Sunday, March 2, 2014

The 2001 Doha Declaration: Probative In A WTO Dispute Process? Yes. Affirmative, Positive Law? Not Quite So Clear.

"We make a living by what we get; we make a life by what we give. . . ."

-- Winston Churchill (1874-1965)

As I shoveled in this morning's luminous yet clear dawn light, I thought some more about my post of yesterday afternoon, and how a potential future IP dispute might play out, in India, between a mythical pharma company with a life-saving, revolutionary patented AIDS/HIV drug -- and the estimated 2.4 million people (essentially all of limited means) living HIV positive there.

Many IP lawyers who work for innovator pharma argue that the Doha Declaration cannot bind anyone, as a matter of positive law, claiming that the required two-thirds member vote to ratify it (as a TRIPS level binding subsequent agreement among members) hasn't yet occured.

That argument utterly forgets that as a simple interpretation of existing TRIPS provisions, handed down in 2001 (during the AIDS in Africa awareness moment), it will be accepted as pretty authoritative, on the issue of members' intent, in any WTO dispute. That is, in any WTO proceeding, the Doha Declaration will be -- at a minimum -- a good faith defense, to claims of IP violations. India would be acting pursuant to the express terms of TRIPS, as interpreted by Doha.

And THAT is to say, in the view of "permitted access" IP lawyers, Doha aimed to explain what TRIPS contemplated, in national health emergencies (specifically in the still-developing economies). And where negotiations with an innovator fail -- compulsory licenses are mentioned -- in TRIPS itself. So, the wise course, for all of innovator pharma -- will not follow a path of WTO litigation or dispute resolution. Imagine now that if the WTO were called upon to decide, and did in fact decide, that compulsory licenses may issue -- without challenge -- in India, Brazil, China or a half dozen other developing nation members. . . what an overwhelming precedent that would be, in all future negotiations/potential disputes. So, on balance, I think we will see no WTO proceedings -- on this issue. The risk of a bad outcome for branded pharma is just too great.

In passing, one other bar branded IP lawyers occasionally cite is in this interesting -- if older -- United Kingdom law review article:
. . . .In cases in which the TRIPS Agreement allows for compulsory licences and other measures, in countries that do have the generic pharmaceutical industry, for example Brazil and India, there is a chance that compulsory licensing will be used. However, the pharmaceutical industries in those countries have previously only produced patent-protected medicines through reverse engineering, something that the TRIPS agreement prohibits. . . .

But this TRIPS "reverse engineering" prohibition -- in a dispute, at the WTO, might count for very little. After all, if India has offered reasonable royalties to the innovator pharma company, and has used the patent applications to teach the art (in the generic plants), AND is relying on the Doha Declaration Sections 4 through 6, to allow local generics to manufacture, AND sells only into India. . . it is hard to imagine how the branded pharma could prevail. That's my $0.02. So. . . Merck is letting her "life" -- in Churchill's memorable turn of phrase -- be defined by what she gives. And I for one am encouraged.

To close out, for now, then: I think that is why Merck granted Cipla an "authorized generic" license to make Isentress®, albeit with different packaging and a different name -- inside India, about two weeks ago. Finally, while the Doha Declaration speaks of a January 1, 2016 potential sunset date, it is also plain that the date may be extended upon any member nation request, as to that nation, at WTO. So this issue is here to stay, well into the 21st Century, in my view.

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