Thursday, May 1, 2014

Despite Intense Lobbying, PhRMA And US Chamber Of Commerce Unable To Label India A "Priority IP Violator"


Overnight, an eleven month long lobbying effort with the offices of the US Trade Representative came to a close, for this year, at least.

Over that time frame, there has been intense pressure -- from both the Chamber of Commerce and PhRMA -- to push India to the top of the list (backgrounder here), along with the Ukraine, as countries against which severe sanctions could be imposed -- at the WTO, for what amounts to an intentional fostering of violations of a common core of basic international intellectual property laws. I should note that PhRMA was successful in getting a special review of India slated to begin this coming Fall. Such "out of cycle" reviews often lead to additional sanctions, if not a full-on "priority" designation. From the PhRMA statement, then -- a bit:

. . . .The Special 301 process garners the high-level attention from our trading partners necessary to redress intellectual property violations and market access concerns within individual markets and to send signals to other U.S. trading partners that protecting American intellectual property is important not only to the U.S. economy but also to patients across the globe. . . .

While we continue to believe that the systemic pattern of undermining patented medicines in India warrant its elevation to Priority Foreign Country status, we welcome the announcement that USTR will initiate an Out-of-Cycle Review of India this fall. Such a review provides a needed avenue for constructive engagement with the incoming Indian government on how to resolve the deteriorating IP environment in India. Nothing less than full engagement in the months ahead is needed to resolve these critical issues. . . .


Of course, keeping India on edge about whether it will be labeled a scofflaw -- with nearly overlapping multi-year "investigations" at the WTO, works primarily as a form of moral suasion. . . not so much as an actual governing iron fist. Think here more of the UN Security Council, than some actual self-executing World govenment arm -- with immediate exrta territorial jurisdiction. The WTO afterall must rely on its member-nations' governments, ultimately, to enforce any sanctions it imposes.

S E G U E. . . .


Separately, the rumor mills in the financial rags are active again -- indicating that Merck's older, off patent drugs may be packed up, and sold off. A price tag of $15 billion has been mentioned, but that is meaningless, until the specific drugs are identified. Such matured, late in life cycle drugs ought to fetch a multiple of slightly less than three times annual sales -- something closer to 2.25 to 2.5 times annual sales. [However, on behalf of Akorn, Inc. John Kapoor was able to make off with AzaSite for only 1.25 times sales, recently -- a legacy Schering Plough set of eye products. That was probably a bottom fisher's abberation, though. Kapoor is a pre-eminent negotiator, on price.] So, if the total aggregated annual sales of such drugs are less than $6.5 billion, anyone paying $15 billion will have. . . overpaid. Just my $0.02.

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