ARTICLE
15 April 2016

Court Can't Review Policy Behind Patent Term Adjustment Statute

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Foley & Lardner
Contributor
Foley & Lardner LLP looks beyond the law to focus on the constantly evolving demands facing our clients and their industries. With over 1,100 lawyers in 24 offices across the United States, Mexico, Europe and Asia, Foley approaches client service by first understanding our clients’ priorities, objectives and challenges. We work hard to understand our clients’ issues and forge long-term relationships with them to help achieve successful outcomes and solve their legal issues through practical business advice and cutting-edge legal insight. Our clients view us as trusted business advisors because we understand that great legal service is only valuable if it is relevant, practical and beneficial to their businesses.
The patents at issue were U.S. 8,090,945 and U.S. 8,103,246, which Ms. Singhal appears to have filed and prosecuted per se.
United States Intellectual Property
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In Singhal v. Lee, the U.S. District Court for the Eastern District of Virginia dismissed a complaint that challenged the Patent Term Adjustment (PTA) awarded to two patents, because the complaint failed to state a claim upon which relief could be granted. Ms. Singhal challenged the "RCE carve-out" on policy grounds, but federal courts lack authority to re-write statutes on that basis.

The Patent Term Adjustment At Issue

The patents at issue were U.S. 8,090,945 and U.S. 8,103,246, which Ms. Singhal appears to have filed and prosecuted per se. The prosecution of both patents included the filing of one or more Requests for Continued Examination (RCEs). When calculating PTA, the USPTO applied 35 USC 154(b)(2)(B) and did not award any PTA for B-delay that occurred after the RCEs were filed.

You can read more about the RCE carve-out here. Ms. Singhal's complaint was filed before the Federal Circuit rejected part of the USPTO's carve-out rule in Novartis v. Lee, which you can read about here.

One of Ms. Singhal's arguments was that the RCE carve-out unjustly penalized applicants who "often have good reason to request continued examination of an application." For example, Ms. Singhal faced several "final" Office Actions that made new prior art rejections, requiring her to file an RCE in order to amend the claims to overcome the new rejections. Without addressing that position on the merits, the court noted that it lacks authority to re-write the statute:

Courts including the Federal Circuit in interpreting § 154 itself – have repeatedly held that they lack authority to re-write a statute simply because a Plaintiff "believes that the delicate balance that Congress struck was erroneous, unwise, or somehow inequitable."

Additional PTA Under Novartis

Even is Ms. Singhal is not entitled to the additional PTA she sought, she might be able to obtain additional PTA under Novartis. That could amount to about three additional months of PTA for the '845 patent and four additional months of PTA for the '246 patent. According to one of the papers filed by the USPTO in this case, the USPTO may recalculate the PTA for both patents consistent with Novartis once this district court proceeding is terminated.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

ARTICLE
15 April 2016

Court Can't Review Policy Behind Patent Term Adjustment Statute

United States Intellectual Property
Contributor
Foley & Lardner LLP looks beyond the law to focus on the constantly evolving demands facing our clients and their industries. With over 1,100 lawyers in 24 offices across the United States, Mexico, Europe and Asia, Foley approaches client service by first understanding our clients’ priorities, objectives and challenges. We work hard to understand our clients’ issues and forge long-term relationships with them to help achieve successful outcomes and solve their legal issues through practical business advice and cutting-edge legal insight. Our clients view us as trusted business advisors because we understand that great legal service is only valuable if it is relevant, practical and beneficial to their businesses.
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