[Congressional Record Volume 152, Number 133 (Wednesday, December 6, 2006)]
[House]
[Pages H8813-H8818]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
VESSEL HULL DESIGN PROTECTION AMENDMENTS OF 2006
Mr. SENSENBRENNER. Mr. Speaker, I move to suspend the rules and pass
the Senate bill (S. 1785) to amend chapter 13 of title 17, United
States Code (relating to the vessel hull design protection), to clarify
the distinction between a hull and a deck, to provide factors for the
determination of the protectability of a revised design, to provide
guidance for assessments of substantial similarity, and for other
purposes, as amended.
The Clerk read as follows:
S. 1785
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Table of contents.
TITLE I--VESSEL HULL DESIGN PROTECTION
Sec. 101. Short title.
Sec. 102. Designs protected.
Sec. 103. Definitions.
TITLE II--INTELLECTUAL PROPERTY PROVISIONS
Sec. 201. Sense of Congress relating to Bayh-Dole Act.
Sec. 202. Filing of applications for extensions of a patent term.
TITLE I--VESSEL HULL DESIGN PROTECTION
SEC. 101. SHORT TITLE.
This title may be cited as the ``Vessel Hull Design
Protection Amendments of 2006''.
SEC. 102. DESIGNS PROTECTED.
Section 1301(a) of title 17, United States Code, is
amended by striking paragraph (2) and inserting the
following:
``(2) Vessel features.--The design of a vessel hull or
deck, including a plug or mold, is subject to protection
under this chapter, notwithstanding section 1302(4).''.
SEC. 103. DEFINITIONS.
Section 1301(b) of title 17, United States Code, is
amended--
(1) in paragraph (2), by striking ``vessel hull, including
a plug or mold,'' and inserting ``vessel hull or deck,
including a plug or mold,'';
(2) by striking paragraph (4) and inserting the following:
``(4) A `hull' is the exterior frame or body of a vessel,
exclusive of the deck, superstructure, masts, sails, yards,
rigging, hardware, fixtures, and other attachments.''; and
(3) by adding at the end the following:
``(7) A `deck' is the horizontal surface of a vessel that
covers the hull, including exterior cabin and cockpit
surfaces, and exclusive of masts, sails, yards, rigging,
hardware, fixtures, and other attachments.''.
[[Page H8814]]
TITLE II--INTELLECTUAL PROPERTY PROVISIONS
SEC. 201. SENSE OF CONGRESS RELATING TO BAYH-DOLE ACT.
(a) Findings.--The Congress finds the following:
(1) Article I, section 8, clause 8, of the United States
Constitution provides that Congress shall have 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''.
(2) The 96th Congress enacted Public Law 96-517, entitled
``An Act to amend the patent and trademark laws'' (commonly
known as the ``Bayh-Dole Act'', in honor of its two lead
sponsors in the Senate, the Honorable Birch Bayh and the
Honorable Bob Dole), in 1980.
(3) For 15 to 20 years before the enactment of the Bayh-
Dole Act, Members of Congress considered, discussed, and
deliberated on the proper resolution of issues implicated by
the Act.
(4) Before the enactment of the Bayh-Dole Act, the United
States was confronted by great economic uncertainty and
presented with unprecedented new challenges from foreign
industrial competition.
(5) Before 1980, only 5 percent of patents owned by the
Federal Government were used by the private sector--a
situation that resulted in the American people being denied
the benefits of further development, disclosure,
exploitation, and commercialization of the Government's
patent portfolio.
(6) The Bayh-Dole Act established a ``single, uniform
national policy designed to . . . encourage private industry
to utilize government financed inventions through the
commitment of the risk capital necessary to develop such
inventions to the point of commercial application'', and
eliminated the 26 different Federal agency policies that had
existed regarding the use of the results of federally funded
research and development.
(7) The Bayh-Dole Act fundamentally changed the Federal
Government's patent policies by enabling inventors or their
employers to retain patent rights in inventions developed as
part of federally funded research grants, thereby promoting
licensing and the leveraging of contributions by the private
sector towards applied research, and facilitating the
transfer of technology from the laboratory bench to the
marketplace.
(8) Examples of the tangible products and technologies that
have resulted from the Bayh-Dole Act include, inter alia, an
improved method for preserving organs for transplant, a
lithography system to enable the manufacture of nano-scale
devices, the development of new chemotherapeutic agents, the
discovery of new therapies for the treatment of patients
diagnosed with rheumatoid arthritis, and countless other
advances in materials, electronics, energy, environmental
protection, and information technologies.
(9) These new therapies, technologies, and inventions,
which have resulted from the collaborative environment
fostered by the Bayh-Dole Act, have directly contributed to
the ability of medical researchers to discover and
commercialize new treatments that alleviate patient
suffering, enhance the ability of doctors to diagnose and
treat disease, and target promising new medical research.
(10) The Bayh-Dole Act has stimulated two of the major
contemporary scientific trends of the last quarter century--
the development of the biotechnology and information
communications industries--and the Act is poised to continue
playing a central role in new fields of innovative
activities, including nanotechnology.
(11) The Bayh-Dole Act has resulted in benefitting
taxpayers by generating millions of dollars in annual
licensing royalties for universities and nonprofit
institutions--revenues that are reinvested in furtherance of
additional research and education programs.
