Category Archives: District Court Decisions

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District Court Dismisses USPTO December 2015 Holidays Case

On December 2, 2016, Judge O’Grady of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the complaint brought by Elm 3DS Innovations, LLC over the “holidays” declared December 22-24, 2015 when the USPTO experienced a power outage that impacted its electronic filing systems. The decision may leave other … Continue reading this entry

District Court Denies Extra Patent Term Adjustment When National Stage Entry Date Falls On A Holiday

Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a U.S. national stage application when the 30-month national stage entry days falls on a Federal holiday? Judge O’Grady of the … Continue reading this entry

Judge Grants Gilead Motion To Invalidate Remicade Patent For Obviousness-Type Double Patenting

The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors” including “intellectual property considerations.” The pending biosimilar patent litigation got one step closer to resolution last week when Judge Wolf of the U.S. District Court for the District of Massachusetts … Continue reading this entry

Apotex Biosimilar Cleared Of Infringement But Pre-Marketing Notice Still Required

In what may be the first decision on the merits in a patent infringement suit brought under the Biologics Price Competition and Innovation Act (BPCIA), the U.S. District Court for Southern District of Florida has found that the method of making the Apotex biosimilar versions of Amgen’s Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) products does not infringe the asserted … Continue reading this entry

Magistrate Judge Nixes TB Test Kit Claims

In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent eligibility requirement of 35 USC § 101, but declined to reach the same conclusion with regard to related method claims. The decision … Continue reading this entry

District Court Upholds Eligibility Of Personalized Medicine Method Claims For FANAPT

In Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., Judge Sleet of the U.S. District Court for the District of Delaware upheld the patent eligibility of personalized medicine method claims related to Vanda’s FANAPT® (iloperidone) product for treating schizophrenia. The claims recite a diagnostic step as well as a treatment step, and were found to recite “significantly … Continue reading this entry

Court Invalidates Improper Multiple Dependent Claims

In Trustees of the University of Pennsylvania v. Eli Lilly and Co., the U.S. District Court for the Eastern District of Pennsylvania refused to correct improper multiple dependent claims and instead held them invalid under 35 U.S.C. § 112, ¶ 5, and therefore not infringed. While some may consider improper multiple dependent claims as failing … Continue reading this entry

District Court Applies Mayo To Treatment Claims But Denies Motion To Dismiss BMS Keytruda Litigation

The U.S. District Court for the District of Delaware accepted Merck’s arguments that method of treatment patents asserted by BMS against its Keytruda product “touch[] upon a natural phenomenon” such that they should be analyzed under the Mayo/Alice patent eligibility framework. However, in view of disputed issues of fact, the presumption of validity, and other presumptions arising from … Continue reading this entry

Court Can't Review Policy Behind Patent Term Adjustment Statute

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 … Continue reading this entry

Will the Federal Circuit Invalidate 13,500 Continuation Patents?

The Federal Circuit is set to hear oral arguments in Immersion Corp. v. HTC Corp. on May 6, 2016. According to the amicus brief filed on behalf of the United States, if the court affirms the district court decision “over 13,500” continuation patents could be invalidated. According to the amicus brief filed by the Intellectual Property Owners … Continue reading this entry

District Court Invalidates Cleveland Clinic Diagnostic Patents On Motion To Dismiss

Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the result is not surprising in view of recent patent eligibility decisions, it serves as reminder of the real-world impact of recent Supreme … Continue reading this entry

Patent Term Adjustment Versus Double Patenting

In Magna Electronics, Inc. v. TRW Automotive Holdings Corp., No. 1:12-cv-654; 1:13-cv-324 (Dec. 10, 2015), Judge Maloney of the U.S. District Court for the Western District of Michigan granted TRW’s motion for partial summary judgement of invalidity based on obviousness-type double patenting over a later-granted child patent. While it was only a matter of time before … Continue reading this entry

Biosimilar Pre-Marketing Notice Always Required

Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the statute requires a biosimilar applicant to give 180 days’ pre-marketing notice after FDA approval even if it has engaged in the BPCIA’s patent … Continue reading this entry

Divided Infringement Between Doctor And Patient

Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the pharmaceutical context, where a patient self-administers a drug. In Eli Lilly and Company v. Teva Parenteral Medicines, Inc., … Continue reading this entry

