09.08.11

Leahy Urges Senators To Oppose Sessions Amendment, Support Passage Of AMERICA INVENTS ACT

WASHINGTON (Thursday, Sept. 8, 2011) – Senator Patrick Leahy (D-Vt.), the lead Senate sponsor of the Leahy-Smith America Invents Act, delivered the following remarks on the Senate floor in opposition to the pending Sessions Amendment.  The Senate will vote later today on three pending amendments to the bill, followed by a vote on final passage.

 

Statement Of Senator Patrick Leahy (D-Vt.),
Chairman, Senate Judiciary Committee,

On The Sessions Amendment

September 8, 2011

The provision that this amendment would strike, section 37 of H.R. 1249, simply adopts the holding of a recent district court decision, codifying existing law about how the U.S. Patent and Trademark Office should calculate filing dates for the purpose of considering a patent term extension.  I oppose the amendment to strike it.

The underlying provision was adopted by the House as a bipartisan amendment on the floor – it was offered by Mr. Conyers and had the support of Ms. Pelosi and Mr. Berman on the Democratic side, and the support of Mr. Cantor, Mr. Paul, and Ms. Bachman on the Republican side.  There is not a wider range of bipartisan support than that. 

This provision is simply about how to calculate filing dates for patent term extensions, although its critics have inaccurately labeled it as something more.  A patent holder on a drug is entitled by statute to apply for an extension of its patent term to compensate for any delay that the Food and Drug Administration (FDA) approval process caused in actually bringing the drug to market.  The patent holder must file that application for extension within 60 days beginning on the date the product received permission for marketing, however there is some ambiguity as to what “date” starts that clock running. 

Only in Washington, D.C., could this system produce such absurd results that the word “date” means not only something different between two agencies – the PTO and the FDA – but is also given two different constructions by the FDA.  The FDA treats submissions to it after normal hours as being received the next business day, but the date of submissions from the FDA are not considered the next business day even if sent after hours.  To complicate matters, the PTO recently changed its own method of defining a “date.”  This can only happen in Washington. 

The confusion over what constitutes a “date” for purposes of a patent extension has affected several companies, but the most notable case involves the Medicines Company’s (MedCo) ANGIOMAX extension application request.  The extension application was denied by the PTO because of the difference in how dates are calculated.  MedCo challenged the PTO’s decision in court, and last August the federal district court in Virginia held the PTO’s decision arbitrary and capricious and MedCo received its patent term extension.

The PTO now abides by the court’s ruling, and applies the sensible “business day” interpretation of the word “date” in the statute.  The provision in the America Invents Act simply codifies that decision.  Ranking Member Grassley aptly summarized a few weeks ago that this provision “improves our patent system fairness through certainty and clarity.” 

This issue has been around for several years now and, in fairness, it was a controversial issue when it would have overturned the PTO’s decision legislatively.  For this reason, Senator Grassley and others opposed this provision when it came up several years ago.  Now that the court has ruled, however, and the PTO has agreed to accept the court’s decision, the provision is simply a codification of current law.  Is there anyone who truly believes it makes sense for the word “date” to receive tortured and different interpretations rather than to have a clear, consistent definition?  It is time to put this issue to bed once and for all.   

The provision may solidify MedCo’s patent term extension, but it applies generally – not just to MedCo – and will bring common sense to the entire filing system.  

If the Senate adopts this amendment, it will lead to a conflict with the House, which will complicate and delay final passage of this important, bipartisan, jobs-creating legislation. 

In this instance, the House expressly considered this matter and voted with a bipartisan majority to adopt the provision that this amendment is seeking to strike.  With all due respect to the Senator from Alabama, who contributed immensely to this bill as ranking member of the Committee last Congress, I understood why he opposed this provision when it was controversial and would have had Congress override the PTO.  But now that a federal court and the PTO have resolved the matter as reflected in the bill, it is not worth delaying enactment of much needed patent reform legislation that can help create jobs and move the economy forward.

I urge all Senators to oppose this amendment to strike. 

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