Philips Exhibit 2022
`Zoll Lifecor v. Philips
`IPR2013-00618
`
`Page 1 of 42
`
`

`
`CONGRESSIONAL RECORD — SENATE
`
`S5403
`
`of the legal system at times and a sup-
`porter at times.
`I think they take a
`principled position in this instance.
`The Wall Street Journal editorial stat-
`ed:
`We take no pleasure in seeing the Medicine
`Company and WilmerHale suffer for their
`mistakes. but they are run by highly paid
`professionals who know the rules and know
`that consistency of enforcement is critical
`to their businesses. Asking Congress
`to
`break the rules as a special favor corrupts
`the law.
`I think that is exactly right. It is ex-
`actly right. Businesses, when they are
`sued by somebody. use the statute of
`limitations every day. This law firm
`makes hundreds of millions of dollars
`in income a year. Their partners aver-
`age over $1 million a year, according to
`the New York Times. That is pretty
`good. They ought to be able to pay a
`decent malpractice
`insurance
`pre-
`mium. The New York Times
`said
`Wi1merHale reported revenues of $962
`million in 2010, with a profit of $1.33
`million per partner.
`Average people have to suffer when
`they miss the statute of limitations.
`Poor people suffer when they miss the
`statute of limitations. But we are un-
`dertaking, at great expense to the tax-
`payers, to move a special interest piece
`of legislation that I don’t believe can
`be justified as a matter of principle. I
`agree with the Wall Street Journal
`that the adoption of it corrupts the
`system. We ought not be a part of that.
`I love the American legal system. It
`is a great system, I know. I have seen
`judges time and time again enter rul-
`ings based on law and fact even if they
`didn’t like it. That is the genius and
`reliability and integrity of the Amer-
`ican legal system. I do not believe we
`can justify, while this matter is still in
`litigation, passing a special act to give
`a wealthy law firm, an insurance com-
`pany, and a health care company spe-
`cial
`relief.
`I
`just don’t believe we
`should do that. I oppose it, and I hope
`my colleagues will join us.
`I think we have a real chance to turn
`this back. Our Congress and our Senate
`will be better for it; we really will. The
`Citizens Against Government Waste
`have taken an interest in this matter
`for some time. They said:
`Congress has no right to rescue a company
`from its own mistakes.
`Companies have a right to assert the
`law. Companies have a right to assert
`the law against individuals. But when
`the time comes for the hammer to fall
`on them for their mistake, they want
`Congress to pass a special relief bill. I
`don’t think it is the right thing to do.
`Mr. President,
`let’s boil it down to
`several things. First, if the company is
`right and the law firm is right that
`they did not miss the statute of limita-
`tions, I am confident the court of ap-
`peals will rule in their favor, and it
`will not be necessary for this Senate to
`act. If they do not prevail in the court
`of appeals and don’t win their argu-
`ment, then there is a provision for pri-
`vate relief in the Congress, and they
`
`ought to pursue that. There are special
`procedures. The litigation will be over,
`and they can bring that action at that
`time.
`That is the basic position we ought
`to be in. A bill that comes out of the
`Judiciary Committee ought to be sen-
`sitive to the legal system, to the im-
`portance of ensuring that the poor are
`treated as well as the rich. The oath
`judges take is to do equal justice to the
`poor and the rich.
`How many other people in this coun-
`try are getting special attention today
`on the floor of the Senate? How many?
`I truly believe this is not good policy.
`I have had to spend far more hours
`fighting this than I have ever wanted
`to when I decided 10 years ago that this
`was not a good way to go forward.
`Many battle this issue. and I hope and
`trust that the Members of the Senate
`who will be voting on this will allow it
`to follow the legitimate process. Let
`the litigation work its way through the
`system.
`If they do not prevail in the litiga-
`tion, let a private relief bill be sought
`and debated openly and publicly to see
`if it is justified. That would be the
`right way
`to
`do
`it—not
`slipping
`through this amendment and then not
`voting to remove it on the basis that
`we should not be amending a bill before
`us. We have every right to amend the
`bill, and we should amend the bill.
