An analysis of TRIPS and its patent provisions relative to access to medicines

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Standards of patentability

Setting the proper standards of patentability is an additional TRIPS flexibility. Article 27 of TRIPS lays down the baseline standards of patentability. It provides that inventions are patentable if they are ‘new, involve an inventive step and are capable of industrial application’. Chisum is of the view that the provisions of article 27(1) that ‘[f]or the purposes of this article, the terms “inventive step” and “capable of industrial application” may be deemed by a member to be synonymous with the terms “non-obvious” and “useful” respectively’ was to accommodate the United States’ ‘non-obviousness’ and ‘utility’ requirements. The TRIPS Agreement does not expressly define novelty and inventive step. To cover this void, countries have further defined them either through statutes, regulatory guidance or case law.
Regarding inventive step, the European Patent Convention defines it as follows: ‘An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art.’225 The European Patent Organisation further states in its manual on invention that ‘[t]o be regarded as an invention, an idea needs to include an inventive step. An inventive step must be non-obvious – that is, it would not readily occur to an expert in the relevant technology.’226 In order words, the inventive step must not be obvious to a person skilled in the arts. In the case of Polymer Powders/Allied Colloids Limited, the Board of the European Patent Organisation described the person skilled in the art in the following words:
Whilst such generally accepted definitions of the notional ‘person skilled in the art’ do not always use identical language to define the qualities of such a person, they do have one thing in common, namely that none of them suggests that he is possessed of any inventive capability. On the contrary, it is the presence of such a capability in the inventor which sets him apart from the notional skilled person.
In the US, for a long time the teaching, suggestion and motivation (TSM) test was used to determine non-obviousness. The TSM test arose from a corpus of cases built over the years by US courts.228 Under the TSM test, ‘an invention was non-obvious if the prior art failed to provide teaching, suggestion, or motivation to combine known elements to reach the claimed invention’. 229 However, in KSR v Teleflex,230 the US Supreme Court overruled the TSM test, stating that ‘a person of ordinary skill is also a person of ordinary creativity, not an automaton’,231 and dwelled on the ‘need to consider common sense and the degree of predictability of the results or advantages obtained by the proposed combination’.
The Revised Bangui Agreement of 1999 does not define all the patent standards. It only lists them as TRIPS does. As discussed further in a subsequent chapter, it is recommended that OAPI, in receiving patent applications, apply a strict standard on inventive step. One way would be to require that the ‘invention is obvious to a person highly skilled in the art’.233 It is submitted that the more expertise considered when evaluating the non-obviousness of an invention, the higher the possibility of that invention to be deemed obvious.

Disclosure

Disclosure requirement is couched in article 29 of TRIPS, which provides:
1 Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.
2 Members may require an applicant for a patent to provide information concerning the applicant’s corresponding foreign applications and grants.
From the above, TRIPS members will require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art. In addition, TRIPS members may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.
Under US law, the patent application must ‘set forth the best mode contemplated by the inventor of carrying out his invention’.248 As was pointed out in the case of Eli Lilly & Co v Barr Laboratories Inc,249 the reason behind the best mode requirement is that it creates a statutory bargained-for-exchange by which a patentee obtains the right to exclude others from practising the claimed invention for a certain time period, and the public receives knowledge of the preferred embodiments for practising the claimed invention.
Furthermore, it has been submitted that, in the absence of strict standards for disclosure, there could be an unwillingness for patent applicants to not fully disclose the details of their invention. As such, they might keep the knowledge of the ‘best mode’ undisclosed, ‘so that they retain a competitive advantage even after the patent expires’.
Article 29(2) of TRIPS gives members the right to require an applicant for a patent to provide information concerning the applicant’s corresponding foreign applications and grants. This could be helpful for countries with limited capacity as it would enable their patent officers to know the status of the patent application in other countries.

