By Donald Zuhn —
BIO CEO Cites Letters from Patient Groups Supporting Longer Exclusivity Period
Last
week, BIO President and CEO Jim Greenwood (at right) noted that a
number of patient groups had joined BIO in seeking passage of a
follow-on biologics bill providing a minimum of 12 years of data
exclusivity. Mr. Greenwood also provided links to a July 13th letter
sent to Sen. Ted Kennedy (D-MA) by the AIDS Institute, Community Access
National Network, CAEAR Foundation, and National Minority AIDS Council;
a July 16th letter sent to Rep. Anna Eshoo (D-CA) by the ALS
Association; and a July 16th letter sent to Rep. Eshoo by the Alliance
for Aging Research. The AIDS Institute et al. letter states that:
Since
1987, approximately 32 drugs have been developed to treat HIV/AIDS.
These innovations have turned what was once a terminal illness into a
potentially chronic, manageable condition. Technology, research, and
innovation have expanded the horizon of possibilities for saving
lives. . . . All of these life-saving drugs were developed with
private investment and it is our opinion that this was only possible
because pharmaceutical and biotechnology companies were able to recoup
their investment in the extensive clinical research and clinical trials
required to make these drugs available to the people that need them.
As a result, the groups "strongly urge [Congress] to include a period of data exclusivity relative to biologics of 12 years."
The letter
from the ALS Association provides an endorsement for Rep. Eshoo's
follow-on biologics bill (H.R. 1548). (Note: As of Tuesday, Rep.
Eshoo's bill has the backing of 139 co-sponsors to 14 for Rep. Waxman's
competing bill.) The ALS Association also informed Rep. Eshoo that it
backed the follow-on biologics bill that had been adopted by the Senate
HELP Committee earlier this month. The ALS letter contends that "any
biosimilars legislation . . . must foster innovation," and therefore,
the group supports a regulatory pathway providing a 12 year period of
data exclusivity.
Finally, the Alliance for Aging Research also announced its support for the follow-on biologics regulatory pathway being proposed by Rep. Eshoo.
Rhode Island Biotech Supports 12-Year Data Exclusivity Period
On Sunday, The Providence Journal reported on the efforts of the Rhode Island BioGroup and the New England Biotech Association to sway public opinion towards a follow-on biologics regulatory pathway providing 12 years of data exclusivity. As part of those efforts, the two trade groups have been running radio spots and full-page newspaper ads. While noting that the possibility of securing patent protection often gets lost in the discussion about data exclusivity, the article incorrectly reports that "[t]he 20-year clock on a drug patent begins to tick down as soon as a company files with the FDA for approval."
Momenta Pharmaceuticals Supports Shorter Exclusivity Period
Last Friday, Mass High Tech posted an article regarding the decision by Cambridge-based Momenta Pharmaceuticals Inc. to support a shorter data exclusivity period. The biologic drug manufacturer has written to Congress to advocate for shorter protections for biologics. According to the MHT report, Momenta's efforts are related to the company's development of a technology platform it says can help make generic versions of the drugs — the platform provides a series of analytic tools to help determine and reproduce exactly how a biologic was made.
BioWorld Today Columnist Says Exclusivity Issue Is Needlessly Thwarting Debate
Karl Thiel, writing earlier this month in BioWorld Today, argues that the White House proposal of seven years of data exclusivity "seems reasonable" in view of Europe's 8-10 year exclusivity period. Mr. Thiel explains that "we require less exclusivity here because our patent system is stronger and fills the gap more effectively." While acknowledging that he doesn't know "what the right number is," Mr. Thiel says that data exclusivity is "an issue that's frankly been blown out of proportion," since "[e]xclusivity runs concurrent to patent life after all." He adds that "in most cases, it's not going to matter whether it's five or seven or 12 years, because the patent protection will supersede the exclusivity period, at least if you have good lawyers."
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