This was a vote on an amendment by Sen. Jeff Sessions (R-AL) that would have clarified that the 60-day period in which companies can apply to extend the term of their patents would begin on the next day—rather than the next business day---following the federal government’s decision allowing the patented product to go on the market. This amendment was offered to legislation overhauling the U.S. patent system.
This 60-day extension period became the subject of a major legal dispute in which MedCo--a biotechnology company that had patented Angiomax (a blood-thinning drug)--was denied a patent extension after submitting an application 61 days after Angiomax was allowed to go on the market. Since MedCo’s application for an extension was one day late, generic versions of Angiomax went on the market in 2010 instead of 2014, costing the company hundreds of millions of dollars in profits. Thus, the House of Representatives passed an amendment to the underlying patent bill stating that the 60-day period in which companies can apply to extend the term of their patents would begin on the next business day following the federal government’s decision allowing the patented product to go on the market. Sessions’ amendment would have removed that provision from the bill—which would have effectively required the 60-day period to begin on the next day following the government’s patent decision.
Sessions urged support for his amendment: “I have practiced law hard in my life. I have been in court many times. I spent 12 years as a U.S. Attorney and tried cases. I am well aware of how the system works. The way the system works in America, you file lawsuits and you are entitled to your day in court. But if you do not file your lawsuit in time, within the statute of limitations, you are out….This matter has gotten a lot of attention. The Wall Street Journal and the New York Times both wrote about it in editorials today….The Wall Street Journal editorial stated: ‘We take no pleasure in seeing the Medicine Company [MedCo] and WilmerHale suffer for their mistakes, but they are run by highly paid professionals who know the rules and know that consistency of enforcement is critical to their businesses. Asking Congress to break the rules as a special favor corrupts the law.' I think that is exactly right. It is exactly right. Businesses, when they are sued by somebody, use the statute of limitations every day.”
Sen. John Kerry (D-MA) opposed Sessions’ amendment: “The current law as it is written says that `to obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director..... Such an application may be only submitted within the sixty-day period beginning on the date the product received permission' under the appropriate provision of law. Now, the FDA [Food and Drug Administration] reasonably interprets this language to mean that if something is received after the close of business on a given business day, it is deemed to be received the next business day. Under this interpretation, the filing by the Medicines Company was indisputably timely. So my colleagues should not come to the floor and take away from entities that are trying to compete and be in the marketplace over some technicality: the suggestion that because something was filed electronically on a particular given day at 5 o'clock in the afternoon when people had gone home--they weren't open--that somehow they deem that not to have been appropriately filed. But rather than accept that commonsense interpretation, the Patent and Trademark Office told the Medicines Company it was late….For companies investing in innovative medicines, the court found that the PTO failed to provide any plausible explanation for this inconsistent approach. It further found that the PTO's interpretation had the effect of depriving applicants of a portion of their time for filing an application.”
The Senate rejected Sessions’ amendment by a vote of 47-51. 36 Republicans and 11 Democrats voted “yea.” 41 Democrats—including a majority of progressives--and 10 Republicans voted “nay.” As a result, the Senate voted to maintain the underlying patent bill’s requirement that the 60-day period in which companies can apply to extend the term of their patents would begin on the next business day following the federal government’s decision allowing the patented product to go on the market.