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Pre- and post-grant opposition application

Generally, a patent opposition refers ‘to the ways in which it is possible to challenge the validity of a patent – both during the period when a patent application is being reviewed, and after the patent has been granted’.251 When the opposition is done during the period when the patent application is reviewed, it is referred to as pre-grant opposition. When the opposition takes place after the patent has been granted, it is referred to as post-grant opposition. Post-grant opposition is best understood as involving administrative procedures rather than judicial revocation or invalidation procedures.
As discussed above, article 27 of TRIPS generally sets out patentability standards to be met before patents are granted. Specific implementation, As above.
See http://patentoppositions.org/how_to_build_an_opposition (accessed 2 January 2014).
however, is dependent on the provisions of national laws. This is provided for in article 62(4) of TRIPS, which provides:
Procedures concerning the acquisition or maintenance of intellectual property rights and, where a member’s law provides for such procedures, administrative revocation and inter partes procedures such as opposition, revocation and cancellation, shall be governed by the general principles set out in paragraphs 2 and 3 of article 41.
Opposition, especially those that are against questionable patent monopolies, if successful, can lead to a price decrease since the patent will be rejected, thereby allowing the production of low-priced generics. This will in turn facilitate access to medicines.
One of the first cases where a patent was opposed by those promoting access to medicines was tested was the case of AIDS Access Foundation & Others v Bristol Myers Squibb & the Department of Intellectual Property.253 In May 2001, a law suit was filed by the AIDS Access Foundation, a Thai AIDS foundation, and two people living with HIV/AIDS, against Bristol-Myers Squibb (BMS) and the Thai Department of Intellectual Property (later added as a co-defendant). The law suit challenged the grant of a patent on the anti-retroviral drug Didanosine (also known as DdI).
The US government held the rights to the original DdI invention, but later BMS licensed the rights to DdI from the US government and filed a secondary patent application in Thailand intended to protect a specific dosage formulation. In this patent application, the invention was limited to a specified dosage range of 5mg to 100mg per dosage unit.
During the examination of the patent application, the Thai Department of Intellectual Property allowed BMS to remove the limitation in the dosage range. Subsequently, the Thai patent office granted a patent for this unlimited invention. The effect of this unlimited patent was to prevent the Thai Government Pharmaceutical Organisation (GPO) from manufacturing any sort of DdI tablet. Faced with this block on local production of the tablets they needed, the AIDS Access Foundation and two individuals challenged the grant of the patent itself. The plaintiffs demanded that BMS amend their patent claim back to the limited dosage range originally asked for. BMS tried to oppose their application on the ground that the complainants had no right under Thai law to challenge a patent.

Chapter 1: Introduction
1.1 Background to TRIPS and access to medicines in sub-Saharan African countries and problem statement
1.2 Research questions
1.3 Definition of concepts
1.4 Significance of research
1.5 Literature review
1.6 Research methodology
1.7 Overview of chapters
1.8. Scope and delineation of study
Chapter 2: An analysis of TRIPS and its patent provisions relative to access to medicines
2.1 Background to the adoption of the TRIPS patent regime relative to access to medicines
2.2 Basic requirements of the TRIPS Agreement relative to patents, access to medicines and human rights
2.3 Data protection/exclusivity
2.4 IP enforcement
2.5 Chapter conclusion
Chapter 3: TRIPS public health flexibilities and post-1995 developments: An analysis of the Doha Declaration on TRIPS and Public Health, the 30 August 2003 Decision, the 2005 Hong Kong Ministerial and subsequent developments
3.1 Definition of concepts: TRIPS public health flexibilities and post-1995 developments
3.2 Limited exceptions under article 30
3.2.1 Bolar exception
3.3 Parallel importation
3.4 Compulsory licences
3.5 Competition-based licences
3.6 Additional flexibilities
3.7 Analyses of laws, cases and controversies surrounding the application of the TRIPS Agreement relative to access to medicines
3.8 Developed countries and compulsory licences: Who is watching the ‘big brothers’
3.9 Doha Declaration clarification of public health flexibilities
3.10 Chapter conclusion
Chapter 4: An analysis of the OAPI patent regime relative to access to medicines
4.1 Access to medicines problems faced by OAPI member states
4.2 History of the OAPI patent regime
4.3 The current OAPI regime
4.4 The patent regime of the Revised Bangui Agreement in relation to access to medicines: Lack of the inclusion of all TRIPS public health flexibilities
4.5 Critical analysis of the limited incorporation of TRIPS public health flexibilities and post-Doha developments in the OAPI regime
4.6 Reasons for the non-incorporation of certain TRIPS flexibilities within the Revised Bangui Agreement of 1999
4.7 Chapter conclusion
Chapter 5: Conclusions and recommendations
5.1 Conclusion (or findings)
5.2. Recommendations
5.3 How the recommendations stated above can be taken forward
Bibliography

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