The MDCO PTE Decision: In Play on Capitol Hill and in Action at the PTO

July 14, 2011

By Kurt R. Karst –      

A recent article published in Roll Call, titled “Hatch-Waxman Act’s Interpretations Threaten Lives, Jobs,” caught our attention.  The article was penned by Delegate Donna Christensen (D-VI) (who is chairwoman of the Congressional Black Caucus Health Braintrust) and expresses the strong support of members of the Congressional Black Caucus for Section 37 of the House-passed version of the America Invents Act (H.R. 1249).  As we recently reported, Section 37 was sponsored by Representative John Conyers (D-MI) and would amend the Patent Term Extension (“PTE”) law at 35 U.S.C. § 156(d)(1) to effectively codify Judge Claude M. Hilton’s August 3, 2010 decision in The Medicines Company v. Kappos, 731 F. Supp. 2d 470 (E.D. Va. 2010), in which Judge Hilton ordered the Patent and Trademark Office (“PTO”) to consider timely filed The Medicines Company’s (“MDCO’s”) PTE application for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin) under a next business day interpretation of the PTE statute.  Although H.R. 1249 includes the PTE provision, the Senate version of the bill (S. 23) does not.  (According to IPO Daily News, some Senators are objecting to a few provisions in the House bill, including Section 37.) 

Section 37 (also dubbed the “MedCo amendment” or the “Dog Ate My Homework Act”) has been controversial, but we will not get into that here.  What is of particular interest to us is a statement in Del. Christensen’s article that Judge Hilton’s “decision benefited not only the Angiomax innovator but also another company with a lifesaving drug that this month applied for patent term restoration based on Hilton’s decision.” 

We did some digging and there appear to be two candidates out there that fit Del. Christensen’s description. 

The first is the PTE application for U.S. Patent No. 6,441,168 (“the ‘168 Patent”) (currently set to expire on April 17, 2020) covering BEYAZ (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium) Tablets.  FDA approved BEYAZ under NDA No. 022532 on September 24, 2011, and a PTE application was submitted to the PTO on November 23, 2010 – or 61 days after NDA approval, including the date of NDA approval.  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.”  But does the next business day rule from The Medicines Company decision apply to the PTE application for the ‘168 Patent?  That is, was notice of the approval letter for NDA No. 022532 received after business hours (i.e., after 4:30 P.M., Eastern Time), thereby making November 23, 2011 day 60 instead of day 61?  (The BEYAZ approval letter does not include a time stamp.)

In March 2011, the PTO issued an Order to Show Cause with respect to the PTE application for the ‘168 Patent citing The Medicines Company decision and saying:

Here, no evidence has been made of record indicating that Applicant received notice of its NDA approval from FDA after FDA’s close of business, i.e., after 4:30 PM EST.  Therefore, without any such evidence, the USPTO presumes that the notice of NDA approval was transmitted to Applicant on September 24, 2010 during FDA’s normal business hours.  Thus, Applicant filed its PTE application one day late, and the eligibility requirement set forth in section 156(d)(1) does not appear to be satisfied and the ‘168 patent appears ineligible for patent term extension for this reason.

The applicant recently responded to the Order to Show Cause providing the requested evidence to the PTO, stating:

[T]he facts are the same as described in The Medicines Company v. Kappos.  Applicant received notice of their NDA Approval from FDA after the close of FDA's business, i.e., after 4:30 PM EST, on September 24, 2010.  Thus, the time period set forth in 35 USC §156(d)(1) started on the next business day, i.e., September 25, 2010.  Thus, the sixty day period set forth in 35 USC §156(d)(1) ended on November 23, 2010, the date that applicant fIled the instant PTE application. Therefore, the application was filed "within" the sixty day period set forth in 35 USC § 156(d)(1).

In this case, the FDA provided notice of the approval in an email received at 4:45 PM on September 24, 2010.

The second candidate is the PTE application for U.S. Patent No. 5,674,860 (“the ‘860 Patent”) covering SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol, which we have previously reported on (here and here).  FDA approved SYMBICORT under NDA No. 021929 on Friday, July 21, 2006, and a PTE application for the '860 Patent was submitted to the PTO on September 19, 2006 – or 61 days after NDA approval, including the date of NDA approval.  According to a recent submission to the PTO, however, FDA approved NDA No. 021929 at 4:36 PM (Eastern) on July 21, 2006.  Therefore, says the applicant, "in accordance with The Medicines Company, Applicant's period to file the PTE application did not begin to run until the first business day following the FDA's after-hours transmission," or Monday, July 24, 2006, "thus rendering the submission of the PTE application on September 19, 2006, timely within the meaning of § 156(d)(1)." 

Categories: Hatch-Waxman