`I
`know Senator GRASSLEY. years ago,
`was on my side. I think it was just the
`two of us who took this position.
`I guess I have more than expressed
`my opinion. I thank the chairman for
`his leadership.
`I thank him and Sen-
`ator G-RASSLEY for their great work on
`this important patent bill.
`I support
`that bill. I believe they have moved it
`forward in a fair way.
`The chairman did not put this lan-
`guage into the bill; it was put in over
`in the House. I know he would like to
`see the bill go forward without amend-
`ments. I urge him to think it through
`and see if he cannot be willing to sup-
`port this amendment. I am confident it
`will not block final passage of the leg-
`islation.
`I yield the floor.
`The PRESIDING OFFICER. The Sen-
`ator from Vermont.
`I will
`Mr. LEAHY. Mr. President,
`speak later about the comments made
`by the distinguished Senator from Ala-
`bama. He has been very helpful in get-
`ting this patent bill through. He is cor-
`rect that this amendment he speaks to
`is one added in the other body, not by
`us. We purposely didn’t have it in our
`bill. I know Senator GRASSLEY will fol-
`low my remarks.
`There is no question in my mind that
`if the amendment of the Senator from
`Alabama were accepted,
`it
`in effect
`will kill
`the bill. Irrespective of the
`merits, it can come up on another piece
`of legislation or as freestanding legis-
`lation. That is fine. But on this bill.
`after 6 years of effort to get this far,
`this bill would die because the other
`body will not take it up again.
`
`September 8, 2011
`brought to the House floor didn’t have
`this language in it. The first vote re-
`jected the attempt to put this language
`in it. It failed. For some reason,
`in
`some way, a second vote was held. and
`it was passed by a few votes. So they
`are not going to reject the legislation
`if we were to amend it.
`What kind of system are we now in-
`volved in in the Senate if we can’t undo
`an amendment? What kind of argument
`is it to say: JEFF, I agree with your
`amendment. and I agree it is right that
`they should not get this special relief.
`but I can’t vote for it because it might
`cause a problem? It will not cause a
`problem. The bill will pass. It should
`never have been put in there in the
`first place.
`Another point of great significance is
`the fact that this issue is on appeal.
`The law firm asserted they thought-
`and it is a bit unusual—that because it
`came in late Friday they had until
`Monday. We can count
`the days to
`Monday—the 60 days or whatever they
`had to file the answer. I don’t know if
`that is good law. but they won. The dis-
`trict court has ruled for them. It is on
`appeal now to the court of appeals.
`This Congress has no business inter-
`fering in a lawsuit that is ongoing and
`is before an appeals court. If they are
`so confident their district court ruling
`is correct, why are they continuing to
`push for this special relief bill, when
`the court of appeals will soon, within a
`matter of months, rule?
`Another point: We have in the Con-
`gress a procedure to deal with special
`relief. If this relief is necessary at all.
`it should go through as a special relief
`bill. I can tell you one reason it is not
`going there now: you can’t ask for spe-
`cial relief while the matter is still in
`litigation, it is still on appeal. Special
`relief also has procedures that one has
`to go through and justify in an objec-
`tive way, which I believe would be very
`healthy in this situation.
`For a decade, virtua1ly—I think it
`has been 10 years——I have been object-
`ing to this amendment. Now we are
`here, I thought it was out. and all of a
`sudden it is slipped in by a second vote
`in the House, and we are told we just
`can’t make an amendment to the bill.
`Why? The Senate set up the legislation
`to be brought forward, and we can offer
`amendments and people can vote for
`them or not.
`This matter has gotten a lot of atten-
`tion. The Wall Street Journal and the
`New York Times both wrote about it in
`editorials today. This is what the New
`York Times said today about it:
`But critics who have labeled the provision
`“The Dog Ate My Homework Act" say it is
`really a special fix for one drug manufac-
`turer, the Medicines Company, and its pow-
`erful
`law firm. Wilmerl-Iale. The company
`and its law firm. with hundreds of millions of
`dollars in drug sales at stake. lobbied Con-
`gress heavily for several years to get the pat-
`ent laws changed.
