or fairly based on the matter disclosed in the specification – this creates ambiguity and lack of fair basis and is in contravention of the requirements for an invention to be registered;
  • The prescribed declaration lodged in respect of the application for the patent or the statement lodged in terms of the Act as required contains a false statement or representation which is material and which the patentee knew or ought to have reasonably known to be false at the time when the statement or representation

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

PATENTS

In cases where a patent application has been filed abroad, South African legislation state that the filing date in the country of first filing will provide the applicant or his successor in title, with the right to file a patent application in any number of contracting states within twelve months of the date  of filing the first application. The later filed application will enjoy a priority status as if these later filed applications had been filed on the same date as the first application.

The priority status includes:

• Applications for the same inventions filed after the first application;
• Events, which in the normal course would be novelty destroying, and which take place after the date of the first application;
• Same invention must form part of the first and alter filed applications;
• Capacity of the first application to serve as the basis for priority is not destroyed on abandonment, rejection or withdrawal thereof;
• Multiple and partial priority rights, as recognised by the Convention, allow the priority of several earlier applications, possibly relating to different aspect of the subject matter to be

TRADEMARKS

The Paris Convention also provide priority where are trademark has been filed in a convention country. In these circumstances the following applies:

• the applicant for registration in that country or his successor or assignee, may file an application for the same mark in South Africa within six months of the first application for that mark filed in the convention country;
• The application filed in South Africa will bear the same filing date as the convention date, with priority to all other applications;
• In terms of the Trademarks Act, the South African Registrar will not permit the South African application to cover any specification broader than the specification for which the convention application was originally filed, though a narrower specification may be covered;
• Partial priority applications cannot be filed in South Africa (as is the case in many other countries by virtue of a registry practice followed);
• Applications filed claiming Convention priority all required documentation must be lodged (together with an English translation where applicable) with the registry within three months from the filing of the South African

Though the Madrid protocol has been approved by the South African Parliament, it has not yet formally been acceded to and not yet promulgated to enable legislation to give effect to international registrations in terms of the Protocol. Until such time, it is not possible to file international registrations with the World Intellectual Property Organisation (WIPO) through the office of the country of origin which would designate South Africa, for example.

6. Are there any non- patent/trademark barriers to competition to protect medicines or devices?

In many instances companies often apply for multiple patents on individual medicines over time in order to prolong their periods of patent protection. South Africa is a member of the World Trade Organisation (WTO) which set general standards of patent protection which all WTO members are required to provide under the Agreement on Trade-Related Aspects of Intellectual Property Rights – commonly known as the TRIPS agreement.

South African Patent law provide for 20-year patent protection and under Trademark Legislation a Trademark is protected for and should be renewed every 10 years.

Competition policy, in relation to patent granting, is more concerned with the questions whether the patent is warranted and necessary to achieve one of the means through which the patents system encourages innovation and whether a patent conveys market power.

If the patent is not warranted and does not encourage innovation, a patent should not be granted as such a patent could impose costs on the public.

The reasoning behind last mentioned suggests that the non-protection should then leave room for competition policy to spur innovation and provide consumers with what they want at optimal prices, quantity and quality. When taking this into consideration when determining whether a patent conveys market power, if an unwarranted patent confers market power on a patent-holder, it can deprive consumers of the benefits of competition without compensating value.

When keeping in mind that the South African patent system does not investigate the merits of each invention or the patent, multiple patents in a single medicine could easily be granted for a 20-year period and for longer if a second patent is granted. Patent-protection is well-known as it is given for a set period, which is important for innovation, particularly of pharmaceutical companies as this presumably enables pharmaceuticals to sustain the prices of medicines, recoup research and development expenditure and finance the development of new products.

Competition policy is seen as instrumental in ensuring access to medicines and ensuring medical technology and innovation in the pharmaceutical sector. International furore has been raised on whether pharmaceutical patents interfere with access to essential medicines in lower income countries.

South Africa is signatory to the TRIPS agreement that commits itself to having certain patent laws in the country. This agreement introduced the minimum standards for protecting and enforcing intellectual property rights and requires WTO members to make patents “available for any inventions, whether products or processes, in all fields of technology”. This also includes patents for pharmaceutical processes and products.

The TRIPS agreement has received some criticism over the years in so far the increased levels of patent protection of medicine prices are concerned. While TRIPS does offer safeguards to remedy the negative effects of patent protection or patent abuse, in practice it is unclear whether and how countries can make use of these safeguards when patents increasingly present barriers to medicine access.

The Companies and Intellectual Properties Council is currently reviewing and involved in preliminary research on a potential move from a depository patent system to a substantive examination system. In the process it has considered several structural options of patent protection systems.

There are some arguments against a substantive examination system where the fact that it will be costly and burdensome has been raised as a potential problem, as well as the fact that it requires an extensive human resource investment.

With that being said, it has the potential to discourage foreign business which South Africa obviously want to avoid, as the aim is to encourage foreign business and investment into the South African economy.

