Protection For Biologics | Companies say patents are not enough
As President Barack Obama and federal politicians debate the particulars of health care reform, Massachusetts biotechnology companies are closely following a provision that would give them 12-year data exclusivity for any biologics they developed.
In recent weeks, U.S. Senate and House committees passed an amendment to the health care reform bill that would that give 12-year data protection for biologics.
Costly Creation
Biologics are different than other pharmaceuticals because they’re proteins that are manufactured in living cells. They’re expensive to develop — with estimates of up to $1 billion per drug — and they’re not cheap once they’re on the market. It’s almost impossible to make exact copies of biologics, which is why the imitators are called biosimilars.
Some, including the president, have pushed for a pathway so these biosimilars can come to the marketplace, which would help reduce health care costs. The president has proposed a seven-year period and a second bill in Congress has proposed a five-year period. Most biotech companies want to see a biologic data exclusivity period for 12 years.
“When you do the math, it’s important to be able to protect a company’s return on investment to pay not only for the successes, but for the failures,” said Jim Green, the director of preclinical development at Cambridge-based Biogen Idec Inc.
The data exclusivity for biologics would run concurrently with patents, with data exclusivity periods often continuing to run after the patents end.
That’s because patent protection starts when patents are approved while the data exclusivity period would begin when the FDA approves the drug.
Not everyone believes that such a long protection period is required.
In June, the FDA released a report that focused on follow-on biologic drug competition, which concluded a 12- to 14-year protection period isn’t necessary. It said that because pioneer biologic drugs are covered by a number of patents including manufacturing and technology patents, additional protection isn’t needed.
But the state’s biotech companies would beg to differ. And they’re saying they’re not only worried about what would happen to their bottom line, they’re also worried about what a slump in the biotech industry would do to the state’s economy.
Massachusetts Biotechnology Council President Robert Coughlin sums up the industry’s outlook pretty succinctly.
“If there is no incentive for people to invest in innovation, these companies and these jobs are going to go overseas,” Coughlin said. “The life sciences industry is one of the few areas of our economy that is growing.”
And at least one local organization has come out publicly for the 12-year period.
Worcester Chamber of Commerce President Richard Kennedy wrote an op-ed piece with Cambridge Chamber of Commerce President Kelly Thompson Clark for the Boston Herald pointing out that a climate of investment and research in biotechnology is “an essential engine for economic growth for our nation.”
“Biotechnology is the bread and butter for Massachusetts,” said Michael Lanava, the Worcester chamber’s business resource manager.
Coughlin added: “We want investors to be able to recoup their investments and to be able to invest in future cures and therapies for unmet medical needs.”
Got news for our Biotech Buzz column? E-mail WBJ Staff Writer Eileen Kennedy at ekennedy@wbjournal.com.
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