[Congressional Record (Bound Edition), Volume 152 (2006), Part 17]
[House]
[Pages 22567-22573]
[From the U.S. Government Publishing Office, www.gpo.gov]




            VESSEL HULL DESIGN PROTECTION AMENDMENTS OF 2006

  Mr. SENSENBRENNER. Mr. Speaker, I move to suspend the rules and

[[Page 22568]]

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.''.

               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

[[Page 22569]]

     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 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

[[Page 22570]]

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 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

[[Page 22571]]

     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 
     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.

[[Page 22572]]

       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?
       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, H.R. 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

[[Page 22573]]

     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.

                          ____________________