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Legislative Roundtable in Orange County, FDA Revises Reviews and IP Update

BIOCOM Hosts Legislative Roundtable in Orange County

On July 11th, BIOCOM had the pleasure of hosting State Senator Tom Harman for a legislative Roundtable in Newport Beach at the offices of PTRM. Senator Harman, a long time supporter of BIOCOM and the life science community, has been representing Orange County in the State Legislature since his election to the Assembly in 2000.

Senator Harman gave an in depth briefing on the state budget and the $17.6 billion deficit the legislature is attempting to address for the coming year. The Senator asserted that the state budget suffers from one major problem; a “spending addiction” on the part of the legislature. “We have been spending way too much money and we have to stop, we can’t just raise taxes” said Harman. The Senator went on to discuss his proposals to control future state spending by tying future budget growth to the increases in the state’s population and inflation.

Additionally, the Senator discussed the regional co-operation of the legislature’s Southern California delegation in working to guarantee that Southern California has a dependable and clean supply of water for agriculture, industry and personal needs. Due to an on-going drought, environmental protection rulings and the possible collapse of an antiquated levee system in the San Joaquin/Sacramento Delta, the Senator detailed his proposal for a peripheral canal that will bypass this sensitive habitat and provide the water that our community needs to thrive.

BIOCOM Legislative Roundtables are regular events which bring together our members and their elected officials in a casual environment to discuss the relevant political and policy issues of the day. This was the second time Senator Harman has joined us for a roundtable and we greatly appreciate his time and insight. For information on future Legislative Roundtables, please contact Faith Picking at fpicking@biocom.org.

FDA Revises Process for Responding to Drug Applications

The FDA is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. The agency will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, it will issue a "complete response" letter that lets a company know the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval. Please read more at the following link: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html

IP Update: A Day Late And $65m Short 

In a compromise between the interests of big pharma and generic drug companies, and as an accommodation to big pharma, the Hatch-Waxman Act includes a provision that allows the innovator drug or medical device company to receive additional patent term to “compensate” for regulatory delay (as determined by a specific formula, but not to exceed 5 years).  For blockbusters that gross millions of dollars a day, the value of this Patent Term Extension (PTE) can really add up.  However, the law requires the patent holder to submit a petition for PTE within 60 days of regulatory approval.  There is no grace period - until now.

In 2001, The Medicines Company submitted their application for PTE for Angiomax one day late.  It was properly rejected.  Since that time the company has been lobbying hard to obtain an extension period.  After several attempts to get it passed within a broader patent reform bill, the company prevailed in getting it passed in the House (H.R. 6344) in a much smaller package.  Knowing this history is essential to understanding the provisions of the just-passed resolution.

If passed into law, the USPTO Director can accept an application for PTE up to three days late if (1) the applicant pays a $65,000,000 fee in the case of an anticoagulant drug or (2) an amount estimated by the Director (in consultation with other administrative agencies) to be equal to the sum of --

  1. any net increase in direct spending arising from the extension of the patent term (including direct spending of the United States Patent and Trademark Office and any other department or agency of the Federal Government);
  2. any net decrease in revenues arising from such patent term extension; and
  3. any indirect reduction in revenues associated with payment of the fee under this subsection.

The legislation attempts to capture revenue impacts to the government for granting the additional term.  To be sure, 65 million dollars is a hefty price, but well worth what the company will receive in revenues over the extended term.  Other late filers (if any) may also avail themselves to the beneficial calculus.

Or you could just file the PTE on time.

Submitted by BIOCOM's Intellectual Property Committee, by Les Overman with Stephen Reiter.  This article is the opinion of the authors and not of their respective employers.

Please send your comments or suggestions to BiocomIP@gmail.com.