The Big Deal in the Realm of Patents: From TPP to CPTPP

 The provisions concerning Intellectual Property Rights (IPRs) were rationalized by the enforcement of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS). In addition to this Agreement, since all countries, developed and developing, alike have substantially grown and witnessed development in the manner of implementing provisions for providing in times of health crisis, TRIPS-plus measures have been adopted by some member states. To remove any barriers obstructing access to medicines, the Doha Declaration on TRIPS and Public Health and the WTO 2005 Ministerial Declaration introducing Art. 31bis in the TRIPS Agreement were implemented. For fostering better protection, preferential trade agreements (PTA) have also been concluded, of which the Trans-Pacific Partnership and later, the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) have been adopted.

What is the Trans-Pacific Partnership (TPP)?

The Trans-Pacific Partnership is essentially a Trade Agreement that is wide in scope to include within its ambit twelve Pacific Rim countries, inclusive of the United States. The Agreement was the master plan of US President Barack Obama; however, it lingered on until Trump assumed presidentship. Due to Donald Trump's decision to withdraw the United States from the world's largest free trade deal, which comprised about forty percent of the entire global economy, the other eleven countries moved ahead while embracing a few changes in the original deal. The new deal came to be known as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).

The TRIPS Agreement provided for minimum and common standards of protection of IPRs. It also provided that any additional protection may be afforded to complement the provisions within it. In such light came the TPP, which contained provisions on patentability, patent extension, test data exclusivity, and patent linkage that could adversely affect access to medicines. It had the following characteristic features:

• It broadened the protection for smell, sound, and color trademarks. It also limited marking to protect the use of common food names.
• It gave additional protection to the trade secrets by proposing criminal sanctions for cyber theft and theft of other trade secrets.
• It extended protection over undisclosed test data submitted for regulatory approval of pharmaceutical, agrochemical, or biological patents.
• It also emphasized that the term of protection for copyright shall be set to a minimum of seventy years after the life term of the author of the original work.
• It also expressed that the patents surrounding biotechnology shall be given extended protection since a majority of the patent term is lost in getting prior approval. Thus, for pharmaceuticals, at least five years of protection shall be mandated, and for agrochemical, the duration shall be at least ten years.

Delving into the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)

The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) or the TPP11 is a trade agreement between eleven countries, namely, Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam, marking up to 13 percent of the world's Gross Domestic Production (GDP).

The CPTPP can be realized as an improvement of the TPP Agreement since it sought to regain a balance in the provisions dealing with IPRs to serve good not only to the interest the United States may have had but also to the other eleven members. It contains a comprehensive chapter on IPRs that establishes the standard of protection of IPRs across the Asia-Pacific region at a regional scale. It aims to provide for a common set of IPR rules to encourage investment and procuration of new ideas and cater to the growth of creative and innovative industries while also addressing the issue of piracy and counterfeits. The obligations are introduced in the following areas:

• In the Field of Patents: The parties to the CPTPP agreed to introduce flexibility provided for in the TPP that allowed patent-term adjustment and its tenure restoration to make good for the delays in obtaining marketing approval. However, it did not define what would constitute an act leading to curtailment of the actual term of the patent, which may lead to ambiguity in the enforcement of such measures. It marks the first Free Trade Agreement (FTA) to have included biologics within its ambit to ensure a longer duration (05years/07years) of protection in line with its objective to ensure data exclusivity.

• In the Field of Copyright: It suspended the obligations provided for in the TPP concerning the term of copyright and related rights. It also suspended the provision dealing with the payment on copyright and related rights, the provision on technological protection measures, and rights management information. The CPTPP also agreed to suspend the provision concerning encryption programs carrying satellite and cable systems. Therefore, the CPTPP does not require Internet Service Providers (ISPs) to monitor, report, or penalize Copyright Infringement.

