[Congressional Record (Bound Edition), Volume 156 (2010), Part 7]
[Senate]
[Page 9423]
[From the U.S. Government Publishing Office, www.gpo.gov]




                        PATENT TERM RESTORATION

  Mr. KERRY. Mr. President, I wish to send an amendment to the desk for 
the purpose of filing at a later time, if it is appropriate. Can they 
simply hold it at the desk?
  The PRESIDING OFFICER. The amendment can be received at the desk.
  Mr. KERRY. Mr. President, the amendment I have sent to the desk is an 
amendment that is very important. It is important to us in 
Massachusetts, but it is also important to a certain number of 
companies in this country that may find themselves in a similar 
situation.
  I wish to express my strong support on the Senate floor tonight for 
the inclusion of this amendment in the upcoming House tax extenders 
bill. The purpose of this amendment is to fix a complete anomaly in the 
patent law that is vital to our State. Let me explain.
  The House provision that is being contemplated will allow for a 
patent application to be filed up to 30 days late, with a penalty to be 
paid by the filer to the Patent and Trademark Office. This provision 
has been drafted so that it can be included in the tax extenders bill. 
Let me explain why this is important and what it does.
  The Medicines Company, which is a New Jersey startup company, 
licensed Angiomax. That is the name of the product. It is a synthetic 
blood thinner. That company invested $200 million in R&D, and it gained 
FDA approval for this product.
  In 2001, the Angiomax's patent term restoration application was 
unintentionally filed after the close of business on the day of the 
filing deadline. It was filed electronically. Because it was filed 
electronically on the day of the deadline beyond the close of business 
in the office, in terms of daytime presence, it was deemed to be filed 
1 day late. It was ruled as being filed 1 day late by the Patent and 
Trademark Office subsequently.
  I remember when I was in law school, people taught me often that 
sometimes the law can have a rigidity that has no common sense and no 
application to day-to-day life. We had a more pejorative term for what 
we called the law under those circumstances.
  The fact is, as a result, the Medicines Company lost almost 5 years 
of earned patent protection with a value of roughly $1 billion.
  As former Surgeon General Dr. Louis Sullivan said:

       The fate of this corrective provision could be a matter of 
     life and death for tens of thousands of patients. The reality 
     is that stark. As drug innovators develop pioneering 
     medicines, the benefits available to patients are increasing. 
     These medical innovators' ability to conduct lifesaving 
     research should not be thwarted by a confusing filing 
     deadline.

  That was the Surgeon General of the United States speaking.
  The provision I submitted in an amendment will simply allow for a 
patent application to be filed up to 30 days late, not just for this 
company but for any company in a similar situation, with a penalty to 
be paid by them to the Patent and Trademark Office.
  Is this something out of the ordinary? No, it is not. Existing patent 
law provides grace periods in up to 30 similar situations. But it 
provides no grace period for a late patent term restoration 
application, just one aberration within the framework of patent 
filings. This provision is consistent with the Hatch-Waxman patent 
restoration filing process and over 30 other provisions of patent law 
which provide for deadline adjustments in order to avoid precisely the 
kind of drastic and disproportionate result we see in this situation. 
The provision provides a modest 3-day grace period if the filing delay 
is unintentional. It also requires successful applicants to pay the 
U.S. Treasury a late filing fee to offset any cost to the Federal 
Government.
  Twice during the 110th Congress, the House passed legislation 
unanimously to correct this anomaly. The Senate Judiciary Committee 
reported a similar provision offered by Senator Kennedy on a bipartisan 
vote of 14 to 2. Unfortunately, these provisions were not enacted into 
law during the 110th Congress. During this Congress, despite the 
efforts of Senate Judiciary Chairman Leahy, the Senate has not found 
the moment to consider this critically needed patent reform 
legislation.
  The Congressional Budget Office projects that the provision will 
produce approximately $30 million in new revenues to our government 
over the next 10 years. Two recent independent economic studies confirm 
that the provision will save up to $1.3 billion in costs for the 
private hospital system over the course of the next 10 years.
  Nearly 50 of the Nation's leading doctors have written to Congress 
urging the enactment of this provision because it will allow lifesaving 
medical research in the treatment and prevention of heart disease and 
stroke--the first and third leading causes of death and disability in 
the United States--to move forward. Without this critical legislation, 
many thousands of patients will be consigned to continued medical 
treatment with antiquated drugs rather than safer, modern synthetic 
innovations.
  Unless the provision is enacted promptly, up to 3,500 jobs in 6 
States may be lost, including up to 2,500 in the State of 
Massachusetts. These jobs include irreplaceable high-skilled jobs 
developed by small business medical innovators. At this moment in our 
economy, the last thing we want to do is strip ourselves of revenues, 
strip ourselves of income, strip ourselves of jobs, and leave our 
patients in a less cared for and potentially lifesaving environment 
than they would be with this. Mr. President, we can't afford to allow 
that to happen, and I don't think Congress should allow a bureaucratic 
misinterpretation of the law to hurt our Nation's public health and to 
cause severe job losses. The provision's enactment will prevent these 
job losses, and it will create new highly skilled jobs.
  The amendment provides a 3-day grace period for the filing of Hatch-
Waxman patent term restoration applications. This provision of a grace 
period, as I said, is consistent with more than 30 other provisions of 
patent law.
  The bill corrects a harmful and confusing procedural anomaly that has 
caused 78 percent of medical innovators--78 percent--to miscalculate 
the deadline to regain the patent life they earned during the costly 
and rigorous FDA review process.
  So I reiterate: The current filing period is so confusing that only 
22 out of 100 medical innovators have been able to calculate the law's 
60-day filing period accurately. The current filing period is a trap 
for the unaware, and penalties are vastly out of proportion to the 
impact of having accidentally missed by a few hours, when you actually 
file correctly on the same day, the application that is due.
  Mr. President, I hope this amendment will be in the tax extenders 
bill, and I intend to fight to see that it is. I think it is an 
appropriate public policy decision in the best interests of our country 
and of the American citizens.
  I yield the floor.

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