[Congressional Record (Bound Edition), Volume 157 (2011), Part 7]
[Senate]
[Page 8969]
[From the U.S. Government Publishing Office, www.gpo.gov]




                             PATENT REFORM

  Mr. GRASSLEY. Mr. President, I wanted to address the issue of patent 
reform--a bill the Senate has already passed by an overwhelming margin. 
It is my understanding the House of Representatives is expecting to 
pass a patent reform bill the House wants, and in the process the House 
wants the Senate to agree very soon thereafter and do it without a 
formal conference.
  I want my colleagues to understand why I hope the House-passed bill 
will contain a provision that was not in our Senate bill but passed 
unanimously out of the House Judiciary Committee.
  The House committee report recognized that the ``need to modernize 
patent laws has found expression in the courts'' but that ``the courts 
are constrained in their decisions by the text of statutes at issue.'' 
That is from the House committee report.
  The House Judiciary Committee amendment that passed unanimously 
resulted from a recent Federal court case that had as its genesis the 
difficulty that the FDA--the Food and Drug Administration--and the 
patent office face when deciding how to calculate Hatch-Waxman 
deadlines. The Hatch-Waxman law was a compromise between drug patent 
holders and the generic manufacturers. Under the Waxman-Hatch law, once 
a patent holder obtains market approval, the patent holder has 60 days 
to request the patent office to restore the patent term--time lost 
because of the FDA's long deliberating process eating up valuable 
patent rights.
  The citation for the case I am talking about is 731 F. Supp 2nd 470. 
The court case found:

     the FDA treats submissions to the FDA received after its 
     normal business hours differently than it treats 
     communications from the agency after normal hours . . . when 
     notice of FDA approval is sent after normal business hours, 
     the combination of the patent trade office's calendar day 
     interpretation and its new counting method effectively 
     deprives applicants of a portion of the 60-day filing period 
     that Congress expressly granted them . . . an applicant could 
     lose a substantial portion, if not all, of its time for 
     filing a patent trademark extension application as a result 
     of mistakes beyond its control . . . an interpretation that 
     imposes such drastic consequences when the government errs 
     could not be what Congress intended.

  That is the end of the judge's statement on why he ruled as he did in 
this particular case. Congress did not intend those drastic 
consequences that happen as a result of a difference between whether 
you are making an application to or an application from an agency. In 
other words, there should not be any difference. Congress did not 
intend the consequences that come from such a different application of 
the law. So the court clarified the law so when FDA sends a notice of 
approval after normal business hours, the 60-day period requesting 
patent restoration begins the next business day. The House Judiciary 
Committee takes the court decision where common sense dictates: to 
protect all patent holders against losing patent extensions as a result 
of confused counting calculations.
  I want to quote Ranking Member Conyers of the House Judiciary 
Committee who sponsored the amendment and committee Chairmen Smith who 
supported Mr. Conyers. Ranking Member John Conyers stated during markup 
the amendment is needed to ``remove what amounts to a trap and would 
clarify the term `business day' . . . and so, our attempt here is to 
make the congressional effort at patent reform more clear, more 
efficient.''
  Chairman Lamar Smith also advocated passage of this amendment during 
markup in the House Judiciary Committee. I will quote him.

       I will recognize myself in support of the amendment. Now, 
     the gentleman's amendment--

  Meaning the Conyers amendment--

     clarifies the counting rules that are imposed on patent 
     holders who must submit documents to the agency within 
     statutory time limits. It has been established that the PTO 
     has inconsistently applied these rules, which is not fair to 
     various patent holders. The gentleman's amendment tracks the 
     recent court case decided in favor of a patent holder that 
     originally applied for an extension 10 years ago. My 
     understanding is that there are not scoring problems with 
     this provision and I support it.

  That is what Chairman Lamar Smith of the House Judiciary Committee 
said.
  This is a commonsense amendment. It improves our patent system 
fairness through certainty and clarity, and I hope the House will leave 
that in their bill when it sends it over here to the Senate.
  My interest in this amendment is because I opposed it 2 or 3 years 
ago when it was first brought up. Because of the court decision, I am 
convinced the different application of the 60-day rule is very unfair. 
As ranking member of the Senate Judiciary Committee, I want the House 
Judiciary Committee to know that several Republican and Democratic 
Senators have asked me to support the Conyers language as well.
  I yield the floor and I suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. BOOZMAN. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.

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