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.

    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 data exclusivity
debate.  In view of last week's 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.  Yesterday, we
summarized the positions of ten individuals or groups that have participated in
the debate (see "Follow-on
Biologics Data Exclusivity Debate Scorecard – Part I").  Today, we examine the positions of
another seven participants in the debate. 
Among those who have advocated for shorter data exclusivity periods (i.e., less than 8 years) are:

•
The AARP, which sent a letter to members of Congress stating that "there
is little to support" the argument that legislation providing up to 5.5
years of data exclusivity "would undermine [the biotech/pharma industry's]
ability to recoup the costs of drug development" (see "BIO CEO Provides Update on Follow-on Biologics
Legislation").  In addition, the organization's letter
asserted that "based on U.S. drug sales alone, many top selling biologics
have recouped their manufacturer’s initial investment several times over in the
last six years — often within a single year."

•
The Federal Trade Commission (FTC), which issued a report on follow-on
biologics stating that a 12-14 year data exclusivity period was not necessary
to promote innovation by pioneer biologics companies (see "No One
Seems Happy with Follow-on Biologics According to the FTC").  The FTC report opines that data
exclusivity would be in addition to the incentives provided by patent
protection and market-based pricing, and thus data exclusivity would provide no
additional incentives to developing biologics drugs.

•
The Office of Management and Budget (OMB), which sent a letter to Rep. Henry
Waxman (D-CA), the Chairman of the House Energy and Commerce Committee, stating
that a follow-on biologics regulatory pathway providing a 7-year data
exclusivity period would "strike[] the appropriate balance between
innovation and competition" (see
"White House Recommends 7-Year Data Exclusivity Period for Follow-on
Biologics").  The OMB letter was was signed by Peter
Orszag, Director of the OMB, and Nancy-Ann DeParle, director of the Office of
Health Reform.

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

•
Dr. John Calfee (at right) of the American Enterprise Institute for Public Policy
Research (AEI), who wrote a white paper indicating that longer data exclusivity
periods would provide the more prudent approach to the regulation of follow-on
biologics (see "AEI Believes
Advantages of Longer Data Exclusivity Period Outweigh Disadvantages").  In his paper, Mr. Calfee stated that "[g]iven
the stakes — a substantial amount of future R&D hangs in the balance —
Congress should exercise an abundance of caution in designing follow-on
biologic legislation so as not to endanger valuable future research," and
concluded that "the social losses from providing for fairly long exclusivity
periods (twelve to fourteen years) would be small compared to what are likely
to be substantial social gains from exclusivity."

•
Democratic National Committee chairman Dr. Howard Dean (at right), who wrote an Op-Ed
piece in The Hill backing legislation
that would provide up to 14.5 years of data exclusivity (see "BIO CEO Provides Update on Follow-on Biologics
Legislation").  Dr. Dean argued that:

A
commonsense and fair approach, similar to the process and timeline currently in
place for generic versions of chemical-based medicines, would allow the
original developer of the biologic to protect the proprietary data used to
develop the medicine for at least 12 years.  A shorter exclusivity period would prematurely rob biotech
innovators of their intellectual property and destroy incentives to develop new
cures.  Most firms would be unable
to recoup their investments in new medicines, which ordinarily top $1 billion and
involve 15 years of research and development.  If we discourage investment, we jeopardize the development
of the next generation of breakthrough medicines and cures.

•
The
Pharmaceutical Research and Manufacturers of America (PhRMA), which issued a
statement warning that "[g]iving short shrift to incentives for innovation
would grind to a halt uniquely American innovation, moving critically important
R&D — and tens of thousands of U.S jobs – overseas," and stating that
"[e]conomists and the venture capitalists whose private investments shore
up this vital, yet vulnerable sector agree:  12 years of data protection, at a bare minimum, are needed
to help recoup the significant development costs for biologic innovators"
(see "PhRMA Supports Follow-on
Biologics Regulatory Pathway Providing 12-Years of Data Exclusivity").  The advocacy group representing
pharmaceutical and biotechnology research companies noted that
"[c]ompanies could still seek approval of competing biologics using their
own data, but for those 12 years no biosimilar competitor could rely on
innovators’ hard–earned data, collected during development that may span a
decade, or more, to seek approval."

•
Senators Orrin Hatch (R-UT), Barbara Mikulski (D-MD), Michael Enzi (R-WY), and
Kay Hagan (D-NC), who wrote a letter to Senate majority leader Harry Reid
(D-NV) noting that "[m]ore than 150 patient groups, research universities,
local chambers of commerce, venture capital groups, and innovators have
expressed strongly that a base 12 years of data exclusivity is crucial to
ensure continued growth in the biotechnology industry and future discoveries
that will make a difference in the lives of millions of patients," and urging
the majority leader "to support the enactment of a pathway for the
approval of biosimilars with a base 12·year period of data exclusivity for
innovator biotechnology companies" (see
"Four Senators Write in Support of 12-Year Data Exclusivity Period").

Readers
are encouraged to review our prior coverage of the papers and letters described
above.

