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USPTO Tweaks Patent Term Adjustment Rules To Accomodate McKesson-Type IDS Submissions

Posted by Courtenay Brinckerhoff on Posted in Patent Term Adjustment; USPTO Proposed Rule Changes

In a Federal Register Notice issued December 1, 2011, the USPTO issued a final rule that tweaks the patent term adjustment rules to permit applicants to promptly file McKesson-type Information Disclosure Statements (IDSs) without incurring a patent term adjustment deduction. The rule change took effect on December 1, 2011.

(The Federal Register Notice indicates that previously proposed changes to the calculation of patent term adjustment when the USPTO reopens prosecution after a Notice of Appeal are being revised and will be published for comment separately.) Continue reading this entry

Federal Circuit Says Regulatory Patent Term Extension Prolongs Life of Entire Patent

Posted by Courtenay Brinckerhoff on Posted in Federal Circuit Decisions; Patent Term Extension

I wrote previously about the patentability issues raised in Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., and Novartis’ ability to rely on unexpected results discovered after the filing date to support non-obviousness.  Here, I look at another interesting issue in the case, related to the scope of a patent term extension under 35 USC § 156 and district court jurisdiction under 35 USC § 291.

The Technology At Issue

The technology at issue relates to truncated forms of Factor VIII, an essential blood-clotting protein. As explained in the Federal Circuit opinion, the proper functioning of Factor VIII depends on its ability to bind another protein, von Willedbrand factor (“vWF”), although Factor VIII can exhibit a procoagulant effect without complexing to vWF. Truncated forms of Factor VIII are based on the discovery that certain portions of the protein are not required for its procoagulant activity, and that region a3 is critical to vWF binding.

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Not The Patent Term Extension Fix We Need

Posted by Courtenay Brinckerhoff on Posted in Patent Reform

The House patent reform bill (HR 1249) that was passed last week includes a provision that impacts the deadline for filing an application for patent term extension under 35 USC § 156 after receiving FDA approval for a patented product. Although the House provision addresses the issue before the district court in The Medicines Co. v. Kappos, it does not provide the fix we need.

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