[Congressional Record Volume 152, Number 125 (Friday, September 29, 2006)]
[Senate]
[Pages S10741-S10745]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. LEAHY:
  S. 4040. A bill to ensure that innovations developed at federally-
funded institutions are available in certain developing countries at 
the lowest possible cost; to the Committee on the Judiciary.
  Mr. LEAHY. Mr. President, today I am pleased to introduce the Public 
Research in the Public Interest Act of 2006. If enacted, this bill will 
save lives and improve the quality of health for millions of families 
living in impoverished nations. Recently, I have introduced and 
cosponsored six bills to address the increasingly important issues that 
relate to global health and the need for earlier access to generic 
medicines in the United States.
  Each year, millions of people needlessly suffer from disease in 
impoverished countries worldwide because they lack access to lifesaving 
medicines. And each year, America's world-renowned research 
universities develop innovative treatments to combat these diseases. 
However, under our current system, these treatments do not get to the 
families in impoverished nations who so desperately need them.
  Today, 15 percent of the world's people consume about 91 percent of 
the world's pharmaceuticals. The high price of lifesaving medicines--
medicines we take for granted--puts them far beyond the reach of 
millions of the most vulnerable populations.
  While the concept of my bill is simple, the implications are 
profound. If passed, my bill would greatly lessen the cost burden of 
generic drugs in the developing world. It would achieve this by 
requiring federally funded research institutions to permit their 
inventions, such as, drugs, vaccines, and innovative medical devices, 
to be provided inexpensively by generic companies distributing medical 
supplies to the developing world.
  Federally funded labs and research institutions have a vital role to 
play in meeting this goal. For example, Yale University has an 
agreement with Doctors Without Borders to permit their generic version 
of its lifesaving AIDS drug to be used for a pilot treatment program in 
South Africa. To date, Yale's humanitarian endeavor, which in no way 
reduced their licensing revenues, continues to save thousands of lives.
  It is time to ensure that public funds truly serve public purposes--
in this instance, delivering essential health care needs at minimal 
costs to American taxpayers, universities, and pharmaceutical 
companies. Unfortunately, this Congress has been tied up in knots 
recently and has been unable to pass even critical appropriations 
bills. The measures before us are crucial. This comprehensive approach 
toward providing better global health aid and better access to generic 
drugs should become law, and I am committed to trying to make it so. I 
look forward to working with my colleagues on both sides of the aisle, 
in this Congress or the next, to enact this important legislation.
  I have recently introduced or sponsored six bills to address the need 
for better access to low-cost generic medicines. Two of these bills 
relate to global health, and four of them address the need for earlier 
access to generic medicines in the United States.

[[Page S10742]]

