Lobbying for a Patent Term Extension

Medicines Company (MDCO) v. Kappos (Fed. Cir. 2011)

The FDA approved the new drug application (NDA) for MDCO’s blockbuster drug Angiomax (bivalirudin) on December 15, 2000.  As it turns out, it is important that the approval came at 5:18 pm on a Friday. After the approval, MDCO filed for a patent term extension (PTE) based upon the delay in the regulatory approval process. Unfortunately, the company waited until February 14, 2001 to file the PTE application — just past the sixty-day period allowed under the statute. The PTO refused to consider the application because it was late. 

MDCO has been fighting its loss of term extension on three fronts: (1) privately with its prosecution firm; (2) in court against the PTO and (3) in the halls of Congress.  It appears that the company is likely be successful in the end.

First, in February 2011, WilmerHale (and its malpractice insurers) agreed to pay MDCO $18 million for past expenses and made available an additional $214 million in case generic bivalirudin goes on the market in the US prior to June 2015 as a result of PTE not being granted or being held valid.   The $18 million reportedly covers the expenses associated with litigation against the PTO and lobbying congress.

In court, the district court applied an “after-business-hours” exception to the statute and therefore agreed with MDCO that the PTE application was timely filed.  The PTO chose not to appeal that decision. However, a German generic manufacturer –  APP Pharma — is attempting to intervene and appeal on behalf of the USPTO. APP has a strong argument on the merits, but a weak argument on its own standing.  The appellate court earlier rejected a motion to bifurcate the appeal between the standing issue and the merits issue and will instead hear them jointly.

Finally, the recent patent reform bill passed in the House of Representatives (H.R. 1249) includes a provision particularly crafted to aide MDCO. The provision says simply that, for the purposes of calculating the PTE application due date, any regulatory after 4:30 pm will be considered to have occurred on the next business day. (Amending 35 U.S.C. 156(d)(1)). That provision, however, is not in the Senate’s version.

Although not written as such, the legislative measure is essentially a private relief bill directed to help MDCO (no other pharmaceutical company has or will make the same mistake).  There is some precedent for straightforward term extensions, including ones for patents covering aspartame (6 years), isoflurane (5 years),  Impro (15 years), glyburide (6 years), gemfibrozil (3 1/2 years), olestra (3 years), oxaprozin (2 years).

Notes: Kurt Karst has been following the case in detail at his FDA Law Blog.

27 thoughts on “Lobbying for a Patent Term Extension

  1. Does anyone know what drug was the subject of 35 U.S.C. 155A? Or why the statute sets forth all those goofy conditions which are probably satisfied by only that drug, instead of just naming the dang thing?

  2. Well, even if it is a private bill, I get the sense of Congress that they were not pleased with the PTO being so anal about the deadline, especially when the mistake was one of negligence (at best) and not one of intention.

  3. I wish. I mean that there could be something that would stop a given specific agency from getting the last word in a specific situation but typically they just go to court, get chevron difference and win the day.

  4. And by “I could be wrong”, you really mean you have no idea and are just making something up.

  5. “but the idea that there is no significant difference between the two political parties is absurd. ”

    It isn’t that absurd.

  6. Mooney–

    “Increasing the cost of health care for the average citizen”? What a bunch of carp.

    I offer no opinion on the desirability or propriety of such private relief bills, but I do offer advice on your political rants:

    Stop making them. They suck.

    So badly, in fact, that they aren’t worth discussing substantively.

  7. Yes, Sec. 18, “Transitional Program for Covered Business-Method Patents” was another surprise last minute amendment. There are only some explanatory remarks reported in the Congressional Record as to some (difficult an needed) terminology definitions made on the Senate floor on the day of S.23 passage.
    Sec. 18 will provide, for a limited term of 4 years, a limited subject matter version of the “Post-grant review” in the same Bill, only for non-technical business methods, but not limited to any post-grant time period, and with special District Court litigation stay and interlocutory appeal provisions, etc.
    But this will be an expensive reexamination proceeding with dangerous estoppels for losing, and real question as to whether the PTO can process reeaminations fast enough, especially with a requirement that the petitioner must be somseone charged with infringement or subject to a lawsuit on the subject business method patent. So as usual, the media hype and the actual likely usage of this seems way overblown.

  8. “I heard in the debates in the House. From the debate, it appeared that the same statutory deadline to file for a PTE was interpreted differently by two different agencies. ”

    I could be wrong, but the agency you’re about to file with probably has the final say in such disputes. I guess the EPA weighing in is not entirely unreasonable, but I don’t think they have much say so here.