(12) The incentives provided under the Act and the exchange
of technology and research between and among the research
community, small businesses, and industry, have resulted in
new cooperative ventures and the emergence of sophisticated
high-technology businesses, which provide a major catalyst
for innovation and entrepreneurial activity.
(13) More than 4,000 new companies have been created to
develop and market academic research and development since
1980, and it is estimated that nearly 2300 of these companies
were still in operation at the end of fiscal year 2003.
(14) Lita Nelsen, director of the Technology Licensing
Office at the Massachusetts Institute of Technology, has
described the Bayh-Dole Act as ``one of the most successful
pieces of economic development and job-creation legislation
in recent history''.
(15) The Bayh-Dole Act was described in a 2002 article in
The Economist (US) as ``[p]ossibly the most inspired piece of
legislation to be enacted in America over the past half-
century. . . . More than anything, this single policy measure
helped to reverse America's precipitous slide into industrial
irrelevance''.
(16) The Government Accountability Office (GAO) found that
university administrators and small business representatives
considered the Bayh-Dole Act to have had ``a significant
impact on their research and innovation efforts''.
(17) A study of business executives found that 9 out of 10
identified the Bayh-Dole Act as an ``important factor'' in
decisions to fund research and development in academia.
(18) Howard Bremer, who served as patent counsel to the
Wisconsin Alumni Research Foundation from 1960 to 1988, once
observed that, ``[o]ne important factor . . . is that the
success was achieved without cost to the taxpayer. In other
words, no separate appropriation of government funds was
needed to establish or manage the effort''.
(19) A 1998 GAO study found that the law had a positive
impact on all involved and that the increased
commercialization of federally funded research that resulted
from implementation of the Act had positively affected both
the Federal Government and the American people.
(20) The President's Council of Advisors on Science and
Technology reported to the President in May 2003 that the Act
``dramatically improved the nation's ability to move ideas
from research and development to the marketplace and into
commerce'' and that the system put in place for transferring
technology from nonprofit institutions, which includes
universities and Government laboratories, to the private
sector has worked well.
(21) The Bayh-Dole Act states, ``[i]t is the policy and
objective of the Congress to promote the utilization of
inventions arising from federally-supported research or
development; . . . to promote collaboration between
commercial concerns and nonprofit organizations, including
universities; . . . to promote the commercialization and
public availability of inventions made in the United States
by United States industry and labor; [and] to ensure that the
Government obtains sufficient rights in federally-supported
inventions to meet the needs of the Government and protect
the public against nonuse or unreasonable use of
inventions''.
(22) The Congress finds that the policies and objectives of
the Bayh-Dole Act have been achieved and that the patent law
has played a critical role in stimulating technological
advances and disclosing useful technical information to the
public.
(23) The Congress finds that federally-funded research at
universities and Government laboratories and the partnerships
between such nonprofit institutions and the private sector
play a critical role in developing the technologies that
allow the United States to lead the world in innovation.
(24) The Bayh-Dole Act and its subsequent amendments, which
include the Trademark Clarification Act of 1984 (Public Law
98-620), have played a vital role in enabling the United
States to become renowned as the world leader in scientific
research, innovation, ingenuity, and collaborative research
that involves institutions of higher education and the
private sector.
(b) Sense of Congress.--It is the sense of Congress that--
(1) the Bayh-Dole Act (Public Law 96-517) has made
substantial contributions to the advancement of scientific
and technological knowledge, fostered dramatic improvements
in public health and safety, strengthened the higher
education system in the United States, served as a catalyst
for the development of new domestic industries that have
created tens of thousands of new jobs for American citizens,
strengthened States and local communities across the country,
and benefitted the economic and trade policies of the United
States; and
(2) it is appropriate that the Congress reaffirm its
commitment to the policies and objectives of the Bayh-Dole
Act by acknowledging its contributions and commemorating the
silver anniversary of its enactment.
SEC. 202. FILING OF APPLICATIONS FOR EXTENSIONS OF A PATENT
TERM.
(a) Findings.--The Congress finds the following:
(1) The Congress historically has provided vigorous support
for innovation in the useful arts by establishing a system of
patent protection for products and processes.
(2) Through section 156 of title 35, United States Code,
the Congress sought to promote the development of innovative
drugs by granting patent term restoration to companies to
recover a portion of the patent term for such drugs that was
consumed during the approval process conducted by the Food
and Drug Administration.
(3) Consistent with the historic purpose of promoting
innovation, patent legislation, and subsequent rules
promulgated by the United States Patent and Trademark Office
(PTO), have routinely given the PTO wide discretion to excuse
late filings and other mistakes that might otherwise result
in the forfeiture of underlying patent rights.
(4) Contrary to this routine practice, however, under
section 156 of title 35, United States Code, the PTO has no
discretion to excuse a filing that is even one day late.
(5) In order to be consistent with the intent of protecting
patent rights and promoting further innovation, the PTO
should be granted limited, circumscribed discretion to
consider patent term restoration applications filed in an
untimely manner.
