In an earlier post, I discussed The Medicines Company’s last-ditch effort to save the exclusivity for its Angiomax product via its US 5,196,404, which was due to expire on March 23, 2010. Last week, the Federal District Court for the Eastern District of Virginia ordered the USPTO to reconsider its decision denying TMC’s application for a patent term extension in light of issues raised by TMC, and to ensure that the patent would not lapse prior to disposition of the suit pending before the court. In response, the USPTO issued an interim extension of the patent until May 23, but then issued a decision in which it again denied TMC’s application. The decision did not rescind the interim extension order, and thus it still stands, unless the EDVa says otherwise before May 23.
TMC’s Problem
To recap the situation, TMC’s application for a patent term extension (PTE) was filed a day late and denied on that basis. So TMC requested reconsideration, but that too was denied in April 2007. Rather than appeal that decision to the courts, TMC turned to lobbying, to try to secure an amendment that would have retroactively allowed for the late PTE filing. But that effort also went nowhere.
The PTO took the bait, allowed the filing of the second reconsideration request, and, as expected, denied it on January 8, 2010. Whereupon, on January 27, less than two months before the ‘404 patent was to expire and close to three years after the second reconsideration request was denied, TMC sued the USPTO, the FDA, the Department of Health and Human Services, and their various heads in federal court in the Eastern District of Virginia, requesting that the court order the USPTO to regard the PTE request as having been timely filed and to grant the PTE. (Undoubtedly, had the PTO denied leave to submit the second reconsideration request, TMC still would have found grounds to sue – denial of due process, perhaps? – and still would have reopened the whole can of worms.)
TMC Goes to Court
TMC’s argument before the court hinged on the meanings of 35 U.S.C. §156(d)(1) and §156(g)(1)(B)(ii), which respectively state in pertinent part
:
§156(d)(1). To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director. Except as provided in paragraph (5), such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use. * * * [emphasis added – DJF]
§156(g)(1)(B)(ii). For purposes of this section, the term "regulatory review period" has the following meanings:(1) (B) The regulatory review period for a new drug, antibiotic drug, or human biological product is the sum of - (i) the period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 became effective for the approved product and ending on the date an application was initially submitted for such drug product under section 351, 505, or 507, and (ii) the period beginning on the date the application was initially submitted for the approved product under section 351, subsection (b) of section 505, or section 507 and ending on the date such application was approved under such section. [emphasis added – DJF]
TMC argued, first, that the FDA itself takes an inconsistent approach with regard to what constitutes a “date” under §156: for papers filed by applicants, the FDA adopted a “business hours” interpretation of the word “date”, such that papers filed with the FDA after business hours were considered to be filed on the next business day; but for papers sent by the FDA, it was the actual calendar date on which the document was sent, even the communication was sent after normal business hours. This inconsistency within the same statutory section is ipso facto arbitrary and capricious, said TMC, and thus in violation of the Administrative Procedures Act.
Furthermore, argued TMC,
(a) the PTO adopted the FDA’s interpretation of “date” in §156(d)(1), when the PTO could instead have adopted its own interpretation of this term, namely an “after hours” definition of this term, and
(b) although the PTO argued that an “after hours” definition of “date” in §156(d)(1) was precluded by the wording of the statute itself, the PTO was wrong, and an “after hours” interpretation of “date” in §156(d)(1) was not foreclosed by the statute.
The Court's Memorandum Order
On March 16, 2010 – seven days before the ‘404 patent was to have expired – the District Court issued a memorandum opinion and order. The court ruled that in denying TMC’s second petition for reconsideration, the PTO had failed to address various many of the arguments set forth by TMC, and that the PTO itself, in earlier litigation regarding §156, had said that these statutory provisions should be “liberally construed” so as to enable the remedial nature of §156 to be given full effect.
The court noted that the PTO had implicitly rejected the possibility of giving a “business hours” interpretation to “date” in §156(d)(1), without giving reasons for its position; and that this interpretation was at odds with the FDA’s own position on the use of this term in §156(g) with respect to papers filed by PTE applicants in their dealings with the FDA, but in it denial of TMC’s second reconsideration request, the PTO had not even tried to reconcile this difference.
The court also noted that §156(d)(1) refers to the date on which the product “received permission”, whereas §156(g)(1)(B)(ii) refers to the date on which the application was “approved”, and therefore the “date” referred to in these sections is not necessarily the same.
Thus the court issued a memorandum opinion and order vacating the PTO’s decision regarding the reconsideration petition and remanding to the PTO for reconsideration of the date of approval under §156, and ordering the PTO to “take such actions as necessary to ensure the ‘404 patent does not expire pending resolution of these proceedings”.
Interim Extension
On March 18, 2010, TMC filed a request for an interim extension in accordance with 35 U.S.C. §156(e)(2). TMC asked for the maximum 1-year interim extension, on the grounds that even if the PTO were to find immediately find that TMC had timely filed its PTE application, it would be well after March 23, 2010 when the matter would finally be resolved – it would take time for the FDA to check the amount of extension due, for that finding to be published, and for the period of public comment to pass before the PTE could be granted. Conversely, wrote TMC, if the PTO again denied the PTE application as having been untimely filed, TMC would still entitled to seek reconsideration and subsequent court review.