The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) and Public Health

The major impact of CPTPP is aimed at public health and nutrition, thereby aiming to promote access to medicines. It impacted innovation in the pharmaceutical sector. The key features that facilitate access to health and the facilities thereof are as follows:

1. Patentability Criteria:

In addition to the requirement of the invention being new, involving an inventive step, and having some industrial utility, there are a few additions required to be made in a signatory's domestic legislation. Parties are required to make patents available for either of the following if not all:

• New uses of a known product;
• New methods of using a known product; or
• New processes of using a known product.

It enhances the scope of protection, which may be available to pharmaceuticals.

2. Redefining Pharmaceutical Patents:

Concerning pharmaceuticals, a new pharmaceutical product means a "product not containing a chemical entity previously approved in a member state." It also provides that any unnecessary delays in seeking the approval of pharmaceuticals shall be avoided, and therefore, such measures shall be adopted that would help expedite the processing of marketing approvals.

3. Provision Regarding Test Data Exclusivity:

For maintaining the test data exclusivity, the Partnership Agreement provides that such information shall be safeguarded from any third person who has not obtained the consent of the originator of such information to market the invention or a similar product for at least five years. 

It may have significant loopholes and pitfalls in addition to the possible gains since, on the one hand, it enables and furthers the idea of public health by ascertaining Patent Protection in favor of the patent holder; however, it may prevent or delay the entry of generics. The few takeaways of the CPTPP are summarized below:

• Low Patentability Standards - It is also known as secondary patenting. Such low standards may be alarming as one single Active Pharmaceutical Ingredient (API) or product may be protected by several patents.
• Patent extension guarantees that there is no adverse impact of delayed implementation of patents. However, if the term of the original patent is extended by such a partnership agreement, the availability of low-cost generic products may be delayed. Also, such a provision will not enable any improvement for developing countries having unequipped Patent Offices.
• The provision of patent linkage that provides a member party with the option to deny the generic version to market the patented product where the same is in force unless the act is authorized by the patent holder can be observed as the grant of additional protection to pharmaceutical companies against generics. It may, on the one hand, hamper the introduction of generics into the mainstream market, while on the other hand, it may also prevent substandard products from entering the market by regulating effective control. Furthermore, it may also slow down the Patent System by enforcing stringent measures to curb Patent Infringements, which may not work in favor of developing countries.

Concluding Remarks

The CPTPP is a TRIP-plus standard that has practical implications on the member states. However, since the CPTPP is an agreement laying common grounds, it may act as a level playing field. It would be interesting to observe in the coming years how such preferential trade agreements turn out to be in the long run in their endeavors of achieving healthy and affordable medicines since it is clear how the entry of generics and biosimilars may be delayed. The cost of enforcement may be affordable for developed nations, but it may be an additional challenge for other signatories.

TRIPs vs. Convention on Biological Diversity: Rivals or Partners?

The Convention on Biological Diversity (CBD) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) have significant implications for the nexus of Intellectual Property Rights (IPRs), biodiversity, and associated knowledge systems. CBD requires parties to safeguard biodiversity and the traditions and knowledge of the indigenous and other local communities associated with this biodiversity. It also lays down the basic elements for access to biodiversity resources and associated knowledge systems. The TRIPS Agreement obliges member states to modify their national IPR regimes to meet much-enhanced international standards, which can have significant implications for biodiversity and the associated knowledge systems. It is often said that there is a direct conflict between TRIPS and CBD. It needs to be checked whether the two threaten each other or work hand in hand.

Objectives of the Agreements

The TRIPS Agreement

The main objectives of the TRIPS Agreement are:

1.     Establishing adequate and effective levels of protection for IPRs; and

2.     Reducing distortions and impediments to international trade from differing standards of protection. 

The TRIPS Agreement lays down minimum standards for Intellectual Property (IP) protection in several areas. As to inventions, Article 27.1 requires Member Countries to grant patents in all areas of technology without discrimination. Article 27.2 provides a general exception to this. A WTO Member need not grant patents for inventions objected to as being contrary to public order or morality, which includes inventions that would damage the environment. 

Nevertheless, such objections must be serious enough to make it necessary to ban the exploitation of the inventions in the Member's territory. Article 27.3 further allows exceptions for plants, animals, and essentially biological processes. However, TRIPS requires some effective protection for plant varieties, whether by patents or otherwise ('Sui Generis' protection, such as plant breeders' rights under UPOV).