  Federally funded laboratories and other research institutions have a 
critical role to play in delivering affordable medicines to those sick 
and suffering worldwide. In 2000, a Senate Joint Economic Committee 
Report found that public research was instrumental in developing 15 of 
the 21 drugs considered by experts to have had the highest therapeutic 
impact on society.
  Between 1970 and 2001, there was a ten-fold increase in the number of 
U.S. patents issued annually to U.S. academic institutions. American 
universities, hospitals, and other nonprofit research centers concluded 
that more than 4,500 license and option agreements were executed in 
2003, more than double the license and option agreements executed in 
1993. A major share of these patents is in the biomedical field.
  The World Health Organization's 2006 Commission on Intellectual 
Property Rights, Innovation, and Public Health has also recently 
recognized the crucial role of universities. The WHO recommended that 
universities adopt licensing practices designed to increase access to 
medicines in developing countries.
  The report also tells the story of one way in which the crucial role 
of university innovations and other publicly funded research in 
promoting global public health first came into the public eye. It is an 
interesting story.
  In 2001, the international organization Medecins Sans Frontieres, or 
MSF, requested Yale University's permission to use its generic life-
saving AIDS drug, stavudine, for a pilot treatment project outside Cape 
Town.
  This was at a time when HIV drugs were first being introduced in the 
developing world. The costs were prohibitive. Scientists at Yale 
University had discovered stavudine's value in the fight against AIDS, 
and Yale University was the key patent holder.
  In response to MSF's request, Yale and Bristol-Myers Squibb jointly 
announced that they would permit the sale of generics in South Africa 
and that Bristol-Myers Squibb would lower the price of its brand-name 
stavudine by 96 percent throughout sub-Saharan Africa.
  The Yale/Bristol-Myers Squibb announcement was highly significant in 
the campaign for access to affordable first-line AIDS treatments. Yale 
and Bristol-Myers Squibb's humanitarian action did not reduce licensing 
revenues with respect to Yale. Meanwhile, Yale's invention to this day 
continues to save thousands of lives. According to a recent report by 
the WHO's AIDS Medicines and Diagnostics Service, stavudine is one of 
the three first-line HIV medicines that together constituted almost 90 
percent of total procurement in 2005.
  Unfortunately, this has been an isolated success story rather than 
the road to greater access for the many important inventions that come 
out of publicly funded research institutions.
  With respect to HIV/AIDS treatment alone, at least two major drugs 
based on university inventions have come to market since the 2001 
stavudine announcement: emtricitabine, developed in large part at Emory 
University and sold by Gilead Sciences as Emtriva; and T-20 developed 
in large part at Duke University and marketed as Fuzeon by Hoffmann-La 
Roche and Trimeris. Just this summer, Yale University announced the 
license of a new candidate for an AIDS drug based on stavudine. Called 
``4'-ethynyl-stavudine'', (or abbreviated more simply as Ed4T). Early 
testing suggests that it may be both more effective and less toxic than 
its famous predecessor.
  But the question is: Will these lifesaving drugs ultimately be 
available in places like sub-Saharan Africa, where HIV infection rates 
range as high as a third of the adult population?
  This bill, the Public Research in the Public Interest Act of 2006, 
would focus on this problem. By allowing licensing by generic companies 
of inventions coming out of publicly funded research institutions--and 
other associated inventions required to produce marketable medicines--
it would drive down the price of new, innovative drugs in areas where 
they would otherwise be effectively unavailable.
  Because the licensing regime this bill proposes is self-enforcing, it 
minimizes both administrative overhead and eliminates the need for 
case-by-case decisions, while preserving important intellectual 
property protections. Because the Act allows the introduction of 
generic or reduced-price drugs only into markets too poor to otherwise 
afford them, its terms do not threaten corporate investments or profits 
in wealthy nations. All generic drugs manufactured under the bill must 
be clearly differentiated from the versions sold in developed nations, 
where the brand-name companies make their profits.
  Moreover, publicly funded research institutions would receive 
royalties from the sale of inventions covered by this bill in 
developing markets. While the initial payment of the royalties will 
typically go to the research institution itself, the bill leaves 
complete freedom to these institutions and their licensee to decide how 
such royalties will ultimately be shared. This freedom is especially 
important because the inventions from universities and other research 
institutions often form only one part of the collection of intellectual 
property necessary to manufacture a finished, marketable drug. The 
appropriate division of the royalties paid by generics for this package 
of rights in the developing world will be different for different drugs 
and medical devices, depending on whether the university's contribution 
is more or less central to the finished product. This Act would allow 
all the various parties the flexibility to divide these royalties 
appropriately.
  I should be clear, however, that the bill I introduce today is an 
initial proposal. I look forward to working with research universities 
in the United States on this important matter. I also intend to work 
with the companies involved in creating, licensing, and bringing to 
market the fruits of America's unparalleled research institutions as we 
continue to shape this solution.
  Indeed, the best answer may not be legislative at all, if the groups 
involved can come together around a different approach. But however it 
is achieved, I believe that increasing the availability of the many 
medical inventions that come from publicly funded research centers is a 
good solution to pressing global health concerns.
  Universities, in particular, are unique institutions with unique 
public commitments. They are, before anything else, institutions 
dedicated to the creation and dissemination of knowledge in the public 
interest. The Public Research in the Public Interest Act of 2006 is 
designed in the spirit of that commitment.
  This bill completes a package of six bills that I have recently 
introduced to increase access to medicines in the United States and to 
address the global public health crisis. While it is the magnitude of 
this problem that demands that we, as a Nation, take action, it is the 
small things, the individual stories that often speak to us most 
clearly at a personal level.
  In my office hangs a photograph I took of three young boys on the 
side of a mountain in Turkey. I found them flying a kite off the edge 
of a cliff that overlooks a vast slum. They had made the toy out of 
scraps of paper, patched together with tape and string, and were flying 
it on the currents rushing up the face of the rock.
  I recalled fearing for their safety as they played so precariously 
close to the edge. But these children faced much greater risks. When my 
grandchildren get sick, we can always be sure they will get the 
medicines they need. For these boys, there is no such guarantee.
  These boys, and the millions of children and others like them around 
the world are the reason behind each of the six bills I have 
introduced.
  Earlier this summer, I introduced a bill which can be the catalyst 
for empowering U.S. generic companies to save the lives or improve the 
health of millions of families in impoverished nations. Under the 
``Life-Saving Medicines Export Act,'' U.S. companies can make low-cost 
generic versions of any medicine for export to impoverished nations 
that face public health crises when those impoverished nations cannot 
produce those life-saving medicines for themselves.
  This bill is based on World Trade Organization agreements permitting 
nations with pharmaceutical industries to help nations in need. The 
World Health Assembly and the World Health Organization have adopted 
resolutions urging all WTO member nations with a generic capability to 
adopt laws that

