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Generic Biotechs Battle to Reduce Patent Protections

By Drug Discovery Trends Editor | January 18, 2010

WASHINGTON (AP) – Makers of generic biotech drugs, backed by the White House and a well-placed congressional ally, are waging an eleventh-hour battle to reduce the competitive protection that the emerging health overhaul bill would give to brand-name producers of the expensive pharmaceuticals.

Biotech drugs, made from living matter and used to treat diseases from cancer to diabetes, have been a growing portion of the pharmaceutical market and are seen as key to the industry’s future. The House- and Senate-passed bills reshaping the nation’s health care system would both grant biotech producers 12 years of protection against lower-cost generic competitors.

Yet with White House and congressional bargainers moving toward a final health bill, White House officials and Rep. Henry Waxman, D-Calif., chairman of the House Energy and Commerce Committee, are trying to reduce the curbs against competition to 10 years or less. The effort was described by industry and congressional officials who spoke on condition of anonymity because the talks are private.

Outside lobbying on the issue has also intensified on both sides. That battle has been waged for months, with brand-name companies widely outspending their generic rivals.

The drive to shrink the protection period has prompted opposition from the pharmaceutical industry, which argues the longer period is needed to encourage the massive investments required to produce biotech products.

“Fair data protection of at least 12 years is critically important to the future of medical progress in America,” said Ken Johnson, a senior vice president of the Pharmaceutical Research and Manufacturers of America.

On Thursday, 38 patients groups and research universities wrote a letter backing the 12-year period to House Speaker Nancy Pelosi, D-Calif., and Senate Majority Leader Harry Reid, D-Nev., who are among the health bill negotiators. It said 12 years of protection would balance patients’ access to the drugs with incentives for companies to develop more of them.

Senators from California, Massachusetts and other states with a heavy pharmaceutical industry presence also wrote Reid urging him to preserve the 12 year period.

The drug industry has been a key supporter of President Barack Obama’s effort to reshape the health care system. It is already under pressure to boost the $80 billion, 10-year contribution it agreed to make to the overhaul last year.

The effort to reduce biotech drug protections could be a way for the administration to pressure the industry to increase its contributions, or to make it easier for Obama to show the $80 billion deal with drugmakers will benefit consumers.

On the other side, the much smaller Generic Pharmaceutical Association is launching a $250,000 advertising campaign on Washington-area television stations and newspapers and has written to Reid and Pelosi seeking support, according to Kathleen Jaeger, the group’s president.

The association argues that allowing generic products on the market sooner would save consumers billions of dollars annually and produce savings for businesses and the government.

“It’s never too late to remind the members that they need to do what’s right,” Jaeger said of her organization’s lobbying.

Waxman declined to comment on the issue.

Date: January 14, 2010
Source: Associated Press


Filed Under: Drug Discovery

 

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