TRADING TECH EXHIBIT 2126
`IBG et al. v. TRADING TECH. - CBM2016-00087
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`Case: 16-120 Document: 2-4 Page: 92 Filed: 03/08/2016
`S5403
`September 8, 2011
`CONGRESSIONAL RECORD — SENATE
`brought to the House floor didn’t have
`ought to pursue that. There are special
`of the legal system at times and a sup-
`this language in it. The first vote re-
`procedures. The litigation will be over,
`porter at times. I think they take a
`jected the attempt to put this language
`and they can bring that action at that
`principled position in this instance.
`in it. It failed. For some reason, in
`time.
`The Wall Street Journal editorial stat-
`That is the basic position we ought
`some way, a second vote was held, and
`ed:
`it was passed by a few votes. So they
`to be in. A bill that comes out of the
`We take no pleasure in seeing the Medicine
`are not going to reject the legislation
`Judiciary Committee ought to be sen-
`Company and WilmerHale suffer for their
`if we were to amend it.
`sitive to the legal system, to the im-
`mistakes, but they are run by highly paid
`What kind of system are we now in-
`professionals who know the rules and know
`portance of ensuring that the poor are
`that consistency of enforcement is critical
`volved in in the Senate if we can’t undo
`treated as well as the rich. The oath
`to their businesses. Asking Congress to
`an amendment? What kind of argument
`judges take is to do equal justice to the
`break the rules as a special favor corrupts
`is it to say: JEFF, I agree with your
`poor and the rich.
`the law.
`amendment, and I agree it is right that
`How many other people in this coun-
`I think that is exactly right. It is ex-
`they should not get this special relief,
`try are getting special attention today
`actly right. Businesses, when they are
`but I can’t vote for it because it might
`on the floor of the Senate? How many?
`sued by somebody, use the statute of
`cause a problem? It will not cause a
`I truly believe this is not good policy.
`limitations every day. This law firm
`problem. The bill will pass. It should
`I have had to spend far more hours
`makes hundreds of millions of dollars
`never have been put in there in the
`fighting this than I have ever wanted
`in income a year. Their partners aver-
`first place.
`to when I decided 10 years ago that this
`age over $1 million a year, according to
`Another point of great significance is
`was not a good way to go forward.
`the New York Times. That is pretty
`the fact that this issue is on appeal.
`Many battle this issue, and I hope and
`good. They ought to be able to pay a
`The law firm asserted they thought—
`trust that the Members of the Senate
`decent malpractice
`insurance pre-
`and it is a bit unusual—that because it
`who will be voting on this will allow it
`mium. The New York Times said
`came in late Friday they had until
`to follow the legitimate process. Let
`WilmerHale reported revenues of $962
`Monday. We can count the days to
`the litigation work its way through the
`million in 2010, with a profit of $1.33
`Monday—the 60 days or whatever they
`system.
`million per partner.
`had to file the answer. I don’t know if
`If they do not prevail in the litiga-
`Average people have to suffer when
`that is good law, but they won. The dis-
`tion, let a private relief bill be sought
`they miss the statute of limitations.
`trict court has ruled for them. It is on
`and debated openly and publicly to see
`Poor people suffer when they miss the
`appeal now to the court of appeals.
`if it is justified. That would be the
`statute of limitations. But we are un-
`This Congress has no business inter-
`right way to do
`it—not slipping
`dertaking, at great expense to the tax-
`fering in a lawsuit that is ongoing and
`through this amendment and then not
`payers, to move a special interest piece
`is before an appeals court. If they are
`voting to remove it on the basis that
`of legislation that I don’t believe can
`so confident their district court ruling
`we should not be amending a bill before
`be justified as a matter of principle. I
`is correct, why are they continuing to
`us. We have every right to amend the
`agree with the Wall Street Journal
`push for this special relief bill, when
`bill, and we should amend the bill. I
`that the adoption of it corrupts the
`the court of appeals will soon, within a
`know Senator GRASSLEY, years ago,
`system. We ought not be a part of that.
`matter of months, rule?
`was on my side. I think it was just the
`I love the American legal system. It
`Another point: We have in the Con-
`two of us who took this position.