That same day (and in accordance with the court order), the PTO granted an interim extension – but only until May 23, 2010.
Even if TMC ultimately loses its bid for a PTE, it’s already won: every additional day of exclusivity for Angiomax is worth over ten million dollars, and its clear that the PTO will continue to grant interim extensions as long as proceedings are pending before the court. The fact that the current interim extension was granted for only two months is a means of ensuring that TMC doesn’t drag out the proceedings longer than allowed by law, but will not result in faster disposition of the case - it will just mean that TMC will file its request for reconsideration on the last possible date. Assuming, that is, that its lawyers at Sidley Austin (who were not the ones who handled the original PTE application) properly docket the deadline. Which of course they will – lightning doesn’t strike in the same place twice, right?
The PTO's Rejection of TMC's Petition on Remand
On March 19, a day after issuing the interim extension, the PTO again determined that TMC’s PTE application wasn’t timely filed. This time, though, the PTO addressed the points that the EDVa court said it had failed to address in its earlier decision denying the second request for reconsideration. Among other things, the PTO said that it had originally determined the (un)timeliness of TMC’s PTE application on its own, without recourse to the FDA’s views on the matter; that a calendar day was the best way to interpret “date” in §156(d)(1) in view of the text, structure and purpose of the statute (among other things noting that a calendar day definition provide the most certainty in interpreting the statute); and that such interpretation of “date” in §156(d)(1) was consistent with both CAFC precedent and the USPTO’s historic practice (noting inter alia that the USPTO consistently uses a calendar day definition of “date” with regard to events outside the USPTO, such as events triggering an on-sale bar, and that the USPTO in its own dealings allows filings until midnight on the date in question). Along the way, the USPTO noted that whereas the patent statute provides the Director with discretion to grant extensions in certain situations, or to allow applicants or patentees to rectify missed filing dates, no such provisions are made for the filing of PTE applications. “By creating such a non-extendable period, Congress provided a date-certain period by which all players would know their future rights.”
Most entertaining were the PTO’s observation brought to support its conclusion that TMC’s predicament was of its own making. Thus the PTO quoted from testimony given before Congress by TMC’s chairman, who averred that “Unfortunately, the 60-day requirement was evidently mistaken for a two-month requirement…” It also cited numerous occasions on which TMC itself stated that approval for Angiomax was granted on December 15, 2000, such as in shareholder’s reports. And no less importantly, noted the PTO, while the USPTO issued its denial of TMC’s reconsideration request in April 2007, TMC did not timely sue the USPTO or the FDA, but instead
“spent the past three years lobbying Congress for a legislative fix to its problem…Thus, it was [TMC]’s choice to place itself on the courthouse steps on the eve of its patent expiration. Just as [TMC] waited until the very last minute to file its PTE application, and them some, it likewise waited to the very last minute to seek redress of the USPTO’s adverse patent term extension decision. [TMC]’s dire situation is therefore exclusively of its own making.”
In my previous post on this topic, I likened TMC’s situation to the person who kills his parents, then pleads for mercy before the court because he’s an orphan. Apparently the USPTO sees it that way as well.
Whither the Third Parties, And Other Conundrums
Aside from the EDVa sanctioning TMC’s gaming of the system, there are other troubling aspects to this story.
For starters, at least one company, Teva, has a pending ANDA for bivalirudin. While the PTO recognized in its most recent decision that third parties (such as Teva) have a stake in the PTE determination, it is unclear that such third parties have any redress in the present situation. I am not sufficiently versed in the administrative procedures act to know if Teva, for example, can intervene in TMC’s petitions, but considerations of justice would seem to mitigate in favor of such intervention. Teva filed a paragraph III certification regarding the ‘404 patent, which means that but for the just-granted extension of the patent, the FDA could approve Teva’s ANDA for bivalirudin later this week. So if FDA approval is the only thing holding Teva back from selling (and no preliminary injunction has issued against Teva on the basis of TMC’s late-granted US 7,582,727 and US 7,598,343 in the pending litigation on those patents, against which Teva amended its ANDA by filing paragraph IV notifications), then TMC will unfairly benefit from the present interim extension, Teva will lose an opportunity to make money, and consumers will pay more for bivalirudin than they otherwise should. In the narrow administrative law view of the case taken by the EDVa, which focuses only on TMC and the USPTO’s actions, those concerns seem to have been lost.
Another interesting question is, why didn’t the USPTO include the explanations it provided in last week’s decision in its decision of January 8, 2010? Inclusion of those explanations would have expedited the matter before the EDVa.
Also, here the USPTO took just two days to issue a 15 page decision with annexes; so why does the USPTO putter around with re-examinations (which are supposed to be handled with “special dispatch”, i.e. quickly), especially in those cases where litigation is pending at the same time? If the USPTO can produce this kind of work this quickly in this case, it can act more quickly in reexaminations. Unless, of course, its new explanations aren’t new but were already in hand weeks ago…in which case, it again must be asked, why didn’t the USPTO include them in its decision of January 8?