  9. Significance always has to be related to a referent.

    In the case of a referent such as a sociological trajectory of western civilization, it is likely that there is in fact no significant difference.

  10. The difference between a “republican politican” and a “democratic politician” falls to the difference between a “republican” and a “democrat” – but the difference is like a spit in the ocean comapred to the similarity in that both contain the word “politician.”

    Okay, grandpa. I’m disappointed with some of the Democratic representatives I’ve voted for in the past, but the idea that there is no significant difference between the two political parties is absurd.

  11. Well, I’m going to walk back my partisan comments above, just a tad. :)

    The difference between a “republican politican” and a “democratic politician” falls to the difference between a “republican” and a “democrat” – but the difference is like a spit in the ocean comapred to the similarity in that both contain the word “politician.”

    That’s why any comments on this blog relating to the difference between “republicans” and “democrats” are just a waste of space.

  12. it’s hard not to feel sorry for MDCO

    My heart BLEEDS for this tiny, struggling company.

  13. Well, I’m going to walk back my partisan comments above, just a tad. :)

    House Roll Call here:

    link to clerk.house.gov

    This is effectively a bipartisan bill in the House, although most Dems appears to support, and most GOP members don’t — at least not as it’s currently being presented.

    Rep. Ed Markey (D-MA) gets the award for all-time most ridiculous comment: ““[r]ight now, America’s next Lipitor or Prozac could be bottled up at the Patent Office and never made available because of uncertainty regarding the patent term extension process….”

    ROTFLMAO

    Thanks, Dennis, for the link to the FDA Law Blog.

  14. Ned, both patentdocs and especially fdalawblog.net have covered this in more detail than was given here. Off the top of my head, MDCO has been lobbying for several years to pass this law, the so-called “The Dog Ate My Homework Act”. It was originally introduced as stand-alone legislation by someone from MA – MDCO’s home district – but didn’t get very far. And yes, it is definitely a piece of private legislation, even if worded as if it has general applicability.

    What happened is pretty clear, and even attested to by MDCO’s CEO in testimony before Congress (in a previous Congress, not this one): after receiving FDA approval, the patent prosecution firm docketed the PTE request for two months instead of 60 days. Oops. Which is why WilmerHale is willing to pay out if necessary (although of the $214 million, only $99 will be covered by malpractice insurance, the rest will be covered by the firm itself over something like 20 years).

    IIRC, when MDCO petitioned to have the PTE submission regarded as timely filed, the USPTO said, forget it, the FDA notice was granted on Friday, so the clock started to run on Saturday, you missed the filing by a day. But then when MDCO asked for reconsideration, the PTO came back with a different rationale, saying the clock started to run on Friday and MDCO missed by two days, not one. This change in rationale gave MDCO’s lawyers at Sidley Austin enough room to shoehorn something in before the court in NDVA on admin law grounds; if the PTO had stuck to its original reasoning, the case wouldn’t have made it to court. Last year the district court found for MDCO, based on the issue of when you start to count the 60-day timeframe, and as Dennis reports the matter is now before the CAFC.

    While it’s hard not to feel sorry for MDCO – this is a big drug, by rights it deserves a PTE – MDCO also played a bit dirty in that it waited for several years after the original petition denial to request reconsideration, during which time several generic drug companies were gearing up to compete. But the issue of laches in pursuing its case before the PTO never came up. Since the PTO didn’t appeal, if the CAFC decides that the intervenor doesn’t have standing, MDCO will win.

  15. Finally, the recent patent reform bill passed in the House of Representatives (H.R. 1249) includes a provision particularly crafted to aide MDCO. The provision says simply that, for the purposes of calculating the PTE application due date, any regulatory after 4:30 pm will be considered to have occurred on the next business day. (Amending 35 U.S.C. 156(d)(1)). That provision, however, is not in the Senate’s version.

    Although not written as such, the legislative measure is essentially a private relief bill directed to help MDCO

    Because MDCO hasn’t made enough money yet? Because the worst thing ever would be if more people could afford bivalirudin?

    Effectively you have the Republican-controlled House voting to increase the cost of health care for the average citizen. Of course, that’s not the first time they’ve done that.

  16. Is the future that, if my issue fee is due on Friday, February 3, 2012 and I pay via EFS on Friday, February 3, 2012 after 4:30 P.M EST, the issue fee shall be deemed received on the next business day? (deemed received on February 6, 2011)?

