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Print Edition StoriesWednesday, July 15, 2009
Senate committee pushes 12-year bio patent limit
By Mass High Tech staff
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In the midst of the Senate health care reform bill debates, a Congressional provision stands to make or break local biotech companies.
Currently, the FDA regulates how long patents are valid for chemical-based drugs. After the patents expire, cheaper generics can enter the market. But biologics — drugs made out of biological material, such as proteins — do not follow any set regulations. Biotech companies argue there is no way to make a perfect copy of a biologic drug, and until now, there has been no pathway to generics.
This week, the Senate Committee on Health, Education, Labor and Pensions voted to approve a 12-year data exclusivity clause, giving biotechnology companies 12 years of drug patent protection and preventing generic drug makers for 12 years from copying the drugs and selling cheaper versions. Despite President Obama’s backing of a seven-year exclusivity limit, the HELP committee, led by U.S. Sen. Edward M. Kennedy, D-Mass., passed the measure 16 to 7.
Kennedy represents seniors and organized labor seeking cheaper generic drugs, as well as the powerful biotech industry that drives much of the Massachusetts economy. Two years ago, Kennedy pushed for 12 years of patent protection after biologic drugs are approved by the FDA. However, last week, as his committee debated the provision, Kennedy offered a different amendment from his original proposal that some biotech companies could see as unfavorable in its protection.
In another twist to the Congressional debates, North Carolina Democratic Sen. Kay Hagan, along with two other senators, offered an amendment with the original 12 years of patent protection — an amendment that Kennedy ultimately voted for. North Carolina, like Massachusetts, houses a strong biotechnology industry.
Robert Coughlin, president and CEO of the Massachusetts Biotechnology Council, wrote a Mass High Tech editorial piece last week addressing the topic: "Because medical innovation is both risky and expensive, Congress must allow the developers of biologic medicines to protect for at least 12 years the proprietary data used to create the original medicine...Our industry’s success is dependent on continued innovation and a strong record of patient safety. But this simply won’t be possible if Congress creates a pathway for biosimilars — including exciting new therapies emanating from embryonic stem cell research — that erodes patient-safety protections or fails to secure adequate incentives for innovation."
The 12-year patent protection limit awaits approval by the full Senate and House.
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