Applied Biosystems Seeks PTA for 2007 Patent

27 August 2013 PharmaPatents Blog

On August 21, 2013, Life Technologies, Corp., Life Technologies, Ltd., Applied Biosystems LLC, and Molecular Probes, Inc. (collectively, “Plaintiffs”) brought suit in the U.S. District Court for the Eastern District of Virginia seeking additional Patent Term Adjustment (PTA) for 36 patents owned by and/or exclusively licensed to Plaintiffs. Their case is a long shot for several reasons.

The Patents at Issue

The 36 patents at issue span from Applied Biosystems’ U.S. Patent 7,259,020, granted August 21, 2007, to Life Technologies’ U.S. Patent 8,173,002, granted May 8, 2012.

Timeliness

The PTA statute provides for judicial review of PTA determinations in 35 USC § 154(b)(4)(A). For patents granted before January 14, 2013, the statute provided that such suits were to be brought within 180 days of the patent’s grant date. Although the patents at issue were granted before January 14, 2013, and more than 180 days ago, Plaintiffs assert that their suit is timely under 28 USC § 2401, because it was brought within six years of the patents’ grant dates.

In particular, Plaintiffs assert that 35 USC § 154(b)(4)(A) applies only to PTA determinations provided with a Notice of Allowance, while the PTA determinations at issue here were not provided until grant. Thus, the general—and more generous–provisions of the APA and 28 USC § 2401 apply.

In the alternative, the plaintiffs assert that equitable tolling should be applied to render the complaint timely.

The Equitable Tolling Argument is Undermined by Novartis v. Kappos

The U.S. District Court for the District of Colombia heard and rejected similar timeliness and tolling arguments in Novartis v. Kappos. The plaintiffs cite that November 15, 2012 decision in their complaint, and assert that the time periods for seeking review of the PTA determinations for their patents should be tolled until that case is finally decided.

(The substantive PTA issues raised in Novartis include both Wyeth-type PTA and Exelixis-type PTA.)

The APA Arguments Are Undermined by the AIA Technical Corrections Act

The AIA Technical Corrections Act amended § 154(b)(4) as follows:

(4) APPEAL OF PATENT TERM ADJUSTMENT DETERMINATION.—
(A) An applicant dissatisfied with a determination made by the Director under paragraph (3) shall have remedy the Director’s decision on the applicant’s request for reconsideration under paragraph (3)(B)(ii) shall have exclusive remedy by a civil action against the Director filed in the United States District Court for the Eastern District of Virginia within 180 days after the grant of the patent the date of the Director’s decision on the applicant’s request for reconsideration. Chapter 7 of title 5 shall apply to such action. Any final judgment resulting in a change to the period of adjustment of the patent term shall be served on the Director, and the Director shall thereafter alter the term of the patent to reflect such change.

The effective date provision states that “the amendments made by this Act shall take effect on the date of the enactment of this Act [January 14, 2013] and shall apply to proceedings commenced on or after such date of enactment.” Although the USPTO has interpreted this effective date provision as applying to patents granted on or after January 14, 2013 for the statutory provisions that it administers, a court might determine that the amendments to § 154(b)(4) apply to district court actions brought on or after January 14, 2013

The PTA at Issue

The Plaintiffs’ complaint appears to seek additional PTA for all patents under the November 1, 2012 decision in Exelixis I , by Judge Ellis, III, of the U.S. District Court for the Eastern District of Virginia. The complaint asserts that USPTO misinterpreted and misapplied 35 USC § 154(b)(3)(B) by failing to award PTA for the USPTO’s failure to grant the patents within three years, when Requests for Continued Examination (RCEs) were not filed until at least three years after the underlying patent applications were filed.

Although Exelixis I supports this argument on the merits, a different judge of the U.S. District Court for the Eastern District of Virginia (Judge Brinkema) upheld the USPTO’s interpretation of 35 USC § 154(b)(3)(B) in Exelixis II. That decision is not cited in the complaint.

Appeals of the Exelixis IExelixis II and Novartis PTA decisions are pending at the Federal Circuit.

Stays for Judicial Economy

The appeal in Novartis may decide whether Plaintiffs are even permitted to bring this suit, or if their complaint was filed too late. The appeals in Exelixis I and Exelixis II may decide whether Plaintiffs have a cause of action on the merits. Perhaps Plaintiffs and the USPTO will ask the court to stay this case while those appeals are heard, to save everyone time and money and conserve precious judicial resources.

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