PTO Once Again Denies PTE for ANGIOMAX Patent . . . But Not Before Issuing an Interim Extension; MDCO is Outraged

March 22, 2010

By Kurt R. Karst –      

Just days after Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) issued his opinion and order vacating the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) and remanding the case to the PTO for further consideration, the PTO, on March 19, 2010, once again denied MDCO’s PTE application in a 15-page decision (accompanied by more than 300 pages of attachments).  Heeding Judge Hilton’s order to “take such actions as necessary to ensure that the ‘404 patent does not expire pending further resolution of these proceedings,” and at the same recognizing the Federal Circuit’s 2007 ruling in Somerset Pharmaceuticals v. Dudas that an interim PTE is not available when the PTO has already denied a PTE application, however, the PTO’s March 19th denial was preceded by a March 18, 2010 decision (here and here) granting MDCO an interim PTE  until May 23, 2010 for the '404 patent.

As we previously reported, Judge Hilton’s March 16, 2010 decision stems from a January 2010 Complaint and Motion for Summary Judgment following the PTO’s January 8, 2010 denial of MDCO’s December 2009 Request for Reconsideration asking the PTO to employ a “rule of construction” under which the Office would consider the 60-day PTE application submission period at 35 U.S.C. § 156(d)(1) to commence on the first business day after the day the FDA transmits notice of NDA approval of the drug product if that transmittal occurs after normal business hours (i.e., after 4:30 PM east coast time in some cases).  In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on Monday, December 18, 2000 and the PTE application would have been timely filed within 35 U.S.C. § 156(d)(1), rather than on Friday, December 15, 2000 when FDA issued its approval letter for the ANGIOMAX NDA (NDA No. 20-873) – albeit at 5:18 PM on that day. 

Judge Hilton in his 18-page opinion, which tracks MDCO’s briefs in the case, explained that the PTO erroneously believed that the Office’s construction of the term “date” in 35 U.S.C. § 156(d)(1) to mean “calendar day” was compelled by the PTE statute and that the Office lacked any discretion to adopt MDCO’s “business day” construction.  Judge Hilton also identified several arguments that MDCO made to support its “business day” construction – i.e., that the focus of 35 U.S.C. § 156(d)(l) is “on the date approval was received, the purpose of § 156(d)(1), the need to ensure that all applicants received the 60 days to file extension applications that Congress required[,] and the ways in which [MDCO’s] interpretation of date in combination with its new counting rule is inconsistent with that requirement” – and faulted the PTO for not considering them and for not providing an analysis of the Office’s plain meaning definition of the term “date” as “calendar day.”

The PTO’s March 19th decision expressly considers each one of these points (although previous decisions appear to have discussed them as well, but not in such detail).  Here are some tidbits from the PTO’s decision:

  • The date stamped on the FDA approval letter covers a calendar day. . . . Congress has not restricted the FDA to approve drugs before a certain time of day such as 4:30 p.m., the cut-off time that Applicant advocates here. Applicant's position that approval must occur on a business day, prior to 4:30 p.m. east coast time, in order to be deemed effective on that day is consequently not supported by statute. Nor does it make sense for the FDA to limit its approval window to a few hours in a day.  Because Applicant essentially argues that FDA must stop official business at 4:30 p.m. east coast time, including halting the review of applications, Applicant's position could also prolong the approval process – to the detriment of industry and the public.

  • MDCO isolates the word "received" from section 156(d)(1) and contends that it shows that Congress intended for the patentee to have constructive receipt of the FDA approval before triggering the 60-day filing window.  In Applicant's view, "an after-hours communication should be deemed to have been received on the next business day."  The presence of the word "received" in section 156(d)(1), however, must be read in context. The statute speaks in terms of the "product receiv[ing] . . . permission for commercial marketing or use." The statute says nothing about the patentee actually or constructively receiving notice of the FDA approval. Hence, Applicant's argument is not fully consistent with the statutory language of section 156(d)(1). In fact, . . . one reason why the term "received" in section 156(d)(1) cannot refer to the actual, or even constructive, receipt of an approval letter is because some permissions within the scope of section 156(d)(I) do not come in the form of approval letters at all. See, e.g., 35 U.S.C. § 156(g)(2)(B)(ii) (specifying that the regulatory review period for a food or color additive ends on the effective date of a regulation).