`is a great system, I know. I have seen
`gress a procedure to deal with special
`I guess I have more than expressed
`judges time and time again enter rul-
`relief. If this relief is necessary at all,
`my opinion. I thank the chairman for
`ings based on law and fact even if they
`it should go through as a special relief
`his leadership. I thank him and Sen-
`didn’t like it. That is the genius and
`bill. I can tell you one reason it is not
`ator GRASSLEY for their great work on
`reliability and integrity of the Amer-
`going there now: you can’t ask for spe-
`this important patent bill. I support
`ican legal system. I do not believe we
`cial relief while the matter is still in
`that bill. I believe they have moved it
`can justify, while this matter is still in
`litigation, it is still on appeal. Special
`forward in a fair way.
`litigation, passing a special act to give
`relief also has procedures that one has
`The chairman did not put this lan-
`a wealthy law firm, an insurance com-
`to go through and justify in an objec-
`guage into the bill; it was put in over
`pany, and a health care company spe-
`tive way, which I believe would be very
`in the House. I know he would like to
`cial relief. I just don’t believe we
`healthy in this situation.
`see the bill go forward without amend-
`For a decade, virtually—I think it
`should do that. I oppose it, and I hope
`ments. I urge him to think it through
`has been 10 years—I have been object-
`my colleagues will join us.
`and see if he cannot be willing to sup-
`ing to this amendment. Now we are
`I think we have a real chance to turn
`port this amendment. I am confident it
`here, I thought it was out, and all of a
`this back. Our Congress and our Senate
`will not block final passage of the leg-
`sudden it is slipped in by a second vote
`will be better for it; we really will. The
`islation.
`in the House, and we are told we just
`Citizens Against Government Waste
`I yield the floor.
`can’t make an amendment to the bill.
`have taken an interest in this matter
`The PRESIDING OFFICER. The Sen-
`Why? The Senate set up the legislation
`for some time. They said:
`ator from Vermont.
`to be brought forward, and we can offer
`Congress has no right to rescue a company
`Mr. LEAHY. Mr. President, I will
`amendments and people can vote for
`from its own mistakes.
`speak later about the comments made
`them or not.
`Companies have a right to assert the
`by the distinguished Senator from Ala-
`This matter has gotten a lot of atten-
`law. Companies have a right to assert
`bama. He has been very helpful in get-
`tion. The Wall Street Journal and the
`the law against individuals. But when
`ting this patent bill through. He is cor-
`New York Times both wrote about it in
`the time comes for the hammer to fall
`rect that this amendment he speaks to
`editorials today. This is what the New
`on them for their mistake, they want
`is one added in the other body, not by
`York Times said today about it:
`Congress to pass a special relief bill. I
`us. We purposely didn’t have it in our
`But critics who have labeled the provision
`don’t think it is the right thing to do.
`bill. I know Senator GRASSLEY will fol-
`‘‘The Dog Ate My Homework Act’’ say it is
`Mr. President, let’s boil it down to
`low my remarks.
`really a special fix for one drug manufac-
`several things. First, if the company is
`There is no question in my mind that
`turer, the Medicines Company, and its pow-
`right and the law firm is right that
`if the amendment of the Senator from
`erful law firm, WilmerHale. The company
`they did not miss the statute of limita-
`Alabama were accepted, it in effect
`and its law firm, with hundreds of millions of
`tions, I am confident the court of ap-
`will kill the bill. Irrespective of the
`dollars in drug sales at stake, lobbied Con-
`peals will rule in their favor, and it
`merits, it can come up on another piece
`gress heavily for several years to get the pat-
`ent laws changed.
`will not be necessary for this Senate to
`of legislation or as freestanding legis-
`act. If they do not prevail in the court
`lation. That is fine. But on this bill,
`That is what the Wall Street Journal
`of appeals and don’t win their argu-
`after 6 years of effort to get this far,
`said in their editorial. The Wall Street
`ment, then there is a provision for pri-
`this bill would die because the other
`Journal understands business reality
`vate relief in the Congress, and they
`body will not take it up again.
`and litigation reality. They are a critic
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`Page 2 of 42
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`TRADING TECH EXHIBIT 2126
`IBG et al. v. TRADING TECH. - CBM2016-00087
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`

`

`S5404
`
`HURRICANE IRENE
`Mr. LEAHY. Mr. President, I will use
`my time to note some of the things
`happening in my own very special
`State of Vermont, the State in which I
`was born.
