And All For The Want Of A Day

In 14.5 years, the drug Lipitor (Pfizer) has generated more than $125 billion in sales. A quick calculation would show that this drug has seen revenues of roughly $24 million a day. It goes without saying that each day counts in the pharmaceutical world. Now imagine missing four years of patent protection over a flagship drug because of one day. This was the situation in a recently filed malpractice suit filed by The Medicines Company (MDCO) against its former patent counsel, Fish & Neave. See The Medicines Co. v. Fish & Neave, et al., No. MRS L-2516-14 (N.J. Super. Ct. Oct. 10, 2014).

Fish & Neave missed a critical deadline for filing a Patent Term Extension (or PTE) application for Angiomax, an anticoagulant used to inhibit a key contributor to the formation of blood clots. According to an Annual Report provided by MDCO, MDCO’s 2013 U.S. sales of the drug exceeded $550 million.

The extension concerned U.S. patent number 5,196,404, the “principal patent covering Angiomax in the United States.” On December 23, 1997, MDCO filed a new drug application for Angiomax with the FDA. Under U.S. law, a new drug cannot be commercially marketed or used until it receives FDA approval. During the FDA review period, the applicant receives no commercial benefit from any patents on the drug. However, to balance the restrictions on commercially benefiting from drugs pending FDA approval, 35 U.S.C. § 156 (the Hatch-Waxman Act) allows the holder of a drug patent to apply for a patent term extension to compensate for the delay in obtaining FDA approval. The timing to file the PTE to the USPTO is “within the sixty-day period beginning on the date the product received permission . . . for commercial marketing or use.” 35 U.S.C. § 156(d)(1).

The FDA’s approval of the new drug application for Angiomax was set forth in a letter faxed to MDCO at 6:17 p.m. on Friday, December 15, 2000. Assuming that Friday December 15, 2000 was day 1, and the 60 day period means calendar days, the critical date for the PTE application for Angiomax was Tuesday, February 13, 2001. If approved, the extension application would have changed the expiration date of the ’404 patent from March 23, 2010 until December 2014. MDCO alleged that the additional patent term translated into approximately $2.0 billion in sales.

The USPTO denied MDCO’s application for patent-term extension, stating that it was untimely because it should have been filed on February 13, 2001, not February 14, 2001. MDCO alleges that Fish & Neave was at fault for the late filing. MDCO further alleges Fish & Neave failed to calculate and docket the correct filing date. Instead, Fish & Neave allegedly assigned responsibility for the filing to an unsupervised part-time law student.

In March 2010, MDCO sought review of the USPTO’s denial of the patent term extension application in the U.S. District Court for the Eastern District of Virginia. Ultimately, the court found for MDCO since the FDA’s approval was sent at 6:17 p.m. on Friday, December 15, 2000. Current FDA practice dictates that submissions received after the close of business are considered filed on the next business day. The court found no reason why the same standard should not apply when the FDA issues approval after the close of business, and thus the clock should start from the next business day. If day 1 started on the day following the day of the faxed transmission, the critical date would fall on February 14, 2001.  MDCO’s application was filed within this time period as determined by Judge Hilton.  See The Medicines Co. v. Kappos, et al., 731 F. Supp. 2d 470 (E.D. Va. 2010).

MDCO ultimately “won” and received the additional four-plus years of patent term extension, but alleges that they suffered “seismic” and “irreparable” damages as a result of millions spent on its legal and legislative battles to obtain the patent term extension. The complaint further alleges reduced stock value and loss of business opportunities.

This case illustrates both the importance of proper IP docketing practices and the duty of law firms to supervise subordinates.  Proper docketing in IP practice is crucial. As the case and numbers show, an error of even one day can make a billion dollar difference.

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