Posts Tagged: "patent term adjustment"

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision today in In re Cellect holding that patent term extension (PTE) and patent term adjustment (PTA) are not the same for purposes of an obviousness-type double patenting (ODP) analysis. Specifically, the court said that “ODP for a patent that has received PTA, regardless whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added.” The opinion was authored by Judge Lourie.

Patent Term Adjustment (PTA) was designed to serve an important purpose – to compensate patentees for time lost during examination due to U.S. Patent and Trademark Office (USPTO) delays. Most industries rely heavily on their patent portfolios to drive business strategies that ultimately impact their bottom line. The impact of patent term is especially acute in the pharmaceutical and biotechnology industries, where companies spend billions of dollars to develop new drugs. For these companies, every day that their patent is in force matters, generating millions in additional revenue. With so much at stake, companies strive to accrue all the patent term they are entitled to under the current statutory regime, including by way of PTA.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Monday said the U.S. Patent and Trademark Office (USPTO) properly deducted days from a patentee’s Patent Term Adjustment (PTA) under Supernus Pharms., Inc. v. Iancu because there were clear steps the applicant could have taken to conclude prosecution. Eurica Califorrniaa owns U.S. Patent 10,245,075 for a “Nondestructive means of ectopic pregnancy management.” Following a lengthy prosecution, the examiner made an amendment indicating minor additional changes to the claim language and issued a notice of allowance on December 11, 2018. Califorrniaa requested an additional interview on January 7, 2019, and included a new proposed amendment.

The United States Patent and Trademark Office (USPTO) is overestimating the term of some of the patents it issues. The general rule is that a patent expires 20 years after the priority date of the application. This rule means that the longer the USPTO is processing an application, the fewer days of term the patent will enjoy if granted. To prevent substantial decrease in the term, Congress instructed the USPTO to extend the life of patents that have suffered delays during prosecution. This extension is known as Patent Term Adjustment (PTA). In addition, Congress burdened the agency with telling the patent applicants how much PTA they are entitled to. To tackle the resulting workload, the USPTO designated the task of applying complex PTA rules to a computer software.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday issued a precedential decision affirming a Virginia district court’s grant of summary judgment for the U.S. Patent and Trademark Office (USPTO) with respect to SawStop Holding LLC’s challenge of the denial of patent term adjustment (PTA) for two of its patents. The CAFC agreed with the district court that PTA was not warranted because the claim at hand did not issue under a decision that reversed an adverse determination of patentability. Instead, “‘the claim remain[ed] under rejection after the Board decision’ and ‘the patent only issue[d] after further prosecution’ and amendment.”

Today, the U.S. Patent and Trademark Office (USPTO) published a notice of proposed rulemaking (NPRM) in the Federal Register announcing that the agency would be revising its rules of practice to require that information disclosure statements related to patent term adjustments (PTAs) be submitted on Form PTO/SB/133. The use of this document is expected to streamline communications between the USPTO and patent applicants regarding delays in patent prosecution and also save agency resources by reducing manual review of PTA statements and leveraging information technology (IT) resources at the agency for automatically detecting and reviewing such statements.

On June 16, the USPTO published a final rule in the Federal Register revising the rules of practice regarding patent term adjustments in light of the U.S. Court of Appeals for the Federal Circuit’s (CAFC) 2019 decision in Supernus Pharmaceuticals v. Iancu, which held that reductions to patent term adjustments must be equal to the time in which the applicant failed to make reasonable efforts to conclude processing or examination of an application.

This week in Other Barks & Bites: the Federal Circuit issued a pair of precedential opinions affirming the USPTO’s determinations on patent term adjustment; Chuck Yeager filed a trademark lawsuit against Airbus; Facebook CEO Mark Zuckerberg met with Capitol Hill lawmakers and President Trump; the Office of Technology Assessment Improvement and Enhancement Act was introduced into both houses of Congress; the Sixth Circuit affirmed the dismissal of a copyright case lodged against musician Steve Winwood; the U.S. Department of Justice announced criminal charges over the theft of pediatric medicine trade secrets; and the NMPA doubled the damages sought against Peloton after finding more unlicensed songs used by the streaming exercise companies.

Last week, the U.S. Court of Appeals for the Federal Circuit reversed a ruling of the U.S. District Court for the Eastern District of Virginia, which had affirmed a patent term adjustment (PTA) calculation of the United States Patent and Trademark Office (USPTO). See Supernus Pharmaceuticals, Inc. v. Iancu, No. 2017-1357 (January 23, 2019). The Federal Circuit held that the USPTO cannot count as applicant delay any period of time during which there was no possible action that the applicant could take to reasonably conclude prosecution. A sensible ruling, and one the panel explained was entirely consistent with both the PTA statute and Gilead Sciences, Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015). “A period of time including no identifiable efforts that could have been undertaken cannot be ‘equal to’ the period of failure to undertake reasonable efforts under the terms of the statute,” wrote Judge Reyna.

The Federal Circuit found that Actelion was required to make an express request to commence early national stage examination. Actelion’s statement “earnestly soliciting early examination,” which made no reference to § 371(f), the PCT, or the national stage, combined with failure to check the box expressly requesting early examination, was an “inconsistent or ambivalent request.” While Actelion was not required to check any boxes, it was still required to make its intentions clear. Thus, the district court did not err in affirming the PTO’s finding that Actelion failed to make an express request for early examination. The Federal Circuit also found no error in the PTO’s determination that the national stage commenced on January 17, 2012, the next workday after a 30-month date that fell on a federal holiday.

Pfizer argued that the original restriction requirement, because it was incomplete, created a delay by failing to provide Pfizer with adequate notice of the basis for rejecting its claims. The District Court ruled that the initial restriction requirement, while arguably incomplete, did in fact place Pfizer on notice of grounds for rejecting its claims, therefore satisfying § 132 and justifying denial of additional term adjustments. The Federal Circuit affirmed.

In this issue of the Federal Circuit Review: (1) Damages for Lost Profits May Not Be Based On Extraterritorial Services Performed by an Infringer’s Customers Under § 271(f); (2) Federal Circuit Invalidates Claims Under the On-Sale Bar for Commercial Exploitation of the Invention Before the Critical Date; and (3) The PTO’s 180-Day Filing Deadline of the Optional Interim Procedure for PTA Reconsideration Request Is Not Arbitrary and Capricious.

In this issue of the Federal Circuit Review: (1) Bad Lawyering Is Not Misconduct For Awarding Attorneys Fees; (2) Continuing Applications Are not Entitled to Patent Term Adjustment for Delay in the Prosecution of the Parent Application.