  • The patent law includes various time periods (other than the one at issue) that are measured from events or actions that do not take place in the USPTO, for example, the publication of a description of the invention, the public use of an invention, the placement of an invention on sale, the filing of an application in a foreign country.  In all instances, the USPTO uses the calendar date for all trigger dates.  Regarding the actions that the USPTO itself takes, the agency, like the FDA, is not limited to "business hours."

  • The USPTO acknowledges that the FDA uses the 4:30 rule in the limited context of electronic submissions to determine when a new drug application is submitted, but the FDA does not use that same rule when assessing the date that same application is approved. . . .  The FDA only applies the 4:30 rule to the beginning date.  That beginning date is not relevant to the 60-day filing window provided in section 156(d)(1) because the date an applicant submits a new drug application to the FDA is unrelated to a time period that turns on a subsequent approval of that application. Instead, it is the ending date in section 156(g)(1)(B)(ii) that is relevant to 60-day filing window of section 156(d)(1) because the conclusion of the review period marks the beginning PTE application filing window. . . .  [T]he USPTO concludes that the best approach is to interpret section 156( d)' s date language in harmony with the FDA's approach to interpreting the ending date language in section 156(g)(1)(B)(ii).

  • Beyond the disharmony it would create with the FDA's interpretation of section 156(g)(1)(B)(ii), there are other problems with MDCO's arguments in favor of the 4:30 rule. First, the FDA's refusal to accept new drug application submissions after 4:30 p.m. bears no logical connection to whether a facsimile transmission sent after that time is received on the same calendar day. . . .  Second, the FDA was conducting business after 4:30 p.m. on December 15,2000, and any other time it takes action. . . .  Third, MDCO fails to consider that a 4:29 p.m. approval would deprive an applicant for a patent term extension of the full 60-day period just as much as a 4:31 p.m. approval.  Finally, . . . [h]ad the FDA notified MDCO of the approval of its drug via postal mail only, MDCO could not allege that the term "date" in section 156(d)(l) means "business day" because there would be no after business hours transmission of approval from the FDA to quibble over. Thus, this entire litigation was made possible solely because the FDA chose to extend a courtesy to MDCO and provide as prompt notification of FDA approval as possible.

  • [T]here are indeed many instances where the USPTO prevents loss of rights due to an applicant, appellant, or patentee's failure to meet certain deadlines. But in all of those cases, Congress has provided the avenue for the relief available at the agency, and thus to the applicant or patentee. In light of that, it speaks volumes that Congress provided no avenue to allow the USPTO to accept a late PTE application filed under section 156. Given Congress's unquestionable awareness that lawyers make mistakes, and the various provisions it provided to redress those mistakes, Congress's failure to include a similar provision related to the section 156(d)(1) 60-day filing window compels the conclusion that Congress did not intend the provision to be remedial, or to be interpreted in a way that benefits late-filing PTE applicants.

And perhaps one of the most important general points . . . .

  • [A] PTE application is a relatively short filing. The statute requires only certain minimal items of information. See 35 U.S.C. § 156 (d)(1)(A)-(E).  Consequently, it is not as if a patent owner needs a full 60-days to assemble an of the necessary information and/or prepare the application. In fact, all the information that MDCO needed, except for its FDA approval, was – available well before December 15,2000.  And on December 15,2900, MDCO received the missing FDA approval.  Thus, MDCO was equipped on December 16, 2000, to file its PTE application.  An applicant for PTE gains no advantage, nor does it receive any additional restored term, by waiting to the last minute to file its PTE.

Apparently outraged at the PTO’s efficiency in expeditiously issuing its denial a mere 72 hours after Judge Hilton’s decision, MDCO’s CEO told the New York Times “Now I’m at war; this is very disconcerting . . . . It’s not even polite, you know what I mean?”

MDCO will almost definitely challenge the PTO’s latest denial.  Absent the interim extension, the ‘404 patent would expire on March 23, 2010.  (The patent is also subject to a 6-month period of pediatric exclusivity.)  Depending on when the case is resolved, additional interim PTEs may follow. 

Categories: Hatch-Waxman