(b) Filing of Applications.--
(1) In general.--Section 156 of title 35, United States
Code, is amended by adding at the end the following new
subsection:
``(i) Unintentional Delay.--The Director may accept an
application under this section that is filed not later than 5
days after the expiration of the 60-day period provided in
subsection (d)(1) if the applicant files a petition showing,
to the satisfaction of the Director, that the delay in filing
the application was unintentional. Such petition must be
filed with the application in the case of an application
filed on or after the date of the enactment of this
subsection and must be filed not later than 5 days after such
date of
[[Page H8815]]
enactment in the case of an application which, on such date
of enactment, is pending, is the subject of a request for
reconsideration of a denial of a patent term extension under
this section, or has been denied a patent term extension
under this section in a case in which the period for seeking
reconsideration of such denial has not yet expired. The
Director shall make a determination on a petition under this
subsection not later than 30 days after the date on which the
petition is received. If no determination has been made on
the petition within that 30-day period, the petition shall be
deemed to be denied.''.
(2) Revival fees.--Section 41(a)(7) of title 35, United
States Code, is amended--
(A) by striking ``or for an'' and inserting ``for an''; and
(B) by inserting after ``reexamination proceeding,'' the
following: ``or for an unintentionally delayed application
for patent term extension,''.
(3) Effective date.--The amendments made by this section
shall take effect on the date of the enactment of this Act,
and shall apply to any application for patent term extension
under section 156 of title 35, United States Code, which--
(A) is filed on or after the date of the enactment of this
Act; or
(B) on such date of enactment--
(i) is pending;
(ii) is the subject of a request for reconsideration of a
denial of a patent term extension under section 156; or
(iii) has been denied a patent term extension under such
section 156 in a case in which the period for seeking
reconsideration of such denial has not yet expired.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Wisconsin (Mr. Sensenbrenner) and the gentleman from Michigan (Mr.
Conyers) each will control 20 minutes.
The Chair recognizes the gentleman from Wisconsin.
General Leave
Mr. SENSENBRENNER. Mr. Speaker, I ask unanimous consent that all
Members may have 5 legislative days within which to revise and extend
their remarks and include extraneous material on S. 1785 currently
under consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Wisconsin?
There was no objection.
Mr. SENSENBRENNER. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise in support of S. 1785, a bill to amend the Vessel
Hull Design Protection Act. The version before us is the manager's
amendment to the bill. In addition to the vessel hull design
amendments, S. 1785 includes the text of three other intellectual
property bills that have been the focus of considerable bipartisan
discussion and deliberation. These bills are not controversial and
therefore have been included as a part of the manager's amendment.
First, S. 1785 amends the Vessel Hull Design Protection Act by
requiring courts to examine the statutorily protected components of a
vessel, the hull as well as the deck, separately when determining
whether a third party has infringed on a design.
This change responds to a Fifth Circuit Court case which, if allowed
to stand, will render the statute meaningless, thereby encouraging
knock-off artists to sell boats with inferior-designed hulls to
consumers. The Judiciary Subcommittee on the Courts, the Internet, and
Intellectual Property reported this bill favorably to the full
committee on March 1, 2006.
Second, S. 1785 includes the text of House Concurrent Resolution 319,
which commemorates the Bayh-Dole Act on its 25th anniversary. This is
the law that enables inventors to retain their property interest in
patented products that are subsidized by Federal financing. The
concurrent resolution was unanimously approved by the Judiciary
Committee earlier this year.
Third, S. 1785 includes the text of H.R. 5120, a bill that amends
title 35, United States Code, to conform certain filing provisions
within the Patent and Trademark Office. This legislation allows the
director of the PTO to accept a pharmaceutical patent extension request
for not later than 5 days after the current statutory deadline, which
is 60 days from the date that the Food and Drug Administration approves
the drug for use.
The applicant must prove to the director's satisfaction that the
delay in filing was unintentional. In any event, the director retains
the discretion to grant or to deny an extension. It is not automatic.
The Subcommittee on Courts, the Internet, and Intellectual Property
conducted a hearing on H.R. 5120 on September 14.
Finally, S. 1785 includes the text of H.R. 2955, the Intellectual
Property Jurisdiction Clarification Act. This measure responds to a
recent court case by reaffirming the plenary authority of the Federal
Circuit to hear all patent appeals, which was the clear intent of
Congress since the circuit's creation in 1982. This bill was reported
by the Judiciary Committee on April 5 of this year by a voice vote.
Mr. Speaker, S. 1785 incorporates timely bipartisan legislation to
enhance public safety, commemorate the Bayh-Dole Act and make other
needed clarifications and improvements to U.S. intellectual property
law.
I urge my colleagues to support the legislation and send it to the
other body to ensure its timely consideration and passage.
Mr. Speaker, I reserve the balance of my time.
Mr. CONYERS. Mr. Speaker, I am pleased to yield myself as much time
as I may consume.
Mr. Speaker, I rise in support of the legislation consisting of these
intellectual property bills that have been very fully and accurately
described by our Chairman Sensenbrenner.
I rise in support of this legislation, which consists of three
intellectual property bllls.
vessel hull protection
First, the bill amends the Vessel Hull Design Protection Act by
requiring courts to examine the copyright protected components of a
vessel--the hull as well as the deck--separately when determining
whether a third party has infringed a design. This change responds to a
5th Circuit case that would render the statute meaningless, thereby
encouraging knock-off artists to sell boats with inferior designed
hulls to consumers.
