The Patent & Trademark Office would have discretion to accept late filings under a bipartisan House bill that would resolve a blunder by The Medicines Company.

Under the bill (¹ HR 5120), the PTO "may accept an application...that is filed not later than five days after the expiration of the 60-day period...if the applicant files a petition showing, to the satisfaction of the Director, that the delay in filing the application was unintentional."

The legislation stems from TMC's delayed filing for Angiomax (bivalirudin), approved for use in coronary angioplasty on Dec. 15, 2000. TMC says it "quickly" set about preparing its patent restoration application, which would have extended the principle patent on the drug, which expires in 2010, by nearly 4.5 years.

"But then human error intervened....The 60-day requirement was evidently mistaken for a two-month requirement, and our patent restoration application was filed on Feb. 14, 2001, within a two-month window, but one day late," TMC CEO Clive Meanwell stated in his written testimony before a House Judiciary/Courts, the Internet & Intellectual Property subcommittee hearing Sept. 14.

Meanwell argued for the public health benefits of the bill by stating that without patent restoration the company will not be able to invest in Angiomax label expansions for use in cardiac surgery and for stroke.

The exec also explained how the bill would support the balance of innovation and access created by Hatch/Waxman by eliminating what he considers a disproportionate penalty for an administrative error.

Generic Pharmaceutical Association President Kathleen Jaeger testified against the bill, stating that it would upset the balance of Hatch/Waxman by enlarging benefits for innovators and is unnecessary since it is meant to benefit a single company.

Jaeger also argued that TMC has the opportunity to seek recourse for its perceived damages. In its second quarter ² 10-Q, TMC explains that it is still able to sue the counsel involved in the late filing. The ³ patent term extension application was submitted by law firm Fish & Neave, which merged with Ropes & Gray in 2005.

- John Rancourt

PTO Would Have Discretion To Accept Late Filings Under House Bill

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