This was a vote on an amendment by Rep. John Conyers (D-MI) that would clarify that the 60-day period for patent term extensions would begin on the next business day following the federal government’s decision allowing the patented product to go on the market.
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.
Conyers urged support for his amendment: “It addresses the confusion regarding the calculation of the filing period for patent term extension applications…By eliminating confusion regarding the deadline for patent term extension applications, this amendment provides the certainty necessary to encourage costly investments in life-saving medical research.”
Conyers’ amendment was supported by some Republicans, including Rep. Scott Garrett (R-NJ), who argued: “So our amendment… will clarify that when the FDA provides the final approval after normal business hours, the 60-day clock begins on the next business day. So by doing this, by ensuring that patent holders will not lose their rights prematurely, what this amendment does is it will not only resolve a longstanding problem but will encourage the development of innovative new drugs as well.”
Opponents of Conyers’ amendment argued that it was essentially a bailout for one pharmaceutical company. Rep. Lamar Smith (R-TX) argued: “…In 2001, a biotech entity called the Medicines Company, or MedCo, submitted an application for a patent extension that the PTO [the Patent and Trademark Office] ruled was 1 day late. This application would have extended patent protection for a drug the company developed called Angiomax. In August 2010, a U.S. district court ordered the PTO to use a more consistent way of determining whether the patent holder submitted a timely patent extension application….The Conyers amendment essentially codifies the district court's decision, but it ignores the fact that this case is on appeal. We need to let the courts resolve the pending litigation. It is standard practice for Congress not to interfere when there is ongoing litigation. If the federal circuit rules against MedCo, generic manufacturers of the drug could enter the marketplace immediately rather than waiting another 5 years. This has the potential to save billions of dollars in health care expenses. While the amendment is drafted so as to apply to other companies similarly situated, as a practical matter, this is a special fix for one company.”
The House agreed to this amendment by a vote of 223-198. Voting “yea” were 155 Democrats—including a majority of progressives—and 68 Republicans. 167 Republicans and 31 Democrats voted “nay.” As a result, the House agreed to an amendment that would clarify 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. In order for Conyers’ amendment to become law, however, it would have to pass the Senate.