`As Vermonters come together and
`continue to grapple with the aftermath
`of storm damage from Irene, I wish to
`focus today on the agriculture disaster
`that has hit us in Vermont and report
`to the Senate and our fellow citizens
`across the Nation about how the raging
`floodwaters wreaked havoc on our
`farming lands and infrastructure in
`Vermont.
`It was 12 days ago now that this enor-
`mous, slow-moving storm hit Vermont
`and turned our calm, scenic brooks and
`creeks into raging gushers. In addition
`to our roads and historic covered
`bridges that were destroyed or carried
`away, we had barns, farmhouses, crops,
`parts of fields, and livestock washed
`away in the rising floodwaters. I recall
`the comments of one farmer who
`watched his herd of cows wash down
`the river, knowing they were going to
`die in the floodwaters.
`Now the cameras have begun to turn
`away, but the cleanup and urgent re-
`pairs are underway. For major parts of
`Vermont’s economy, the worst effects
`of this storm are yet to come. For our
`dairy farmers, who are the bedrock of
`our economy and keystones of our
`communities, the toll of this disaster
`has been heavy and the crises has
`lasted longer as they have struggled to
`take care of their animals while the
`floodwaters recede.
`This
`is a photograph of East
`Pittsford, VT, taken by Lars Gange
`just over a week ago. The water we see
`is never there. It is there now. Look at
`this farm’s fields, they are destroyed.
`Look at homes damaged and think
`what that water has done.
`As I went around the state with our
`Governor and Vermont National Guard
`General Dubie the first couple of days
`after the storm hit, we went to these
`places by helicopter and I cannot tell
`you how much it tore at my heart to
`see the state, the birthplace to me, my
`parents, and grandparents. To see
`roads torn up, bridges that were there
`when my parents were children, washed
`away. Historic covered bridges, mills,
`barns, businesses just gone and what it
`has done to our farmers, it is hard, I
`cannot overstate it.
`Our farmers have barns that are com-
`pletely gone, leaving no shelter for ani-
`mals. They are left struggling to get
`water for their animals, to rebuild
`fencing, to clean up debris from flooded
`fields and barns, and then to get milk
`trucks to the dairy farms. Remember,
`these cows have to be milked every sin-
`gle day. We also have farmers who do
`not have any feed or hay for their ani-
`mals because it all washed away. As
`one farmer told me, the cows need to
`be milked two or three times every
`day, come hell or high water. This
`farmer thought he had been hit with
`both, hell and high water.
`
`Case: 16-120 Document: 2-4 Page: 93 Filed: 03/08/2016
`September 8, 2011
`CONGRESSIONAL RECORD — SENATE
`While reports are still coming in
`Vermont, as it will be to other States
`from the farms that were affected, the
`coping with the same disaster. I worry
`list of damages and the need for crit-
`the support they need to rebuild may
`ical supplies, such as feed, generators,
`not be there, as it has been in past dis-
`fuel, and temporary fencing is on the
`asters, when we have rebuilt after hur-
`rise. As we survey the farm fields and
`ricanes, floods, fires and earthquakes
`communities, we know it will be dif-
`to get Americans back in their homes,
`ficult to calculate the economic im-
`something Vermonters have supported
`pacts of this violent storm on our agri-
`even though in these past disasters
`culture industry in Vermont.
`Vermont was not touched.
`So I look forward to working with
`Many of our farmers were caught by
`the Appropriations Committee and
`surprise as the unprecedented, rapidly
`with all Senators to ensure that
`rising
`floodwaters
`inundated their
`FEMA, USDA and all our Federal agen-
`crops, and many have had to deal with
`cies have the resources they need to
`the deeply emotional experience of los-
`help all our citizens at this time of dis-
`ing animals to the fast-moving flood-
`aster, in Vermont and in all our states.
`waters. We have farms where whole
`Unfortunately, programs such as the
`fields were washed away and their fer-
`Emergency Conservation Program and
`tile topsoil sent rushing down river.
`the Emergency Watershed Protect Pro-
`The timing could not have been worse.
`gram have been oversubscribed this
`Corn, which is a crucial winter feed for
`year, and USDA has only limited funds
`dairy cows, was just ready for harvest,
`remaining. We also face the grim fact
`but now our best corn is in the river
`that few of our farms had bought crop
`bottoms and is ruined. Other farms had
`insurance and so may not be covered
`just prepared their ground to sow win-
`by USDA’s current SURE Disaster Pro-
`ter cover crops and winter greens; they
`gram.
