[Ip-health] Will USTR undermine Obama on biosimilars at Trans-Pacific trade negotiations?

Peter Maybarduk pmaybarduk at citizen.org
Fri May 27 13:08:36 PDT 2011

Inside U.S. Trade - 05/27/2011
USTR Signals Support For Longer Data Protection For Biologics In TPP
Posted: May 26, 2011
The Office of the U.S. Trade Representative signaled last week it will pursue stronger patent protections for biosimilar drugs than for conventional medicines in the Trans-Pacific Partnership (TPP) negotiations, as demanded by U.S. pharmaceutical companies, according to informed sources.

In a May 20 briefing for private-sector stakeholders, USTR officials indicated they may propose granting as much as 12 years of data exclusivity for biosimilar drugs -- also known as biologics -- these sources said. The officials, however, did not fully commit to doing so, they said.

A 12-year data exclusivity period would reflect provisions in the U.S. health care reform bill that was signed into law last year. At the same time, the officials said they were aware of the fact that President Obama's fiscal year 2012 budget proposal called for a reduction of the data exclusivity period for biologics to seven years.

Either of these periods would be a jump up from the five years of data exclusivity for pharmaceuticals that the United States has negotiated in past trade deals.

During the data exclusivity period, generic drug manufacturers are barred from accessing the clinical data typically generated by brand-name drug companies. This delays the marketing of cheaper, generic competitor drugs.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and others are urging USTR to secure 12 years of data exclusivity for biologics in the TPP talks in order to match the provisions of U.S. law (Inside U.S. Trade, April 29).

"We seek reciprocity in trade agreements," said Lila Feisee, vice president of global intellectual property at the Biotechnology Industry Organization. "There should be reciprocity in our trade partners as well."

This would mean the eight other TPP parties would be expected to adopt the same 12-year data exclusivity period for biologics.

A private-sector source pointed out that the negotiating objectives in the 2002 fast-track law, which has expired, states that negotiators should ensure that any IPR measure should "reflect a standard of protection similar to that found in United States law."

The USTR officials in the briefing did not say for certain whether the United States will table a complete proposal on intellectual property rights (IPR) before the next round of TPP negotiations in Vietnam scheduled for mid-June, but signaled that they are working toward this goal, at least with respect to pharmaceutical patent provisions, sources said.

In a related development, Assistant USTR for IPR Stan McCoy did not commit to making a complete IPR proposal by the Vietnam round. At a May 16 event, he said it is difficult "to say with certainty what we're going to do when."

"The next round will be in Vietnam and we're looking at what we can table for that round and it's all kind of an ongoing process inside the administration," McCoy said. USTR has already tabled most of its proposed IPR text, but has not yet tabled the most crucial provisions on patent protections and other IPR topics.

At the briefing, one USTR official made it "very clear" that the U.S. government does not intend to replicate the patent provisions in the May 10 agreement, one informed source said. That agreement, struck in 2007 between House Democrats and the Bush administration, eased requirements for data exclusivity for conventional drugs, patent linkage and patent term extension in the FTAs with Panama, Peru and Colombia to improve access for affordable medicines.

The official said that "2007 was 2007," and "2011 is 2011," in an apparent signal that the 2007 deal as negotiated is not directly relevant for the TPP deal, sources said.

For instance, USTR noted that new domestic legislation, such as the health care reform bill establishing a 12-year data exclusivity for biologics, is one example of how the circumstances differ now when considering whether the May 10 standards are still relevant for TPP, sources said.

The pharmaceutical industry has launched a major lobbying campaign to get USTR to disregard the May 10 deal and make the U.S.-Korea FTA the basis of its TPP proposals on pharmaceuticals (Inside U.S. Trade, April 29).

In the briefing, USTR said that it has not yet tabled text on pharmaceutical pricing and reimbursement policies, but said it is under consideration. But USTR gave no clues on whether such provisions would stand as a separate chapter or if they would be included in other chapters, sources said.

Industry wants these provisions to be included as a way to mandate more transparency for or altogether counteract national drug pricing programs, which they say can restrict market access and profits for U.S. drug companies.

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