`That is what the Wall Street Journal
`said in their editorial. The Wall Street
`Journal understands business reality
`and litigation reality. They are a critic
`
`Page 2 of 42
`
`Page 2 of 42
`
`

`
`S5404
`
`CONGRESSIONAL RECORD — SENATE
`
`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.
`of East
`This
`is
`a
`photograph
`Pittsford, VT,
`taken by Lars Grange
`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.
`
`While reports are still coming in
`from the farms that were affected, the
`list of damages and the need for crit-
`ical supplies, such as feed, generators,
`fuel, and temporary fencing is on the
`rise. As we survey the farm fields and
`communities. we know it will be dif-
`ficult
`to calculate the economic im-
`pacts of this violent storm on our agri-
`culture industry in Vermont.
`Many of our farmers were caught by
`surprise as the unprecedented, rapidly
`rising floodwaters
`inundated
`their
`crops, and many have had to deal with
`the deeply emotional experience of los-
`ing animals to the fast-moving flood-
`waters. We have farms where whole
`fields were washed away and their fer-
`tile topsoil sent rushing down river.
`The timing could not have been worse.
`Corn. which is a crucial winter feed for
`dairy cows. was just ready for harvest,
`but now our best corn is in the river
`bottoms and is ruined. Other farms had
`just prepared their ground to sow win-
`ter cover crops and winter greens; they
`lost significant amounts of topsoil.
`River banks gave way, and we saw
`wide field buffers disappear overnight,
`leaving the crops literally hanging on
`ledges
`above
`rivers.
`as
`at
`the
`Kingsbury farm in Warren, VT. Vege-
`table farming is Vermont’s
`fastest
`growing agricultural sector, and, of
`course,
`this is harvest
`season. Our
`farmers were not able to pick these
`crops,
`this storm picked many fields
`clean.
`Many Vermonters have highly pro-
`ductive gardens that they have put up
`for their families to get through the
`winter by canning and freezing. Those
`too have been washed away or are con-
`sidered dangerous for human consump-
`tion because
`of
`the
`contaminated
`floodwaters. Vermont farmers have a
`challenging
`and
`precarious
`future
`ahead of them as they look to rebuild
`and plan for next year’s crops, knowing
`that in our State it can be snowing in
`11/2 or 2 months.
`I have been heartened, however. by
`the many stories I have heard from
`communities where people are coming
`together to help one another. For in-
`stance. at
`the Intervale Community
`Farm on the Winooski River, volun-
`teers came out to harvest the remain-
`ing dry fields before the produce was
`hit by still rising floodwaters.
`When the rumors spread that Beth
`and Bob Kennett at Liberty Hill Farm
`in Rochester had no power and needed
`help milking—well, people just started
`showing up. By foot, on bike, all ready
`to lend a hand to help milk the cows.
`Fortunately for them and for the poor
`cows, the Vermont Department of Ag-
`riculture had managed to help get
`them fuel and the Kennetts were milk-
`ing again, so asked the volunteer farm
`hands to go down the road, help some-
`body else and they did.
`Coping with damage and destruction
`on this scale is beyond the means and
`capability of a small State such as
`ours. and Federal help with the re-
`building effort will be essential
`to
`
`Page 3 of 42
`
`September 8, 2011
`Vermont, as it will be to other States
`coping with the same disaster. I worry
`the support they need to rebuild may
`not be there, as it has been in past dis-
`asters, when we have rebuilt after hur-
`ricanes, floods, fires and earthquakes
`to get Americans back in their homes,
`something Vermonters have supported
`even though in these past disasters
`Vermont was not touched.
`So I look forward to working with
`the Appropriations Committee
`and
`with all Senators
`to ensure
`that
`FEMA, USDA and all our Federal agen-
`cies have the resources they need to
`help all our citizens at this time of dis-
`aster. in Vermont and in all our states.
`Unfortunately. programs such as the
`Emergency Conservation Program and
`the Emergency Watershed Protect Pro-
`gram have been oversubscribed this
`year, and USDA has only limited funds
`remaining. We also face the grim fact
`that few of our farms had bought crop
`insurance and so may not be covered
`by USDA’s current SURE Disaster Pro-
`gram.
