Here We Go Again! MDCO Launches Another Lawsuit Against the PTO Over ANGIOMAX PTE

March 26, 2010

By Kurt R. Karst –   

Earlier today, The Medicines Company (“MDCO”) announced that the company filed a new Administrative Procedure Act (“APA”) lawsuit in the U.S. District Court for the Eastern District of Virginia (Alexandria Division) challenging the Patent and Trademark Office’s (“PTO”) March 19, 2010 decision denying a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering MDCO’s ANGIOMAX (bivalirudin) drug product.  This is the second MDCO lawsuit over the issue. 

On March 16, 2010 Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) issued an opinion vacating the PTO’s earlier denial of a PTE for the ‘404 patent and remanded the case to the PTO for further consideration.  (See our previous post here)  The PTO’s March 19th decision – issued less than three days after Judge Hilton remanded the case to the PTO (an amazing feat of government efficiency!) – rejected MDCO’s proposed “rule of construction” under which the PTO 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).  Briefly, in the case of the PTE application for the ‘404 patent, 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 (at 5:18 PM) for the ANGIOMAX NDA (NDA No. 20-873).

The day before issuing its PTE denial, the PTO issued an interim PTE (61-days) (later corrected) consistent with Judge Hilton’s order that the PTO “take such actions as necessary to ensure that the ‘404 patent does not expire pending further resolution of these proceedings.”  Absent the interim PTE, the ‘404 patent would have naturally expired on March 23, 2010.  Unless the PTO’s latest decision is vacated, the PTO is presumably unable to issue another interim PTE given the Federal Circuit’s 2007 decision in Somerset Pharmaceuticals v. Dudas that an interim PTE is not available when the PTO has already denied a PTE application. 

The PTO reasoned in its March 19th decision that a “calendar day” rather than a “business day” construction of the PTE statute (35 U.S.C. § 156(d)(1)) is appropriate because, among other things, MDCO’s construction would create disharmony with FDA’s interpretation of 35 U.S.C. § 156(g)(1)(B)(ii).  Under 35 U.S.C. § 156(d)(1), 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” (i.e., within 60-days of the date of NDA approval).  Under 35 U.S.C. § 156(g)(1)(B)(ii), for purposes of calculating the PTE “regulatory review period,” the approval phase begins on the date the NDA application was initially submitted under FDC Act § 505 for the approved product and ends “on the date such application was approved under such section.”

MDCO alleges in its latest lawsuit that the PTO’s March 19th decision violates the APA for a litany of reasons.  Specifically, that the decision:

  • Disregards the District Court's March 16 Opinion;
  • Disregards the text, strcture, and purpose of 3S U.S.C. § 156(d)(1);
  • Ignores and conflicts with the remedial purposes of the Hatch-Waxman Act;
  • Adopts a statutory interpretation that would produce absurd consequences;
  • Adopts a statutory interpretation that would deprive applicants of the full 60-day period provided by statute to prepare and file a [PTE] application;
  • Fails generally to provide a reasoned explanation for the decision it reaches;
  • Erroneously relies on inapposite cases;
  • Fails to adequately explain the inconsistency between the interpretation of the phrase “beginning on the date” as applied by the FDA and PTO under the same statute;
  • Fails to provide a reasoned explanation of the purported difficulties of administering a "business day" rule;
  • Erroneously claims to be adhering to a "historic practice";
  • Misconstrues and fails adequately to respond to MDCO's arguments;
  • Fails to explain its departure from past PTO precedent; and
  • Erroneously relies on irrelevant factors.

Among other things, MDCO asks the court to vacate the PTO’s March 19th PTE denial and declare that the company timely filed its PTE application, and order the PTO to “immediately” grant an interim PTE for the ‘404 patent “and to take any additional present or future actions as are necessary to enable MDCO to protect its rights and to ensure that [the ‘404 patent] does not expire prior to issuance of a certificate of extension.”

Categories: Hatch-Waxman