By
Donald Zuhn —
Earlier
this month, James Love and James Glassman, writing in the Congressional
newspaper Roll Call, expressed "alarm"
regarding recent Congressional action concerning the establishment of a
follow-in biologics (FOB) regulatory pathway ("Don't Kill Competition for High-Tech Drugs"). That action included the recent passage by the House
Committee on Energy and Commerce of a health care reform bill containing a
licensure pathway for biosimilar biological products that would prevent the FDA
from approving a biosimilar application until 12 years after the date on which
the reference product (i.e., the
innovator biologic) was first licensed (see
"House Committee Approves Health Care Reform Bill Calling for 12-Year
Exclusivity Period"),
and prior approval by the Senate Health, Education, Labor and Pensions (HELP) Committee
of an amendment providing a 12-year data exclusivity period for biologic drug
makers (see "Senators Champion
12-Year Data Exclusivity in Senate").
James
Love (at right), the director of the public interest
advocacy group Knowledge Ecology International, and
James Glassman (below left) the former
under secretary of State for public diplomacy and public affairs in the George
W. Bush administration and editor of Roll
Call from 1988-93, contend that passage of FOB provisions by the House
Energy and Commerce and Senate HELP Committees would "make it difficult, if not
impossible, for generic drugs to compete with biologics, even after patents
have expired." The authors
add that these provisions, if reconciled and passed into law, have "the
potential to harm millions of sick people, in the United States and beyond."
Mr.
Love's and Mr. Glassman's assertions are based on a comparison of the predicted
impact of the House and Senate provisions with that of the Hatch-Waxman Act,
which they note provided "streamlined procedures [that] lowered the cost
of entry by generic suppliers and created a highly competitive environment that
has saved consumers billions of dollars." According to the authors, the FOB regulatory pathway
currently being proposed by Congress is "deeply flawed and will reduce, or
even eliminate, potentially significant savings to consumers."
Mr.
Love and Mr. Glassman make it clear that the "flaw" in the process is the
exclusivity period, which unlike the 5-year period for small molecule generics
under Hatch-Waxman, at present stands at 12-years for biogenerics. They state that "[t]he original
proposal for biogenerics would have retained most of the features of the 1984
Hatch-Waxman Act, including the five-year exclusion [i.e., exclusivity period]." However, their assertion is not entirely accurate, since one of the two
House FOB bills introduced last spring (H.R. 1548) called for up to 14.5 years
of exclusivity (see "Second
Follow-on Biologics Bill Is Introduced in House"). It also disregards the White House's
call, in June, for an exclusivity period longer than 5 years (see "White House Recommends 7-Year
Data Exclusivity Period for Follow-on Biologics"). Instead, the authors argue that "after
an intense lobbying campaign by the manufacturers of biologics, new amendments
to the Senate and House versions of the bill made it much more difficult for
makers of generics to enter the market." Again, this statement is somewhat disingenuous in that it
ignores the fact that Rep. Anna Eshoo (D-CA), who helped introduce the 12-year
amendment in the House Energy and Commerce Committee, also introduced H.R. 1548
last spring as well as a similar bill in the last Congress (see "New Follow-on Biologics Bill
Introduced in the House"). Thus, Rep. Eshoo did not succumb to
"an intense lobbying campaign" in introducing the amendment, but
rather has been pushing for a double-digit exclusivity period since March of
2008. (In fact, in proposing a
12-year period, Rep. Eshoo actually backed off the longer period she had
been seeking.)
Noting
that "Members of Congress from both parties have claimed that long
monopolies are needed to stimulate investments in research and
development," the authors declare their strong disagreement with this
position. Although they
acknowledge that developmental costs for new biologics are "undoubtedly
expensive," they contend that "this is just as true for products that
the FDA classifies as 'small-molecule,' or conventional, drugs as it is for
biologics." Mr. Love and Mr.
Glassman also argue that "innovation has prospered under the Hatch-Waxman
regime." Biologic manufacturers,
however, would likely disagree with these assertions, and Amgen Inc. Vice
President and Law & Intellectual Property Officer Stuart Watt did just that
last March in a presentation at the Biotechnology Industry Organization (BIO)
Intellectual Property Counsels' Committee (IPCC) conference (see "Amgen VP Makes Case for Longer
Exclusivity Period in Follow-on Biologics Legislation").
Mr.
Love and Mr. Glassman conclude their article by noting that while Article I,
Section 8, Clause 8 of the Constitution confers upon Congress the power
"[t]o promote the Progress of Science and useful Arts, by securing for
limited Times to Authors and Inventors the exclusive Right to their respective
Writings and Discoveries," the Founders "understood the need for
balance in creating monopolies that were temporary" — i.e., which existed for limited times. The authors state that "[e]ndless monopolies,
particularly those created by regulatory measures, must be avoided,"
concluding that "a 12-year exclusion simply does not meet the test of
logic."
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