Time is money in biotech data gap
Companies favor 12-year rights for biologics; consumer advocates want five
U.S. Rep. Christopher Van Hollen Jr. is working on a compromise solution to a hotly brewing political fight over how long biotechnology companies would have data protection for biologic drugs.
With biotechnology a major part of the state's economy, several of the state's leaders, including Gov. Martin O'Malley and Sen. Barbara Mikulski, have lined up in support of a bill that would give biotech companies at least 12 years of data exclusivity for their biologic drugs.
Biologics, unlike conventional drugs, are derived from living cells such as proteins.
That bill, H.R. 1548, is co-sponsored by Reps. Roscoe Bartlett (R-Dist. 6) of Buckeystown, C.A. "Dutch" Ruppersberger (D-Dist. 2) of Timonium and Frank Kratovil (D-Dist. 1) of Stevensville.
Consumer advocate groups support Rep. Henry Waxman's bill, H.R. 1427, which is co-sponsored by Rep. John P. Sarbanes (D-Dist. 3) of Towson. It would give the biotech companies five years of exclusive use. President Barack Obama has called for a compromise of seven years.
Van Hollen (D-Dist. 8) of Kensington said many factors are involved in lowering the cost of health care for consumers, and biologic protection is "one piece in the mix."
Biologics cannot be treated the same as other pharmaceuticals because they have longer development times, he said.
"You don't want to take away the incentive for innovation," Van Hollen said. "You might also cut short research on very similar drugs that will help some of the chronic diseases."
Van Hollen said he has not taken a position on how long the protection should be, but was trying to reach a compromise satisfactory to the needs of consumers and biotech manufacturers.
Sandi Dennis, general counsel of the trade group Biotechnology Industry Organization, said it is difficult to predict where the legislation is headed. The two competing bills remain in committee and could be incorporated into the massive health care reform bill.
But consumer groups are actively lobbying to prevent the 12-year protection for biotechs.
"In all frankness, we cannot be supportive of any generic biologics legislation that would be an empty promise to the Americans we represent and serve," said a statement issued by AARP, the Consumers Union and the Coalition for a Competitive Pharmaceutical Market.
Generic versions are seen as a way of saving consumers money.
"We need markets that drive innovation, not those that reward monopoly," said U.S. Public Interest Research Group's health care advocate Larry McNeely, whose group supports Waxman's bill.
But biotechnology companies say they need the longer protection from generics to recoup their investment into the research and development of the biologics.
"It's said that $800 million is needed to recoup the cost of product development and the failures associated with getting it to market," said Scott E. Koenig, president and CEO of biotech company MacroGenics of Rockville, which is developing a new product to treat juvenile diabetes.
At a Senate hearing, Mikulski called biotechnology companies "the face of the new economy."
"I'm speaking up for the 1,000 biotech firms in Maryland," the senator said.
Mikulski said those opposing the 12 years of protection were mischaracterizing the biotechs.
"I don't like them portrayed as robber barons profiteering off the miseries of life," she said.
Staff Writer Robert Rand contributed to this report.
Correction: The original version of this report incorrectly referred to a dispute over patent protection for biologics. Instead, the dispute centers on how many years biotechnology companies can have exclusive use of their proprietary data in developing the treatments.