[Ip-health] Pharmalot: PhRMA Wants 12 Years Data Protection In TPP Talks

Peter Maybarduk pmaybarduk at citizen.org
Mon May 2 12:00:23 PDT 2011


The PhRMA trade group is urging the US Trade Representative to go beyond provisions contained in the Korea-US trade deal, known as KORUS, and include 12 years of data exclusivity for biologics in the Trans-Pacific Partnerships talks that are under way, according to Inside US Trade.

The push contrasts with a White House proposal earlier this year to shrink exclusivity to seven years from 12 years, a move that would roll back a provision in health care reform. You may recall that brand-name drugmakers won a 12-year exclusivity period last year as part of an effort to create a so-called FDA approval pathway for biosimilars. Generic drugmakers, of course, wanted a shorter term.

The issue is new, however, for US trade agreements. Drugmakers usually want the USTR to replicate patent provisions found in KORUS into the TPP context, but KORUS did not contain 12 years of data exclusivity for biologics. Why? This provision was not part of US law when KORUS was negotiated, Inside US Trade notes.

“The recent passage of a biosimilars regulatory pathway in the United States recognizes the importance of data protection and the evolution of the innovative biopharmaceutical industry,” PhRMA wrote in this document that is used for TPP lobbying. “Protection consistent with US law – ie, at least 12 years for biologics and at least 5 years for nonbiologics, with adjustments to be made for future indications, is essential.”

“We think anything that is agreed to in any agreement, including TPP, has got to meet the level of US law,” Harrison Cook, an Eli Lilly vp of international government affairs tells Inside US Trade. Twelve years of data exclusivity for biologics is important because it “creates parity with the strong patent protection you would expect to have on a chemical drug.” He added that KORUS is still considered a “gold standard” for IP protections, but data protection could be improved.

The newsletter goes on to note the US has demanded trading partners agree to provide five years of data exclusivity for drugs in past free-trade deals, although data exclusivity provisions of trade deals with Panama, Colombia, and Peru were altered in response to objections from public health advocates. However, until last year, there was no provision for a specific data exclusivity period for biologics.

Public health advocates do not want the provision to appear in the TPP agreement and warn that if the US obtains a 12-year exclusivity period, biosimilar producers would not only be barred from producing biosimilars in the US for that period of time, but also in other countries, the newsletter writes.

“This is not about rational standards. It’s simply about a powerful lobby taking anything and everything it can get,” Peter Maybarduk, who heads the Access to Medicines Program at Public Citizen, writes us. “Twelve-year government-issued monopoly protection is a terrible idea here at home that will help keep healthcare costs high. But applied to developing countries through a Trans-Pacific FTA, it’s simply cruel. This shows PhRMA’s hubris and sense of entitlement, given that the Obama administration has recently proposed reducing the term of years for exclusive protection of biologics in the US.”

Brand-name drugmakers argue that 12 years of data exclusivity is needed to recover R&D investments and that additional protection is needed for biologics because of the nature of patent protections. Thye note that, under the new regulatory pathway, biosimilars do not have to be identical and patents may be circumvented because these are not technically the same as the original drugs.

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