Revisiting the Trans Pacific partnership agreement

Last week’s State of the Union address highlighted important aspects of President Obama’s second term agenda. President Obama identified Trans Pacific Partnership(TPP) agreement as a top trade priority and reaffirmed his commitment to conclude negotiations on the Trans Pacific Partnership agreement. To quote, “To boost American exports, support American jobs, and level the playing field in the growing markets of Asia, we intend to complete negotiations on a Trans-Pacific Partnership.”

Image from here

In an earlier article Swaraj had elucidated five major areas of concern in the TPP. The Trans Pacific partnership agreement started out as a four nation agreement between Brunei, Chile, New Zealand, and Singapore and gradually expanded to include Australia, Peru, Vietnam, United States,  Malaysia, Mexico and Canada. Japan was expected to join TPP negotiations, however as reported here, Japan may consider dropping support for TPP.If the ongoing negotiations between the member nations are successful, then the TPP would encompass USD 21 trillion in economic activity.

Some intellectual property provisions as detailed in leaked draft US IP chapter of TPP agreement can be found here and here. Readers may remember that Swaraj had posted a detailed analysis of the various provisions of TPP, which can be accessed here and here. I have only analyzed the provisions which were not discussed earlier.

Article 1 of TPP requires that “Each Party shall, at a minimum, give effect to this Chapter.”
Article 8.2 of TPP requires that patents for inventions pertaining to plants and animals should be made patent eligible. The TPP agreement also requires that therapeutic, diagnostic and surgical methods for treatment of humans and animals should be eligible for patent protection.
In addition TPP article 8.1 requires that new forms, uses, or methods of using a known product; may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the known efficacy of that product. I believe this provision was incorporated keeping in mind India’s controversial Section 3(d).
It should be noted that Article 8.10 of TPP states that “disclosure of a claimed invention shall be considered to be sufficiently clear and complete if it provides information that allows the invention to be made and used by a person skilled in the art, without undue experimentation, as of the filing date.” However this provision does not expressly mandate disclosure of best mode, thus leaving open the possibility that an inventor may withhold the best mode for himself and subsequently patent the best mode as a distinct invention altogether.
Other TRIPS plus provisions included in the text of US IP chapter of TPP include:

  • Patent linkage provisions, thus allowing presumption of validity of patent (article 9.5) 
  • Elimination pre-grant opposition of patents (article 8.7) 
  • Patent term extensions and /or adjustments: Extension of patent terms beyond 20 years to compensate for delays in regulatory approval and/or delays on the part of patent office [Articles 8.6(b) and article 8.6(c)] 
  • Data exclusivity provisions: Five-year data exclusivity for a new chemical entity (never registered before) and three years data exclusivity provisions for new indications of pharmaceutical drugs whenever new clinical trial data is submitted [Articles 9.2(b) and 9.2(c)] 

Furthermore, Article 13.1 expressly mandates expedited grant of preliminary injunctions and specifies a time period of ten days to execute such requests barring exceptional cases.

Although Article 10 of TPP agreement states that, “In recognition of the commitment to access to medicines that are supplied in accordance DOHA declaration this Chapter does not and should not prevent the effective utilization of the TRIPS/health” , the TRIPS plus provisions and directive text of TPP and might hinder effective implementation of DOHA declaration.

Why should we bother? It is highly likely that TPP will affect other countries apart from those currently involved in negotiations. Countries that are not parties may be coerced into becoming members by imposing TPP agreement as a precondition for other bilateral trade agreements .Alternatively countries that are not members may be evaluated against TPP standards in the annual Special 301 process administered by the USTR.
The next round of negotiations i.e. the sixteenth round is scheduled to be held In Singapore from March 4th -13th and will play a major role in determining the pace and direction for future negotiations.

Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

One comment.

  1. Subhasree

    Lovely post, Madhulika!

    What needs to be seen is if India musters enough political and economic clout to bypass agreements like TPP ( for I am sure the US trade lobby will push for similar trade agreements to tap into the lucrative Indian Market)


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