`lost significant amounts of topsoil.
`But those are the things I am work-
`River banks gave way, and we saw
`ing on to find ways to help our farmers
`wide field buffers disappear overnight,
`and to move forward to help in the
`leaving the crops literally hanging on
`commitment to our fellow Americans.
`ledges above
`rivers, as at
`the
`For a decade, we have spent billions
`Kingsbury farm in Warren, VT. Vege-
`every single week on wars and projects
`table farming is Vermont’s fastest
`in far-away lands. This is a time to
`growing agricultural sector, and, of
`start paying more attention to our
`course, this is harvest season. Our
`needs here at home and to the urgent
`farmers were not able to pick these
`needs of our fellow citizens.
`crops, this storm picked many fields
`I see my friend from Iowa on the
`clean.
`floor, and I yield the floor.
`Many Vermonters have highly pro-
`The PRESIDING OFFICER. The sen-
`ductive gardens that they have put up
`ior Senator from Iowa.
`for their families to get through the
`winter by canning and freezing. Those
`AMENDMENT NO. 600
`Mr. GRASSLEY. Mr. President, I rise
`too have been washed away or are con-
`to rebut the points Senator SESSIONS
`sidered dangerous for human consump-
`made, and I do acknowledge, as he said
`tion because of the contaminated
`on the floor, that 2 or more years ago
`floodwaters. Vermont farmers have a
`I was on the same page he is on this
`challenging and precarious
`future
`issue. What has intervened, in the
`ahead of them as they look to rebuild
`meantime, that causes me to differ
`and plan for next year’s crops, knowing
`from the position Senator SESSIONS is
`that in our State it can be snowing in
`taking? It is a district court case giv-
`11⁄2 or 2 months.
`I have been heartened, however, by
`ing justice to a company—as one cli-
`the many stories I have heard from
`ent—that was denied that sort of jus-
`communities where people are coming
`tice because bureaucrats were acting in
`together to help one another. For in-
`an arbitrary and capricious way.
`Senator SESSIONS makes the point
`stance, at the Intervale Community
`you get equal justice under the law
`Farm on the Winooski River, volun-
`from the judicial branch of government
`teers came out to harvest the remain-
`and that Congress should not try to
`ing dry fields before the produce was
`override that sort of situation. Con-
`hit by still rising floodwaters.
`When the rumors spread that Beth
`gress isn’t overriding anything with
`and Bob Kennett at Liberty Hill Farm
`the language in the House bill that he
`in Rochester had no power and needed
`wants to strike because that interest
`help milking—well, people just started
`was satisfied by a judge’s decision; say-
`showing up. By foot, on bike, all ready
`ing that a particular entity was denied
`to lend a hand to help milk the cows.
`equal justice under the law because a
`Fortunately for them and for the poor
`bureaucrat, making a decision on just
`cows, the Vermont Department of Ag-
`exactly what counts as 60 days, was
`riculture had managed to help get
`acting in an arbitrary and capricious
`them fuel and the Kennetts were milk-
`way. So this language in the House bill
`ing again, so asked the volunteer farm
`has nothing to do with helping a spe-
`hands to go down the road, help some-
`cial interest. That special interest was
`body else and they did.
`satisfied by a judge who said an entity
`Coping with damage and destruction
`was denied equal justice under the law
`on this scale is beyond the means and
`because a bureaucrat was acting in an
`capability of a small State such as
`arbitrary and capricious manner.