    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 data exclusivity debate.  In view of last week's 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 timely.  Today, we summarize
the positions of ten individuals or groups that have participated in the
debate.  Among those who have advocated
for shorter data exclusivity periods (i.e.,
less than 8 years) are:

•
Alex Brill (at right), a principal at Matrix Global Advisors, LLC and former chief
economist to the House Ways and Means Committee, who released a white paper entitled
"Proper Duration of Data Exclusivity for Generic Biologics:  A Critique," which asserts that a
follow-on biologics regulatory pathway providing a data exclusivity period of
seven years would be "sufficient for maintaining strong incentives to
innovate while fostering a competitive marketplace" (see "Former
House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is
Sufficient").  The paper, which was
funded by Teva Pharmaceuticals, finds fault with some aspects of an economic
model described by Duke University economist Henry Grabowski in a paper
published in Nature Reviews Drug
Discovery, and specifically determines that a biologic's
"break-even" point (i.e.,
"the number of years required for an average portfolio of biologic drug
investments to recoup all development and fixed production costs and to also
reward the investors their expected (double-digit) rate of return") is
just under 9 years — as opposed to Prof. Grawbowski's calculation of between
12.9 and 16.2 years.

•
Dr. Laurence J. Kotlikoff (at right), a professor of economics at Boston University, who authored
a report entitled "Stimulating Innovation in the Biologics Industry:  A Balanced Approach to Marketing
Exclusivity," which contends that Congress should look to the Hatch-Waxman
model (which generally provides four years of data exclusivity and one year of
approval exclusivity) when determining an appropriate exclusivity period (see "BU Economics Professor
Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation").  The report, which was funded by Teva
Pharmaceuticals USA, concludes that "[t]here are, quite simply, no
compelling differences between the chemical-based and protein-based medication
industries to justify deviating from a policy [embodied in the Hatch-Waxman
Act] that has succeeded for over a quarter of a century in both dramatically
reducing drug prices and stimulating innovation."

• The National Coalition on Health Care (NCHC),
which describes itself as a non-profit and "rigorously non-partisan"
coalition comprised of more than 70 organizations, and which wrote a letter to the Senate
Health Committee urging it "to oppose generic biologics legislation that
contains excessive periods of exclusivity or that contains other unnecessary
and significant barriers to generic, biologic competition."  The group concluded that "[t]he
five year period of exclusivity provided in [Rep. Waxman's biosimilar bill]
follows the Hatch-Waxman model and is the appropriate period of
exclusivity," and suggested that "[a]n unnecessarily long period of
exclusivity would . . . diminish the incentives for other companies to continue
innovating, actually resulting in less innovation over time." (see "NCHC Sends Letter on
Biosimilars to Senate Health Committee").

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

•
Amgen Inc. Vice President and Law & Intellectual Property Officer Stuart
Watt, who told attendees of the Biotechnology Industry Organization (BIO)
Intellectual Property Counsels' Committee (IPCC) conference in March 2009 that
an exclusivity period of at least 12 years is needed to provide incentives to
innovator drug companies to continue developing new biologic drugs (see "Amgen VP Makes Case for Longer
Exclusivity Period in Follow-on Biologics Legislation").  In support of a 12-year
exclusivity period, Mr. Watt pointed to three factors:  the research and development costs for
bringing a biologic drug to market ($1 billion), the average product
development time (12-15 years), and the product development risk (1 out of 100
candidates).

•
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood (at right), who stated
that BIO supports a 14-year exclusivity period, noting that while "[l]ots
of folks in the generic industry think it should be less," BIO was
concerned that "if the industry does not have enough time to recover its
investments, those investments will never be made" (see "BIO CEO Outlines Challenges for Obama Administration").

•
Eli Lilly and
Company Senior Vice President and General Counsel Robert Armitage (at right), who stated In an interview with the Washington Legal Foundation (WLF) that "Lilly
has been adamant that a period of data exclusivity of 15-20 years for
innovative products would represent the best policy choice for overall patient
welfare," and further, that a 5-year or 10-year period of data exclusivity did not
"make sense" in view of the safety hurdles and small number of new
medicines coming to market (see
"Washington Legal Foundation 'Conversations With' Series
Examines IP Issues").

•
In a paper primarily concerned with patent reform (as evidenced by its
title: "Promoting Innovation
with Patent Reform: A Memo to President-elect Obama"), Senior Legal Policy
Analyst Andrew Grossman (at right) of The Heritage Foundation also touched on the issue of
data exclusivity under a follow-on biologics regulatory pathway (see "Heritage Foundation Offers
Patent Reform Proposals to the New President").  Stating that "[w]ithout adequate
data exclusivity, innovation in the biotech sector will dry up, leading to
fewer lifesaving treatments and eroding America's leadership in this
field," Mr. Grossman advised against "[i]mposing a short exclusivity
period or otherwise limiting enforcement of biologic patents."  While exclusivity periods of between
0-14 years had been proposed in various follow-on biologics bills introduced in
the House and Senate at the time of the publication, the Heritage Foundation paper only mentions the 14-year
period.