Bayh-Dole Resolution
Section 201 of the package consists of H. Con. Res. 319, a resolution
that commemorates the Bayh-Dole Act on its 25th anniversary. The Bayh-
Dole Act, named after Sen. Birch Bayh (D-IN) and Sen. Bob Dole (R-KS),
is the law that enables inventors to retain their property interests in
patented products that are subsidized by federal funding. It is fitting
that we again have senators named Bayh and Dole in the Senate. The
Committee reported this bill favorably in April.
Patent Term Extension Applications
Section 202 consists of the text of H.R. 5120. It permits the
Director of the Patent and Trademark Office to accept late-filed
requests for patent term extension. The applicant must prove that the
delay in filing was unintentional. In addition, the Director retains
the discretion to grant an extension and is not required to issue one.
I urge my colleagues to vote ``yes'' on this legislation.
Mr. Speaker, I am now pleased to recognize the gentleman from Oregon
(Mr. Wu), from the Science Committee, for as much time as he may
consume.
Mr. WU. I thank the ranking member, and I thank the chairman.
Mr. Speaker, I rise in support of section 201 of S. 1785 and, in
particular, its well-deserved commendation of the Bayh-Dole Act of
1980. This act, and its 1984 amendments, were cited by The Economist in
December 14, 2002, as possibly the most inspired piece of legislation
to be enacted in the past half century.
The reasons are apparent if one looks at the revolutionary changes
that began with Bayh-Dole. In 1980, perhaps half a dozen universities
were strongly committed to commercialization of university research
results. Today, it is hard to find a university that does not have a
tech transfer licensing program to take advantage of this legislation.
In the 1970s, we were struggling to keep up with international
competition. Bayh-Dole made research universities a major tool in our
tool box as an antidote to that decline.
Initially, by keeping the intellectual property rights to the ideas
they generated, universities were able to bring in revenues, share with
professor inventors, as industry began to commercialize the fruits of
university research. Some of the inventions in biotechnology and
computer software and hardware by institutions such as the Oregon
Health and Science University, the University of Oregon and Stanford
University, were listed by AUTM, the Association of University
Technology Managers, in the top 100 inventions that changed American
life.
As success has mounted and more and more university professors
thought about the commercial implications of their work, new
opportunities opened
[[Page H8816]]
up for professors. This led to university research centers, research
parks and technology transfer offices, adding many more services as
professors began startup companies. Bayh-Dole is a major reason why
both research universities and small high-tech companies with
university roots are such major drivers of today's American economy.
None of this would have been possible without the cooperation of the
Committee on the Judiciary and its Courts Subcommittee and the
Committee on Science and its Technology Subcommittee, where I am proud
to serve as subcommittee ranking Democratic member.
It is fitting that Chairman Sensenbrenner, who was on both committees
at the time of the 1984 amendments, and who went on to serve as
chairman of both full committees, has chosen to bring this
commemoration forward in a bipartisan manner that involves both
committees.
I thank both gentlemen. I thank him for his continued leadership, and
I look forward to working with him, not only to commend Bayh-Dole
today, but perhaps also to update and improve in the coming years after
a successful quarter century run.
Mr. SENSENBRENNER. Mr. Speaker, I yield 3 minutes to the gentleman
from Tennessee (Mr. Jenkins).
Mr. JENKINS. Thank you, Chairman Sensenbrenner, for yielding this
time.
Mr. Speaker, H.R. 5120, which is incorporated into section 202 of S.
1785 has drawn bipartisan sponsorship from 23 of our colleagues in the
House. I introduced this measure because I believe it is both good
patent policy and sound health care policy.
It corrects an inequity in the patent law and will encourage
important innovation in medical research, precisely the purpose that
Congress sought to accomplish in enacting the Hatch-Waxman Act. In the
patenting process, there are several examples of relief that are
available for late filings, late payments and deficient filings.
By enacting section 202 of S. 1785, we are continuing to promote the
basic purpose of Hatch-Waxman, and we are strengthening Hatch-Waxman.
It is important to do this so that our Nation will continue to lead the
way in medical research, and so that patients will not be denied
promising new innovative developments.
Mr. Speaker, I include for the Record letters from medical
practitioners and consumer groups from across this country supporting
this legislation. Included are letters from the Cleveland Clinic
Foundation Heart Center, the Emory University Healthcare Heart Center,
and the University of California Los Angeles Medical Center Cardiology
Section. Their credentials and their views are impressive. They
emphasize the health care advantages of this measure, particularly its
effect on opening up new advantageous avenues of medical research to
prevent and treat stroke.
The Carlyle Fraser Heart Center
at Crawford Long Hospital,
Athens, GA, June 15, 2006.
Congressman John Lewis,
House of Representatives,
Washington, DC.
Dear Representative Lewis: I received a phone call today
from Clive Meanwell, Chief Executive Officer of The Medicines
Company, regarding H.R. 5120, relating to the patent
restoration provisions of the Hatch-Waxman law. I am the
Director of Interventional Cardiology at Emory Crawford Long
Hospital and have been on the faculty of Emory University
School of Medicine for thirteen years. I am also the
President of the Greater Atlanta Division of the American
Heart Association (AHA), and a medical reporter for FOX-5
television. The major focus of my profession is the care of
patients with advanced and complex cardiovascular disease,
particularly those undergoing interventional procedures
(commonly known as stents) of the arteries of their heart and
elsewhere in the body.
