As noted here and elsewhere, The Medicines Company (TMC) failed to secure a patent term extension (PTE) for US 5,196,404, its patent on bivalirudin, a peptide drug that is used as an anti-coagulant during surgery and marketed by TMC as Angiomax. The deadline for filing a request for PTE is 60 days after FDA approval, but the FDA and USPTO determined that TMC filed its PTE request for the bivalirudin patent one day late. Oops. The patent is set to expire next month, on March 23.
But when you have a drug worth several hundred million dollars per year, like Angiomax, you don’t take no for an answer. So TMC first tried to get the USPTO and the FDA to change their minds, filing a request for reconsideration in 2002. No dice. Then the Congressman from TMC’s district introduced legislation that would have provided a fix, but the bill is still languishing on Capitol Hill. So TMC secured two further patents, US 7,582,727 and US 7,598,343, on what Madison Avenue might call “new and improved” versions of bivalirudin (with a third application still in the pipeline at the USPTO), promptly listed those in the Orange Book, and when Teva filed paragraph IV certifications against those patents, sued Teva for infringement in October and December 2009. Unfortunately for TMC, since Teva’s ANDA for bivalirudin was filed before the new patents were listed in the Orange Book, there’s no automatic 30-month stay, and the best TMC can hope for right now in that litigation is a preliminary injunction, which may or may not issue before March 23, if it issues at all.
The latest round in the saga is that last week TMC filed suit against the USPTO, the FDA, the Department of Health and Human Services, and their various heads. Two days later TMC filed a motion for summary judgment (Download TMC SJ motion). TMC’s argument boils down to the following:
1. The FDA faxed its approval letter for Angiomax to TMC after business hours on Friday, December 15, 2000.
2. The FDA regards after-hours submissions made to the FDA under 35 U.S.C. §156 as having been filed on the next business day.
3. In contrast, the PTO and the FDA regard the after-hours fax to TMC, a communication from the FDA under 35 U.S.C. §156, as having been sent on December 15, i.e. on the day it was sent, rather than December 18, 2000, the next business day.
4. The PTO and FDA should interpret like terms in 35 U.S.C. §156 consistently, and thus, consistent with FDA policy regarding incoming submissions, should regard the FDA’s approval letter as having been sent on December 18, 2000, i.e. the next business day. If the date of the approval letter was December 18, 2000, then the PTE request, submitted on February 14, 2001, was timely filed.
TMC asserts some other points, e.g. in the context of a refusal of request for reconsideration in 2007, the USPTO announced for the first time a new policy of calculating the 60 day deadline as beginning on the date the FDA approval letter was mailed, and not beginning on the next day, as had been done until that point (with the effect being that the PTE request was filed two days late rather than a day late). But the crux of its argument is that the inconsistency in interpretations of deadlines under the same statutory section is not required by the statute itself, and therefore constitutes arbitrary and capricious agency action.
Reading the SJ motion, it’s hard not to feel some sympathy for TMC: it picked up a drug product that other companies didn’t want and brought it to market, at a cost of several hundred million dollars, and then it (or its lawyers) goofed when calculating the deadline for filing the PTE request.
And it does sound ridiculous that the FDA can use a double-standard when it comes to dating incoming submissions from pharma companies (must be received by the end of the business hours to be accorded a filing date of that day) versus outgoing correspondence (given the date on which it is sent, even if sent after-hours).
It also sounds ridiculous that the USPTO has apparently changed its view mid-stream, and now for purposes of calculating the deadline for requesting a PTE says the 60 day window starts on the day the FDA mailed its approval, whereas filing deadlines for claiming priority from patent applications or for filing responses to Office Actions begin the day after filing (e.g. if you file a provisional on January 1, you have until the following January 1, not December 31, to file a non-provisional claiming priority therefrom; a response to an action mailed on February 1 with a three month deadline must be filed by May 1 to avoid incurring extension fees).
None of that, however, changes the fact that TMC (or its lawyers) goofed. Reading between the lines (I have not checked PACER to see if any of the documents referred to in the SJ motion are available, let alone read them), it seems that TMC only decided to rely on the distinction in the FDA’s practice regarding the dating of incoming versus outgoing correspondence after the mix-up occurred. True, if TMC had reasoned a priori that the effective date for the FDA’s approval letter was December 18, and that its filing deadline should be calculated as 60 days beginning December 18 inclusive, then it would have determined that the deadline was February 16, a Sunday, and might have pushed its filing up to Friday, February 14. But TMC doesn’t actually allege that it calculated the date in accordance with the December 18 date; TMC only asserts that now, December 18 is the date that should be used to calculate the PTE filing deadline. More importantly, when you’re dealing with what is likely to be a big seller for you, you err on the side of caution in calculating the date; and normally, you assume the date something was mailed or faxed is the date stamped on it. In which case TMC should have calculated the deadline correctly. So it seems unlikely that TMC itself bought into this “next business day” calculation at the time it filed the PTE request.
