By
Donald Zuhn —

Over
the past twelve months, Patent Docs
has reported on a number of papers, letters, and statements that outline
positions taken by various players in the follow-on biologics (FOB) data
exclusivity debate.  In view of the
recent Time magazine article
"How Drug-Industry Lobbyists Got Their Way on Health Care," which
mentions that Duke University Prof. Henry Grabowski's oft-cited data
exclusivity study was funded by the Pharmaceutical Research and Manufacturers
of America (PhRMA) and two partisan patient groups (see "Time Magazine on Data Exclusivity Debate"),
a review of these players and their positions on the issue seems
appropriate.  Last week, we
summarized the positions of seventeen individuals or groups that have
participated in the debate (see
"Follow-on Biologics Data Exclusivity Debate Scorecard" – Part I
and Part II).  Today, we examine the positions of
another eleven participants in the debate.  Among those who have advocated for shorter data exclusivity
periods (i.e., less than 8 years)
are:

•
Alfred Engelberg, a New York patent attorney who represented the Generic
Pharmaceutical Industry Association and played a role in the passage of the
Hatch-Waxman Act in 1984; Dr. Aaron Kesselheim, a patent attorney and
Instructor in Medicine at the Harvard Medical School; and Dr. Jerry Avorn, a
Professor of Medicine at the Harvard Medical School, who published an article
in the New England Journal of Medicine
contending that FOB legislation being proposed in the House and Senate, which
provides 12 years of data exclusivity, would "upset[] the delicate balance
between the interests of consumers and those of innovators" (see "NEJM Authors Say Five Years of
Data Exclusivity Would Be Sufficient").  The authors also argue that
"[e]ven if the new legislation is adopted, manufacturers of potential
follow-on products would probably prefer to ignore the new pathway and opt to
file a standard BLA, which would not be subject to the 12-year delay," and
therefore contend that "as currently fashioned, the biosimilar legislation
would have no value, because it would create a pathway that would scarcely be
used."  The authors therefore suggest
that the legislation currently being proposed in the House and Senate be
amended to "give the FDA the mandate to evaluate and approve biosimilar
drugs in a reasonable period, starting, as with small-molecule products, 5
years after the approval of the original drug."

•
James Love, the director of the public interest advocacy group Knowledge
Ecology International; and James Glassman, the former under secretary of State
for public diplomacy and public affairs in the George W. Bush administration,
who authored an article in the Congressional newspaper Roll Call expressing "alarm" regarding Congressional
action to establish a follow-in biologics (FOB) regulatory
pathway, and contending 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" (see "Roll
Call Authors Unite against Current Follow Biologics Legislation").  The authors 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]," and assert 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."

•
Momenta Pharmaceuticals Inc., which issued a statement supporting a shorter
data exclusivity period (see "Follow-on
Biologics News Briefs – No. 6").  The Cambridge-based company, which is
developing a technology platform that provides a series of analytic tools to
help determine and reproduce exactly how a biologic drug was made, did not specify
the particular data exclusivity period that it was seeking.

Among
those who have advocated for longer data exclusivity periods (i.e., 10 or more years) are:

•
The AIDS Institute, Community Access National Network, CAEAR Foundation, and
National Minority AIDS Council, which sent a letter to Sen. Ted Kennedy in July
noting that approximately 32 HIV/AIDS drugs had been developed since 1987, and
opining that "[a]ll of these life-saving drugs were developed with private
investment [that] 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" (see
"Follow-on Biologics News Briefs – No. 6").  The signatories to this letter
therefore "strongly urge [Congress] to include a period of data
exclusivity relative to biologics of 12 years."

•
The Alliance for Aging Research, which sent a letter to Rep. Anna Eshoo (D-CA) announcing
its support for Rep. Eshoo's FOB bill — which would have provided up to 14.5
years of data exclusivity (see "Follow-on
Biologics News Briefs – No. 6").

•
The ALS Association, which also sent a letter to Rep. Eshoo arguing that
"any biosimilars legislation . . . must foster innovation," and
therefore supporting a regulatory pathway providing a 12 year period of data
exclusivity (see "Follow-on
Biologics News Briefs – No. 6").

•
The California Healthcare Institute (CHI), an independent organization
comprising more than 250 biomedical companies and academic and research
institutions involved in researching and advocating policy to forward the
interests of California's biomedical community, which issued a statement
"support[ing] the development of a science-based biosimilars approval
pathway that employs the best science to make sure that products are safe for
patients, that encourages price competition among manufacturers, and provides
ample incentives to encourage continued private-sector investment in the next
generation of breakthroughs," and stating that it was "pleased" that Congressional legislation would "provide[] for 12 years of data exclusivity"
(see "Follow-on Biologics News
Briefs – No. 7").