[[Page S10743]]

implement that agreement. On December 6, 2005, the Office of the U.S. 
Trade Representative announced that it ``welcomes'' efforts to ``allow 
countries to override patent rights when necessary to export lifesaving 
drugs to developing countries that face public health crises but cannot 
produce drugs for themselves.''

  This bill addresses the urgent needs of millions of low-income 
families in impoverished nations while protecting the interests of the 
patent owners of these life-saving medicines. As in the Public Research 
in the Public Interest Act, introduced today, generic companies are 
only permitted to use the compulsory license in the bill in developing 
nations, where low-income families are simply too poor to purchase the 
``brand-name'' versions, and the generic versions must be clearly 
marked as not for resale in developed nations. Thus, both bills pose 
the risk of minimal losses for patent holders while generating new 
revenue for the brand-name companies from the royalties on generic 
sales.
  The four additional bills that complete this ``Access to Medicines'' 
package seek to preserve incentives for U.S. generic companies to enter 
and compete in the market. Increased competition leads to lower prices 
and saved lives.
  First, in the wake of the Supreme Court refusal to hear the drug 
patent case called Federal Trade Commission (FTC) v. Schering-Plough, I 
joined fellow Judiciary Committee members--Senators Kohl, Grassley and 
Schumer--in introducing legislation to explicitly prohibit brand-name 
drug manufacturers from using pay-off agreements to keep cheaper 
generic equivalents off the market. Such payments are a distortion in 
the market that harms patients. I was stunned that the U.S. Supreme 
Court refused to hear a case so important to our senior citizens. The 
Federal Trade Commission asked the Supreme Court to hear the arguments 
but the Court refused at the request of the Justice Department. It 
seems there may be no justice--until that bill is passed--for our 
seniors needing costly patented medicines but live where the brand-name 
company has paid generic companies not to compete.
  Then, in July, I joined Senators Rockefeller and Schumer in 
introducing legislation to ban ``authorized generics'' that can stifle 
true generic competition. I said at the time that ``the giant drug 
companies keep coming up with ways to avoid real competition and 
consumers need to be able to count on Congress to close each new 
anticompetitive loophole they come up with.'' If enacted, that bill 
will close this anti-competitive loophole in the Hatch-Waxman Act and 
will preserve the incentives Congress created for generic companies to 
enter the market to supply American citizens and seniors with lower-
cost drugs.
  The fifth bill introduced was with Senator Kohl. That bill is 
intended to stop frivolous Citizen Petitions designed to delay 
introduction of generic drugs into the market place. Recently, large 
pharmaceutical companies have exploited that petition process to keep 
their profits high. In addition, I joined with Senators Schumer, 
Clinton and Stabenow on the Access to LifeSavings Medicine Act which 
related to developing a fast-track process for approving generic 
versions of biologic medicines.
  I want to thank Stacy Kern-Scheerer with Senate Legislative Counsel 
who provided very helpful guidance under extreme pressure in drafting 
this short, but complex bill. She and Bill Baird, also with Senate 
Legislative Counsel, did a great job with a rapid turnaround.
  I believe that these six bills, together, can save millions of lives. 
Recognizing the great need, there have been significant voluntary 
efforts made by brand-name pharmaceutical companies, foundations, and 
nonprofits who have already donated life-saving medicines, time, 
personnel and money to help in the fight against deadly diseases both 
in America and abroad. I commend and greatly appreciate those efforts. 
Nonetheless, much remains to be done. My bills will both add to and 
complement existing efforts, by making sure even cutting edge 
treatments are available in developing countries, and by ensuring that 
America's aid dollars and the contributions of private philanthropists 
are used as efficiently as they can possibly be used.
  The President's Emergency Plan for AIDS Relief Report to Congress 
reported that ``[i]n every case generics prices present an opportunity 
for cost savings; in some cases, the branded price per pack of a drug 
is up to 11 times the cost of the approved generic version.''
  The current global public health crisis is one of the great callings 
of our time. As a nation, we cannot afford to ignore this threat. Our 
own health and aspects of our national security depend on it.
  We have become far more aware today of how much our own health 
depends on what takes place half a world away. Whether it is AIDS, 
SARS, West Nile Virus, the Avian Flu, or the encroaching menace of 
multi-drug resistant bacteria, we are all at risk. We are only an 
airplane flight away from wherever an outbreak may occur--a place where 
the medical innovations developed in this country to combat these 
devastating diseases may not be available to keep the outbreak under 
control.
  In a post-9/11 world, our well-being is intimately connected with 
that of other nations. Health is an essential building block for a 
strong economy, and vital to maintain a thriving democracy. Through 
increasing access to essential medicines throughout the world, the 
United States can help to give developing nations a chance to flourish, 
while improving U.S. relations with large segments of the world's 
population.
  President Franklin Roosevelt once said: ``The test of our progress is 
not whether we add more to the abundance of those who have much; it is 
whether we provide enough, for those who have little.''
  We are fortunate, at some times and on some issues, to be able to do 
both. Now is one of those times, and this is one of those issues. I 
hope my colleagues will join me in supporting my efforts this year on 
the global public health crisis, including today's addition, the Public 
Research in the Public Interest Act of 2006.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 4040