My own suspicion is that TMC either calculated the deadline as two months, rather than 60 days, beginning on December 15, thus making the deadline February 14; or it calculated the deadline as two months beginning from December 16, making the deadline February 15, 2001, a Saturday, and pushed the filing up to the last business day before the deadline. It’s not necessarily unreasonable to confuse a 2-month deadline with a 60-day deadline, but the statute does say 60 days, not two months. And whereas the statute provides the Director with discretion to extend certain deadlines, the deadline for filing a PTE isn’t one of them.
TMC’s implied assertion, viz. that it’s unfair to penalize TMC for missing the filing by a single day, also rings hollow. The law is full of examples where a single day makes all the difference. If you were born 18 years before election day, you get to vote; but if your 18th birthday falls the day after election day, you don’t get to vote.
Nor does TMC make a compelling argument for why the inconsistency in FDA policy regarding dating, if it needs to be resolved, should be resolved as TMC proposes it, viz. that after-hours communications from the FDA should be accorded a date of the next business day. Why shouldn’t the matter be resolved in the other direction, so that the filing date of a paper would be the day on which it is submitted? On its face, that seems a more logical approach.
Anyway, whatever sympathy one might have toward TMC’s predicament tends to dissipate in view of the fact that the suit was filed so close to the date of patent expiration, when, evidently, the suit could have been filed almost three years earlier. According to the SJ motion, TMC filed a request for reconsideration that was rejected by the USPTO in April 2007; in December 2009 it filed a second request for consideration, which was rejected in January 2010, and only then did TMC file suit under the Administrative Procedures Act. But already in 2007, TMC argued that the FDA’s and PTO’s calculation of the deadline was improper, and should have started from December 18, 2000. So if TMC had these arguments in hand in 2007, why did it wait over two-and-half years to again request reconsideration and then to sue the PTO, the FDA and HHS?
I don’t know enough about APA proceedings to know if TMC could have sued right away in 2007, or if laches (an equitable argument) could apply in the present case (a case brought at law) due to the delay, but I hope that that’s part of the Federal Government’s response.
The delay in the filing of the suit isn’t just whistling Dixie: there was reliance by third parties on the non-issuance of the PTE. Teva/Barr/Pliva filed an ANDA with a paragraph III certification regarding the patent in question (i.e. that it won’t sell its product until after the expiration of the patent), not a paragraph IV certification. Grant of a PTE here will force Teva to revise its ANDA to include a P-IV certification against this patent; or to wait close to another five years to introduce its product, until the extension expires; or to launch its product at risk. But since the ‘404 patent was listed in the Orange Book at the time the ANDA was originally filed, if the PTE is granted and Teva files a P-IV certification, TMC would be entitled to a 30-month stay when it sues Teva for infringement of the ‘404 patent (unlike the already pending suits on the newly listed patents). Which presumably is why TMC waited to file suit against the government.
Finally, an interesting question to ponder is, what happens if the court doesn’t rule before the patent expires? Or if it rules against TMC but TMC appeals? 35 U.S.C. §156(e)(2) says,
(2) If the term of a patent for which an application has been submitted under subsection (d)(1) would expire before a certificate of extension is issued or denied under paragraph (1) respecting the application, the Director shall extend, until such determination is made, the term of the patent for periods of up to one year if he determines that the patent is eligible for extension.
§156(e)(2) empowers the Director to issue a temporary extension under because the PTO hasn’t yet completed its determination of the eligibility of the patent for the extension. But that’s not the case here. Here, the PTO’s position is that, for purposes of §156(d)(1) and (e)(2), TMC didn’t submit an application, because the so-called application was submitted after the deadline and therefore, for purposes of the statute, was not submitted. There is no provision for the Director to issue an interim extension because there is a dispute over whether or not the PTE application was timely filed. (§156(d)(5)(B) provides for interim extensions when FDA review is still ongoing.) But if no interim extension is granted, and on appeal TMC wins, what then? And if the court preliminarily orders the Director to grant an interim extension, only to eventually rule against TMC, will TMC have to compensate Teva, and the consumers who paid higher prices than they should have while the temporary extension was in place?
Against the foregoing discussion, the last line of its SJ motion is almost comical. It reads, “The Court should also order the PTO to take such actions as necessary to ensure that the ‘404 patent does not expire pending further resolution of these proceedings”. Well, sure. Wait until the last minute to file suit and then ask that the court ensure your rights aren’t harmed as a result of that late filing – in so doing possible unnecessarily prejudicing third parties and the public. It’s not quite the classic case of the man who kills his parents, then pleads for mercy before the court because he’s an orphan, but it’s not so far off either.
So by waiting to file its suit, TMC has created a cloud over the status of the ‘404 patent. TMC is the only beneficiary of the existence of that cloud. While it’s not as good a position to be in as having the PTE in hand, it’s not a bad position for a company that missed its filing deadline.