I am writing in support of H.R. 5120 because I understand
that, if it passes, the anticoagulant drug Angiomax may
become eligible for patent term restoration. This would allow
for further investment in clinical development. Angiomax is a
critically important product which is used in the
overwhelming majority (thousands) of the interventional
procedures at Emory. Angiomax is an important therapy because
it provides safe, effective, and cost-effective anti
coagulation during interventional procedures. In addition,
several Emory physicians have performed extensive research on
Angiomax. Emory was one of the leading U.S. centers in a
recent trial studying this product. I am perhaps one of the
Nation's leading experts and researchers in this area and
have lectured internationally and published extensively in
this area. Within the last month, we submitted approximately
twenty individual research abstracts on Angiomax to the
American Heart Association and Transcatheter Cardiovascular
Therapeutics national meetings. Our research shows that
Angiomax provides equal efficacy to other drugs, costs less,
is easier to use, and causes less risk of bleeding
complications. Bleeding complications have been shown to
increase mortality and are particularly common in patients
who are: elderly, female, African-American, and those with
kidney disease, anemia, and high blood pressure. I have
attached two of our abstracts highlighting the consequences
of bleeding complications. These types of patients make up
the majority of the patients at our institution. Better
outcomes and a reduction in healthcare costs with Angiomax is
what we want for the patients of our community.
But that is only part of the story. Patent term restoration
for Angiomax is important because preliminary experience
suggests that Angiomax may be useful in preventing and
treating stroke but more studies are needed. Stroke is the
Nation's number one cause of disability and third leading
cause of death. Over 700,000 Americans suffer strokes each
year--one every 45 seconds; over 165,000 die and many
thousand more are disabled for life. I know that you are
aware that Georgia is part of the high-risk ``stroke belt''.
In my capacity with the AHA, one of our major initiatives is
reducing the risk of stroke. Unfortunately, the blood
thinning and clot-busting agents currently utilized to treat
stroke patients can cause dangerous side effects, including
intracranial bleeds (as was seen so vividly with Israeli
Prime Minister Sharon). Angiomax may be useful in the
prevention and treatment of strokes with fewer bleeding side
effects. But the very costly and time-consuming clinical
trials (which Emory will likely be involved with) which will
be needed to explore this and other promising new uses (such
as patients undergoing open-heart surgery) will not be
feasible unless patent term restoration under the Hatch-
Waxman Act is available to the drug's developer.
It is vital that H.R. 5120 be enacted so that research in
stroke is undertaken to evaluate the use of Angiomax in the
treatment and prevention of this debilitating disease. I
would be happy to discuss this matter further with you at
your convenience.
Very truly yours,
Steven V. Manoukian, M.D.,
Director, Interventional Cardiology, Emory Crawford Long
Hospital, Emory University School of Medicine.
____
The 60 Plus Association,
Arlington, VA, September 13, 2006.
Hon. F. James Sensenbrenner,
Chairman, House Committee on the Judiciary, Washington, DC.
Dear Chairman Sensenbrenner: On behalf of the members of
the 60 Plus Association, I am writing to inform you of our
support for H.R. 5120, a bill to Amend Title 35, United
States Code, To Conform Certain Filing Provisions within the
Patent and Trademark Office. This important legislation would
amend the Hatch-Waxman Act, correcting a disconcerting
irregularity in the Act that hinders drug innovation and
life-saving research.
Patent law is designed to encourage innovation and
advancement. The Hatch-Waxman Act supports this purpose in a
variety of ways including not penalizing the owner of a drug
patent for the time it has to wait for FDA approval. However,
the Act's rigid 60-day deadline for filing an application for
patent term restoration with the Patent and Trademark Office
(PTO) undermines these objectives, as it does not allow the
PTO any discretion to excuse minor mistakes. H.R. 5120 would
provide the PTO with this vital discretionary authority to
accept an application for patent term restoration filed
within 5 days after the current deadline if the PTO finds
that the filing delay was unintentional.
As you are probably aware, coronary artery disease kills
500,000 Americans each year--earning the dubious distinction
of being the leading cause of death in America for both men
and women. And stroke is the Nation's number one cause of
disability, affecting 700,000 Americans each year. Angiomax
is a drug which has already been shown safe and effective in
angioplasties and has shown initial promise for patients with
coronary artery disease or stroke. Unfortunately, because of
a minor administrative error that caused its manufacturer's
application to be filed one day late, Angiomax may never
reach these cardiac and stroke patients, even though it had
earned the right to patent restoration.
H.R. 5120 would prevent such destructive and unnecessary
results, now and in the future. A similar clerical error has
already happened to two other companies, who also missed the
filing deadline by one day. And, human error being what it
is, it is virtually certain to happen to other companies in
the future.
The 60 Plus Association urges the House Judiciary Committee
to support this important, bipartisan legislation that will
benefit millions of seriously ill patents, many of whom are
60 years of age and older. It is incredibly unfortunate that
years of patent protection on drugs are forfeited due to a
[[Page H8817]]
minor clerical error and, as a result, the benefits of
further research and development of critical drugs are often
lost.
The 60 Plus Association appreciates your leadership on this
issue. We hope you will consider these points and support
this vital legislation--legislation that will directly
benefit the aging population. If you have any questions or
concerns, please do not hesitate to contact me.
Thank you for your consideration.
Sincerely,
Jim Martin,
President, 60 Plus Association.
____
RetireSafe,
September 13, 2006.