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Public Research in the 
     Public Interest Act of 2006''.

     SEC. 2. PURPOSE AND FINDINGS.

       (a) Purpose.--The purpose of this Act is to promote global 
     public health and America's national security by ensuring 
     that innovations developed at federally-funded institutions 
     are available in eligible developing countries at the lowest 
     possible cost.
       (b) Findings.--Congress finds the following:
       (1) It is in the national interest of the United States 
     that people around the world live healthier lives, and that 
     they perceive the United States in a more favorable light.
       (2) The United States Government funds a major portion of 
     all academic research.
       (3) Congress funds universities and Federal research 
     laboratories as institutions dedicated to the creation and 
     dissemination of knowledge in the public interest.
       (4) The Federal Government's investment in science and 
     technology fuels a thriving pharmaceutical industry and 
     rising longevity and quality of life in the United States. In 
     2000, a Senate Joint Economic Committee Report found that 
     public research was instrumental in developing 15 of the 21 
     drugs considered by experts to have had the highest 
     therapeutic impact on society.
       (5) Millions of people with HIV/AIDS in developing 
     countries need antiretroviral drugs. More than 40,000,000 
     people worldwide have HIV and 95 percent of them live in 
     developing countries. Malaria, tuberculosis, and other 
     infectious diseases kill millions of people a year in 
     developing nations.
       (6) The World Health Organization (``WHO'') has estimated 
     that \1/3\ of the world's population lacks regular access to 
     essential medicines, including antiretroviral drugs. The WHO 
     reported that just by improving access to existing medicines 
     roughly 10,000,000 lives could be saved around the world 
     every year.
       (7) To help address the access to medicines crisis, the 
     World Health Organization's 2006 Commission on Intellectual 
     Property Rights, Innovation, and Public Health recommended 
     that universities adopt licensing practices designed to 
     increase access to medicines in developing countries.
       (8) The Department of State has reported to Congress under 
     the President's Emergency Plan for AIDS Relief that, ``[I]n 
     every case generics prices present an opportunity for cost 
     savings; in some cases, the branded price per pack of a drug 
     is up to 11 times the cost of the approved generic 
     version.''.

[[Page S10744]]

       (9) Since sales of the patented, brand-name versions of 
     such medicines are minimal or non-existent in many 
     impoverished regions of the world, allowing generic versions 
     of those medicines will have minimal impact on the sales of 
     brand-name, patented versions in such regions, or the 
     licensing revenues of publicly funded research institutions, 
     while saving an untold number of lives.

     SEC. 3. DEFINITIONS.

