Source: https://www.fdalawblog.net/2010/08/mdco-prevails-in-angiomax-pte-case-district-court-grants-summary-judgment-will-the-pto-appeal/
Timestamp: 2019-04-24 15:53:47+00:00

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

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