Hon. F. James Sensenbrenner,
Chairman, House Committee on the Judiciary,
Washington, DC.
Dear Chairman Sensenbrenner: On behalf of the almost
400,000 senior citizens represented by RetireSafe, I am
writing to inform you of our support of H.R. 5120,
legislation that would correct a troubling anomaly in the
patent law that can hinder innovation and stymie life-saving
research. Currently, the Hatch Waxman Act allows the owner of
a drug patent to obtain time restored to its patent to make
up for time lost while awaiting FDA approval. H.R. 5120 would
permit the Patent and Trademark Office to accept an
application within 5 days of the deadline if the PTO
determines the filing delay was unintentional.
RetireSafe urges the House Judiciary Committee to support
this much needed legislation that can benefit millions of
seriously ill patents. It's unfortunate, but when years of
patent protection on a drug are forfeited due to a minor
clerical error, the benefits of further research and
development of critical drugs is often lost. Ironically,
there are more than 30 patent laws and regulations on the
books giving the PTO the discretion to accept minor
application errors and late filings, but not under Hatch-
Waxman. We believe such rigid rules undermine the intent and
basic purposes of the patent law.
Furthermore, there are absolutely no downsides to fixing
this problem. The bill would not upset the balance of Hatch-
Waxman; it would simply avoid a premature cutoff of earned
patent rights due to minor clerical error. Generic
manufactures will also still have the same right they now
enjoy to file an application to bring out a new drug, and
this right would still be keyed to the date FDA approves the
patent owner's drug use.
For instance, take the case of the drug Angiomax, made by a
small drug company, which had earned the right to patent
restoration but missed the filing deadline by one day.
Research into promising new applications of Angiomax for
cardiac and stroke patients--applications which are critical
to older Americans--will be cut short if this legislation is
not passed. If Angiomax loses its patent protection
prematurely, this critical research opportunity will be lost
entirely as it will never be conducted by generic
manufacturers. The end result will mean that 13 million
Americans including the millions of seniors with coronary
artery disease will never benefit from this potentially life-
saving drug.
Angiomax is just one example of a drug that has faced this
filing deadline issue. Two other companies have missed the
Hatch-Waxman filing deadline by one day and others will
doubtless make minor filing errors in the future. Cardiac and
stroke patients will clearly benefit from this bill. H.R.
5120 is good public policy that will help save lives and
provide a better quality of life for seriously ill patients,
and it should be enacted immediately.
In short, H.R. 5120 does not give anything to patent owners
that the Hatch-Waxman law did not intend to give them and
does not take anything away from the generic manufactures
that the Hatch-Waxman law intended to provide. It merely
gives PTO the discretion to consider whether or not to accept
an application for patent term restoration after hearing all
the facts.
I urge you and your committee to support H.R. 5120 and help
millions of seniors in this country who are currently
suffering or at risk for coronary artery disease and need
innovative life-saving medications. It is my hope you will
agree that H.R. 5120 is good public policy with an overriding
public health benefit.
Sincerely,
Michelle Plasari,
RetireSafe.
____
FreedomWorks,
Washington, DC, September 13, 2006.
Hon. F. James Sensenbrenner, Jr.,
Chairman, Committee on the Judiciary, House of
Representatives, Washington, DC.
Hon. John Conyers, Jr.,
Ranking Member, Committee on the Judiciary, Washington, DC.
Dear Chairman Sensenbrenner and Ranking Member Conyers, on
behalf of the 800,000 members of Freedom Works, I am writing
to urge your support for H.R. 5120, a bill that would address
a concern that has arisen in patent law and provide an
environment that facilitates innovation and continued
development of products that are beneficial to potentially
millions of Americans. Freedom Works has a long history of
involvement with issues arising from the drug approval
process, promoting policies that eliminate unnecessary delays
that limit consumer access to important new therapies. In
addition, Freedom Works believes that at times the patent
process may be abused and generics provide an important
source of competition that generates substantial benefits to
consumers. This legislation, however, is not an abuse of the
system; it is an adjustment to the process that will ensure
continued research and development. This issue also
highlights the burden imposed by the drug approval process
and I would urge Congress to also consider reforms in this
area as well to ensure Americans have the access to the best
care possible.
Briefly, H.R. 5120 would grant the U.S. Patent Office the
discretion to consider an application for patent term
restoration that unintentionally has been filed late, but
within five days of the expiration of the 60-day filing
period established in the Hatch-Waxman Act (see 35 U.S.C.
Section 156(d)(1)). The U.S. Patent Office has the discretion
to accept late-filed submissions in a variety of patent and
trademark proceedings, but it does not in instances of patent
term restoration filings. H.R. 5120 would correct this
anomaly.
Under the Hatch-Waxman Act, patent term restoration is an
inducement for innovators and firms to undertake risky, time-
consuming, and costly drug development and the FDA approval
processes. Without patent term restoration, incentives for
drug innovation are diminished and consumers would bear the
costs as fewer resources are devoted to important lifesaving
drug therapies.
As an example, the Medicines Company failed to receive
patent restoration because its filing was unintentionally
filed one day late. The firm was in the process of conducting
important additional research on Angiomax, a drug initially
approved as a blood thinning agent. New research, however,
suggests that Angiomax may be beneficial for use in the
prevention and treatment of stroke, which is the leading
cause of disability and third leading cause of death in the
United States. Unfortunately, without patent restoration, the
ability to conduct the additional research and commit to the
costly approval process are eliminated, leaving consumers
with fewer choices for critical health care decisions.
