MDCO Prevails in ANGIOMAX PTE Case – District Court Grants Summary Judgment; Will the PTO Appeal?

By Kurt R. Karst –   

On August 3rd, Judge Claude Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) granted  The Medicines Company’s (“MDCO’s”) Motion for Summary Judgment in a long-running dispute (involving all three branches of the federal government) over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering MDCO’s ANGIOMAX (bivalirudin).  In an Order accompanying Judge Hilton’s 31-page opinion, the court remanded the case to the U.S. Patent and Trademark Office (“PTO”) to consider MDCO’s PTE application for the ‘404 patent “timely filed and to adopt an interpretation of § 156(d)(l) that includes a next business day construction for filing of a [PTE]  application.” 

We’ve blogged on MDCO’s efforts to obtain a PTE for the ‘404 patent on several occasions (see e.g., here, here, here, and here), so we won’t give you the blow-by-blow account and all of the twists and turns over the years, but here is the skinny on the current case . . . .

In his August 3rd Opinion, Judge Hilton agreed with MDCO that “the proper interpretation of § 156(d)(1) is a business day construction of the phrase ‘beginning on the date.’  Of the parties’ competing interpretations the business day construction is consistent with the statute’s text, structure, and purpose.”  According to Judge Hilton:

A business day interpretation is consistent with the remedial nature of § 156(d) (1) by limiting the unnecessary and arbitrary loss of property rights.  A business day construction is consistent with the notice function of § 156(d)(1), which focuses on when the product receives permission, such that it would be fair for the applicant's filing period to begin.  Just as the FDA and numerous other agencies apply a business day rule when required to act within a specified time period after receiving a document, an applicant's period to file a PTE application should not begin running until the first business day following the FDA's after-hours transmission of an approval letter.  Moreover, if § 156 is to serve its remedial purpose, it must be construed to require notice to applicants seeking to remedy their losses by filing extension applications.

Section 156(d)(1)'s use of the word "received" supports a business day interpretation. It reinforces the distinction between the act of FDA approval and the point at which an applicant is deemed to have received constructive notice of that approval. A business day interpretation ensures that the phrase "beginning on the date" is given the same meaning in both § 156(d)(1) and § 156(g)(1)(B)(ii). The parallel language and purposes of these two provisions show that Congress wanted the respective dates to be calculated in the same way.

A business day interpretation ensures that, under the PTO's new method of counting days, applicants do not lose a portion of the period Congress granted them. Congress intended for the applicant to have sixty days. The PTO interpreted the statute in a manner that deprives an applicant the sixty days that Congress intended for them to receive. [(citation omitted)]

So now the big question on everyone’s mind is whether the PTO will appeal the decision to the U.S. Court of Appeals for the Federal Circuit.  (Interestingly, the Federal Circuit recently ruled against the PTO on another PTE issue in Photocure ASA v. Kappos, striking down the PTO’s interpretataion of 35 U.S.C. § 156(a)(5)(A).)  We'll keep you posted on any word of an appeal!  And certainly FDA has to be mulling over the decision and considering what reach a business day concept could arguably be asserted with respect to approval decisions, such as after-hours ANDA tentative approvals where 180-day exclusivity forfeiture is concerned.