`But those are the things I am work-
`ing on to find ways to help our farmers
`and to move forward to help in the
`commitment to our fellow Americans.
`For a decade, we have spent billions
`every single week on wars and projects
`in far-away lands. This is a time to
`start paying more attention to our
`needs here at home and to the urgent
`needs of our fellow citizens.
`I see my friend from Iowa on the
`floor, and I yield the floor.
`The PRESIDING OFFICER. The sen-
`ior Senator from Iowa.
`AMENDMENT NO. soo
`Mr. GRASSLEY. Mr. President, I rise
`to rebut the points Senator SESSIONS
`made, and I do acknowledge. as he said
`on the floor, that 2 or more years ago
`I was on the same page he is on this
`issue. What has
`intervened,
`in the
`meantime,
`that causes me to differ
`from the position Senator SESSIONS is
`taking? It is a district court case giv-
`ing justice to a company—as one cli-
`ent—that was denied that sort of jus-
`tice because bureaucrats were acting in
`an arbitrary and capricious way.
`Senator SESSIONS makes the point
`you get equal
`justice under the law
`from the judicial branch of government
`and that Congress should not try to
`override that sort of situation. Con-
`gress isn’t overriding anything with
`the language in the House bill that he
`wants to strike because that interest
`was satisfied by a judge’s decision; say-
`ing that a particular entity was denied
`equal justice under the law because a
`bureaucrat, making a decision on just
`exactly what counts as 60 days, was
`acting in an arbitrary and capricious
`way. So this language in the House bill
`has nothing to do with helping a spe-
`cial interest. That special interest was
`satisfied by a judge who said an entity
`was denied equal justice under the law
`because a bureaucrat was acting in an
`arbitrary and capricious manner.
`This amendment is not about a spe-
`cial interest. This amendment is about
`
`Page 3 of 42
`
`

`
`September 8, 2011
`uniformity of law throughout the coun-
`try because it is wrong—as the judge
`says—for a bureaucracy to have one
`sort of definition of when 60 days be-
`gins—whether
`it
`is
`after business
`hours,
`if something goes out, or,
`if
`something comes in,
`it includes the
`day it comes in. So we are talking
`about how we count 60 days, and it is
`about making sure there is a uniform
`standard for
`that based upon law
`passed by Congress and not upon one
`judge’s decision that applies to one spe-
`cific case.
`I would say, since this case has been
`decided, there are at least three other
`entities that have made application to
`the Patent Office to make sure they
`would get equal justice under the law
`in the same way the entity that got
`help through the initial decision of the
`judge. So this is not about special re-
`lief for one company. This is about
`what is a business day and having a
`uniform definition in the law of the
`United States of what a business day
`is, not based upon one district court
`decision that may not be applied uni-
`formly around our Nation.
`So it is about uniformity and not
`about some bailout, as Senator SES-
`SIONS says. It is not about some fero-
`cious lobbying effort, as Senator SES-
`SIONS has said. It is not just because
`one person was 1 hour late or 1 day
`late, because how do you know whether
`they are 1 hour late or 1 day late if
`there is a different definition under one
`circumstance of when 60 days starts
`and another definition under other cir-
`cumstances of when a 60-day period
`tolls?
`Also, I would suggest to Senator SES-
`SIONS that this is not Congress inter-
`fering in a court case that is under ap-
`peal because the government lost this
`case and the government is not appeal-
`ing. Now,
`there might be some other
`entity appealing for their own interests
`to take advantage of something that is
`very unique to them.
`But just in case we have short memo-
`ries,
`I would remind my colleagues
`that Congress does sometimes interject
`itself into the appeal process. and I
`would suggest one time we did that
`very recently, maybe 6 years ago—and
`that may not be very recent, but it is
`not as though we never do it—and that
`was the Protection of Lawful Com-
`merce Act of 2005, when Congress inter-
`jected itself into an issue to protect
`gun manufacturers from pending law-
`suits. It happens that 81 Senators sup-
`ported that particular effort to inter-
`ject ourselves into a lawsuit.