       In this Act:
       (1) Associated medical product.--The term ``associated 
     medical product'', when used in relation to a subject 
     invention, means any medical product of which the 
     manufacture, use, sale, offering for sale, import, or export 
     relies upon or is covered by the rights guaranteed by title 
     in that invention.
       (2) Associated rights.--The term ``associated rights,'' 
     when used in relation to a subject invention, means--
       (A) all patent and marketing rights, possessed by a current 
     or former holder of title in that invention, or licensee of 
     rights guaranteed by such title, that are reasonably 
     necessary to make, use, sell, offer to sell, import, export, 
     or test any associated medical product ever made, used, sold, 
     offered for sale, imported, or exported by that party; and
       (B) the right to rely on biological, chemical, biochemical, 
     toxicological, pharmacological, metabolic, formulation, 
     clinical, analytical, stability, and other information and 
     data for purposes of regulatory approval of any associated 
     medical product.
       (3) Drug.--The term ``drug'' has the meaning given such 
     term in section 201 of the Federal Food, Drug and Cosmetic 
     Act (21 U.S.C. 321).
       (4) Eligible country.--The term ``eligible country'' means 
     any country of which the economy is classified by the World 
     Bank as ``low-income'', or ``lower-middle-income''.
       (5) Fair royalty.--The term ``fair royalty'', when used in 
     relation to a subject invention, means--
       (A) for a country classified by the World Bank as ``low-
     income'' at the time of the sales on which royalties are due, 
     2 percent of a licensee's net sales of associated medical 
     products in such country; and
       (B) for a country classified by the World Bank as ``lower-
     middle-income'' at the time of sales on which royalties are 
     due, 5 percent of a licensee's net sales of associated 
     medical products in such country.
       (6) Invention.--The term ``invention'' means any invention 
     or discovery which is or may be patentable or otherwise 
     protectable under title 35, United States Code, or any novel 
     variety of plant which is or may be protectable under the 
     Plant Variety Protection Act (7 U.S.C. 2321 et seq.).
       (7) Medical device.--The term ``medical device'' means a 
     device, as defined in section 201(h) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321(h)), and includes any 
     device component of any combination product, as that term is 
     used in section 503(g) of such Act (21 U.S.C. 353(g)).
       (8) Medical product.--The term ``medical product'' means 
     any drug, treatment, prophylaxis, vaccine, or medical device.
       (9) Neglected research.--The term ``neglected research'' 
     means any use of a subjected invention or the associated 
     rights in an effort to develop medical products for a rare 
     disease or condition, as defined in section 526(a)(2) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb(a)(2)).
       (10) Subject institution.--The term ``subject institution'' 
     means any institution of higher education (as such term is 
     defined in section 101(a) of the Higher Education Act of 1965 
     (20 U.S.C. 1001(a)) or research that receives federal 
     financial assistance, including Federal laboratories as 
     defined in section 12(d) of the Stevenson-Wydler Technology 
     Innovation Act of 1980 (15 U.S.C. 3710a(d)).
       (11) Subject invention.--The term ``subject invention'' 
     means any invention--
       (A) conceived or first actually reduced to practice by a 
     subject institution, or its employees in the course of their 
     employment, on or after the effective date of this Act; or
       (B) in which a subject institution holds title, provided 
     the invention was first conceived or reduced to practice on 
     or after the effective date of this Act.

     SEC. 4. ACCESS TO LIFESAVING MEDICINES DEVELOPED AT 
                   GOVERNMENT FUNDED INSTITUTIONS.