  17. If an Actor learns his or her part through learned behavior… for the scenes as in (example)the AWARD WINNING RAIN MAN DID…. Then in a REAL Perry Mason world… who does not live through the evidence the same way? You need to go to the real subjects. Those you believe … and those you don’t. “ARMCHAIR” A new definition for ARMCHAIR. FOR THOSE THAT HAVE SEEN AND DEFINED WHAT IS IS.. AND FOR THE DEFINERS THEMSELVES.. be it those that can define it, or those that have the experience to redefine it as in.. what Judy my sister defined to a waitress at a Thanksgiving dinner to a Waitress saying she was in the business. At the time I along with most of my family were embarresed by her offering to the Waitress at the time… But as in many things I hear and bang around in my PEA BRAIN, she taught me a valuable lesson then. She was what she spoke of.

  18. I guess not being a Lawyer, what I say might not mean anything. But here goes. Why can’t all of you get a Law firm, file a class action as John Doe. And ask for the Congress to work in the country’s best interest. And then as a bunch of John Doe’s work together to make sense of what needs to be done in the USPTO, which surely is in relationship to as a Bicycle being the main wheel that drives the chain to move the Bicycle.
    We will fail as a Country if we don’t do something. I may not have the answer. But John Doe does.

  19. This story just reaffirms my view that the AIA is as tainted and corrupt as the process by which it passed. Just like Obamacare. Time for another revolution folks.

  20. I haven’t investigated this case, but this post does not sound at all like full story.

    I heard in the debates in the House. From the debate, it appeared that the same statutory deadline to file for a PTE was interpreted differently by two different agencies. I heard, IIRC, that MDCO was in compliance with the one interpretation but not with the other.

    The argument for a statutory change in the house was that the present statute was subject to two different legitimate interpretations that had to be clarified and that it was not a private relief for one company. Based on this representation, the amendment to the bill passed.

    The nays argued that it was a private relief bill for one law firm. That view was supported by nearly half the house, but it lost narrowly.

    I don’t know who was in fact right, but the story here seems to be incomplete.

  21. Really,
    I talked with one guy for 5 or 6 weeks. I send him Drawings right away. he says they are lost way after after I am told to send another Check by the Secretary. I Don’t resend the Drawings though they are not the issue.
    almost 5 weeks later I get the Search… He is gone after I get the Search. And it has the three Drawings he claims are all I can have in a Patent. No Computer. And of course he knows this. So he can tell me ANYTHING!
    Then I get another Guy. Claiming he is now my “LAWYER”.
    He asks me to send the Drawings again. Only 3 again as instructed earlier. And still I wonder what? So I make him a Model.
    About a couple weeks later I get an app. to sign. I won’t It needs changes. So i also send hima model i made.
    I am at work I get a call from a Guy named Brian Taylor. The discussion is all about the Jet Ski Fender, nothing else?
    After a good nights sleep I GET IT!
    I didn’t have a computer when the Gazette was published so I went to the Library, and there it was my Jet Ski Fender boobing beside a Solid Swim Platform.
    The same photo as on the front of my Fake Patent. So I without Computer didn’t know that my REAL PATENT was probably just about the Jet Ski Fender. But the truth is I still never got a real one. So my First Patent I thought was really my fake Patent.
    So Brian Taylor was the link that they chose… SCREEN MAYBE? They had already filed my Idea for themselves and gave me the crumbs. But they let me think I had a Patent that was worth something.
    So my First Patent was a design Patent although I paid approx. 4,000.00 for it. So to begin with I don’t think you can mix apples and oranges.. as in Design first as a Parent and then Utility as a child.
    So now the Pic that was on the cover, is no longer on the cover.
    So as I said earlier the Oct 19 th cover letter. And the # 19 is missing on the Utility. And another thing the Guerwood was born on the 19th.
    And when I told the first guy I wanted my Application to reflect a fender hanging over the side of the boat. He said NO! It had already been invented. And when I told Him why can’t my I have a Fender like the Jet Ski on the side… He said No you can’t It has already been invented. That was July of 1995! And the single one.. He claims was Lemke? That is why I filed the second one. They also took the Independent claim, Claim 1 from me and left it down on the Jet Ski Fender, claiming he (Lawyer #2) knew what he was doing, and said it was a cake walk
    Corruption?
    So I never got a Computer until I came back from Fla.
    I had a Computer in 1995 that my son played games on. And I typed on, a Commodore 64. But there was no Internet connection. And I don’t even know if it could be connected.

  22. Always nice to see that our Congress is the best money can buy. Between this and the handout to banks for the DataGeneral patent, we know that lobbying dollars work.

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