[Ip-health] WSJ: Blood Boils Over Bill To Protect Biotech Drugs

Mon Jul 13 12:50:16 2009

The Wall Street Journal
Monday, July 13, 2009
Blood Boils Over Bill To Protect Biotech Drugs

By ALICIA MUNDY

WASHINGTON -- The biotech industry is moving closer to a victory in
Congress that would protect lucrative drugs from generic-drug
competition for a lengthy period, though the issue continues to rile up
lawmakers and consumer advocates.

The Senate Health, Education, Labor and Pensions Committee will be
looking at a bill this week that would grant so-called biologic drugs --
those engineered from living cells -- made by companies like Amgen Inc.
a total of 13=BD years of intellectual-property protection, which is about
twice the length of time proposed by the White House.

The proposal, introduced by the committee's chairman, Sen. Edward
Kennedy (D.,Mass.), would be part of an ambitious health-care overhaul
sought by President Barack Obama. It may prevail because it would help
keep the pharmaceutical industry on board with the overhaul, said
industry lobbyists and Senate staffers.

But the question of how long to protect brand-name biologics'
intellectual property -- referred to as their 'exclusivity' -- has
caused a rift in the health committee, which oversees the Food and Drug
Administration, and in the overall Senate, industry representatives and
Senate staff said.

It has also sparked an advertising battle between consumer groups, which
want a shorter period of exclusivity for biologics, and the industry,
which has said such an approach would hamper innovation.

Biologics, such as Amgen's Epogen for cancer patients, are generally
made from proteins manufactured in living cells, and they are far more
complex than traditional chemical drugs. The biologics industry is
growing at 18% a year and could hit $100 billion in sales by 2011,
according to generic drug makers.

Without sufficient exclusivity, "the biotech industry will not have the
incentive to take high risks required for development and innovation in
biologic life-saving drugs," said industry lobbyist Jim Greenwood.

Sen. Kennedy, whose state includes large biotechnology companies and
research centers, has consistently advocated the brand-name makers'
position, as have some other Democratic health committee members,
including Patty Murray (D., Wash.) and Barbara Mikulski (D., Md.).

But some other Democratic senators, including Chuck Schumer of New York
and Sherrod Brown of Ohio, as well as the chairman of the House Energy
and Commerce Committee, California's Henry Waxman, favor strict limits
on brand-name biotechnology products to cut drug costs.

Messrs. Brown and Schumer and Mr. Waxman have introduced separate bills
this year, supported by consumer groups, that propose a base of five
years' exclusivity, with a possibility of extension.

"Biotechnology start-up involves high risk and high cost, but you can't
give these companies open-ended protection from generics," said Sen.
Brown in an interview.

A report in June by the Federal Trade Commission rejected the industry's
stance and said 12 to 14 years of exclusivity would harm patients by
unnecessarily delaying access to affordable drugs. The White House
recently wrote lawmakers that it favors seven years.

The Kennedy legislation is expected to go to the Senate Finance
Committee, which is driving the health-care overhaul package. Its
chairman, Max Baucus, has supported longer exclusivity for brand-name
makers. His staff said he wouldn't comment before his bill is released.

Leaders of the health committee are trying to avoid a public showdown
over the issue and may not produce a formal proposal until there is more
unanimity on their panel, industry representatives and Senate staffers said=
.

Mr. Schumer, who serves on the finance committee, said he thinks there
may be stronger support for lower exclusivity in the Senate as a whole.

A separate House bill strongly propelled by the Biotechnology Industry
Organization, the biotech lobby, and PHRMA, the Pharmaceutical Research
and Manufacturers Association, which represents brand-name drug makers,
would provide at least 12 years of protection for brand-name biologics.

AARP, the lobby group for seniors, recently wrote health-committee
members saying it could not support a broader health-care bill that
included "double-digit exclusivity."

The group is in an escalating advertising war against BIO and PHRMA. It
has been running full-page ads in political publications saying: "Don't
believe brand-name companies' myths" about needing exclusivity.

BIO, the industry's lobby in Washington, struck back in radio
advertisements last week accusing seniors of wanting a "free ride" for
generic makers.

The biggest wave of commercials so far has come from PHRMA, whose
members include some biotech companies. Radio ads accused supporters of
short exclusivity periods of selling out American workers.

The ads claim shorter exclusivity causes job loss, and say that pending
proposals to allow faster generic versions would "outsource jobs to
copycat manufacturers in India and China."

Write to Alicia Mundy at alicia.mundy@wsj.com

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--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/