•
The Intellectual Property Owners Association (IPO) Board, which passed a resolution
during its 2008 Annual Meeting supporting biosimilar legislation that would "promote[]
continued innovation by providing at least 14 years of data exclusivity for an
innovator’s biological product with additional periods of exclusivity available
for new indications and/or for approval for use in the pediatric population (see "Follow-on Biologics News
Briefs – No. 1").

•
Johnson & Johnson executive director for biotechnology policy Audrey
Philips, who contended that follow-on biologics legislation should strike "the
right balance between saving money and still having medicines to advance in the
future," and concluded that a 5-year exclusivity period would
"certainly have a chilling effect on [biotech] investment" (see
"Follow-on Biologics News Briefs – No. 3").  Instead, Ms. Philips argued for a 14-year
exclusivity period.

•
The National Venture Capital Association (NVCA), which released the results of a
study conducted by Iain Cockburn, Professor of Finance and Economics at
the Boston University School of Management, and Josh Lerner, Professor of
Investment Banking at the Harvard University School of Business, suggesting
that "a data exclusivity period of at least 12 years for innovator
products is a critical fulcrum in the effort to balance cost with the preservation
of biotech innovation" (see
"NVCA Study Supports 12-Year Data Exclusivity Period").  In particular, the NVCA concludes that
"the exclusivity period should be at least 12 years so that investors in
innovation can exceed the [cost of capital] hurdle rate," and states that
a 7-year data exclusivity period "would not be long enough to clear the
20% hurdle rate for investing in early stage companies," and would
"drastically reduce such investments and thwart future innovation in a
meaningful way."

Readers
are encouraged to review our prior, more detailed coverage of the paper, letters, and statements described
above.

    By
Donald Zuhn ––

A
report in last week's Time magazine focuses
on the ongoing debate over "an obscure but crucial health-care provision":  follow-on biologics data exclusivity —
the period of time that generic biologic manufacturers would have to wait
before they are allowed to use an innovator's data to secure FDA approval for
their generic biologics, or biosimilars, under a follow-on biologics regulatory
pathway.  The article, entitled
"How Drug-Industry Lobbyists Got Their Way on Health Care,"
examines the reasons behind the passage, by the House Committee on Energy and
Commerce, of a health care reform amendment that would prevent the FDA from
approving a biosimilar application until 12 years after the date on which the
reference product — the innovator biologic — was first licensed (see "House Committee Approves
Health Care Reform Bill Calling for 12-Year Exclusivity Period").  (The Senate Health, Education, Labor
and Pensions (HELP) Committee has approved a similar amendment; see "Senators Champion 12-Year Data
Exclusivity in Senate.")

The
Time article nicely characterizes the
dilemma facing both the House and Senate on the data exclusivity issue, stating that
legislators are trying to balance the need "to foster cost-saving
competition without killing the financial incentives that have put the U.S.
biotechnology industry at the vanguard of medical science and without stifling
the development of even more drugs that could save lives and eliminate
suffering."  However, while acknowledging
the adverse consequences that might result if Congress chooses the
"wrong" data exclusivity period, the article seems to side with Rep.
Henry Waxman (D-CA), who favors a 5-year data exclusivity period, and the generic
drug manufacturers rather than with innovator companies and their army of lobbyists.  With respect
to the passage of a 12-year data exclusivity period by the House Committee on
Energy and Commerce — a Committee chaired by Rep. Waxman — the article argues
that "Waxman's loss . . . was a big victory for drug companies, which have
spent more than any other segment of the medical industry to make sure that
they come out winners in the effort to overhaul the nation's health-care
system."  The article notes
that biotech/pharma companies and their trade associations utilized 1,288
lobbyists and spent more than $110 million in the first six months of the year lobbying
lawmakers.  In a paragraph at the
end of the article, Teva Pharmaceutials' expenditure of $2 million on lobbying
is mentioned, but lobbying efforts by the rest of the generic industry or its
trade associations (such as the Generic Pharmaceutical Association, where Rep.
Waxman spoke on September 18th and back in February; see "Congressman Waxman Tells GPhA Meeting that Hatch-Waxman
Model Will Work for Follow-on Biologics")
are not explored.

In
addition to Rep. Waxman's call for a 5-year data exclusivity period, the
article discusses the Obama Administration's support for a 7-year period (see "White House Recommends 7-Year
Data Exclusivity Period for Follow-on Biologics")
and the FTC's support for no data exclusivity period (see "No One Seems Happy with Follow-on Biologics According to
the FTC").  The article also
mentions the study conducted by Duke University Prof. Henry Grabowski (see "Professor Grabowski's Economic
Analysis of Data Exclusivity for Follow-on Biologic Drugs"), which is frequently
cited in support of double-digit exclusivity periods, but notes that Prof.
Grabowski's study was funded by the Pharmaceutical Research and Manufacturers
of America (PhRMA) and two patient groups:

One,
called RetireSafe, receives regular infusions of "general operating
support" from Pfizer and operates out of a small Washington law-firm
office.  . . .  The other group, the Alliance of Aging
Research, is also run by the drug industry. Its chairman is the managing
partner of Foxkiser, a drug-company consultant, and its vice chairman is with
Novartis.

The
Time article does not mention,
however, that Prof. Grawbowski's study remains the only peer-reviewed analysis
of the topic.