 

CBD

The main objectives of CBD are:

1.     Protecting the biodiversity; 

2.     Promoting its sustainable use; and 

3.     Sharing the benefits of such use equitably between providers and users. 

CBD recognizes that some genetic resources have commercial potential. The Convention's measures go further than encouraging benefit-sharing. They are designed to vigorously promote activities (including co-operation in research and development and private investment to develop genetic resources) needed to create the products or technologies that will give rise to benefits to be shared. Thus, the Convention includes provisions that are based on voluntary co-operation and voluntary licensing of rights and which require respect for IPRs (i.e., Article 16).

The Convention also explicitly recognizes and supports "adequate and effective protection" for IPRs (Article 16.2). It reflects the understanding reached during CBD negotiations, as per which, in technology transfers under CBD, IP must be respected. CBD was explicitly tailored to avoid a conflict with the other major instruments dealing with IP Protection, namely, the then-nascent TRIPS agreement.

Areas of Conflict

The primary area of conflict is that while CBD assigns sovereignty in biological resources to the countries that possess them, TRIPS allows these resources to be patented. Within one country, the state's sovereignty takes precedence, and the CBD framework may prevail. But between a foreign IPR holder and a sovereign state, the state's jurisdiction is limited and cannot countervail the IP rights holder. It is, therefore, argued by many that TRIPS takes away rights that are given by CBD. Furthermore, the concern is that patenting of genetic resources encourages unsustainable use and also encourages 'biopiracy.'

Also, TRIPS states that patents must be provided for all fields of technology; therefore, the use or exploitation of biological resources must be protected by IPRs. There is no mechanism for sharing benefits between a patent holder in one country and the donor of material in another country from which the invention is derived. CBD, on the other hand, gives developing countries a legal basis to demand a share of benefits. TRIPS does not have any provision requiring prior informed consent for access to biological resources, which may subsequently be protected by an IPR. CBD gives states the legal authority to diminish the incidence of biopiracy by requiring prior informed consent. TRIPS ignores this authority and thus promotes biopiracy.

The safeguarding of public health and nutrition, and the public interest in general, shall be subject to the private interest of IP rights holders as reflected in the provisions of the TRIPS Agreement. Parallelly, CBD places the public interest and common good over private property and vested interests. TRIPS is directly contradictory to this.

Resolving the Conflict

IP protection per se does not contribute to the preservation of biological diversity (except perhaps in a few instances where the deposit of biological material for patent purposes helps to preserve ex situ what subsequently becomes lost in situ). However, it seems beyond doubt that it can help to encourage uses, including sustainable uses of biological material, in the same way as IP protection helps to encourage all novel uses. Above all, it can contribute to equitable sharing of the benefits of such use. Economists tell us that most of the benefits of innovation (particularly agricultural innovation) go ultimately to consumers. IPRs provide a method of recovering some of these benefits from consumers by way of higher prices. These benefits are then available, at least in principle, not only for paying for research and development but also for sharing with the providers of essential biological materials. Without IP protection, such benefits cannot be recovered.

Finally, it should be noted that if any of the provisions of CBD and the TRIPS agreement were found to conflict, it would be the TRIPS Agreement that controls for state parties to both treaties. Under the Vienna Law on Treaties, the agreement either later (in time) or clearer and more specific on the issue will control. In the case of the TRIPS Agreement and CBD, both factors would result in the TRIPS Agreement controlling for state parties to both treaties.

Best Practices

TRIPS and CBD can work as partners in the long run. For ensuring that both the agreements work hand in hand, the following best practices need to be followed:

• Recognize that CBD has primacy over the WTO, specifically in biodiversity and traditional knowledge systems.
• Ensure that the review of the TRIPS Agreement allows sovereign states to exclude all life forms and related knowledge from IPR systems. 
• Urgently recognize a priori collective rights of indigenous people and local communities over their biodiversity and related knowledge.