`ours, and Federal help with the re-
`This amendment is not about a spe-
`building effort will be essential to
`cial interest. This amendment is about
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`Page 3 of 42
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`TRADING TECH EXHIBIT 2126
`IBG et al. v. TRADING TECH. - CBM2016-00087
`
`

`

`Case: 16-120 Document: 2-4 Page: 94 Filed: 03/08/2016
`S5405
`September 8, 2011
`CONGRESSIONAL RECORD — SENATE
`The government does not deny that when
`uniformity of law throughout the coun-
`was treating everybody the same, so
`notice of FDA approval is sent after normal
`everybody gets equal justice under the
`try because it is wrong—as the judge
`business hours, the combination of the Pat-
`law, they know what the law is, and
`says—for a bureaucracy to have one
`ent and Trademark Office’s calendar day in-
`they don’t have to rely upon maybe
`sort of definition of when 60 days be-
`terpretation and its new counting method ef-
`some court decision in one part of the
`gins—whether
`it
`is after business
`fectively deprives applicants of a portion of
`country that maybe they can argue in
`hours, if something goes out, or, if
`the 60-day filing period that Congress ex-
`another part of the country, and also
`something comes in, it includes the
`pressly granted them . . . Under PTO’s inter-
`to tell bureaucrats, as the judge said,
`day it comes in. So we are talking
`pretation, the date stamped on the FDA ap-
`proval letter starts the 60-day period for fil-
`that you can’t act in an arbitrary and
`about how we count 60 days, and it is
`ing an application, even if the Food and Drug
`capricious way. But bureaucrats might
`about making sure there is a uniform
`Administration never sends the letter . . .
`act in an arbitrary and capricious way,
`standard for that based upon law
`An applicant could lose a substantial por-
`in a way unknown to them, if we don’t
`passed by Congress and not upon one
`tion, if not all, of its time for filing a Patent
`have a uniform definition of what a
`judge’s decision that applies to one spe-
`Trademark Extension application as a result
`business day is.
`cific case.
`of mistakes beyond its control . . . An inter-
`So I oppose the effort to strike sec-
`I would say, since this case has been
`pretation that imposes such drastic con-
`tion 37 from the patent reform bill for
`decided, there are at least three other
`sequences when the government errs could
`the reasons I have just given, but also
`not be what Congress intended.
`entities that have made application to
`for the reasons that were already ex-
`So the judge is telling us in the Con-
`the Patent Office to make sure they
`pounded by the chairman of this com-
`gress of the United States that because
`would get equal justice under the law
`mittee that at this late date, after 6
`we weren’t precise, there is a question
`in the same way the entity that got
`years of trying to get a patent reform
`as to when Congress intended 60 days
`help through the initial decision of the
`bill done—and we haven’t had a patent
`to start to toll. And the question then
`judge. So this is not about special re-
`reform bill for over a decade, and it is
`is, If it is treated one way for one per-
`lief for one company. This is about
`badly needed—we shouldn’t jeopardize
`son and another way for another per-
`what is a business day and having a
`the possible passage of this bill to the
`son, or if one agency treats it one way
`uniform definition in the law of the
`President of the United States for his
`and another agency treats it another
`United States of what a business day
`signature by sending it back to the
`way, is that equal justice under the
`is, not based upon one district court
`other body and perhaps putting it in
`law? I think it is very clear that the
`decision that may not be applied uni-
`jeopardy. But, most important, I think
`judge said it was not. I say the judge
`formly around our Nation.
`we ought to have a clear signal of what
`So it is about uniformity and not
`was correct. Congress certainly should
`is a business day, a definition of it, and
`about some bailout, as Senator SES-
`not expect nor allow mistakes by the
`this legislation and section 37 makes
`SIONS says. It is not about some fero-
`bureaucracy to up-end the rights and
`that very clear.
`cious lobbying effort, as Senator SES-
`provisions included in the Hatch-Wax-
`This past June, I addressed this issue
`SIONS has said. It is not just because
`man Act or any other piece of legisla-
`in a floor statement, and I want to
`one person was 1 hour late or 1 day
`tion we might pass.
`quote from that because I wanted my
`The court ruled that when the Food
`late, because how do you know whether
`colleagues to understand why I hoped
`and Drug Administration sent a notice
`they are 1 hour late or 1 day late if
`the House-passed bill would contain
`of approval after business hours, the 60-
`there is a different definition under one
`section 37 that was not in our Senate
`day period requesting patent restora-
`circumstance of when 60 days starts
`bill but that was passed out of the
`tion begins the next business day. It is
`and another definition under other cir-
`House Judiciary Committee unani-
`as simple as that.
`cumstances of when a 60-day period
`mously. Speaking as ranking member
`The House, by including section 37,
`tolls?
