“TRIP” ped Compliance - Patently Absurd or Patents Revisited ?!.

 "It is not uncommon to charge the difference between promise and performance, between profession and reality, upon deep design and studied deceit: but the truth is, that there is very little hypocrisy in the world; we do not so often endeavour or wish to impose on others as on ourselves; we resolve to do right, we hope to keep our resolutions, we declare them to confirm our own hope, and fix our own inconstancy by calling witnesses of our actions; but at last habit prevails, and those whom we invited to our triumph laugh at our defeat” - Samuel Johnson

Ironically , since the tabling of the Patents (Amendment) Bill, 2004 in Parliament, we hear amidst the din of criticism , a confused cry from our legislators as to whether we have complied with TRIPS Agreement or not . It will be interesting to revisit certain “home truths” about TRIPS compliance in this scenario.

To begin with , TRIPS for most educated people, still stands for Trade Related Intellectual Property Rights regime and not the TRIP ups the Electricity system is capable of delivering year after year, summer after summer. In trying to analyse whether the Government has truly implemented the essence of it’s TRIPS obligations, a perspective will have to be developed about the history of this trade related system in light of the International developments .

The TRIPS Agreement formed part of the multilateral trade obligations of the developing countries like India only a decade back when  the confused rumblings of the Post-Dunkel GATT were set to rest. In the entire history of it’s development , issues as to access to medicines and the “public health emergency” and licensing regimes concerns were repeatedly underscored and agitated by policy makers , interest groups and stakeholders alike. Declaration as to public health emergency clause made in the TRIPS Agreement in 2001 surrounded the most intense debates sparked by monopolist pharma majors, policy makers, Governments alike in perhaps what was best understood to be the last major conundrum this regime would court. The compulsory licensing regime today has ensured that the formal framework to recognise and implement  public health concerns has been firmly put in place .

However, it remains to be seen whether the affirmation of the commitment of developed country Members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country Members pursuant to article 66.2 obligations will be forthcoming as the traditional premise on which it was opposed stands mitigated.

Article 7 of the TRIPS Agreement  was intended to ensure technology transfer to all developing countries , which underscores the need for Foreign Direct Investments to industrially work cutting edge technology. As of today it seems this will only jeopardise the interests of developing nations which have under-developed Institutionalisation of the R&D industry and FDI norms to support the same in practical terms . Therefore, implementation has to be seen in light of the scenario provided as a support system for Research and development in general-both long term and short-term .

Understandably, the essence of the TRIPS Agreement under Article 27.3 was to provide for a form of Intellectual Property rights regime for  all fields of invention except a few. Surgical, prophylactic, diagnostic , curative methods of treatment were kept out from the purview of the patenting monopoly as the concerns surrounding the health care industry were considered too ethically profound to be worthy of any monopolistic restriction  .

However, the pharmacetical industry has realised that over the years, methods of treatment have developed on another plane , that of Gene therapy and Recombinant DNA therapy. The biotechnology boom has thus , in part ,  wiped out the fears of having entire  systems of medicine in the hands of a choosen few. But have we really opened to this sunrise sector which merits some incentive in the nature of monopolies to ensure it’s developmental survival vis-a-vis pharmaceuticals

Also as new fields of technology open up are we really ready in terms of clear understanding as to what will be understood as industrial applicability. Perhaps from this standpoint, Indian Patent Law has to look inwardly as to the basis of it’s implementation in terms of the Patenting system in substantive and practical terms for pharmaceuticals. Reflections include addressing fears of “evergreening” by bloated chemical compound related claims as product patents by pharma majors to “invigorate” their monopolistic tendencies, understanding as to where novelty and research effort in fields like pharmaceuticals lies, allowing for research-both small scale and large scale  will hold the key to the future of product patents , a crucial component of the TRIPS Agreement.

The Exclusive Marketing Rights regime – a precursor to the product patents that will be best remembered for it’s controversial culmination in the grant which have shown the gaps between drug regulatory authorities and a efficient legal framework for enforcing public rights and those of the patentee (read rights holder). Truly, the morning shows the day. And as stated above, habit has become our undoing as lax regulatory systems will invite industrialists to play with human life before they seek to further it’s cause by providing easy access to medicine. It is quixotic that we have been worried about hypocritically about provision to treatment and medicines but not to health care itself. The answer to this lies truly in those who invite us to their triumph only to “laugh at” their defeat .

( The author, Ashish Gosain , is an Associate, Intellectual Property with the renowned law firm, Fox Mandal.)

[Ed: Views expressed herein are the views of the author only]

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