`So, Mr. President, in a more formal
`way. I want to repeat some of what I
`said this past summer when I came to
`the Senate floor and suggested to the
`House of Representatives that I would
`appreciate very much if they would put
`into the statutes of the United States a
`uniform definition of a business day
`and not leave it up to a court to maybe
`set that standard so that it might not
`be applied uniformly and. secondly, to
`make sure it was done in a way that
`
`S5405
`CONGRESSIONAL RECORD — SENATE
`The government does not deny that when
`notice of FDA approval is sent after normal
`business hours, the combination of the Pat-
`ent and Trademark 0ffice’s calendar day in-
`terpretation and its new counting method ef-
`fectively deprives applicants of a portion of
`the 60-day filing period that Congress ex-
`pressly granted them .
`.
`. Under PTO’s inter-
`pretation. the date stamped on the FDA ap-
`proval letter starts the 60-day period for fil-
`ing an application, even if the Food and Drug
`Administration never sends the letter .
`.
`.
`An applicant could lose a substantial por-
`tion, if not all. of its time for filing a Patent
`Trademark Extension application as a result
`of mistakes beyond its control .
`.
`. An inter-
`pretation that
`imposes such drastic con-
`sequences when the government errs could
`not be what Congress intended.
`So the judge is telling us in the Con-
`gress of the United States that because
`we weren’t precise, there is a question
`as to when Congress intended 60 days
`to start to toll. And the question then
`is, If it is treated one way for one per-
`son and another way for another per-
`son, or if one agency treats it one way
`and another agency treats it another
`way,
`is that equal
`justice under the
`law? I think it is very clear that the
`judge said it was not. I say the judge
`was correct. Congress certainly should
`not expect nor allow mistakes by the
`bureaucracy to up-end the rights and
`provisions included in the Hatch-Wax-
`man Act or any other piece of legisla-
`tion we might pass.
`The court ruled that when the Food
`and Drug Administration sent a notice
`of approval after business hours, the 60-
`day period requesting patent restora-
`tion begins the next business day. It is
`as simple as that.
`The House, by including section 37.
`takes the court case, where common
`sense dictates to protect all patent
`holders against
`losing patent exten-
`sions as a result of confused counting
`calculations. Regrettably, misunder-
`standings about
`this provision have
`persisted, and I think you hear some of
`those misunderstandings in the state-
`ment by Senator SESSIONS.
`This provision does not apply to just
`one company. The truth is that it ap-
`plies to all patent holders seeking to
`restore the patent term time lost dur-
`ing FDA deliberations—in other words,
`allowing what Hatch-Waxman tries to
`accomplish:
`justice for everybody. In
`recent weeks, it has been revealed that
`already three companies covering four
`drug patents will benefit by correcting
`the government’s mistake.
`It does not cost the taxpayers money.
`The Congressional Budget Office deter-
`mined that it is budget-neutral.
`Section 37 has been pointed out as
`maybe being anticonsumer, but it is
`anything but anticonsumer.
`I would
`quote Jim Martin, chairman of the 60-
`Plus Association. He said:
`We simply can’t allow bureaucratic incon-
`sistencies to stand in the way of cutting-
`edge medical research that is so important
`to the increasing number of Americans over
`the age of 60. This provision is a common-
`sense response to a problem that unneces-
`sarily has ensnared far too many pharma-
`ceutical companies and caused inexcusable
`delays in drug innovations.
`
`was treating everybody the same. so
`everybody gets equal justice under the
`law,
`they know what the law is. and
`they don’t have to rely upon maybe
`some court decision in one part of the
`country that maybe they can argue in
`another part of the country, and also
`to tell bureaucrats, as the judge said,
`that you can’t act in an arbitrary and
`capricious way. But bureaucrats might
`act in an arbitrary and capricious way,
`in a way unknown to them. if we don't
`have a uniform definition of what a
`business day is.