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

LIST OF EXCLUSIONS FROM PATENTABILITY

Section 25 provides specific indication on what shall not be deemed an invention for the purposes of this Act. Anything which consist of:

• A discovery;
• A scientific theory;
• A mathematical method;
• A literary, dramatic, musical or artistic work or any other aesthetic creation
• A scheme, rule or method for performing  a  mental  act,  playing  a  game  or  doing business;
• A program for a computer;
• The presentation of

LIST OF EXCLUSIONS FROM REGISTERING A TRADEMARK

Section 10 of the Trademarks Act No 194 of 1993, set out the marks that are excluded from registration as trademarks. These include inter alia, a mark that:

• Does not constitute a trademark in terms of Section 10(1);

In terms of Section 10(2) it is a mark that:

• Is not capable of distinguishing within the meaning of section 9 of the Act (section 10(2)(a));
• Consists exclusively of a sign or indication which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin or other characteristics of the goods or services (section 10(2)(b));
• A mark which consists exclusively of a sign or indication which has become customary in the current language or in the bona fide and established practices in the trade(section 10(2)(c));
• Is one in relation to which the applicant has no bona fide claim to proprietorship (section 10(3));
• The applicant has no bona fide intention of using as a trademark, either himself or through a person permitted by him to use the mark as contemplated in section 38 of the Act (section 10(4));
• Consists exclusively of the shape, configuration, colour or pattern of goods where such shape, is necessary to obtain a specific technical result, or results from the nature of the goods (section 10(5));
• Constitutes, or the essential part of which constitutes, a reproduction, imitation or translations of a well-known mark that is entitled to protection under the Paris Convention for the Protection of Industrial Property and is used on identical or similar goods; where use of the mark is likely to cause deception or confusion (section 10(6));
• Is the subject of an application for protection which was made mala fide (section 10(7)) ;
• Consists of or contains the national flag or the armorial bearing or any other State emblem of South Africa or of a convention country (section 10(8));
• A mark which contains any word, letter or device indicating State patronage (section 10(9));
• A mark which contains any word, letter or device indicating State patronage (section 10(10));
• Consists of a container for goods or the shape, configuration, colour or patent of goods, where the registration of such mark is likely to limit the development of any art or industry (section 10(11));
• Is inherently deceptive or the use of which would be likely to deceive or cause confusion, be contrary to law, be contra bonos mores, or be likely to give offence to any class of persons (section 10(12));
• As a result of the manner in which it has been used, would be likely to cause deception or confusion (section 10(13));
• Is identical to a registered trademark belonging to a different proprietor or so similar to the it that the use thereof in relation to goods or services in respect of which it is sought to be registered would be likely to deceive or cause confusion, unless the person making the earlier application consents to the registration of such mark (section 10(14));
• Is identical to a mark which is the subject of an earlier application by a different person, or so similar there to that the use thereof in relation to goods or services in respect of which it is sought to be registered and which are the same as or similar to the goods or services in respect of which the earlier application is made, would be likely to deceive or cause confusion, unless the person making the earlier application consents to the registration of such mark (section 10(15));

• Is the subject of an earlier application as contemplated in section 10(15) of the Act, if the registration of that mark is contrary to existing rights of the person making the later application for registration as contemplated in that paragraph (section 10(16));
• Is identical or similar to a trademark which is already registered and is well known in the Republic of South Africa, if the use of the mark sought to be registered would be likely to take unfair advantage of, or be detrimental to the distinctive character or the repute of the registered trademark, notwithstanding the absence of deception or confusion (section 10(17));

The Act confirm that a mark shall not be refused registration by virtue of the provisions of paragraph (2) or, if registered, shall not be liable to be removed from the register by virtue of the said provisions if at the date of the application for registration or at the date of an application for removal from the register, as the case may be, it has in fact become capable of distinguishing within the meaning of section 9 as a result of use made of the mark.

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

TRADEMARKS

A licence refers to the relationship between the proprietor of a trademark and the entity authorised by the proprietor to use that trademark in relation to goods manufactured and sold or in respect of the services rendered.

In terms of Section 38 of the Trademarks Act, registration of a user of a mark shall be prima facie evidence that the use of the registered trademark by the user is permitted use as contemplated by section 38(1).

The Trademark regulations confirm in regulation 39 that an application must be brought to the Registrar for the registration under section 38(6) of the Act for a person to be able to act as a registered user of a registered trademark and such application must be made by the registered proprietor on Form TM7 with the relevant accompanying documentation included.

It can therefore be inferred that a trademark license agreement, whether it is with a foreign licensor or not, must be provided to the Registrar in order for the confirmation of approved usage to be on file and on record in South Africa.

PATENTS

A licence agreement in respect of a patent is an agreement in terms of which the licensor grants to the licensee exploitation rights in terms of the invention. The licence can take different forms such as an agreement in writing, oral agreement or tacit agreement.

There are specific timelines involved in the recording of a licence against a patent – it must be made within six months of the event entitling the recording of such licence, or within six months of the grant of the patent. In cases where the licence agreement had been before such a grant, the Registrar may extend this time limit on application and on payment of the prescribed fee.

There is no explicit indication that the licencing is affected by the fact that it is extended by a foreign licensor, nor is there direct indication that such licence is required to be registered against a patent.

This is confirmed by the wording in Section 53 (1) of the Patents Act which state: “At any time after the date of the sealing of a patent, the patentee may apply (own emphasis) to the registrar for the patent to be endorsed with the words “licences of right” and where such an application is made the registrar shall, if satisfied that the patentee is not precluded by contract from granting licences under the patent, cause the patent to be endorsed accordingly.