Unlike other areas of patent law, the inflexible filing
deadline is clearly draconian. The Hatch-Waxman act provides
incentives to invest in the costly and time-consuming drug
approval process, yet the inflexibility built into the
current law can destroy those incentives and have a
disproportionate impact on the process, and reduce
opportunities for innovation. H.R. 5120 brings this
application of patent law more in line with the broader
process for patent and trademark proceedings. Given the
importance of innovation in the field of health care, and the
potential impact on the lives of Americans, I urge you to
support this important legislation.
Sincerely,
Matt Kibbe,
President and CEO.
____
Center for Individual Freedom,
Alexandria, VA, September 12, 2006.
Hon. F. James Sensenbrenner, Jr.,
Chairman, House Judiciary Committee, Washington, DC.
Congressman John Conyers, Jr.,
Ranking Member, House Judiciary Committee, Washington, DC.
Dear Congressman Sensenbrenner and Congressman Conyers: On
behalf of the Center for Individual Freedom and its more than
250,000 supporters and activists nationwide, I am writing to
urge you to support H.R. 5120. This bill grants the Patent
and Trade Office Director the discretion, where fair and
appropriate, to accept slightly overdue patent-term
restoration applications under the Hatch-Waxman law.
Under current law, an application unintentionally filed
even one day late must be denied--the Director possesses
absolutely no discretion whatsoever. Such a rigid command
creates unfair outcomes, and arbitrarily jeopardizes
enormously valuable property rights.
Throughout other realms of business, legal, and personal
life, equitable grace periods exist. For example, other
federal agencies such as the Internal Revenue Service possess
discretion to accept slightly overdue submissions. If even
the ``Tax Man'' can have a heart, the Patent and Trademark
Office should also be allowed similar discretion.
It is also important to put H.R. 5120 into perspective: the
bottom line is that a company should not have to pay the
price of millions or even billions of dollars in revenue due
to a simple and unintentional clerical error. Companies
invest billions of dollars in product research and
development, and recouping those investments through patent
protection is what allows our innovative economy to thrive.
Moreover, other patent laws and regulations allow the
Patent and Trade Office discretion to excuse minor mistakes,
such as filing documents or making payments. Thus the current
Hatch-Waxman deadline provision stands as an anomaly by
prohibiting any type of discretion. In our view, this anomaly
should be fixed, and H.R. 5120 does just that.
If an individual unintentionally pays their mortgage
payment one day late, does the bank seize their home? No. If
property taxes are paid one day late due to a bank
disbursement error, does the government automatically seize
your property? Obviously not. Should a different standard
apply to a company whose very existence depends upon a patent
that they hold?
[[Page H8818]]
Opponents of this rational legislation claim that it would
somehow benefit one particular company, but that is
incorrect. Rather, any company that can prove that its slight
delay was unintentional would be treated more fairly. This is
simply good public policy.
Indeed, the only beneficiaries of perpetuating the current
regulations are generic companies who stand to gain an unfair
windfall by pouncing whenever a patent owner accidentally
files a few days late. Perpetuating such inequitable
windfalls for generic companies is an inappropriate public
policy result. Maintaining the Hatch-Waxman mandate as-is
will lead to the further loss of highly valuable patent
rights for no good reason. In contrast, fixing it through
H.R. 5120 will help all innovators, both present and future.
Further, H.R. 5120 does not give the patent holder a
``carte blanche, no questions asked'' grace period. It does
not allow for indefinite patents, nor does it imply continued
protections due to intentional negligence. Rather, it allows
a five-day grace period for a patent restoration filing that
was unintentionally delayed. Five days.
Finally, Congress routinely revisits statutes in order to
fix loopholes and anomalies. Very simply, mistakes happen, as
does the law of unintended consequences. In the case of
Hatch-Waxman, allowing a simple five-day grace period will
not undermine or compromise the growth of the generics market
in the United States. Rather, H.R. 5120 will merely align
patent restoration filing rules with the other discretions
enjoyed by the Patent and Trademark Office.
Accordingly, the Center for Individual Freedom urges you
and all members of the Judiciary Committee to pass H.R. 5120,
allowing it full consideration by the U.S. House of
Representatives. Fairness and equity demands it, and we will
monitor members' votes on this critical matter and
communicate them to our constituency.
Thank you very much for your time and consideration.
Sincerely,
Timothy H. Lee,
Director of Legal and Public Affairs.
____
The Cleveland Clinic
Foundation Heart Center,
Cleveland, OH, April 24, 2006.
Congresswoman Stephanie Tubbs Jones,
House of Representatives,
Washington, DC.
Dear Representative Tubbs Jones: I understand that you are
considering a bill, HR 5120, related to the patent
restoration provisions of the Hatch-Waxman law. I am an
interventional cardiologist practicing at the Cleveland
Clinic. I engage in the clinical care of patients with
cardiovascular disease as well as in clinical research
related to this complex and unique group of patients.
I am writing in support of H.R. 5120 because I understand
that, if it passes, the anticoagulant drug Angiomax may
become eligible for patent term restoration. This would allow
for further investment in clinical development. I use
Angiomax and have been involved In the study of Angiomax in
acute care cardiovascular procedures, including heart attack
and angina. Angiomax is an important therapy that provides
safe and effective anticoagulation in interventional
procedures with less bleeding than other treatments. These
advantages also save the health care system money by reducing
bleeding and providing single drug therapy versus combination
drug therapy.
