Monday, April 05, 2010

Hatch-Waxman Patent Term Extension Deadlines: Business Day or Calendar Day?

35 U.S.C. section 156(d)(1) provides:

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.
The Medicines Company ("MDCO") received a patent relating to Angiomax that was originally filed on December of 1997.  Almost three years after the date of filing - by letter date-stamped Friday, December 15, 2000 and transmitted to MDCO by fax at 6:17PM, the FDA sent written notice that the Angiomax NDA was approved.

On February 14, 2001, MDCO submitted its patent trerm extension application to the USPTO, claiming that, due to the length of regulatory review, the expiration of the patent should be changed from March 2010 to December 2014.

After referring to the FDA, the PTO held that "the submission of the patent term extension application on February 14, 2001" - 61 days after December 15, 2000 - was "untimel within the meaning of 35 U.S.C. section 156(d)(1)."  As such, the application was denied.

MDCO countered that in light of the text and purpose of the Hatch-Waxman Act, the word "date" should be read to mean "business day."  Under this interpretation, if the FDA transmits notice of approval after business hours, the drug is deemed to have "received permission . . . for commercial marketing or use" on the next business day.  Thus, the 60-day period began running Monday, December 18, 2000 (and not December 15).

Over the next 8 years, MDCO engaged in aprotracted adminitrative proceedings that sought to overturn the PTO's finding that the application was "untimely."  When the case reached the E.D. Va., the court found that the PTO erred in concluding that the "calendar day" definition it used was either mandated by either the statute or Federal Circuit precedent.  The Court also held that the Hatch-Waxman Act should be interpreted "liberally" in light of its "remedial" nature.  Accordingly, the District Court vacated the PTO's denial and remanded for further consideration, giving the PTO discretion in interpreting the statute.

Less than 3 days after the District Court's opinion, the PTO issued another denial of the application, stating that "the best definition of 'date' in section 156(d)(1) is 'calendar day' based upon the text, structure, and purpose of the statute."

On March 25, MDCO filed another complaint against the PTO, arguing that the agency's decision was "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."

Read/download the complaint here (link)

Read/download the USPTO's decision denying the patent term extension (link)

Read/download the previous opinion by the E.D. Va. (link)

2 Comentários:

Patent Attorney said...

Since when has 'business day' ever been applicable to a term of anything on patents? It's always based on calendar day... only "exception" is when it falls on a weekend or holiday, you get until the next Monday or business day, but even that doesn't contradict the calendar system.

Dan Feigelson said...

Peter, it's nice to see someone else is also posting on this topic, but I think you left out two critical points:

1. There's no reason MDCO couldn't have filed suit against the USPTO back in early 2007, when its petition for reconsideration was denied. Instead, it waited until December 2009, requested leave for a further reconsideration petition, made a completely new argument (the calendar/business day distinction, which it had never raised until that point), and then when the PTO granted leave and rejected the petition, filed suit. Yet neither MDCO's delay in filing suit, nor the fact that it waited until the last minute to raise the new argument that it could have earlier raised, figured in the judge's calculus.

2. The judge ordered the USPTO to ensure that the '404 patent wouldn't expire before the court proceedings were completed. So the same day it again denied MDCO's petition, the USPTO issued a temporary two-month extension, until May 23, 2010, and MDCO promptly listed that patent in the Orange Book. With the filing of the new complaint, no doubt an additional temporary extension will be forthcoming.

So assuming that the courts ultimately say that 60 days means 60 calendar days, this means that MDCO will be benefiting from an extension it doesn't deserve, simply because it gamed the system. And it doens't have to compensate it generic competitors, or consumers, for the high prices it can still charge because of the temporary extension. (Of course, if the courts ultimately rule that 60 days mean 60 business days, then the temporary extension will have been deserved.)

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