Sep 16

The “No One Works On Friday Evening” Amendment?

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As the NY Times recently reported, law firm WilmerHale may have been 1-2 days late when it filed an application for a patent extension for the Medicines Company’s Angiomax product.  To be valid, applications for patent extensions must be made within 60 days of a drug’s approval by the Food and Drug Administration.  The United States Patent and Trademark Office ruled that the Medicines Company had missed the deadline by a day or two.  The Medicines Company maintained that because it had received F.D.A. approval for Angiomax after the customary close of business on a Friday, the 60-day clock should not have started ticking until the next Monday.

The patent extension is valuable to the Medicines Company.  Without the extension, the NY Times reports that Angiomax could have been vulnerable to generic competition as early as September 2010.  With the extension, the Medicines Company is able to ward off generic competition until June 2015.  According to the NY Times, virtually all of the Medicines Company’s 2010 revenue is attributable to Angiomax.

It’s not surprising that the Medicines Company sought a legislative solution to avoid losing its golden egg four years early.  The NY Times reports that the company has spent more than $17 million on its lobbying efforts.

Its lawyers, Wilmer Cutler Pickering Hale & Dorr (which markets itself as WilmerHale) were also potentially on the hook.  The NY Times reports:

In February, WilmerHale agreed to pay $18 million to the Medicines Company to compensate it for its legal and lobbying costs. It also agreed to pay as much as $214 million more if a generic version of Angiomax reached the market before June 15, 2015, because the extension application was deemed late. Part of the payment would be covered by the firm’s insurer.

But the Medicines Company and WilmerHale can breathe a sigh of relief today.  The “America Invents Act,” signed into law by President Obama today, provides the exact relief that the Medicines Company and WilmerHale sought.  It provides that if permission for a product is transmitted after 4:30 P.M. Eastern Time on a business day, or is transmitted on a day that is not a business day, “the product shall be deemed to receive such permission on the next business day.”  Further, despite the fact that most of the provisions of the Act do not go into effect until one year from now, the Act helpfully makes 4:30 P.M. Eastern Time cut-off amendment effective in time to help the Medicines Company by providing that the amendment is applicable to any patent extension “that is pending on, that is filed after, or as to which a decision regarding the application is subject to judicial review on, the date of the enactment of this Act.”