Court Orders and PTO Grants Second Interim PTE for ANGIOMAX

May 24, 2010

By Kurt R. Karst –   

Late last Friday, in a case that is full of twists and turns, the U.S. District Court for the Eastern District of Virginia (Alexandria Division) added another twist (or turn) and ordered the U.S. Patent and Trademark Office (“PTO”) to issue a second interim Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin).  Heeding the court’s order, the PTO granted the second interim PTE. 

The long-running dispute over a PTE for the ‘404 patent, which was originally scheduled to expire on March 23, 2010, and is subject to a 6-month period of pediatric exclusivity, concerns the proper interpretation of the PTE statute at 35 U.S.C. § 156(d)(1).  That provision states that the submission of a PTE application must occur “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.”  FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under New Drug Application (“NDA”) No. 20-873, and MDCO submitted its PTE application to the PTO on February 14, 2001 – 62 days after NDA approval (including the December 15, 2000 date of approval).  MDCO had petitioned 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.  In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on December 18, 2000 and the PTE application would have been timely filed pursuant to 35 U.S.C. § 156(d)(1)

As we previously reported, the first interim PTE was granted (here and here) on March 18, 2010, and was scheduled to expire on May 23, 2010.  That interim PTE preceded the PTO’s March 19, 2010 denial of a PTE for the ‘404 patent.  That denial led MDCO to file a second lawsuit [insert link] challenging the PTO’s decision.  (In the first lawsuit, in a March 16, 2010 opinion Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) vacated the PTO’s previous denial of a PTE for the ‘404 patent based on MDCO’s “rule of construction” argument and remanded the case to the PTO “for reconsideration as to the date of approval under [35 U.S.C. § 156] and to take such actions as necessary to ensure that the ‘404 patent does not expire pending further resolution of these proceedings.”)  In the latest lawsuit, MDCO and the PTO have filed cross-motions for summary judgment (here and here) and generic applicants Teva and APP Pharmaceuticals have filed amicus briefs (here and here). 

The court’s May 21, 2010 order was prompted by MDCO’s May 20, 2010 Emergency Motion for Miscellaneous Relief in which the company requested “emergency relief to enforce the Court’s prior Order [(i.e., March 16, 2010)] and ensure that [the ’404 patent] does not expire during the pendency of these judicial review proceedings.”  According to MDCO:

The Court has now advised the parties that it will not be issuing a decision in this case by May 23, 2010, the date on which the ’404 patent is now due to expire.  The PTO, however, has taken the position, despite the Court’s Remand Order, that it will not grant any further extensions of the ’404 patent—the result of which would be that the patent would lapse prior to a decision by this Court on the merits of MDCO’s challenge. . . .  [T]his Court should, at a minimum, re-affirm that the PTO is required under the Remand Order to take such actions as necessary to extend the ’404 patent until this Court decides the pending cross-motions for summary judgment. The Court should also clarify that the extension must continue, at the very least, for a reasonable period of time after the Court rules to ensure orderly further proceedings.

The PTO position referred to by MDCO in its emergency motion is that the Office does not have the authority to grant a second interim PTE in this case because the statute and case law does not permit it.  The PTE statute at 35 U.S.C. § 156(e)(2) states:

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. [(emphasis added)]

In other words, an interim PTE is not available when the PTO has already denied a PTE application, which is what happened in this case when the PTO issued its March 19th denial.  (The first interim PTE was issued on March 18th and was therefore consistent with the statute.)  This is the same conclusion the Federal Circuit came to in its 2007 ruling in Somerset Pharmaceuticals v. Dudas

Although the PTO argues in its opposition brief that “a court does not have the ‘equitable power’ to order an agency to violate an Act of Congress by exceeding statutory limits on its authority,” the PTO nevertheless states in closing that “[i]n the event, however, that this Court does decide to grant a temporary restraining order, Defendants contend that this temporary restraining order should only extend until this Court issues a decision on the pending cross-motions for summary judgment and should not encompass any future judicial proceedings.” 

The court’s May 21st order is brief and makes no mention of 35 U.S.C. § 156(e)(2) or the Somerset decision.  It orders the PTO to “take such actions as are necessary to ensure that the ‘404 patent does not expire until at least ten (10) days after this Court issues an Order deciding the pending cross motions for summary judgment.”  And the PTO has apparently obliged and granted a second interim PTE . . . . but presumably without an analysis of 35 U.S.C. § 156(e)(2) or the Somerset decision, and without a specific expiration date (as it is unknown when the court will issue its order).  If this is the case, then MDCO will unlikely be able to amend its Orange Book listing for the ‘404 patent to reflect the second interim PTE. 

Outside of the current litigation, we understand that MDCO is continuing to push for passage of a bill that will legislatively extend the PTE for the ‘404 patent.  A version of the bill – the so-called “Dog Ate My Homework Act” – has been proposed in previous Congresses (see our previous posts here, here, and here).  We understand that the latest legislative push is to get the bill attached to the Tax Extenders Act of 2009 (H.R.4213). 

Categories: Hatch-Waxman