Last-Ditch Effort to Jettison “The Dog Ate My Homework Act” from the America Invents Act Fails

By Kurt R. Karst –      

On September 8th, the U.S. Senate passed, by an 89-9 vote, H.R. 1249, the Leahy-Smith America Invents Act.  Final passage of the bill, which will make significant changes to the U.S. patent system, was preceded by a contentious vote on, you guessed it, Section 37 (often referred to as “The Dog Ate My Homework Act” or the “Medco fix”), which would legislatively resolve The Medicines Company’s (“MDCO’s”) decade-long battle to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin). 

As we previously reported (here, here, and here), as the prospects of patent reform grew over the past few months (after the House passage of H.R. 1249), so too did lobbying efforts to ensure inclusion of Section 37 in the Senate-passed bill.  Those efforts took the form of portraying Section 37 as a law of general applicability affecting multiple companies and products (3 that we know of, not including ANGIOMAX) rather than as single company (including a law firm and its malpractice insurer) legislation. 

That portrayal rankled some Senators.  Earlier this week, Senators Jeff Sessions (R-AL), Joe Manchin (D-WV), Tom Coburn (R-OK), and Mike Lee (R-UT) proposed Senate Amendment 600, the text of which states: “On page 149, line 20, strike all through page 150, line 16.”  Those line references are to entire Section 37 of the House-passed H.R. 1249, which states:

SEC. 37. CALCULATION OF 60-DAY PERIOD FOR APPLICATION OF PATENT TERM EXTENSION.

(a) IN GENERAL.—Section 156(d)(1) of title 35, United States Code, is amended by adding at the end the following flush sentence:

‘‘For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, 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, the product shall be deemed to receive such permission on the next business day. For purposes of the preceding sentence, the term ‘business day’ means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5.’’.

(b) APPLICABILITY.—The amendment made by subsection (a) shall apply to any application for extension of a patent term under section 156 of title 35, United States  Code, that is pending on, that is filed after, or as to which a decision regarding the application is subject to judicial review on, the date of the enactment of this Act.

Senators Sessions and Coburn urged the Senate in a September 7th “Dear Colleague Letter” to support passage of their amendment, stating:

While many of us had supported the Senate version of H.R. 1249, the  “Leahy-Smith America Invents Act,” the House version contains a controversial special interest provision (Section 37) that was added via amendment during a confusing and highly-unusual floor debate. Initially, the amendment failed by a vote of 209 to 208.  When some Members objected that they had not been able to vote, the original vote was vacated.  The second time around, the amendment was adopted by 19 votes.  We believe this apparent confusion is attributable to the fact that Section 37, or the “Medco fix,” looks like a benign, technical change to an obscure section of the U.S. Code. But it is actually an illustration of Washington at its worst – a bailout for a well-connected, big law firm and its malpractice insurer and a brand pharmaceutical manufacturer, which have hired an army of lobbyists. The provision is a special interest matter which is currently in litigation and cannot be justified.

The letter goes on to provide several reasons why the Senate should vote to strike Section 37: “First, this case is in active litigation. . . .  Second, this provision addresses a problem that does not exist. . . .  Third, if this language becomes law, it would permit Medco to delay the launch of a generic version of Angiomax by an additional five years (2015). . . .  Finally, Congress has a private relief process for dealing with cases such as this.” 

Despite these pleas, the Senate rejected, by a 51-47 vote, Senate Amendment 600, paving the way for a final vote on, and passage of, H.R. 1249.  (The September 8th Senate floor debate on Senate Amendment 600 is available here.)  If President Obama signs the Leahy-Smith America Invents Act into law, the ongoing battle in the U.S. Court of Appeals for the Federal Circuit will presumably be mooted, and the last chapter in this story may very well have been written.

As we say goodbye (or is it “hello”?) to “The Dog Ate My Homework Act” (although there may still be more interesting things to come on this drug), we leave you with a list of all the FDA Law Blog postings on this topic (a blogography of sorts).  Queue up Green Day’s Time Of Your Life:

• August 2, 2007 – The “Dog Ate My Homework Act” Resurfaces
• June 25, 2008 – Going Once . . . Twice . . . Sold – One PTE to the Company from Massachusetts for $65 Million
• October 26, 2009 – The Medicines Company Continues Lobbying Push for ANGIOMAX Patent Term Extension Legislative Fix; Latest Iteration of the “Dog Ate My Homework Act” Maintains $65 Million Late Fee
• December 15, 2009 – The Medicines Company Initiates an 11th Hour Push for ANGIOMAX Patent Term Extension; Petitions PTO to Adopt a Rule of Construction for Determining NDA Approval Date
• January 20, 2010 – Down and Out in MA – The PTO Denies The Medicines Company’s Request for Reconsideration for ANGIOMAX Patent Term Extension
• February 1, 2010 – The Medicines Company Tosses Up a Hail Mary Pass – Sues PTO and FDA Over ANGIOMAX Patent Term Extension Decisions
• March 17, 2010 – PTO’s ANGIOMAX PTE Denial is Vacated and the Case Goes Back to PTO – What Happens in the Interim?
• March 22, 2010 – PTO Once Again Denies PTE for ANGIOMAX Patent . . . But Not Before Issuing an Interim Extension; MDCO is Outraged
• March 26, 2010 – Here We Go Again! MDCO Launches Another Lawsuit Against the PTO Over ANGIOMAX PTE
• May 24, 2010 – Court Orders and PTO Grants Second Interim PTE for ANGIOMAX
• May 27, 2010 – Sen. Kerry Introduces ANGIOMAX PTE Amendment to Tax Extenders Act of 2009
• August 3, 2010 – MDCO Prevails in ANGIOMAX PTE Case – District Court Grants Summary Judgment; Will the PTO Appeal?
• September 2, 2010 – APP Moves Forward With Appeal Notice in ANGIOMAX PTE Litigation in Light of PTO/FDA Indecision
• September 9, 2010 – All Eyes are on APP’s Intervention Motion as the Government Bows Out of ANGIOMAX PTE Litigation
• February 6, 2011 – The Fat Lady Goes Back to Her Dressing Room; Federal Circuit Denies MDCO Motions in ANGIOMAX PTE Litigation
• April 20, 2011 – Amendment to the America Invents Act Would Give MDCO Some Legislative Security in Battle Over ANGIOMAX PTE
• June 28, 2011 – Efforts to Obtain a PTE for ANGIOMAX Patent Continue as the U.S. House Passes an Amendment to the America Invents Act in “After Business Hours” Vote
• August 11, 2011 – ANGIOMAX – The Other Patent Battle
• August 21, 2011 – Strength in Numbers? The Lobbying Push for a PTE