       (a) Grant of License.--
       (1) In general.--As a condition of receiving Federal 
     assistance, any subject institution that conceives, reduced 
     to practice, or holds title in a subject invention shall be 
     required to grant irrevocable, perpetual, nonexclusive 
     licenses to the invention and any associated rights the 
     institution may own or ever acquire, to any party requesting 
     such a license pursuant to subsection (g).
       (2) Purpose of license.--The licenses described under 
     paragraph (1) shall be for the sole purpose of--
       (A) supplying medical products in accordance with 
     subsection (e); or
       (B) conducting neglected research anywhere in the world, 
     royalty-free.
       (b) Incorporation Into Title.--The open-licensing 
     requirement created by subsection (a) and all licenses 
     granted thereunder shall be part of the subject institution's 
     title in a subject invention. No transfer or license may be 
     interpreted in any manner inconsistent with making any grant 
     under subsection (a) effective, or in any manner that 
     prevents or frees the holder of title in the invention from 
     granting licenses.
       (c) Subsequent Licenses.--
       (1) In general.--If a subject institution licenses or 
     grants rights in a subject invention to any other party, as a 
     condition of such grant the licensee or grantee, and any 
     future sublicensees or subsequent grantees, ad infinitum, 
     shall also be required in perpetuity, to grant irrevocable, 
     perpetual, nonexclusive licenses on any associated rights 
     which the licensee or grantee may own or later acquire, to 
     any party requesting such a license pursuant to subsection 
     (g).
       (2) Purpose of license.--The licenses shall be for the sole 
     purposes described in subsection (a)(2).
       (3) Application of this subsection.--This subsection 
     applies to licenses for a subject invention acquired under 
     subsection (a).
       (d) Construction.--No grant or licensee of any subject 
     invention may be interpreted in any manner that prevents or 
     frees the grantee or licensee from granting licenses for 
     associated rights under subsection (c).
       (e) License for Supply of Medical Products.--
       (1) In general.--A license under subsection (a)(2)(A) shall 
     be a license for the sole purpose of permitting the making, 
     using, selling, offering to sell, importing, exporting, and 
     testing of medical products in eligible countries and the 
     making and exporting of medical products worldwide for the 
     sole purpose of supplying medical products to eligible 
     countries.
       (2) Labeling.--If the recipient of a license under 
     subsection (a) exercises its right to make and export a 
     medical product in any country other than an eligible country 
     for the sole purpose of export to an eligible country, then 
     the licensee shall use reasonable efforts to visibly 
     distinguish the medical product it manufactures from any 
     similar medical product sold by others in the country of 
     manufacture, provided that such reasonable efforts do not 
     require the licensee to expend significant expense.
       (3) Royalties.--
       (A) License of subject invention.--A license of a subject 
     invention under subsection (a)(2)(A) shall be irrevocable and 
     perpetual so long as the licensee submits to the licensor 
     payment of a fair royalty on sales of any associated medical 
     product within 90 days of such sales. Failure or refusal of 
     the licensor to accept the fair royalty shall not terminate 
     or affect in any way the license.
       (B) License of associated rights.--A license of associated 
     rights to a subject invention under subsection (a)(2)(A) 
     shall be royalty free.
       (f) Transfer.--In accordance with subsections (a) through 
     (d), any license or other transfer of a subject invention by 
     a subject institution or the licensee or grantee of such 
     institution for a subject invention, shall be invalid 
     unless--
       (1) the license or grant includes a clause, ``This grant or 
     license is subject to the provisions of the Public Research 
     in the Public Interest Act of 2006.'';
       (2) the licensor or grantor complies with the notification 
     requirements of subsection (h); and
       (3) the license or grant does not include any terms that 
     contradict any requirement of this Act.
       (g) Procedures for Acquisition of Licenses.--
       (1) In general.--Any party, upon providing to the Food and 
     Drug Administration--
       (A) notification of its intent to supply medical products 
     or conduct neglected research as provided in subsection (a);
       (B) a specific list of the rights it wishes to license for 
     those purposes; and
       (C) the names of the party or parties it believes are 
     obligated to grant such licenses under subsections (a) 
     through (d),
     shall automatically be deemed to receive the license so 
     requested without the need for any further action on the part 
     of the licensing party if the party or parties specified in 
     the request do not object and notify the requesting party of 
     such objection, within 30 days of the publication of such 
     request by the Administration.
       (2) Enforcement action.--
       (A) In general.--If the party or parties specified under 
     paragraph (1) object to the grant of a requested license, the 
     requesting party may bring an action to enforce its right to 
     a license of a subject invention or associated rights under 
     subsections (a) through (d).
       (B) Process.--In any suit under this subsection, the 
     requesting party shall be entitled to separate, expedited 
     review of the legal issues required to adjudicate whether it 
     is entitled to the requested license, without prejudice to 
     any other issues in the lawsuit. If the party objecting to 
     the license is found to have objected without reasonable 
     cause or without a good faith belief that there was a 
     justifiable controversy under the facts and the law, the 
     party requesting the license shall be entitled to attorney's 
     fees, other reasonably necessary costs of the lawsuit, and 
     treble damages from the objecting party.
       (3) Publication.--The Food and Drug Administration shall 
     publish any request made under paragraph (1) within 15 days 
     of receipt of such request. The Food and Drug Administration 
     shall also make reasonable efforts to directly notify the 
     parties named in any such request.
       (h) Notification of Transfer or License of Subject 
     Inventions.--The holder of title or any license in a subject 
     invention shall notify the Food and Drug Administration of 
     any grant or license of rights in that invention. The Food 
     and Drug Administration

[[Page S10745]]

     shall publish all such notifications within 15 days of 
     receipt.
                                 ______