`of the Senate Judiciary Committee
`takes the court case, where common
`Also, I would suggest to Senator SES-
`now and back in June when I spoke, I
`sense dictates to protect all patent
`SIONS that this is not Congress inter-
`wanted the House Judiciary Committee
`holders against losing patent exten-
`fering in a court case that is under ap-
`to know that several Republican and
`sions as a result of confused counting
`peal because the government lost this
`Democratic Senators had asked me to
`calculations. Regrettably, misunder-
`case and the government is not appeal-
`support this provision as well.
`standings about this provision have
`ing. Now, there might be some other
`Section 37 resulted from a recent
`persisted, and I think you hear some of
`entity appealing for their own interests
`Federal court case that had as its gen-
`those misunderstandings in the state-
`to take advantage of something that is
`esis the difficulty the FDA—the Food
`ment by Senator SESSIONS.
`very unique to them.
`and Drug Administration—and the Pat-
`This provision does not apply to just
`But just in case we have short memo-
`ent Office face when deciding how to
`one company. The truth is that it ap-
`ries, I would remind my colleagues
`calculate Hatch-Waxman deadlines.
`plies to all patent holders seeking to
`that Congress does sometimes interject
`The Hatch-Waxman law of the 1980s
`restore the patent term time lost dur-
`itself into the appeal process, and I
`was a compromise between drug patent
`ing FDA deliberations—in other words,
`would suggest one time we did that
`holders and the generic manufacturers.
`allowing what Hatch-Waxman tries to
`very recently, maybe 6 years ago—and
`Under the Waxman-Hatch law, once a
`accomplish: justice for everybody. In
`that may not be very recent, but it is
`patent holder obtains market approval,
`recent weeks, it has been revealed that
`not as though we never do it—and that
`the patent holder has 60 days to re-
`already three companies covering four
`was the Protection of Lawful Com-
`quest the Patent Office to restore the
`drug patents will benefit by correcting
`merce Act of 2005, when Congress inter-
`patent terms—time lost because of the
`the government’s mistake.
`jected itself into an issue to protect
`FDA’s long deliberating process eating
`It does not cost the taxpayers money.
`gun manufacturers from pending law-
`up valuable patent rights.
`The Congressional Budget Office deter-
`suits. It happens that 81 Senators sup-
`The citation to the case I am refer-
`mined that it is budget-neutral.
`ported that particular effort to inter-
`ring to is in 731 Federal Supplement
`Section 37 has been pointed out as
`ject ourselves into a lawsuit.
`2nd, 470. The court found—and I want
`maybe being anticonsumer, but it is
`So, Mr. President, in a more formal
`to quote more extensively than I did
`anything but anticonsumer. I would
`way, I want to repeat some of what I
`back in June. This is what the judge
`quote Jim Martin, chairman of the 60–
`said this past summer when I came to
`said about bureaucrats acting in an ar-
`Plus Association. He said:
`the Senate floor and suggested to the
`bitrary and capricious way and when
`We simply can’t allow bureaucratic incon-
`House of Representatives that I would
`does the 60 days start.
`sistencies to stand in the way of cutting-
`appreciate very much if they would put
`The Food and Drug Administration treats
`edge medical research that is so important
`into the statutes of the United States a
`submissions to the FDA received after its
`to the increasing number of Americans over
`uniform definition of a business day
`normal business hours differently than it
`the age of 60. This provision is a common-
`and not leave it up to a court to maybe
`treats communications from the agency
`sense response to a problem that unneces-
`after normal business hours.
`set that standard so that it might not
`sarily has ensnared far too many pharma-
`be applied uniformly and, secondly, to
`Continuing to quote from the deci-
`ceutical companies and caused inexcusable
`sion:
`make sure it was done in a way that
`delays in drug innovations.
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`Page 4 of 42
`
`TRADING TECH EXHIBIT 2126
`IBG et al. v. TRADING TECH. - CBM2016-00087
`
`

`

`Case: 16-120 Document: 2-4 Page: 95 Filed: 03/08/2016
`S5406
`September 8, 2011
`CONGRESSIONAL RECORD — SENATE
`ment rather than to have a clear, con-
`have labeled it as something a lot
`We have also heard from prominent
`sistent definition? Let’s actually try to
`more. A patent holder on a drug is en-
`doctors from throughout the United
`put this issue to bed once and for all.