Patent term restoration for Angiomax is important because
preliminary experience suggests that Angiomax may be useful
in preventing and treating stroke, but more studies are
needed. Stroke is the nation's number one cause of disability
and third leading cause of death. Over 700,000 Americans
suffer strokes each year--one every 45 seconds; over 165,000
die and many thousands more are disabled for life,
Unfortunately, the blood thinning and clot-busting agents now
available to treat stroke patients can cause dangerous side
effects, including intracranial bleeds (as was seen so
vividly with Israeli Prime Minister Sharon). Angiomax may be
useful in the prevention and treatment of strokes with fewer
side effects. But the very costly and time-consuming clinical
trials needed to explore this promising new use won't be
feasible unless patent term restoration under the Hatch-
Waxman Act is available to the drug's developer.
It is vital that H.R. 5120 be enacted so that research on
Angiomax in the prevention and treatment of strokes is
undertaken to evaluate the drug in the treatment and
prevention of this debilitating disease. I am available to
discuss this matter further with you at your convenience.
Very truly yours,
Deepak L. Bhatt,
Associate Director, Cleveland Clinic Cardiovascular
Coordinating Center, Staff, Cardiac, Peripheral, and
Carotid Intervention, Associate Professor of Medicine,
Department of Cardiovascular Medicine, Cleveland Clinic
Foundation.
____
Department of Medicine, UCLA School of Medicine, Center
for the Health Sciences,
Los Angeles, CA September 6, 2006.
Congresswoman Nancy Pelosi,
House of Representatives,
Washington, DC.
Dear Congresswoman: I understand that the Subcommittee on
Courts, the Internet and Intellectual Property of the
Judiciary Committee of the House of Representatives is
considering a bill, H.R. 5120, relating to the patent
restoration provisions of the Hatch-Waxman law. I am an
interventional cardiologist practicing at The UCLA Medical
Center and the Greater Los Angeles Veterans Administration
Medical Center. I engage in the clinical care of patients
with cardiovascular disease as well as in clinical research
related to this complex and unique group of patients.
I am writing in support of H.R. 5120 because I understand
that, if it passes, the anticoagulant drug Angiomax may
become eligible for patent term restoration. This would allow
for further investment in clinical development. I use
Angiomax and have been involved in the study of Angiomax in
acute care cardiovascular procedures. Angiomax is an
important therapy that provides safe and effective
anticoagulation in interventional procedures with less
bleeding than other treatments. These advantages also save
money by reducing bleeding and providing single drug therapy
versus combination drug therapy.
Patent term restoration for Angiomax is important because
preliminary experience suggests that Angiomax may be useful
in preventing and treating stroke but more studies are
needed. Stroke is the Nation's number one cause of disability
and third leading cause of death. Over 700,000 Americans
suffer strokes each year--one every 45 seconds; over 165,000
die and many thousands more are disabled for life.
Unfortunately, the blood thinning and clot-busting agents now
available to treat stroke patients can cause dangerous side
effects, including intracranial bleeds (as was seen so
vividly with Israeli Prime Minister Sharon). Angiomax may be
useful in the prevention and treatment of strokes with fewer
side effects. But the very costly and time-consuming clinical
trials needed to explore this promising new use won't be
feasible unless patent term restoration under the Hatch-
Waxman Act is available to the drug's developer.
It is vital that H.R. 5120 be enacted so that research in
stroke is undertaken to evaluate the use of Angiomax in the
treatment and prevention of this debilitating disease. I am
available to discuss this matter further with you at your
convenience.
Very truly yours,
Ramin Ebrahimi,
Associate Clinical Professor, University of California
Los Angeles, Director, Cardiac Catheterization
Laboratory, Greater Los Angeles VA Medical Center,
Assistant Director, Nuclear Cardiology, Greater Los
Angeles VA Medical Center.
____
Section 202 is narrowly tailored legislation. It simply confers
discretion on the Patent Office to consider an unintentionally late-
filed patent term restoration application submitted to the Patent
Office within 5 days of the 60-day deadline in current law. It does not
confer any substantive rights on any applicant, but merely allows the
applicant to present the facts surrounding the late filing to the
Patent Office. The director of the Patent Office then has 30 days to
rule on the petition.
Honest mistakes should not cause irreparable hardship for innovators
or patients. A few days unintentional late filing mistake at the Patent
Office should not be cause for blocking promising medical research that
could lead to important health care advantages.
Mr. Speaker, I appreciate all the efforts the committee has invested
in bringing this legislation to the floor, and I hope that we can now
proceed with the enactment of S. 1758.
Mr. CONYERS. Mr. Speaker, I yield back the balance of my time.
Mr. SENSENBRENNER. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Wisconsin (Mr. Sensenbrenner) that the House suspend the
rules and pass the Senate bill, S. 1785, as amended.
The question was taken; and (two-thirds of those voting having
responded in the affirmative) the rules were suspended and the Senate
bill, as amended, was passed.
The title of the Senate bill was amended so as to read: ``An Act to
make certain improvements relating to intellectual property, and for
other purposes.''.
A motion to reconsider was laid on the table.
____________________