•
Governors Deval Patrick of Massachusetts, M. Jodi Rell of Connecticut, Bill
Ritter, Jr. of Colorado, John Markell of Delaware, Martin O'Malley of Maryland,
Beverly Perdue of North Carolina, Theodore Kulongoski of Oregon, Donald Carcieri
of Rhode Island, Luis Fortuño of Puerto Rico, and Christine Gregoire of
Washington, who sent a letter to Speaker of the House Nancy Pelosi (D-CA),
House minority leader John Boehner (R-OH), Senate majority leader Harry Reid
(D-NV), and Senate minority leader Mitch McConnell (R-KY) stating that
"the balance struck in the Senate Health, Education, Labor and Pensions
Committee on 12 years of data exclusivity for biologics represents a critical
element needed to ensure appropriate incentives for continued biomedical
innovation" (see "Governors
Send Letter to Congressional Leaders in Support of 12-Year Data Exclusivity
Period").  In their letter, the Governors assert that "[i]nnovator companies
must be provided with at least 12 years of non-patent data exclusivity to allow
for recovery of their original investment and to ensure licensing payments to
our research institutions."  Governors Patrick, Ritter, Markell,
O'Malley, Perdue, Kulongoski, and Gregoire are Democrats, and Governors Rell,
Carcieri, and Fortuño are Republicans — Gov. Fortuño is also a member of the
New Progressive Party of Puerto Rico.

•
Dr.
Henry Grabowski (at right), a Professor of Economics at The Fuqua School of Business at
Duke University, who published a paper in Nature
Reviews Drug Discovery, in which he determined that the "break
even" point for biologic drugs requires a data exclusivity period from
between 12.9 and 16.2 years (see
"Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on
Biologic Drugs").  In his paper, Dr. Grabowski cautions
that the discount rates used to calculate the break even periods are
conservative and that "smaller publicly listed biotechnology companies and
non-listed private biotechnology firms would generally have a much higher cost
of capital," suggesting that the actual "break even" point may
require even longer data exclusivity periods.  As noted above, Dr. Grabowski's study was funded in part by
the Pharmaceutical Research and Manufacturers of America (PhRMA).

•
The Rhode Island BioGroup and the New England Biotech Association, which ran
radio spots and full-page newspaper ads supporting an FOB regulatory pathway
providing 12 years of data exclusivity (see
"Follow-on Biologics News Briefs – No. 6").

In addition to the above advocates, at least one other group has addressed the
data exclusivity issue without taking a position on an appropriate
exclusivity period:

•
Deloitte Consulting LLP, which published a paper assessing the differences
between the small molecule pharma industry, which was a stable and mature in
1984 when Hatch-Waxman was implemented, and the biotech industry, which is
nascent and complex (both scientifically and financially), and concluding that
"[i]n establishing a path to market for follow-on biologics, Congress may
need to employ a different set of levers to achieve the same results" (see "Deloitte White Paper Addresses
Unintended Consequences of Follow-on Biologic Regulatory Pathway").  The Deloitte paper, which was authored
by Jim Hollingshead and Rob Jacoby, suggests that an FOB regulatory pathway
patterned too closely on the Hatch-Waxman regime would likely have unintended,
and potentially adverse, consequences for the biotech industry.

In
summary, the following advocates support "shorter" data exclusivity
periods:

•
Federal Trade Commission — 0 years
•
Alfred Engelberg, Dr. Aaron Kesselheim, and Dr. Jerry Avorn (NEJM authors) — 5 years
•
Dr. Laurence J. Kotlikoff — 5 years
•
James Love and James Glassman (Roll Call
authors) — 5 years
•
National Coalition on Health Care — 5 years
•
AARP — 5.5 years
•
Alex Brill — 7 years
•
Office of Management and Budget — 7 years
•
Momenta Pharmaceuticals Inc. — undefined

And
the following advocates support "longer" data exclusivity periods:

•
AIDS Institute, Community Access National Network, CAEAR Foundation, and
National Minority AIDS Council — 12 years
•
ALS Association — 12 years
•
California Healthcare Institute — 12 years
•
Governors Deval Patrick, M. Jodi Rell, Bill Ritter, Jr., John Markell, Martin O'Malley,
Beverly Perdue, Theodore Kulongoski, Donald Carcieri, Luis Fortuño, and Christine
Gregoire — 12 years
•
National Venture Capital Association — 12 years
•
Pharmaceutical Research and Manufacturers of America — 12 years
•
Rhode Island BioGroup and New England Biotech Association — 12 years
•
Senators Orrin Hatch (R-UT), Barbara Mikulski (D-MD), Michael Enzi (R-WY), and
Kay Hagan (D-NC) — 12 years
•
Stuart Watt (Amgen Inc.) — 12 years
•
Dr. John Calfee (American Enterprise Institute) — 12 to 14 years (period
mentioned but not specifically endorsed)
•
Dr. Henry Grabowski — 12.9 and 16.2 years
•
Biotechnology Industry Organization — 14 years
•
Andrew Grossman (Heritage Foundation) — 14 years (period mentioned but not
specifically endorsed)
•
Intellectual Property Owners Association — 14 years
•
Audrey Philips (Johnson & Johnson) — 14 years
•
Alliance for Aging Research — 14.5 years
•
Dr. Howard Dean (Democratic National Committee) — 14.5 years
•
Robert Armitage (Eli Lilly) – 15-20 years

Readers
are encouraged to review our prior coverage of the papers and letters described
in this series.  Patent Docs will continue to update the
list of data exclusivity debate participants — on both sides of the issue —
as additional players make their positions known.