Table 3 Summary of available TRIPS flexibilities

Patentability criteria and exemption from patentability based on what constitutes novelty.

Article 27.1 of TRIPS does not specify what constitutes “new” or how the novelty requirement should be met. According to Para 4 of the Doha Declaration countries may interpret provisions of this Article in a manner that seeks to protect public health and ensure access to medicines.

The TRIPS Agreement requires countries and jurisdictions to adopt and implement substantive and procedural examination procedures to ensure that patentability criteria are met prior to granting patents. Substantive examination of patent applications provides a higher degree of certainty as to the novelty and veracity of knowledge covered in a patent than that provided by a system that simply registers patent applications.

Countries may opt to interpret ‘novelty’ in domestic legislation in a manner that excludes new and second uses of medicines. This flexibility is applied to prevent frivolous patent applications from new uses, formulations, dosages or combinations of known or previously patented medicines, evergreening, or the creation of patent thickets around one invention.

Research exception

Article 30 of TRIPS states that “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking into account of the legitimate interests of third parties.

The terms limited exceptions have been defined by the WTO Dispute Settlement Panel^a as “exception under which use of the patented product for scientific experimentation, during the term of the patent without consent is not infringement”

Countries can therefore allow this exception in their national law in order to allow for the development of local scientific and technological knowledge and competencies to reverse engineer pharmaceutical products for generic production and for developing them further to better suit local conditions.

Regulatory review exception (Bolar exception)

This is also anchored in Article 30 of TRIPS.

This exception allows the use of a patented invention during the patented term without consent of the patent holder for purposes of developing information to obtain market approval. It allows generic producers to use patented knowledge for purposes of attaining regulatory approval for generic products before expiry of the patent(s), while the patent holder has the right to request, within specified conditions, an extension of the patent term to compensate for the delay in the drug regulatory and market approval process.

This exception facilitates market entry by competitors immediately after the end of the patent term and is therefore an instrument that is specifically designed to ensure early access to generic medicines.

Compulsory licensing

Article 31 of TRIPS allows exploitation of patented subject matter through government authorization without the patent holder’s consent, for the supply of the domestic market of the member authorizing such license, for reason of national emergency and public non-commercial use.

Paragraph 6 of the Doha Declaration and Article 31(bis) of TRIPS makes it possible, under specific conditions for compulsory licensing for export through regional trade areas (RTAs), which make it possible for bulk purchases and economies of scale.

Para 5 (b) the Doha Declaration clarifies that each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.

Article 31 of TRIPS stipulates conditions for the issuance of a compulsory license by a member state. Provisions of Article 31 (f) and (h) make it impossible for countries with insufficient or no manufacturing capacity to use this flexibility. Questions of market viability for a single national market made it unattractive to use this flexibility.

Para.6 of the Doha Declaration sought a solution to situations where a foreign producer can supply patented pharmaceutical products, which are not available in a country with no sufficient manufacturing capacity. This has been addressed through Article 31(bis), which entered into force on 23 January 2017.

Exhaustion of rights and parallel importation

Article 6 of TRIPS states that “For the purpose of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights”

Para 5(d) of the Doha Declaration reaffirms that countries are free to determine their own regimes for exhaustion of patent rights without challenge.

This provision allows importation and resale in a country without consent of the patent holder of a patented product put on the market of the exporting country by the patent holder or in a legal manner. International level of exhaustion provides the most flexibility, followed by regional and lastly national.

It is a legal doctrine according to which an IP right holder cannot prevent further distribution or resale of goods after consenting to the first sale. In such a situation the right holder is considered to have exhausted its right over those goods.

Patent term extension

Article 33 of TRIPS provides that the patent term is 20 years from the filing date.

Countries may consider limiting patent term extension in national law for pharmaceutical products.

Limits on test data protection

Article 39.3 of TRIPS states that “Members, when requiring, as a condition of approving the marketing of pharmaceuticals … which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves considerable effort shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

This provision allows countries to determine how to protect test data in the public interest. This provision does not demand data exclusivity, which has the potential of blocking entry of generic versions of patented medicines. Rather, it demands protection from unfair commercial use. TRIPS does not define unfair commercial use nor does it provide guidance on how protection can be achieved.

Countries may therefore incorporate in domestic legislation the right of regulatory authorities to rely on available data to assess new drugs for market entry.

Transition periods for LDCs

Article 66.1 of TRIPS states that “In view of the special needs and requirements of least developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for the period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council of TRIPS shall, upon duly motivated request by a least-developed country Member in order to enable them to create a sound an viable technological base”

Para7 of the Doha Declaration states that ‘… LDC will not be obliged, with respect to pharmaceutical products to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections …’

TRIPS Council decision IP/C/64 of 2013 for the extension of transition period for LDCs under Article 66.1 to 1 July 2021.

TRIPS Council decisions IP/C/73 and TRIPS General Council decision WT/L/971 stating that LDC members are not obliged to protect pharmaceutical patents or to provide means for filing patents and provide patent protection and exclusive marketing rights until January 2033.

In 2013 the TRIPS Council decided to extend the transition period for LDC members to fully comply with the TRIPS Agreement to 1 July 2021.

LDC Members are exempt from the patentability requirement under Article 27.1 of TRIPS covering pharmaceutical products until 2033, also known as the pharmaceutical product transition period

Enactment of a patent opposition system

Under Article 62.4 of the TRIPS Agreement Member States are required to enact laws that provide procedures for the acquisition and maintenance of intellectual property rights as well as for administrative revocation, opposition and cancellation. These procedures are to be guided by principles of fairness and equity and should not be unnecessarily complicated or costly, or entail unreasonable time limits or unwarranted delays according to Article 41.2 of the TRIPS Agreement.

A patent opposition system could function pre or post patent grant and serves as an additional administrative layer of review that prevents the grant of invalid patents through the participation of third parties in the review process.