Angiomax, also known as bivalirudin, is an anti-clotting drug given to patients undergoing angioplasty, a procedure to open clogged arteries. The drug was patented by the Medicines Company and had 2009 sales of $401.2 million, nearly $383 million of which were in the United States.
The Medicines Company, which is unprofitable, also sells another drug, but Angiomax accounts for virtually all of its revenue. Back in 2001, the Medicines Company just missed the deadline to apply for a patent extension at the United States Patent and Trademark Office (USPTO).
The company appealed twice to the USPTO, and then sued when the appeals were rejected. It also hired lobbyists to try to win passage of federal legislation referred to, by critics, as “The Dog Ate My Homework Act” — that would retroactively allow the patent office to accept the company’s tardy application.
As a result, their US patent is due to expire on Tuesday 23, March 2010. Had they filed in time, they would have had a patent monopoly until December 2014. Generic versions of the drug are now expected by September 2010, costing the company and saving patients hundreds of millions of dollars.
Last Tuesday, a week before expiry, a federal judge granted a last-minute stay of execution, ordering the patent office to reconsider its rejection of Medicines’ 2001 filing. The ruling, by Judge Claude M. Hilton of the United States District Court in Alexandria, Va., also ordered the patent office to ensure that the Angiomax patent did not expire during the reconsideration period.
Under the Hatch-Waxman Act,a company has 60 days to file for patent term extension from receiving Notice that a drug has received FDA approval. The company’s position is that because the F.D.A. approval came after the close of business, the 60-day period for should not have started ticking until the next business day — the following Monday. The patent office rejected that argument, saying the law gave it no leeway.
Judge Hilton considered the office had been too inflexible. If the F.D.A. receives an application for approval of a drug after 5 p.m., he said, it records the application as having been received the next business day. So the office’s interpretation, the judge wrote, “plainly conflicts with the F.D.A.’s interpretation of the same word in the same statute.”
“It’s a draconian penalty for an administrative mistake,” said Clive A. Meanwell, the chief executive.
“For me to conduct the big Phase 3 trials, which I’d love to do, I need time and exclusivity,” Mr. Meanwell said. “I could not do these trials on behalf of Teva,” he said, referring to the big generic drug manufacturer.
In the meantime, the Medicines Company has sued three companies that are moving to sell generic versions of Angiomax: Teva, Pliva, also now owned by Teva, and APP.
By Friday, however, the USPTO had already concluded its review. In a 15-page decision, accompanied by more than 300 pages of attachments, it defended its decision. It said Medicines had waited until the last minute to file the fairly simple patent extension application. It also said the company did not sue the patent office until the patent had nearly expired, instead spending years lobbying Congress. “MDCO’s dire situation is therefore exclusively of its own making,” it said.
Angiomax had about $400 million in sales last year, of which $383 million were in the United States. Sales of the drug account for virtually all the company’s revenue. Medicines Company shares dropped 15 percent on Friday, to $7.88.
The patent office did, however, honor Judge Hilton’s order to grant an interim patent extension while it deliberated. So the patent will now expire at the end of the day on May 23, instead of next Tuesday, March 23.
With poetic justice, the USPTO described this as a 60-day extension on Thursday, although it is actually 61 days, i.e. a similar mistake to that which the company made nine years ago. However, the patent office corrected its mistake the next day.