`So I oppose the effort to strike sec-
`tion 37 from the patent reform bill for
`the reasons I have just given, but also
`for the reasons that were already ex-
`pounded by the chairman of this com-
`mittee that at this late date. after 6
`years of trying to get a patent reform
`bill done—and we haven’t had a patent
`reform bill for over a decade, and it is
`badly needed—we shouldn’t jeopardize
`the possible passage of this bill to the
`President of the United States for his
`signature by sending it back to the
`other body and perhaps putting it in
`jeopardy. But, most important, I think
`we ought to have a clear signal of what
`is a business day, a definition of it, and
`this legislation and section 37 makes
`that very clear.
`This past June, I addressed this issue
`in a floor statement. and I want
`to
`quote from that because I wanted my
`colleagues to understand why I hoped
`the House-passed bill would contain
`section 37 that was not in our Senate
`bill but
`that was passed out of the
`House
`Judiciary Committee unani-
`mously. Speaking as ranking member
`of
`the Senate Judiciary Committee
`now and back in June when I spoke, I
`wanted the House Judiciary Committee
`to know that several Republican and
`Democratic Senators had asked me to
`support this provision as well.
`Section 37 resulted from a recent
`Federal court case that had as its gen-
`esis the difficulty the FDA—the Food
`and Drug Administration——and the Pat-
`ent Office face when deciding how to
`calculate Hatch-Waxman
`deadlines.
`The Hatch-Waxman law of the 1980s
`was a compromise between drug patent
`holders and the generic manufacturers.
`Under the Waxman-Hatch law, once a
`patent holder obtains market approval,
`the patent holder has 60 days to re-
`quest the Patent Office to restore the
`patent terms—time lost because of the
`FDA’s long deliberating process eating
`up valuable patent rights.
`The citation to the case I am refer-
`ring to is in 731 Federal Supplement
`2nd, 470. The court found—and I want
`to quote more extensively than I did
`back in June. This is what the judge
`said about bureaucrats acting in an ar-
`bitrary and capricious way and when
`does the 60 days start.
`The Food and Drug Administration treats
`submissions to the FDA received after its
`normal business hours differently than it
`treats communications
`from the agency
`after normal business hours.
`Continuing to quote from the deci-
`sion:
`
`Page 4 of 42
`
`Page 4 of 42
`
`

`
`S5406
`
`We have also heard from prominent
`doctors from throughout
`the United
`States. They wrote to us stating that
`section 67 “is critically important to
`medicine and patients.
`In one case
`alone, the health and lives of millions
`of Americans who suffer from vascular
`disease are at stake .
`.
`. Lives are lit-
`erally at stake. A vote against
`this
`provision will delay our patients access
`to cutting-edge discoveries and treat-
`ments. We urgently request your help
`in preserving section 37.”
`So section 37 improves our patent
`system fairness through certainty and
`clarity, and I urge my colleagues to
`join me in voting to preserve this im-
`portant provision as an end in itself,
`but also to make sure we do not send
`this bill back to the House of Rep-
`resentatives and instead get it to the
`President, particularly on a day like
`today when the President is going to be
`speaking to us tonight about
`jobs.
`I
`think having an updated patent
`law
`will help invention,
`innovation,
`re-
`search, and everything that adds value
`to what we do in America and preserve
`America’s greatness in invention and
`the advancement of science.
`In conclusion, I would say it is very
`clear to me that the court concluded
`that the Patent and Trademark Office,
`and not some company or its lawyers,
`had erred, as is the implication here. A
`consistent
`interpretation ought
`to
`apply to all patent holders in all cases,
`and we need to resolve any uncertainty
`that persists despite the court’s deci-
`sion.
`I yield the floor.
`The PRESIDING OFFICER. The sen-
`ior Senator from Vermont
`is recog-
`nized.
`Mr. LEAHY. Mr. President, I thank
`the distinguished Senator from Iowa
`for his words, and I join with the Sen-
`ator from Iowa in opposing the amend-
`ment for two reasons. First, as just
`simply as
`a practical matter,
`the
`amendment would have the effect, if it
`passed, of killing the bill because it is
`not going to be accepted in the other
`body, and after 6 years or more of work
`on the patent bill, it is gone. But also,
`on just the merits of it, the provision
`this amendment strikes, section 37 of
`H.R. 1249, simply adopts the holding of
`a recent district court decision codi-
`fying existing law about how the Pat-
`ent and Trademark Office should cal-
`culate 5 days for the purpose of consid-
`ering a patent term extension. So those
`are the reasons I oppose the amend-
`ment to strike it.