`titled by statute to apply for an exten-
`States. They wrote to us stating that
`The provision may solidify Medco’s
`sion of its patent term to compensate
`section 67 ‘‘is critically important to
`patent term extension, but it applies
`for any delay the Food and Drug Ad-
`medicine and patients. In one case
`generally, not to this one company, as
`ministration approval process caused
`alone, the health and lives of millions
`has been suggested. It brings common
`in actually bringing the drug to mar-
`of Americans who suffer from vascular
`sense to the entire filing system.
`ket. The patent holder not only has to
`disease are at stake . . . Lives are lit-
`However, if the Senate adopts the
`file the extension within 60 days begin-
`erally at stake. A vote against this
`amendment of the Senator from Ala-
`ning on the date the product received
`provision will delay our patients access
`bama, it will lead to real conflict with
`permission for marketing, but there is
`to cutting-edge discoveries and treat-
`the House. It is going to complicate,
`some ambiguity as to when the date is
`ments. We urgently request your help
`delay, and probably end passage of this
`that starts the clock running.
`in preserving section 37.’’
`important bipartisan jobs-creating leg-
`So section 37 improves our patent
`Only in Washington, DC, could the
`islation.
`system fairness through certainty and
`system produce such absurd results
`Keep in mind, yesterday I said on the
`clarity, and I urge my colleagues to
`that the word ‘‘date’’ means not only
`floor that each one of us in this body
`join me in voting to preserve this im-
`something different between two agen-
`could write a slightly different patent
`portant provision as an end in itself,
`cies—the PTO and the FDA—but then
`bill. But we do not pass 100 bills, we
`but also to make sure we do not send
`it is given two different constructions
`pass 1. This bill is supported by both
`this bill back to the House of Rep-
`by the FDA. If this sounds kind of eso-
`Republicans and Democrats across the
`resentatives and instead get it to the
`teric, it is. I have been working on this
`political spectrum. People on both
`President, particularly on a day like
`for years and it is difficult to under-
`sides of the aisle have been working on
`today when the President is going to be
`stand. But the courts have codified it.
`this issue for years and years in both
`speaking to us tonight about jobs. I
`Let’s not try to change it yet again.
`bodies. We have a piece of legislation.
`What happens is that the FDA treats
`think having an updated patent law
`Does everybody get every single thing
`submissions to it after normal hours as
`will help invention, innovation, re-
`they want? Of course not. I am chair-
`being received the next business day.
`search, and everything that adds value
`man of the Senate Judiciary Com-
`But the dates of submissions from the
`to what we do in America and preserve
`mittee. I don’t have everything in this
`FDA are not considered the next busi-
`America’s greatness in invention and
`bill I want, but I have tried to get
`ness day, even if sent after hours. To
`the advancement of science.
`something that is a consensus of the
`In conclusion, I would say it is very
`complicate matters, the PTO recently
`large majority of the House and the
`clear to me that the court concluded
`changed its own method of defining
`Senate, and we have done this.
`that the Patent and Trademark Office,
`what is a ‘‘date.’’
`In this instance, in this particular
`If this sounds confusing even in
`and not some company or its lawyers,
`amendment, the House expressly con-
`Washington, you can imagine how it is
`had erred, as is the implication here. A
`sidered this matter. They voted with a
`outside of the bureaucracy. Confusion
`consistent
`interpretation ought to
`bipartisan majority to adopt this pro-
`over what constitutes the ‘‘date’’ for
`apply to all patent holders in all cases,
`vision the amendment is seeking to
`purposes of a patent extension has af-
`and we need to resolve any uncertainty
`strike. With all due respect to the dis-
`fected several companies. The most no-
`that persists despite the court’s deci-
`tinguished Senator from Alabama, who
`table case involves the Medicines Com-
`sion.
`contributed immensely to the bill as
`I yield the floor.
`pany’s ANGIOMAX extension applica-
`ranking member of the committee last
`The PRESIDING OFFICER. The sen-
`tion request.
`Congress, I understood why he opposed
`ior Senator from Vermont is recog-
`The extension application was denied
`this provision when it was controver-
`nized.
`by the PTO because of the difference in
`sial and would have had Congress over-
`Mr. LEAHY. Mr. President, I thank
`how dates are calculated. MedCo chal-
`ride the PTO. But now that the PTO
`the distinguished Senator from Iowa
`lenged the PTO’s decision in court, and
`and court have resolved the matter as
`for his words, and I join with the Sen-
`last August the federal district c