Strength in Numbers? The Lobbying Push for a PTE

August 21, 2011

By Kurt R. Karst –      

Recently we reported on the “other battle” going on concerning patents listed in the Orange Book for The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) Injection.  With patent reform reportedly high on President Obama’s agenda, and with the fast approaching September 6th return of House and Senate Members from recess, when, according to Senate Majority Leader Harry Reid (D-NV), the House-passed patent reform bill – the America Invents Act (H.R. 1249) – will be the first item taken up for consideration in the Senate, we thought an update was in order on where things stand with MDCO’s efforts to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX. 

Section 37 of H.R. 1249, titled “Calculation of 60-day period for application of patent term extension,” would amend the PTE law at 35 U.S.C. § 156(d)(1) to provide that the 60-day period “beginning on the date the product received permission . . . for commercial marketing or use” would begin on the next business day “if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day.”  This provision would 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 MDCO’s PTE application for the ‘404 patent.  (We note that FDA recently informed the PTO that the 180-day period for filing a due diligence petition for a determination of whether the PTE applicant acted with due diligence during the regulatory review period passed without the filing of such a petition.)  Senator Reid recently filed cloture on a motion to proceed with H.R. 1249.  Barring any amendments added to the bill in the Senate, the House would not need to further consider the legislation.  

Interest in (read lobbying for and against) the inclusion of Section 37 in what might become the enacted version of the America Invents Act has been running high.  A few weeks back, we reported on two instances in which PTE applicants for patents covering BEYAZ (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium) Tablets and SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol notified the PTO that, pursuant to The Medicines Company decision, their PTE applications should be considered timely filed because of after business hours NDA approvals.  Since that post, we have become aware of a third instance in which The Medicines Company decision has been raised in a petition to the PTO. 

Specifically, AstraZeneca AB (“Astra”) contends in a recent Request for Reconsideration of Final Agency Action submitted to the PTO that its PTE application for U.S. Patent No. 5,817,338 (“the ‘338 patent”) covering PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets was timely submitted.  As we previously reported, the PTO determined in December 2008 that the 60-day period for submitting a PTE application for the ‘338 patent began on June 20, 2003, when FDA approved NDA No. 021229, and ended on August 18, 2003, making Astra’s August 19, 2003 PTE application untimely.  According to Astra, however, FDA approved NDA No. 021229 at 4:47 PM on June 20th.  Therefore, Astra states:

in accordance with [sic] district court’s decision in 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.  The next business day was Monday, June 23, 2003.  If the first day of the 60 day period set forth in 35 U.S.C. § 156(d)(1) was June 23, 2003, then [sic] 60 day period ended on August 21, 2003, thus rendering the submission of the PTE Application on August 19, 2003, timely within the meaning of § 156(d)(1).

After business hours approvals have provided fodder for MDCO to lobby on Capitol Hill for the inclusion of Section 37 in the America Invents Act, portraying Section 37 as a law of general applicability rather than as single company legislation.  One lobbying piece that is supposedly circulating on Capitol Hill includes a table identifying several instances in which PTE applications were allegedly filed late under the PTO’s pre-The Medicines Company counting method in which the day of approval counted as day 1.  “[T]o the extent transmission of FDA approval for these drugs occurred after normal business hours, Section 37 could also benefit these additional innovators – who also were caught in a procedural trap by the PTO,” says the two-page lobbying piece. 

Advocacy letters have also been submitted to Members of Congress.  A letter from Massachusetts General Hospital to Sens. Herb Kohl (D-WI) and Michael Lee (R-UT) extends the hospital’s support for the inclusion of Section 37 in H.R. 1429.  Another letter signed by 25 doctors from across the country and sent to U.S. Senate leaders says that the passage of Section 37 “is critically important to medicine and patients,” that “[b]y clarifying the rules on patent restoration, the provision will help all companies – both now and in the future – by providing the certainty necessary to encourage them to invest the money and effort needed to bring innovative new drugs to the market,” and that “[t]he provision will also ensure that government officials interpret the rules in a consistent manner.” 

Meanwhile, the Generic Pharmaceutical Association (“GPhA”) has been lobbying against inclusion of Section 37 in the America Invents Act.  In June, GPhA lamented over the House’s “failure to correct a fatal flaw in the bill.”  According to FDA Week (subscription required), GPhA is currently focusing its patent reform lobbying efforts on stripping Section 37 from the America Invents Act.