`The underlying provision adopted by
`the House is a bipartisan amendment
`on the floor. It was offered by Mr. CON-
`YERS, and it has the support of Ms.
`PELOSI and Mr. BERMAN on the Demo-
`cratic side and the support of Mr. CAN-
`TOR, Mr. PAUL, and Mrs. BACHMANN on
`the Republican side. I have a very hard
`time thinking of a wider range of bi-
`partisan support than that.
`The provision is simply about how
`they are calculating filing dates for
`patent extensions, although its critics
`
`CONGRESSIONAL RECORD — SENATE
`September 8, 2011
`ment rather than to have a clear, con-
`have labeled it as something a lot
`sistent definition? Let’s actually try to
`more. A patent holder on a drug is en-
`titled by statute to apply for an exten-
`put this issue to bed once and for all.
`The provision may solidify Medco’s
`sion of its patent term to compensate
`patent term extension, but it applies
`for any delay the Food and Drug Ad-
`generally, not to this one company, as
`ministration approval process caused
`has been suggested. It brings common
`in actually bringing the drug to mar-
`sense to the entire filing system.
`ket. The patent holder not only has to
`However,
`if the Senate adopts the
`file the extension within 60 days begin-
`amendment of the Senator from Ala-
`ning on the date the product received
`bama, it will lead to real conflict with
`permission for marketing, but there is
`the House. It is going to complicate,
`some ambiguity as to when the date is
`delay, and probably end passage of this
`that starts the clock running.
`important bipartisan jobs-creating leg-
`Only in Washington, DC, could the
`islation.
`system produce such absurd results
`Keep in mind, yesterday I said on the
`that the word “date" means not only
`floor that each one of us in this body
`something different between two agen-
`could write a slightly different patent
`cies—the PTO and the FDA—but then
`bill. But we do not pass 100 bills, we
`it is given two different constructions
`pass 1. This bill is supported by both
`by the FDA. If this sounds kind of eso-
`Republicans and Democrats across the
`teric, it is. I have been working on this
`political
`spectrum. People on both
`for years and it is difficult to under-
`sides of the aisle have been working on
`stand. But the courts have codified it.
`this issue for years and years in both
`Let’s not try to change it yet again.
`bodies. We have a piece of legislation.
`What happens is that the FDA treats
`Does everybody get every single thing
`submissions to it after normal hours as
`they want‘? Of course not. I am chair-
`being received the next business day.
`man of
`the Senate Judiciary Com-
`But the dates of submissions from the
`mittee. I don’t have everything in this
`FDA are not considered the next busi-
`bill I want, but I have tried to get
`ness day, even if sent after hours. To
`something that is a consensus of the
`complicate matters, the PTO recently
`large majority of the House and the
`changed its own method of defining
`Senate, and we have done this.
`what is a “date.”
`In this instance,
`in this particular
`If
`this
`sounds confusing even in
`amendment,
`the House expressly con-
`Washington, you can imagine how it is
`sidered this matter. They voted with a
`outside of the bureaucracy. Confusion
`bipartisan majority to adopt this pro-
`over what constitutes the “date” for
`vision the amendment
`is seeking to
`purposes of a patent extension has af-
`strike. With all due respect to the dis-
`fected several companies. The most no-
`tinguished Senator from Alabama, who
`table case involves the Medicines Com-
`contributed immensely to the bill as
`pany’s ANGIOMAX extension applica-
`ranking member of the committee last
`tion request.
`Congress, I understood why he opposed
`The extension application was denied
`this provision when it was controver-
`by the PTO because of the difference in
`sial and would have had Congress over-
`how dates are calculated. MedCo chal-
`ride the PTO. But now that the PTO
`lenged the PTO’s decision in court, and
`and court have resolved the matter as
`last August the federal district court
`reflected in the bill, it is not worth de-
`in Virginia held the PTO’s decision ar-
`laying enactment of much-neede