Court Won't Review USPTO Denial Of Inter Partes Review

In a decision issued on April 18, 2014, Judge Payne of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the case brought by Dominion Dealer Solutions, LLC to challenge the USPTO’s decisions denying petitions to institute inter partes review of five patents granted to Autoalert, Inc. As I predicted in this … Continue reading this entry

Delayed Restriction Requirement Does Not Result In Patent Term Adjustment For Divisional Application

In Mohsenzadeh v. Lee (decided March 19, 2014), the U.S. District Court for the Eastern District of Virginia held that the Patent Term Adjustment (PTA) statute does not provide PTA to a divisional application when the USPTO takes longer than 14 months to issue a Restriction Requirement in the parent application. While this decision is not surprising, … Continue reading this entry

District Court Sides With USPTO On Patent Term Adjustment

In Abraxis Bioscience, LLC v. Kappos, Civil Action No. 1:11-cv-00730., (D.D.C. Jan. 08, 2014), Judge Howell of the U.S. District Court for the District of Colombia upheld the USPTO’s interpretation of the Patent Term Adjustment (PTA) statute that relates to the impact that a Request for Continued Examination (RCE) has on a PTA award.  This decision … Continue reading this entry

District Court Again Rejects Equitable Tolling For Patent Term Adjustment Case

In Daiichi Sankyo Co. v. Rea (D. D.C. Dec. 3, 2013), the U.S. District Court for the District of Columbia rejected the plaintiff’s arguments that equitable tolling should apply to permit its claim for additional Patent Term Adjustment (PTA) under Wyeth. In so doing, the court followed much of the reasoning in Novartis AG v. Kappos … Continue reading this entry

District Court Upholds USPTO Patent Term Adjustment Deduction For Information Disclosure Statement

In Gilead Sciences, Inc. v. Rea, the U.S. District Court for the Eastern District of Virginia upheld the USPTO Patent Term Adjustment (PTA) rule that provides for a PTA deduction when an applicant files a “supplemental reply or other paper” after a reply has been filed. In the case at issue, the applicant had filed … Continue reading this entry

Myriad Preliminary Injunction Hearing To Be Held September 11, 2013

The hearing on Myriad’s motion for a preliminary injunction against Ambry Genetics is scheduled for September 11, 2013, before Judge Robert A. Shelby at the U.S. District Court for the Central District of Utah. The primary question before the court is whether it should issue a preliminary injunction to stop Ambry from selling its allegedly … Continue reading this entry

District Court Refuses To Review USPTO Decision To Institute Post Grant Review Of Versata Covered Business Method Patent

In Versata Development Corp. v. Rea, the U.S. District Court for the Eastern District of Virginia dismissed Versata’s challenge of the PTAB’s decision to institute post grant review of its patent for lack of jurisdiction. The court based its decision on alternative grounds, finding that the America Invents Act (AIA) “precludes judicial review of the … Continue reading this entry

The Patent Term Adjustment Pendulum Swings The Other Way

On January 28, 2013, Judge Brinkema of the U.S. District Court for the Eastern District of Virginia issued a decision in a different Exelixis v. Kappos Patent Term Adjustment (PTA) case (1:12cv574) (Exelixis II) that affirms the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(i). Judge Brinkema’s decision in Exelixis II is in direct conflict with … Continue reading this entry

USPTO Appeals Exelixis Patent Term Adjustment Decision

As expected, the USPTO has filed a Notice of Appeal in the Exelixis patent term adjustment (PTA) case. As I summarized in this article, in a decision issued November 1, 2012 in Exelixis, Inc. v. Kappos, the U.S. District Court for the Eastern District of Virginia found that the USPTO’s interpretation and application of the … Continue reading this entry

District Court Denies Equitable Tolling, Fifth Amendment Taking In Novartis Patent Term Adjustment Case

In another significant Patent Term Adjustment (PTA) case decided last week (Novartis AG v. Kappos, Civ. Action No. 10-cv-1138 (Nov. 15, 2012)), the U.S. District Court for the District of Columbia found that Novartis could benefit from “ordinary tolling” but not “equitable tolling” in its efforts to obtain additional PTA for 23 patents. This decision by … Continue reading this entry